☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | ||
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, par value $0.0001 | BNTC | The Nasdaq Stock Market LLC |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
Emerging growth company | ☐ |
BENITEC BIOPHARMA INC.
INDEX TO FORM
1 | ||||||
2 | ||||||
ITEM 1. | Financial Statements | |||||
ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |||||
ITEM 3. | Quantitative and Qualitative Disclosures About Market Risk | |||||
ITEM 4. | Controls and Procedures | |||||
ITEM 1. | Legal Proceedings | |||||
ITEM 1A. | Risk Factors | |||||
ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds | |||||
ITEM 3. | Defaults Upon Senior Securities | |||||
ITEM 4. | Mine Safety Disclosures | |||||
ITEM 5. | Other Information | |||||
ITEM 6. | Exhibits | |||||
ITEM 1. Financial Statements |
September 30, 2022 | June 30, 2022 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 16,534 | $ | 4,062 | ||||
Restricted cash | 13 | 14 | ||||||
Trade and other receivables | 3 | 3 | ||||||
Prepaid and other assets | 531 | 741 | ||||||
Total current assets | 17,081 | 4,820 | ||||||
Property and equipment, net | 179 | 222 | ||||||
Deposits | 25 | 25 | ||||||
Other assets | 119 | 135 | ||||||
Right-of-use | 711 | 771 | ||||||
Total assets | $ | 18,115 | $ | 5,973 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Trade and other payables | $ | 2,368 | $ | 1,880 | ||||
Accrued employee benefits | 385 | 400 | ||||||
Lease liabilities, current portion | 258 | 252 | ||||||
Total current liabilities | 3,011 | 2,532 | ||||||
Lease liabilities, less current portion | 491 | 559 | ||||||
Total liabilities | 3,502 | 3,091 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Stockholders’ equity: | ||||||||
Common stock, $0.0001 par value- 40,000,000 shares authorized; 25,809,533 shares and 8,171,690 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively | 3 | 1 | ||||||
Additional paid-in capital | 168,768 | 152,453 | ||||||
Accumulated deficit | (153,420 | ) | (148,327 | ) | ||||
Accumulated other comprehensive loss | (738 | ) | (1,245 | ) | ||||
Total stockholders’ equity | 14,613 | 2,882 | ||||||
Total liabilities and stockholders’ equity | $ | 18,115 | $ | 5,973 | ||||
September 30, | June 30, | |||||||
2021 | 2021 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 15,727 | $ | 19,769 | ||||
Trade and other receivables | 3 | 25 | ||||||
Prepaid and other assets | 642 | 814 | ||||||
Total current assets | 16,372 | 20,608 | ||||||
Property and equipment, net | 323 | 375 | ||||||
Deposits | 25 | 9 | ||||||
Other assets | 169 | 185 | ||||||
Right-of-use | 947 | 202 | ||||||
Total assets | $ | 17,836 | $ | 21,379 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Trade and other payables | $ | 1,106 | $ | 880 | ||||
Accrued employee benefits | 301 | 276 | ||||||
Lease liabilities, current portion | 194 | 213 | ||||||
Total current liabilities | 1,601 | 1,369 | ||||||
Lease liabilities, less current portion | 760 | 0 | ||||||
Total liabilities | 2,361 | 1,369 | ||||||
Commitments and contingencies (Note 12) | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Common stock, $0.0001 par value—10,000,000 shares authorized; 8,171,690 shares issued and outstanding at September 30, 2021 and June 30, 2021, respectively | 1 | 1 | ||||||
Additional paid-in capital | 151,854 | 151,583 | ||||||
Accumulated deficit | (135,164 | ) | (130,119 | ) | ||||
Accumulated other comprehensive loss | (1,216 | ) | (1,455 | ) | ||||
Total stockholders’ equity | 15,475 | 20,010 | ||||||
Total liabilities and stockholders’ equit y | $ | 17,836 | $ | 21,379 | ||||
Three Months Ended September 30 | ||||||||||||||||
Three Months Ended September 30, | 2022 | 2021 | ||||||||||||||
2021 | 2020 | |||||||||||||||
Revenue: | ||||||||||||||||
Revenues from customers | $ | 0 | $ | 55 | ||||||||||||
Licensing revenues from customers | ||||||||||||||||
Total revenues | 0 | 55 | $ | — | $ | — | ||||||||||
— | — | |||||||||||||||
Operating expenses | ||||||||||||||||
Royalties and license fees | 0 | 134 | ||||||||||||||
Research and development | 2,780 | 774 | 2,660 | 2,780 | ||||||||||||
General and administrative | 2,042 | 1,837 | 1,920 | 2,042 | ||||||||||||
Total operating expenses | 4,822 | 2,745 | 4,580 | 4,822 | ||||||||||||
Loss from operations | (4,822 | ) | (2,690 | ) | (4,580 | ) | (4,822 | ) | ||||||||
Other income (loss): | ||||||||||||||||
Foreign currency transaction loss | (240 | ) | (54 | ) | (507 | ) | (240 | ) | ||||||||
Interest expense, net | (1 | ) | (1 | ) | (9 | ) | (1 | ) | ||||||||
Other income, net | — | 27 | ||||||||||||||
Unrealized gain on investment | 18 | — | 3 | 18 | ||||||||||||
Total other loss, net | (223 | ) | (28 | ) | ||||||||||||
Total other income (loss), net | (513 | ) | (223 | ) | ||||||||||||
Net loss | $ | (5,045 | ) | $ | (2,718 | ) | $ | (5,093 | ) | $ | (5,045 | ) | ||||
Other comprehensive income: | ||||||||||||||||
Unrealized foreign currency translation gain | 239 | 178 | 507 | 239 | ||||||||||||
Total other comprehensive income | 239 | 178 | 507 | 239 | ||||||||||||
Total comprehensive loss | $ | (4,806 | ) | $ | (2,540 | ) | $ | (4,586 | ) | $ | (4,806 | ) | ||||
Net loss | $ | (5,045 | ) | $ | (2,718 | ) | $ | (5,093 | ) | $ | (5,045 | ) | ||||
Net loss per share: basic and diluted | $ | (0.47 | ) | $ | (0.62 | ) | ||||||||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.62 | ) | $ | (2.45 | ) | ||||||||||
Weighted average number of shares outstanding: basic and diluted | 10,855,710 | 8,171,690 | ||||||||||||||
Weighted-average shares outstanding: | ||||||||||||||||
Basic and diluted | 8,171,690 | 1,108,374 | ||||||||||||||
Accumulated | ||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | |||||||||||||||||||
Balance at June 30, 2021 | 8,171,690 | $ | 1 | $ | 151,583 | $ | (130,119 | ) | $ | (1,455 | ) | $ | 20,010 | |||||||||||
Share-based compensation | — | — | 271 | — | — | 271 | ||||||||||||||||||
Foreign currency translation gain | — | — | — | — | 239 | 239 | ||||||||||||||||||
Net loss | — | — | — | (5,045 | ) | (5,045 | ) | |||||||||||||||||
Balance at September 30, 2021 | 8,171,690 | 1 | 151,854 | (135,164 | ) | (1,216 | ) | 15,475 | ||||||||||||||||
Balance at June 30, 2022 | 8,171,690 | 1 | 152,453 | (148,327 | ) | (1,245 | ) | 2,882 | ||||||||||||||||
Issuance of common stock, pre-funded warrants, and common warrants sold for cash, net of offering costs of $1,869 | 17,637,843 | 2 | 16,013 | 16,015 | ||||||||||||||||||||
Share-based compensation | — | — | 302 | — | — | 302 | ||||||||||||||||||
Foreign currency translation gain | — | — | — | — | 507 | 507 | ||||||||||||||||||
Net loss | — | — | — | (5,093 | ) | — | (5,093 | ) | ||||||||||||||||
Balance at September 30, 2022 | 25,809,533 | $ | 3 | $ | 168,768 | $ | (153,420 | ) | $ | (738 | ) | $ | 14,613 | |||||||||||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | |||||||||||||||||||
Balance at June 30, 2020 | 1,108,374 | $ | 1 | $ | 128,826 | $ | (116,636 | ) | $ | (1,953 | ) | $ | 10,238 | |||||||||||
Share-based compensation | — | — | 38 | — | — | 38 | ||||||||||||||||||
Forfeiture of share-based payments | — | — | (14 | ) | 14 | — | — | |||||||||||||||||
Foreign currency translation gain | — | — | — | — | 178 | 178 | ||||||||||||||||||
Net loss | — | — | — | (2,718 | ) | (2,718 | ) | |||||||||||||||||
Balance at September 30, 2020 | 1,108,374 | $ | 1 | $ | 128,850 | $ | (119,340 | ) | $ | (1,775 | ) | $ | 7,736 | |||||||||||
Three Months Ended September 30, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (5,093 | ) | $ | (5,045 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 42 | 52 | ||||||
Amortization of right-of-use | 60 | 50 | ||||||
Unrealized gain on investment | (3 | ) | (18 | ) | ||||
Share-based compensation expense | 302 | 271 | ||||||
Changes in operating assets and liabilities: | ||||||||
Other assets | 220 | 179 | ||||||
Trade and other payables | 500 | 293 | ||||||
Accrued employee benefits | (11 | ) | (8 | ) | ||||
Lease liabilities | (62 | ) | (52 | ) | ||||
Net cash used in operating activities | (4,045 | ) | (4,278 | ) | ||||
Cash flows from investing activities: | ||||||||
Net cash used in investing activities | — | — | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of common stock, pre-funded warrants, | 17,884 | — | ||||||
Shares and pre-funded warrant issuance costs | (1,869 | ) | — | |||||
Net cash provided by financing activities | 16,015 | — | ||||||
Effects of exchange rate changes on cash, cash equivalents, and restricted cash | 501 | 236 | ||||||
Net increase (decrease) in cash, cash equivalents, and restricted cash | 12,471 | (4,042 | ) | |||||
Cash, cash equivalents, and restricted cash, beginning of period | 4,076 | 19,783 | ||||||
Cash, cash equivalents, and restricted cash, end of period | $ | 16,547 | $ | 15,741 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Re-measurement of operating leaseright-of-use | $ | — | $ | 794 | ||||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | |||||||||||||||||||
Balance at June 30, 2021 | 8,171,690 | $ | 1 | $ | 151,583 | $ | (130,119 | ) | $ | (1,455 | ) | $ | 20,010 | |||||||||||
Share-based compensation | — | — | 271 | — | — | 271 | ||||||||||||||||||
Foreign currency translation gain | — | — | — | — | 239 | 239 | ||||||||||||||||||
Net loss | — | — | — | (5,045 | ) | — | (5,045 | ) | ||||||||||||||||
Balance at September 30, 2021 | 8,171,690 | $ | 1 | $ | 151,854 | $ | (135,164 | ) | $ | (1,216 | ) | $ | 15,475 | |||||||||||
Three Months Ended | ||||||||
September 30, | ||||||||
2021 | 2020 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (5,045 | ) | $ | (2,718 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 52 | 45 | ||||||
Amortization of right-of-use | 50 | 47 | ||||||
Unrealized loss on investment | (18 | ) | 0 | |||||
Share-based compensation expense | 271 | 38 | ||||||
Changes in operating assets and liabilities: | ||||||||
Trade and other receivables | 0 | 27 | ||||||
Other assets | 179 | 374 | ||||||
Trade and other payables | 293 | (119 | ) | |||||
Accrued employee benefits | (8 | ) | (8 | ) | ||||
Lease liabilities | (52 | ) | (46 | ) | ||||
Net cash used in operating activities | (4,278 | ) | (2,360 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | 0 | (173 | ) | |||||
Net cash used in investing activities | 0 | (173 | ) | |||||
Effects of exchange rate changes on cash and cash equivalents | 236 | 182 | ||||||
Net decrease in cash and cash equivalents | (4,042 | ) | (2,351 | ) | ||||
Cash and cash equivalents, beginning of period | 19,769 | 9,801 | ||||||
Cash and cash equivalents, end of period | $ | 15,727 | $ | 7,450 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Re-measurement of operatinglease right-of-use assets | $ | 794 | $ | 0 | ||||
Principal place of business/country of incorporation | ||
Benitec Biopharma Proprietary Limited (“BBL”) | Australia | |
Benitec Australia Proprietary Limited | Australia | |
Benitec Limited | United Kingdom | |
Benitec, Inc. | USA | |
Benitec LLC | USA | |
RNAi Therapeutics, Inc. | USA | |
Tacere Therapeutics, Inc. | USA | |
Benitec IP Holdings, Inc. | USA |
Level 1: | Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. |
Level 2: | Inputs, other than quoted prices that are observable, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. |
Level 3: | Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use. |
Software | 3-4 years | |
Lab equipment | 3-7 years | |
Computer hardware | 3-5 years | |
Leasehold improvements | shorter of the lease term or estimated useful lives |
Revenues from customers (US$’000) | Three Months ended September 30, 2021 | Three Months ended September 30, 2020 | ||||||
Licensing revenue from services transferred overtime | $ | — | $ | 55 | ||||
September 30, | June 30, | |||||||
(US$’000) | 2022 | 2022 | ||||||
Cash at bank | $ | 16,534 | $ | 4,062 | ||||
Restricted cash | 13 | 14 | ||||||
Total | $ | 16,547 | $ | 4,076 |
(US$’000) | September 30, 2021 | June 30, 2021 | ||||||
Cash at Bank | $ | 15,727 | $ | 19,769 | ||||
Total | $ | 15,727 | $ | 19,769 | ||||
(US$’000) | September 30, 2021 | June 30, 2021 | ||||||
Prepaid expenses | $ | 763 | $ | 967 | ||||
Security deposit | 14 | 15 | ||||||
Market value of listed shares | 34 | 17 | ||||||
Total other assets | 811 | 999 | ||||||
Less: non-current portion | (169 | ) | (185 | ) | ||||
Current portion | $ | 642 | $ | 814 | ||||
September 30, | June 30, | |||||||
(US$’000) | 2022 | 2022 | ||||||
Prepaid expenses | $ | 643 | $ | 871 | ||||
Market value of listed shares | 7 | 5 | ||||||
Total other assets | 650 | 876 | ||||||
Less: non-current portion | (119 | ) | (135 | ) | ||||
Current portion | $ | 531 | $ | 741 | ||||
(US$’000) | September 30, 2021 | June 30, 2021 | ||||||
Software | $ | 14 | $ | 14 | ||||
Lab equipment | 1,328 | 1,329 | ||||||
Computer hardware | 26 | 26 | ||||||
Leasehold improvements | 24 | 24 | ||||||
Total property and equipment, gross | 1,392 | 1,393 | ||||||
Accumulated depreciation and amortization | (1,069 | ) | (1,018 | ) | ||||
Total property and equipment, net | $ | 323 | $ | 375 | ||||
September 30, | June 30, | |||||||
(US$’000) | 2022 | 2022 | ||||||
Software | $ | 6 | $ | 6 | ||||
Lab equipment | 1,343 | 1,343 | ||||||
Computer hardware | 30 | 31 | ||||||
Leasehold improvements | 24 | 24 | ||||||
Total property and equipment, gross | 1,403 | 1,404 | ||||||
Accumulated depreciation and amortization | (1,224 | ) | (1,182 | ) | ||||
Total property and equipment, net | $ | 179 | $ | 222 |
(US$’000) | September 30, 2021 | June 30, 2021 | ||||||
Trade payable | $ | 323 | $ | 274 | ||||
Accrued license fees | 135 | 140 | ||||||
Accrued professional fees | 99 | 13 | ||||||
Accrued OPMD project costs | 351 | 279 | ||||||
Accrued bonuses | 112 | — | ||||||
Other payables | 86 | 174 | ||||||
Total | $ | 1,106 | $ | 880 | ||||
September 30, | June 30, | |||||||
(US$’000) | 2022 | 2022 | ||||||
Trade payable | $ | 608 | $ | 422 | ||||
Accrued license fees | 112 | 120 | ||||||
Accrued professional fees | — | 131 | ||||||
Accrued OPMD project costs | 1,194 | 1,089 | ||||||
Accrued consultant fees | 3 | 47 | ||||||
Accrued offering costs | 323 | — | ||||||
Other payables | 128 | 71 | ||||||
Total | $ | 2,368 | $ | 1,880 | ||||
(US$’000) | Operating lease right-of- use assets | |||
Balance at July 1, 2021 | $ | 202 | ||
Re-measurement during the period | 794 | |||
Amortization of right of use asset | (49 | ) | ||
Operating lease right-of-use | $ | 947 | ||
(US$’000) | Operating lease right- of- use assets | |||
Balance at July 1, 2022 | $ | 771 | ||
Amortization of right of use asset | (60 | ) | ||
Operating lease right-of-use | $ | 711 | ||
(US$’000) | Operating lease liabilities | |||
Balance at July 1, 2022 | $ | 811 | ||
Principal payments on operating lease liabilities | (62 | ) | ||
Operating lease liabilities at September 30, 2022 | 749 | |||
Less: non-current portion | (491 | ) | ||
Current portion at September 30, 2022 | $ | 258 | ||
(US$’000) | Operating lease liabilities | |||
Balance at July 1, 2021 | $ | 213 | ||
Re-measurement during the period | 794 | |||
Principal payments on operating lease liabilities | (51 | ) | ||
Operating lease liabilities at September 30, 2021 | 954 | |||
Less: non-current portion | (760 | ) | ||
Current portion at September 30, 2021 | $ | 194 | ||
(US$’000) | September 30, 2021 | |||
2022 | 235 | |||
2023 | 287 | |||
2024 | 297 | |||
2025 | 228 | |||
Total operating lease payment s | 1,047 | |||
Less imputed interest | (93 | ) | ||
Present value of operating lease liabilities | $ | 954 | ||
(US$’000) | September 30, 2022 | |||
2023 | 214 | |||
2024 | 295 | |||
2025 | 291 | |||
Total operating lease payments | 800 | |||
Less imputed interest | (51 | ) | ||
Present value of operating lease liabilities | $ | 749 |
Common Stock from Warrants | Weighted- average Exercise Price (per share) | |||||||
Outstanding at July 1, 2021 | 107,095 | $ | 10.50 | |||||
Outstanding and exercisable at September 30, 2021 | 107,095 | $ | 10.50 |
Common Stock from Warrants | Weighted- average Exercise Price (per share) | |||||||
Outstanding at July 1, 2022 | 107,095 | $ | 10.50 | |||||
Pre-funded warrants issued September 1 5 , 2022 | 12,171,628 | $ | 0.0001 | |||||
Series 2 Warrants issued September 1 5 , 2022 | 29,809,471 | $ | 0.66 | |||||
Outstanding at September 30, 2022 | 42,088,194 | $ | 0.49 | |||||
Exercisable at September 30, 2022 | 12,278,723 | $ | 0.09 |
Stock Options | Weighted- average Exercise Price | Weighted- average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||||
Outstanding at June 30, 2021 | 702,064 | $ | 7.16 | 8.07 years | $ | — | ||||||||||
Outstanding at September 30, 2021 | 702,064 | 7.16 | 7.82 years | $ | — | |||||||||||
Exercisable at September 30, 2021 | 54,158 | $ | 47.90 | 1.84 years | $ | — | ||||||||||
Stock Options | Weighted- average Exercise Price | Weighted- average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||||
Outstanding at June 30, 2022 | 738,064 | $ | 6.95 | 7.18 years | $ | — | ||||||||||
Expired | 5,665 | $ | 45.92 | |||||||||||||
Outstanding at September 30, 2022 | 732,399 | 6.65 | 6.99 years | $ | — | |||||||||||
Exercisable at September 30, 2022 | 269,509 | $ | 12.47 | 6.06 years | $ | — | ||||||||||
Three Months Ended September 30, | ||||||||
(US$’000) | 2021 | 2020 | ||||||
Research and development | $ | 81 | $ | 9 | ||||
General and administrative | 190 | 29 | ||||||
Total share-based compensation expense | $ | 271 | $ | 38 | ||||
Three Months Ended | ||||||||
September 30, | ||||||||
(US$’000) | 2022 | 2021 | ||||||
Research and development | $ | 30 | $ | 81 | ||||
General and administrative | 272 | 190 | ||||||
Total share-based compensation expense | $ | 302 | $ | 271 | ||||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of financial condition and operating results together with our consolidated financial statements and the related notes and other financial information included elsewhere in this document.
Overview
We endeavor to become the leader in discovery, development, and commercialization of therapeutic agents capable of addressing significant unmet medical need via the application of the silence and replace approach to the treatment of genetic disorders.
Benitec Biopharma Inc. (“Benitec” or the “Company” or in the third person, “we” or “our”) is a development-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary platform, called
BB-301
The targeted gene silencing effects of RNAi, andin conjunction with the durable transgene expression achievable via the use of modified viral vectors, imbues the silence and replace approach haswith the potential to produce long-term silencing of disease-causing genes along with simultaneous replacement of wild type gene function following a single administration of the proprietary genetic medicine. We believe that this novel attributemechanistic profile of the current and future investigational agents under developmentdeveloped by Benitec maycould facilitate the achievement of robust and durable clinical activity while greatly reducing the dosing frequenciesfrequency of drug administration traditionally expected for medicines employed for the management of chronic diseases.
Additionally, the achievement of long-term gene silencing and gene replacement may significantly reduce the risk of patient
COVID-19
COVID-19 has
Certain elements of our research and development efforts are conducted globally, including the ongoing development of our silence and replace therapeutic for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD), and will be dependent upon our ability to initiatecomplete preclinical studies and initiate clinical studies despite the
As we continueendeavor to actively advancecomplete our preclinicaldevelopment programs, including ourthe ongoing Toxicology and Biodistribution study
15
completion of GMP manufacturing of
We have also implemented a halt of non-essential business travel and a rotation system whereby staff work from home and attend the laboratory on designated days which may result in a reduction of laboratory work and a halt
The net proceeds to the Company from the public offering were approximately $16 million, after deducting underwriting discounts and commissions and public offering expenses payable by the Company, and excluding any proceeds the Company may receive upon exercise of the pre-funded warrants or the common warrants. The Company currently intends to use the net proceeds for the clinical development of BB-301, including the natural history lead-in study and the Phase 1b/2a BB-301 treatment study, for the continued advancement of development activities for other existing and new product candidates, for general corporate purposes and for strategic growth opportunities. The Company will have broad discretion in determining how the proceeds of the public offering will be used, and its discretion is not limited by the aforementioned possible uses.
Nasdaq Listing
On September 6, 2022, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying us that the minimum bid price per share for our common stock fell below $1.00 for a period of 30 consecutive business days and that therefore we did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).
The letter also states that we will be provided 180 calendar days, or until March 6, 2023, to regain compliance with the minimum bid price requirement. In accordance with Rule 5810(c)(3)(A), we can regain compliance if at any time during the 180-day period the closing bid price of our common stock is at least $1.00 for a minimum of 10 consecutive business days. If by March 6, 2023, we cannot demonstrate compliance with the Rule 5550(a)(2), we may be eligible for additional time. To qualify for additional time, we will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and we will need to provide written notice of our intention to cure the deficiency during the second compliance period. If we are not eligible for the second compliance period, then the Nasdaq Staff will provide notice that our securities will be subject to delisting. At such time, we may appeal the delisting determination to a Hearings Panel.
We intend to monitor the closing bid price of our common stock and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirement. These options include completing a reverse stock split of our common stock for the purpose of meeting the closing bid price requirement. We are seeking stockholder approval to effect a reverse stock split at our upcoming Annual Meeting of Stockholders scheduled for December 7, 2022. Completing a reverse stock split will not, in of itself, cause us to remain in compliance with Nasdaq’s listing standards.
Development Programs
Our Pipeline
The following table sets forth ourthe current product candidatescandidate and theirthe development status:
Table 1. Pipeline: Oculopharyngeal Muscular Dystrophy and Chronic Hepatitis B Virus Infection
BB-301
We are developing BB-301
Figure 3. Overview of the
BB-301
16
OPMD is a rare disease, however, patients have been diagnosed with OPMD in at least 33 countries. Patient populations suffering from OPMD are well-identified, and significant geographical clustering has been noted for patients with this disorder, whichdisorder. Each of these attributes could simplifyfacilitate efficient clinical development and global commercialization efforts.
PABPN1 is a ubiquitous factor that promotes the interaction between the poly(A) polymerase and CPSF (cleavage and polyadenylation specificity factor) and, thus, controls the length of mRNA poly(A) tails, mRNA export from the nucleus, and alternative poly(A) site usage. The characteristic genetic mutation underlying OPMD results in trinucleotide repeat expansion(s) within exon 1 of PABPN1 and results in an expanded poly-alanine tract at the
No therapeutic agents are approved for the treatment of OPMD. Additionally, there are no surgical interventions capable of alteringavailable to OPMD patients that modify the long-term natural history of OPMD are available.
Benitec has previously outlined the core
As referenced above, the BB-301
• | Support the validation and optimization of the newly designed route and method ofBB-301 administration, |
Confirm the efficiency of vector transduction and transgene expression in the key tissue compartments underlying the morbidity and mortality that comprises the natural history of OPMD, confirm
• | Confirm the optimal BB-301 doses in advance of initiation of human clinical studies, |
Facilitate the optimal drug doses in advance of initiation of human clinical studies, and facilitate observation of key toxicological data-points.
The
Benitec conducted the
• | Biologically significant and dose-dependent levels of BB-301 tissue transduction (i.e., delivery of the multi-functional BB-301 genetic construct into the target pharyngeal muscle cells), |
• | Broad-based and dose-dependent expression of the three distinct genes comprising the BB-301 gene construct within the pharyngeal muscle cells, and |
Biologically significant and dose-dependent levels of
The Pilot Dosing Study evaluated the safety and biological activity of two concentrations of
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vg/mL with a high injection volume) following direct intramuscular injection into the Hypopharyngeus (HP) muscles and the Thyropharyngeus (TP) muscles of Beagle dogs via the use of a proprietary delivery device employed in an open surgical procedure. The HP muscle in Beagle dogs corresponds to the Middle Pharyngeal Constrictor muscle in human subjects, and the TP muscle in Beagle dogs corresponds to the Inferior Pharyngeal Constrictor muscle in human subjects.
Molecular analyses are ongoinghave been completed for the canine subjects treated in the
The key preliminary resultsinterim data-sets are summarized here:
Figure 4. Pharyngeal Muscle Tissue Transduction Levels for
Regarding Gene Expression Levels Observed for
• | BB-301 encodes two distinct siRNA species (i.e., siRNA13 and siRNA17) which are each, independently, capable of inhibiting (i.e., “silencing”) the expression of the mutant form of the PABPN1 protein and the wild type (i.e., endogenous) form of the PABPN1 protein (importantly, the mutant form of the PABPN1 protein underlies the development, and progression, of OPMD). |
• | BB-301 also codes for a wild type version of the PABPN1 protein whose intracellular expression is unaffected by the inhibitory activities of siRNA13 and siRNA17; this “codon optimized” transcript drives the expression of a PABPN1 protein (i.e., coPABPN1) which serves to replenish the endogenous form of the PABPN1 protein and to replace the mutant form of PABPN1 that underlies the development and progression of OPMD in diseased tissues. |
• | For comparative purposes, it should be noted that the average range of expression for wild type PABPN1 within the pharyngeal muscle cells of Beagle dogs is 4.5 copies per cell-to-7.8 copies per cell. |
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Figure 5. siRNA13 Expression Levels for
Figure 6. siRNA17 Expression Levels for
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Figure 7. coPABPN1 Expression Levels for
Regarding WildTypeWild Type PABPN1 Silencing (i.e., target “knock-down”) Observed for
• | As noted above, BB-301 encodes two distinct siRNA species (i.e., siRNA13 and siRNA17) which are each, independently, capable of inhibiting (i.e., “silencing”) the expression of all forms of the PABPN1 protein (siRNA13 and siRNA17 silence the expression of both wild type PABPN1 [wtPABPN1] and mutant PABPN1). |
• | While the Beagle dog subjects treated in the BB-301 Pilot Dosing Study do not express mutant PABPN1, the level of BB-301-driven gene silencing for the PABPN1 target can be indirectly assessed in these study subjects due to the equivalent inhibitory effects of siRNA13 and siRNA17 on both wtPABPN1 and mutant PABPN1. |
• | Thus, the wtPABPN1 silencing activity observed in the BB-301 Pilot Dosing Study serves as a surrogate for the silencing activity that would be anticipated in the presence of mutant PABPN1. |
• | BB-301 has been evaluated in prior non-clinical studies in animals that express mutant PABPN1 and, as a result, manifest the symptomatic phenotype of OPMD; in the symptomatic animal model of OPMD (i.e. the A17 mouse model), the achievement of PABPN1 silencing levels of 31% inhibition (or higher) following BB-301 administration led to resolution of OPMD disease symptoms and the elimination of the histopathological hallmarks of OPMD. |
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Figure 8. PABPN1 Silencing (i.e., “target knock-down”) Achieved by BB-301 within Pharyngeal Muscle Tissues
There are key methodological distinctions between the current
The newly developedcurrent proprietary methodsmethod of
Figure 9.
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Figure 10. Impact of Benitec-Initiatedthe Methodological Improvements to the
Following the disclosure of the positive
Summary of Regulatory Interactions:
• | Benitec successfully completed the regulatory interactions required to support initiation of the OPMD clinical development program in 2022 |
• | Successful regulatory engagement comprised the completion of the following meetings: |
• | Preclinical Trial Application (Pre-CTA) Consultation Meeting with Health Canada |
• | Scientific Advice Meeting with The National Agency for the Safety of Medicines and Health Products in France (L’Agence nationale de sécurité du médicament et des produits de santé or “ANSM”) |
• | Type C Meeting with the U.S. Food and Drug Administration (“FDA”) |
Benitec will begin the OPMD clinical development program in Beagle dogs
Summary of the Phase 1b/2a clinical study slated for initiationBB-301 Clinical Development Program:
• | The BB-301 clinical development program will begin in 2022, and the conduct of the development program will comprise approximately 76-weeks of follow-up for each OPMD study participant, inclusive of: |
• | 6-month pre-treatment observation periods employing quantitative radiographic imaging techniques for evaluation of the baseline disposition and natural history of OPMD-derived dysphagia in each study participant |
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• | 1 day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose escalation cohort study |
• | 52-weeks of post-dosing follow-up for conclusive evaluation of the primary and secondary endpoints of the Phase 1b/2a BB-301 treatment study |
• | The OPMD Natural History Study will begin in 2022, and this observational study will facilitate the characterization of OPMD patient disposition at baseline and assess subsequent rates of progression of dysphagia (swallowing impairment) in subjects with OPMD via the use of quantitative radiographic measures of global swallowing function and pharyngeal constrictor muscle function along with clinical assessments and patient-reported self-assessments of swallowing function |
• | Videofluoroscopic Swallowing Studies (VFSS) will be conducted to complete the following methodological assessments: |
• | Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) |
• | Pharyngeal Area at Maximum Constriction (PhAMPC) |
• | Pharyngeal Constriction Ratio (PCR) |
• | Clinical measures of global swallowing capacity and oropharyngeal dysphagia |
• | Patient-reported measures of oropharyngeal dysphagia |
• | The natural history of dysphagia observed for each OPMD study participant, as characterized by the quantitative radiographic measures and the clinical and patient self-reported assessments outlined above, will serve as the baseline for comparative assessments of safety and efficacy of BB-301 upon rollover of OPMD study subjects from the Natural History Study onto the Phase 1b/2a BB-301 treatment study |
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• | Upon the achievement of 6-months of follow-up in the Natural History Study, OPMD Natural History Study participants can become eligible for enrollment onto the Phase 1b/2a treatment study with the investigational genetic medicine, BB-301, which uses an AAV9-based gene therapy approach for the treatment of OPMD-derived dysphagia |
• | This first-in-human (FIH) clinical trial will be a Phase 1b/2a, open-label, dose escalation study to evaluate the safety and clinical activity of intramuscular doses of BB-301 administered to the pharyngeal muscles of subjects with OPMD |
• | Upon rollover from the Natural History Study onto the Phase 1b/2a BB-301 treatment study, the follow-up of OPMD study participants will continue for 52-weeks, and the primary endpoints (safety and tolerability) and secondary endpoints (comprising the quantitative radiographic measures of global swallowing function and pharyngeal constrictor muscle function, and the clinical and patient-reported assessments noted above) will be evaluated during each 90-day period following Day 1 (Day 1 represents the day of BB-301 intramuscular injection). |
Royalties, milestone payments and other license fees
We are required to pay royalties, milestone payments and other license fees in connection with our licensing of intellectual property from third parties, including as discussed below.
We have collaborated with Biomics Biotechnologies Co., Ltd., or Biomics, pursuant to several collaboration agreements in relation to single-stranded RNA and shRNA sequences for treatment of hepatitis B. In July 2015, we entered into
October 2020 Capital Raise
On October 6, 2020, the Company announced the closing of an underwritten public offering of common stock and common stock equivalents. The Company received gross proceeds of approximately $11.5 million and net proceeds of approximately $9.9 million from the offering.
April 2021 Capital Raise
On April 30, 2021, the Company announced the closing of an underwritten public offering of common stock and common stock equivalents. The Company received gross proceeds of approximately $14.3 million and net proceeds of approximately $12.7 million from the offering.
September 2022 Capital Raise
On September 15, 2022, the Company announced the closing of an underwritten public offering of common stock and common stock equivalents. The Company received gross proceeds of approximately $17.9 million and net proceeds of approximately $16.0 million from the offering.
Results of Operations
Revenues
The Company has not generated any revenues from the sales of products. Revenues from licensing fees and interest income are included in the revenue from customers line item on our consolidated statements of operations and comprehensive loss. Our licensing fees have been generated through the licensing of our ddRNAi technology to biopharmaceutical companies. The following table sets forth a summary of our revenues for each of the periods set forth below:
Three Months Ended September 30, | ||||||||
2021 | 2020 | |||||||
(US$’000) | ||||||||
Revenues: | ||||||||
Revenues from customers | $ | — | $ | 55 | ||||
Total revenues | $ | — | $ | 55 | ||||
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Royalties and License Fees
Royalties and license fees consist primarily of payments we are required to remit for royalties and other payments related
Research and Development Expenses
Research and development expenses relate primarily to the cost of conducting clinical
The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance at the end of each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel, and equity-based compensation expense. General and administrative expenses also include facility expenses, professional fees for legal, consulting, accounting and audit services and other related costs.
We anticipate that our general and administrative expenses may increase as the Company focuses on the continued development of the
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Operating Expenses
The following tables setsets forth a summary of our expenses for each of the periods set forth below:
Three Months Ended September 30, | ||||||||
2021 | 2020 | |||||||
(US$’000) | ||||||||
Operating Expenses: | ||||||||
Royalties and license fees | $ | — | $ | 134 | ||||
Research and development | 2,780 | 774 | ||||||
General and administrative | 2,042 | 1,837 | ||||||
Total operating expenses | $ | 4,822 | $ | 2,745 | ||||
Three Months Ended | ||||||||
September 30, | ||||||||
2022 | 2021 | |||||||
(US$ 000) | ||||||||
Operating Expenses: | ||||||||
Research and development | 2,660 | 2,780 | ||||||
General and administrative | 1,920 | 2,042 | ||||||
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Total operating expenses | $ | 4,580 | $ | 4,822 | ||||
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During the three months ended September 30, 20212022 and 2020,September 30, 2021, respectively, we incurred $0 and $0.1 million in royalties and license fees.
General and administrative expense was $2.0totaled $1.9 million and $1.8$2.0 million for the three months ended September 30, 2022 and September 30, 2021, and 2020.respectively. The increasedecrease for the three monththree-month period was due to the small increasesdecreases in salaries and wages, insurance, consultants, legal and accounting fees.state and local taxes.
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Other Income (Expense)
The following tables setsets forth a summary of our other income (loss) for each of the periods set forth below:
Three Months Ended September 30, | ||||||||
2021 | 2020 | |||||||
Other Income (Loss): | ||||||||
(US$’000) | ||||||||
Foreign currency transaction loss | $ | (240 | ) | $ | (54 | ) | ||
Interest expense, net | (1 | ) | (1 | ) | ||||
Other income, net | — | 27 | ||||||
Unrealized gain on investment | 18 | — | ||||||
Total other loss, net | $ | (223 | ) | $ | (28 | ) | ||
Three Months Ended | ||||||||
September 30, | ||||||||
2022 | 2021 | |||||||
(US$’000) | ||||||||
Other Income (Loss): | ||||||||
Foreign currency transaction loss | $ | (507 | ) | $ | (240 | ) | ||
Interest expense, net | (9 | ) | (1 | ) | ||||
Unrealized gain on investment | 3 | 18 | ||||||
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Total other income (loss), net | $ | (513 | ) | $ | (223 | ) | ||
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The other loss,income (loss), net during the three months ended September 30, 20212022 and 2020,September 30, 2021, respectively, totaled $0.2 million$(513) thousand and $28$(223) thousand, which consists of foreign currency transaction loss,losses, interest expense, other income, and unrealized gain on investment. Foreign currency transaction gain haslosses have increased due to a change in foreign exchange rates. Other income, net decreased due to no longer receiving
Liquidity and Capital Resources
The Company has incurred cumulative losses and negative cash flows from operations since our predecessor’s inception in 1995. The Company had accumulated losses of $135.2$153 million as of September 30, 2021.2022. We expect that our research and development expenses may increase due to the continued development of the OPMD program. It is also likely that there will be an increase in the general and administrative expenses due to the obligations of being a domestic public company in the United States as a result of
We had no borrowings as atof September 30, 20212022 and do not currently have a credit facility.
As of September 30, 2021,2022, we had cash and cash equivalents of approximately $15.7$16.5 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts.
The following table sets forth a summary of the net cash flow activity for each of the periods set forth below:
Three Months Ended September 30, | ||||||||
2021 | 2020 | |||||||
(US$’000) | ||||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (4,278 | ) | $ | (2,360 | ) | ||
Investing activities | — | (173 | ) | |||||
Effects of exchange rate changes on cash and cash equivalents | 236 | 182 | ||||||
Net decrease in cash | $ | (4,042 | ) | $ | (2,351 | ) | ||
Three Months Ended | ||||||||
September 30, | ||||||||
2022 | 2021 | |||||||
(US$’000) | ||||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (4,045 | ) | $ | (4,278 | ) | ||
Investing activities | — | — | ||||||
Financing activities | 16,015 | — | ||||||
Effects of exchange rate changes on cash and cash equivalents | 501 | 236 | ||||||
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Net increase (decrease) in cash | $ | 12,471 | $ | (4,042 | ) | |||
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Operating activities
Net cash used in operating activities for the three months ended September 30, 2022 and 2021 and 2020 was $4.3$4.0 million and $2.4$4.3 million, respectively. Net cash used in operating activities was primarily the result of our net loss, partially offset by non-cash expenses, and changechanges in working capital, and a decreaseincluding an increase in payables.
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Financing activities
Net cash used in investingprovided by financing activities was $16.0 million and $0 for the three months ended September 30, 2022 and 2021, and 2020respectively. Cash from financing activities in 2022 was $0 and $0.2 million, respectively. The change was primarily related to a decrease in purchasesthe issuance of equipment in 2021 as there were none compared to purchases of $0.2common stock, pre-funded warrants, and Series 2 warrants, including $17.9 million in gross proceeds from the same period of 2020.
The future of the Company as an operating business will depend on its ability to manage operating costs and budgeted amounts and obtain adequate financing. While we continue to progress discussions and advance opportunities to engage with pharmaceutical companies and continue to seek licensing partners for ddRNAi in disease areas that are not our focus, there can be no assurance as to whether we will enter into such arrangements or what the terms of any such arrangement could be.
While we have established some licensing arrangements, we do not have any products approved for sale and have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize one of our current or future product candidates.
Unless and until we establish significant revenues from licensing programs, strategic alliances or collaboration arrangements with pharmaceutical companies, or from product sales, we anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of product candidates and begin to prepare to commercialize any product that receives regulatory approval. We are subject to the risks inherent in the development of new gene therapy products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. We estimate that our cash and cash equivalents will be sufficient to fund the Company’s operations for at least for the next twelve months.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
• | the timing and costs of our planned clinical trials for our ddRNAi and silence and replace product candidates; |
• | the timing and costs of our planned preclinical studies for our ddRNAi and silence and replace product candidates; |
• | the number and characteristics of product candidates that we pursue; |
• | the outcome, timing, and costs of seeking regulatory approvals; |
• | revenue received from commercial sales of any of our product candidates that may receive regulatory approval; |
• | the terms and timing of any future collaborations, licensing, consulting, or other arrangements that we may establish; |
• | the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
• | the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims; and |
• | the extent to which we need to in-license or acquire other products and technologies. |
Contractual Obligations and Commercial Commitments
On October 1, 2016, the Company entered into an operating lease for office space in Hayward, California that originally expired in April 2018. The Company has entered into lease amendments that extendextended the lease commitment through June 2025.
The Company enters into contracts in the normal course of business with third-party contract research organizations, contract development and manufacturing organizations and other service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments.
Critical Accounting Policies and Significant Accounting Estimates
The preparation of consolidated financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make judgments, assumptions and estimates that affect the amounts reported. Note 2 of the Notes to Consolidated Financial Statements included in this Quarterly Report on Form
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A critical accounting policy is defined as one that is both material to the presentation of the Company’s consolidated financial statements and requires management to make difficult, subjective, or complex judgments that could have a material effect on the Company’s financial condition or results of operations. Specifically, these policies have the following attributes: (1) the Company is required to make assumptions about matters that are highly uncertain at the time of the estimate; and (2) different estimates the Company could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on the Company’s financial condition or results of operations.
Estimates and assumptions about future events and their effects cannot be determined with certainty. The Company bases its estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as the Company’s operating environment changes. These changes have historically been minor and have been included in the consolidated financial statements as soon as they became known. In addition, management is periodically faced with uncertainties, the outcomes of which are not within its control and will not be known for prolonged periods of time. These uncertainties are discussed in the section above entitled “Risk Factors.” Based on a critical assessment of its accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that the Company’s consolidated financial statements are fairly stated in accordance with accounting principles generally accepted in the United States of America and provide a meaningful presentation of the Company’s financial condition and results of operations.
Management believes that the following are critical accounting policies:
Research and Development Expense
Research and development expenses relate primarily to the cost of conducting clinical and
The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance at the end of each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred.
Share-based Compensation Expense
The Company records share-based compensation in accordance with ASC 718,
Recent Accounting Pronouncements
Accounting Standards recently adopted
None.
New Accounting Standards and Interpretations not yet mandatory or early adopted
ASU
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide the information pursuant to this Item.
Item 4. Controls and Procedures
We have established disclosure controls and procedures (as defined in
There were no changes in our internal controls over financial reporting during the quarter ended September 30, 20212022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We do not expect that our disclosure controls and procedures or our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
We are currently not a party to any material legal proceedings.
Item 1A. Risk Factors
There have been no material changes to the risk factors disclosed in Item 1A of the Company’s Annual Report on Form
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
None.
Item 6. Exhibits.
* | Filed herewith. |
** | Furnished, not filed. |
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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 our behalf by the undersigned thereunto duly authorized.
Benitec Biopharma Inc. | ||||||
Dated: November | ||||||
/s/ Jerel Banks | ||||||
Jerel Banks | ||||||
Executive Chairman and Chief Executive Officer | ||||||
(principal executive officer) | ||||||
/s/ Megan Boston | ||||||
Megan Boston | ||||||
Executive Director (principal financial and accounting officer) |
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