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 |
-0206 | ||
(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 | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
2 | ||||||
3 | ||||||
3 | ||||||
3 | ||||||
4 | ||||||
5 | ||||||
7 | ||||||
8 | ||||||
17 | ||||||
32 | ||||||
32 | ||||||
33 | ||||||
33 | ||||||
33 | ||||||
33 | ||||||
33 | ||||||
33 | ||||||
33 | ||||||
34 |
• | the success of our plans to develop and potentially commercialize our product candidates; |
• | the timing of the initiation and completion of preclinical studies and clinical trials; |
• | the timing and sufficiency of patient enrollment and dosing in any future clinical trials; |
• | the timing of the availability of data from clinical trials; |
• | the timing and outcome of regulatory filings and approvals; |
• | unanticipated delays; |
• | sales, marketing, manufacturing and distribution requirements; |
• | market competition and the acceptance of our products in the marketplace; |
• | regulatory developments in the United States of America; |
• | the development of novel AAV vectors; |
• | the plans of licensees of our technology; |
• | the clinical utility and potential attributes and benefits of ddRNAi and our product candidates, including the potential duration of treatment effects and the potential for a “one shot” cure; |
• | our dependence on our relationships with collaborators and other third parties; |
• | expenses, ongoing losses, future revenue, capital needs and needs for additional financing, and our ability to access additional financing given market conditions and other factors, including our capital structure; |
• | the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan; |
• | our intellectual property position and the duration of our patent portfolio; |
• | the impact of local, regional, and national and international economic conditions and events; and |
• | the impact of the current COVID-19 pandemic, the disease caused by the SARS-CoV-2 |
March 31, |
June 30, |
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2022 |
2021 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Trade and other receivables |
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Prepaid and other assets |
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Total current assets |
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Property and equipment, net |
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Deposits |
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Other assets |
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Right-of-use |
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Trade and other payables |
$ | $ | ||||||
Accrued employee benefits |
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Lease liabilities, current portion |
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Total current liabilities |
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Lease liabilities, less current portion |
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Total liabilities |
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Commitments and contingencies (Note 10) |
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Stockholders’ equity: |
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Common stock, $ value- shares authorized; |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
) | ||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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Three Months Ended |
Nine Months Ended |
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March 31, |
March 31, |
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2022 |
2021 |
2022 |
2021 |
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Revenue: |
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Licensing revenues from customers |
$ | $ | $ | $ | ||||||||||||
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Total revenues |
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Operating expenses |
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Royalties and license fees |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income (loss): |
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Foreign currency transaction gain (loss) |
( |
) | ( |
) | ||||||||||||
Interest expense, net |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income (expense), net |
( |
) | ( |
) | ||||||||||||
Unrealized loss on investment |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
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Total other income (loss), net |
( |
) | ( |
) | ( |
) | ||||||||||
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Other comprehensive income: |
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Unrealized foreign currency translation (loss) gain |
( |
) | ( |
) | ( |
) | ||||||||||
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Total other comprehensive (loss) income |
( |
) | ( |
) | ( |
) | ||||||||||
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Total comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Net loss per share: |
||||||||||||||||
Basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Weighted average number of shares outstanding: basic and diluted |
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Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Loss |
Total Stockholders’ Equity |
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Shares |
Amount |
|||||||||||||||||||||||
Balance at June 30, 2020 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Forfeiture of share-based payments |
— | — | ( |
) | — | — | ||||||||||||||||||
Foreign currency translation gain |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||||||
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Balance at September 30, 2020 |
( |
) | ( |
) | ||||||||||||||||||||
Issuance of common stock and pre-funded warrants sold for cash, net of issuance costs of $ |
— | — | ||||||||||||||||||||||
Exercise of pre-funded warrants |
— | — | — | — | — | |||||||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Forfeiture of share-based payments |
— | — | ( |
) | — | — | ||||||||||||||||||
Foreign currency translation gain |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
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Balance at December 31, 2020 |
( |
) | ( |
) | ||||||||||||||||||||
Exercise of pre-funded warrants |
— | — | ||||||||||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Foreign currency translation loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Net loss |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
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|
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|
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Balance at March 31, 2021 |
$ | $ | |
$ | ( |
) | $ | ( |
) | $ | |
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|
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Loss |
Total Stockholders’ Equity |
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Shares |
Amount |
|||||||||||||||||||||||
Balance at June 30, 2021 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Foreign currency translation gain |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
|
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Balance at September 30, 2021 |
( |
) | ( |
) | ||||||||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Foreign currency translation loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Net loss |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
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Balance at December 31, 2021 |
( |
) | ( |
) | ||||||||||||||||||||
Share-based compensation |
— | — | — | |||||||||||||||||||||
Foreign currency translation loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||||||
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Balance at March 31, 2022 |
$ | $ | |
$ | ( |
) | $ | ( |
) | $ | ||||||||||||||
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Nine Months Ended |
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March 31, |
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2022 |
2021 |
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Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
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Amortization of right-of-use |
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Unrealized loss on investment |
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Share-based compensation expense |
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Changes in operating assets and liabilities: |
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Trade and other receivables |
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Other assets |
||||||||
Trade and other payables |
||||||||
Accrued employee benefits |
||||||||
Lease liabilities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
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|
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Cash flows from investing activities: |
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Purchases of property and equipment |
( |
) | ||||||
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Net cash used in investing activities |
( |
) | ||||||
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Cash flows from financing activities: |
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Proceeds from issues of shares and pre-funded warrants |
||||||||
Shares and pre-funded warrant issuance costs |
( |
) | ||||||
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Net cash provided by financing activities |
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|
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Effects of exchange rate changes on cash and cash equivalents |
( |
) | ||||||
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|
|||||
Net increase (decrease) in cash and cash equivalents |
( |
) | ||||||
Cash and cash equivalents, beginning of period |
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|
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Cash and cash equivalents, end of period |
$ | $ | ||||||
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Supplemental disclosure of cash flow information: |
||||||||
Re-measurement of operating lease right-of-use |
$ | $ | |
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Principal place of business/country of incorporation | ||
Benitec Biopharma Proprietary Limited (“BBL”) |
||
Benitec Australia Proprietary Limited |
||
Benitec Limited |
||
Benitec, Inc. |
||
Benitec LLC |
||
RNAi Therapeutics, Inc. |
||
Tacere Therapeutics, Inc. |
||
Benitec IP Holdings, Inc. |
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 |
4 | |
Lab equipment |
7 | |
Computer hardware |
5 | |
Leasehold improvements |
(US$’000) |
March 31, 2022 |
June 30, 2021 |
||||||
Prepaid expenses |
$ | $ | ||||||
Security deposit |
||||||||
Market value of listed shares |
||||||||
Total other assets |
||||||||
Less: non-current portion |
( |
) | ( |
) | ||||
Current portion |
$ | $ | ||||||
(US$’000) |
March 31, 2022 |
June 30, 2021 |
||||||
Software |
$ | $ | ||||||
Lab equipment |
||||||||
Computer hardware |
||||||||
Leasehold improvements |
||||||||
Total property and equipment, gross |
||||||||
Accumulated depreciation and amortization |
( |
) | ( |
) | ||||
Total property and equipment, net |
$ | $ | ||||||
(US$’000) |
March 31, 2022 |
June 30, 2021 |
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Trade payable |
$ | $ | ||||||
Accrued license fees |
||||||||
Accrued professional fees |
||||||||
Accrued research and development |
||||||||
Other payables |
||||||||
Total |
$ | $ | ||||||
(US$’000) |
Operating lease right-of- use assets |
|||
Balance at July 1, 2021 |
$ | |||
Re-measurement during the period |
||||
Amortization of right of use asset |
( |
) | ||
Operating lease right-of-use |
$ | |||
(US$’000) |
Operating lease liabilities |
|||
Balance at July 1, 2021 |
$ | |||
Re-measurement during the period |
||||
Principal payments on operating lease liabilities |
( |
) | ||
Operating lease liabilities at March 31, 2022 |
||||
Less: non-current portion |
( |
) | ||
Current portion at March 31, 2022 |
$ | |||
(US$’000) |
March 31, 202 2 |
|||
2022 |
$ |
|||
2023 |
||||
2024 |
||||
2025 |
||||
Total operating lease payments |
||||
Less imputed interest |
( |
) | ||
Present value of operating lease liabilities |
$ | |||
Common Stock from Warrants |
Weighted- average Exercise Price (per share) |
|||||||
Outstanding at July 1, 2021 |
$ | |||||||
|
|
|
|
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Outstanding and exercisable at March 31, 2022 |
$ |
Stock Options |
Weighted- average Exercise Price |
Weighted- average Remaining Contractual Term |
Aggregate Intrinsic Value |
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Outstanding at July 1, 2021 |
$ | $ | — | |||||||||||||
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Outstanding at September 30, 2021 |
$ | — | ||||||||||||||
Granted |
$ | — | ||||||||||||||
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Outstanding at March 31, 2022 |
$ | — | ||||||||||||||
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Exercisable at March 31, 2022 |
$ | $ | — | |||||||||||||
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Three Months Ended March 31, |
Nine Months Ended March 31, |
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(US$’000) |
2022 |
2021 |
2022 |
2021 |
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Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
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Total share-based compensation expense |
$ | $ | $ | $ | ||||||||||||
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• | Support the validation and optimization of the newly designed route and method of BB-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 the optimal BB-301 doses in advance of initiation of human clinical studies, |
• | Facilitate the observation of key toxicological data-points. |
• | 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 levels of target gene knock-down (i.e., inhibition of the expression of the gene of interest) within the pharyngeal muscle cells. |
• | 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 |
• | 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 |
• | 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. |
• | Benitec successfully completed the regulatory interactions required to support initiation of the BB-301 clinical development program in 2022 |
• | Successful regulatory engagement comprised the completion of the following meetings: |
• | Pre-Clinical 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”) |
• | 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 |
• | 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 |
• | 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 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). |
Three Months Ended March 31, |
Nine Months Ended March 31, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
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(US$’000) |
||||||||||||||||
Revenues: |
||||||||||||||||
Licensing revenues from customers |
$ | 48 | $ | 1 | $ | 73 | $ | 57 | ||||||||
|
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|||||||||
Total revenues |
$ | 48 | $ | 1 | $ | 73 | $ | 57 | ||||||||
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|
|
Three Months Ended March 31, |
Nine Months Ended March 31, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(US$’000) |
||||||||||||||||
Operating Expenses: |
||||||||||||||||
Royalties and license fees |
$ | — | $ | 7 | $ | — | $ | 122 | ||||||||
Research and development |
2,171 | 2,758 | 8,096 | 4,700 | ||||||||||||
General and administrative |
1,337 | 1,029 | 5,093 | 4,976 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 3,508 | $ | 3,794 | $ | 13,189 | $ | 9,798 | ||||||||
|
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|
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|
Three Months Ended March 31, |
Nine Months Ended March 31, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
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(US$’000) |
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Other Income (Loss): |
||||||||||||||||
Foreign currency transaction gain (loss) |
$ | 229 | $ | (113 | ) | $ | 36 | $ | (167 | ) | ||||||
Interest expense, net |
(10 | ) | (2 | ) | (22 | ) | (5 | ) | ||||||||
Other income (expense), net |
(29 | ) | 1 | (29 | ) | 37 | ||||||||||
Unrealized loss on investment |
(5 | ) | (2 | ) | (10 | ) | (3 | ) | ||||||||
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|
|
|
|
|
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Total other income (loss), net |
$ | 185 | $ | (116 | ) | $ | (25 | ) | $ | (138 | ) | |||||
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|
|
|
|
Nine Months Ended March 31, |
||||||||
2022 |
2021 |
|||||||
(US$’000) |
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Net cash provided by (used in): |
||||||||
Operating activities |
$ | (11,044 | ) | $ | (7,675 | ) | ||
Investing activities |
— | (362 | ) | |||||
Financing activities |
— | 9,854 | ||||||
Effects of exchange rate changes on cash and cash equivalents |
(95 | ) | 370 | |||||
|
|
|
|
|||||
Net (decrease) increase in cash |
$ | (11,139 | ) | $ | 2,187 | |||
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• | 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. |
Number | Description of Document | |
31.1 | ||
31.2 | ||
32.1 | ||
32.2 | ||
101.INS | Inline XBRL Instance Document* | |
101.SCH | Inline XBRL Taxonomy Extension Schema Document* | |
101.CAL | Inline XBRL Calculation Linkbase Document* | |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document* | |
101.LAB | Inline XBRL Label Linkbase Document* | |
101.PRE | Inline XBRL Taxonomy Presentation Linkbase Document* | |
104 | Cover Page Interactive Data File—the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
* | Filed herewith. |
** | Furnished, not filed. |
Benitec Biopharma Inc. | ||
Dated: May 16, 2022 |
||
/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) |