UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE

ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED JANUARYOCTOBER 31, 2022

 

OR

 

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

ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM __ TO __

 

COMMISSION FILE NO. 000-54318

 

ONCOSEC MEDICAL INCORPORATED

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

nevada 98-0573252
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
   
24 NORTH MAIN STREET  
PENNINGTON, NJ 08534
(Address of principal executive offices) (Zip Code)

 

(855) 662-6732

(Registrant’s telephone number, including area code)

 

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

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share ONCS Nasdaq Capital Market

 

Indicate by check mark 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 ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ 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 accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
  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

 

The number of shares outstanding of the Registrant’s Common Stock, $0.0001 par value, was 39,350,363 2,970,515as of MarchDecember 15, 2022.

 

 

 

 

OncoSec Medical Incorporated

Form 10-Q

for the Quarterly Period Ended JanuaryOctober 31, 2022

 

PART I—FINANCIAL INFORMATION3
Item 1.Financial Statements:3
 Condensed Consolidated Balance Sheets as of JanuaryOctober 31, 2022 (unaudited) and July 31, 202120223
 Condensed Consolidated Statements of Operations for the three and six months ended JanuaryOctober 31, 2022 and 2021 (unaudited)4
 Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended JanuaryOctober 31, 2022 and 2021 (unaudited)5
 Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and six months ended JanuaryOctober 31, 2022 and 2021 (unaudited)6
 Condensed Consolidated Statements of Cash Flows for the sixthree months ended JanuaryOctober 31, 2022 and 2021 (unaudited)87
 Notes to Condensed Consolidated Financial Statements (unaudited)98
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations26
Item 3.Quantitative and Qualitative Disclosures about Market Risk3534
Item 4.Controls and Procedures3534
PART II—OTHER INFORMATION35
Item 1.Legal Proceedings35
Item 1A.Risk Factors35
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds36
Item 3.Defaults Upon Senior Securities36
Item 4.Mine Safety Disclosures36
Item 5.Other Information36
Item 6.Exhibits3736
SIGNATURES3837

 

2

 

 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements:Statements.

 

OncoSec Medical Incorporated

Condensed Consolidated Balance Sheets

 

 January 31, 2022  July 31, 2021  October 31, 2022  July 31, 2022 
 (Unaudited)      (Unaudited)     
Assets                
Current assets                
Cash and cash equivalents $25,230,993  $45,951,233  $5,729,691  $12,299,740 
Prepaid expenses and other current assets  2,696,899   3,228,191   2,903,468   2,932,731 
Total Current Assets  27,927,892   49,179,424   8,633,159   15,232,471 
Property and equipment, net  1,071,001   928,821   933,701   978,614 
Intangible assets, net  413,471   448,412   361,059   378,529 
Operating lease right-of-use assets  5,149,229   5,445,744   3,931,083   4,665,515 
Other long-term assets  527,733   273,523   579,960   623,239 
Total Assets $35,089,326  $56,275,924  $14,438,962  $21,878,368 
                
Liabilities and Stockholders’ Equity        
Liabilities and Stockholders’ Equity (Deficit)        
                
Liabilities                
Current liabilities                
Accounts payable and accrued liabilities $3,454,209  $5,561,645  $4,802,456  $4,208,222 
Accrued compensation related  582,842   320,655   468,618   376,977 
Operating lease liabilities  1,037,252   845,483   978,570   1,111,571 
Note payable  497,223   1,234,133   659,870   936,558 
Total Current Liabilities  5,571,526   7,961,916   6,909,514   6,633,328 
Operating lease liabilities, net of current portion  4,702,622   5,238,207   3,513,897   4,126,636 
Liability under co-promotion agreement - related party  5,000,000   5,000,000   5,000,000   5,000,000 
Total Liabilities  15,274,148   18,200,123   15,423,411   15,759,964 
                
Commitments and Contingencies (Note 8)  -   -         
                
Stockholders’ Equity        
Common stock authorized – 100,000,000 common shares with a par value of $0.0001 as of January 31, 2022 and July 31, 2021, common stock issued and outstanding – 39,349,269 and 39,152,610 common shares as of January 31, 2022 and July 31, 2021, respectively  3,935   3,916 
Stockholders’ Equity (Deficit)        
Common stock authorized – 4,545,455 common shares with a par value of $0.0001 as of October 31, 2022 and July 31, 2022, common stock issued and outstanding – 1,790,741 and 1,790,051 common shares as of October 31, 2022 and July 31, 2022, respectively  179   179 
Additional paid-in capital  287,539,711   286,337,291   288,767,020   288,236,945 
Warrants issued and outstanding – 1,706,190 warrants as of January 31, 2022 and July 31, 2021  3,591,734   3,591,734 
Accumulated other comprehensive income (loss)  173,874   (79,109)
Warrants issued and outstanding – 75,897 and 77,554 warrants as of October 31, 2022 and July 31, 2022, respectively  3,368,509   3,591,734 
Accumulated other comprehensive income  898,906   247,211 
Accumulated deficit  (271,494,076)  (251,778,031)  (294,019,063)  (285,957,665)
Total Stockholders’ Equity  19,815,178   38,075,801 
Total Liabilities and Stockholders’ Equity $35,089,326  $56,275,924 
Total Stockholders’ Equity (Deficit)  (984,449)  6,118,404 
Total Liabilities and Stockholders’ Equity (Deficit) $14,438,962  $21,878,368 

*On November 9, 2022, the Company effectuated a 1 for 22 reverse stock split. Shares have been retroactively restated.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3

 

OncoSec Medical Incorporated

Condensed Consolidated Statements of Operations

(Unaudited)

 

 January 31, 2022  January 31, 2021  

January 31,

2022

  January 31, 2021  October 31, 2022  October 31, 2021 
 Three Months Ended  Six Months Ended  Three Months Ended 
 January 31, 2022  January 31, 2021  

January 31,

2022

  January 31, 2021  October 31, 2022  October 31, 2021 
Revenue $-  $-  $-  $-  $- $- 
Expenses:                     
Research and development  6,825,540   8,915,381   13,471,311   18,714,740   4,768,372   6,645,771 
General and administrative  2,590,893   2,110,696   5,860,616   5,351,429   2,538,497   3,269,723 
Loss from operations  (9,416,433)  (11,026,077)  (19,331,927)  (24,066,169)  (7,306,869)  (9,915,494)
Other expense, net  (2,583)  (440)  (4,594)  (1,063)
Other income (expense), net  38,098   (2,010)
Interest expense  (5,382)  (4,722)  (13,427)  (10,856)  (11,081)  (8,045)
Foreign currency exchange gain (loss), net  (480,072)  328,592   (363,147)  151,674   (781,546)  116,924 
Loss before income taxes  (9,904,470)  (10,702,647)  (19,713,095)  (23,926,414)  (8,061,398)  (9,808,625)
Income tax expense  2,950   1,450   2,950   2,950 
Income tax (benefit) expense  -   - 
Net loss $(9,907,420) $(10,704,097) $(19,716,045) $(23,929,364) $(8,061,398) $(9,808,625)
Basic and diluted net loss per common share $(0.25) $(0.37) $(0.50) $(0.86) $(4.50) $(5.51)
Weighted average shares used in computing basic and diluted net loss per common share  39,314,860   28,676,719   39,246,095   27,723,948   1,790,301   1,780,788 

*On November 9, 2022, the Company effectuated a 1 for 22 reverse stock split. Shares have been retroactively restated.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4

 

OncoSec Medical Incorporated

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

 

 

January 31,

2022

  January 31, 2021  January 31, 2022  January 31, 2021  October 31, 2022  October 31, 2021 
 Three Months Ended  Six Months Ended  Three Months Ended 
 

January 31,

2022

  January 31, 2021  January 31, 2022  January 31, 2021  October 31, 2022  October 31, 2021 
              
Net Loss $(9,907,420) $(10,704,097) $(19,716,045) $(23,929,364) $(8,061,398) $(9,808,625)
Foreign currency translation adjustments  383,376   (358,134)  252,983   (265,819)  651,695   (130,393)
Comprehensive Loss $(9,524,044) $(11,062,231) $(19,463,062) $(24,195,183) $(7,409,703) $(9,939,018)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5

 

OncoSec Medical Incorporated

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(Unaudited)

 

Three Months Ended JanuaryOctober 31, 2022

 

  Shares  Amount  Capital  Shares  Amount  Loss  Deficit  Equity 
  Common Stock  Additional Paid-In  Warrants  Accumulated
Other Comprehensive
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Shares  Amount  Loss  Deficit  Equity 
Balance, October 31, 2021  39,202,590  $3,921  $286,979,197   1,706,190  $3,591,734  $(209,502) $(261,586,656) $28,778,694 
Stock-based compensation expense  15,179   1   356,666               356,667 
Tax withholdings paid on equity awards        (4,886)              (4,886)
Tax shares sold to pay for tax withholdings on equity awards        4,762               4,762 
Common stock issued for services                                
Common stock issued for services, shares                                
Exercise of common stock warrants                                
Exercise of common stock warrants, shares                                
Cancellation of expired warrants                                
Cancellation of expired warrants, shares                                
January 2021 Public Offering, net of $2,970,165 issuance costs                                
January 2021 Public Offering, net of $2,970,165 issuance costs, shares                                
Dividends declared ($0.00 per share)                                
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs                                
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs, shares                                
Exercise of common stock warrants                                
Exercise of common stock warrants, shares                                
Exercise of common stock options  130,000   13   202,787               202,800 
Common stock issued for employee stock purchase plan  1,500      1,185               1,185 
Other comprehensive income                 383,376      383,376 
Net loss                    (9,907,420)  (9,907,420)
Balance, January 31, 2022  39,349,269  $3,935  $287,539,711   1,706,190  $3,591,734  $173,874  $(271,494,076) $19,815,178 
  Shares  Amount  Capital  Shares  Amount  Income  Deficit  Equity 
  Common Stock  Additional Paid-In  Warrants  Accumulated
Other Comprehensive
  Accumulated  Total
Stockholders’ Equity
 
  Shares  Amount  Capital  Shares  Amount  Income  Deficit  (Deficit) 
Balance, July 31, 2022  1,790,051  $179  $288,236,945   77,554  $3,591,734  $247,211  $(285,957,665) $6,118,404 
Stock-based compensation expense  690      307,030               307,030 
Tax withholdings paid on equity awards        (2,646)              (2,646)
Tax shares sold to pay for tax withholdings on equity awards        2,466               2,466 
Cancellation of expired warrants        223,225   (1,657)  (223,225)         
Other comprehensive income                 651,695      651,695 
Net loss                    (8,061,398)  (8,061,398)
Balance, October 31, 2022  1,790,741  $179  $288,767,020   75,897  $3,368,509  $898,906  $(294,019,063) $(984,449)

 

Six Months Ended January 31,*On November 9, 2022, the Company effectuated a 1 for 22 reverse stock split. Shares have been retroactively restated.

 

  Common Stock  Additional Paid-In  Warrants  Accumulated
Other Comprehensive
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Shares  Amount  Loss  Deficit  Equity 
Balance, July 31, 2021  39,152,610  $3,916  $286,337,291   1,706,190  $3,591,734  $(79,109) $(251,778,031) $38,075,801 
Stock-based compensation expense  52,659   5   956,569               956,574 
Tax withholdings paid on equity awards        (33,005)              (33,005)
Tax shares sold to pay for tax withholdings on equity awards        32,385               32,385 
Common stock issued for services  12,500   1   42,499               42,500 
Exercise of common stock options  130,000   13   202,787               202,800 
Common stock issued for employee stock purchase plan  1,500      1,185               1,185 
Other comprehensive income                 252,983      252,983 
Net loss                    (19,716,045)  (19,716,045)
Balance, January 31, 2022  39,349,269  $3,935  $287,539,711   1,706,190  $3,591,734  $173,874  $(271,494,076) $19,815,178 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

Three Months Ended JanuaryOctober 31, 2021

 

  Common Stock  Additional Paid-In  Warrants  Accumulated
Other Comprehensive
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Shares  Amount  Income (Loss)  Deficit  Equity 
Balance, October 31, 2020  27,694,604  $2,769  $230,282,585   3,114,288  $5,708,127  $72,811  $(219,835,567) $16,230,725 
Common stock issued for employee stock purchase plan  1,538      5,798               5,798 
Exercise of common stock warrants  882,261   88   4,178,747   (882,261)  (1,135,035)        3,043,800 
Exercise of common stock options  158,248   16   261,710               261,726 
Stock-based compensation expense  6,541   1   478,158               478,159 
Tax withholdings paid on equity awards        (12,927)              (12,927)
Tax shares sold to pay for tax withholdings on equity awards        13,937               13,937 
Cancellation of expired warrants        242,143   (10,712)  (242,143)         
January 2021 Public Offering, net of $2,970,165 issuance costs  7,711,284   771   39,055,561               39,056,332 
Common stock issued for services  37,500   4   127,496               127,500 
Dividends declared ($0.00 per share)                        
Other comprehensive loss                 (358,134)     (358,134)

Net loss

                   (10,704,097)  (10,704,097)
Balance, January 31, 2021  36,491,976  $3,649  $274,633,208   2,221,315  $4,330,949  $(285,323) $(230,539,664) $48,142,819 
                 Accumulated       
        Additional        Other     Total 
  Common Stock  Paid-In  Warrants  Comprehensive  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Shares  Amount  Loss  Deficit  Equity 
Balance, July 31, 2021  1,779,664  $178  $286,341,029   77,554  $3,591,734  $(79,109) $(251,778,031) $38,075,801 
Stock-based compensation expense  1,704      599,907               599,907 
Tax withholdings paid on equity awards        (28,119)              (28,119)
Tax shares sold to pay for tax withholdings on equity awards        27,623               27,623 
Common stock issued for services  568      42,500               42,500 
Net loss                    (9,808,625)  (9,808,625)
Other comprehensive loss                 (130,393)     (130,393)
Other comprehensive income/(loss)                 (130,393)     (130,393)
Balance, October 31, 2021  1,781,936  $178  $286,982,940   77,554  $3,591,734  $(209,502) $(261,586,656) $28,778,694 

 

Six Months Ended January 31, 2021*On November 9, 2022, the Company effectuated a 1 for 22 reverse stock split. Shares have been retroactively restated.

  Common Stock  Additional Paid-In  Warrants  Accumulated
Other Comprehensive
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Shares  Amount  Income (Loss)  Deficit  Equity 
Balance, July 31, 2020  23,054,474  $2,305  $214,789,808   3,114,288  $5,708,127  $(19,504) $(206,610,300) $13,870,436 
Balance  23,054,474  $2,305  $214,789,808   3,114,288  $5,708,127  $(19,504) $(206,610,300) $13,870,436 
Common stock issued for employee stock purchase plan  1,538      5,798               5,798 
Exercise of common stock warrants  882,261   88   4,178,747   (882,261)  (1,135,035)        3,043,800 
Exercise of common stock options  158,248   16   261,710                261,726 
Stock-based compensation expense  13,082   1   2,372,180               2,372,181 
Tax withholdings paid on equity awards        (26,459)              (26,459)
Tax shares sold to pay for tax withholdings on equity awards        28,049               28,049 
Cancellation of expired warrants        242,143   (10,712)  (242,143)         
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs  4,608,589   461   13,513,177               13,513,638 
January 2021 Public Offering, net of $2,970,165 issuance costs  7,711,284   771   39,055,561               39,056,332 
Common stock issued for services  62,500   7   212,494               212,501 
Dividends declared ($0.00 per share)                        
Other comprehensive loss                 (265,819)    (265,819)
Net loss                   

(23,929,364

)  (23,929,364)
Other comprehensive Income (loss)                 (265,819)      (265,819)
Balance, January 31, 2021  36,491,976  $3,649  $274,633,208   2,221,315  $4,330,949  $(285,323) $(230,539,664) $48,142,819 
Balance  36,491,976  $3,649  $274,633,208   2,221,315  $4,330,949  $(285,323) $(230,539,664) $48,142,819 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

76

 

 

OncoSec Medical Incorporated

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 January 31, 2022  January 31, 2021  October 31, 2022  October 31, 2021 
 Six Months Ended  Three Months Ended 
 January 31, 2022  January 31, 2021  October 31, 2022  October 31, 2021 
Operating activities                
Net loss $(19,716,045) $(23,929,364) $(8,061,398) $(9,808,625)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  129,959   108,068   62,383   63,996 
Amortization of right-of-use asset  325,316   417,059   251,486   94,880 
Stock-based compensation  956,574   2,372,181   307,030   599,907 
Common stock issued for services  42,500   212,501      42,500 
Foreign currency exchange (gain) loss, net  363,147   (151,674)  781,546   (116,924)
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets  508,205   246,393   202,785   270,956 
Other long-term assets  (290,876)  (21)  27,784    
Accounts payable and accrued liabilities  (2,118,642)  240,307   472,903   (1,076,281)
Accrued compensation related  262,186   84,041   91,641   166,712)
Operating lease liabilities  (343,817)  (189,373)  (262,794)  (105,373)
Net cash used in operating activities  (19,881,493)  (20,589,882)  (6,126,634)  (9,868,252)
                
Investing activities        
Purchase of fixed assets  (244,857)   
Purchase of intangible assets     (250,000)
Net cash used in investing activities  (244,857)  (250,000)
        
Financing activities                
Proceeds from issuance of common stock through ESPP  1,185   5,798 
Proceeds from issuance of common stock     57,004,411 
Payment of financing and offering costs  (15,500)  (4,157,379)  (66,469)   
Proceeds from exercise of warrants     3,043,800 
Proceeds from exercise of options  202,800   261,726 
Proceeds from co-promotion agreement     5,000,000 
Principal payments on note payable  (736,910)  (330,144)  (276,688)  (367,124)
Tax withholdings paid on equity awards  (33,005)  (26,459)  (2,646)  (28,119)
Tax shares sold to pay for tax withholdings on equity awards  32,385   28,049   2,466   27,623 
Net cash provided by (used in) financing activities  (549,045)  60,829,802 
Net cash used in financing activities  (343,337)  (367,620)
Effect of exchange rate changes on cash and cash equivalents  (44,845)  (13,811)  (100,078)  (8,606)
Net increase (decrease) in cash and cash equivalents  (20,720,240)  39,976,109 
Net decrease in cash and cash equivalents  (6,570,049)  (10,244,478)
Cash and cash equivalents, at beginning of period  45,951,233   20,354,462   12,299,740   45,951,233 
Cash and cash equivalents, at end of period $25,230,993  $60,330,571  $5,729,691  $35,706,755 
                
Supplemental disclosure for cash flow information:                
Cash paid during the period for:                
Interest $13,427  $6,089  $11,081  $8,045 
Income taxes $2,950  $2,950  $  $ 
Noncash investing and financing transactions:                
Amount accrued for purchase of intangible asset $  $245,000 
Expiration of warrants $  $242,143  $223,225  $ 
Increase in right-of-use assets and operating lease liabilities resulting from contract modification $  $338,819 
Decrease in right-of-use assets and operating lease liabilities resulting from contract modification $482,946 $ 
Amounts accrued for offering costs $  $277,062  $

188,028

  $ 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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OncoSec Medical Incorporated

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 1—Nature of Operations and Basis of Presentation

 

OncoSec Medical Incorporated (together with its subsidiary, unless the context indicates otherwise, being collectively referred to as the “Company”) began its operations as a biotechnology company in March 2011. The Company has not generated any revenues since its inception. The Company was incorporated in the State of Nevada on February 8, 2008 under the name of Netventory Solutions, Inc. and changed its name to OncoSec Medical Incorporated in March 2011 when it began operating as a biotechnology company.

 

The Company is a late-stage immuno-oncology company focused on designing, developing and commercializing innovative, proprietary, intra-tumoral DNA-based therapeutics delivered by electroporation (“EP”) to stimulate and augment anti-tumor immune responses for the treatment of cancers. Its core technology, platform ImmunoPulse®, is a drug-device therapeutic modality platform comprised of a proprietary intratumoral electroporation (“EP”) deliveryOncoSec Medical System EP device (the “OMS EP Device”) and a proprietary DNA plasmid delivery and application method that triggersenables transient expression of target proteinrecombinant therapeutic molecules in cells. The OMS EP Device is designed to deliverpromote cellular uptake of plasmid DNA-encoded drugsDNA injected directly into a solid tumor and promote an immunological response againsttumors to allow subsequent expression of the cancer.encoded therapeutic protein. The OMS EP Device can be adapted to treat different tumor types, and consists of an electrical pulse generator and disposable applicators.applicator. The Company’s lead product candidate is a DNA-encodedplasmid encoding interleukin-12 (“IL-12”) called tavokinogene telseplasmid (“TAVO™”). The OMS EP Device is used to deliver TAVO™ intratumorally,into cells in tumor lesions, with the aim of reversingovercoming the immunosuppressive microenvironment in the treated tumor and elicit systemic tumor-specific immune responses in cancer patients. The activationActivation of thean appropriate anti-tumor inflammatory response in the treated tumorlesion can drive the immune system to mount a systemic anti-tumor response against untreated tumors in other parts of the body. In 2017, the Company received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for TAVO™ in metastatic melanoma, which could qualify TAVO™-EP for expedited FDA review, a rolling Biologics License Application (“BLA”) review and certain other benefits.

benefits to achieve faster registration of a therapeutic product.

 

The Company’s primary focus is to pursue its study of TAVO™-EP in combination with KEYTRUDA® (pembrolizumab) in melanoma. In October 2022, due to its financial position, the Company decreased all clinical activity outside of its melanoma clinical pipeline, including trials and studies involving triple negative breast cancer (“TNBC”). and squamous cell carcinoma of the head and neck.

 

The Company’s KEYNOTE-695 studyclinical trial is a registration-directed, Phase 2b open-label, single-arm,non-randomized, multicenter studytrial in approximately 100 patients treated with TAVO™-EP in combination with KEYTRUDA® (pembrolizumab) in anti-PD-1 checkpoint inhibitor (nivolumab or pembrolizumab) relapsed or refractory metastatic melanoma,melanoma. The KEYNOTE-695 clinical trial is being conducted in the United States, Canada, Australia and Europe. In May 2017, the Company entered into a clinical trial collaboration and supply agreement with a subsidiary of Merck & Co., Inc. (“Merck”) in connection with the KEYNOTE-695 study.trial. Pursuant to the terms of the agreement, each company will bear its own costs related to manufacturing and supply of its product, as well as be responsible for its own internal costs. The Company is the studytrial sponsor and is responsible for external costs. The studytrial completed enrollment of the primary cohortCohort 1 in December 2020. In December 2020, the protocol was amended to include an additional cohort, consisting of patients who progressed onwere exposed to prior treatment with ipilimumab in addition toand progressed on prior anti-PD-1 checkpoint inhibitor. The amendment also enabled enrollment of approximately 25 additional patients to be treated with an updated version of the OMS EP Device (i.e., GenPulseTMgenerator and Series 3 Applicator), in preparation for potentially seeking FDA approval. Based on and subject toDatabase lock for the outcome105 patients enrolled in Cohort 1 was in October 2022. The final data analysis of the studykey secondary endpoints, including objective response rate by investigator, was announced in November 2022, and feedback from the FDA,final data analysis of the Company plansprimary endpoint, objective response rate (ORR) by blinded independent central review (BICR) is expected to file for accelerated approval withbe available during the FDA for this patient population infirst calendar quarter of 2023.

 

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The Company’s KEYNOTE-890 studyclinical trial is a Phase 2, open-label, single-arm,non-randomized, multicenter studytrial conducted in the United States and Australia to evaluate the safety and efficacy of TAVO™-EP in combination with KEYTRUDA® in patients with inoperable locally advanced or metastatic TNBC who have previously failed at least one systemic chemotherapy or immunotherapy (Cohort 1) or TAVO™-EP in combination with KEYTRUDA® and chemotherapy in patients with inoperable locally advanced or metastatic TNBC who have had no prior systemic therapy in the advanced or metastatic setting (Cohort 2).

In May 2018, the Company entered into a second clinical trial collaboration and supply agreement with a subsidiary of Merck with respect to the KEYNOTE-890 study,trial, Cohort 1. Pursuant to the terms of the agreement, each company will bear its own costs related to manufacturing and supply of its product, as well as be responsible for its own internal costs. The Company is the studytrial sponsor and is responsible for external costs. In June 2020, the Company amended its second clinical trial collaboration and supply agreement to include KEYNOTE-890, Cohort 2.2, for the frontline treatment of patients with inoperable locally advanced or metastatic TNBC with the combination of TAVO-EP, KEYTRUDA, and chemotherapy. Enrollment of Cohort 1 (26 patients) was completed (26 patients) in December 2020. Interim data for Cohort 1 was initially presented at the San Antonio Breast Cancer Symposium (“SABCS”) in December 2019, and an update on this cohort was presented at the SABCS in December 2021. Enrollment of Cohort 2 (target 40 patients) began in January 2021 and is expected2021. Enrollment to be completed in 2022.

In May 2019,Cohort 2 has been closed as of October 2022; the Company supported commencementhas deferred further development of an investigator-initiated Phase 1 clinical trial conducted byTAVO™-EP for the Universitytreatment of California San Francisco (“UCSF”) Helen Diller Family Comprehensive Cancer Center. This study targets patients with Squamous Cell CarcinomaTNBC in order to focus its efforts and resources on the ongoing development of the Head & Neck and is a single-arm open-label clinical trialTAVO™-EP in which 68 evaluable patients will receive TAVO™, KEYTRUDA® and epacadostat. Recruitment on this study has been halted after the last patient was treated in June 2021 while the Company and UCSF consider alterations in the design of the study.

melanoma.

 

In August 2020, the Company supported commencement of an investigator-initiated Phase 2 studyclinical trial conducted by the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate TAVO™-EP as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO® (nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma. This studytrial has been designed to evaluate whether the addition of TAVO™-EP can increase the published anti-tumorcomplete pathological response rate observed with monotherapy OPDIVO®, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors. This studytrial began enrolling patients in December of 2020. Enrollment for this trial wasis expected to be completed in 2022. However,calendar year 2023. Preliminary data from this trial was presented at an international medical conference, the completion date is under evaluation given current recruitment rates and may extend beyondSociety for Immunotherapy of Cancer (SITC), in November 2022.

 

In November 2020, the Company obtained an exclusive license to the Cliniporator® electroporation gene electrotransfer platform from IGEA Clinical Biophysics. This platform has been used for electrochemotherapy in and outside of Europe in over 200 major oncological centers to treat cutaneous metastatic cancer nodules, including melanoma. The license encompasses a broad field of use for gene delivery in oncology, including use as part of the Company’s visceral lesionVisceral Lesion applicator (“VLA”) program.

In April 2020, the Company announced that Providence Cancer Institute, a part of Providence St. Joseph Health (“Providence”), was pursuing a first-in-human Phase 1 clinical trial of the Company’s novel DNA-encodable, investigational vaccine, CORVax12, which is designed to act as a prophylactic vaccine to prevent COVID-19. CORVax12 consists of the Company’s existing product candidate, TAVO™, in combination with an immunogenic component of the SARS-CoV-2 virus developed by researchers at the National Institutes of Health National Institute of Allergy and Infectious Diseases (“NIAID”). Providence investigators filed and received an Investigator-Initiated Investigational New Drug (“IND”) Application; however, at this time, Providence does not intend to continue further enrollment in this study.

In April 2021, the Company announced that it received authorization to CE mark the OMS EP Device for use in solid tumors. That CE mark indicates compliance with Medical Device Directives (MDD) of the European Commission for the OMS EP Device as configured at the time. Subsequent to receiving the CE mark for that version of the OMS EP Device, the Company has advanced the design of the applicator component of the OMS EP Device. This newer version of the OMS EP Device, which still includes the GenPulseTM generator, is currently used as an investigational device in clinical trial sites in Australia, the EU and Switzerland. The Company is currently seeking FDA agreement for investigational use of the GenPulseTM as the generator component of the OMS EP Device in US clinical sites.

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The Company intends tomay continue to pursue potential new trials and studies related to TAVO™,-EP, in various tumor types. In addition, the Company is also developing its next-generation EP device and applicator, including advancements toward prototypes, pursuing discovery research to identify other product candidates that, in addition to IL-12, can be encoded into proprietary plasmid-DNA and delivered intratumorally using EP. Specifically, the Company is developing proprietary technology to potentially treat liver, lung, bladder, pancreatic and other difficult to treat visceral lesions through the direct delivery of plasmid-based IL-12 with the VLA.

 

The VLA is beingintended and may be designed to work with low voltage EP generators, including but not limited to the Company’s proprietary APOLLOTM APOLLO™ EP generator and Cliniporator®Cliniporator®, and it is expected to enable transfection of immunologically relevant genes into cells located in visceral organs.primary or metastatic tumor lesions. For example, the Company may develop this proprietary technology to treat liver, lung, bladder, pancreatic and other difficult to treat visceral lesions. In early 2020, the Company had two poster presentations, one at the Society for Interventional Oncology and one at the Society for Interventional Radiology, where it presented early preclinical data pertaining to visceral delivery of plasmid therapy. Additionally,plasmid-based therapeutics at meeting of the Society for Interventional Oncology and the Society for Interventional Radiology, and the Company has since successfully completed several large animal studies to assess VLA design.the VLA. The Company expected to bring a VLA into the clinic in 2023. However, this timeline is under evaluation and may extend beyond 2023. The Company believes that the flexibilityhas deferred further development of the Company’s proprietary plasmid-DNA technology allowsVLA in order to focus its efforts and resources on the Company to deliver other immunologically relevant molecules into the tumor microenvironmentongoing development of TAVO™-EP in addition to the delivery of plasmid-DNA encoding for IL-12.melanoma.

 

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Restructuring Plan

On October 2, 2022, the Company’s Board of Directors authorized a restructuring plan (the “Restructuring Plan”) that is designed to prioritize clinical activities in melanoma to reduce operating expenses while advancing the Company’s lead product candidate, TAVO™ EP, toward near-term data milestones in connection with the KEYNOTE-695 clinical trial. As part of the Restructuring Plan, the Company restructured its internal operations and reduced its workforce by approximately 45%, or 17 employees.

The Company established a collaborationcurrently estimates that it will incur charges of approximately $750,000 to $800,000 in connection with Emerge Health Pty (“Emerge”), the leading Australian company providing full registration, reimbursement, sales, marketingRestructuring Plan, consisting primarily of cash expenditures for employee transition, notice period and distribution servicesseverance payments, retention bonus payments, and related costs. The Company expects that the majority of therapeutic productsthe restructuring charges will be incurred in Australiathe fourth calendar quarter of 2022 and New Zealand, to commercialize TAVO™first calendar quarter of 2023, and make it available under Australia’s Special Access Scheme (“SAS”). Emerge was acquired in late 2019 and in June 2021 informedthat the execution of the Restructuring Plan will be substantially complete by the second calendar quarter of 2023.

The charges that the Company expects to incur in connection with the Restructuring Plan are estimates and subject to a number of assumptions, and actual results may differ materially. The foregoing estimated amounts do not include any non-cash charges associated with stock-based compensation. The Company expects to operationalize additional cost reduction actions that oncology will not be a core therapeutic focus for Emerge into the future. The collaboration was terminated effective October 1, 2021, and the Company will not continueinclude other incremental cost reduction actions unrelated to participate in the SAS program.workforce reductions.

Unaudited Interim Financial Information

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of JanuaryOctober 31, 2022, the condensed consolidated statements of operations for the three and six months ended JanuaryOctober 31, 2022 and 2021, the condensed consolidated statements of comprehensive loss for the three and six months ended JanuaryOctober 31, 2022 and 2021, the condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended JanuaryOctober 31, 2022 and 2021, and the condensed consolidated statements of cash flows for the sixthree months ended JanuaryOctober 31, 2022 and 2021, are unaudited, but include all adjustments (consisting of normal recurring adjustments) that, in the opinion of management, isare necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented.presented and necessary in order to make the Company’s financial statements not misleading. The condensed consolidated results of operations for the three and six months ended JanuaryOctober 31, 2022 shown herein are not necessarily indicative of the consolidated results that may be expected for the year ending July 31, 2022,2023, or for any other period. These condensed consolidated financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the fiscal year ended July 31, 2021,2022, included in the Company’s Annual Report on Form 10-K (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (“SEC”) on October 29, 2021.31, 2022. The condensed consolidated balance sheet at July 31, 20212022 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by U.S. GAAP for complete financial statements.

 

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Note 2—Significant Accounting Policies

Reverse Stock Split

The Board of Directors of the Company approved a reverse stock split of the Company’s authorized, issued and outstanding shares of common stock at a ratio of 1-for-22 (the “Reverse Stock Split”). The Reverse Stock Split became effective on November 9, 2022 (the “Effective Date”). All share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted, on a retrospective basis, to reflect the Reverse Stock Split, unless otherwise stated. The number of authorized shares were also proportionately adjusted and the par value remained unaffected. The Company will issue one whole share of the post-Reverse Stock Split Common Stock to any stockholder who otherwise would have received a fractional share as a result of the Reverse Stock Split. As a result, no fractional shares will be issued in connection with the Reverse Stock Split and no cash or other consideration will be paid in connection with any fractional shares that would otherwise have resulted from the Reverse Stock Split.

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, OncoSec Medical Australia PTY LTD. All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Use of Estimates

 

The accompanying condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which requires managementManagement to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. SuchSignificant accounting estimates includerelated to the Company’s ability to continue as a going concern and certain calculations related to that determination, stock-based compensation, the accrual of research, product development and clinical obligations, impairment of long-lived assets, determining the Incremental Borrowing Rate for calculating Right-Of-Use (“ROU”) assets and lease liabilities and accounting for income taxes, including the related valuation allowance on the deferred tax asset and uncertain tax positions.determination. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates.

 

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Segment Reporting

 

The Company operates in a single industry segment—the discovery and development of novel immunotherapeutic product candidates to improve treatment options for patients and physicians, intended to treat a wide range of oncology indications.


Cash and Cash Equivalents

 

The Company considers all highly liquid investments that are readily convertible into cash and have an original maturity of three months or less at the time of purchase to be cash equivalents.

 

Concentrations and Credit Risk

 

The Company maintains cash balances at a small number of financial institutions in both the United States and Australia and such balances commonly exceed the $250,000amount insured by the Federal Deposit Insurance Corporation and $250,000AUD (approximately $176,000 160,000USD) insured by the Australian Financial Claims Scheme. The Company has not experienced any losses in such accounts and managementManagement believes that the Company does not have significant credit risk with respect to such cash and cash equivalents.

 

Property and Equipment

 

The Company’s capitalization threshold is $5,000 for property and equipment. The cost of property and equipment is depreciated on a straight-line basis over the estimated useful lives of the related assets. The useful lives of property and equipment for the purpose of computing depreciation are as follows:

Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation

Computers and equipment: 3 to 10 years
Computer software: 1 to 3 years
Leasehold improvements: Shorter of lease period or useful life

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Construction-in-progress is stated at cost, which relates to the cost of equipment not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use.

Intangible Assets

 

Definite life intangible assets include a license. Intangible assets are recorded at cost. License agreement cost representrepresents the fair value of the license agreement on the date acquired. Intangible assets are amortized on a straight-line basis over their estimated useful life.

 

Impairment of Long-Lived Assets

 

The Company periodically assesses the carrying value of intangible and other long-lived assets, and whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. The assets are considered to be impaired if the Company determines that the carrying value may not be recoverable based upon its assessment, which includes consideration of the following events or changes in circumstances:

 

 the asset’s ability to continue to generate income from operations and positive cash flow in future periods;
   
 loss of legal ownership or title to the asset(s);
   
 significant changes in the Company’s strategic business objectives and utilization of the asset(s); and
   
 the impact of significant negative industry or economic trends.

 

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If the assets are considered to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Fair value is determined by the application of discounted cash flow models to projectprojected cash flows from the assets. In addition, the Company bases estimates of the useful lives and related amortization or depreciation expense on its subjective estimate of the period the assets will generate revenue or otherwise be used by it. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less selling costs. The Company also periodically reviews the lives assigned to long-lived assets to ensure that the initial estimates do not exceed any revised estimated periods from which the Company expects to realize cash flows from its assets.

 

Research and Development Expenses

 

Research and development expenses consist of costs incurred for internal projects, as well as partner-funded collaborative research and development activities. These costs include direct and research-related overhead expenses, which include salaries, stock-based compensation and other personnel-related expenses, facility costs, supplies, depreciation of facilities and laboratory equipment, as well as research consultants and the cost of funding research at universities and other research institutions, and are expensed as incurred. Costs to acquire technologies that are utilized in research and development that have no alternative future use, are expensed when incurred. In accordance with Accounting Standards Codification (“ASC”) 730-20, the Company accounts for upfront, non-refundable research and development payments received from a related party as a long-term liability as there has not been a substantive and genuine transfer of risk and there is a presumption that the Company is obligated to repay the related party.

 

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Accruals for Research and Development Expenses and Clinical Trials

 

The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company accounts for these expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company determines accrual estimates through financial models and takes into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates.

 

Fair Value of Financial Instruments

 

The carrying amounts for cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses and notes payable approximate fair value due to the short-term nature of these instruments. It is management’sManagement’s opinion that the Company is not exposed to significant interest, currency, or credit risks arising from its other financial instruments and that their fair values approximate their carrying values except where expressly disclosed.

 

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in the absence of a principal, most advantageous market for the specific asset or liability.

 

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.

 

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The three tiers are defined as follows:

 

Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets at the measurement date. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment.
  
Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities.
  
Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

 

The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management.Management.

 

Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.

 

The Company had no assets or liabilities that required remeasurement on a recurring basis as of JanuaryOctober 31, 2022 and July 31, 2021.2022.

 

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Warrants

 

The Company assesses its warrants as either equity or a liability based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s balance sheet and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s balance sheet at their fair value on the date of issuance and are re-measured on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. Management estimates the fair value of these liabilities using option pricing models and assumptions that are based on the individual characteristics of the warrants or other instruments on the valuation date, as well as assumptions for future financings, expected volatility, expected life, yield and risk-free interest rate. As of JanuaryOctober 31, 2022 and July 31, 2021,2022, all outstanding warrants issued by the Company were classified as equity.

 

Net Loss Per Share

 

The Company computes basic net loss per common share by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period plus additional shares to account for the dilutive effect of potential future issuances of common stock relating to stock options and other potentially dilutive securities using the treasury stock method.

 

The Company did not include shares underlying stock options, restricted stock units and warrants issued and outstanding during any of the periods presented in the computation of net loss per share, as the effect would have been anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per share because of their anti-dilutive effect:

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

 

For the Three and Six Months Ended

 For the Three and Six Months Ended  

For the Three

Months Ended

  

For the Three

Months Ended

 
 January 31, 2022  January 31, 2021  October 31, 2022  October 31, 2021 
Stock options  2,436,059   2,359,604   129,261   129,656 
Restricted stock units  89,985   19,332   2,020   4,780 
Warrants  1,706,190   2,221,315   75,897   77,554 
Total  4,232,234   4,600,251   207,178   211,990 

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Stock-Based Compensation

 

The Company grants equity-based awards (typically stock options or restricted stock units) under its stock-based compensation plan and occasionally outside of its stock-based compensation plan, with terms generally similar to the terms under the Company’s stock-based compensation plan. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model. For employees, directors and consultants, the fair value of the award is measured on the grant date. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The Company estimates the fair value of restricted stock unit awards based on the closing price of the Company’s common stock on the date of issuance.grant.

 

Employee Stock Purchase Plan

 

Employees may elect to participate in the Company’s stockholder-approved employee stock purchase plan. The stock purchase plan allows for the purchase of the Company’s common stock at not less than 85% of the lesser of (i) the fair market value of a share of common stock on the beginning date of the offering period and (ii) the fair market value of a share of common stock on the purchase date of the offering period, subject to a share and dollar limit as defined in the plan and subject to the applicable legal requirements. There are two six-month offering periods during each fiscal year, ending on January 31 and July 31.

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In accordance with applicable accounting guidance, the fair value of awards under the stock purchase plan is calculated at the beginning of each offering period. The Company estimates the fair value of the awards using the Black-Scholes option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and the offering period. This fair value is then amortized at the beginning of the offering period. Stock-based compensation expense is based on awards expected to be purchased at the beginning of the offering period, and therefore is reduced when participants withdraw during the offering period.

 

Leases

 

The Company determines if an arrangement is a lease at inception. Operating lease ROUright of use (“ROU”) assets represent the Company’s right to use an underlying asset during the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases are included in ROU assets, current operating lease liabilities, and long-term operating lease liabilities on the Company’s condensed consolidated balance sheets.

 

Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of 12 months or less are not recognized on the condensed consolidated balance sheets. The Company’s leases do not contain any residual value guarantees. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company accounts for lease and non-lease components as a single lease component for all its leases.

 

Foreign Currency Translation

 

The Company uses the U.S. Dollar as the reporting currency for its financial statements. Functional currency is the currency of the primary economic environment in which an entity operates. The functional currency of the Company’s wholly owned subsidiary is the Australian dollar.

 

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Assets and liabilities of the Company’s subsidiary are translated into U.S. Dollars at period-end foreign exchange rates, and revenues and expenses are translated at average rates prevailing throughout the period. Translation adjustments are included in “Accumulated other comprehensive income” as a separate component of stockholders’ equity, and in the “Effect of exchange rate changes on cash and cash equivalents,” on the Company’s condensed consolidated statements of cash flows. Transaction gains and losses including intercompany transactions denominated in a currency other than the functional currency of the entity involved are included in “Foreign currency exchange gain (loss), net” on the Company’s condensed consolidated statements of operations.

 

Accumulated Other Comprehensive Income (Loss)

 

Accumulated other comprehensive income (loss) includes foreign currency translation adjustments related to the Company’s subsidiary in Australia and is excluded from the accompanying condensed consolidated statements of operations.

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Australia Research and Development Tax Credit

 

The Company’s wholly-owned Australian subsidiary incurs research and development expenses, primarily in the course of conducting clinical trials. The Company’s Australian research and development activities qualify for the Australian government’s tax credit program, which provides a 43.5% credit for qualifying research and development expenses. The tax credit does not depend on the Company’s generation of future taxable income or ongoing tax status or position. Accordingly, the credit is not considered an element of income tax accounting under ASC 740 “Income Taxes” and is recorded against qualifying research and development expenses.

The CARES Act

On March 27, 2020, the president signed into law the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) providing nearly $2 trillion in economic relief to eligible businesses impacted by the coronavirus outbreak. The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer social security payments, net operating loss (“NOL”) utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. In addition to the Small Business Administration (“SBA”) loan received in April 2020, the Company continues to review, and intends to seek, any other available potential benefits under the CARES Act as well as any future legislation signed into law during 2022. The effects of the CARES Act did not have a significant impact on the Company’s condensed consolidated financial statements during the three and six months ended January 31, 2022 and 2021.expenses

 

Recent Accounting Pronouncements

 

No recent accounting pronouncements are anticipated to have an impact on or related to the Company’s financial condition, results of operations, or related disclosures.

 

Note 3—Going Concern and Management’s Plans

The Company has sustained losses in all reporting periods since inception, with an accumulated deficit of approximately $271294 million as of JanuaryOctober 31, 2022. These losses are expected to continue for an extended period of time. Further, the Company has never generated any cash from its operations and does not expect to generate such cash in the near term. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the issuance date of the condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.

 

As of March 2,December 1, 2022, the Company had cash and cash equivalents of $22.18.1 million. Since inception, cash flows from financing activities have been the primary source of the Company’s liquidity. Based on the Company’s current cash levels, the Company believes its cash resources are insufficient to meet the Company’s anticipated needs for the 12 months following the date the condensed consolidated financial statements are issued.

 

15

The Company recognizes it will need to raise additional capital to continue operating its business and fund its planned operations, including research and development, clinical trials and, if regulatory approval is obtained, commercialization of its product candidates. In addition, the Company will require additional financing if it desires to in-license or acquire new assets, research and develop new compounds or new technologies and pursue related patent protection, or obtain any other intellectual property rights or other assets. There is no assurance that additional financing will be available to the Company when needed, that managementManagement will be able to obtain financing on terms acceptable to the Company, or whether the Company will become profitable and generate positive operating cash flow. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Similarly, if our common stock is delisted from the Nasdaq Capital Market, it may limit our ability to raise additional funds. Seefunds (see Note 12Nasdaq Deficiency Notices.12). The ongoing COVID-19 pandemic has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all. If the Company is unable to raise sufficient additional funds when needed, on favorable terms or at all, the Company will not be able to continue the development of its product candidates as currently planned or at all, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses or cease operations, any of which would have a significant negative impact on itsthe Company’s prospects and financial condition.

 

17

Note 4—Balance Sheet Details

 

Property and Equipment

 

Property and equipment, net, is comprised of the following:

Schedule of Property and Equipment, Net

 January 31, 2022  July 31, 2021  October 31, 2022  July 31, 2022 
Equipment and furniture $1,944,540  $1,919,301  $1,944,540  $1,944,540 
Computer software  109,242   109,242   109,242   109,242 
Leasehold improvements  32,651   32,651   32,651   32,651 
Construction in progress  446,367   234,409   446,367   446,367 
Property and equipment, gross  2,532,800   2,295,603   2,532,800   2,532,800 
Accumulated depreciation and amortization  (1,461,799)  (1,366,782)  (1,599,099)  (1,554,186)
Total $1,071,001  $928,821  $933,701  $978,614 

 

Depreciation and amortization expense recorded for the three months ended JanuaryOctober 31, 2022 and 2021 was approximately $48,00045,000 and $46,000, respectively..

 

Depreciation and amortization expense recorded for the sixthree months ended JanuaryOctober 31, 2022 and 2021 was approximately $95,00047,000 and $96,000, respectively..

 

Intangible Assets

 

Intangible assets, net, is comprised of the following:

Schedule of Intangible Assets

 January 31, 2022  July 31, 2021  October 31, 2022  July 31, 2022 
License $495,000  $495,000  $495,000  $495,000 
Accumulated amortization  (81,529)  (46,588)  (133,941)  (116,471)
Total $413,471  $448,412  $361,059  $378,529 

 

In November 2020, the Company licensed generator technology for use in its clinical trials and other research and development efforts. Unless earlier terminated, the term of the license agreement will remain in effect for 85 months. The Company has determined that the license has alternative future uses in research and development projects. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 85 months.

 

16

Intangible asset amortization expense recorded for the three months ended JanuaryOctober 31, 2022 and 2021 was approximately $17,000 and $12,000, respectively..

 

Intangible asset amortization expense recorded for the sixthree months ended JanuaryOctober 31, 2022 and 2021 was approximately $35,00017,000 and $12,000, respectively..

 

18

At JanuaryOctober 31, 2022, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows:

Schedule of Amortization Expense of Intangible Assets

  Jan 31,2022 
Years ending July 31,        
2022 – the remainder of the fiscal year $34,942 
2023  69,882 
2023 – the remainder of the fiscal year  $52,412 
2024  69,882    69,882 
2025  69,882    69,882 
2026  69,882    69,882 
2027   69,882 
Thereafter  99,001    29,119 
Total $413,471   $361,059 

Accounts Payable and Accrued Liabilities

 

Accounts payable and accrued liabilities are comprised of the following:

Schedule of Accounts payablePayable and accrued liabilitiesAccrued Liabilities

 January 31, 2022  July 31, 2021  October 31, 2022  July 31, 2022 
Research and development costs $2,622,088  $4,206,926  $3,402,401  $3,210,627 
Professional services fees  748,483   1,229,040   1,319,890   877,411 
Other  83,638   125,679   80,165   120,184 
Total $3,454,209  $5,561,645  $4,802,456  $4,208,222 

 

Accrued Compensation

 

Accrued compensation is comprised of the following:

Schedule of Accrued Compensation

 January 31, 2022  July 31, 2021  October 31, 2022  July 31, 2022 
Accrued payroll $319,304  $311,590  $208,781  $311,662 
401K payable  8,584   9,065   15,579   7,333 
Accrued severance  254,954   -   244,258   57,982 
Total $582,842  $320,655  $468,618  $376,977 

 

Note 5—Note Payable

 

On July 1, 2021,11, 2022, the Company entered into a finance agreement with AFCO Premium Credit LLC (“AFCO”). Pursuant to the terms of the agreement, AFCO loaned the Company the principal amount of $1,355,9191,027,986, which would accrue interest at 2.8945.248% per annum, to partially fund the payment of the premium of the Company’s Director & Officer insurance. The agreement requires the Company to make eleven monthly payments of $125,05695,923, including interest starting on July 18, 2021.2022. At JanuaryOctober 31, 2022, the outstanding balance related to this finance agreement was $497,223659,870.

 

17

Note 6—Stockholders’ Equity

January 2021 Offering

On January 25, 2021, the Company completed the offer and sale of an aggregate of 7,711,284 shares of its common stock at a purchase price of $5.45per share in a public offering. The gross proceeds from the offering were approximately $42.0 million, and the net proceeds, after deducting the placement agent’s fee and other offering fees and expenses paid by the Company, were approximately $39.1 million. In connection with the offering, the Company paid the underwriters an aggregate cash fee equal to 6.0% of the gross proceeds of the offering, as well as legal and other expenses equal to approximately $0.4 million.

August 2020 Offering

On August 19, 2020, the Company completed the offer and sale of an aggregate of 4,608,589 shares of its common stock at a purchase price of $3.25per share in a registered direct public offering. The gross proceeds from the offering were approximately $15.0 million, and the net proceeds, after deducting the placement agent’s fee and other offering fees and expenses paid by the Company, were approximately $13.5 million. In connection with the offering, the Company paid the placement agent and other financial advisors an aggregate cash fee equal to 8.0% of the gross proceeds of the offering, as well as legal and other expenses equal to approximately $0.3 million.

19

Outstanding Warrants

 

At JanuaryOctober 31, 2022, the Company had outstanding warrants to purchase 1,706,19075,897 shares of its common stock, with exercise prices ranging from $3.45 75.90to $16.80275.00, all of which were classified as equity instruments. These warrants expire at various dates between October 2022April 2023 and May 2024.

 

China Grand Pharmaceutical and Healthcare Holdings Limited and Sirtex Medical US Holdings, Inc.

 

On October 10, 2019, the Company and Grand Decade Developments Limited (“GDDL”), a direct, wholly-owned subsidiary of Grand Pharmaceutical Group Limited (formerly China Grand Pharmaceutical and Healthcare Holdings Limited,Limited), a company formed under the laws of the British Virgin Islands (“CGP”), and its affiliate, Sirtex Medical US Holdings, Inc., a Delaware corporation (“Sirtex”) entered into Stock Purchase Agreements (as amended, the “Purchase Agreements”), pursuant to which the Company agreed to sell and issue to CGP and Sirtex 454,545 shares and 90,909 shares, respectively, of the Company’s common stock for a total purchase price of $30.0 million. The net proceeds, after deducting offering fees and expenses paid by the Company, were approximately $28.0 million. This transaction closed on February 7, 2020 (the “Closing”). Pursuant to whichthe Purchase Agreements, CGP and Sirtex were given the right under certain circumstances to purchase in the future additional shares of common stock at a purchase price equal to the same exercise price paid by each warrant holder in order to maintain CGP and Sirtex’s respective ownership percentages of the outstanding shares of common stock of the Company as of October 10, 2019.the Closing.

 

Note 7—Stock-Based Compensation

 

The OncoSec Medical Incorporated 2011 Stock Incentive Plan (as amended and approved by the Company’s stockholders (the “2011 Plan”)), authorizes the Company’s Board of Directors to grant equity awards, including but not limited to, stock options and restricted stock units, to employees, directors and consultants. The 2011 Plan authorizes a total of 209,0914,600,000 shares of common stock for issuance. Under the 2011 Plan, incentive stock options are to be granted at a price that is no less than 100% of the fair value of the Company’s common stock at the date of grant. Stock options vest over a period specified in the individual option agreements entered into with grantees and are exercisable for a maximum period of 10years after the date of grant. Incentive stock options granted to stockholders who own more than 10% of the outstanding stock of the Company at the time of grant must be issued at an exercise price of no less than 110% of the fair value of the Company’s common stock on the date of grant.

 

Modification of Stock Option Awards

During the six months ended January 31, 2021, the compensation committee of the Company’s Board of Directors approved the accelerated vesting of 791,019 and 91,666 previously granted time-vesting awards for employees and directors, respectively. The Company accounted for the effects of the stock option modifications described above under the guidance of ASC 718 as follows:

● The unamortized compensation costs associated with the time-vesting options was expensed on the date of acceleration, which was approximately $1.2 million and $0.1 million for the employees and directors, respectively.

● Upon modification, it is required under ASC 718 to analyze the fair value of the instruments, before and after the modification, recognizing additional compensation cost for any incremental value. The Company computed the fair value of the award immediately prior to the modification and compared the fair value to that of the modified award. Since the value of the awards were less after the modification as compared to immediately prior to the modification, no additional compensation expense was recorded.

Stock Options

 

During the sixthree months ended JanuaryOctober 31, 2022, the Company granted an equity award that consisted of options to purchase 2,273 shares of its common stock to a director under the 2011 Plan. The stock options issued to a director have a 10-year term, vest over one year and have an exercise price of $9.94.

During the three months ended October 31, 2021, the Company granted options to purchase 23,400 and 25,0001,064 shares of its common stock to employees and a consultant under the 2011 Plan, respectively.Plan. The stock options issued to employees have a 10-year term, vest over two years and have exercise prices ranging from $2.0144.22 to $2.26. The stock options issued to the consultant have a 10-year term, vest over one year and have an exercise price of $1.42.

During the six months ended January 31, 2021, the Company granted options to purchase 787,251, 125,000 and 25,000 shares of its common stock to employees, directors and a consultant under the 2011 Plan, respectively. The stock options issued to employees have a 10-year term, vest over three years and have exercise prices ranging from $3.43 to $6.28. The stock options issued to directors have a 10-year term, vest over one year and have an exercise price of $3.43. The stock options issued to the consultant have a 10-year term, vest over one year and have an exercise price of $3.82.

20

During the six months ended January 31, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4), the Company granted an inducement equity award that consisted of options to purchase 300,000 shares of its common stock to an employee outside the 2011 Plan. The stock options issued to the employee are nonqualified, have a 10-year term, vest over one year and have an exercise price of $3.5649.72.

 

The Company accounts for stock-based compensation based on the fair value of the stock-based awards granted and records forfeitures as they occur. As such, the Company recognizes stock-based compensation cost only for those stock-based awards that vest over their requisite service period, based on the vesting provisions of the individual grants. The service period is generally the vesting period, with the exception of stock options granted pursuant to a consulting agreement, in which case the stock option vesting period and the service period are defined pursuant to the terms of the consulting agreement.

 

18

The following assumptions were used for the Black-Scholes calculation of the fair value of stock-based compensation related to stock options granted during the periods presented:

 

Schedule of Assumptions used to Calculate Fair Value of Stock Based Compensation

 

Six Months Ended

January 31, 2022

 

Six Months Ended

January 31, 2021

  

Three Months

Ended

October 31, 2022

 

Three Months

Ended

October 31, 2021

 
Expected term (years) 5.006.00 years 5.00 6.50 years   5.125.49 years   5.13 6.00 years 
Risk-free interest rate 0.691.30% 0.270.65%  4.074.09%  0.690.92%
Volatility 86.9890.74% 85.31 88.95%  89.9691.75%  86.9888.89%
Dividend yield  0%  0%  0%  0%

 

The Company’s expected volatility is derived from the historical daily change in the market price of its common stock. The Company uses the simplified method to calculate the expected term of options issued to employees, non-employees and directors, as the Company does not have much stock option exercise history and thus does not have enough information on exercise behavior to calculate a refined expected term based on that information. The risk-free interest rate used in the Black-Scholes calculation is based on the prevailing U.S. Treasury yield in effect at the time of grant, commensurate with the expected term. For the expected dividend yield used in the Black-Scholes calculation, the Company has never paid any dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable future.

 

The following is a summary of the Company’s 2011 Plan and non-Plan stock option activity for the sixthree months ended JanuaryOctober 31, 2022:

 

Summary of Stock Option Activity

  Options  

Weighted

Average

Exercise

Price

  

Weighted -

average Remaining Contract
(in years)

  

Aggregate

Intrinsic

Value

($000)

 
Outstanding - July 31, 2021  3,111,642  $3.27                     
Granted  48,400  $1.76         
Exercised  (130,000) $1.56         
Forfeited/Cancelled  (593,983) $3.75         
Outstanding - January 31, 2022  2,436,059  $3.22   8.7  $- 
Exercisable - January 31, 2022  1,877,040  $3.07   8.6  $- 
  Options  

Weighted

Average

Exercise

Price

  

Weighted -

Average Remaining Contract
(in years)

  

Aggregate

Intrinsic

Value

($000)

 
Outstanding - July 31, 2022  133,973  $57.34         
Granted  2,273  $9.94         
Forfeited/Cancelled  (6,985) $133.46         
Outstanding - October 31, 2022  129,261  $52.39   8.3  $- 
Exercisable - October 31, 2022  104,238  $56.79   8.1  $           - 

 

The weighted-average grant date fair value of stock options granted during the sixthree months ended JanuaryOctober 31, 2022 and 2021 was $1.247.31 and $2.6633.00, respectively.

 

As of JanuaryOctober 31, 2022, the Company has approximately $1.30.5 million in unrecognized stock-based compensation expense attributable to the outstanding options, which is expected to be recognized over a weighted-average period of 1.230.60 years.

21

 

Stock-based compensation expense recorded in the Company’s condensed consolidated statements of operations for the three and six months ended JanuaryOctober 31, 2022 resulting from stock options awarded to the Company’s employees, directors and consultants was approximately $0.3 million million and $0.8 million, respectively.. Of the total expense, $0.20.1 million and $0.5 million, respectively, was recorded to research and development and $0.10.2 million and $0.3 million, respectively was recorded in general and administrative in the Company’s condensed consolidated statements of operations for the three and six months ended JanuaryOctober 31, 2022.

 

Stock-based compensation expense recorded in the Company’s condensed consolidated statements of operations for the three and six months ended JanuaryOctober 31, 2021 resulting from stock options awarded to the Company’s employees, directors and consultants was approximately $0.40.5 million and $2.3 million, which included approximately $0 and $1.3 million, respectively, related to the accelerated vesting of time-vesting options.million. Of the total expense, $0.3million and $1.3 million respectively, was recorded to research and development and $0.10.2 million and $1.0 million, respectively, was recorded in general and administrative in the Company’s condensed consolidated statements of operations for the three and six months ended JanuaryOctober 31, 2021.

 

19

Restricted Stock Units (“RSUs”)

 

For the three months ended JanuaryOctober 31, 2022, and 2021, the Company recorded approximately $54,000 and $42,00053,000 in stock-based compensation related to RSUs, which is reflected in the condensed consolidated statements of operations.

 

For the sixthree months ended JanuaryOctober 31, 2022 and 2021, the Company recorded approximately $130,000 and $69,00076,000 in stock-based compensation related to RSUs, which is reflected in the condensed consolidated statements of operations.

 

The following table summarize RSUs issued and outstanding:

 

SummarizeSummary of Restricted Stock Units

  RSUs  

Weighted

Average

Grant Date

Fair Value

 
Nonvested - July 31, 2021  442,749  $3.24 
Vested  (52,659) $3.35 
Forfeited/Cancelled  (300,105) $3.16 
Nonvested - January 31, 2022  89,985  $3.43 
  RSUs  

Weighted

Average

Grant Date

Fair Value

 
Nonvested - July 31, 2022  2,710  $74.94 
Vested  (690) $76.62 
Nonvested - October 31, 2022  2,020  $74.37 

 

As of JanuaryOctober 31, 2022, there was approximately $0.30.1 million unrecognized compensation cost related to unvested RSUs. This amount is expected to be recognized over a weighted-average period of 1.350.63 years.

Shares Issued to Consultants

 

During the three months ended JanuaryOctober 31, 2022 and 2021, 0 and 37,500 shares of common stock valued at $0 and approximately $0.1 million, respectively, were issued to a consultant for services. During the six months ended January 31, 2022 and 2021, 12,500 and 62,500568 shares of common stock valued at approximately $0.04million and $0.2 million, respectively, were issued to a consultant for services. The common stock share values were based on the closing stock price of the Company’s common stock on the date the shares were granted.

 

2015 Employee Stock Purchase Plan

 

Under the Company’s 2015 Employee Stock Purchase Plan (“ESPP”), the Company is authorized to issue 50,0002,273 shares of the Company’s common stock. At JanuaryOctober 31, 2022, there were 28,2941,218 shares remaining available for issuance under the ESPP.

22

 

The ESPP is considered a Type B plan under FASB ASC Topic 718 because the number of shares a participant is permitted to purchase is not fixed based on the stock price at the beginning of the offering period and the expected withholdings. The ESPP enables the participant to “buy-up” to the plan’s share limit, if the stock price is lower on the purchase date. As a result, the fair value of the awards granted under the ESPP is calculated at the beginning of each offering period as the sum of:

 

 15% of the share price of an unvested share at the beginning of the offering period,
 85% of the fair market value of a six-month call on the unvested share aforementioned, and
 15% of the fair market value of a six-month put on the unvested share aforementioned.

 

The fair market value of the six-month call and six-month put are based on the Black-Scholes option valuation model.

For the six-month offering period to endending on January 31, 2023, the following assumptions were used: six-month maturity, 2.91% risk free interest, 75.04% volatility, 0% forfeitures and $0 dividends. For the six-month offering period that ended on January 31, 2022, the following assumptions were used: six-month maturity, 0.05% risk free interest, 72.99% volatility, 0% forfeitures and $0 dividends. For the six-month offering period ended January 31, 2021, the following assumptions were used: six-month maturity, 0.1% risk free interest, 122.84% volatility, 0% forfeitures and $0 dividends.

 

Approximately $1,200 300and $4,1001,200 was recorded as stock-based compensation during the sixthree months ended JanuaryOctober 31, 2022 and 2021, respectively.

 

20

Common Stock Reserved for Future Issuance

 

The following table summarizes all common stock reserved for future issuance at JanuaryOctober 31, 2022:

Summary of Common Stock Reserved for Future Issuance 

     
Common Stock options outstanding (within the 2011 Plan and outside of the terms of the 2011 Plan)  2,436,059129,261 
Common Stock reserved for restricted stock unit releasesettlement  89,9852,020 
Common Stock authorized for future grant under the 2011 Plan  1,569,82980,069 
Common Stock reserved for warrant exercise  1,706,19075,897 
Shares issuable under CGP and Sirtex stock purchase agreements (Note 6)  1,924,00185,585 
Common Stock reserved for future ESPP issuance  28,2941,218 
Total Common Stock reserved for future issuance  7,754,358374,050 

 

Note 8—Commitments and Contingencies

 

Contingencies

 

The Company is not a party to any other legal proceeding or aware of any other threatened action as of the date of this report.

 

Employment Agreements

 

The Company has entered into employment agreements with certain executive officers and certain other key employees. Generally, the terms of these agreements provide that, if the Company terminates the officer or employee other than for cause, death or disability, or if the officer terminates his or her employment with the Company for good cause, the officer shall be entitled to receive certain severance compensation and benefits as described in each such agreement.

 

23

Note 9—Leases

 

Lease Agreements

On August 31, 2022, the Company provided a six month notice to MawIt Inc. (the “Six Month Notice”) for a property at Pennington, New Jersey, which serves as the Company’s New Jersey corporate headquarters. Under the Six Month Notice, the Company will not be renewing the lease and will be vacating the property before February 28, 2023. The Company remeasured the lease payments and recorded decreases of ROU asset for approximately $120,000 and lease liabilities of approximately $120,000 for this operating lease.

On October 17, 2022, the Company provided a notice to Explora BioLabs (the “Notice”) for a property at San Diego, California, which serves as the Company’s lab space. Under the Notice, the Company will terminate the lease on December 16, 2022. The Company accounted for the Notice as a contract modification, and accordingly, recorded decreases of ROU asset for approximately $363,000 and lease liabilities of approximately $363,000 for this operating lease.

 

The Company has operating leases for corporate offices and lab space. These leases have remaining lease terms of approximately oneless than a year to sevenfour years, some of which include options to extend the lease. For any lease where the Company is reasonably certain that a renewal option will be exercised, the lease payments associated with the renewal option period are included in the ROU asset and lease liability as of JanuaryOctober 31, 2022.

 

21

Supplemental balance sheet information related to leases as of JanuaryOctober 31, 2022 was as follows:

 

Schedule of Operating Lease Liabilities

Operating Leases:    

As of October 31,

2022

  

As of July 31,

2022

 
Operating lease right-of-use assets $5,149,229  $3,931,083  $4,665,515 
Operating Leases:            
Current portion included in current liabilities $1,037,252  $978,570  $1,111,571 
Long-term portion included in non-current liabilities  4,702,622   3,513,897   4,126,636 
Total operating lease liabilities $5,739,874  $4,492,467  $5,238,207 

 

Supplemental lease expense related to leases is as follows:

 

Schedule of Lease Expenses

 

For the Three Months Ended

January 31, 2022

 

For the Six

Months Ended

January 31, 2022

  

For the Three

Months Ended

October 31, 2022

 

For the Three

Months Ended

October 31, 2021

 
Operating lease cost $377,318  $747,110  $379,116  $369,792 
Total lease expense $377,318  $747,110  $379,116  $369,792 

 

Other information related to leases where the Company is the lessee is as follows:

 

Schedule of Other Information Related to Leases

  

As of

JanuaryOctober 31, 2022

 
Weighted-average remaining lease term  4.53.9 years
 
Weighted-average discount rate  9.9610.13%

 

Supplemental cash flow information related to operating leases is as follows:

 

Schedule of Cash Flow Information Related to Operating Leases

 

For the Three Months Ended

January 31, 2022

 

For the Six

Months Ended

January 31, 2022

  

For the Three

Months Ended

October 31, 2022

 

For the Three

Months Ended

October 31, 2021

 
Cash paid for operating lease liabilities $385,327 $765,611  $390,424  $380,284 
Total cash flows related to operating lease liabilities $385,327 $765,611  $390,424  $380,284 

 

Future minimum lease payments under non-cancellable leases as of JanuaryOctober 31, 2022 is as follows:

 

Schedule of Future Minimum Lease Payments Under Non-Cancellable Lease

Years ending July 31,       
2022 – the remainder of the fiscal year $777,389 
2023  1,585,224 
2023 – the remainder of the fiscal year  $1,054,361 
2024  1,539,142    1,350,056 
2025  1,516,126    1,390,558 
2026  1,533,882    1,432,274 
Thereafter  240,688 
2027   240,688 
Total minimum lease payments  7,192,451    5,467,937 
Less: Imputed interest  (1,452,577)   (975,470)
Total $5,739,874   $4,492,467 

 

2422

 

Note 10—401(k) Plan

 

Effective May 15, 2012, the Company adopted a defined contribution savings plan pursuant to Section 401(k) of the Code. The plan is for the benefit of all qualifying employees and permits voluntary contributions by employees of up to 100% of eligible compensation, subject to the maximum limits imposed by Internal Revenue Service. The terms of the plan allow for discretionary employer contributions and the Company currently matches 100% of its employees’ contributions, up to 3% of their annual compensation. The Company’s contributions are recorded as expense in the accompanying condensed consolidated statements of operations andoperations. The Company’s contributions totaled approximately $28,000 and $32,00047,000 for the three months ended JanuaryOctober 31, 2022 and 2021, respectively.2022. The Company’s contributions totaled approximately $81,000 and $60,00054,000 for the sixthree months ended JanuaryOctober 31, 2022 and 2021, respectively.2021.

 

Note 11—Related Party Transactions

 

Except as disclosed elsewhere herein, below are the Company’s related party transactions for the three and six months ended JanuaryOctober 31, 2022 and 2021.

 

Equity Offerings

On January 25, 2021, the Company completed the offer and sale of an aggregate of 7,711,284 shares of its common stock at a purchase price of $5.45 per share in a public offering (See Note 6). CGP and Sirtex participated in the offering. Each of CGP and Sirtex exercised its right of participation in future offerings in order to maintain respective ownership percentages of the outstanding shares of common stock of the Company upon close, and purchased 3,389,198 and 677,839 shares of common stock, respectively, at a purchase price of $5.45 per share.

On August 19, 2020, the Company completed the offer and sale of an aggregate of 4,608,589 shares of its common stock at a purchase price of $3.25per share in a registered direct offering (See Note 6). CGP and Sirtex participated in the registered direct offering and maintained their respective ownership percentages of the outstanding shares of common stock of the Company upon close, and purchased 1,999,000 and 399,800 shares of common stock, respectively, at a purchase price of $3.25 per share.

Co-Promotion Agreement

In January 2021, the Company entered into a co-promotion agreement with Sirtex, pursuant to which the Company granted Sirtex the option to co-promote TAVO™-EP for the treatment of anti-PD-1 refractory locally advanced or metastatic melanoma in the U.S., including its territories and possessions. In consideration for the option, the Company received an upfront, non-refundable payment of $5.0million from Sirtex (the “option fee”). The option to co-promote is non-exclusive and may be exercised at any time by Sirtex from the effective date until 90 days following the receipt by Sirtex of a complete copy of the final BLA filed by the Company with the FDA (the “option period”). If Sirtex exercises the option, the Company will receive an additional non-refundable and non-creditable option exercise fee of $25.0million, comprised of $20.0million in cash, and $5.0million for the issuance of common shares of the Company determined by the average closing price of the stock for the 30 days prior to the date of receipt of the exercise notice for the option.

 

Under the terms of the co-promotion agreement, if Sirtex exercises the co-promote option, the Company will pay to Sirtex a high-teens to low-twenties royalty (“promotion(the “promotion fee”) of U.S. net sales of the TAVO™ products. The co-promotion agreement will continue until the earlier of the expiration of the option period without Sirtex extending the option or the eighth anniversary of the first FDA approval of the BLA, and can be extended by mutual agreement between the Company and Sirtex. During the co-promotion term, the Company is responsible for funding approximately two-thirds of the promotional costs incurred by Sirtex and Sirtex shall be responsible for approximately one-third.

 

The Company has determined that the co-promotion agreement represents a funded research and development arrangement within the scope of ASC Subtopic 730-20, Research and Development—Research and Development Arrangements (ASC 730-20). The Company concluded that there has not been a substantive and genuine transfer of risk related to the co-promotion agreement and the Company’s ongoing development of TAVO™-EP as there is a presumption that the Company is obligated to repay Sirtex based on the significant related party relationship that exists between the parties. This significant related party relationship is based on Sirtex’s approximate 8% ownership of the outstanding shares of the Company’s common stock, and that of its significant equity holder, CGP (which owns 49% of Sirtex), which, at the time of entering into the agreement, owned approximately 42%42% of the outstanding shares of the Company’s common stock and is the Company’s largest shareholder.

 

The Company has determined that the appropriate accounting treatment under ASC 730-20 is to record any proceeds received from Sirtex for the co-promote option or upon exercise of the option as cash and cash equivalents as the Company has the ability to direct the usage of funds, and as a corresponding long-term liability (“Liability under co-promotion agreement – related party”) on the Company’s condensed consolidated balance sheet when received. The liability will remain on the balance sheet until (i) Sirtex exercises the option which results in royalties paid by the Company to Sirtex based on the net sales of the TAVO™ products, or (ii) Sirtex does not exercise the option and the co-promotion agreement is terminated by the parties.

As of JanuaryOctober 31, 2022, the balance of the Liability under co-promotion agreement – related party relates to the option fee payment of $5.0 million received from Sirtex.

23

 

Note 12—Nasdaq Deficiency NoticesNotice

On February 9,June 2, 2022, the Company received notice (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price of the Company’sits common stock had been below $1.00$1.00 per share for 30 consecutive business days as of the date of the Notice. The Notice hashad no immediate effect on the listing of the Company’s common stock, which will continuecontinues to trade at this time on the Nasdaq Capital Market under the symbol “ONCS.”

 

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until August 8, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period. In the event the Company does not regain compliance by August 8, 2022, the Company may be eligible for an additional 180 calendar day grace period if it meets the continued listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not regain compliance within the allotted compliance period(s), Nasdaq will provide notice that the Company’s common stock will be subject to delisting from the Nasdaq Capital Market. In that event, the Company may appeal such delisting determination to a hearings panel.

On November 29, 2021, the Company notified Nasdaq that Robert E. Ward had resigned as a member of the Board of Directors and the Company’s Audit Committee, as disclosed on the Company’s Current Report filed on Form 8-K on November 30, 2021. After giving effect to Mr. Ward’s resignation, the Company’s Audit Committee no longer consists of three independent members as required by Nasdaq Listing Rule 5605(c)(2)(A).

On December 8, 2021,25, 2022, the Company received a letter from Nasdaq notingconfirming that the Company no longer compliedhad regained compliance with Nasdaq Listing Rule 5550(a)(2) that requires companies listed on Nasdaq to maintain a minimum bid price of at least $1.00 per share to ensure continued listing (the “Listing Requirement”). The Company completed a 1-for-22 reverse stock split of its authorized, issued and outstanding shares of Common Stock on November 9, 2022. The Company regained compliance with the requirementListing Requirement after the closing bid price for its common stock listed on Nasdaq equaled or exceeded $1.00per share for 10 consecutive business days.

Note 13—Subsequent Events

Reverse Stock Split

The Board of Listing Rule 5605.Directors of the Company approved a reverse stock split of the Company’s authorized, issued and outstanding shares of common stock at a ratio of 1-for-22 (the “Reverse Stock Split”). The letterReverse Stock Split became effective on November 9, 2022 (the “Effective Date”). All share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted, on a retrospective basis, to reflect the Reverse Stock Split, unless otherwise stated. The number of authorized shares were also acknowledgedproportionately adjusted and the par value remained unaffected. The Company will issue one whole share of the post-Reverse Stock Split Common Stock to any stockholder who otherwise would have received a fractional share as a result of the Reverse Stock Split. As a result, no fractional shares will be issued in connection with the Reverse Stock Split and no cash or other consideration will be paid in connection with any fractional shares that would otherwise have resulted from the Listing Rules provideReverse Stock Split.

24

Convertible Promissory Note – Related Party

On November 25, 2022 (the “Funding Date”), the Company entered into a cure period in order forConvertible Promissory Note and Security agreement with GDDL, a British Virgin Islands limited company and a wholly owned subsidiary of Grand Pharmaceutical Group Limited, pursuant to which the Company issued a Secured Convertible Promissory Note (the “Note”) to GDDL. The Note has a principal amount of $2,000,000, bears interest at a rate of 5% per annum until November 25, 2023 and 10% per annum thereafter (the “Interest Rate”) and matures on November 25, 2024 (the “Maturity Date”), on which date the principal balance and all accrued interest under the Note shall be due and payable. The Interest Rate will be 10% per annum upon occurrence of an event of default, including, but not limited to, the failure by the Company to regain compliance untilmake payment of principal or interest due under the earlierNote on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws. The principal and interest accrued on the Note may be prepaid without any further agreement of the parties to the Note, or converted (as described below) upon the agreement of the parties to the Note, at any time without penalty to the Company.

Subject to the consent of GDDL, the Note is convertible into such number of fully paid and non-assessable shares of the Company’s next annual meetingcommon stock, par value $0.0001 per share (the “Common Stock”) as determined by dividing (i) any portion of stockholders orthe unpaid principal and accrued interest of the Note then outstanding by (ii) the greater of (a) the last closing bid price of a share of Common Stock as reported on the Nasdaq Capital Market (“Nasdaq”) on the date the Company and GDDL agree to such conversion and (b) the average closing bid price of a share of Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date, subject to a share cap of 360,769 shares of Common Stock (the “Share Cap”), representing 19.99% of the total issued and outstanding shares of Common Stock as of November 23,25, 2022.

 

WeAdditionally, if at any time after the Funding Date the last closing bid price of a share of Common Stock as reported on the Nasdaq for ten consecutive trading days or the average closing bid price of a share Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date is equal to or exceeds $44.00 (subject to any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other substantially similar transaction), GDDL may require that the Company prepay the Note through conversion of the then outstanding principal and/or any accrued interest thereon into shares of Common Stock, in whole or in part.

The unpaid principal of and any accrued interest on the Note constitute unsubordinated obligations of the Company and are currently evaluating our alternativessenior and preferred in right of payment to resolve these listing deficiencies. Toall equity securities of the extentCompany outstanding as of the Funding Date, which are secured by all of the Company’s right, title and interest, in and to certain of the Company’s intellectual property rights in Hong Kong, Taiwan, China and South Korea, as specified in the Note; provided, however, that wethe Company may incur or guarantee additional indebtedness after the Funding Date, whether such indebtedness are unablesenior, pari passu or junior to resolve these listing deficiencies, there isthe obligations under the Note.

December 2022 Offering

On November 30, 2022, the Company entered into a riskSecurities Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Investors”) that ourclosed on December 1, 2022, pursuant to which the Company sold, issued, and delivered, in a registered public offering (the “Offering”) (i) 1,166,667 shares of the Company’s common stock (the “Common Stock”), par value $0.0001 per share (each a “Share” and collectively the “Shares”); (ii) pre-funded warrants in lieu of shares of Common Stock (the “Pre-Funded Warrants”) to purchase shares of Common Stock and (iii) 1,166,667 Common Warrants (the “Common Warrants” and collectively with the Pre-Funded Warrants, the “Warrants”) to purchase shares of Common Stock, to the Investors. Under the terms of the Purchase Agreement, the Company agreed to sell one share of its Common Stock or a Pre-Funded Warrant and one Common Warrant for each share of Common Stock or Pre-Funded Warrant sold at a price of $3.00. For each Pre-Funded Warrant sold in the Offering, the number of shares of Common Stock offered was decreased on a one-for-one basis. The Pre-Funded Warrants are exercisable immediately upon the date of issuance, may be delistedexercised at any time until all of the Pre-Funded Warrants are exercised in full and have a nominal exercise price of $0.0001 per share. The Common Warrants are exercisable immediately upon the date of issuance and have an exercise price of $3.00 per share, subject to adjustment. The Common Warrants will expire five (5) years from Nasdaq, which would adversely impact liquiditythe date of our common stock and potentially result in even lower bid prices for our common stock.issuance.

 

The Offering closed on December 1, 2022. The Company received gross proceeds of $3,500,001 in connection with the Offering before deducting placement agent fees and other offering expenses.

25

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

Unless the context indicates otherwise, all references to “OncoSec,” “the Company,” “we,” “us” and “our” in this report refer to OncoSec Medical Incorporated and its consolidated subsidiary. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes included in this report.

 

This discussion and analysis of our financial condition and results of operations is not a complete description of our business or the risks associated with an investment in our common stock. As a result, this discussion and analysis should be read together with our condensed consolidated financial statements and related notes included in this report, as well as the other disclosures in this report and in the other documents we file from time to time with the Securities and Exchange Commission, or SEC, including our Annual Report on Form 10-K for our fiscal year ended July 31, 20212022 filed with the SEC on October 29, 202131, 2022 (the “Annual Report”). Pursuant to Instruction 2 to paragraph (b) of Item 303 of Regulation S-K promulgated by the SEC, in preparing this discussion and analysis, we have presumed that readers have access to and have read the discussion and analysis of our financial condition and results of operations included in the Annual Report.

 

This discussion and analysis and the other disclosures in this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. Forward-looking statements relate to future events or circumstances or our future performance and are based on our current assumptions, expectations and beliefs about future developments and their potential effect on our business. All statements in this report that are not statements of historical fact could be forward-looking statements. The forward-looking statements in this discussion and analysis and elsewhere in this report include statements about, among other things, the status, progress and results of our clinical programs and our expectations regarding our liquidity and performance, including our expense levels, and the potential impact of the COVID-19 pandemic. Forward-looking statements are only predictions and are not guarantees of future performance, and they are subject to known and unknown risks, uncertainties and other factors, including the risks described under the heading “Risk Factors” herein and in Part I, Item IA of the Company’s most recent Annual Report on Form 10-K and similar discussions contained in the other documents we file from time to time with the SEC. In light of these risks, uncertainties and other factors, the forward-looking events and circumstances described in this report may not occur and our results, levels of activity, performance or achievements could differ materially from those expressed in or implied by any forward-looking statements we make. As a result, you should not place undue reliance on any of our forward-looking statements. Forward-looking statements speak only as of the date they are made, and unless required to by law, we undertake no obligation to update or revise any forward-looking statement for any reason, including to reflect new information, future developments, actual results or changes in our expectations. Unless otherwise stated herein, all share and per share numbers relating to the Company’s common stock prior to the effectiveness of the Reverse Stock Split have been adjusted to give effect to the Reverse Stock Split.

 

Overview

 

We are a late-stage immuno-oncology company focused on designing, developing and commercializing innovative, proprietary, intra-tumoral DNA-based therapeutics to stimulate and to augment anti-tumor immune responses for the treatment of cancers. Our core technology platform ImmunoPulse® is a drug-device therapeutic modality platform comprised of proprietary intratumoral electroporation (“EP”) delivery devices (the “OMS EP Device”) and a proprietary DNA plasmid delivery and application method that triggers transient expression of target protein in cells. The OMS EP Device is designed to deliverpromote cellular uptake of plasmid DNA-encoded drugs directly into a solid tumor and promote an immunological response against the cancer. The OMS EP Device can be adapted to treat different tumor types, and consists of an electrical pulse generator a reusable handle andpaired with disposable applicators. Our lead product candidate is a DNA-encoded interleukin-12 (“IL-12”) called tavokinogene telseplasmid (“TAVO™”). The OMS EP Device is used to deliver TAVO™ intratumorally, with the aim of reversing the immunosuppressive microenvironment in the treated tumor. The activation of the appropriate inflammatory response can drive a systemic anti-tumor response against untreated tumors in other parts of the body. In 2017, we received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for TAVO™ in metastatic melanoma, which could qualify TAVO™ for expedited FDA review, a rolling Biologics License Application review and certain other benefits.

 

26

Our current focus is to pursue our study of TAVO™-EP in combination with KEYTRUDA® (pembrolizumab) in melanoma and triple negative breast cancer.melanoma.

 

26

Performance Outlook

 

WeAs a result of recent cash runway and working capital limitations, we expect to use our available working capital in the near term primarily for the advancement of our existing and planned clinical melanoma programs, including performancedelivery of the KEYNOTE-695 and KEYNOTE-890 studies and,trial results. In order to a lesser extent, the continuation ofpreserve our existing working capital, we have decreased clinical work on our other clinical trials and studies.studies, including those involving triple negative breast cancer. We anticipate our spending on clinical programs and the development of our next-generation OMS EP Device will continue throughout our current fiscal year, primarily in support of the KEYNOTE-695 and KEYNOTE-890 studies, while ouryear. Our spending on research and development programs will be prioritized to support development of TAVO™-EP in melanoma, based on our current focus on the KEYNOTE-695 and KEYNOTE-890 studies. Wetrial. Due to ongoing restructuring efforts, we expect our cash-based general and administrative expenses to remain relatively flat in the near term, as we seek to continue to leverage internal resources and automate processes to decrease our outside services expenses. See “Results of Operations” below for more information.

 

Restructuring Plan

On October 2, 2022, our Board of Directors authorized a restructuring plan (the “Restructuring Plan”) that is designed to prioritize clinical activities in melanoma to reduce operating expenses while advancing our lead product candidate, TAVO™ EP, toward near-term data milestones in connection with the KEYNOTE-695 clinical trial. As part of the Restructuring Plan, we restructured our internal operations and reduced our workforce by approximately 45%, or 17 employees.

We currently estimate that we will incur charges of approximately $750,000 to $800,000 in connection with the Restructuring Plan, consisting primarily of cash expenditures for employee transition, notice period and severance payments, retention bonus payments, and related costs. We expect that the majority of the restructuring charges will be incurred in the fourth calendar quarter of 2022 and first calendar quarter of 2023, and that the execution of the Restructuring Plan will be substantially complete by the second calendar quarter of 2023.

The charges that we expect to incur in connection with the Restructuring Plan are estimates and subject to a number of assumptions, and actual results may differ materially. The foregoing estimated amounts do not include any non-cash charges associated with stock-based compensation. We expect to operationalize additional cost reduction actions that will include other incremental cost reduction actions unrelated to workforce reductions.

COVID-19

 

Our operational and financial performance have been affected by the COVID-19 pandemic. Our clinical trials have experienced delays in patient enrollment, potentially due to prioritization of hospital resources toward the COVID-19 pandemic or concerns among patients about participating in clinical trials during a public health emergency. The COVID-19 pandemic is also affecting the operations of government entities, such as the FDA, as well as contract research organizations, third-party manufacturers, and other third-parties upon whom we rely. The extent of the impact on our operations cannot be ascertained at this time.

 

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Results of Operations for the Three Months Ended JanuaryOctober 31, 2022 Compared to the Three Months Ended JanuaryOctober 31, 2021

 

The unaudited financial data for the three months ended JanuaryOctober 31, 2022 and 2021 is presented in the following table and the results of these two periods are included in the discussion thereafter.

 

January 31,

2022

 

January 31,

2021

 

$

Change

 

%

Change

  

October 31,

2022

 

October 31,

2021

 

$

Change

 

%

Change

 
Revenue $-  $-  $-  -  $- $- $-  - 
Expenses                                
Research and development  6,825,540   8,915,381   (2,089,841)  (23)  4,768,372   6,645,771   (1,877,399)  (28)
General and administrative  2,590,893   2,110,696   480,197   23   2,538,497   3,269,723   (731,226)  (22)
Loss from operations  (9,416,433)  (11,026,077)  1,609,644   (15)  (7,306,869)  (9,915,494)  2,608,625   (26)
Other expense, net  (2,583)  (440)  (2,143)  487 
Other income (expense), net  38,098   (2,010)  40,108   (1995)
Interest expense  (5,382)  (4,722)  (660)  14   (11,081)  (8,045)  (3,036)  38 
Foreign currency exchange gain (loss), net  (480,072)  328,592   (808,664)  (246)  (781,546)  116,924   (898,470)  (768)
Loss before income taxes  (9,904,470)  (10,702,647)  798,177   (7)  (8,061,398)  (9,808,625)  1,747,227   (18)
Income tax expense  2,950   1,450   1,500   103 
Income tax (benefit) expense  -   -   -   - 
Net loss $(9,907,420) $(10,704,097) $796,677   (7) $(8,061,398) $(9,808,625) $1,747,227   (18)

 

Revenue

 

We have not generated any revenue since our inception, and we do not anticipate generating revenue in the near term.

 

Research and Development Expenses

 

Our research and development expenses decreased by approximately $2.1$1.8 million, from $8.9$6.6 million during the three months ended JanuaryOctober 31, 2021 to $6.8$4.8 million during the three months ended JanuaryOctober 31, 2022. This decrease was primarily due to: (i) a $1.1$1.3 million decrease in clinical trial related costs to support our various clinical studiestrials and costs for discovery research and product development, and (ii) a $0.9$0.2 million decrease in stock-based compensation to employees and consultants and (iii) a $0.3 million decrease in payroll and related benefit expenses primarily related to a $0.6 million decrease due to decreased headcount offset by a $0.3 million increase due to severance cost and retention bonuses.

General and Administrative

Our general and administrative expenses decreased by $0.8 million, from $3.3 million during the three months ended October 31, 2021, to $2.5 million during the three months ended October 31, 2022. This decrease was primarily due to the following: (i) a $0.3 million decrease in consulting expenses, (ii) a $0.2 million decrease in payroll and related benefit expenses primarily due to bonuses awarded during the three months ended January 31, 2021, while no bonuses were awarded during the three months ended January 31, 2022.

27

General and Administrative

Our general and administrative expenses increaseda $0.4 million decrease in severance cost offset by $0.5 million, from $2.1 million during the three months ended January 31, 2021, to $2.6 million during the three months ended January 31, 2022. This increase was largely due to the following: (i) a $0.8 million increase in legal expenses, primarily related to the $1 million in insurance recoveries received in connection with prior litigation with Alpha Holdings, Inc. during the prior period, (ii) a $0.2 million increase in insurance costssalary and related to increased D&O insurance premiums, andbenefits as executive positions were filled during the second half of fiscal year 2022, (iii) a $0.2 million increase in director fees paid to the members of the Leadership Committee of the Company’s Board of Directors. These increases were partially offset by a $0.5$0.1 million decrease in payrolllegal expenses, and (iv) a $0.2$0.1 million decrease in stock-based compensation to employees and consultants.

Other Expense, Net

Other expense, net, increased by approximately $2,000, from less than $1,000 for the three months ended January 31, 2021 to $3,000 for the three months ended January 31, 2022. This increase was primarily due to increased tax expense related to the increased interest income from an intercompany loan during the current period.

 

Foreign Currency Exchange Gain (Loss), Net

 

Foreign currency exchange gain (loss), net, decreased by approximately $0.8$0.9 million from a $0.3$0.1 million gain during the three months ended JanuaryOctober 31, 2021 to a $0.5$0.8 million loss for the three months ended JanuaryOctober 31, 2022. This decrease was primarily due to unrealized foreign currency transaction loss recognized in connection with theour Australian subsidiary’s intercompany loan.

 

Results of Operations for the Six Months Ended January 31, 2022 Compared to the Six Months Ended January 31, 2021

The unaudited financial data for the six months ended January 31, 2022 and January 31, 2021 is presented in the following table and the results of these two periods are included in the discussion thereafter.

  

January 31,

2022

  

January 31,

2021

  

$

Change

  

%

Change

 
Revenue $-  $-  $-   - 
Expenses                
Research and development  13,471,311   18,714,740   (5,243,429)  (28)
General and administrative  5,860,616   5,351,429   509,187   10 
Loss from operations  (19,331,927)  (24,066,169)  4,734,242   (20)
Other expense, net  (4,594)  (1,063)  (3,531)  332 
Interest expense  (13,427)  (10,856)  (2,571)  24 
Foreign currency exchange gain (loss), net  (363,147)  151,674   (514,821)  (339)
Loss before income taxes  (19,713,095)  (23,926,414)  4,213,319   (18)
Income tax expense  2,950   2,950   -   - 
Net loss $(19,716,045) $(23,929,364) $4,213,319   (18)

Revenue

We have not generated any revenue since our inception, and we do not anticipate generating revenue in the near term.

28

Research and Development Expenses

Our research and development expenses decreased by approximately $5.2 million, from $18.7 million during the six months ended January 31, 2021 to $13.5 million during the six months ended January 31, 2022. This decrease was primarily due to the following: (i) a $4.2 million decrease in clinical trial-related costs to support our various clinical studies and costs for discovery research and product development, (ii) a $0.4 million decrease in payroll and related benefit expenses, primarily due to bonuses awarded during the six months ended January 31, 2021, while no bonuses were awarded during the six months ended January 31, 2022, partially offset by payroll and related benefit expenses incurred in connection with the Company’s increased headcount during the six months ended January 31, 2022, and (iii) a $0.7 million decrease in stock-based compensation expense to employees and consultants, as there was an accelerated vesting of options during the six months ended January 31, 2021 that was not repeated during the six months ended January 31, 2022.

General and Administrative

Our general and administrative expenses increased by approximately $0.5 million, from $5.4 million during the six months ended January 31, 2021, to $5.9 million during the six months ended January 31, 2022. This increase was largely due to the following: (i) a $0.7 million increase in legal costs, primarily related to $1 million in insurance recoveries received in connection with prior litigation with Alpha Holdings, Inc. in the prior period, (ii) a $0.4 million increase in insurance costs related to increased D&O insurance premiums, and (iii) a $0.2 million increase in director fees paid to the members of the Leadership Committee of the Company’s Board of Directors. These increases were partially offset by a $0.9 million decrease in stock-based compensation expense to employees and consultants, as there was an accelerated vesting of options during the six months ended January 31, 2021 that was not repeated during the six months ended January 31, 2022.

Other Expense, Net

Other expense, net, increased by approximately $4,000 from $1,000 for the six months ended January 31, 2021 to $5,000 for the six months ended January 31, 2022. This increase was primarily due to increased tax expense related to the increased interest income from an intercompany loan and the reduced interest income as a result of a lower return on our investments during the current period.

Foreign Currency Exchange Gain (Loss), Net

Foreign currency exchange gain (loss), net, decreased by approximately $0.5 million from a $0.2 million gain during the six months ended January 31, 2021 to a $0.4 million loss for the six months ended January 31, 2022. This increase was primarily due to unrealized foreign currency transaction loss recognized in connection with the Australian subsidiary’s intercompany loan.

Liquidity and Capital Resources

 

Working Capital

 

The following table and subsequent discussion summarize our working capital as of each of the periods presented:

 

  

At

January 31, 2022

  

At

July 31, 2021

 
Current assets $27,927,892  $49,179,424 
Current liabilities  5,571,526   7,961,916 
Working capital $22,356,366  $41,217,508 

29

  

At

October 31, 2022

  

At

July 31, 2022

 
Current assets $8,633,159  $15,232,471 
Current liabilities  6,909,514   6,633,328 
Working capital $1,723,645  $8,599,143 

 

Current Assets

 

Current assets as of JanuaryOctober 31, 2022 decreased by $21.3$6.6 million to $27.9$8.6 million, from $49.2$15.2 million as of July 31, 2021.2022. This decrease was primarily related to the decrease of cash and cash equivalents in the amount of $6.6 million. The decrease in cash was due to cash used to support our operations during the sixthree months ended JanuaryOctober 31, 2022.

Current Liabilities

 

Current liabilities as of JanuaryOctober 31, 2022 decreasedincreased by $2.4$0.3 million to $5.6$6.9 million, from $8.0$6.6 million as of July 31, 2021.2022. This decreaseincrease was primarily due to a decrease in accounts payable and accrued expenses pertainingattributable to our manufacturing and clinical research activities.negative cash flow from operations.

 

Cash Flow

 

Cash Used in Operating Activities

 

Net cash used in operating activities for the sixthree months ended JanuaryOctober 31, 2022 was $19.9$6.1 million, as compared to $20.6$9.9 million for the sixthree months ended JanuaryOctober 31, 2021. The $0.7$3.7 million decrease in cash used in operating activities was primarily attributable to a decrease in cash used to support our operating activities, including but not limited to, our clinical trials, research and development activities and general working capital requirements.

Cash Used in Investing Activities

Net cash used in investing activities for the six months ended January 31, 2022 was $0.2 million, as compared to $0.3 million for the six months ended January 31, 2021. During the six months ended January 31, 2022, the Company purchased fixed assets for use in its clinical trials. During the six months ended January 31, 2021, the Company licensed generator technology for use in its clinical trials and other research and development efforts.

Cash (Used in) Provided by Financing Activities

 

Net cash used in financing activities was $0.5$0.3 million for the sixthree months ended JanuaryOctober 31, 2022, as compared to $60.8$0.4 million cash provided byused in financing activities for the sixthree months ended JanuaryOctober 31, 2021. Net cash used in financing activities during the sixthree months ended JanuaryOctober 31, 2022 was primarily attributable to payments on a note payable.payable and payments on offering costs. Net proceedscash used in financing activities during the sixthree months ended JanuaryOctober 31, 2021 was primarily attributable to the $52.6 million net proceeds received from the August 2020 and January 2021 securities offerings, $5 million received from the co-promotion agreement with Sirtex, and $3.3 million received from warrant and option exercises.payments on a note payable.

 

Uses of Cash and Cash Requirements

 

Our primary uses of cash have been to finance clinical and research and development activities focused on the identification and discovery of new potential product candidates, the development of innovative and proprietary medical approaches for the treatment of cancer, and the design and advancement of pre-clinical and clinical trials and studies related to our pipeline of product candidates. We also use our capital resources on general and administrative activities and building and strengthening our corporate infrastructure, programs and procedures to enable compliance with applicable federal, state and local laws and regulations.

 

Our primary objectives for the next 12 months are to continue the advancement of our KEYNOTE-695 and KEYNOTE-890 studies and, to a lesser extent, our other ongoing clinical trials and studies,trial and to continue our research and development activities for our next-generation EP device and drug discovery efforts.device. In addition, we expect to pursue capital-raising transactions, which could include equity or debt financings, in the near term to fund our existing and planned operations and acquire and develop additional assets and technology consistent with our business objectives as opportunities arise.

 

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Going Concern and Management’s Plans

 

The Company hasWe have sustained losses in all reporting periods since inception, with an accumulated deficit of approximately $271$294 million as of JanuaryOctober 31, 2022. These losses are expected to continue for an extended period of time. Further, the Company haswe have never generated any cash from itsour operations and doesdo not expect to generate such cash in the near term. The aforementioned factors raise substantial doubt about the Company’sour ability to continue as a going concern within one year from the issuance date of the condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Companywe be unable to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.

 

As of March 2,December 1, 2022, the Companywe had cash and cash equivalents of $22.1$8.1 million. Since inception, cash flows from financing activities hashave been the primary source of the Company’sour liquidity. Based on itsour current cash levels, the Company believes itswe believe our cash resources are insufficient to meet the Company’sour anticipated needs for the 12 months following the date the condensed consolidated financial statements are issued.

 

The Company recognizes itWe will need to raise additional capital to continue operating itsour business and fund itsour planned operations, including research and development, clinical trials and, if regulatory approval is obtained, commercialization of its product candidates. In addition, the Companywe will require additional financing if it desireswe desire to in-license or acquire new assets, research and develop new compounds or new technologies and pursue related patent protection, or obtain any other intellectual property rights or other assets. There is no assurance that additional financing will be available to the Companyus when needed, that managementManagement will be able to obtain financing on terms acceptable to the Company,us, or whether the Companywe will become profitable and generate positive operating cash flow. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Similarly, if our common stock is delisted from the Nasdaq Capital Market, it may limit our ability to raise additional funds. See “Nasdaq Deficiency Notices”Notice” below. The ongoing COVID-19 pandemic has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all. If the Company iswe are unable to raise sufficient additional funds when needed, on favorable terms or at all, the Companywe will not be able to continue the development of itsour product candidates as currently planned or at all, will need to reevaluate itsour planned operations and may need to delay, scale back or eliminate some or all of itsour development programs, reduce expenses or cease operations, any of which would have a significant negative impact on itsour prospects and financial condition.

 

Sources of Capital

 

We have not generated any revenue since our inception, and we do not anticipate generating revenue in the near term. Historically, we have raised the majority of the funding for our business through offerings of our common stock and warrants to purchase our common stock. If we issue equity or convertible debt securities to raise additional funds, our existing stockholders would experience further dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. If we incur debt, our fixed payment obligations, liabilities and leverage relative to our equity capitalization would increase, which could increase the cost of future capital. Further, the terms of any debt securities we issue or borrowings we incur, if available, could impose significant restrictions on our operations, such as limitations on our ability to incur additional debt or issue additional equity or other operating restrictions that could adversely affect our ability to conduct our business, and any such debt could be secured by any or all of our assets pledged as collateral. Additionally, we may incur substantial costs in pursuing future capital, including investment banking, legal and accounting fees, printing and distribution expenses and other costs.

 

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Reverse Stock Split

Our Board of Directors approved a reverse stock split of the Company’s authorized, issued and outstanding shares of common stock at a ratio of 1-for-22 (the “Reverse Stock Split”). The Reverse Stock Split became effective on November 9, 2022 (the “Effective Date”). All share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted, on a retrospective basis, to reflect the Reverse Stock Split, unless otherwise stated. The number of authorized shares were also proportionately adjusted and the par value remained unaffected. We will issue one whole share of the post-Reverse Stock Split Common Stock to any stockholder who otherwise would have received a fractional share as a result of the Reverse Stock Split. As a result, no fractional shares will be issued in connection with the Reverse Stock Split and no cash or other consideration will be paid in connection with any fractional shares that would otherwise have resulted from the Reverse Stock Split.

Convertible Promissory Note – Related Party

On November 25, 2022 (the “Funding Date”), we entered into a Convertible Promissory Note and Security agreement with Grand Decade Developments Limited (“GDDL”), a British Virgin Islands limited company and a wholly owned subsidiary of Grand Pharmaceutical Group Limited, pursuant to which we issued a Secured Convertible Promissory Note (the “Note”) to GDDL. The Note has a principal amount of $2,000,000, bears interest at a rate of 5% per annum until November 25, 2023 and 10% per annum thereafter (the “Interest Rate”) and matures on November 25, 2024 (the “Maturity Date”), on which date the principal balance and all accrued interest under the Note shall be due and payable. The Interest Rate will be 10% per annum upon occurrence of an event of default, including, but not limited to, the failure by us to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by us of a case under any applicable bankruptcy or insolvency laws. The principal and interest accrued on the Note may be prepaid without any further agreement of the parties to the Note, or converted (as described below) upon the agreement of the parties to the Note, at any time without penalty to us.

Subject to the consent of GDDL, the Note is convertible into such number of fully paid and non-assessable shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) as determined by dividing (i) any portion of the unpaid principal and accrued interest of the Note then outstanding by (ii) the greater of (a) the last closing bid price of a share of Common Stock as reported on the Nasdaq Capital Market (“Nasdaq”) on the date the Company and GDDL agree to such conversion and (b) the average closing bid price of a share of Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date, subject to a share cap of 360,769 shares of Common Stock (the “Share Cap”), representing 19.99% of the total issued and outstanding shares of Common Stock as of November 25, 2022.

Additionally, if at any time after the Funding Date the last closing bid price of a share of Common Stock as reported on the Nasdaq for ten consecutive trading days or the average closing bid price of a share Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date is equal to or exceeds $44.00 (subject to any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other substantially similar transaction), GDDL may require that the Company prepay the Note through conversion of the then outstanding principal and/or any accrued interest thereon into shares of Common Stock, in whole or in part.

The unpaid principal of and any accrued interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all equity securities of the Company outstanding as of the Funding Date, which are secured by all of the Company’s right, title and interest, in and to certain of the Company’s intellectual property rights in Hong Kong, Taiwan, China and South Korea, as specified in the Note; provided, however, that the Company may incur or guarantee additional indebtedness after the Funding Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note.

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December 2022 Offering

On November 30, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Investors”) that closed on December 1, 2022, pursuant to which the Company sold, issued, and delivered, in a registered public offering (the “Offering”) (i) 1,166,667 shares of the Company’s common stock (the “Common Stock”), par value $0.0001 per share (each a “Share” and collectively the “Shares”); (ii) pre-funded warrants in lieu of shares of Common Stock (the “Pre-Funded Warrants”) to purchase shares of Common Stock and (iii) 1,166,667 Common Warrants (the “Common Warrants” and collectively with the Pre-Funded Warrants, the “Warrants”) to purchase shares of Common Stock, to the Investors. Under the terms of the Purchase Agreement, the Company agreed to sell one share of its Common Stock or a Pre-Funded Warrant and one Common Warrant for each share of Common Stock or Pre-Funded Warrant sold at a price of $3.00. For each Pre-Funded Warrant sold in the Offering, the number of shares of Common Stock offered was decreased on a one-for-one basis. The Pre-Funded Warrants are exercisable immediately upon the date of issuance, may be exercised at any time until all of the Pre-Funded Warrants are exercised in full and have a nominal exercise price of $0.0001 per share. The Common Warrants are exercisable immediately upon the date of issuance and have an exercise price of $3.00 per share, subject to adjustment. The Common Warrants will expire five (5) years from the date of issuance.

The Offering closed on December 1, 2022. The Company received gross proceeds of $3,500,001 in connection with the Offering before deducting placement agent fees and other offering expenses.

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Nasdaq Deficiency NoticesNotice

As previously disclosed, on February 9,On June 2, 2022, the Companywe received notice (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price of the Company’sour common stock had been below $1.00 per share for 30 consecutive business days as of the date of the Notice. The Notice hashad no immediate effect on the listing of the Company’sour common stock, which will continuecontinues to trade at this time on the Nasdaq Capital Market under the symbol “ONCS.”

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until August 8, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period. In the event the Company does not regain compliance by August 8, 2022, the Company may be eligible for an additional 180 calendar day grace period if it meets the continued listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not regain compliance within the allotted compliance period(s), Nasdaq will provide notice that the Company’s common stock will be subject to delisting from the Nasdaq Capital Market. In that event, the Company may appeal such delisting determination to a hearings panel.

On November 29, 2021, the Company notified Nasdaq that Robert E. Ward had resigned as a member of the Board of Directors and the Company’s Audit Committee, as disclosed on the Company’s Current Report filed on Form 8-K on November 30, 2021. After giving effect to Mr. Ward’s resignation, the Company’s Audit Committee no longer consists of three independent members as required by Nasdaq Listing Rule 5605(c)(2)(A).

 

On December 8, 2021, the CompanyNovember 25, 2022, we received a letter from Nasdaq notingconfirming that the Company no longer compliedhad regained compliance with Nasdaq Listing Rule 5550(a)(2) that requires companies listed on Nasdaq to maintain a minimum bid price of at least $1.00 per share to ensure continued listing (the “Listing Requirement”). The Company completed a 1-for-22 reverse stock split of its authorized, issued and outstanding shares of Common Stock on November 9, 2022. The Company regained compliance with the requirement of Listing Rule 5605. The letter also acknowledged thatRequirement after the Listing Rules provide a cure period in orderclosing bid price for the Company to regain compliance until the earlier of the Company’s next annual meeting of stockholders or November 23, 2022.

We are currently evaluating our alternatives to resolve these listing deficiencies. To the extent that we are unable to resolve these listing deficiencies, there is a risk that ourits common stock may be delisted fromlisted on Nasdaq which would adversely impact liquidity of our common stock and potentially result in even lower bid pricesequaled or exceeded $1.00 per share for our common stock.10 consecutive business days.

 

Critical Accounting Policies

 

Use of Estimates

 

The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”),GAAP, which requires managementManagement to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. SuchSignificant accounting estimates include the Company’srelated to our ability to continue as a going concern and certain calculations related to that determination, stock-based compensation, the accrual of research, product development and clinical obligations, impairment of long-lived assets, determining the Incremental Borrowing Rate for calculating Right-Of-Use (“ROU”) assets and lease liabilities and accounting for income taxes, including the related valuation allowance on the deferred tax asset and uncertain tax positions. The Company bases itsdetermination. We base our estimates on historical experience and on various other assumptions that it believeswe believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, the Company reviews itswe review our estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates.

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Impairment of Long-Lived Assets

The Company periodically assesses the carrying value of intangible and other long-lived assets, and whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. The assets are considered to be impaired if the Company determines that the carrying value may not be recoverable based upon its assessment, which includes consideration of the following events or changes in circumstances:

the asset’s ability to continue to generate income from operations and positive cash flow in future periods;
loss of legal ownership or title to the asset(s);
significant changes in the Company’s strategic business objectives and utilization of the asset(s); and
the impact of significant negative industry or economic trends.

If the assets are considered to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Fair value is determined by the application of discounted cash flow models to project cash flows from the assets. In addition, the Company bases estimates of the useful lives and related amortization or depreciation expense on its subjective estimate of the period the assets will generate revenue or otherwise be used by it. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less selling costs. The Company also periodically reviews the lives assigned to long-lived assets to ensure that the initial estimates do not exceed any revised estimated periods from which the Company expects to realize cash flows from its assets.

 

Research and Development Expenses

 

Research and development expenses consist of costs incurred for internal projects, as well as partner-funded collaborative research and development activities. These costs include direct and research-related overhead expenses, which include salaries, stock-based compensation and other personnel-related expenses, facility costs, supplies, depreciation of facilities and laboratory equipment, as well as research consultants and the cost of funding research at universities and other research institutions, and are expensed as incurred. Costs to acquire technologies that are utilized in research and development that have no alternative future use, are expensed when incurred. In accordance with ASCAccounting Standards Codification (“ASC”) 730-20, the Company accountswe account for upfront, non-refundable research and development payments received from a related party as a long-term liability as there has not been a substantive and genuine transfer of risk and there is a presumption that the Company iswe are obligated to repay the related party.

 

Accruals for Research and Development Expenses and Clinical Trials

The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company accounts for these expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company determines accrual estimates through financial models and takes into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates.

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Equity-Based Awards

 

The Company grantsWe grant equity-based awards (typically stock options or restricted stock units) under our stock-based compensation plan and occasionally outside of our stock-based compensation plan, with terms generally similar to the terms under our stock-based compensation plan. The Company estimatesWe estimate the fair value of stock option awards using the Black-Scholes option valuation model. For employees, directors and consultants, the fair value of the award is measured on the grant date. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The Company estimatesWe estimate the fair value of restricted stock unit awards based on the closing price of the Company’s common stock on the date of issuance.

Australia Research and Development Tax Credit

Our Australian, wholly-owned, subsidiary incurs research and development expenses, primarily in the course of conducting clinical trials. The Australian research and development activities qualify for the Australian government’s tax credit program, which provides a 43.5% credit for qualifying research and development expenses. The tax credit does not depend on our generation of future taxable income or ongoing tax status or position. Accordingly, the credit is not considered an element of income tax accounting under ASC 740 and is recorded against qualifying research and development expenses in the Company’s condensed consolidated statements of operations.grant.

 

Leases

 

The Company determinesWe determine if an arrangement is a lease at inception. Operating lease ROUright of use (“ROU”) assets represent the Company’sour right to use an underlying asset during the lease term, and operating lease liabilities represent the Company’sour obligation to make lease payments arising from the lease. Operating leases are included in ROU assets, current operating lease liabilities, and long-term operating lease liabilities on the Company’s condensedour consolidated balance sheets.

 

Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using our incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’sOur lease terms may include options to extend or terminate the lease when it is reasonably certain that the Companywe will exercise that option. Leases with a term of 12 months or less are not recognized on the condensed consolidated balance sheet. The Company’ssheets. Our leases do not contain any residual value guarantees. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company accountsWe account for lease and non-lease components as a single lease component for all its leases.

 

Recent Accounting Pronouncements

 

Information regarding recent accounting pronouncements is contained in Note 2 to our condensed consolidated financial statements included in this report.

Off-Balance Sheet Arrangements

We are not party to any off-balance sheet transactions. We have no guarantees or obligations other than those which arise out of normal business operations.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, or Exchange Act, is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, or the SEC, and that such information is accumulated and communicated to our management, including our Interim Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures reflects the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our Interim Principal Executive Officer and our Principal Financial Officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as of JanuaryOctober 31, 2022. Based on such evaluation, our Interim Principal Executive Officer and Principal Financial Officer concluded that, as of JanuaryOctober 31, 2022, our disclosure controls and procedures were effective.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during our fiscal quarter ended JanuaryOctober 31, 2022 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.

 

From time to time, we are involved in legal proceedings in the ordinary course of our business. Refer to Note 8: Commitments and Contingencies for more information on legal proceedings.

 

ITEM 1A. RISK FACTORS.

There have been no material changes in our risk factors from those disclosed in Part I, Item 1A to our Annual Report on Form 10-K for the fiscal year ended July 31, 2021,2022, except as noted below. The risk factors disclosed in Part I, Item 1A to our Annual Report on Form 10-K for the fiscal year ended July 31, 2021,2022, in addition to the other information set forth in this report, could materially affect our business, financial condition, or results of operations.

 

35

The terms of the Convertible Promissory Note may have a negative impact on our business and the value of our securities and may result in substantial dilution to our other equity securityholders.

The Convertible Promissory Note provides for certain terms that may have a negative impact on our business. Our obligations under the Convertible Promissory Note mature on November 25, 2025. The obligations under the Convertible Promissory Note are secured and the lenders thereunder will have a claim against right, title and interest, in and to certain of the Company’s intellectual property rights in Hong Kong, Taiwan, China and South Korea, as specified in the Convertible Promissory Note. If we are unable to make the necessary payments, we will be in default under the terms of the Convertible Promissory Note. As a result, the noteholders would be able to foreclose on their security interests in our intellectual property. An event of default would adversely affect our business, financial condition, results of operations and prospects. Additionally, the Convertible Promissory Notes are convertible into common stock, subject to certain terms and conditions, which may result in dilution to our other equity securityholders.

If our stock price continues to remain below $1.00, our common stock mayWe will be subject to delisting from The Nasdaq Stock Market, which would materially reduceif we are unable to comply with the liquidity ofindependence requirements for our common stockBoard and have an adverse effect on our market price.Board committees.

 

On February 9, 2022,Prior to the Company received Notice (the “Notice”) from Nasdaq that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid priceclosing of the Company’s common stock has been below $1.00 per share for 30 consecutive business days. The Notice has no immediate effect on the listingOffering in December 2022, we qualified as a “controlled company” and availed ourselves of the Company’s common stock, which will continue to trade at this time oncertain “controlled company” exemptions under the Nasdaq Capital Marketcorporate governance rules. As a controlled company, we were not required to have a majority of “independent directors” on our Board as defined under the symbol “ONCS.”Nasdaq rules, or have a compensation, nominating or governance committee composed entirely of independent directors. In light of our prior status as a controlled company, our Board had determined to utilize the majority board independence exemption and the exemption applying to compensation committee member independence.

 

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until August 8, 2022, to regain compliance with the minimum bid price requirement. To regain compliance,Since the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period. In the event the Company does not regain compliance by August 8, 2022, the Company may be eligible for an additional 180 calendar day grace period if it meets the continued listing requirement for market value of publicly held shares ($1 million)Offering, we no longer qualify as a “controlled company” and, all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice to Nasdaq of its intentionsubject to cure the deficiency during the second compliance periodperiods, we are required to have a majority of our directors be “independent directors,” as defined by effecting a reverse stock split, if necessary.Nasdaq rules. In addition, Nasdaq rules require that, subject to specified exceptions, each member of our compensation committee must also satisfy Nasdaq’s independence criteria. If the Company does not regain compliance within the allotted compliance period(s), Nasdaq will provide notice that the Company’s common stockwe are unable to comply with these requirements, we will be subject to delisting from Nasdaq, which could have an adverse impact on the liquidity and market price of our securities.

 If we fail to satisfy the Nasdaq’s minimum stockholders’ equity requirement of $2.5 million, our common stock will be delisted from Nasdaq, Capital Market. In that event,which could have an adverse impact on the Company may appeal such delisting determination to a hearings panel.liquidity and market price of our securities.

 

We are currently evaluatingsubject to the Equity Standard of Nasdaq’s continued listing requirements. Under the Equity Standard, we are required to maintain a minimum stockholders’ equity of $2.5 million. As of October 31, 2022, our alternativesstockholders’ deficit was $(984,449). As a result, we expect Nasdaq will notify us that, based on our stockholders’ deficit of $(984,449) as of October 31, 2022, we are no longer in compliance with such minimum stockholders’ equity requirement. If we receive such notice from Nasdaq, in accordance with Nasdaq rules, we will have 45 calendar days from the date of the notification to resolvesubmit a plan to regain compliance. If our compliance plan is accepted, we may be granted up to 180 calendar days from the listing deficiency. Todate of the extent thatinitial notification to evidence compliance. If Nasdaq does not accept our plan, we may request a hearing, at which hearing we would present our plan to a Nasdaq Hearings Panel.

If we are unable to resolveobtain Nasdaq acceptance of our plan to have a minimum stockholders’ equity requirement of $2.5 million or satisfy any of the other continued listing deficiency, there is a risk thatrequirements, Nasdaq may take steps to delist our common stock may be delisted from Nasdaq, whichstock. Such a delisting would adversely impactlikely have an adverse effect on the market liquidity of our common stock, potentiallysecurities, decrease the market price of our securities, result in even lower bid pricesthe potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities, and adversely affect our ability to obtain financing for the continuation of our operations.

Provisions of Our common stock, and warrants could discourage an acquisition of us by a third party.

Certain provisions of the common warrants that we issued in the Offering could make it more difficult or expensive for a third party to acquire us. The common warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the common warrants. Further, the common warrants provide that, in the event of certain transactions constituting “fundamental transactions,” with some exception, holders of such warrants will have the right, at their option, to require us to obtain financing throughredeem such common warrants for cash at a price described in such warrants. These and other provisions of the sale of our common stock.warrants could prevent or deter a third party from acquiring us.

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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

Not applicable.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

None.

 

ITEM 5. OTHER INFORMATION.

 

None.

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ITEM 6. EXHIBITS.

 

The following exhibits are either filed or furnished with this report:

 

3.1

Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 of our Current Report on Form 8-K, filed on December 17, 2021)

10.1*

OncoSec Medical Incorporated 2015 Employee Stock Purchase Plan
31.1* Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934
   
31.2* Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934
   
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
   
32.2** Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
101.INS* Inline XBRL Instant Document
   
101.SCH* Inline XBRL Taxonomy Extension Schema Document
   
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document
   
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document
   
104* Cover Page Interactive Data File (embedded within the Inline XBRL document in Exhibit 101)

 

* Filed herewith.

** Furnished herewith.

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SIGNATURES

 

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

 

ONCOSEC MEDICAL INCORPORATED 
  
By:/s/ Kevin SmithRobert H. Arch, Ph.D. 
 Kevin SmithRobert H. Arch, Ph.D. 
 Interim President and Chief Executive Officer 
 (Interim Principal Executive Officer) 
   
Dated: MarchDecember 15, 2022 
By:/s/ George Chi 
 George Chi 
 Chief Financial Officer 
 (Principal Financial Officer) 
   
Dated: MarchDecember 15, 2022 

 

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