UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

(Mark One)

[X]

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended December 31, 20192020

 

Or

[  ]

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period _______ to _______

 

Commission file number 000-56008

[new001.jpg]

PREDICTIVE TECHNOLOGY GROUP, INC.

(Exact name of registrant as specified in its charter)

Nevada

 

90-1139372

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. employer identification number)

 

 

 

2735 Parleys Way, Suite 205, Salt Lake City, Utah

 

84109

(Address of principal executive offices)

 

(Zip Code)

+1 (888) 407-9761

(Registrant’sRegistrant's telephone number, including area code)

 

-i-

Securities registered pursuant to Section 12(g) of the Exchange Act:

 

Title of each class

Common Stock, $.001 Par Value Per Share


-i-


Indicate by check whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X ] No [ ] 

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large"large accelerated filer,” “accelerated" "accelerated filer,” “smaller" "smaller reporting company”company" and “emerging"emerging growth company”company" in Rule 12b-2 of the Exchange Act. (Check one):

 

Larger Accelerated Filer [  ]

Accelerated Filer [  ]

Non-Accelerated Filer [  ] (Do not check if a smaller reporting company)

Smaller Reporting Company [X]

Emerging growth company [  ]

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

 

The number of shares of Predictive common stock outstanding as of February 14, 202015, 2021 was 295,936,766.299,596,808.

-ii-


PREDICTIVE TECHNOLOGY GROUP, INC.

QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED DECEMBER 31, 20192020

 

INDEX

 

PART I - FINANCIAL INFORMATION

 

Item 1.

Financial Statements

2

 

 

 

 

Unaudited Condensed Consolidated Balance Sheets as of December 31, 20192020 and June 30, 20192020

2

 

 

 

 

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended December 31, 20192020 and 20182019

3

 

 

 

 

Unaudited Condensed Consolidated Statements of Cash Flows for the three and six months ended December 31, 20192020 and 20182019

4-54

 

 

 

 

Unaudited Condensed Consolidated Statements of Stockholders’Stockholders' Equity for the three and six months ended December 31, 20192020 and 20182019

6

 

 

 

 

Unaudited Notes to Condensed Consolidated Financial Statements

7

 

 

 

Item 2.

Management’sManagement's Discussion and Analysis of Financial Condition and Results of Operations

4126

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

5533

 

 

 

Item 4.

Controls and Procedures

5533

 

 

 

 

PART II - OTHER INFORMATION

5635

Item 1.

Legal Proceedings

5635

 

 

 

Item 1A.

Risk Factors

5736

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

5736

 

 

 

Item 3.

Defaults Upon Senior Securities

5836

 

 

 

Item 4.

Mine Safety Disclosures

5836

 

 

 

Item 5.

Other Information

5836

 

 

 

Item 6.

Exhibits

5936

-1-

PART I - FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

As of

 

As of

 

December 31,

  

June 30,

 

December 31,

 

June 30,

 

2019

  

2019

 

2020

 

2020

ASSETS

ASSETS

 

    

ASSETS

 

   

Current assets:

Current assets:

 

  

 

 

Current assets:

 

 

 

 

Cash

$

255,502

 

$

1,618,244

Cash

$

134,376

$

331,228

Accounts receivable, net of allowance for doubtful accounts

of $864,331 and $687,064

 

437,377

  

1,250,476

Accounts receivable, net of allowance for doubtful accounts

of $187,502 and $239,392

 

318,712

 

136,903

Due from equity method investee

 

-

  

184,443

Inventory

 

594,467

 

1,514,841

Inventory

 

3,845,101

  

5,775,185

Other current assets

 

5,341,657

 

5,720,561

Other current assets

 

217,224

  

103,080

Total current assets

Total current assets

 

4,755,204

  

8,931,428

Total current assets

 

6,389,212

 

7,703,533

Fixed assets, net of depreciation

 

6,156,360

  

6,974,441

Property, plant, and equipment, net

Property, plant, and equipment, net

 

4,572,873

 

5,305,099

Operating lease right of use assets

Operating lease right of use assets

 

1,528,163

  

-

Operating lease right of use assets

 

684,100

 

1,115,308

License agreements, net of amortization

License agreements, net of amortization

 

17,063,522

  

18,062,315

License agreements, net of amortization

 

15,034,027

 

16,064,728

Patents, net of amortization

Patents, net of amortization

 

6,468,137

  

6,850,490

Patents, net of amortization

 

5,726,034

 

6,085,785

Trade secrets, net of amortization

Trade secrets, net of amortization

 

42,307,169

  

45,336,335

Trade secrets, net of amortization

 

25,741,436

 

29,236,447

Other intangible assets, net of amortization

Other intangible assets, net of amortization

 

337,526

  

383,931

Other intangible assets, net of amortization

 

259,764

 

295,788

Equity method investments

Equity method investments

 

35,329,167

  

51,717,719

Equity method investments

 

11,987,558

 

12,731,383

Goodwill

Goodwill

 

5,254,451

  

5,254,451

Goodwill

 

             -

 

5,254,451

Other long-term assets

Other long-term assets

 

14,543

  

67,075

Other long-term assets

 

57,468

 

49,893

Total assets

Total assets

$

119,214,242

 

$

143,578,185

Total assets

$

70,452,472

$

83,842,415

LIABILITIES AND STOCKHOLDERS' EQUITY

LIABILITIES AND STOCKHOLDERS' EQUITY

 

  

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

Current liabilities:

Current liabilities:

 

  

 

 

Current liabilities:

 

 

 

 

Accounts payable

Accounts payable

$

3,823,829

 

$

4,943,178

Accounts payable

$

6,192,005

$

4,988,319

Accrued liabilities

Accrued liabilities

 

1,931,818

  

1,857,771

Accrued liabilities

 

7,515,817

 

8,046,814

Deferred revenue

Deferred revenue

 

512,280

  

469,376

Deferred revenue

 

748,017

 

381,889

Operating lease liability, current portion

Operating lease liability, current portion

 

859,442

  

-

Operating lease liability, current portion

 

716,343

 

914,473

Finance lease liability, current portion

Finance lease liability, current portion

 

646,020

  

504,488

Finance lease liability, current portion

 

666,879

 

649,492

Notes payable, current portion

Notes payable, current portion

 

6,364,309

 

705,234

Subscription payable, current portion

Subscription payable, current portion

 

2,155,000

  

6,300,000

Subscription payable, current portion

 

7,206,610

 

5,150,000

Total current liabilities

Total current liabilities

 

9,928,389

  

14,074,813

Total current liabilities

 

29,409,980

 

20,836,221

Operating lease liability

 

714,713

  

-

Finance lease liability

 

1,189,104

  

1,511,554

Subscription payable

 

7,531,610

  

4,040,610

Notes payable

 

10,080,000

  

400,000

Operating lease liability, net of current portion

Operating lease liability, net of current portion

 

-

 

243,378

Finance lease liability, net of current portion

Finance lease liability, net of current portion

 

516,855

 

861,613

Notes payable, net of current portion

Notes payable, net of current portion

 

2,211,910

 

4,465,985

Subscription payable, net of current portion

Subscription payable, net of current portion

 

-

 

2,056,610

Deferred tax liabilities

Deferred tax liabilities

 

1,536,445

  

11,014,745

Deferred tax liabilities

 

300,896

 

300,896

Other non-current liabilities

Other non-current liabilities

 

131,627

 

154,430

Total liabilities

Total liabilities

 

30,980,261

  

31,041,722

Total liabilities

 

32,571,268

 

28,919,133

 

  

 

 

 

 

 

 

Stockholders' equity:

Stockholders' equity:

 

  

 

 

Stockholders' equity:

 

 

 

 

Common stock, par value $0.001, 282,985,560 and 273,761,955

     

shares issued and outstanding at December 31, 2019 and

     

June 30, 2019; 900,000,000 shares authorized

 

282,986

  

273,762

Common stock, par value $0.001, 299,596,808

Common stock, par value $0.001, 299,596,808

    

shares issued and outstanding at December 31, 2020 and June 30,

shares issued and outstanding at December 31, 2020 and June 30,

    

2020, respectively; 900,000,000 shares authorized

2020, respectively; 900,000,000 shares authorized

 

299,597

 

299,597

Additional paid-in capital

Additional paid-in capital

 

163,224,275

  

153,604,830

Additional paid-in capital

 

187,449,292

 

181,862,823

Accumulated deficit

Accumulated deficit

 

(74,970,125)

  

(41,102,849)

Accumulated deficit

 

(149,436,980)

 

(126,872,115)

Total controlling interest

Total controlling interest

 

88,537,136

  

112,775,743

Total controlling interest

 

38,311,909

 

55,290,305

Non-controlling interest

Non-controlling interest

 

(303,155)

  

(239,280)

Non-controlling interest

 

(430,705)

 

(367,023)

Total stockholders' equity

Total stockholders' equity

 

88,233,981

  

112,536,463

Total stockholders' equity

 

37,881,204

 

54,923,282

Total liabilities and stockholders' equity

Total liabilities and stockholders' equity

$

119,214,242

 

$

143,578,185

Total liabilities and stockholders' equity

$

70,452,472

$

83,842,415

 See accompanying notes 

-2-


PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE LOSS

 

Three months ended December 31,

 

Six months ended December 31,

Three months ended December 31,

 

Six months ended December 31,

2019

 

2018

 

2019

 

2018

2020

 

2019

 

2020

 

2019

Revenue

$

7,336,640

$

10,687,036

$

15,595,898

$

18,750,838

$4,067,488$7,336,640$9,158,492$15,595,898

Cost of goods sold, exclusive of depreciation & amortization shown below

 

5,840,256

  

3,059,136

 

 

13,022,246

  

6,107,692

 

 2,828,692

5,840,256

6,293,829

13,022,246

            

Operating expenses:

 

          

 

 

Selling and marketing

 

3,049,593

  

3,431,157

  

6,201,563

  

5,838,593

 

 872,156

3,049,593

1,933,954

6,201,563

General and administrative

 

7,034,770

  

2,878,614

  

13,413,647

  

5,544,762

 

4,910,346

7,034,770

10,167,845

13,413,647

Research and development

 

2,364,350

  

1,759,560

  

4,192,700

  

2,365,644

 

 557,381

2,364,350

928,223

4,192,700

Depreciation and amortization

 

2,775,073

  

2,035,360

  

5,385,318

  

3,701,082

 

1,751,562

2,775,073

4,235,645

5,385,318

Loss on impairment

 

-

-

7,015,326

-

Total operating expenses

 

15,223,786

  

10,104,691

  

29,193,228

  

17,450,081

 

8,091,445

15,223,786

24,280,993

29,193,228

 

          

 

 

Operating loss

 

(13,727,402)

  

(2,476,791)

  

(26,619,576)

  

(4,806,935)

 

(6,852,649)

(13,727,402)

(21,416,330)

(26,619,576)

 

          

 

 

Loss on equity method investment

 

(16,249,252)

  

(600,116)

  

(16,388,552)

  

(914,898)

Interest income (expense)

 

(297,736)

  

489

  

(371,218)

  

912

Gain (loss) on equity method investment

 

26,020

(16,249,252)

(743,825)

(16,388,552)

Interest expense

 

(304,774)

(297,736)

(483,658)

(371,218)

Gain on disposal of asset

 

-

-

21,318

-

Total other loss

 

(16,546,988)

  

(599,627)

  

(16,759,770)

  

(913,986)

 

(278,754)

(16,546,988)

(1,206,165)

(16,759,770)

 

          

 

 

Loss before income taxes

 

(30,274,390)

  

(3,076,418)

  

(43,379,346)

  

(5,720,921)

 

(7,131,403)

(30,274,390)

(22,622,495)

(43,379,346)

 

          

 

 

Benefit from income taxes

 

4,239,780

  

713,526

  

9,448,195

  

1,325,978

Benefit from (provision for) income taxes

 

(5,000)

4,239,780

(6,052)

9,448,195

 

          

 

 

Net loss & comprehensive loss

$

(26,034,610)

 

$

(2,362,892)

 

$

(33,931,151)

 

$

(4,394,943)

$

(7,136,403)

$

(26,034,610)

$

(22,628,547)

$

(33,931,151)

 

          

 

 

Net loss non-controlling interest

 

(31,941)

  

(33,454)

  

(63,875)

  

(61,123)

Net loss attributable to non-controlling interest

 

(31,602)

(31,941)

(63,682)

(63,875)

            

Net loss attributable to common shareholders

$

(26,002,669)

 

$

(2,329,438)

 

$

(33,867,276)

 

$

(4,333,820)

$

(7,104,801)

$

(26,002,669)

$

(22,564,865)

$

(33,867,276)

           

 

 

Weighted average common shares outstanding, basic & diluted

 

283,126,298

  

263,278,417

  

282,203,748

  

258,672,982

 

299,596,808

283,126,298

299,596,808

282,203,748

 

          

 

 

Basic & diluted loss per share attributable to common shareholders

$

(0.09)

 

$

(0.01)

 

$

(0.12)

 

$

(0.02)

$

(0.02)

$

(0.09)

$

(0.08)

$

(0.12)


See accompanying notes

-3-

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

  

Six months ended December 31,

Six months ended December 31,

2019

 

2018

2020

2019

        

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

$

(33,931,151)

$

(4,394,943)

$

(22,628,547)

$

(33,931,151)

Adjustments to reconcile net loss to net cash provided by (used

in) operating activities:

 

 

Depreciation and amortization

5,385,318

3,700,091

 

4,235,645

5,385,318

Provision for bad debts

177,560

-

Loss on impairment

 

7,015,326

-

Provision for (recovery of) bad debts

 

(51,890)

177,560

Share based compensation

9,628,669

1,982,854

 

5,586,469

9,628,669

Deferred income taxes

(9,478,300)

(1,325,978)

 

-

(9,478,300)

Non-cash lease expense

329,515

-

 

431,208

           329,515

Losses on equity method investment

16,388,552

914,898

 

743,825

16,388,552

Changes in operating assets and liabilities:

 

 

Accounts receivable

635,982

(29,650)

 

(129,919)

635,982

Inventory

1,930,084

(121,072)

 

920,374

1,930,084

Prepaid expenses

(114,144)

(21,309)

Other assets

52,532

(6,569)

 

371,329

(61,612)

Accounts payable

(707,469)

1,345,996

 

1,163,208

(707,469)

Accrued liabilities

74,047

14,315

 

(553,800)

74,047

Operating lease liability

(329,067)

-

 

(441,508)

          (329,067)

Deferred revenue

42,904

-

 

366,128

            42,904

Net cash provided by (used in) operating activities

 

(9,914,968)

2,058,633

Net cash used in operating activities

 

(2,972,152)

(9,914,968)

 

 

Cash flows from investing activities:

 

 

Purchases of property and equipment

(476,856)

(1,204,756)

 

(299,951)

(476,856)

Cash acquired from acquisitions, net

-

799,980

Cash payments on equity method investee stock subscription

(470,000)

(1,184,392)

 

-

(470,000)

Capitalization of patent acquisition costs

-

(140,675)

Net cash used in investing activities

 

(946,856)

(1,729,843)

 

(299,951)

(946,856)

 

 

 

Cash flows from financing activities:

 

 

Cash proceeds from stock subscriptions

-

1,025,000

Proceeds from issuance of promissory notes and borrowings on revolving line of credit

9,680,000

-

 

3,405,000

       9,680,000

Principal payments on finance leases

(180,918)

-

 

(329,749)

        (180,918)

Net cash provided by financing activities

 

9,499,082

1,025,000

 

3,075,251

9,499,082

 

 

Net increase (decrease) in cash and cash equivalents

 

(1,362,742)

1,353,790

Net decrease in cash and cash equivalents

 

(196,852)

(1,362,742)

Cash and cash equivalents at the beginning of the period

 $

1,618,244

$

1,206,139

$

331,228

$

1,618,244

Cash and cash equivalents at the end of the period

$

255,502

$

2,559,929

$

134,376

$

255,502


(Continued)

-4-


PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

The following is a summary of supplemental cash flow activities:

     

 

 

Six months ended December 31,

 

 

2019

 

2018

Warrants issued for trade secrets

$

-

$

13,860,000

Common stock issued for the acquisition of InceptionDX, LLC

 

-

 

14,260,000

Revaluation of warrants issued for licenses

 

-

 

(4,449,213)

Reduction in number of equity method investee units subscribed

 

-

 

(1,850,000)

Common stock issued and deferred tax liabilities assumed for the acquisition of Regenerative Medical Technologies, Inc.

 

-

 

12,266,667

Right-of-use assets obtained in exchange for new operating lease liabilities

 

1,903,222

 

-

     

 

 

Six months ended December 31,

 

 

2020

 

2019

Right-of-use assets obtained in exchange for new operating lease liabilities

 $

-

$

1,903,222

Capital expenditures in accounts payable

 

136,955

 

-

Finance lease payments in accounts payable

 

143,172

 

-

 

See accompanying notes

(Concluded)


-5-

PREDICTIVE TECHNOLOGY GROUP, INC.

-5-

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’STOCKHOLDERS' EQUITY

 

Common Stock

 

Additional

 

Subscription

 

Non-Controlling

 

Accumulated

 

Stockholders’

 

Shares

 

Amount

 

Paid in Capital

 

Receivable

 

Interest

 

Deficit

 

Equity

BALANCES AT JUNE 30, 2018

247,624,069

  $

247,624

  $

108,049,300

  $

(1,025,000)

  $

(120,152)

  $

(25,813,957)

  $

81,337,815

Common stock issued for acquisition of InceptionDX, LLC

15,500,000

 

15,500

 

14,244,500

       

14,260,000

Common stock issued for services

50,000

 

50

 

43,450

       

43,500

Common stock cancelled

(1,200,000)

 

(1,200)

 

1,200

       

-

Warrants issued for trade secrets

    

13,860,000

       

13,860,000

Cash received from common stock subscriptions

      

325,000

     

325,000

Share based compensation

    

928,846

       

928,846

Net loss

        

(27,669)

 

(2,004,382)

 

(2,032,051)

BALANCES AT SEPTEMBER 30, 2018

261,974,069

  $

261,974

  $

137,127,296

  $

(700,000)

  $

(147,821)

  $

(27,818,339)

  $

108,723,110

Common stock issued for acquisition of Regenerative Medical Technologies, Inc.

10,000,000

 

10,000

 

9,190,000

       

9,200,000

Share based compensation

    

1,010,505

       

1,010,505

Revaluation of warrants issued for licenses

    

(4,449,211)

       

(4,449,211)

Cash received from common stock subscriptions

      

700,000

     

700,000

Net loss

        

(33,454)

 

(2,329,438)

 

(2,362,892)

BALANCES AT   DECEMBER 31, 2018

271,974,069

  $

271,974

  $

142,878,590

  $

-

  $

(181,275)

  $

(30,147,777)

  $

112,821,512

              
 

Common Stock

 

Additional

 

Subscription

 

Non-Controlling

 

Accumulated

 

Stockholders’

 

Shares

 

Amount

 

Paid in Capital

 

Receivable

 

Interest

 

Deficit

 

Equity

BALANCES AT JUNE 30, 2019

273,761,955

$

273,762

$

153,604,830

$

-

$

(239,280)

$

(41,102,849)

$

112,536,463

Share based compensation

    

4,994,600

       

4,994,600

Cashless exercise of warrants

9,223,605

 

9,224

 

(9,224)

       

-

Net loss

        

(31,934)

 

(7,864,607)

 

(7,896,541)

BALANCES AT SEPTEMBER 30, 2019

282,985,560

$

282,986

$

158,590,206

$

-

$

(271,214)

$

(48,967,456)

$

109,634,522

Share based compensation

    

4,634,069

       

4,634,069

Net Loss

        

(31,941)

 

(26,002,669)

 

(26,034,610)

BALANCES AT   DECEMBER 31, 2019

282,985,560

  $

282,986

  $

163,224,275

  $

-

  $

(303,155)

  $

(74,970,125)

  $

88,233,981

 

Common Stock

 

Additional

 

Non-Controlling

 

Accumulated

 

Stockholders'

 

Shares

 

Amount

 

Paid in Capital

 

Interest

 

Deficit

 

Equity

BALANCES AT JUNE 30, 2019

273,761,955

$

273,762

$

153,604,830

$

(239,280)

$

(41,102,849)

$

112,536,463

Share based compensation

    

4,994,600

     

4,994,600

Cashless exercise of warrants

9,223,605

 

9,224

 

(9,224)

      

Net loss

   

(31,934)

 

(7,864,607)

 

(7,896,541)

BALANCES AT SEPTEMBER 30, 2019

282,985,560

$

282,986

$

158,590,206

$

(271,214)

$

(48,967,456)

$

109,634,522

Share based compensation

    

4,634,069

     

4,634,069

Net Loss

      

(31,941)

 

(26,002,669)

 

(26,034,610)

BALANCES AT DECEMBER 31, 2019

282,985,560

 $

282,986

 $

163,224,275

 $

(303,155)

 $

(74,970,125)

 $

88,233,981

            
 

Common Stock

 

Additional

 

Non-Controlling

 

Accumulated

 

Stockholders'

 

Shares

 

Amount

 

Paid in Capital

 

Interest

 

Deficit

 

Equity

BALANCES AT JUNE 30, 2020

299,596,808

$

299,597

$

181,862,823

$

(367,023)

$

(126,872,115)

$

54,923,282

Share based compensation

    

2,936,580

     

2,936,580

Net loss

      

(32,080)

 

(15,460,064)

 

(15,492,144)

BALANCES AT SEPTEMBER 30, 2020

299,596,808

$

299,597

$

184,799,403

$

(399,103)

$

(142,332,179)

$

42,367,718

Share based compensation

    

2,649,889

     

2,649,889

Net Loss

      

(31,602)

 

(7,104,801)

 

(7,136,403)

BALANCES AT   DECEMBER 31, 2020

299,596,808

 

299,597

 

187,449,292

 

(430,705)

 

(149,436,980)

$

37,881,204

 

See accompanying notes



-6-


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1- BUSINESS DESCRIPTION AND SIGNIFICANT ACCOUNTING POLICIES

BUSINESS DESCRIPTION:

Predictive Technology Group, Inc., together with its subsidiaries (collectively, “PTG”, “Predictive”"PTG" or the “Company”"Company"), develops and commercializes discoveries and technologies involved in novel molecular diagnostic, therapeutic, and Human Cellular and Tissue-Based Products (“("HCT/Ps”Ps"). The Company uses this information as the cornerstone in the development of new diagnostics that assess a person’sperson's risk of disease and develop pharmaceutical therapeutics and HCT/Ps for use by healthcare professionals to improve outcomes in their patients.  The Company’sCompany's corporate headquarters are located in Salt Lake City, Utah.

SEGMENT INFORMATION:

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance.  The Company operates in two reportable segments, which are differentiated by product.  The HCT/P segment offers minimally manipulated tissue products intended for homologous use, prepared utilizing proprietary extraction methods that reduce the loss of important scaffolding, growth factors and cytokines.  The Company’sCompany's Diagnostics and Therapeutics segment uses data analytics for disease identification and subsequent therapeutic intervention through novel gene-based diagnostics, and companion therapeutics. Lastly, the “Unallocated Corporate”"Unallocated Corporate" column in the table below represents those headquarters activities that do not qualify as operating segments and which are not allocated to operating segments in information provided to the CODM. We currently operate and sell our products exclusively in the United States.

During the fourth quarter of 2019, we realigned our segment reporting to separately present headquarters costs inSegment information available to the CODM.  The presentation of the comparative information has been recast to conform to the 2019 presentation.

-7-

Segment revenue and operating income (loss)werewas as follows during the periods presented:

         

 

HCT/Ps

Diagnostics & Therapeutics

 

Unallocated Corporate

Total

 

HCT/Ps

Diagnostics & Therapeutics

 

Unallocated Corporate

Total

Three months ended December 31, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

$

2,654,565

$

1,412,923

$

-

$

4,067,488

Depreciation and amortization

 

 

192,201

 

1,469,968

 

89,393

 

1,751,562

Share based compensation

 

 

445,733

 

140,769

 

2,063,387

 

2,649,889

Segment operating loss

 

 

(2,407,999)

 

(2,137,781)

 

(2,306,869)

 

(6,852,649)

Three months ended December 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

7,289,265

$

47,375

$

 -

$

7,336,640

 

$

              7,289,265

$

47,375

$

-

$

7,336,640

Depreciation and amortization

 

 

937,923

 

1,756,560

 

80,590

 

2,775,073

 

 

                 937,923

 

1,756,560

 

80,590

 

2,775,073

Share based compensation

 

 

1,242,875

 

254,353

 

3,136,841

 

4,634,069

 

 

              1,242,875

 

254,353

 

3,136,841

 

4,634,069

Segment operating loss

 

 

(7,067,094)

 

(3,261,117)

 

(3,399,191)

 

(13,727,402)

 

 

(7,067,094)

 

(3,261,117)

 

(3,399,191)

 

(13,727,402)

Three months ended December 31, 2018

 

 

 

 

 

 

 

 

 

Six months ended December 31, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

$

10,687,036

$

-

$

-

$

10,687,036

 

$

              6,523,823

$

2,634,669

$

-

$

9,158,492

Depreciation and amortization

 

 

771,416

 

1,181,317

 

82,627

 

2,035,360

 

 

1,160,265

 

2,950,927

 

178,453

 

4,235,645

Share based compensation

 

 

316,089

 

8,186

 

686,230

 

1,010,505

 

 

                 803,906

 

281,539

 

4,501,024

 

5,586,469

Segment operating loss

 

 

(507,527)

 

(1,249,673)

 

(719,591)

 

(2,476,791)

 

 

(11,574,824)

 

(4,449,239)

 

(5,392,267)

 

(21,416,330)

Six months ended December 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

15,473,896

$

122,002

$

-

$

15,595,898

 

$

15,473,896

$

122,002

$

-

$

15,595,898

Depreciation and amortization

 

 

1,836,868

 

3,387,858

 

160,592

 

5,385,318

 

 

1,836,868

 

3,387,858

 

160,592

 

5,385,318

Share based compensation

 

 

2,914,331

 

704,454

 

6,009,884

 

9,628,669

 

 

2,914,331

 

704,454

 

6,009,884

 

9,628,669

Segment operating loss

 

 

(13,611,080)

 

(6,489,756)

 

(6,518,740)

 

(26,619,576)

 

 

(13,611,080)

 

(6,489,756)

 

(6,518,740)

 

(26,619,576)

Six months ended December 31, 2018

 

 

 

 

 

 

 

 

 

Revenues

 

$

18,750,838

$

-

$

-

$

18,750,838

Depreciation and amortization

 

 

1,512,884

 

2,012,840

 

175,358

 

3,701,082

Share based compensation

 

 

371,838

 

8,186

 

1,602,830

 

1,982,854

Segment operating loss

 

 

(838,369)

 

(2,216,214)

 

(1,752,352)

 

(4,806,935)

-8-


Three months ended December 31,

Six months ended December 31,

2019

2018

2019

2018

Total operating loss for reportable segments

$

(10,328,211)

$

(1,757,200)

$

(20,100,836)

$

(3,054,583)

Unallocated amounts:

Unallocated Corporate

 

(3,399,191)

 

 

(719,591)

 

(6,518,740)

  

(1,752,352)

Other loss

(16,546,988)

(599,627)

(16,759,770)

(913,986)

Loss before income taxes

$

(30,274,390)

$

(3,076,418)

$

(43,379,346)

 

$

(5,720,921)


 

 

 

 

 

 

 

As of December 31,

 

 As of June 30,

Total Assets

 

2019

 

2019

HCT/Ps

$

16,302,925

$

21,052,082

Diagnostics and therapeutics

 

101,442,833

 

120,665,445

Unallocated corporate

 

1,468,484

 

1,860,658

Total Assets

$

119,214,242

$

143,578,185

-9--7-


Three months ended December 31,

Six months ended December 31,

2020

2019

2020

2019

Total operating loss for reportable segments

$

(4,545,780)

$

(10,328,211)

$

(16,024,063)

$

(20,100,836)

Unallocated amounts:

Unallocated Corporate

 

(2,306,869)

 

 

(3,399,191)

 

(5,392,267)

  

(6,518,740)

Other loss

(278,754)

(16,546,988)

(1,206,165)

(16,759,770)

Loss before income taxes

$

(7,131,403)

$

(30,274,390)

$

(22,622,495)

 

$

(43,379,346)

 

 

As of December 31,

 

 As of June 30,

Total Assets

 

2020

 

2020

HCT/Ps

$

4,136,183

$

11,980,175

Diagnostics and therapeutics

 

65,286,919

 

70,394,152

Unallocated corporate

 

1,029,370

 

1,468,088

Total Assets

$

70,452,472

$

83,842,415

BASIS OF PRESENTATION:

The accompanying condensed consolidated financial statements have been prepared by Predictive Technology Group, Inc. (the “Company” or “Predictive”) in accordance with U.S. generally accepted accounting principles (“GAAP”("GAAP") for financial information and pursuant to the applicable rules and regulations of the Securities and Exchange Commission (“SEC”("SEC"). The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.  All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying financial statements contain all adjustments (consisting of normal and recurring accruals) necessary to present fairly all financial statements in accordance with U.S. GAAP.  

The condensed consolidated financial statements herein should be read in conjunction with the Company’sCompany's audited consolidated financial statements and notes thereto for the fiscal year ended June 30, 2019,2020, included in the Company’sCompany's Annual Report on Form 10-K for the fiscal year ended June 30, 2019.2020. Operating results for the three and six months ended December 31, 20192020 may not necessarily be indicative of results to be expected for any other interim period or for the full fiscal year.

-8-

Fiscal YearEnd

The Company operates on a fiscal year basis with the fiscal year ending on June 30.

Consolidation

These consolidated financial statements include the financial statements of Predictive Technology Group, Inc. and its wholly owned subsidiaries.  All inter-company accounts and transactions have been eliminated in consolidation. 

Cash Equivalents

The Company considers all highly-liquid investments with a maturity of three months or less, when purchased, to be cash equivalents.  The Company places its temporary cash investments with high-quality financial institutions.  

Going Concern

The accompanying condensed consolidated financial statements have been prepared under the assumption that the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from any inability of the Company to continue as a going concern.

-10-

The Company incurred a net loss attributable to common stockholders of $33,867,276$22,564,865 and net cash outflows from operations of $2,972,152 for the six months ended December 31, 2019 and net cash outflows from operations of $9,914,968.2020. At December 31, 2019,2020, the Company had $255,502$134,376 of cash and negative working capital of $4,861,267.$23,020,768. The Company's historical and current use of cash in operations combined with limited liquidity resources raise substantial doubt regarding the Company’sCompany's ability to continue as a going concern. Management may seek additional capital through debt financings, collaborative or other funding arrangements with partners, sale of assets, or through other sources of financing. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all.all to mitigate the substantial doubt that exists. If the Company is unable to raise additional capital when required or on acceptable terms, this could have a material adverse effect on liquidity. In such a case, the Company may be required to scale back or to discontinue the promotion of currently available products, scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Trade Accounts Receivable and Allowance for Doubtful Accounts

Trade accounts receivable are primarily comprised of amounts due from sales of the Company’sCompany's HCT/P products and sales of medical diagnostic testing services that are recorded at the invoiced amount, andas well as deposits in transit from credit card processors. The allowance for doubtful accounts is based on the Company’sCompany's best estimate of the amount of probable losses in the Company’sCompany's existing accounts receivable, which is based on historical write-off experience, customer creditworthiness, facts and circumstances specific to outstanding balances, and payment terms. Account balances are charged against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The Company does not have any off-balance-sheet credit exposure related to its customers and does not require collateral.

Inventories

Inventories consist primarily of HCT/Ps produced by Predictive Biotech, Inc. ("Predictive Biotech"), a wholly owned subsidiary and laboratory supplies used in genetic testing performed by Predictive Laboratories, Inc. ("Predictive Labs") and HCT/Ps produced by Predictive Biotech, Inc. ("Predictive Biotech"). We value inventory at the lower of cost or net realizable value. We determine the cost of inventory using the standard cost method, which approximates actual cost based on a first-in, first-out method.  All other costs, including administrative costs, are expensed as incurred.

We analyze our inventory levels at least quarterly and write down inventory that has a cost basis in excess of its expected net realizable value, or that is considered in excess of normal operating levels, as determined by management.  We also reserve for the quantity of quarantined (WIP) inventory that is not expected to pass quality control based on historical averages. The related costs are recognized as cost of goods sold in the condensed consolidated statements of operations.

-11-

Stock Subscriptions Receivable

Stock subscriptions are recorded as contra-equity on the day the subscription agreement is signed and accepted by the Company.  As of December 31, 2019 and June 30, 2019, all stock subscribed has been fully paid. 

Prepaid Expenses

Amounts paid in advance for expenses are accounted for as prepaid expenses and classified as current assets if such amounts are to be recognized as expense within one year from the balance sheet date.

-9-

Property, Plant and Equipment

Lab equipment, furniture and computer equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method based on the lesser of estimated useful lives of the related assets or the underlying lease term. Lab equipment items have depreciable lives of 5 years, furniture items have depreciable lives of 5 to 7 years, and computer equipment items have depreciable lives of 3 years. Repair and maintenance costs are charged to expense as incurred. Amortization of assets recorded under finance leases is included in depreciation expense.

The Company reviews property and equipment for impairment. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amounts to future undiscounted cash flows the assets are expected to generate. If property and equipment are considered to be impaired, the impairment to be recognized equals the amount by which the carrying value of the assets exceeds its fair market value.

Leases

We have entered into operating and finance lease agreements primarily for office and laboratory facilities and laboratory equipment located in Salt Lake City, Utah with lease periods expiring between 20202021 and 2022.2023.

We determine if an arrangement is a lease at inception. For all classes of underlying assets, we elect not to recognize right of use assets or lease liabilities when a lease has a lease term of 12 months or less at the commencement date and does not include an option to purchase the underlying asset that we are reasonably certain to exercise. Operating lease assets and liabilities are included on our consolidated balance sheet beginning July 1, 2019. Finance lease assets are included in property, plant, and equipment, net.

-12-

Operating lease assets and liabilities are recognized at the present value of the future lease payments at the lease commencement date. The interest rate used to determine the present value of the future lease payments is our incremental borrowing rate, because the interest rate implicit in most of our leases is not readily determinable. Our incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in economic environments where the leased asset is located. Operating lease assets also include any prepaid lease payments and lease incentives. Our lease terms include periods under options to extend or terminate the lease when it is reasonably certain that we will exercise that option. We generally use the base, non-cancelable, lease term when determining the lease assets and liabilities. Operating lease expense is recognized on a straight-line basis over the lease term.

Our lease agreements generally contain lease and non-lease components. Non-lease components primarily include payments for maintenance and utilities. We combine fixed payments for non-lease components with our lease payments and account for them together as a single lease component, which increases the amount of our lease assets and liabilities.together.

Intangible Assets and Other Long-Lived Assets

Intangible and other long-lived assets are comprised of acquired patents, licenses, trade secrets and other intellectual property.  Acquired intangible assets are recorded at fair value and amortized over the shorter of the contractual life or the estimated useful life.

The Company reviews definite-lived intangible assets for impairment. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amounts to future undiscounted cash flows the assets are expected to generate. If identifiable intangibles are considered to be impaired, the impairment to be recognized equals the amount by which the carrying value of the assets exceeds its fair market value.

Indefinite-lived intangible

As of June 30, 2020, the Company had identified indicators of impairment for certain of its long-lived assets not subjectfor certain of its long-lived assets and performed an impairment test related to amortization are reviewedthose long-lived assets. An impairment charge of $10,041,556 was recorded related to assets acquired with Regenerative Medical Technologies, Inc. (see Note 3).

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for impairment annually, typically atCoreCyte with the beginningFDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the fourth fiscal quarter, or wheneverknee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events or changesthat led to this decision began with the receipt of a Warning Letter from the FDA in circumstances indicateAugust 2020, it was determined that the carrying valuedecision to stop selling CoreCyte was an indicator of an asset may not be recoverable.  Such eventsimpairment as of September 30, 2020.  Impairment charges of $0 and circumstances may include sweeping regulatory changes, shifts in market demand that would negatively impact revenue, overall industry deterioration, dramatic increase$1,760,875 were recognized related to the trade secrets in the number of competitors, rapidly increasing costs related to production inputs, significant changesHCT/P segment in Company management or Company strategy, or significant litigation.  The Company first assesses qualitative factors above to determine whether it is necessary to perform the quantitative impairment test to identify any impairment loss.three and six months ended December 31, 2020, respectively (see Note 3).   There were no impairments for the three and six months ended December 31, 2019.

Recoverability of assets to be held and used is measured by a comparison

-10-

Additional delays in the commercial launch of the carrying amount of an asset or asset group to estimated future undiscounted net cash flows, or fair value,Company's diagnostic products such as those that may result from a prolongation of the related asset or group of assets over their remaining lives.  COVID-19 pandemic would adversely affect our business and potentially lead to additional impairment charges in the future.

-13-

Certain of the Company’sCompany's patents are currently subject to litigation (see Note 14)11) to determine whether the seller of the patents had satisfactoryfaithfully represented the nature of their ownership of patents that were sold to the Company. The seller of the patents represented that all rights, title, and interest to the patents was transferred to the Company as part of the sale.  However, the Company and its patent counsel have identified information in the US Patent and Trademark Office's (USPTO's) registry that calls into question whether the seller of the patents had all rights, title, and interest in the patents when they were then sold to the Company. The Company raised these concerns with the seller of the patents but was unable to secure clear and satisfactory proof on a voluntary basis. These patents have a carrying value of $6,468,137$5,726,034 on our condensed consolidated balance sheet as of December 31, 2019.2020. While there is some question as to whether the litigation is in its early stages and may reach a broad range of possible outcomes,Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the patents.

Revenue Recognition

We derive our revenue primarily from two sources.  One source is the sales of HCT/P products to clinicians. The majority of our contracts with customers have a single performance obligation, and all of our contracts with customers have a duration of less than one year. Revenue is recognized when control of the product passes to the customer, typically upon confirmation of delivery of the product to the customer. As our products must remain frozen during transit, we typically ship our products overnight. Revenue is recognized in an amount that reflects the expected consideration to be received in exchange for such goods or services. As such, customer orders are recorded as deferred revenue prior to delivery of products or services ordered.

The other source of revenue is from the sale of our Assurance VR™ COVID-19 RT-PCR test.  Our contracts with customers have a single performance obligation, and all of our contracts with customers have a duration of less than one year. Revenue is recognized when a valid test result is passed to the customer, which is done electronically.  Revenue is recognized in an amount that reflects the expected consideration to be received in exchange for test results. 

Generally, we require authorization from a credit card or verification of receipt of payment before we ship products to customers for HCT/P related revenues. From time to time we grant credit to these customers with normal credit terms (typically 30 days). For Assurance VR™ COVID-19 RT-PCR test related revenues we typically send an invoice the same or next day once valid test results have been sent electronically.  Payment terms are based on normal credit terms (typically 10 to 30 days).  We do not recognize assets associated with costs to obtain or fulfill a contract with a customer, as the amortization period for any such costs if capitalized would be one year or less.

Shipping and handling is considered a fulfillment activity, as it takes place prior to the customer obtaining control of the product, and fees charged to customers are included in net revenue upon completion of our performance obligation. Shipping and handling expenses are included in cost of sales. We present revenue net of sales taxes, discounts, and expected returns.

Goodwill

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that it is at least reasonably possible that the patents may become impaireddecision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020.  Impairment charges of $0 and $5,254,451 were recognized related to the goodwill in the near term depending onHCT/P segment in the information gained duringthree and six months ended December 31, 2020, respectively (see Note 3).   There were no impairment charges for the legal discovery processthree and six months ended December 31, 2019.

Equity Method Investment

We apply the outcomeequity method of the litigation.

accounting for investments in which we have significant influence but not a controlling interest. The Company reviews equity method investments for impairment whenever events or changes in circumstances indicate that the carrying amount of the investment may not be recoverable in accordance with generally accepted accounting principles. This determination requires significant judgment. In making this judgment, the Company considers available quantitative and qualitative evidence in evaluating potential impairment of these investments. If it is determined that an indicator of impairment exists, the Company assesses whether the carrying value exceeds the fair value of the asset. If the carrying value of the investment exceeds its fair value, the Company will evaluate, among other factors, general market conditions, the duration and extent to which the carrying value is greater than the fair value, and the Company’sCompany's intent and ability to hold, or plans to sell, the investment. The Company also considers specific adverse conditions related to the financial health of and business outlook for the investee, including industry and sector performance, changes in technology, and operational and financing cash flow factors. Once a decline in fair value is determined to be other-than-temporary, an impairment charge will be recorded and a new carrying basis in the investment will be established. The Company recorded an impairment charge of $15,932,016charges totaling $37,907,283 related to our equity method investment in Juneau Biosciences, LLC for the year ended June 30, 2020 (see Note 7)4). There were no impairments for the three and six months ended December 31, 2020.  The Company recorded an impairment loss of $15,932,106 for the three and six months ended December 31, 2019.

 

-11-

Revenue RecognitionPaycheck Protection Program Loan

We derive our revenue primarily

On May 6, 2020, Company received loan proceeds of $1,665,985 under the Paycheck Protection Program ("PPP") under a promissory note from sales of HCT/P products to clinicians.a commercial bank (the "PPP Loan"). The majority of our contracts with customers have a single performance obligation, and all of our contracts with customers have a duration of less than one year. Revenue is recognized when controlPPP, established as part of the product passesCARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times the customer, typically upon confirmation of deliveryaverage monthly payroll expenses of the product toqualifying business. As amended, the customer. As our products must remain frozen during transit, we typically ship our products overnight. Revenue is recognized in an amountCARES act provides that reflects the expected consideration to be received in exchange for such goods or services. As such, customer ordersloans and accrued interest are recordedforgivable after twenty-four weeks as deferred revenue prior to delivery of products or services ordered.

Generally, we require authorization from a credit card or verification of receipt of payment before we ship products to customers. From time to time we grant credit to our customers with normal credit terms (typically 30 days). We do not recognize assets associated with costs to obtain or fulfill a contract with a customer,long as the amortization periodborrower uses the loan proceeds for any such costs if capitalized would be one yeareligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The PPP Loan is included in notes payable in the condensed consolidated balance sheets. Should all or less.

Shipping and handling is considered a fulfillment activity, as it takes place prior to the customer obtaining controlpart of the product, and fees charged to customers are includedPPP Loan be forgiven, the amount forgiven will be derecognized through other income in net revenue upon completion of our performance obligation. Shipping and handling expenses are included in cost of sales. We present revenue net of sales taxes, discounts, and expected returns.the period when forgiveness is granted by the governing authority.

-14-

Deferred Revenue

We recognize a contract liability when customer payment precedes the completion of our performance obligations.

The following table provides information about deferred revenue from contracts with customers, including significant changes in deferred revenue balances during the period (in thousands).period.

   

 

 

Amount

Deferred revenue at June 30, 2019

$

469,376

Increase due to deferral of revenue at period end

 

512,280

Decrease due to beginning contract liabilities recognized as revenue

 

(469,376)

Deferred revenue at December 31, 2019

$

512,280

 

 

Six months ended December 31,

 

 

2020

 

2019

Deferred revenue – beginning balance

$

381,889

$

469,376

Increase due to deferral of revenue at period end

 

748,017

 

512,280

Decrease due to beginning contract liabilities recognized as revenue

 

 

(381,889)

 

 

(469,376)

Deferred revenue – ending balance

 $

748,017

 $

512,280

Research and Product Development Costs

The Company expenses research and product development costs as incurred.

Product Liability and Warranty Costs

The Company maintains product liability insurance and has not experienced any related claims from its product offerings. The Company also offers a warranty to customers providing that its products will be delivered free of any material defects.  There have been no material costs incurred since inception based on estimated return rates.  The Company reviews the adequacy of its accrual on a quarterly basis.

Share-Based Compensation

The Company issues share-based compensation awards in the form of stock option grants. We use the Black-Scholes-Merton option pricing model to estimate the fair value of options granted under our equity incentive plans. The Black-Scholes-Merton option valuation model requires the use of assumptions, including the expected term of the award and the expected share price volatility. The Company uses the "simplified" method to estimate the expected option term. Stock-based compensation is measured at the grant date for all stock-based awards made to employees and non-employees based on the fair value of the awards. Stock-based compensation is recognized as expense on a straight-line basis over the requisite service period, which is generally the vesting period.

The estimated fair value of performance-contingent equity awards is expensed using an accelerated method over the term of the award once we have determined that it is probable that performance milestones will be achieved. Compensation expense for equity awards that contain performance conditions is based on the grant date fair value of the award. Compensation expense is recorded over the requisite service period based on management's best estimate as to whether it is probable that the shares awarded are expected to vest. We assess the probability of the performance milestones being met on a continuous basis.

Income Taxes

In order to determine the Company’sCompany's quarterly provision for income taxes, the Company uses an estimated annual effective tax rate that is based on expected annual income and applicable federal and state tax rates.  Deferred tax assets and liabilities are recorded to reflect the future tax consequences attributable to the effects of differences between the carrying amounts of existing assets and liabilities for financial reporting and for income tax purposes. Deferred taxes are calculated by applying enacted statutory tax rates and tax laws to future years in which temporary differences are expected to reverse. The impact on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate change is enacted.  

-15-

-12-

Other Comprehensive Loss

Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss is equal to net loss for the three and six months ended December 31, 20192020 and 2018.2019.

Measurement of Fair Value

The fair value of a financial instrument is the amount that could be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets are marked to bid prices and financial liabilities are marked to offer prices. Fair value measurements do not include transaction costs. A fair value hierarchy is used to prioritize the quality and reliability of the information used to determine fair values.  Categorization within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. The fair value hierarchy is defined in the following three categories:

Level 1: Quoted market prices in active markets for identical assets or liabilities.

Level 2: Observable market-based inputs or inputs that are corroborated by market data.

Level 3: Unobservable inputs that are not corroborated by market data.

During the three and six months ended December 31, 20192020 and 2018,2019, we did not have any remeasurements of non-financial assets measured at fair value on a non-recurring basis subsequent to their initial recognition.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of sales and expenses during the reporting periods.  Key estimates in the accompanying unaudited condensed consolidated financial statements include, among others, revenue recognition, allowances for doubtful accounts and product returns, provisions for obsolete inventory, valuation of long-lived assets, and deferred income tax asset valuation allowances.  Actual results could differ materially from these estimates.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, “Financial"Financial Instruments – Credit Losses (Topic 326)" which introduces new guidance for the accounting for credit losses on instruments within its scope. The new guidance as amended by subsequent ASUs, introduces an approach based on expected losses to estimate credit losses on certain types of financial instruments. For trade receivables, the Company will be required to use a forward-looking expected loss model rather than the incurred loss model for recognizing credit losses which reflects losses that are probable. For public business entities that meetAfter the definitionissuance of a U.S. Securities and Exchange Commission (SEC) filer, excluding entities eligible to beASU 2019-10, the guidance is effective for smaller reporting companies as defined by the SEC, the amendments in this Update are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoptionapplication of the guidance is permitted.permitted for all entities for fiscal years beginning after December 15, 2018, including the interim periods within those fiscal years. Application of the amendments is through a cumulative-effect adjustment to retained earnings as of the effective date. The Company is currently evaluating the impact of this update on the condensed consolidated financial statements.

-16-

In December 2019, the FASB issued ASU 2019-12, "Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes" (ASU 2019-12), which eliminates certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. This ASU also includes guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. ASU 2019-12 is effective for annual and interim periods in fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company is currently assessing the impact of ASU 2019-12 on its consolidated financial statements.

Recently Adopted Accounting Standards

In February 2016, the FASB established Topic 842, Leases, by issuing Accounting Standards Update (ASU) No. 2016-02, which requires lessees to recognize leases on the balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use model (ROU) that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement.-13-

The new standard was effective for us on July 1, 2019. A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. If an entity chooses the second option, the transition requirements for existing leases also apply to leases entered into between the date of initial application and the effective date. The entity must also recast its comparative period financial statements and provide the disclosures required by the new standard for the comparative periods. We used the effective date as our date of initial application. Consequently, financial information was not updated, and the disclosures required under the new standard were not provided for dates and periods before July 1, 2019.

The new standard provides a number of optional practical expedients in transition. We elected the ‘package of practical expedients’, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. We elected all of the new standard’s available transition practical expedients that are applicable.

The new standard also provides practical expedients for an entity’s ongoing accounting. We elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. We also elected the practical expedient to not separate lease and non-lease components for all of our leases, other than for leases of real estate.

-17-

NOTE 2 CORRECTION OF PREVIOUSLY-ISSUED UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Subsequent to the issuance of the Company's condensed consolidated financial statements for the three and six months ended December 31, 2018, the Company discovered (i) an error in the Company's accounting for income taxes, primarily with regard to the impact of income taxes on the Company's accounting for business combinations and asset acquisitions, and (ii) a clerical error in the calculation of volatility used as an input to the Black-Scholes model used to value the warrants issued as consideration for the acquisition of certain intellectual property.  As a result, the Company has corrected the accompanying condensed consolidated statements of operations and comprehensive loss and the statements of stockholders' equity for the three and six months ended December 31, 2018 from amounts previously reported to (i) record a benefit from income taxes of $713,526 and $1,325,978 for the three and six months, respectively, and (ii) record $358,333 and $632,233 in share based compensation expense for the three and six months, respectively , and (iii) record amortization expense related to intangible assets by $42,826 and $36,118 for the three and six months, respectively.

Additionally, the Company identified the following errors in the calculation of weighted average shares outstanding underlying the calculation of earnings per share for the three and six months ended December 31, 2018.  Common shares in the amount of 23,127,666 issued prior to the 2017 fiscal year were thought to have been cancelled, when in fact they remain legally outstanding.  The weighted average shares outstanding used to calculate earnings per share were also calculated incorrectly, such that the total corrected weighted average shares outstanding increased by 33,167,000 and 28,561,565 for the three and six months, respectively, from amounts previously reported. The error did not affect reported earnings per share in any period.

The condensed consolidated statement of cash flows for the six months ended December 31, 2018 has also been corrected for the adjustments to the condensed consolidated statement of operations discussed above, and to correct the presentation of certain investing and financing activities as follows. First, cash acquired from the acquisition of InceptionDX, LLC was reclassified from financing to investing activities.  Second, the amount of cash paid under our subscription payable previously incorrectly reported as $1,142,089 and incorrectly included in financing activities. The cash paid under our subscription has been corrected to $1,184,392 by reclassifying certain immaterial noncash activity to operating activities and has been reclassified to investing activities.

In addition to the impact of the corrections described above, the condensed consolidated statements of operations for the six months ended December 31, 2018 includes certain insignificant corrections in presentation that were made to conform to the fiscal 2019 annual financial statements.

-18-

The following tables present the effects of the corrections to the condensed consolidated statements of operations and comprehensive loss for the three and six months ended December 31, 2018 and the statement of cash flows for the six months ended December 31, 2018.

Unaudited consolidated statement of operations

 

 

 

 

 Three months ended December 31,

 

 

 

 

2018

 

 

 

 

(As reported)

 

(Adjustment)

 

(Restated)

Revenue from operations (net)

 $    10,687,036

 

 $   -

 

$    10,687,036

Cost of goods sold, exclusive of depreciation & amortization shown below

         3,059,136

 

-

 

3,059,136

 

 

 

 

 

 

 

 

 

Selling and marketing

3,431,157

 

-

 

3,431,157

General and administrative

2,520,281

 

358,333

 

2,878,614

Research and development

1,759,560

 

-

 

1,759,560

Depreciation and amortization

1,992,534

 

42,826

 

2,035,360

 

Total operating expense

9,703,532

 

401,159

 

10,104,691

Loss from operations

     (2,075,632)

 

(401,159)

 

(2,476,791)

 

 

 

 

 

 

 

 

 

     Other loss

(599,627) 

 

-

 

(599,627)

Loss before income taxes

(2,675,259)

 

(401,159)

 


(3,076,418)

Benefit from income taxes

-

 

713,526

 

713,526

Net loss

   (2,675,259)

 

312,367

 

  (2,362,892)

 

Net loss non-controlling interest

(33,454)

 

-

 


(33,454)

Net loss controlling interest

 $  (2,641,805)

 

 $  312,367

 

 $  (2,329,438)

 

 

 

 

 

 

 

 

 

Loss per common share

 

  

 

 

Basic and diluted

$           (0.01)

 

$              -

 

 $           (0.01)

 

 

 

 

 

 

 

 

 

Average common shares

 

 

 

 

 

Basic and diluted

            230,111,417

 

33,167,000

 

263,278,417

 

 

 

 

 

 

 

 

 

-19-


 

 

 

 

 Six months ended December 31,

 

 

 

 

2018

 

 

 

 

(As reported)

 

(Adjustment)

 

(Restated)

Revenue from operations (net)

 $    18,750,838

 

 $   -

 

$    18,750,838

Cost of goods sold, exclusive of depreciation & amortization shown below

         5,925,871

 

181,821

 

6,107,692

 

 

 

 

 

 

 

 

 

Selling and marketing

5,853,876

 

(15,283)

 

5,838,593

General and administrative

5,079,761

 

465,001

 

5,544,762

Research and development

2,364,950

 

694

 

2,365,644

Depreciation and amortization

3,664,964

 

36,118

 

3,701,082

 

Total operating expense

16,963,551

 

486,530

 

17,450,081

Loss from operations

     (4,138,584)

 

(668,351)

 

(4,806,935)

 

 

 

 

 

 

 

 

 

     Other loss

(913,986) 

 

-

 

(913,986)

Loss before income taxes

(5,052,570)

 

(668,351)

 


(5,720,921)

Benefit from income taxes

-

 

1,325,978

 

1,325,978

Net loss

   (5,052,570)

 

657,627

 

  (4,394,943)

 

Net loss non-controlling interest

(61,123)

 

-

 


(61,123)

Net loss controlling interest

 $  (4,991,447)

 

 $  657,627

 

 $  (4,333,820)

 

 

 

 

 

 

 

 

 

Loss per common share

 

  

 

 

Basic and diluted

$           (0.02)

 

$              -

 

 $           (0.02)

 

 

 

 

 

 

 

 

 

Average common shares

 

 

 

 

 

Basic and diluted

            230,111,417

 

28,561,565

 

258,672,982

-20-

Unaudited consolidated statement of cash flows

 

Six months ended December 31, 2018

 

 

(As reported)

 

(Adjustment)

 

(Restated)

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

$

 (5,052,570)

657,627

$       (4,394,943)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

     

Depreciation and amortization

 

   3,663,973

 

36,118

 

 3,700,091

Share based compensation

 

       1,308,318

 

674,536

 

    1,982,854

Deferred income taxes

 

-

 

(1,325,978)

 

  (1,325,978)

Losses on equity method investment

 

       914,898

 

-

 

    914,898

Changes in operating assets and liabilities:

 

     

Accounts receivable

 

     (29,650)

 

-

 

  (29,650)

Inventory

 

(121,072)

 

-

 

    (121,072)

Prepaid expenses

 

       (21,309)

 

-

 

     (21,309)

Other assets

 

       (6,569)

 

-

 

     (6,569)

Accounts payable

 

   1,345,996

 

-

 

 1,345,996

Accrued liabilities

 

     14,315

 

-

 

   14,315

Net cash provided by operating activities

 

 2,016,330

 

42,303

 

    2,058,633

 

 

     

Cash flows from investing activities:

 

     

Purchases of property and equipment

 

 (1,204,756)

 

-

 

  (1,204,756)

   Cash acquired from acquisitions, net

 

-  

 

799,980

 

    799,980

   Cash payments on stock subscription

 

-  

 

(1,184,392)

 

(1,184,392)

   Capitalization of patent acquisition costs

 

     (140,675)

-

  (140,675)

Net cash used in investing activities

       (1,345,431)

(384,412)

(1,729,843)

 

Cash flows from financing activities:

 

     

   Cash proceeds from stock subscriptions

 

       1,025,000

 

-

 

    1,025,000

   Cash acquired from acquisitions, net

 

799,980

 

(799,980)

 

-  

   Cash payments on stock subscription

 

 (1,142,089)

 

1,142,089

 

-

Net cash provided by financing activities

 

     682,891

 

342,109

 

     1,025,000

 

 

     

Net increase in cash and cash equivalents

 

     1,353,790

 

-

 

  1,353,790

Cash and cash equivalents at the beginning of the period

 $

     1,206,139

$

-

 

$           1,206,139

Cash and cash equivalents at the end of the period

$

     2,559,929

$

-

 

$           2,559,929

-21-

NOTE 3 BUSINESS COMBINATIONS AND ASSET ACQUISITIONS

Inception DX, LLC

On August 22, 2018, the Company entered into an agreement captioned “Securities Purchase Agreement” with the members of Inception DX, LLC (“Inception”), a Utah limited liability company. Under the terms of the agreement, the Company acquired Inception for 15,500,000 shares of common stock. Inception owns laboratory equipment, partial interest in database records for over 31,900,000 individuals for use in genetics research, 400,000 units in Juneau Biosciences, LLC, initial CLIA registration, CLIA lab protocols, and other assets. Once the CLIA registration is completed, Inception will be used as a CLIA-certified laboratory by Predictive Technology Group, Inc. and its affiliates.

The stock issued was for cash, laboratory equipment, membership units in Juneau Biosciences, LLC (“Juneau units”), and trade secrets related to the DNA database and protocols related to a future use as a CLIA laboratory. The Juneau units were valued based on the value assigned when the Company entered into a subscription to purchase units of Juneau ($1.10 per unit).  The equipment will be depreciated over 5 years.  The proprietary data, DNA library, protocols, research and methods are classified as trade secrets in our industry.  The Company will amortize the trade secrets over an estimated useful life of 15 years.   

The stock price on August 22, 2018 was $0.92 per share, indicating a purchase price of $14,260,000 requiring allocation:

   

Assets:

 

Amount

Cash

$

 799,980

Lab equipment

 

1,177,750

Investment in non-controlling interest

 

440,000

Trade secrets

 

11,842,270

Total purchase price

$

14,260,000

-22-

Taueret Laboratories, LLC Asset Purchase

On August 22, 2018, the Company entered into an agreement captioned “Asset Purchase Agreement” (the “Purchase Agreement”) with Taueret Laboratories, LLC and its members. Under the terms of the Purchase Agreement, the Company issued warrants exercisable for 16,500,000 shares of the Company’s common stock. The warrants were exercisable at fair market value of the Company’s common stock on the closing date. In consideration for the warrants, the Company acquired (i) approximately 1,000 degenerative disc disease related DNA samples, related family records, relevant clinical records (including approximately 600 affected probands) and 800 ancestry matched control samples, (ii) whole exome sequencing data on approximately 300 degenerative disc disease samples, over 800 local controls, and published reference populations, together with initial analysis of the markers, (iii) project plan, study paperwork, promotional study and materials used in the research study, (iv) exclusive use of a DNA biobank that has a collection of over 300,000 samples for multiple diseases that the Company may target, (v) the remaining interest in database records for over 31,900,000 individuals for use in genetics research, and (vi) other assets.

The warrants issued are for proprietary data and methods that are otherwise a trade secret in our industry.  Therefore, the Company determined to classify the assets purchased as trade secrets with a 15-year life.  The Company used a Black Scholes calculation to determine valuation of the warrants of $13,860,000. As the purchase of the trade secrets with common stock warrants resulted in a difference between book and tax basis in the trade secrets, the carrying amount of the trade secrets was increased to $18,480,000 to reflect the deferred tax liability of $4,620,000 assumed in the transaction.

The fair value of the warrants was determined using the following inputs to the Black Scholes model:

Risk-free interest rate

2.7%

Expected dividend yield

0%

Expected life (in years)

 5.0

Expected volatility

150%

Expected volatility was calculated from the historical volatility of the Company’s common stock.

-23-

Regenerative Medical Technologies, Inc.

On December 19, 2018 the Company executed a merger with the shareholders of Regenerative Medical Technologies, Inc. (“RMT”), a Utah corporation. The Company acquired RMT for 10,000,000 shares of common stock. RMT holds various assets including (i) models, methods and protocols for collection of birthing tissue and DNA samples, (ii) patient registry models, methods and protocols to collect clinical outcomes and electronic medical records, and (iii) designs and methodologies relating to many initiatives that are complementary to anticipated product offerings and ongoing research, and (iv) other assets.

The fair value of consideration paid was determined based on our stock price of $0.92 on the date of acquisition. In addition, the Company recognized a deferred tax liability of $3,066,667 related to the differences between book and tax basis arising from the acquisition, resulting in a total purchase price of $12,266,667. The Company determined that the assets acquired qualify for treatment as trade secrets within industry.  The trade secrets will be amortized over an estimated useful life of 10 years.  

Taueret Laboratories, LLC Acquisition

On March 22, 2019, the Company completed the acquisition of Taueret Laboratories, LLC (“Taueret”) pursuant to the Securities Purchase Agreement (as amended, the “Purchase Agreement”), dated January 1, 2019. Pursuant to the terms of the Purchase Agreement, the Company acquired all of the outstanding units of Taueret. The Company and its affiliates plan to use Taueret’s CLIA-certified laboratory to perform diagnostic testing services.

The Purchase Agreement also specifies that the Company may, at its sole discretion, put certain patents related to the diagnosis and treatment of Preeclampsia (the “Preeclampsia IP”) back to the members of Taueret at any time prior to December 31, 2020 (the “Preeclampsia Option”). On December 31, 2020, an additional payment of $8,547,000 in cash will become due if the Company has not exercised the Preeclampsia Option. After considering the relevant accounting guidance, we determined that the Preeclampsia Option was not part of the business combination with Taueret, because the Preeclampsia Option was included in the Purchase Agreement primarily to benefit the acquirer.

The Company acquired Taueret and the Preeclampsia Option for total consideration of $931,817, net of cash acquired of $85,964. The consideration was paid as 552,995 shares of the Company’s common stock. The common stock was valued at the closing price on the date of the closing of the merger, adjusted for a 20% discount for lack of marketability related to a contractually stipulated lockup provision with a period of one year. The consideration was allocated between the business combination and the Preeclampsia Option on a relative fair value basis with $917,511 allocated to the business combination and $100,000allocated to the Preeclampsia Option. The Preeclampsia Option was recorded in intangible assets and will be amortized on a straight-line basis over the period the option is exercisable.

Total consideration transferred was allocated to tangible and intangible assets acquired and liabilities assumed based on their fair values as of the acquisition date.  

-24-

Management estimated the fair value of tangible and intangible assets and liabilities in accordance with the applicable accounting guidance for business combinations and utilized the services of third-party valuation consultants.  These amounts are provisional and may be adjusted during the measurement period, which expires no later than one year from the acquisition date, if new information is obtained that, if known, would have affected the amounts recognized as of the acquisition date.

   

Assets:

Fair Value

Current assets

$

663,262

Laboratory equipment

190,397

Software

239,000

Intangible Assets

311,000

Total assets acquired

1,403,659

Liabilities:

 

Accrued liabilities

(68,181)

Capital lease obligation

(54,291)

Total liabilities assumed

(122,472)

Bargain purchase gain

(363,676)

Total fair value of purchase price

$

917,511

Consideration allocated to Preeclampsia Option

 

100,000

Total consideration

$

1,017,511

Less: Cash acquired

 

(85,694)

Total consideration transferred

$

931,817

Identifiable intangible assets

The Company acquired intangible assets that consisted of an internally developed laboratory information management system which had an estimated fair value of $239,000, CLIA regulatory licenses with a fair value of $295,000, and customer relationships with a fair value of $16,000. The fair value of the software was determined using the replacement cost method.  The fair value of the CLIA licenses were estimated using the excess earnings method. The estimated net cash flows were discounted using a discount rate of 22%, which is based on the estimated internal rate of return for the acquisition and represents the rate that market participants might use to value the intangible assets. The projected cash flows were based on key assumptions such as estimates of revenues and operating profits. The Company will amortize the intangible assets on a straight-line basis over their estimated useful lives of 15 years for the CLIA license and 5 years for the software and customer relationships. This amortization is deductible for income tax purposes.  

-25-

Bargain purchase gain

Any excess of fair value of acquired net assets over the purchase price (negative goodwill) has been recognized as a gain in the period the acquisition was completed. We have reassessed whether all acquired assets and assumed liabilities have been identified and recognized and performed remeasurements to verify that the consideration paid, assets acquired, and liabilities assumed have been properly valued. The remaining excess has been recognized as a gain in other income and expense in the consolidated statement of operations. The bargain purchase gain partly resulted from the allocation of the total consideration between the business combination and the Preeclampsia Option. We also believe we were able to negotiate a bargain price due to the desire of the sellers to induce the Company to purchase the Preeclampsia Option contemporaneously with the business combination.

NOTE 4 INVENTORIES

The composition of inventories is as follows:

As of

As of

 

 

December 31,

 

June 30,

 

 

2019

 

2019

Finished goods

 $

1,896,878

 $

918,199

Work-in-process

 

1,747,321

 

4,485,349

Raw materials and supplies

 

200,902

 

371,637

Total inventory on hand

 $

3,845,101

 $

5,775,185


-26-

NOTE 52 PROPERTY, PLANT AND EQUIPMENT, NET

The composition of property, plant, and equipment is as follows:

 

As of

 

As of

 

As of

 

As of

 

December 31,

 

June 30,

 

December 31,

 

June 30,

 

2019

 

2019

 

2020

 

2020

Computer equipment

647,500

 $

530,815

779,105

 $

759,192

Furniture

 

230,747

 

224,324

 

230,747

 

230,747

Lab equipment

 

2,210,695

 

2,469,652

 

2,610,555

 

2,215,409

Software

 

928,369

 

923,369

 

1,008,713

 

1,008,713

Leasehold improvements

 

997,416

 

870,098

 

1,006,215

 

1,006,215

Other fixed assets in progress

 

183,937

 

69,886

 

18,943

 

91,195

Lab equipment subject to finance lease

 

2,774,907

 

2,774,907

 

2,774,907

 

2,774,907

Total property, plant, and equipment

 

7,973,571

 

7,863,051

 

8,429,185

 

8,086,378

 

 

 

 

 

 

 

 

Accumulated depreciation

 

(1,487,354)

 

(862,851)

 

(2,669,102)

 

(2,002,744)

Accumulated depreciation – leased assets

 

(329,857)

 

(25,759)

 

(1,187,210)

 

(758,535)

 

 

 

 

 

 

 

 

Property, plant and equipment, net

 $

6,156,360

 $

6,974,441

 $

4,572,873

 $

5,305,099

Depreciation expense for the three month periods ended December 31, 2020 and 2019 was $524,620 and 2018 was $546,714and $125,880,$546,714, respectively. Depreciation expense for the six month periods ended December 31, 2020 and 2019 was $1,075,033 and 2018 was $928,601and $209,014,$928,601, respectively.

-27-

NOTE 63 GOODWILL & INTANGIBLE ASSETS

Intangible assets primarily consist of amortizable purchased licenses, patents, and trade secrets.  The following summarizes the amounts reported as intangible assets:

 

 

Carrying Amount

 

Accumulated Amortization

 

 

Net

 

Weighted Average Remaining Amortization Period (Years)

At December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

Licenses

 

$

21,337,981

 

$

(4,274,459)

 

$

17,063,522

 

8.5

Patents

 

 

9,750,000

 

 

(3,281,863)

 

 

6,468,137

 

8.5

Trade Secrets

 

 

56,675,936

 

 

(14,368,767)

 

 

42,307,169

 

8.5

Other

 

 

411,000

 

 

(73,474)

 

 

337,526

 

10.5

Goodwill

 

 

5,254,451

 

 

N/A

 

 

5,254,451

 

N/A

Total intangible assets

 

$

93,429,368

 

$

(21,998,563)

 

$

71,430,805

 

8.5

           

 

Carrying Amount

 

Accumulated Amortization

  

Net

 

Weighted Average Remaining Amortization Period (Years)

 

Carrying Amount

 

Accumulated Amortization

 

 

Net

 

Weighted Average Remaining Amortization Period (Years)

At June 30, 2019:

 

 

 

 

 

 

 

 

 

 

 

At December 31, 2020:

At December 31, 2020:

 

 

 

 

 

Licenses

 

$

21,337,981

 

$

(3,275,666)

 

$

18,062,315

 

9.0 

Licenses

 

$

21,337,981

 

$

(6,303,954)

 

$

15,034,027

 

7.5

Patents

 

 

9,750,000

 

 

(2,899,510)

 

 

6,850,490

 

9.0 

Patents

 

 

9,750,000

 

 

(4,023,966)

 

 

5,726,034

 

7.5

Trade Secrets

 

 

56,675,936

 

 

(11,339,601)

 

 

45,336,335

 

8.9 

Trade Secrets

 

 

32,547,380

 

 

(6,805,944)

 

 

25,741,436

 

10.5

Other

 

 

411,000

 

 

(27,069)

 

 

383,931

 

11.0

Other

 

 

411,000

 

 

(151,236)

 

 

259,764

 

9.5

Goodwill

 

 

5,254,451

 

 

N/A

 

 

5,254,451

 

N/A

Goodwill

 

 

-

 

 

N/A

 

 

-

 

N/A

Total intangible assets

 

$

93,429,368

 

$

(17,541,846)

 

$

75,887,522

 

9.0 

Total intangible assets

 

$

64,046,361

 

$

(17,285,100)

 

$

46,761,261

 

9.1

            

 

Carrying Amount

 

Accumulated Amortization

  

Net

 


Weighted Average Remaining Amortization Period (Years)

At June 30, 2020:

At June 30, 2020:

 

 

 

 

 

 

Licenses

Licenses

 

$

21,337,981

 

$

(5,273,253)

 

$

16,064,728

 

8.0

Patents

Patents

 

 

9,750,000

 

 

(3,664,215)

 

 

6,085,785

 

8.0

Trade Secrets

Trade Secrets

 

 

46,634,380

 

 

(17,397,933)

 

 

29,236,447

 

7.9

Other

Other

 

 

411,000

 

 

(115,212)

 

 

295,788

 

10.0

Goodwill

Goodwill

 

 

5,254,451

 

 

N/A

 

 

5,254,451

 

N/A

Total intangible assets

Total intangible assets

 

$

83,387,812

 

$

(26,450,613)

 

$

56,937,199

 

8.0

-28--14-

Estimated future amortization expense related to intangible assets consists of the following as of December 31, 2019:2020:

    

Year Ending June 30

 

 

Amount

2020

 

$

4,452,050

2021

 

 

8,514,306

2022

 

 

6,022,890

2023

 

 

6,022,890

2024

 

 

6,022,890

Thereafter

 

 

35,141,328

Year Ending June 30,

 

Amount

2021

$

2,430,070

2022

 

4,860,141

2023

 

4,860,141

2024

 

4,860,141

2025

 

4,860,141

Thereafter

 

24,890,627

Total amortization expense for the three months ended December 31, 2020 and 2019 was $1,226,942 and 2018 was $2,228,359 and $1,909,480respectively.respectively. Total amortization expense for the six months ended December 31, 2020 and 2019 was $3,160,612 and 2018$4,456,717 respectively.

Impairment of Trade Secrets

As of June 30, 2020, the Company identified indicators of impairment related to the assets acquired with Regenerative Medical Technologies, Inc. Specifically, development of the assets acquired has proceeded significantly more slowly than originally planned due to the departure of key personnel and related difficulties in obtaining patient consent required to use the acquired assets in the Company's research activities. The Company determined the fair value of the assets acquired to be $334,000 using the cost to recreate method, which resulted in an impairment charge of $10,041,556 for the year ended June 30, 2020. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy. The impaired assets and the related impairment charge are included in the Diagnostics and Therapeutics segment.

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020 in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was $4,456,717determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020. The Company estimated the fair value of the reporting unit using the discounted cash flow method, as the forecasted cash flows during the remaining economic life of the trade secrets (less than one year) were forecasted to be negative. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy. As a result, impairment charges of $0 and $3,492,069respectively.$1,760,875 were recognized related to the trade secrets in the HCT/P segment in loss on impairment in the condensed consolidated statement of operations and comprehensive loss for the three and six months ended December 31, 2020, respectively. There were no impairment charges for the three and six months ended December 31, 2019.

Endometriosis license

On December 28, 2016, Predictive Therapeutics LLC and Juneau amended and restated the license agreement dated July 9, 2015. The license granted the Company the right to market the Company's diagnostic testing products in the field of fertility and use the patents underlying those products. The license was subsequently amended in March 2018 to expand the scope of the license to include the entire field of endometriosis and pelvic pain. The term of the license is equal to the life of the licensed patents.

 

An additional license fee of $2,000,000 is due and payable once the Company has received profits of $25,000,000 related to the intellectual property licensed under the agreement.

Upon first

Under the license, as amended, (i) upon the commercial sale of the licensed assay,rights to the Company willARTguide™ or a license thereof we are required to issue to Juneau common sharesstock with a market value of $2,500,000.$2,500,000, (ii) Juneau is entitled toreceives a royalty equal toof 50% of net sales, adjusted to exclude certain costs and fees, and subject to certain minimums.

In March of 2018, the Company’s licenses with Juneau were amended to reduce the royalty rate and expand the scope of the licenses to include the entire field of endometriosis and pelvic pain. The Company issued 1,000,000 shares of common stock and 14,000,000 warrants with an exercise price of $0.80 per shareprofits as consideration.

-29-

In December of 2018 the Company and Juneau agreed to renegotiate the price paid for the license.  The warrants issued initially for this license agreement were cancelled, and new warrants were issued with an increased exercise price of $0.90 per share, resultingdefined in a decrease in the value assigned to the license agreement, (iii) we must have minimum sales of $4,449,211. The replacement of the warrants resulted in an additional deferred tax liability of $290,263, resulting in a net decrease$12.5 million in the carrying valuetwelve month period beginning nine months after commercial launch, (iv) during the second year following launch we must have minimum sales of $30 million, and (v) during the licensesthird year following launch and each year thereafter we must have minimum annual sales of $4,158,948.  There was$60 million. If we fail to meet these metrics the license is null and void unless Predictive (a) presents written plan to Juneau describing how Predictive will use reasonable commercial efforts to improve sales and (b) Predictive agrees to spend an associated adjustment to amortization expense. The fair value of the replacement warrants were determined using the following inputsamount equal to the Black Scholes model:difference between the projected minimum sales and actual sales on an enhanced sales and marketing effort over the next year.

-15-

Risk-free interest rate

2.7%

Expected dividend yield

0%

Expected life (in years)

 5.0

Expected volatility

150%

Companion diagnostic license

In addition to the license for the commercialization of assays and related services for the prognosis and monitoring of endometriosis in the infertility market, the Company entered into a license agreement with Juneau to use the assay as a companion diagnostic test in conjunction with endometriosis therapeutics that may be developed from intellectual property owned by the Company and Juneau. OnceThis license agreement was amended and restated on August 1, 2016.

The agreement initially required a $250,000 license fee which was paid during 2013 and 2014.  A subsequent milestone payment of 250,000 shares of Company stock was paid to Juneau on October 19, 2016. If FDA approval is granted on any companion diagnostic test, a final milestone payment of $250,000 is due.

The agreement requires a 2% royalty to be paid to Juneau on the sale of patented therapeutic products specifically covered by the agreement.

The Company amortizes the licenses over the life of the underlying patents.patent.

Goodwill

We recorded goodwill of $5,254,451 from the acquisition of Predictive Biotech, Inc. (formerly Renovo Biotech, Inc.) that was completed on March 28, 2016.

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020.  The Company estimated the fair value of the reporting unit using the discounted cash flow method. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy.  The fair value of the reporting unit was determined to have fallen below its carrying value, which resulted in impairment charges of $0 and $5,254,451 that were recognized in the HCT/P segment in loss on impairment in the condensed consolidated statement of operations and comprehensive loss for the three and six months ended December 31, 2020, respectively. There were no impairments of goodwill for the three and six months ended December 31, 2019.

Changes in the goodwill balance during the six months ended December 31, 2020 were as follows.

 

 

Goodwill

 

Accumulated Impairment Losses

As of June 30, 2020

$

5,254,451

$

-

Impairment of Goodwill

 

-

 

(5,254,451)

As of December 31, 2020

 $

5,254,451

 $

(5,254,451)

NOTE 74 EQUITY METHOD INVESTMENT

Juneau Biosciences, LLC

The Company’sCompany's investment in Juneau is accounted for under the equity method and included in the Diagnostics and Therapeutics segment.method. The following table summarizes the investment:

      

 

As of

December 31, 
2019

 

As of

June 30,
2019

 

 

 

 

 

 

Carrying amount

$

35,329,167

 

$

51,717,719

 

 

 

 

 

 

Ownership percentage

 

48.3%

 

 

48.4%

-30-

 

As of

December 31, 
2020

 

As of

June 30,
2020

 

 

 

 

 

 

Carrying amount

$

11,987,558

 

$

12,731,383

Ownership percentage

 

48.3%

 

 

48.3%

In December 2017, the Company and Juneau reached verbal agreement on a stock subscription arrangement. The Company agreed to purchase 15,681,818 Class A Units of Juneau at a price of $1.10 per unit. Subsequent amendments reduced the number of units purchased to 13,000,000. In early 2018, the terms were finalized and memorialized in a subscription agreement executed by the Company and Juneau. Under the terms of the agreement (as amended), the subscription is to be paid in installments through September 30, 2021. The Company has the option to cancel the subscription.  If this option is exercised, any units of Juneau issued to the Company but not paid will be cancelled. The agreement includes certain restrictions on the use of funds provided under the subscription agreement and grants the Company the right to appoint a minority of Juneau’sJuneau's Board of Managers. Should the Company elect not to fund the entire subscription, Juneau's obligations to the Company that are not related to the license agreements (see Note 6)3) will terminate.

-16-

On September 25, 2019, the Company and Juneau executed an amendment to the subscription agreement. The amendment reduced the total number of Class A Units purchased to 13,000,000 and changed the schedule of payments due under the subscription agreement. In addition, a receivable due from Juneau in the amount of $184,443 was applied to the subscription payable balance.

On February 10, 2020, the Company and Juneau Biosciences, LLC, its equity method investee, executed an amendment to the agreement captioned "Third Amended and Restated Subscription Agreement." Under the terms of the agreement, the Company issued common stock, par value $0.001, with a value of $2,430,000 (the "Equity Payment") based on the closing market price on the agreement date that was applied against the subscription payable. The amendment also changed the schedule of cash payments due under the subscription agreement to purchase units of Juneau. The schedule of payments as of December 31, 20192020 under the amended agreement is as follows:

Year Ending June 30

 

Amount

2020

$

1,330,000

2021

 

1,800,000

2022

 

       5,300,000

2023

 

                1,256,610   

 

$

9,686,610

Summarized financial information for

Year Ending June 30

 

Amount

2021

 

5,150,000

2022

 

      2,056,610

 

$

7,206,610

The Company is currently $2,150,000 in arrears on payment on the Company’s equity method investee assubscription. Should Juneau declare the Company in default and cancel the subscription, our unpaid units of and for its fiscal year end is presented in the following tables:

Juneau Biosciences, LLC

 

Year ended December 31, 2019

 

Year ended December 31, 2018

 

 

 

Unaudited

 

 

Revenue (related party)

$

202,010

$

2,554,037

Gross profit

 

202,010

 

2,554,037

Loss from operations

 

(1,890,382)

 

(2,419,890)

Net loss

 

(1,889,921)

 

(2,419,824)

Net loss attributable to Predictive Technology Group, Inc.

 

(912,454)

 

(1,200,238)

-31-Juneau would be cancelled.

Impairment

The Company reviews its equity method investment on a quarterly basis to determine whether a triggering event has occurred that could necessitate an impairment test. During the three months ended December 31, 2019, the Company’sCompany's stock price declined from $1.67 per share to $0.73 per share, which was determined to qualify as a triggering event for impairment tests of our reporting units, intangible assets, and equity method investments. In addition, there had been delays in the commercialization of product licensed from Juneau. At June 30, 2020, the COVID-19 pandemic caused impediments to clinical research which are expected to further delay the commercialization of our genetic testing products. These factors triggered a second impairment test as of June 30, 2020.

We

For each of the impairment tests as of December 31, 2019 and June 30, 2020, we engaged a third-party valuation firm to assist us in determining whether the carrying value of our equity method investment had fallen below the carrying value. The valuation wasvaluations were performed using a combination of the cost approach, the income approach, and calibration of the fair values of the Company’sCompany's operating segments and equity method investment to the Company’sCompany's overall market capitalization. These valuation approaches use inputs that qualify as Level 3 in the fair value hierarchy. As a result of the valuation, it was determined that the fair value of our equity method investment had fallen to $35,329,167 at December 31, 2019, necessitating an impairment charge of $15,932,016.$15,932,016 during the three months ended December 31, 2019.  At June 30, 2020, it was determined that the fair value of our equity method investment had fallen to $12,731,383, necessitating a further impairment charge of $21,975,267. The total impairment charge ischarges of $37,907,283 are included in Lossloss on equity method investment in the condensed consolidated statement of operations.

operations for the year ended June 30, 2020. The impairment wasimpairments were determined to be other than temporary based on the magnitude of the decline in fair value.

There were no impairments during the six months ended December 31, 2020.

NOTE 85 ACCRUED LIABILITIES

 

 

As of

 

As of

 

 

December 31,

 

June 30,

 

 

2019

 

2019

Employee compensation and benefits

 $

888,911

816,451

Other

 

1,042,907

 

         1,041,320

Total accrued liabilities

 $

1,931,818

 $

1,857,771

Accrued liabilities at December 31, 2020 and June 30, 2020 were as follows:

 

 

As of

 

As of

 

 

December 31,

 

June 30,

 

 

2020

 

2020

Employee compensation and benefits

 $

582,244

1,493,484

Income tax payable

 

115,649

 

110,649

Customer deposit

 

5,000,000

 

5,000,000

Other

 

1,817,924

 

1,442,681

Total accrued liabilities

 $

7,515,817

 $

8,046,814

-17-

The customer deposit of $5,000,000 relates to a partial deposit received from the distributor of the Company's Assurance AB™ product. Under the terms of the agreement with the distributor, the purchase order may not be cancelled and product may only be returned if damaged in transit or subject to a recall order. In an effort to expeditiously satisfy the Company's obligations under the agreement with the distributor, the Company paid the full amount of the partial deposit to the Company's U.S. supplier. The deposit paid to the supplier is included in other current assets on the condensed consolidated balance sheets. If the Assurance AB test does not receive Emergency Use Authorization from the FDA, the deposit paid to the Company's supplier may become impaired. As of the date of this filing, the Company has withdrawn its original EUA application and is planning on filing a new EUA application for a version of the product designed to meet testing needs anticipated during the vaccination phase of the pandemic. The Company will fulfill the purchase order upon receipt of the remaining deposit amount due from the distributor under the distribution agreement. As of the date of the financial statements, no additional deposits have been made. The customer has requested a refund of the deposit. See further discussion in Note 11.

NOTE 96 DEBT

From June to

Notes payable were as follows:

 

 

As of

 

As of

 

 

December 31,

 

June 30,

 

 

2020

 

2020

Promissory notes

 $

6,710,234

$

3,305,234

Revolving line of credit

 

200,000

 

200,000

Paycheck Protection Program Loan

 

1,665,985

 

1,665,985

Total notes payable

 $

8,576,219

 $

5,171,219

Less: Current portion

 

(6,364,309)

 

(705,234)

Total long-term notes payable

$

2,211,910

$

4,465,985

Future maturities of notes payable are as follows:

   

Year Ending June 30

 

Amount

2021

 

4,616,447

2022

 

3,129,289

2023

 

637,548

2024

 

192,935

 

$

8,576,219

Promissory notes

As of December 2019, the Company issued31, 2020, unsecured promissory notes to six accredited investors in the total amountwith a face value of $9,360,000.$2,600,000 were outstanding. The promissory notes bear 12% simple interest and mature from November 2021 to March 2022.  

On June 4, 2020, trade payables due to a vendor in the amount of $705,234 were converted into an unsecured note payable due on November 15, 2020. The note bears interest at 3% per annum, increasing to 5% if the note is not paid when otherwise due. As of December 31, 2020 the note holder has increased the interest to 5%.

In July and August 2020, the Company issued promissory notes to an accredited investor in the amount of $1,000,000. The notes bear interest at 15% per annum and mature on September 21, 2020. The notes are secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test.

On September 25, 2020, the Company and the same accredited investor amended and restated the outstanding notes and increased the principal amount by $2,000,000 to a total of $3,000,000. The amended promissory note bears 15% simple interest. No payments on the two-year anniversaryamended promissory note are due until September 2021, at which time monthly payments equal to 1/36th of each note.the outstanding principal and interest amount shall commence. Interest accruing prior to September 2021 will be added to the principal amount. Any remaining principal and interest shall be due on September 30, 2022. The notesamended promissory note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test and may be repaidprepaid without penalty.

-18-

On December 18, 2020, the Company issued a promissory note with a face value of $405,000.  The note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test.  The note bears interest at 5% per annum and matures sixty days from execution.

The Company entered into a Consulting Agreement with the same accredited investor on the same date that the promissory notes were amended. The Company will provide various services in connection with the accredited investor's COVID-19 testing business, including technical consultation and sales lead generation. The Company may earn up to $1,000,000 in milestone payments and shall earn a commission of 5% of the accredited investor's sales generated from sales leads provided by the Company. Amounts earned under the Consulting Agreement shall first be applied to any time.balance outstanding under the amended promissory notes. The Company's total compensation under the Consulting Agreement is capped at $4,000,000. The agreement may be cancelled by the accredited investor without penalty.  See Note 12 regarding an update to this Consulting Agreement.

Revolving line of credit  

In September 2019, the Company and thean accredited investor entered into a Revolving Loan Agreement whereby anthe accredited investor agreed to lend the Company up to an additional $3,000,000. At December 31, 2020, $200,000 is outstanding and $2,800,000 is available. Amounts drawn under the revolving loan will be charged interest at a rate of 12% and may be repaid at any time. There was $720,000 outstanding under the Revolving Loan Agreement as of December 31, 2019. All amounts outstanding under the revolving loan are due upon the expiration of the revolving loan facility on September 30, 2021.

-32-

Paycheck Protection Program Loan

On May 6, 2020, Company received loan proceeds of $1,665,985 under the Paycheck Protection Program ("PPP") under a promissory note from a commercial bank (the "PPP Loan"). The PPP, established as part of the CARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of the qualifying business. The loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.

The application for these funds requires the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. Some of the uncertainties related to the Company's operations that are directly related to COVID-19 include, but are not limited to, the severity of the virus, the duration of the outbreak, governmental, business or other actions (which could include limitations on operations or mandates to provide products or services), impacts on the supply chain, and the effect on customer demand or changes to operations. In addition, the health of the Company's workforce and its ability to meet staffing needs are uncertain and is vital to its operations.

The PPP Loan certification further requires the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. While the Company does have availability under its Revolving Loan Agreement, the $2.8 million that is available is in place to support working capital needs, along with current cash on hand. Further, the Company has a lack of history of being able to access the capital markets. As a result, the Company believes it meets the certification requirements.

The receipt of December 31, 2019, unsecured promissory notes bearing 12%these funds, and the forgiveness of the loan attendant to these funds, is dependent on the Company having initially qualified for the loan and qualifying for the forgiveness of such loan based on our future adherence to the forgiveness criteria.

The term of the Company's PPP Loan is two years. The annual interest with a face valuerate on the PPP Loan is 1% and no payments of $9,360,000 remain outstanding. The notes mature from June to December 2021. Notes with a face value of $400,000 matureprincipal or interest are due during the fiscal year ended June 30, 2021, withsix-month period beginning on the remainder maturing duringdate of the fiscal year ended June 30, 2022.PPP Loan. The PPP Loan is subject to any new guidance and new requirements released by the Department of the Treasury.

Fair value

The fair value of the Company's outstanding debt obligations as of December 31, 20192020 was $10,080,000,$7,497,000, which was determined based on a discounted cash flow model using an estimated market rate of interest of 12%15.00%, which is classified as Level 2 within the fair value hierarchy.

NOTE 107 INCOME TAXES

In order to determine the Company’s quarterly provision for income taxes, the Company used an estimated annual effective tax rate that is based on expected annual income and applicable federal and state tax rates.  The Tax Cuts and Jobs Act reduced the federal corporate tax rate to 21% in the fiscal year ended June 30, 2019.  Section 15 of the Internal Revenue Code stipulates that the Company’s fiscal year ended June 30, 2019, had a blended corporate tax rate of 28%, which is based on the applicable tax rates before and after the Tax Act and the number of days in the year. For the fiscal years ending after June 30, 2019, the Company’s federal corporate tax rate is 21%.  Certain significant or unusual items are separately recognized in the quarter during which they occur and can be a source of variability in the effective tax rate from quarter to quarter.

The Company recognized income tax benefitsexpense (benefit) of $4,239,780$5,000 and $713,526($4,239,780) for the three-month periods ended December 31, 2020 and 2019, respectively, and 2018, respectively. The Company recognized income tax benefitsexpense (benefit) of $9,448,195$6,052 and $1,325,978($9,448,195) for the six monthsix-month periods ended December 31, 20192020 and 2018,2019, respectively. The Company’sCompany's recognized effective tax rate differs from the U.S. federal statutory rate for the threesix months ended December 31, 2020 primarily due to state income taxes and share based compensation, offset by changes in the valuation allowance in deferred tax assets. The Company's recognized effective tax rate differs from the U.S. federal statutory rate for the six months ended December 31, 2019 primarily due to state income taxes, share based compensation and excess tax benefits arising from the exercise of commons stock warrants during the period, and tax benefits resulting from the impairment of our equity method investment (see Note 7), as well as an increase in the valuation allowance on deferred tax assets.  The Company’s recognized effective tax rate differs from the U.S. federal statutory rate for the three and six months ended December 31, 2018 primarily due to state income taxes and share based compensation.period.

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NOTE 11 STOCKHOLDER’S8 STOCKHOLDER'S EQUITY

The Company has issued various warrants exercisable for our common stock outside of the 2015 Stock Option Plan (see Note 13)10). The warrants were issued to raise capital, as compensation for acquisitions of intellectual property, and as compensation for services.

In September 2019, the Company entered into an agreement with a consultant for research and development services. In consideration for these services, the Company granted warrants to the consultant exercisable for 1,250,000 shares of the Company’s common stock with a strike price equal to the closing price of the Company’s common stock on the date of grant. Warrants to acquire 625,000 shares vested upon issuance. Of the remaining warrants, 375,000 vest on March 1, 2020 and 225,000 vest on September 1, 2020. The warrants expire ten years from the date of issuance.

On July 16, 2019 and August 1, 2019, a total of 11,000,000 common stock warrants issued to FlagshipSailsRx, LLC, our former sales and marketing contractor, were exercised pursuant to a cashless exercise feature. The cashless exercise resulted in the issuance of 9,172,157 shares of common stock and the cancellation of 1,827,843 warrants as consideration for the exercise price.

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The following is a summary of warrant activity from June 30, 20192020 through December 31, 2019:2020:

 

 

 

 

Number of Warrants

 

Weighted Average Exercise Price

 

Weighted Average

Remaining Contractual Life

(Years)

Warrant:

 

 

 

 

 

 

 

 

Outstanding June 30, 2019

68,253,520

$

0.78

 

3.6

 

Granted

 

1,250,000

 

1.73

 

9.7

 

Exercised

 

(9,223,605)

 

0.50

 

2.7

 

Forfeited/ Cancelled

 

(1,836,395)

 

0.50

 

2.7

Outstanding December 31, 2019

58,443,520

$

0.85

 

3.3

 

 

 

 

Number of Warrants

 

Weighted Average Exercise Price

 

Weighted Average

Remaining Contractual Life

(Years)

Warrant:

 

 

 

 

 

 

 

 

Outstanding June 30, 2020

53,093,520

$

0.78

 

3.6

 

Granted

 

-

 

-

 

-

 

Exercised

 

-

 

-

 

-

 

Forfeited/ Cancelled

 

-

 

-

 

-

Outstanding December 31, 2020

53,093,520

$

0.78

 

3.1

The Company recognizes expense for warrants issued for services that are subject to graded vesting on a straight-line basis. Share based compensation expense related to warrants issued for services for the three months ended December 31, 2020 and 2019 was $16,500 and 2018 was $1,361,172, and $358,333, respectively.  Share based compensation expense related to warrants issued for services for the six months ended December 31, 2020 and 2019 was $458,191 and 2018 was $3,251,384, and $944,778, respectively.

As of December 31, 2019,2020, unrecognized compensation cost related to warrants issued for services was $4,010,755$66,000 and is expected to be recognized over a weighted average period of 1.36 years.1.08 years

 

NOTE 129 EARNINGS PER COMMON SHARE (EPS)

The computation of weighted average shares outstanding and the basic and diluted earnings per common share for the following periods consisted of the following:

 

Net

 

Average Shares

 

Per Share

Net

 

Weighted

Average Shares

 

Per Share

Loss

 

Outstanding

 

Amount

Loss

 

Outstanding

 

Amount

Three months ended December 31, 2020

Three months ended December 31, 2020

 

 

 

 

Basic and diluted EPS attributable to common shareholders

Basic and diluted EPS attributable to common shareholders

(7,104,801)

 

299,596,808

 

$(0.02)

Three months ended December 31, 2019

Three months ended December 31, 2019

 

 

 

 

Three months ended December 31, 2019

 

 

 

 

Basic and diluted EPS attributable to common shareholders

$(26,002,669)

 

283,126,298

 

$(0.09)

Three months ended December 31, 2018

 

 

 

 

Basic and diluted EPS attributable to common shareholders

Basic and diluted EPS attributable to common shareholders

$(2,329,438)

 

263,278,417

 

$(0.01)

Basic and diluted EPS attributable to common shareholders

(26,002,669)

 

283,126,298

 

$(0.09)

Six months ended December 31, 2019

 

 

 

 

Six months ended December 31, 2020

 

 

 

 

Basic and diluted EPS attributable to common shareholders

$(33,867,276)

 

282,203,748

 

$(0.12)

Basic and diluted EPS attributable to common shareholders

(22,564,865)

 

299,596,808

 

$(0.08)

Six months ended December 31, 2018

 

 

 

 

Six months ended December 31, 2019

 

 

 

 

Basic and diluted EPS attributable to common shareholders

$(4,333,820)

 

258,672,982

 

$(0.02)

Basic and diluted EPS attributable to common shareholders

(33,867,276)

 

282,203,748

 

$(0.12)

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Potentially dilutive securities that would be excluded from the calculation of diluted net loss per common share because to include them would be anti-dilutive are as follows:

 

 

As of December 31,

 

As of December 31,

 

2019

2018

 

2020

2019

Warrants for common stock

 

58,443,520

64,993,520

 

53,093,520

58,443,520

Options for common stock

 

25,921,050

6,446,250

 

27,635,400

25,921,050

 

 84,364,570

71,439,770

 

80,728,920

 84,364,570

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NOTE 1310 STOCK OPTION PLAN

In 2015, a Stock Option Plan was adopted to advance the interests of the Company and its shareholders by helping the Company obtain and retain the services of employees, officers, consultants, independent contractors and directors, upon whose judgment, initiative and efforts the Company is substantially dependent, and to provide those persons with further incentives to advance the interests of the Company. Eligible participants include employees, officers, certain consultants, or directors of the Company or its subsidiaries.  

The number of shares, terms, and vesting periods are determined by the Company’sCompany's Board of Directors or a committee thereof on an award-by-award basis. Awards provided under the Plan generally vest in three equal annual installments. The maximum term of options issued under the plan is 10 years from the date of grant. The aggregate number of shares of Option Stock that may be issued pursuant to the exercise of Options granted under this Plan will not exceed fifteen percent (15%) of the total outstanding shares of the Company's common stock. The Company settles exercises of stock option awards by issuing new shares. Forfeitures are recognized as they occur.

A summary of option activity is as follows for the six months ended December 31, 2019:

 

 

Number of shares

 

Weighted average exercise price

Options outstanding at June 30, 2019

24,407,750

 $

1.74

Options granted

2,595,800

 

1.40

Less:

 

 

 

 

Options exercised

-

 

-

 

Options canceled or expired

(1,082,500)

 

1.65

Options outstanding at end of period

       25,921,050

 $

1.72

-35-2020:

 

 

Number of shares

 

Weighted average exercise price

Options outstanding at June 30, 2020

30,014,704

 $

1.47

Options granted

15,000

 

0.44

Less:

 

 

 

 

Options exercised

-

 

-

 

Options canceled or expired

(2,394,304)

 

1.32

Options outstanding at December 31, 2020

       27,635,400

 $

1.48

Share based compensation expense related to options issued under the 2015 Plan for the three months ended December 31, 2020 and 2019 was $2,633,389 and 2018 was $3,272,897, respectively, and $652,172, respectively. Share based compensation expense related to options issued under the 2015 Plan for the six months ended December 31, 2020 and 2019 was $5,128,278 and 2018 was $6,377,285, and $1,038,076, respectively.

The Company recognizes expense for awards subject to graded vesting on a straight-line basis. As of December 31, 2019,2020, there was $27,462,272of$14,341,473 of total unrecognized share-based compensation expense related to stock options issued under the 2015 Stock Option Plan that will be recognized over a weighted-average period of 2.431.53 years.

NOTE 1411 COMMITMENTS AND CONTINGENCIES

Licenses

The Company has commitments under license agreements which are described in Note 6.3.

Leases

On October 10, 2019, substantially all of the Company’sCompany's operating leases of office and laboratory space were amended to extend the expiration dates of the leases to September 30, 2021. The Company also leased an additional 6,711 square feet of office and storage space that commenced on November 1, 2019 and expires on September 30, 2021.

In March 2019, the Company entered into finance leases of laboratory equipment.  The validation process for the leased equipment was completed and payments commenced in October 2019.  The leases expire in September 2022,2023, at which time the Company has the option to purchase the leased equipment for one dollar.  

-21-

The table below presents the future minimummaturities of lease paymentsobligations under operating and finance leases:

       

Year Ending June 30,

 

Operating

 

Finance

 

Total

2020

$

476,816

$

393,090

$

869,906

2021

 

979,071

 

748,361

 

1,727,432

2022

 

       246,888

 

740,797

 

987,685

2023

 

                -   

 

 167,719

 

167,719

2024

 

                -   

 

-

 

-

Total cash payments

 

1,702,775

 

2,049,967

 

3,752,742

Less: Imputed interest

 

(128,619)

 

(214,844)

 

(343,463)

Total lease liability

$

1,574,156

$

1,835,123

$

3,409,279

-36-

Year Ending June 30,

 

Operating

 

Finance

 

Total

2021

 

493,775

 

317,959

 

811,734

2022

 

       246,888

 

740,798

 

987,686

2023

 

                -   

 

167,719

 

167,719

2024

 

                -   

 

-

 

-

2025

 

                -   

 

-

 

-

Total cash payments

 

740,663

 

1,226,476

 

1,967,139

Less: Imputed interest

 

(24,320)

 

(42,742)

 

(67,061)

Total lease liability

$

716,343

 

1,183,734

 

1,900,078

Lease information for the three and six months ended December 31, 2020 and 2019 is as follows:

 

 

 

Three months ended December 31, 2019

 

Six months ended December 31, 2019

Lease cost

 

 

  

Finance lease cost

 

 

  

 

Amortization of right of use assets

$

156,057

$

180,469

 

Interest on lease liabilities

 

     40,488

 

44,901

Operating lease cost

 

223,051

 

327,455

Short-term lease cost

 

450

 

64,787

Total lease cost

$

420,046

$

617,612

 

 

 

 

  

Cash paid for amounts included in the measurement of

 

 

  

lease liabilities

 

 

  

 

Operating cash flows from finance leases

$

40,488

$

44,901

 

Operating cash flows from operating leases

 

224,088

 

329,517

 

Financing cash flows from finance leases

 

156,057

 

180,469

 

 

 

 

  

Weighted average remaining lease term — finance leases (Years)

 

 2.61

  

Weighted average remaining lease term — operating leases (Years)

 

     1.75

  

Weighted average discount rate — finance leases

 

8.06%

  

Weighted average discount rate — operating leases

 

8.63%

  

Lease expense under operating leases was $108,201 and $159,979for the three and six month periods ended December 31, 2018, respectively.

-37-

Three Months

Ended

December 31, 2020

Three Months

Ended

December 31, 2019

Lease cost

 

 

  

Finance lease cost

 

 

  

 

Amortization of right of use assets

$

217,971

$

156,057

 

Interest on lease liabilities

 

26,357

 

40,488

Operating lease cost

 

236,683

 

223,051

Short-term lease cost

 

5,985

 

450

Total lease cost

$

486,996

$

420,046

 

 

 

   

Cash paid for amounts included in the measurement of

 

   

lease liabilities

 

   

 

Operating cash flows from finance leases

$

26,357

$

40,488

 

Operating cash flows from operating leases

 

194,525

 

224,088

 

Financing cash flows from finance leases

 

166,590

 

156,057

 

 

 

 

 

 

Six Months

Ended

December 31, 2020

 

Six Months
Ended

December 31, 2019

Lease cost

 

 

  

Finance lease cost

 

 

  

 

Amortization of right of use assets

$

432,309

$

180,469

 

Interest on lease liabilities

 

55,961

 

44,901

Operating lease cost

 

473,366

 

327,455

Short-term lease cost

 

8,739

 

64,787

Total lease cost

$

970,375

$

617,612

 

 

 

   

Cash paid for amounts included in the measurement of

 

   

lease liabilities

 

   

 

Operating cash flows from finance leases

$

55,961

$

44,901

 

Operating cash flows from operating leases

 

431,208

 

329,515

 

Financing cash flows from finance leases

 

329,749

 

180,918

 

 

 

   

Weighted average remaining lease term - finance leases (Years)

 

1.47

  

Weighted average remaining lease term - operating leases (Years)

 

0.75

  

Weighted average discount rate - finance leases

 

8.10%

  

Weighted average discount rate - operating leases

 

8.63%

  

-22-

Purchase commitments

In March 2019, in connection with the lease of laboratory equipment described above, the Company agreed to purchase a fixed quantity of the consumables used by the equipment for a total of $1,386,710. The Company is obligated to pay for the consumables in twelve fixed monthly installments beginning in October 2019. At December 31, 2019,2020, the Company had taken delivery of consumables worth $248,724$93,909 in excess of the installment amounts paid. The amount due for goods that have been delivered is included in accrued liabilities on the condensed consolidated balance sheet. Remaining payments due under the purchase commitment total $693,355 during the year ending June 30, 2020 and $346,477$577,795 during the year ending June 30, 2021.

Legal proceedings

On or about July 13, 2018, RTJ, LLC and two of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Jack Turner, Jr., an employee of Predictive Biotech, Inc. The plaintiffs had acted in a distributor capacity. The relationship was terminated. Plaintiffs are alleging breach of contract, promissory estoppel, unjust enrichment, fraud, breach of fiduciary duty, defamation, false light, and tortious interference. Based on the information available to us, we do not believe any of the RTJ proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

On or about May 1, 2019, Surgenex, LLC and one of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Doug Schmid, an employee of Predictive Biotech, Inc. In 2014 Surgenex contracted with Utah Cord Bank, Inc., a former employer of Doug Schmid, to assist Surgenex in the doing work relating to allograft tissue. Schmid was later hired by Predictive Biotech, Inc. In connection with Schmid’sSchmid's employment with Predictive Biotech, Surgenex has filed a lawsuit alleging unjust enrichment, conspiracy, conversion, tortious interference with contractual and business relations, violations of trade secrets act, and other claims. Based on the information available to us, we do not believe the Surgenex proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

-38-

On or about July 12, 2019, Predictive Technology Group, Inc. and Predictive Therapeutics, LLC, a subsidiary of Predictive Technology Group, Inc. filed a lawsuit against Michael Schramm. Schramm had previously acted as our patent agent. While acting as our patent agent,(Schramm). Schramm entered into an agreement to sell us certain patents and patent applications in consideration for equity securities. Schramm represented that he owned all right,rights, title, and interest in and to the intellectual property. We were subsequently advised by theour patent counsel who replaced Schramm that, Schramm’s representation was false.while the patents are registered with the US Patent and Trademark Office in the Company's name, the Company may not have a full interest in the patents. An unrelated third-party law firm placed a lien on the patents due to non-payment of legal fees by a third-party entity to whom certain assets were sold by another third-party entity that originally owned the patents.  The Company raised these concerns with Schramm, who did not provide satisfactory evidence addressingconfirming that the concerns of our current patent counsel.Company had sole title to the patents.  We sued Schramm for breach of contract, conversion and on other legal theories and are seeking, among other things, rescission of the purchase and sale transaction. While there is some question as to whether the Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the said patents. Schramm filed a counterclaim against us and Bradley C. Robinson, our Chief Executive Officer and Transfer Online, Inc., our transfer agent. Schramm is alleging he did not make any false representations. He is alleging, among other things, that various parties involved in the transaction committed breach of contract, conversion, violations of Nevada state law for failure to transfer securities, breach of fiduciary duty, tortious interference, and civil conspiracy.  Based on the information available to us, we do not believe the Schramm proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the counterclaim, have not discovered any evidence of wrongdoing with respect to the allegations in the counterclaim and will vigorously prosecute our claims against Schramm.

On or about March 18, 2020, Predictive Biotech, Inc. filed a lawsuit in the Utah District Court against Auxocell Laboratories, Inc. ("Auxocell") for breach of contract, product liability, breach of warranty, negligent misrepresentation and other claims relating to defects in laboratory equipment Auxocell sold to Predictive Biotech. Alleged damages include wasted umbilical cord tissue, lost inventory, costs associated with particulate testing, reputational injury, and related claims. On or about August 24, 2020, Auxocell answered the Complaint by denying the claims and asserting counterclaims of its own for breach of a confidentiality clause and failure to pay for devices. The Company answered and denied the counterclaims on December 14, 2020. Initial discovery has commenced and the current schedule has a discovery cut-off date of April 1, 2021. The litigation is still in discovery and as such we provide no opinion or assessment of the likely outcome of the litigation.

On or about November 11, 2020, Mackey Investment, LLLP ("Mackey") filed a lawsuit in Utah District Court against Predictive Technology Group, Inc and several officers of the Company. Mackey subscribed for and purchased 500,000 shares of Predictive common stock for $480,000 on or about January 29, 2020. Mackey was given all of the Company's SEC filings as part of his due diligence. Mackey is alleging that Predictive failed to disclose material information in connection with its investment and is alleging breach of contract, fraudulent inducement, violations of the Utah Uniform Securities Act, and conspiracy. The suit also seeks civil penalties and treble and punitive damages. The Company filed an answer denying the claims in the Complaint on or about December 4, 2020. Discovery has commenced, but we have not received discovery responses. We deny the allegations in the complaint and will vigorously defend against these allegations.

-23-

On or about April 30, 2020, Equitas Bio/Pharma Solutions, LLC ("Equitas") filed a lawsuit against Predictive Technology Group in New York District Court alleging nonpayment of "at least $551,080" in amounts owing under Master Service Agreement and Project Work Orders as of the date of filing. The claims are for breach of contract, breach of covenant of good faith and fair dealing and fraud. The basis of the fraud claim alleges that Predictive "made specific statements to Equitas that it was able to and intend to perform its obligations under the agreements" and at "the time Predictive made these promises it had no intention of keeping them." We agree that amounts are owed under the agreements, but we deny all allegations in the complaint relating to breach of covenant of good faith and fraud. Amounts due as of December 31, 2020 are included in accounts payable in the condensed consolidated balance sheets.

In June 2020, Wellgistics, LLC, the distributor of the Company's Assurance AB product, requested that the partial deposit paid on their non-cancellable purchase order of $5 million (see Note 5) be returned. As the purchase order is contractually non-cancellable and the Company performed on the order in good faith by transmitting the deposit to the Company's supplier, the request to return the deposit was not honored. To date there has been no legal action taken by either party.

As of December 31, 2019,2020, we did not record a liability related to these matters (other than amounts recorded in accounts payable as described above) as it was determined that an unfavorable resolution is either not currently probable or that an amount or relevant range is not reasonably estimable, or both. However, litigation is inherently unpredictable and it is possible that losses may occur. Any unfavorable resolution of any of these matters could materially affect our condensed consolidated financial position, cash flows, or results of operations. All legal costs associated with litigation are expensed as incurred.

-39-

COVID-19

On March 11, 2020, the World Health Organization declared the novel coronavirus ("COVID-19"), a respiratory illness first identified in Wuhan, China, a pandemic. The global spread of COVID-19 has created significant volatility, uncertainty, and economic disruption. Governments in affected regions have implemented, and may continue to implement, safety precautions which include quarantines, travel restrictions, business closures, cancellations of public gatherings and other measures as they deem necessary. Many organizations and individuals, including the Company and its employees, are taking additional steps to avoid or reduce infection, including limiting travel and working from home. These measures are disrupting normal business operations both in and outside of affected areas and have had significant negative impacts on businesses and financial markets worldwide.

The Company experienced operational and financial impacts from the COVID-19 pandemic beginning late in the third quarter of fiscal 2020, including the impact of stay-at-home mandates and related safety measures such as the delay of elective medical procedures, resulting in a decline in the volume of procedures using the Company's products.

The long- term severity of the material impact of the COVID-19 pandemic on the Company's business will continue to depend on a number of factors, including, but not limited to, the further duration and severity of the pandemic, including the effects of the new COVID-19 variants, and the continued extent and severity of the impact on the Company's customers and suppliers, all of which are uncertain and cannot be predicted. The impact of COVID-19 on the Company's results of operations and cash flows has been material and is expected to continue to be material for the remainder of this calendar year. Given the dynamic nature of this situation, the Company is currently unable to accurately predict the impact of COVID-19 on its future operations and financial results or cash flows for the foreseeable future and whether the impact of COVID-19 could lead to potential impairments.

FDA Warning Letter

We received a Warning Letter from the FDA on August 17, 2020 regarding the marketing of our allograft product, CoreCyte. The letter alleges inappropriate marketing of CoreCyte as a treatment for COVID-19 and challenges the eligibility of CoreCyte for regulation under section 361 of the Public Health Service Act. Products regulated solely under section 361 of the Public Health Service Act do not require premarket approval. The Company is currently working with the FDA to address the concerns raised in the Warning Letter to the FDA's satisfaction. The Company believes that it has complied with all applicable regulations to date.

Past due payments

As of December 31, 2020, many of the Company's obligations were significantly past due. As a result, our creditors may have grounds to take adverse action against the Company, including but not limited to lawsuits and seizure of collateral. Any such actions taken by our creditors could have material adverse impact on our operations or financial condition.

-24-

NOTE 1512 SUBSEQUENT EVENTS

Management has evaluated subsequent events through February 14,15, 2020, the date on which the financial statements were available to be issued.

On December 31, 2019, four accredited investors agreedJanuary 14, 2021, the Company entered into an amended and restated Promissory Note and Security Agreement with Prophase Labs, Inc.  This amendment modified the terms as described in substanceNote 6 above. The Company received additional proceeds in the amount of $1,000,000, which raised the outstanding amount to accept repayment$4,000,000, less $250,000, recognized as earned under the consulting agreement, for a total outstanding amount of $3,750,000. The amended promissory note bears 15% simple interest. Payments are to be made on a per test basis based on volume starting the 10th of the following month after recording a monthly sales volume, beginning March 10th for February sales.  Payments will not exceed the aggregate amounts due on the note, and will be applied first to interest, then principal. No other payments are due on the promissory note until September 2021, at which time monthly payments equal to 1/36th of the outstanding principal and interest amount shall commence.  If payments being made based on testing volume are greater, those will govern repayment. Unpaid interest accruing prior to September 2021 will be added to the principal amount. Any remaining principal and interest shall be due on September 30, 2022. The amended promissory note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test and may be prepaid without penalty

On January 14, 2021, the Company terminated its consulting agreement with ProPhase Labs, Inc. (see Note 6) in equity sharesorder to facilitate the closing of the amended and restated note as described above.

On February 9, 2021, Company received loan proceeds of an additional $1.7 million under the Paycheck Protection Program ("PPP") under a new promissory note from a commercial bank (the "PPP Second Loan"). The PPP, established as part of the CARES Act, provides for promissory notes with a face valueloans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of $8,420,000the qualifying business. The loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.

The application for these funds requires the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. Some of the uncertainties related to the Company's operations that are directly related to COVID-19 include, but are not limited to, the severity of the virus, the duration of the outbreak, governmental, business or other actions (which could include limitations on operations or mandates to provide products or services), impacts on the supply chain, and the $720,000 outstanding under ofeffect on customer demand or changes to operations. In addition, the Revolving Loan Agreement, as well as $311,918 in accrued interest thereon. For accounting purposes, the debt was not considered extinguished until the Company issued the shares in after the balance sheet date. Subsequent to the balance sheet date, the debt was extinguished in full by issuing 12,947,833 shareshealth of the Company's common stock based on the closing market price on December 31, 2019 of $0.73 per share.workforce and its ability to meet staffing needs are uncertain and is vital to its operations.

On January 29, 2020,

The PPP Second Loan certification further requires the Company sold 500,000 sharesto take into account our current business activity and our ability to access other sources of our common stock, par value $0.001,liquidity sufficient to an accredited investor atsupport ongoing operations in a price of $0.96 per share.

On February 10, 2020,manner that is not significantly detrimental to the business. While the Company and Juneau Biosciences, LLC, its equity method investee, executed an amendment to the agreement captioned “Third Amended and Restated Subscription Agreement.” Under the terms of the agreement, the Company issued common stock, par value $0.001, with a value of $2,430,000 (the “Equity Payment”) based on the closing market price on the agreement date that was applied against the subscription payable. The amendment also changed the schedule of cash payments due under the subscription agreement to purchase units of Juneau. The pro forma schedule of payments as of December 31, 2019 under the amended agreement is as follows, with the Equity Payment included in the amount shown for the fiscal year ended June 30, 2020:

Year Ending June 30

 

Amount

2020

$

3,030,000

2021

 

4,600,000

2022

 

       2,056,610

 

$

9,686,610

In February 2020, the Company borrowed $200,000does have availability under its Revolving Loan Agreement, the $2.8 million that is available is in place to support working capital needs, along with an accredited investor. current cash on hand. Further, the Company has a lack of history of being able to access the capital markets, exacerbated by our stock not being listed on a national exchange. As a result, the Company believes it meets the certification requirements.

The Company also borrowed an additional $450,000 under a promissory note with a second accredited investor. The promissory note bears 12% simple interestreceipt of these funds, and maturesthe forgiveness of the loan attendant to these funds, is dependent on the two-year anniversaryCompany having initially qualified for the loan and qualifying for the forgiveness of such loan based on our future adherence to the forgiveness criteria. The term of the note.Company's PPP Second Loan is five years. The note may be repaid atannual interest rate on the PPP Loan is 1% and no payments of principal or interest are due during the six-month period beginning on the date of the PPP Loan. The PPP Loan is subject to any time.new guidance and new requirements released by the Department of the Treasury.

-40-

-25-

Item 2. MANAGEMENT’SMANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

General

The following discussion and analysis should be read in conjunction with the audited ConsolidatedCondensed consolidated Financial Statements and accompanying notes thereto included in the Company’sCompany's Annual Report on Form 10-K as of and for the fiscal year ended June 30, 2019.2020.  Unless otherwise noted, all of the financial information in this Report is condensed consolidated financial information for the Company.

General

Predictive Technology Group, Inc., a Salt Lake City, UT life sciences company, is a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through unique novel gene-based diagnostics, biotechnology treatments and companion therapeutics. Through its’its' wholly-owned subsidiaries, Predictive Biotech, Predictive Laboratories, and Predictive Therapeutics, the company focuses on clinical categories such as: Endometriosis, Degenerative Disc Disease and Human Cell and Tissue Products (“("HCT/P”P"). In addition to Predictive Biotech’sBiotech's efforts to advance regenerative medicine, Predictive Laboratories is committed to assisting women in overcoming the devastating consequences of endometriosis via appropriate early-stage diagnosis and subsequent treatment. During the three and six months ended December 31, 2020 we reported total revenues of $4,067,488 and $9,158,492, respectively. We reported net losses attributable to common shareholders of $7,104,801 and $22,564,865, resulting in net losses per common share of $(0.02) and $(0.08), respectively. During the three and six months ended December 31, 2019 we reported total revenues of $7,336,640 and $15,595,898, respectively. We reported net losses attributable to common shareholders of $26,002,669 and $33,867,276, resulting in net losses per common share of $(0.09) and $(0.12), respectively.  During the three and six months ended December 31, 2018 we reported total revenues of $10,687,036 and $18,750,838, respectively. We reported net losses attributable to common shareholders of $2,329,438 and $4,333,820 resulting in net losses per common share of $(0.01) and $(0.02), respectively.

Our business units have been aligned with how the Chief Operating Decision Maker reviews performance and makes decisions in managing the Company.  The business units have been aggregated into two reportable segments: Human Cell and Tissues Products (HCT/Ps) and diagnostics and therapeutics. Predictive Biotech’sBiotech's HCT/Ps are processed in our FDA registered lab. Our minimally manipulated tissue products are prepared utilizing proprietary extraction methods that reduce the loss of important scaffolding, growth factor and general cytokines and are intended for homologous use.  Predictive Laboratory’sThe diagnostics and therapeutics segment uses data analytics for disease identification and subsequent therapeutic intervention through unique novel gene-based diagnostics, biotechnology treatments and companion therapeutics.

-41-

Business Highlights

Diagnostics and Therapeutics

On January 28, 2020, we announced a potential collaboration agreement with Atrin Pharmaceuticals LLC to develop molecular diagnostic tools to facilitate improved selection of cancer patients who would most benefit from treatment with DNA Damage and Response (DDR) inhibitors, including Atrin’s and other small molecule ATR inhibitors. Atrin and Predictive will jointly utilize Predictive Laboratories’ state-of-the-art sequencing capabilities and genomics expertise to identify cancer patients with specific molecular markers that predict the level of clinical response to Atrin’s, and other, targeted therapies. This is intended to improve patient outcomes as well as improve Atrin’s ability to successfully progress its product pipeline, and upon commercialization, improve on the treatments for women with cancer. Predictive, with its proprietary list of already identified genes and state-of-the-art sequencing capabilities, believes it is the ideal molecular diagnostic partner to help Atrin successfully advance their therapeutic pipeline through clinical development. The companies believe that this collaboration may become a ‘game changer’ in oncology, as treatment continues to progress towards individualized precision medicine. As Atrin advances multiple Investigational New Drug (IND) applications and progresses their lead product candidate ATRN-119 into a first-in-human clinical study this year, Predictive’s portfolio of genomic tests will help Atrin better identify cancer patient populations whose genetic profiles will likely have an optimal clinical response to Atrin’s proprietary anti-cancer therapeutics. The collaboration will help optimize the safety and clinical efficacy of Atrin’s targeted cancer therapeutics and other DDR drug candidates. Atrin will have access to Predictive’s proprietary GenDB databases and women’s health biobank to better understand the clinical spectrum of germline mutations in DDR pathways. The companies will also study common gynecologic disorders, such as endometriosis, associated with the development of cancers in affected patients. The goal of this collaboration is to develop actionable predictive molecular and companion diagnostics and therapeutics for these common disorders and related cancers.

On October 16, 2019, Kenneth Ward, M.D., Chief executive officer of Juneau Biosciences; Rakesh Chettier M.S., director of biostatistics of Predictive Laboratories; and Hans Albertsen, Ph.D., chief scientific officer of Juneau Biosciences, received the 2019 Endometriosis Special Interest Group (EndoSIG) Prize Paper in the “Best in Clinical/Population Science” category at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress & Expo in Philadelphia. The scientific breakthroughs reported in these award-winning discoveries provide us with insights into new non-hormonal therapies. The team’s research is based on the genetic markers of endometriosis discovered by Juneau and Predictive scientists in recent years, and uncovers molecular pathways involved in the pathogenesis of endometriosis-induced lesions in women at risk for the disease.  Dr. Ward, a board-certified physician in obstetrics and gynecology, perinatology, clinical genetics and molecular genetics, presented two scientific papers at the Annual ASRM meeting:  a poster entitled, “Endometriosis risk allele in WNT4 may interact with rare mutations in HDAC2 gene” and an oral abstract entitled, “Somatic cancer driver mutations in endometriosis lesions contribute to secondary cancer risk.”

On October 14, 2019, we launched the full U.S. market availability of ARTguide™ to evaluate the risk for endometriosis and other genetic causes of infertility in women. Endometriosis can be a debilitating disease for many women as it can cause severe pelvic pain, inflammation, adhesions to the fallopian tubes and uterus, and often, infertility. ARTguide can predict a patient’s risk of endometriosis early on so that women have a better understanding of their barriers to conception, and therefore their physician can create a more personalized infertility treatment plan. ARTguide is appropriate for all women considering use of ART to overcome difficulty conceiving or carrying a pregnancy.

-42-

On October 15, 2019, we entered into an agreement with CLSA Capital Markets Limited, a CITIC Securities Company, to provide introductions to potential strategic partners and regulatory guidance to support the launch of our proprietary genetic-based products into China’s (PRC) rapidly growing markets for women’s health and fertility. We anticipate introducing ARTguide™ among other fertility diagnostics to the Chinese market. In 2016 the National Health and Family Planning Commission of the PRC reported that 40 million Chinese couples were experiencing fertility issues.  Similarly, the American Society for Reproductive Medicine (ASRM) reported in 2017 that an estimated 25% of Chinese women of childbearing age struggled with infertility issues.  In 2018 the European Society of Human Reproduction and Embryology estimated that approximately 800,000 assisted reproductive technology (ART) cycles, such as in vitro fertilization (IVF), were being performed in China annually.  Chinese women are driving the fertility markets both in China and medical tourism industries overseas.  The global IVF market is expected to grow at an annual rate of 10.2% and to reach $36.2 billion by 2026.  The U.S. Center for Disease Control reported that of the patients who sought fertility care in 2017, 284,385 ART cycles were performed resulting in 78,052 live born infants with ART accounting for 1.7% of all infants born in the U.S. annually.

In October 2019, we launched FertilityDX™, a comprehensive genetic testing service that identifies barriers to healthy pregnancy and birth, allowing doctors to tailor fertility treatments. The objective of FertilityDX™ is to provide couples considering ART with an understanding of the genetic and medical obstacles that may be affecting their fertility and provide doctors with genetically relevant information to help their patients have a healthy baby. FertilityDX™ provides information by evaluating three key areas: contributors to (or causes of) infertility, risks of pregnancy complications, and risks for serious genetic conditions in offspring. The test will be launched in select fertility clinics across the United States.

In August 2019, we collected over 2,500 DNA samples along with comprehensive medical records since acquiring our CLIA operations in March 2019. We broadened our research initiatives by acquiring new sample collections in chronic pain, pregnancy complications, autism, and both female and male infertility. Personalized medicine and the development of new therapeutics are expected to play a critical role in human health. Access to high-quality biospecimens from our biobank will be important for furthering our biomedical and translational research, and ultimately its development of personalized molecular diagnostics and clinical therapies. Current sample collection efforts are designed to strategically augment our existing library of over 300,000 DNA samples that we believe will produce valuable insights into future research and development projects.

-43-

On August 9, 2019, we launched PGxPLUS+™, a pharmacogenomic test panel being marketed to pain clinics for patients with chronic pain.  PGxPLUS+™ evaluates genetic factors that play a major role in an individual’s response to medications.  In parallel, we reached a milestone of enrolling 350 patients with chronic pain into an Investigational Review Board-approved clinical study aimed at providing additional insight into the mechanisms of chronic pain and responses to pain therapies. We are approaching chronic pain and the opioid crisis on multiple fronts. We have developed and in-licensed important prognostic DNA tests and novel treatments for osteoarthritis, lumbar disc disease, endometriosis, and other conditions causing chronic pain.  In 2016, the Institute of Medicine estimated that up to one-third of the U.S. population lives with ongoing pain.  Chronic pain is often triggered by one of these common conditions, and over time can develop into a chronic pain syndrome, which is a disease itself. The PGxPLUS+™ test evaluates 112 genetic variants across 38 genes that affect the metabolism of over 150 common medications, including pain medications.  More than 90% of the population has one or more gene variants that affect the efficacy or safety of prescription drugs. Variation in drug metabolism is largely determined by an individual’s genetic profile, blood levels of a drug may vary up to 1,000-fold in similar patients taking identical doses of the same drug.  Pharmacogenomics is the study of the role of our genome in drug responses.

On July 29, 2019, we entered into an agreement with the Preeclampsia Foundation to expand the study of genetic factors associated with preeclampsia. The study will advance the Preeclampsia Foundation’s database of collected preeclampsia medical information and will be utilized by Predictive Laboratories to develop a proprietary test for the early detection of women at risk for preeclampsia. Preeclampsia affects 5-8%, or approximately 300,000, pregnancies every year in the United States, sometimes causing severe adverse maternal and fetal outcomes, including organ failure, massive blood loss, permanent disability or even death. Globally, preeclampsia is a leading cause of pregnancy complications, preterm births and related disabilities. The deaths of approximately 76,000 mothers and 500,000 babies annually are attributable to preeclampsia. Healthcare providers, even in medically advanced countries, are hampered by imprecise diagnostic tools. The Preeclampsia Registry, a key program of the Preeclampsia Foundation’s research mission, is a patient registry that collects paired medical information and biological samples. Using established Institutional Review Board-approved protocols, we and the Preeclampsia Foundation will request samples from more than 2,500 existing and new registry participants for sequencing analysis. We have been granted a period of exclusive access to research data resulting from these new samples enrolled in the Preeclampsia Registry, after which samples and sequencing data will be available to other investigators for future research. This collaboration complements and extends our ongoing preeclampsia research initiatives. Over 20,000 DNA samples from our biorepository relating to preeclampsia and associated obstetric syndromes are being analyzed.

Human Cell and Tissue Products (HCT/P)

In November 2019, Predictive Biotech’s HCT/P processing facility successfully achieved the internationally recognized ISO 13485 certification over the Company’s system of laboratory quality controls.

In December 2019, Predictive Biotech submitted to the Centers for Medicare and Medicaid Services (CMS) a HCPCS code application for each of the company’s four allograft products (CoreCyte™, PolyCyte™, AmnioCyte Plus™ and AmnioCyte™) as part of the company’s strategy to obtain insurance reimbursement.

-44-

Results of Operations for the Three Months Ended December 31, 20192020 and 20182019

 

Revenue

 

 

Three months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Revenue

 

$

7,336,640

 

 

$

10,687,036

 

 

$

(3,350,396)

The decrease

 

 

Three months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

HCT/P

 

$

2,654,565

 

 

$

7,289,265

 

 

$

(4,634,700)

Diagnostics and Therapeutics

  

1,412,923

   

47,375

   

1,365,548

Total

 

$

4,067,488

  

$

7,336,640

  

$

(3,269,152)

Revenue in revenuethe HCT/P segment for the three months ended December 31, 2019 is primarily due to the decline in sales volume of allograft products compared to2020 decreased by $4.6 million from $7.3 million for the three months ended December 31, 2018.2019. The Company believes the decrease in sales volume is primarily due to increased United States Food and Drug Administration (“FDA”) enforcement efforts affecting the regenerative medicine industry as a whole,impact of the COVID-19 pandemic, which has negatively impactedcaused continued sales declines due to closure of customer clinics and reduced patient visits to those clinics that remain open.

In October 2020, the sizeCompany notified the FDA that it had suspended sales of the marketCoreCyte allograft product pending the anticipated filing of an IND application with the FDA. CoreCyte represented 51.0% of the Company's sales for regenerative medicine servicesthe six months ended December 31, 2020. While commercial success cannot be guaranteed, the Company is executing its transition plan related to the CoreCyte IND application and caused a contraction ofexpects to generate additional sales of allograft products.  Specifically, the FDA has issued warnings to competitors regarding their safety practicesfrom new and increased regulatory scrutiny of potentially inappropriate marketing practices of some providers of regenerative medicine services. Predictive Biotech, Inc. continues to be the market share leader of regenerative medicineexisting products in the US with an excellent safety and quality record of over 100,000 allografts implanted and no adverse events.near term.

Revenues

Revenue in ourthe diagnostics and therapeutics segment were not material for the periods shown.three months ended December 31, 2020 increased by $1.4 million from zero due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020.

-26-

Cost of goods sold (Exclusive of Depreciation & Amortization)

 

 

Three months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Cost of goods sold

 

$

5,840,256

 

 

$

3,059,136

 

 

$

2,781,120

Cost of goods sold as a % of sales

 

 

79.6

%

 

 

28.6

%

 

 

 

 

 

Three months ended

 

 

 

 

 

 

December 31,

 

 

 

 

Cost of goods sold

 

2020

 

 

2019

 

 

Change

   HCT/P

 

$

1,812,339

 

 

$

5,840,256

 

 

$

(4,027,917)

   Diagnostics and Therapeutics

  

1,016,353

   

-

   

1,016,353

Total

 

$

2,828,692

  

$

5,840,256

  

$

(3,011,564)

            

Cost of goods sold as a % of sales

 

 

  

 

 

  

 

 

 

   HCT/P

  

  68.3

%

  

79.6

%

   

   Diagnostics and Therapeutics

  

71.9

%

  

-

%

   

Cost of goods sold in the HCT/P segment for the three months ended December 31, 2020 decreased to $1.8 million from $5.8 million for the three months ended December 31, 2019. Approximately $1.2 million of decrease is due to decreased sales. The remaining decreases are primarily comprised of $1.0 million in scrap expense, $0.5 million in personnel costs, and $0.3 million in freight and transaction costs. Scrap expense for the three months ended December 31, 2019 increasedwas abnormally high, primarily due to $5.8 milliondefective components supplied by a specific vendor (see Note 11 to the accompanying condensed consolidated financial statements for a summary of legal action taken against the vendor). The remaining decreases resulted from $3.1 milliondecreased sales and decreases in production capacity made in response to the decrease in sales.

Cost of goods sold in the diagnostics and therapeutics segment for the three months ended December 31, 2018. The increase is primarily2020 increased to $1.0 million from zero due to $1.9 million in scrap expense and idle capacity costs resulting from efforts to curtail production in response to the trend in sales. In addition, there was a $0.8 million increase in scrap expense due to a decrease in average quality control pass rates for WIP product compared tointroduction of the threeAssurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2018.2020. The profitability of the COVID-19 testing business is sensitive to testing volume, with higher marginal profitability per unit after fixed costs are covered.

Cost of sales in our diagnostics and therapeutics segment was not material for the periods shown.

-45-

Selling and marketing expenses

 

 

 

Three months ended

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

Selling and marketing expense

 

 

$

3,049,593

 

 

$

3,431,157

 

 

$

(381,564)

 

Selling and marketing expense as a % of sales

 

 

 

41.6

%

 

 

32.1

%

 

 

 

 

 

 

 

Three months ended

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

 

Selling and marketing expense

 

 

$

872,156

 

 

$

3,049,593

 

 

$

(2,177,437)

 

Selling and marketing expense as a % of sales

 

 

 

21.4

%

 

 

41.6

%

 

 

 

 

Selling and marketing expenses for the three months ended December 31, 20192020 decreased to $3.0$0.9 million from $3.4$3.0 million for the three months ended December 31, 2018.2019. The decrease is due to increasesdecreases in personnel costs of $0.6$0.8 million, offset by a decrease in commissions expense of $1.0$0.7 million, and stock based compensation of $0.3 million.

Substantially all of our selling and marketing expenses were incurred in the HCT/P segment.

-27-

General and Administrative Expenses

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

General and administrative expense

 

 

$

7,034,770

 

 

$

2,878,614

 

 

$

4,156,156

General and administrative expense as a % of sales

 

 

 

95.9

%

 

 

26.9

%

 

 

 

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

General and administrative expense

 

 

$

4,910,346

 

 

$

7,034,770

 

 

$

(2,124,424)

General and administrative expense as a % of sales

 

 

 

120.7

%

 

 

95.9

%

 

 

 

General and administrative expenses for the three months ended December 31, 2019 increased2020 decreased to $7.0$4.9 million from $2.9$7.0 million for the three months ended December 31, 2018.2019. Approximately $3.3$2.0 million of the increasedecrease is due to increaseddecreased share-based compensation expenses. Personnel costs also increased by $0.6 million.

-46-

Research and Development Expenses

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Research and development expense

 

 

$

2,364,350

 

 

$

1,759,560

 

 

$

604,790

Research and development expense as a % of sales

 

 

 

32.2

%

 

 

16.5

%

 

 

 

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

Research and development expense

 

 

$

557,381

 

 

$

2,364,350

 

 

$

(1,806,969)

Research and development expense as a % of sales

 

 

 

13.7

%

 

 

32.2

%

 

 

 

Research and development expenses for the three months ended December 31, 2019 increased2020 decreased to $2.4$0.6 million from $1.8$2.4 million for the three months ended December 31, 2018.2019. Approximately $0.1 million of the decrease is due to decreased payroll expense, with the remainder driven by reallocation of resources previously used in R&D expenses primarily related to perform the development of new HCT/P products and continued development of molecular diagnostic tests.Assurance VR COVID-19 test.

Depreciation and amortization expense

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Depreciation and amortization expense

 

 

$

2,775,073

 

 

$

2,035,360

 

 

$

739,713

Depreciation and amortization expense as a % of sales

 

 

 

37.8

%

 

 

19.0

%

 

 

 

 

 

 

Three months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

Depreciation and amortization expense

 

 

$

1,751,562

 

 

$

2,775,073

 

 

$

(1,023,511)

Depreciation and amortization expense as a % of sales

 

 

 

43.1

%

 

 

37.8

%

 

 

 

Depreciation and amortization expense increaseddecreased compared to the same period in the prior fiscal year primarily due to an increasea decrease in our intangible asset portfolio arising from the business combinations and asset acquisitionsimpairment of RMT described in Note 3 to the accompanying condensed consolidated financial statements.   Capital expenditures to acquire property, plant, and equipment in connection with our laboratory expansion also contributed to the increase.   

-47-

Other loss

 

 

Three months ended

 

 

 

 

 

December 31,

 

 

 

 

 

2019

 

 

2018

 

Change

Other loss

 

$

16,546,988

 

 

$

599,627

 

$

15,947,361

 

 

Three months ended

 

 

 

 

 

December 31,

 

 

 

 

 

2020

 

 

2019

 

Change

Other loss

 

$

278,754

 

 

$

16,546,988

 

$

(16,268,234)

Other loss for the three months ended December 31, 2019 increased2020 decreased to $16.5$0.3 million from $0.6$16.5 million for the three months ended December 31, 2018.2019. The increasedecrease was primarily driven by the $15.9 million impairment charge recognized in December 2019 related to our equity method investment in Juneau Biosciences, LLC.LLC

-28-

Results of Operations for the Six Months Ended December 31, 20192020 and 20182019

 

Revenue

 

 

Six months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Revenue

 

$

15,595,898

 

 

$

18,750,838

 

 

$

(3,154,940)

The decrease

 

 

Six months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

HCT/P

 

$

6,523,823

 

 

$

15,473,896

 

 

$

(8,950,073)

Diagnostics and Therapeutics

  

2,634,669

   

122,002

   

2,512,667

Total

 

$

9,158,492

  

$

15,595,898

  

$

(6,437,406)

Revenue in revenuethe HCT/P segment for the threesix months ended December 31, 20192020 decreased by $9.0 million from $15.5 million for the six months ended December 31, 2019. The decrease is primarily due to the decline inimpact of the COVID-19 pandemic, which has caused continued sales volumedeclines due to closure of customer clinics and reduced patient visits to those clinics that remain open.

In October 2020, the Company notified the FDA that it had suspended sales of the CoreCyte allograft products compared toproduct pending the threeanticipated filing of an IND application with the FDA. CoreCyte represented 51.0% of the Company's sales for the six months ended December 31, 2018.  The2020. While commercial success cannot be guaranteed, the Company believesis executing its transition plan related to the decrease inCoreCyte IND application and expects to generate additional sales volume is due to increased United States Foodfrom new and Drug Administration (“FDA”) enforcement efforts affecting the regenerative medicine industry as a whole, which has negatively impacted the size of the market for regenerative medicine services and caused a contraction of sales of allograft products.  Specifically, the FDA has issued warnings to competitors regarding their safety practices and increased regulatory scrutiny of potentially inappropriate marketing practices of some providers of regenerative medicine services. Predictive Biotech, Inc. continues to be the market share leader of regenerative medicineexisting products in the US with an excellent safety and quality record of over 100,000 allografts implanted and no adverse events.near term.

Revenues

Revenue in ourthe diagnostics and therapeutics segment were not material for the periods shown.six months ended December 31, 2020 increased by $2.5 million from $0.1 million due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020

-48-

Cost of goods sold (Exclusive of Depreciation & Amortization)

 

 

Six months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Cost of goods sold

 

$

13,022,246

 

 

$

6,107,692

 

 

$

6,914,554

Cost of goods sold as a % of sales

 

 

83.5

%

 

 

32.6

%

 

 

 

 

 

Six months ended

 

 

 

 

 

 

December 31,

 

 

 

 

Cost of goods sold

 

2020

 

 

2019

 

 

Change

   HCT/P

 

$

4,198,999

 

 

$

13,022,246

 

 

$

(8,823,247)

   Diagnostics and Therapeutics

  

2,094,830

   

-

   

2,094,830

Total

 

$

6,293,829

  

$

13,022,246

  

$

(6,728,417)

            

Cost of goods sold as a % of sales

 

 

  

 

 

  

 

 

 

   HCT/P

  

64.4

%

  

84.2

%

   

   Diagnostics and Therapeutics

  

79.5

%

  

-

%

   

Cost of goods sold in the HCT/P segment for the six months ended December 31, 2020 decreased to $4.2 million from $13.0 million for the six months ended December 31, 2019. Approximately $3.0 million of decrease is due to decreased sales. The remaining decreases are primarily comprised of $1.8 million in scrap expense, $0.5 million in personnel costs, and $0.3 million in freight and transaction costs. Scrap expense for the six months ended December 31, 2019 increasedwas abnormally high, primarily due to $13.0 milliondefective components supplied by a specific vendor (see Note 11 to the accompanying condensed consolidated financial statements for a summary of legal action taken against the vendor). The remaining decreases resulted from $6.1 milliondecreased sales and decreases in production capacity made in response to the decrease in sales.

Cost of goods sold in the diagnostics and therapeutics segment for the six months ended December 31, 2018. The increase is primarily2020 increased to $2.1 million from zero due to $3.8 million in scrap expense relatedthe introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020. The profitability of the COVID-19 testing business is sensitive to HCT/P product that did not pass quality control, or that is not expected to pass quality control. The increase in quality control failure rates above normal levels was primarily due to issuestesting volume, with a component supplied by a specific vendor.  An additional $1.9 million in scrap expense and other idle capacityhigher marginal profitability per unit after fixed costs resulted from efforts to curtail production in response to the trend in sales.are covered

Cost of sales in our diagnostics and therapeutics segment was not material for the periods shown.

-29-

Selling and marketing expenses

 

 

 

Six months ended

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

Selling and marketing expense

 

 

$

6,201,563

 

 

$

5,838,593

 

 

$

362,970

 

Selling and marketing expense as a % of sales

 

 

 

39.8

%

 

 

31.1

%

 

 

 

 

 

 

 

Six months ended

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

 

Selling and marketing expense

 

 

$

1,933,954

 

 

$

6,201,563

 

 

$

(4,267,609)

 

Selling and marketing expense as a % of sales

 

 

 

21.1

%

 

 

39.8

%

 

 

 

 

Selling and marketing expenses for the six months ended December 31, 2019 increased2020 decreased to $6.2$1.9 million from $5.8$6.2 million for the six months ended December 31, 2018.2019. The increasedecrease is due to increasesdecreases in personnel costs of $1.6$1.0 million, and increased bad debt expense of $0.2 million, offset by a decrease in commissions expense of $1.4$3.2 million.

Substantially all of our selling and marketing expenses were incurred in the HCT/P segment.

-49-

General and Administrative Expenses

 

 

 

Six months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

General and administrative expense

 

 

$

13,413,627

 

 

$

5,544,762

 

 

$

7,868,865

General and administrative expense as a % of sales

 

 

 

86.0

%

 

 

29.6

%

 

 

 

 

 

 

Six months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

General and administrative expense

 

 

$

10,167,845

 

 

$

13,413,627

 

 

$

(3,245,782)

General and administrative expense as a % of sales

 

 

 

111.0

%

 

 

86.0

%

 

 

 

General and administrative expenses for the six months ended December 31, 2019 increased2020 decreased to $13.4$10.2 million from $5.5$13.4 million for the six months ended December 31, 2018.2019. Approximately $5.6$3.4 million of the increasedecrease is due to increaseddecreased share-based compensation expenses. Personnel costs increasedalso decreased by $1.8$0.1 million.  The decreases in personnel costs resulted primarily from the April 2020 reduction in force.

Research and Development Expenses

 

 

 

Six months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Research and development expense

 

 

$

4,192,700

 

 

$

2,365,644

 

 

$

1,827,056

Research and development expense as a % of sales

 

 

 

26.9

%

 

 

12.6

%

 

 

 

 

 

Six months ended

 

 

 

 

 

December 31,

 

 

 

  

2020

 

 

2019

 

Change

Research and development expense

 

$

928,223

 

 

$

4,192,700

 

$

(3,264,477)

Research and development expense as a % of sales

 

 

10.1

%

 

 

26.9

%

 

 

Research and development expenses for the six months ended December 31, 2019 increased2020 decreased to $4.2$0.9 million from $2.4$4.2 million for the six months ended December 31, 2018. The increase was primarily2019. Approximately $1.8 million of the decrease is due to decreased share-based compensation expense, with the remainder driven by an increasereallocation of $1.5 millionresources previously used in share based compensation expense.R&D to perform the Assurance VR COVID-19 test.

-50-

-30-

Depreciation and amortization expense

 

 

 

Six months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

Depreciation and amortization expense

 

 

$

5,385,318

 

 

$

3,701,082

 

 

$

1,684,236

Depreciation and amortization expense as a % of sales

 

 

 

34.5

%

 

 

19.7

%

 

 

 

 

 

 

Six months ended

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

Depreciation and amortization expense

 

 

$

4,235,645

 

 

$

5,385,318

 

 

$

(1,149,673)

Depreciation and amortization expense as a % of sales

 

 

 

46.2

%

 

 

34.5

%

 

 

 

Depreciation and amortization expense increaseddecreased compared to the same period in the prior fiscal year primarily due to an increasea decrease in our intangible asset portfolio arising from the business combinations and asset acquisitionsimpairment of RMT described in Note 3 to the accompanying condensed consolidated financial statements.   Capital expenditures

Loss on impairment

            

 

 

Six months ended

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020

 

 

2019

 

Change

 

Loss on Impairment

 

$

7,015,326

  

$

-

 

$

7,015,326

 

Loss on impairment for the six months ended December 31, 2020 increased to acquire property, plant, and equipment in connection with our laboratory expansion also contributed$7.0 million due to the increase.impairment of $5.2 million in goodwill and $1.8 million in trade secrets in the HCT/P segment (see Note 3 to the accompanying condensed consolidated financial statements).  

 

Other loss

 

 

Six months ended

 

 

 

 

 

December 31,

 

 

 

 

 

2019

 

 

2018

 

Change

Other loss

 

$

16,759,770

 

 

$

913,986

 

$

15,845,784

 

 

Six months ended

 

 

 

 

 

December 31,

 

 

 

 

 

2020

 

 

2019

 

Change

Other loss

 

$

1,206,165

 

 

$

16,759,770

 

$

(15,553,605)

Other loss for the six months ended December 31, 20192020 decreased to $16.8$1.2 million from $0.9$16.8 million for the six months ended December 31, 2018.2019. The increasedecrease was primarily driven by the $15.9 million impairment charge recognized in December 2019 related to our equity method investment in Juneau Biosciences, LLC.

-51-

Liquidity and Capital Resources

The Company incurred a net loss attributable to common stockholders of $33,867,276$22,564,865 and net cash outflows from operations of $2,972,152 for the six months ended December 31, 2019 and net cash outflows from operations of $9,914,968.2020. At December 31, 2019,2020, the Company had $255,502$134,376 of cash and negative working capital of $4,861,267.$23,020,768. The Company's historical and current use of cash in operations combined with limited liquidity resources raise substantial doubt regarding the Company's ability to continue as a going concern. Management may seek additional capital through debt financings, collaborative or other funding arrangements with partners, sale of assets, or through other sources of financing. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all.all to mitigate the substantial doubt that exists. If the Company is unable to raise additional capital when required or on acceptable terms, this could have a material adverse effect on liquidity. In such a case, the Company may be required to scale back or to discontinue the promotion of currently available products, scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations.

-31-

Our capital deployment strategy focuses on use of resources in two key areas: research and development, and the commercialization of our HCT/Ps and diagnostic products. We believe that research and development provides the best return on invested capital.  We also allocate capital for acquisitions that support our business strategy.

The following table represents the condensed consolidated cash flow statement:

 

 

Six months ended

 

 

 

 

December 31,

 

 

 

 

2019

 

2018

Change

Cash provided by (used in) operating activities

 

$

(9,914,968)

 

$

2,058,633

$

(11,973,601)

Cash used in investing activities

 

 

(946,856)

 

 

(1,729,843)

 

782,987

Cash provided by financing activities

 

 

9,499,082

 

 

1,025,000

 

8,474,082

Net increase (decrease) in cash and cash equivalents

 

 

(1,362,742)

 

 

1,353,790

  

Cash and cash equivalents at the beginning of the six months

 

 

1,618,244

 

 

1,206,139

  

Cash and cash equivalents at the end of the period

 

$

255,502

 

$

2,559,929

  

 

Six months ended

 

 

 

 

December 31,

 

 

 

 

2020

 

2019

 

Change

Cash used in operating activities

$

(2,972,152)

 

$

(9,914,968)

 

$

  6,942,816

Cash used in investing activities

 

(299,951)

 

 

(946,856)

 

 

    646,905

Cash provided by financing activities

 

3,075,251

 

 

9,499, 082

 

 

(6,423,831)

Net decrease in cash and cash equivalents

 

(196,852)

 

 

(1,362,742)

 

 

 

Cash and cash equivalents at the beginning of the period

 

331,228

 

 

1,618,244

 

 

 

Cash and cash equivalents at the end of the period

$

134,376

 

$

255,502

 

 

 

Cash Flows from Operating Activities

The increasedecrease in cash used in operating activities for the six months ended December 31, 20192020 compared to the six months ended December 31, 20182019 was primarily due to decreases in cash paid to suppliers and employees as a $29.5 million increaseresult of reductions in net loss,production and a $8.1 million increaseproduction capacity made in deferred income tax benefits, offset by increases of non-cash addbacks for loss on equity method investment of $15.5 million, share based compensation of $7.6 million, and depreciation and amortization of  $1.7 million.  response to decreasing sales.

-52-

Cash Flows from Investing Activities

The decrease in cash used in investing activities for the six months ended December 31, 20192020 compared to the six months ended December 31, 20182019 was primarily due to a decrease in cash paid onfor equity under our subscription payableagreement of $0.7$0.5 million and a decrease in cash paid for capital expenditures of $0.7$0.2 million. These changes were partly offset by $0.8 million in cash received from the acquisition of InceptionDX, LLC.

Cash Flows from Financing Activities

The increasedecrease in cash provided by financing activities for the six months ended December 31, 20192020 compared to the six months ended December 31, 20182019 was primarily due to the receipt of $3.4 million in proceeds from the issuance of promissory notes, while during last year $9.7 million in proceeds from the issuance of promissory notes offset by a decrease of $1.0 million in cash received from stock subscriptions.was received.  

 

Effects of Inflation

We do not believe that inflation has had a material impact on our business, sales, or operating results during the periods presented.

Off-Balance Sheet Arrangements

We currently do not have any off-balance sheet arrangements or financing activities with special-purpose entities.

-32-

Critical Accounting Policies

Critical accounting policies are those policies which are both important to the presentation of a company’scompany's financial condition and results and require management’smanagement's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.  There have been no recent significant changes to our accounting policies during the six months ended December 31, 2019, other than the adoption of ASU 2016-02 discussed in detail in Footnote 1 to the accompanying unaudited condensed consolidated financial statements.  For a further discussion of our critical accounting policies, see our Annual Report on Form 10-K for the fiscal year ended June 30, 2019.2020.

-53-

Certain Factors That May Affect Future Results of Operations

The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company’scompany's future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such “forward-looking statements”"forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.

All statements in this report, other than statements of historical fact, are forward-looking statements for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. All forward-looking statements included in this report are made as of the date hereof and are based on information available to us as of such date. We assume no obligation to update any forward-looking statement. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “potential,”"may," "will," "expects," "plans," "anticipates," "intends," "believes," "estimates," "potential," or “continue,”"continue," or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are based upon reasonable assumptions at the time made, there can be no assurance that any such expectations or any forward-looking statement will prove to be correct. Our actual results will vary, and may vary materially, from those projected or assumed in the forward-looking statements. Future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not anticipate, including, without limitation, product recalls and product liability claims; infringement of our technology or assertion that our technology infringes the rights of other parties; termination of supplier relationships, or failure of suppliers to perform; inability to successfully manage growth; delays in obtaining regulatory approvals or the failure to maintain such approvals; concentration of our revenue among a few customers, products or procedures; development of new products and technology that could render our products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition, availability of labor and materials, cost increases, and fluctuations in and obsolescence of inventory; volatility of the market price of our common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; integration of business acquisitions; and other factors referred to in our reports filed with the SEC, including our Registration Statement on Form 10. All subsequent forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Additional factors that may have a direct bearing on our operating results are discussed in Item 1A “Risk Factors”"Risk Factors" in our Registration Statement on Form 10. In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report or in any document incorporated by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to us or to any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.

-54-

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4.  Controls and Procedures

1. Disclosure Controls and Procedures

We maintain disclosure controls and procedures (Disclosure Controls) within the meaning of Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our Disclosure Controls are designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act, such as this Quarterly Report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’sCommission's rules and forms. Our Disclosure Controls are also designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our Disclosure Controls, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily applied its judgment in evaluating and implementing possible controls and procedures.

-33-

As of the end of the period covered by this Quarterly Report on Form 10-Q, we evaluated the effectiveness of the design and operation of our Disclosure Controls, which was done under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Based on the evaluation of our Disclosure Controls, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2019,2020, our Disclosure Controls were not effective due to a material weaknessweaknesses in the Company’sCompany's internal control over financial reporting as disclosed below.

2.

Management's Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, a company's principal executive and principal financial officers and effected by the Company's board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.  In making this assessment, management used the criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO").

Based on our prior assessment, as of June 30, 2019, management has concluded that our internal control over financial reporting was not effective as of December 31, 2020, due to athe following material weakness related to insufficient controls over the accounting for the income tax effects of business combinations and asset acquisitions. weaknesses:

·

The Company has a material weakness in the design and operation of its controls regarding its accounting for its equity method investment, including the proper elimination of intercompany profit included in assets acquired by the Company from its equity method investment and possible impairment of the investment. The identification of intercompany profit to be eliminated and the identification and compilation of data, assumptions, and computations used to determine the estimated fair value is not sufficiently precise in its preparation and review to identify misstatements that could become material.

·

Separately, the Company has a material weakness in the design and operation of its controls over the timely recording of forfeitures of share-based compensation awards and the application of the amortization method used to recognize expense related to share based compensation awards, which could become material

·

The Company has a material weakness in the design and operation of its controls related to the timely execution of contracts.

A “material weakness”"material weakness" is a deficiency, or a combination of deficiencies, in Internal Control over Financial Reporting ("ICFR"), such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.  Such material weakness has

Because of its inherent limitations, internal control over financial reporting may not yetprevent or detect misstatements or prevent or detect all error and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions, and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been remediated asdetected. Projections of December 31, 2019.any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

-55-

3.

Plan to Remediate Material Weaknesses

3. Plan to Remediate Material Weakness

We plan to enhance existing controls by improving their design and to design and implement new controls applicable to our income taxequity method accounting, to ensure that our income taxequity method investment balances are accurately calculated and appropriately reflected in our financial statements on a timely basis. Specifically,We are in the process of implementing a software solution to automate the accounting for share based compensation awards. We are also planning to enhance our controls over the recording of forfeitures to ensure that forfeitures are recorded timely. Lastly, we plan to enhance existing controls and design, and implement new controls to ensure that contracts and agreements are executed timely and that executed copies of contracts are retained

We plan to devote significant time and attention to remediate the above material weakness as soon as reasonably possible. As we continue to evaluate our controls, we will add incremental controlsmake the necessary changes to determineimprove the income tax effects of unique transactions. We have engaged third party income tax experts to assist in the preparationoverall design and operation of our income tax provisions.controls. We believe that improving the design of existing controls, adding incremental controls to determine the tax effects of unique transactions, and engaging third party tax specialiststhese actions will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting; however, there can be no guarantee that such remediation will be sufficient. We will continue to monitor the effectiveness of our controls and will make any further changes management determines appropriate.

4.

4.

Change in Internal Control over Financial Reporting

Except as described above, thereThere were no changes in our internal control over financial reporting that occurred during the three monthsquarter ended December 31, 2019,2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

-34-

PART II - Other Information

Item 1.  Legal Proceedings

On or about July 13, 2018, RTJ, LLC and two of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Jack Turner, Jr., an employee of Predictive Biotech, Inc. The plaintiffs had acted in a distributor capacity. The relationship was terminated. Plaintiffs are alleging breach of contract, promissory estoppel, unjust enrichment, fraud, breach of fiduciary duty, defamation, false light, and tortious interference. Based on the information available to us, we do not believe any of the RTJ proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

On or about May 1, 2019, Surgenex, LLC and one of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Doug Schmid, an employee of Predictive Biotech, Inc. In 2014 Surgenex contracted with Utah Cord Bank, Inc., a former employer of Doug Schmid, to assist Surgenex in the doing work relating to allograft tissue. Schmid was later hired by Predictive Biotech, Inc. In connection with Schmid’sSchmid's employment with Predictive Biotech, Surgenex has filed a lawsuit alleging unjust enrichment, conspiracy, conversion, tortious interference with contractual and business relations, violations of trade secrets act, and other claims. Based on the information available to us, we do not believe the Surgenex proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

-56-

On or about July 12, 2019, Predictive Technology Group, Inc. and Predictive Therapeutics, LLC, a subsidiary of Predictive Technology Group, Inc. filed a lawsuit against Michael Schramm. Schramm had previously acted as our patent agent. While acting as our patent agent,(Schramm). Schramm entered into an agreement to sell us certain patents and patent applications in consideration for equity securities. Schramm represented that he owned all right,rights, title, and interest in and to the intellectual property. We were subsequently advised by theour patent counsel who replaced Schramm that, Schramm’s representation was false.while the patents are registered with the US Patent and Trademark Office in the Company's name, the Company may not have a full interest in the patents. An unrelated third-party law firm placed a lien on the patents due to non-payment of legal fees by a third-party entity to whom certain assets were sold by another third-party entity that originally owned the patents.  The Company raised these concerns with Schramm, who did not provide satisfactory evidence addressingconfirming that the concerns of our current patent counsel.Company had sole title to the patents.  We sued Schramm for breach of contract, conversion and on other legal theories and are seeking, among other things, rescission of the purchase and sale transaction. While there is some question as to whether the Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the said patents. Schramm filed a counterclaim against us and Bradley C. Robinson, our Chief Executive Officer and Transfer Online, Inc., our transfer agent. Schramm is alleging he did not make any false representations. He is alleging, among other things, that various parties involved in the transaction committed breach of contract, conversion, violations of Nevada state law for failure to transfer securities, breach of fiduciary duty, tortious interference, and civil conspiracy.  Based on the information available to us, we do not believe the Schramm proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the counterclaim, have not discovered any evidence of wrongdoing with respect to the allegations in the counterclaim and will vigorously prosecute our claims against Schramm.

On or about March 18, 2020, Predictive Biotech, Inc. filed a lawsuit in the Utah District Court against Auxocell Laboratories, Inc ("Auxocell") for breach of contract, product liability, breach of warranty, negligent misrepresentation and other claims relating to defects in laboratory equipment Auxocell sold to Predictive Biotech. Alleged damages include wasted umbilical cord tissue, lost inventory, costs associated with particulate testing, reputational injury, and related claims. On or about August 24, 2020, Auxocell answered the Complaint by denying the claims and asserting counterclaims of its own for breach of a confidentiality clause and failure to pay for devices. The Company answered and denied the counterclaims on December 14, 2020. Initial discovery has commenced and the current schedule has a discovery cut-off date of April 1, 2021. The litigation is still in discovery and as such we provide no opinion or assessment of the likely outcome of the litigation.

On or about November 11, 2020, Mackey Investment, LLLP ("Mackey") filed a lawsuit in Utah District Court against Predictive Technology Group, Inc and several officers of the Company.  Mackey subscribed for and purchased 500,000 shares of Predictive common stock for $480,000 on or about January 29, 2020. Mackey was given all of the Company's SEC filings as part of his due diligence. Mackey is alleging that Predictive failed to disclose material information in connection with its investment and is alleging breach of contract, fraudulent inducement, violation of the Utah Uniform Securities Act, and conspiracy. The suit also seeks civil penalties and treble and punitive damages. The Company filed an Answer denying the claims in the Complaint on or about December 4, 2020. Discovery has commenced, but we have not received discovery responses. We deny the allegations in the complaint and will vigorously defend against these allegations.

On or about April 30, 2020, Equitas Bio/Pharma Solutions, LLC ("Equitas") filed a lawsuit against Predictive Technology Group in New York District Court alleging nonpayment of "at least $551,080" in amounts owing under Master Service Agreement and Project Work Orders as of the date of filing. The claims are for breach of contract, breach of covenant of good faith and fair dealing and fraud. The basis of the fraud claim alleges that Predictive "made specific statements to Equitas that it was able to and intend to perform its obligations under the agreements" and at "the time Predictive made these promises it had no intention of keeping them." We agree that amounts are owed under the agreements, but we deny all allegations in the complaint relating to breach of covenant of good faith and fraud. Amounts due as of December 31, 2020 are included in accounts payable in the condensed consolidated balance sheets.

-35-

In June 2020, Wellgistics, LLC, the distributor of the Company's Assurance AB product, requested that the partial deposit paid on their non-cancellable purchase order of $5 million be returned. As the purchase order is contractually non-cancellable and the Company performed on the order in good faith by transmitting the deposit to the Company's supplier, the request to return the deposit was not honored. To date there has been no legal action taken by either party.

As of December 31, 2019,2020, we did not record a liability related to these matters (other than amounts recorded in accounts payable as described above) as it was determined that an unfavorable resolution is either not currently probable or that an amount or relevant range is not reasonably estimable, or both. However, litigation is inherently unpredictable and it is possible that losses may occur. Any unfavorable resolution of any of these matters could materially affect our condensed consolidated financial position, cash flows, or results of operations. All legal costs associated with litigation are expensed as incurred.

Item 1A. Risk Factors

There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2019.2020. 

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds.

During the six months ended December 31, 2019, the Company issued (or is obligated to issue) the following shares:

1) In September 2019, the Company entered into an agreement with a consultant for research and development services. The consultant is an accredited investor. In consideration for these services, the Company granted warrants to the consultant exercisable for 1,250,000 shares of the Company’s common stock with a strike price equal to the closing price of the Company’s common stock on the date of grant. Warrants to acquire 625,000 shares vested upon issuance. Of the remaining warrants, 375,000 vest on March 1, 2020 and 225,000 vest on September 1, 2020.  The warrants expire ten years from the date of issuance.None.

2) On December 31, 2019, four accredited investors agreed to accept repayment in equity shares for promissory notes with a face value of $8,420,000 and the $720,000 outstanding under of the Revolving Loan Agreement, as well as $311,918 in accrued interest thereon. The debt was repaid in full by issuing 12,947,833 shares of the Company’s common stock based on the closing market price on December 31, 2019 of $0.73 per share.

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All securities issued by us that are referenced above are deemed "restricted securities" within the meaning of that term as defined in Rule 144 of the Securities Act and have been issued pursuant to the "private placement" exemption under Section 4(a)(2) of the Securities Act. Such transactions did not involve a public offering of securities, no underwriter was involved with the transactions, and no commissions were paid. All purchasers in the private placement had access to information on the Company necessary to make an informed investment decision. We have been informed that all purchasers are able to bear the economic risk of this investment and are aware that the securities were not registered under the Securities Act and cannot be re-offered or re-sold unless they are registered or are qualified for sale pursuant to an exemption from registration. The transfer agent and registrar of the Company was instructed to mark "stop transfer" on its ledger regarding these shares. 

Neither the Company nor any person acting on its behalf offered or sold the securities by means of any form of general solicitation or general advertising.

The securities were acquired for the purchasers own account and not with the view to sell, or for resale in connection with any distribution. A legend was placed on the certificates issued stating that the securities have not been registered under the Securities Act and cannot be sold or otherwise transferred without an effective registration or an exemption therefrom

 

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

None.


Item 5. Other Information

In Item 12 of our Annual Report on Form 10-K  as of and for the year ended June 30, 2019, we reported that Eric Olson, Executive Vice President and Chief Executive Officer of Predictive Biotech, Inc., was the beneficial owner of  7,500,000 shares of our common stock held by Integrity Trust Company, LLC. These 7,500,000 common shares were cancelled and 7,500,000 shares were issued to Integrity Capital Holdings, LLC. Mr. Olson remains the beneficial owner of the shares.

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Item 6. EXHIBITS

  

Exhibit No.

Identification of Exhibit

 

31.1

Section 302 Certification of Chief Executive Officer (filed herewith)

31.2

Section 302 Certification of Principal Financial Officer (filed herewith)

32.1

Section 906 Certification of Chief Executive Officer (filed herewith)

32.2

Section 906 Certification of Principal Financial Officer (filed herewith)

101

XBRL Interactive Data Tags

 

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SIGNATURES

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Predictive Technology Group, Inc.,

(Registrant)

 

 

 

 

By:

/s/ Bradley C. Robinson

February 14, 202016, 2021

 

Bradley C. Robinson

Chief Executive Officer and Director

(Principal Executive Officer)

 

 

 

 

By:

/s/ Simon Brewer

February 14, 202016, 2021

 

Simon Brewer

Chief Accounting Officer

(Principal Accounting and Principal Financial Officer)

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EXHIBIT 31.1

CERTIFICATION

I, Bradley C. Robinson, certify that:

1.

I have reviewed this quarterly report of Predictive Technology Group, Inc. (“("the registrant”registrant") on Form 10-Q;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’sregistrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)

Evaluated the effectiveness of the registrant’sregistrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)

Disclosed in this report any change in the registrant’sregistrant's internal control over financial reporting that occurred during the registrant’sregistrant's most recent fiscal quarter (the registrant’sregistrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sregistrant's internal control over financial reporting.

 5.

The registrant’sregistrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sregistrant's auditors and the audit committee of the registrant’sregistrant's board of directors (or persons performing the equivalent functions):

 

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’sregistrant's ability to record, process, summarize and report financial information; and

 

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’sregistrant's internal control over financial reporting.

 

By:

/s/ Bradley C. Robinson

February 14, 202016, 2021

 

Bradley C. Robinson

Chief Executive Officer

(Principal Executive Officer)

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EXHIBIT 31.2

CERTIFICATION

I, Simon Brewer, certify that:

 

1.

I have reviewed this quarterly report of Predictive Technology Group, Inc. (“("the registrant”registrant") on Form 10-Q;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’sregistrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)

Evaluated the effectiveness of the registrant’sregistrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)

Disclosed in this report any change in the registrant’sregistrant's internal control over financial reporting that occurred during the registrant’sregistrant's most recent fiscal quarter (the registrant’sregistrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sregistrant's internal control over financial reporting.

 5.

The registrant’sregistrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sregistrant's auditors and the audit committee of the registrant’sregistrant's board of directors (or persons performing the equivalent functions):

 

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’sregistrant's ability to record, process, summarize and report financial information; and

 

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’sregistrant's internal control over financial reporting.

 

By:

/s/ Simon Brewer

February 14, 202016, 2021

 

Simon Brewer

Chief Accounting Officer

(Principal Accounting and Principal Financial Officer)

-61-

-39-

EXHIBIT 32.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

 

Pursuant to 18 U.S.C. Section 1350,

As adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

I, Bradley C. Robinson, certify, to my best knowledge and belief, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Predictive Technology Group, Inc., on Form 10-Q for the quarter ended December 31, 20192020 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Predictive Technology Group, Inc.

 

By:

/s/ Bradley C. Robinson

February 14, 202016, 2021

 

Bradley C. Robinson

Chief Executive Officer

(Principal Executive Officer)

-62-

 

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EXHIBIT 32.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER

 

Pursuant to 18 U.S.C. Section 1350,

As adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

I, Simon Brewer, certify, to my best knowledge and belief, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Predictive Technology Group, Inc. on Form 10-Q for the quarter ended December 31, 2019,2020, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Predictive Technology Group, Inc.

 

By:

/s/ Simon Brewer

February 14, 202016, 2021

 

Simon Brewer

Chief Accounting Officer

(Principal Accounting and Principal Financial Officer)

-41-

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