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Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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☐
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Transition Report under Section 13 or 15(d) of the Securities Exchange Act of 1934
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Delaware
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84-462-0206
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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3940 Trust Way Hayward, California
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94545
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.0001
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BNTC
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The Nasdaq Stock Market LLC
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Large Accelerated Filer
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Accelerated Filer
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Non-Accelerated Filer
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☒
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Smaller Reporting Company
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☒ |
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Emerging Growth Company
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Page
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PART I
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Item 1.
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3
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Item 1A.
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39
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Item 1B.
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82
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Item 2.
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83
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Item 3.
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83
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Item 4.
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83
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PART II
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Item 5.
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84
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Item 6.
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84
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Item 7.
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85
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Item 7A.
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94
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Item 8.
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F-1
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Item 9.
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F-27
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Item 9A.
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F-27
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Item 9B.
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F-27
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PART III
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Item 10.
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III-1
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Item 11.
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III-5
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Item 12.
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III-11
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Item 13.
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III-12
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Item 14.
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III-13
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PART IV
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Item 15.
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IV-1
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Item 16.
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IV-2
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IV-3
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• |
BENITEC BIOPHARMA
®
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BENITEC
®
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GIVING DISEASE THE SILENT TREATMENT
®
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SILENCING GENES FOR LIFE
®
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the success of our plans to develop and potentially commercialize our product candidates;
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the timing of the initiation and completion of preclinical studies and clinical trials;
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the timing and sufficiency of patient enrollment and dosing in any future clinical trials;
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the timing of the availability of data from clinical trials;
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the timing and outcome of regulatory filings and approvals;
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unanticipated delays;
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sales, marketing, manufacturing and distribution requirements;
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market competition and the acceptance of our products in the marketplace;
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regulatory developments in the United States;
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the development of novel AAV vectors;
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the plans of licensees of our technology;
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the clinical utility and potential attributes and benefits of ddRNAi and our product candidates,
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including the potential duration of treatment effects and the potential for a “one shot” cure;
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our dependence on our relationships with collaborators and other third parties;
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expenses, ongoing losses, future revenue, capital needs and needs for additional financing;
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the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan;
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our intellectual property position and the duration of our patent portfolio;
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the impact of local, regional, and national and international economic conditions and events; and
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the impact of the current
COVID-19
pandemic, the disease caused by the
SARS-CoV-2
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Clinical management requires repeat administration of the siRNA-based therapeutic agent for multiple cycles to maintain efficacy;
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Long-term patient compliance challenges due to dosing frequencies and treatment durations;
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Therapeutic concentrations of siRNA are not stably maintained because the levels of synthetic siRNA in the target cells decrease over time;
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Novel chemical modifications or novel delivery materials are typically required to introduce the siRNA into the target cells, making it complicated to develop a broad range of therapeutics agents;
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Potential adverse immune responses, resulting in serious adverse effects;
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Requirement for specialized delivery formulations for genetic disorders caused by mutations of multiple genes; and
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siRNA acts only to silence genes and cannot be used to replace defective genes with normally functioning genes.
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Chronically express RNAi molecules inside of the target, diseased, cells (to serially silence the intracellular production of mutant, disease-causing, protein and the wildtype protein of interest);
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Simultaneously drive the expression of a wildtype variant of the protein of interest (to restore native intracellular biological processes); and
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AAV vectors can accommodate the multi-functional DNA expression cassettes containing the engineered wildtype transgenes and the novel genes encoding short hairpinRNA/microRNA molecules (shRNA/miRNA) that are required to support the development of therapeutic agents capable of the achievement of the goals of the silence and replace approach to therapy.
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A DNA construct is delivered to the nucleus of the target cell by a gene therapy vector (A) such as an AAV vector;
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Once inside of the nucleus, the DNA construct drives the continuous production of shRNA molecules (B) which are processed by an enzyme called Dicer into siRNAs (C);
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The processed siRNA is incorporated into RISC and silences the target gene using the same mechanism shown in Figure 1; and
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When the DNA expression cassette is additionally comprised of a wildtype transgene, upon entry of the DNA construct into the nucleus of the target cell via the use of the AAV vector, the DNA construct also drives the continuous production of wildtype protein (to restore native intracellular biological processes).
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A first mover advantage for ddRNAi-based therapeutics;
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A proprietary ddRNAi-based silence and replace technology platform that may potentially enable the serial development of single-administration therapeutics capable of facilitating sustained, long-term silencing of disease-causing genes and concomitant replacement of wildtype gene function;
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A proprietary AAV vector technology which improves the endosomal escape capability of virus produced in insect cells using a baculovirus system. This technology has broad application in
AAV-based
gene therapies;
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The capabilities to drive the development of a pipeline of programs focused on chronic diseases with either large patient populations, or rare diseases, which may potentially support the receipt of Orphan Drug Designation, including OPMD; and
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A growing portfolio of patents protecting improvements to our ddRNAi, and silence and replace, technology and product candidates through at least 2036, with additional patent life anticipated through at least 2040.
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Selectively develop proprietary and partnered programs; and
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Continue to explore and secure research and development partnerships with global biopharmaceutical companies supported by the differentiated nature of our scientific platform and intellectual property portfolio.
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Seeking and maintaining patents claiming our ddRNAi and silence and replace technologies and other inventions relating to our specific products in development or that are otherwise commercially and/or strategically important to the development of our business;
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Protecting and enforcing our intellectual property rights; and
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Strategically licensing intellectual property from third parties to advance development of our product candidates.
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Intravenous administration of trehalose; and
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The use of autologous myoblast transplant.
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Multiple A17 animal cohorts received single doses of
BB-301
(over a range of doses spanning 4x10
8
vg/muscle-to-7.5x10
11
vg/muscle) and, following
BB-301
administration, each cohort was observed for
14-weeks
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BB-301
was injected into the Tibialis Anterior (TA) muscle of 10 week
old-to-12
14-weeks
post administration, each A17 cohort was anesthetized and the contractile properties of the injected TA muscles were analyzed via
in-situ
muscle electrophysiology
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Intermediate doses of
BB-301
resulted in 75% silencing of PABPN1 and 26% replacement of wild type PABPN1 activity, leading to full restoration of muscle strength, clearance of INIs, and a reduction of fibrosis
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An additional experiment conducted over the course of
20-weeks
demonstrated that more modest doses of
BB-301
(which supported only partial resolution of the disease phenotype at
week-14)
were,
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surprisingly, able to facilitate significant benefit at
20-weeks,
as evidenced by full restoration of all parameters relating to muscle strength, weight and INI formation
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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);
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Broad-based and dose-dependent expression of the three distinct genes comprising the
BB-301
gene construct within the pharyngeal muscle cells; and
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Durable 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.
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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 wildtype (i.e., endogenous) form of the PABPN1 protein (importantly, the mutant form of the PABPN1 protein underlies the development and progression of OPMD).
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BB-301
also codes for a wildtype version of the PABPN1 protein whose intracellular expression is unaffected by the inhibitory activities of siRNA13 and siRNA17, and this codon optimized PABPN1 protein (i.e., coPABPN1) 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.
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For comparative purposes, is 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
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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 wildtype PABPN1 [wtPABPN1] and mutant PABPN1).
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While the Beagle dog subjects treated in the current
BB-301
Pilot Dosing Study do not express mutant PABPN1, the level of
BB-301-driven
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Thus, the wtPABPN1 silencing activity observed in the current
BB-301
Pilot Dosing Study serves as a surrogate for the activity that would be anticipated in the presence of mutant PABPN1.
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BB-301
has been evaluated in prior
non-clinical
studies in animals that express mutant PABPN1 and manifest the key signs and symptoms of OPMD and, in these animal models of OPMD, the achievement of PABPN1 silencing levels of 31% inhibition or higher led to complete resolution of OPMD disease symptoms and correction of the histological hallmarks of OPMD.
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Country or Territory
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Trade Mark (program)
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Application or
Registration number |
Status
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USA | BENITEC BIOPHARMA | 86190065 | Registered | |||
USA | SILENCING GENES FOR LIFE | 86488147 | Registered | |||
Australia | SILENCING GENES FOR LIFE | 1448041 | Registered | |||
Australia | BENITEC BIOPHARMA | 1448046 | Registered | |||
Australia |
BENITEC - logo
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1448052 | Registered | |||
Australia | Nervarna | 1526478 | Registered | |||
Australia | TRIBETARNA | 1526479 | Registered | |||
Australia | HEPBARNA | 1526483 | Registered | |||
International Bureau (WIPO) – designating EU; UK and US | GIVING DISEASE THE SILENT TREATMENT | 1389399 | Registered | |||
USA | BENITEC | 86795296 | Registered | |||
USA | GIVING DISEASE THE SILENT TREATMENT | 79226988 | Registered | |||
European Union | BENITEC | 14680003 | Registered | |||
Australia | BENITEC | 1728797 | Registered | |||
Australia | BENITEC | 1103049 | Registered | |||
Australia | BENITEC | 1103300 | Registered | |||
Australia | GIVING DISEASE THE SILENT TREATMENT | 1851660 | Registered | |||
United Kingdom | BENITEC | 3238275 | Registered |
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nonclinical pharmacology and toxicology laboratory and animal tests according to good laboratory practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations;
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submission of an IND application which must become effective before human clinical trials may begin;
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adequate and well-controlled human clinical trials according to GCPs and any additional requirements for the protection of human research subjects and their health information to establish the safety and efficacy of the investigational product for each targeted indication;
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submission of a biologics license application, or BLA, to the FDA;
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FDA’s
pre-approval
inspection of manufacturing facilities to assess compliance with cGMPs and, if applicable, the FDA’s good tissue practices, or GTPs, for the use of human cellular and tissue products to prevent the introduction, transmission, or spread of communicable diseases;
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FDA’s audit of clinical trial sites that generated data in support of the BLA; and
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FDA approval of a BLA, which must occur before a product can be marketed or sold.
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Phase I includes the initial introduction of an investigational product into humans. Phase I clinical trials may be conducted in patients with the target disease or condition or on healthy volunteers. These studies are designed to evaluate the safety, metabolism, pharmacokinetics and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. During Phase I clinical trials, sufficient information about the investigational product’s pharmacokinetics and pharmacological effects may be obtained to permit the design of Phase II clinical trials. The total number of participants included in Phase I clinical trials varies, but is generally in the range of 20 to 80.
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Phase II includes the controlled clinical trials conducted to evaluate the effectiveness of the investigational product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risks associated with the product. Phase II clinical trials are typically well- controlled, closely monitored, and conducted in a limited patient population, usually involving no more than several hundred participants. Phase IIa trials provide information on the impact of dose ranging on safety, biomarkers and proof of concept, while Phase IIb trials are patient dose-ranging efficacy trials.
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Phase III clinical trials are controlled clinical trials conducted in an expanded patient population at geographically dispersed clinical trial sites. They are performed after preliminary evidence suggesting effectiveness of the investigational product has been obtained, and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the product, and to provide an adequate basis for product approval. Phase III clinical trials usually involve several hundred to several thousand participants. In most cases, the FDA requires two adequate and well controlled Phase III clinical trials to demonstrate the efficacy of the product. FDA may accept a single Phase III trial with other confirmatory evidence in rare instances where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.
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the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;
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the applicant consents to a second orphan medicinal product application; or
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the applicant cannot supply enough orphan medicinal product.
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We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. If we are unable to achieve or sustain profitability, the market value of our common stock will likely decline;
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We have never generated any revenue from product sales and may never be profitable;
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We will need to continue our efforts to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain capital when needed may negatively impact our ability to continue as a going concern;
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Our product candidates are based on ddRNAi and silence and replace technology. Currently, no product candidates utilizing ddRNAi technology or silence and replace technology have been approved for commercial sale and our approach to the development of ddRNAi technology and silence and replace technology may not result in safe, effective or marketable products;
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We are early in our product development efforts and our current product candidates are still in preclinical development. We may not be able to obtain regulatory approvals for the commercialization of our product candidates;
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Issues that may impact delivery of our therapeutics to the cell could adversely affect or limit our ability to develop and commercialize product candidates;
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We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours; and
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If we are unable to obtain or protect sufficient intellectual property rights related to our product candidates, we may not be able to obtain exclusivity for our product candidates or prevent others from developing similar competitive products.
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continue our research and preclinical development of our product candidates;
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expand the scope of our current preclinical studies for our product candidates or initiate clinical, additional preclinical or other studies for product candidates;
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seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
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further develop the manufacturing process for our product candidates;
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change or add additional manufacturers or suppliers;
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seek to identify and validate additional product candidates;
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acquire or
in-license
other product candidates and technologies, which may or may not include those related to our ddRNAi technology and delivery vectors for our therapeutic candidates;
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maintain, protect and expand our intellectual property portfolio;
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create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and
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experience any delays or encounter issues with any of the above.
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establishing proof of concept in preclinical studies and clinical trials for our product candidates;
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successfully initiating and completing clinical trials of our product candidates;
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obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;
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maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties;
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establishing and maintaining successful licenses, collaborations and alliances with third parties;
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developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;
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establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved;
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launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure;
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obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options;
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obtaining favorable coverage and reimbursement rates for our products from third-party payers;
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addressing any competing technological and market developments;
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identifying and validating new product candidates; and
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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of any future clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;
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the results of any future clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for approval;
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the patients recruited for a particular clinical program may not be sufficiently broad or representative to assure safety and effectiveness in the full population for which we seek approval;
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the results of any future clinical trials may not confirm the positive results from earlier preclinical studies or clinical trials;
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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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the data collected from any future clinical trials of our product candidates may not be sufficient to the satisfaction of FDA or comparable foreign regulatory authorities to support the submission of a biologics license application, or BLA, or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
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the FDA or comparable foreign regulatory authorities may only agree to approve a product candidate under conditions that are so restrictive that the product is not commercially viable;
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regulatory agencies might not approve or might require changes to our manufacturing processes or facilities; or
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regulatory agencies may change their approval policies or adopt new regulations in a manner rendering our clinical data insufficient for approval.
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restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
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restrictions on the products, manufacturers or manufacturing process;
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warning letters;
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civil and criminal penalties;
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injunctions;
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suspension or withdrawal of regulatory approvals;
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product seizures, detentions or import bans;
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voluntary or mandatory product recalls and publicity requirements;
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total or partial suspension of production;
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imposition of restrictions on operations, including costly new manufacturing requirements; and
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refusal to approve pending BLAs or supplements to approved BLAs.
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finding and diagnosing patients;
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severity of the disease under investigation;
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design of the clinical trial protocol;
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size and nature of the patient population;
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eligibility criteria for the trial in question;
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perceived risks and benefits of the product candidate under study;
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proximity and availability of clinical trial sites for prospective patients;
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availability of competing therapies and clinical trials;
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clinicians’ and patients’ perceptions of the potential advantages of the product being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating;
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patient referral practices of physicians;
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ability to monitor patients adequately during and after treatment; and
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the
COVID-19
pandemic.
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difficulty in establishing or managing relationships with contract research organizations, or CROs, clinical sites and physicians;
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different standards for the conduct of clinical trials;
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our inability to locate and engage qualified local consultants, physicians and partners; and
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the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of biopharmaceutical and biotechnology products and treatments.
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inability to generate sufficient preclinical, toxicology or other data to support the initiation of human clinical trials;
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delays in reaching consensus with regulatory agencies on trial design;
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identifying, recruiting and training suitable clinical investigators;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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delays in obtaining required IRB or IBC approval at each clinical trial site;
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delays in recruiting suitable patients to participate in our clinical trials, including as a result of the current
COVID-19
pandemic;
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imposition of a clinical hold by regulatory agencies, including after an inspection of our clinical trial operations or trial sites;
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failure by our CROs, other third parties or us to adhere to clinical trial requirements;
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failure to perform in accordance with the FDA’s good clinical practices, or GCP, or applicable regulatory requirements in other countries;
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inability to manufacture, test, release, import or export for use sufficient quantities of our product candidates for use in clinical trials;
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failure to manufacture our product candidate in accordance with cGMP requirements or applicable regulatory guidelines in other countries;
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delays in the testing, validation and manufacturing of our product candidates;
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delays in the delivery of our product candidates to the clinical trial sites;
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delays in having patients complete participation in a trial or return for post-treatment
follow-up;
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clinical trial sites dropping out of a trial;
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occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits;
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changes in regulatory requirements and guidance that require amending or submitting new clinical trial protocols;
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clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or discontinue product development programs; or
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the severity, duration and impact of the
COVID-19
pandemic.
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fail to obtain, or be delayed in obtaining, marketing approval for our product candidates;
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obtain approval for indications or patient populations that are not as broad as intended or desired;
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obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
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need to change the way the product is administered;
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be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;
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have regulatory authorities withdraw their marketing approval of the product after granting it;
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have regulatory authorities impose restrictions on distribution of the product in the form of a risk evaluation and mitigation strategy, or REMS, or modified REMS, that limit our ability to commercialize the product;
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be subject to the addition of labeling statements, such as warnings or contraindications;
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be sued and held liable for harm caused to patients; or
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experience damage to our reputation.
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regulatory authorities may withdraw approvals of such product candidate;
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regulatory authorities may require additional warnings on the label;
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we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
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we may be required to change the way a product candidate is administered or conduct additional clinical trials;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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the development of relevant product candidates may be delayed or impaired altogether if we are unable to appropriately select patients for enrollment in our clinical trials;
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• |
our relevant therapeutic product candidate may not receive marketing approval if its effective use depends on a related diagnostic in the regulatory authority’s judgment; and
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we may not realize the full commercial potential of any therapeutic product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients with the specific genetic alterations targeted by our therapeutic product candidates.
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issue a warning letter asserting that we are in violation of the law;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw regulatory approval;
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suspend any ongoing clinical trials;
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refuse to permit government reimbursement of our product by government-sponsored third-party payers;
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refuse to approve a pending BLA or supplements to a BLA submitted by us for other indications or new product candidates;
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seize our product; or
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refuse to allow us to enter into or continue supply contracts, including government contracts.
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a collaborator may shift its priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;
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a collaborator may cease development in an area that is the subject of a collaboration agreement;
|
• |
a collaborator may change the success criteria for a particular program or product candidate in development, thereby delaying or ceasing development of such program or product candidate in development;
|
• |
a collaborator with development or commercialization obligations may not commit sufficient financial or human resources to the development, marketing, distribution or sale of a product, or may otherwise fail in development or commercialization efforts;
|
• |
a collaborator with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirement;
|
• |
a collaborator could independently develop, or develop with unrelated parties, products that compete directly or indirectly with our product candidates;
|
• |
a collaborator may exercise its rights under the agreement to discontinue our collaboration;
|
• |
a dispute may arise between us and a collaborator concerning the development or commercialization of a product candidate, resulting in a delay in milestones, royalty payments, or discontinuation of a program and possibly resulting in costly litigation or arbitration that may divert management attention and resources;
|
• |
a collaborator may not adequately protect the intellectual property rights associated with a product candidate;
|
• |
a collaborator may use our proprietary information or intellectual property in such a way as to expose us actual or threatened litigation from a third party, patent office proceedings or other risks that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; and
|
• |
a collaborator may own or
co-own,
or have a license to use, intellectual property rights associated with a product candidate that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property rights.
|
• |
an inability to conduct necessary preclinical studies to progress our product candidates to clinical trials;
|
• |
an inability to initiate or continue any future clinical trials of product candidates under development;
|
• |
delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates;
|
• |
loss of the cooperation of a collaborator;
|
• |
subjecting our product candidates to additional inspections by regulatory authorities;
|
• |
requirements to cease distribution or to recall batches of our product candidates; and
|
• |
in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.
|
• |
the safety and efficacy of our product candidates;
|
• |
our ability to offer our products for sale at competitive prices;
|
• |
the relative convenience and ease of administration of our product candidates;
|
• |
the prevalence and severity of any adverse side effects associated with our product candidates;
|
• |
the terms of any approvals and the countries in which approvals are obtained;
|
• |
limitations or warnings contained in any labeling approved by the FDA or comparable foreign regulatory authorities;
|
• |
conditions upon the approval imposed by FDA or comparable foreign regulatory authorities, including, but not limited to, a REMS;
|
• |
the willingness of patients to try new treatments and of physicians to prescribe these treatments;
|
• |
the availability of government and other third-party payer coverage and adequate reimbursement; and
|
• |
the availability of alternative effective treatments for the disease indications our product candidates are intended to treat and the relative risks, benefits and costs of those treatments.
|
• |
different regulatory requirements for approval of biopharmaceutical products in foreign countries;
|
• |
reduced protection for intellectual property rights;
|
• |
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
• |
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
• |
workforce uncertainty in countries where labor unrest is more common than in Australia or the United States;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
• |
business interruptions resulting from geopolitical actions, including war and terrorism, natural disasters, including earthquakes, typhoons, floods and fires and disease pandemics and epidemics, including the current
COVID-19
pandemic.
|
• |
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;
|
• |
federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
• |
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
• |
the federal Open Payments program, created under the ACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the CMS information related to payments or other transfers of value made to physicians, and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members by the 90th day of each subsequent calendar year, and disclosure of such information will be made by CMS on a publicly available website; and
|
• |
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by
non-governmental
third-party payers, including private insurers; state and foreign laws that require biopharmaceutical or biotechnology companies to comply with the industry voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that
|
require biopharmaceutical or biotechnology manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
• |
impairment of our business reputation;
|
• |
withdrawal of clinical trial participants;
|
• |
costs due to related litigation;
|
• |
distraction of management’s attention from our primary business;
|
• |
substantial monetary awards to patients or other claimants;
|
• |
the inability to commercialize our product candidates;
|
• |
decreased demand for our product candidates, if approved for commercial sale; and
|
• |
increased cost, or impairment of our ability, to obtain or maintain product liability insurance coverage.
|
• |
the scope of rights granted under the license agreement and other interpretation-related issues;
|
• |
the extent to which our technology and processes infringe on intellectual property of a licensor that is not subject to the licensing agreement;
|
• |
the sublicensing of patent and other rights under any collaborative relationships we might enter into in the future;
|
• |
our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
|
• |
the ownership of inventions and
know-how
resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
|
• |
the priority of invention of patented technology.
|
• |
results of our clinical trials;
|
• |
regulatory actions;
|
• |
actual or expected fluctuations in our operating results;
|
• |
changes in market valuations of similar companies;
|
• |
changes in our key personnel;
|
• |
changes in financial estimates or recommendations by securities analysts;
|
• |
strategic decisions by us or our competitors, such as acquisitions, collaborations, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
|
• |
the passage of legislation or other regulatory developments in the United States and other countries affecting us or our industry;
|
• |
changes in trading volume of our common stock on Nasdaq;
|
• |
sales of our common stock by us, our executive officers or our shareholders in the future; and
|
• |
conditions in the financial markets or changes in general economic conditions, including as a result of the current
COVID-19
pandemic.
|
Year Ended June 30, | ||||||||
2021
|
2020
|
|||||||
(US$’000)
|
||||||||
Revenues:
|
||||||||
Revenues from customers
|
$ | 59 | $ | 97 | ||||
Government research and development grants
|
— | 5 | ||||||
|
|
|
|
|||||
Total revenues
|
$ | 59 | $ | 102 | ||||
|
|
|
|
Year Ended June 30, | ||||||||
2021
|
2020
|
|||||||
(US$’000)
|
||||||||
Expenses:
|
||||||||
Royalties and license fees
|
$ | 123 | $ | (185 | ) | |||
Research and development
|
7,020 | 3,001 | ||||||
General and Administrative
|
6,512 | 5,567 | ||||||
|
|
|
|
|||||
Total expenses
|
13,655 | 8,383 | ||||||
|
|
|
|
Year Ended June 30, | ||||||||
2021
|
2020
|
|||||||
(US$’000)
|
||||||||
Other Income (Loss):
|
||||||||
Foreign currency transaction loss
|
(333 | ) | (88 | ) | ||||
Interest income (expense), net
|
(6 | ) | 62 | |||||
Other income, net
|
37 | 34 | ||||||
Unrealized gain (loss) on investment
|
16 | (1 | ) | |||||
|
|
|
|
|||||
Total other income (loss)
|
(286 | ) | 7 | |||||
|
|
|
|
Year Ended June 30, | ||||||||
2021
|
2020
|
|||||||
(US$’000)
|
||||||||
Net cash provided by (used in):
|
||||||||
Operating activities
|
$ | (12,832 | ) | $ | (7,535 | ) | ||
Investing activities
|
(221 | ) | (94 | ) | ||||
Financing activities
|
22,522 | 1,770 | ||||||
|
|
|
|
|||||
Net increase (decrease) in cash
|
$ | 9,469 | $ | (5,859 | ) | |||
|
|
|
|
• |
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.
|
Item 8.
|
Financial Statements and Supplementary Data.
|
F-2
|
||||
F-4
|
||||
F-5
|
||||
F-6
|
||||
F-7
|
||||
F-8
|
• |
Obtaining an understanding and evaluating the design of certain internal controls related to the critical audit matter. This included controls over the development of the estimated amount of accrued costs incurred by the contract research organizations and contract manufacturing organizations (the “R&D service providers”) during the period.
|
• |
Inquiring with Company personnel responsible for overseeing the research and development activities to understand progress of the activities completed to date for selected R&D service providers.
|
• |
Confirming with selected R&D service providers or inspecting the key terms and conditions of the contracts between the Company and the respective R&D service providers, the documentation of the Company as to the completion status and arriving at an estimate of the accrual amounts based thereon and comparing it to the amounts recorded by the Company.
|
• |
Performing an analysis by comparing the estimated accrual balances at year end to the actual amounts that were ultimately invoiced by the R&D service providers and/or paid by the Company for selected R&D service providers.
|
|
|
June 30,
2021 |
|
|
June 30,
2020 |
|
||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 19,769 | $ | 9,801 | ||||
Trade and other receivables
|
25 | 59 | ||||||
Prepaid and other assets
|
814 | 949 | ||||||
|
|
|
|
|||||
Total current assets
|
20,608 | 10,809 | ||||||
Property and equipment, net
|
375 | 374 | ||||||
Deposits
|
9 | 9 | ||||||
Other assets
|
185 | — | ||||||
Right-of-use
|
202 | 395 | ||||||
|
|
|
|
|||||
Total assets
|
$ | 21,379 | $ | 11,587 | ||||
|
|
|
|
|||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Trade and other payables
|
$ | 880 | $ | 741 | ||||
Accrued employee benefits
|
276 | 203 | ||||||
Lease liabilities, current portion
|
213 | 192 | ||||||
|
|
|
|
|||||
Total current liabilities
|
1,369 | 1,136 | ||||||
Lease liabilities, less current portion
|
— | 213 | ||||||
|
|
|
|
|||||
Total liabilities
|
1,369 | 1,349 | ||||||
Commitments and contingencies (Note 12)
|
||||||||
Stockholders’ equity:
|
||||||||
Common stock, $0.0001 par value—10,000,000 shares authorized; 8,171,690 and 1,108,374 shares issued and outstanding at June 30, 2021 and 2020, respectively
|
1 | 0 | ||||||
Additional
paid-in
capital
|
151,583 | 128,827 | ||||||
Accumulated deficit
|
(130,119 | ) | (116,636 | ) | ||||
Accumulated other comprehensive loss
|
(1,455 | ) | (1,953 | ) | ||||
|
|
|
|
|||||
Total stockholders’ equity
|
20,010 | 10,238 | ||||||
|
|
|
|
|||||
Total liabilities and stockholders’ equity
|
$ | 21,379 | $ | 11,587 | ||||
|
|
|
|
Year Ended June 30,
|
||||||||
2021
|
2020
|
|||||||
Revenue:
|
||||||||
Revenues from customers
|
$ | 59 | $ | 97 | ||||
Government research and development grants
|
— | 5 | ||||||
|
|
|
|
|||||
Total revenues
|
59 | 102 | ||||||
Operating expenses
|
||||||||
Royalties and license fees
|
123 | (185 | ) | |||||
Research and development
|
7,020 | 3,001 | ||||||
General and administrative
|
6,512 | 5,567 | ||||||
|
|
|
|
|||||
Total operating expenses
|
13,655 | 8,383 | ||||||
|
|
|
|
|||||
Loss from operations
|
(13,596 | ) | (8,281 | ) | ||||
Other income (loss):
|
||||||||
Foreign currency transaction loss
|
(333 | ) | (88 | ) | ||||
Interest income (expense), net
|
(6 | ) | 62 | |||||
Other income, net
|
37 | 34 | ||||||
Unrealized gain (loss) on investment
|
16 | (1 | ) | |||||
|
|
|
|
|||||
Total other income (loss), net
|
(286 | ) | 7 | |||||
|
|
|
|
|||||
Net loss
|
$ | (13,882 | ) | $ | (8,274 | ) | ||
|
|
|
|
|||||
Other comprehensive income (loss):
|
||||||||
Unrealized foreign currency translation gain (loss)
|
498 | (89 | ) | |||||
|
|
|
|
|||||
Total other comprehensive income (loss)
|
498 | (89 | ) | |||||
|
|
|
|
|||||
Total comprehensive loss
|
$ | (13,384 | ) | $ | (8,363 | ) | ||
|
|
|
|
|||||
Net loss
|
$ | (13,882 | ) | $ | (8,274 | ) | ||
|
|
|
|
|||||
Net loss per share:
|
||||||||
Basic and diluted
|
$ | (3.23 | ) | $ | (8.10 | ) | ||
|
|
|
|
|||||
Weighted-average shares outstanding:
|
||||||||
Basic and diluted
|
4,295,416 | 1,021,193 | ||||||
|
|
|
|
|
|
Common Stock
|
|
|
Additional
Paid-in
Capital |
|
|
Accumulated
Deficit |
|
|
Accumulated
Other Comprehensive Loss |
|
|
Total
Stockholders’ Equity |
|
|||||||||
|
|
Shares
|
|
|
Amount
|
|
||||||||||||||||||
Balance at June 30, 2019
|
856,765 |
$
|
— |
$
|
127,328 |
$
|
(108,870 | ) |
$
|
(1,864 | ) |
$
|
16,594 | |||||||||||
Common stock sold for cash, net of offering costs
$240 |
186,666 | — | 1,720 | — | — | 1,720 | ||||||||||||||||||
Issuance and exercise of
pre-funded
warrants, net of transaction costs of $240
|
27,526 | — | 50 | — | — | 50 | ||||||||||||||||||
Cashless exercise of purchase warrants
|
37,417 | — | — | — | — | — | ||||||||||||||||||
Share-based compensation
|
— | — | 237 | — | — | 237 | ||||||||||||||||||
Forfeitures of share-based payments
|
— | — | (508 | ) | 508 | — | — | |||||||||||||||||
Foreign currency translation loss
|
— | — | — | — | (89 | ) | (89 | ) | ||||||||||||||||
Net loss
|
— | — | — | (8,274 | ) | — | (8,274 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2020
|
1,108,374 | $ | — | $ | 128,827 | $ | (116,636 | ) | $ | (1,953 | ) | $ | 10,238 | |||||||||||
Common stock sold for cash, net of offering costs of
$3,228 |
6,504,154 | 1 | 22,518 | — | — | 22,519 | ||||||||||||||||||
Exercise of
pre-funded
warrants
|
559,162 | — | 3 | — | — | 3 | ||||||||||||||||||
Share-based compensation
|
— | — | 634 | — | — | 634 | ||||||||||||||||||
Forfeitures of share-based payments
|
— | — | (399 | ) | 399 | — | — | |||||||||||||||||
Foreign currency translation gain
|
— | — | — | — | 498 | 498 | ||||||||||||||||||
Net loss
|
— | — | — | (13,882 | ) | — | (13,882 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2021
|
8,171,690 | $ | 1 | $ | 151,583 | $ | (130,119 | ) | $ | (1,455 | ) | $ | 20,010 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
June 30, |
|
|||||
|
|
2021
|
|
|
2020
|
|
||
Cash flows from operating activities:
|
||||||||
Net loss
|
$ | (13,882 | ) | $ | (8,274 | ) | ||
Adjustments to reconcile net loss to net cash from operating activities:
|
||||||||
Depreciation and amortization
|
231 | 190 | ||||||
Amortization of
right-of-use
|
193 | 184 | ||||||
Loss on disposal of fixed assets
|
— | 1 | ||||||
Unrealized (gain) loss on investment
|
(16 | ) | 1 | |||||
Share-based compensation expense
|
634 | 237 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Trade and other receivables
|
28 | 2,396 | ||||||
Prepaid and other assets
|
(4 | ) | (457 | ) | ||||
Trade and other payables
|
55 | (1,696 | ) | |||||
Accrued employee benefit payable
|
121 | 57 | ||||||
Lease liability
|
(192 | ) | (174 | ) | ||||
|
|
|
|
|||||
Net cash used in operating activities
|
(12,832 | ) | (7,535 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(221 | ) | (95 | ) | ||||
Proceeds from disposal of property and equipment
|
— | 1 | ||||||
|
|
|
|
|||||
Net cash used in investing activities
|
(221 | ) | (94 | ) | ||||
|
|
|
|
|||||
Cash flows from financing activities:
|
||||||||
Proceeds from issues of shares and
pre-funded
warrants
|
25,750 | 2,250 | ||||||
Share issue transaction costs
|
(3,228 | ) | (480 | ) | ||||
|
|
|
|
|||||
Net cash provided by financing activities
|
22,522 | 1,770 | ||||||
|
|
|
|
|||||
Net increase (decrease) in cash and cash equivalents
|
9,469 | (5,859 | ) | |||||
Cash and cash equivalents, beginning of year
|
9,801 | 15,718 | ||||||
Effects of exchange rate changes on cash and cash equivalents
|
499 | (58 | ) | |||||
|
|
|
|
|||||
Cash and cash equivalents, end of year
|
$ | 19,769 | $ | 9,801 | ||||
|
|
|
|
|||||
Supplemental disclosure of cash flow information:
|
||||||||
Initial measurement of operating lease
right-of-use
|
$ | — | $ | (579 | ) | |||
|
|
|
|
|
|
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
|
June 30,
2021 |
June 30,
2020 |
|||||||
Exchange rate on balance sheet dates
|
||||||||
USD: AUD Exchange Rate
|
0.7506 | 0.6877 | ||||||
Average exchange rate for the period
|
||||||||
USD: AUD Exchange Rate
|
0.7470 | 0.6711 |
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)
|
|
Year
ended
June 30,
2021 |
|
|
Year
ended
June 30,
2020 |
|
||
Licensing revenue
|
$ | 59 | $ | — | ||||
Royalty revenue
|
— | 93 | ||||||
Service revenue*
|
— | 4 | ||||||
|
|
|
|
|||||
Total
|
$ | 59 | $ | 97 | ||||
|
|
|
|
*
|
On July 9, 2018, the Company entered into a License and Collaboration Agreement with Axovant. Pursuant to the Agreement, the Company granted Axovant an exclusive worldwide license to develop, manufacture, and commercialize products containing the Company’s product known as
BB-301,
which was designed for the potential treatment of Oculopharyngeal Muscular Dystrophy. Licensing revenue consists of payments for the Company’s intellectual property related to
BB-301
and the transfer of the right to use the intellectual property of the Company’s
BB-301
license to Axovant. Service revenue consists of payments for services provided to Axovant during the term of the license agreement signed in July 2018. On June 6, 2019, the termination of the License and Collaboration Agreement with Axovant was announced. The termination of the Agreement was effective as of September 3, 2019. The termination discharges all future performance obligations under the contract at the termination date.
|
Other revenues (US$’000)
|
|
Year
ended
June 30,
2021 |
|
|
Year
ended
June 30,
2020 |
|
||
Government research and development grants
|
$ | — | $ | 5 | ||||
|
|
|
|
|||||
Total
|
$ | — | $ | 5 | ||||
|
|
|
|
Disaggregated revenue (US$’000)
|
Year ended June 30, 2021
|
|||||||||||||||
Licensing
|
Royalties
|
Development
activities
|
Total
|
|||||||||||||
Services transferred over time
|
$ | 59 | $ | — | $ | — | $ | 59 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total
|
$ | 59 | $ | — | $ | — | $ | 59 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Disaggregated revenue (US$’000)
|
Year ended June 30, 2020
|
|||||||||||||||
Licensing
|
Royalties
|
Development
activities
|
Total
|
|||||||||||||
Services transferred at a point in time
|
$ | — | $ | — | $ | 4 | $ | 4 | ||||||||
Services transferred over time
|
— | 93 | — | 93 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total
|
$ | — | $ | 93 | $ | 4 | $ | 97 | ||||||||
|
|
|
|
|
|
|
|
(US$’000)
|
June 30,
2021 |
June 30,
2020 |
||||||
Cash at Bank
|
$ | 19,769 | $ | 5,231 | ||||
Term Deposit
|
— | 4,570 | ||||||
|
|
|
|
|||||
Total
|
$ | 19,769 | $ | 9,801 | ||||
|
|
|
|
(US$’000) |
June 30,
2021 |
June 30,
2020 |
||||||
Prepaid expenses
|
$ | 967 | $ | 861 | ||||
Security deposit
|
15 | 69 | ||||||
Other deposit
|
— | 18 | ||||||
Market value of listed shares
|
17 | 1 | ||||||
|
|
|
|
|||||
Total other assets
|
999 | 949 | ||||||
Less:
non-current
portion
|
(185 | ) | — | |||||
|
|
|
|
|||||
Current portion
|
$ | 814 | $ | 949 | ||||
|
|
|
|
(US$’000)
|
June 30,
2021 |
June 30,
2020 |
||||||
Software
|
$ | 14 | $ | 11 | ||||
Lab equipment
|
1,329 | 1,109 | ||||||
Computer hardware
|
26 | 26 | ||||||
Leasehold improvements
|
24 | 24 | ||||||
|
|
|
|
|||||
Total property and equipment, gross
|
1,393 | 1,170 | ||||||
Accumulated depreciation and amortization
|
(1,018 | ) | (796 | ) | ||||
|
|
|
|
|||||
Total property and equipment, net
|
$ | 375 | $ | 374 | ||||
|
|
|
|
(US$’000)
|
June 30,
2021 |
June 30,
2020 |
||||||
Trade payable
|
$ | 274 | $ | 282 | ||||
Accrued license fees
|
140 | 54 | ||||||
Accrued professional fees
|
13 | 155 | ||||||
Accrued CRO fees
|
279 | 49 | ||||||
Other payables
|
174 | 201 | ||||||
|
|
|
|
|||||
Total
|
$ | 880 | $ | 741 | ||||
|
|
|
|
• |
The Company need not reassess whether any expired or existing contracts are or contain leases.
|
• |
The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases).
|
• |
The Company need not reassess initial direct costs for any existing leases.
|
• |
The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s
right-of-use
|
(US$’000)
|
Operating
lease
right-of-
use assets |
|||
Initial measurement
at July 1, 2019
|
$ | 579 | ||
Amortization of right of use asset
|
(184 | ) | ||
|
|
|||
Balance at June 30, 2020
|
395 | |||
Amortization of right of use asset
|
(193 | ) | ||
|
|
|||
Operating lease
right-of-use
|
$ | 202 |
(US$’000)
|
Operating
lease
liabilities
|
|||
Initial measurement
at July 1, 2019
|
$ | 579 | ||
Principal payments on operating lease liabilities
|
(174 | ) | ||
|
|
|||
Operating lease liabilities at June 30, 2020
|
405 | |||
Principal payments on operating lease liabilities
|
(192 | ) | ||
|
|
|||
Operating lease liabilities at June 30, 2021
|
213 | |||
Less:
non-current
portion
|
— | |||
|
|
|||
Current portion at June 30, 2021
|
$ | 213 | ||
|
|
(US$’000)
|
June 30,
2021 |
|||
2022
|
218 | |||
|
|
|||
Less imputed interest
|
(5 | ) | ||
|
|
|||
Present value of operating lease liabilities
|
$ | 213 | ||
|
|
Common
Stock
from
Warrants
|
Weighted-
average
Exercise
Price (per
share)
|
|||||||
Outstanding at July 1, 2019
|
38,329 | $ | 82.50 | |||||
Granted
|
241,716 | 10.50 | ||||||
Exercised
|
(27,526 | ) | 10.50 | |||||
Cashless exercise
|
(107,095 | ) | 10.50 | |||||
Forfeited
|
— | — | ||||||
|
|
|||||||
Outstanding and exercisable at June 30, 2020
|
145,424 | 29.48 | ||||||
|
|
|||||||
Granted
|
559,162 | 3.09 | ||||||
Exercised
|
(559,162 | ) | 3.10 | |||||
Forfeited
|
(38,329 | ) | 82.50 | |||||
|
|
|||||||
Outstanding and exercisable at June 30, 2021
|
107,095 | $ | 10.50 | |||||
|
|
Stock
Options
|
Weighted-
average
Exercise
Price
|
Weighted-
average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding at July 1, 2019
|
86,462 | 64.20 | 3.58 years | $ | — | |||||||||||
Forfeited
|
(16,308 | ) | 102.66 | |||||||||||||
|
|
|||||||||||||||
Outstanding at June 30, 2020
|
70,154 | 60.42 | 2.89 years | — | ||||||||||||
Exercisable at June 30, 2020
|
41,829 | 69.81 | 2.59 years | — | ||||||||||||
Granted
|
640,320 | 3.29 | ||||||||||||||
Forfeited
|
(8,410 | ) | 153.79 | |||||||||||||
|
|
|||||||||||||||
Outstanding at June 30, 2021
|
702,064 | 7.16 | 8.07 years | — | ||||||||||||
|
|
|||||||||||||||
Exercisable at June 30, 2021
|
54,158 | $ | 47.90 | 2.09 years | $ | — | ||||||||||
|
|
|
|
|
|
|
|
Fiscal Year Ended
June 30, |
||||||||
2021
|
2020
|
|||||||
Expected volatility
|
112.0-127.4
|
% |
102.9-104.1
|
% | ||||
Expected term
|
3.5 - 6 years
|
5 years | ||||||
Risk-free interest rate
|
0.44-0.55
|
% |
1.28-1.67
|
% | ||||
Expected dividend yield
|
— | % | — | % | ||||
|
|
|
|
(US$’000)
|
June 30,
|
|||||||
2021
|
2020
|
|||||||
Research and development
|
$ | 212 | $ | 16 | ||||
General and administrative
|
422 | 221 | ||||||
|
|
|
|
|||||
Total share-based compensation expense
|
$ | 634 | $ | 237 | ||||
|
|
|
|
(US$’000)
|
|
Year Ended
June 30, |
|
|||||
|
|
2021
|
|
|
2020
|
|
||
United States
|
|
$
|
(7,911
|
)
|
|
$
|
(299
|
)
|
International
|
|
|
(5,971
|
)
|
|
|
(7,975
|
)
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
(13,882
|
)
|
|
$
|
(8,274
|
)
|
|
|
|
|
|
|
|
(US$’000)
|
Year Ended
June 30, |
|||||||
2021
|
2020
|
|||||||
Deferred tax assets:
|
||||||||
Net operating losses
|
$ | 15,902 | $ | 13,153 | ||||
Other
|
230 | 209 | ||||||
Lease liability
|
45 | 85 | ||||||
Share-based compensation
|
88 | — | ||||||
Intangible assets
|
212 | — | ||||||
|
|
|
|
|||||
Gross deferred tax assets
|
16,477 | 13,447 | ||||||
Less valuation allowance
|
(16,223 | ) | (13,290 | ) | ||||
|
|
|
|
|||||
254 | 157 | |||||||
Deferred tax liabilities:
|
||||||||
Right-of-use
|
(42 | ) | (83 | ) | ||||
Fixed assets
|
(76 | ) | (74 | ) | ||||
Prepaid expenses
|
(136 | ) | — | |||||
|
|
|
|
|||||
Total deferred tax liabilities
|
(254 | ) | (157 | ) | ||||
|
|
|
|
|||||
Net deferred taxes
|
$ | — | $ | — | ||||
|
|
|
|
(US$’000)
|
Amount
|
Expiration
Years
|
||||||
Net operating losses, federal (post-December 31, 2017)
|
$ | 8,797 | Do not expire | |||||
Net operating losses, federal (post-December 31, 2017)
|
— | — | ||||||
Net operating losses, state
|
5,314 |
2031-2034
|
||||||
Net operating losses, Australia
|
52,623 | Do not expire |
|
|
Year Ended
June 30, |
|
|||||
|
|
2021
|
|
|
2020
|
|
||
Statutory rate
|
21.00 | % | 21.00 | % | ||||
Permanent differences
|
(8.9 | %) | (2.4 | %) | ||||
Share-based payments
|
(0.32 | %) | (0.74 | %) | ||||
Change in valuation allowance
|
(13.9 | %) | (24.12 | %) | ||||
Foreign tax rate differential
|
2.12 | % | 6.26 | % | ||||
|
|
|
|
|||||
Total
|
(0.00 | %) | (0.00 | %) | ||||
|
|
|
|
(US$’000)
|
Year Ended
June 30, |
|||||||
2021
|
2020
|
|||||||
Net loss attributable to common stockholders
|
($ | 13,882 | ) | ($ | 8,274 | ) | ||
Weighted average number of shares used in calculating basic and diluted earnings per share
|
4,295,416 | 1,021,193 | ||||||
|
|
|
|
|||||
Basic and diluted loss per share
|
($ | 3.23 | ) | ($ | 8.10 | ) | ||
|
|
|
|
Name
|
Age
|
Position
|
||
Jerel Banks | 46 | Chief Executive Officer, Director | ||
Megan Boston | 49 | Executive Director, Director | ||
J. Kevin Buchi(1)(2)(3) | 66 | Director | ||
Peter Francis(1)(2)(3) | 65 | Director | ||
Edward Smith (1)(2)(3) | 50 | Director |
(1) |
Member of the audit committee.
|
(2) |
Member of the compensation committee.
|
(3) |
Member of the nominating and corporate governance committee.
|
• |
Mr. Smith is a Class I director, and his current term will expire at the annual meeting of stockholders to be held in 2023;
|
• |
Messrs. Buchi and Francis are Class II directors, and their initial terms will expire at the annual meeting of stockholders to be held in 2021; and
|
• |
Mr. Banks and Ms. Boston are Class III directors, and their terms will expire at the annual meeting of stockholders to be held in 2022.
|
• |
comply with all laws that govern us and our operations;
|
• |
act honestly and with integrity and fairness in all dealings with others and each other;
|
• |
avoid or manage conflicts of interest;
|
• |
use our assets responsibly and in the best interests of the company; and
|
• |
be responsible and accountable for our actions.
|
(1) |
Ms. Boston’s salary was paid in Australian dollars and has been converted to U.S. dollars using a conversion rate of A$1.00 to $0.747, and A$1.00 to $0.671, for the fiscal years ended June 30, 2021 and June 30, 2020, respectively. From July 1, 2020 through September 15, 2020, Dr. Banks’s and Ms. Boston’s salary was $400,000 and $246,510 respectively. As of September 16, 2020 through the remainder of the fiscal year ended June 30, 2021, Dr. Banks’s and Ms. Boston’s salary was, $450,000 and $284,831, respectively.
|
(2) |
In respect of the fiscal year ended June 30, 2020, the Compensation Committee paid discretionary annual bonuses to Dr. Banks and Ms. Boston. The amount of such bonuses was paid in the fiscal year ended June 30, 2021. The amount of cash bonuses earned in respect of the fiscal year ended June 30, 2021 is not calculable through the latest practicable date. The Compensation Committee expects to determine such bonuses in November 2021, and the amounts of these bonuses will be disclosed in a filing by the Company in a Current Report on Form
8-K
under Item 5.02(f) once the amounts are determined.
|
(3) |
Amount represents the aggregate grant date fair value of stock and option awards granted by the Company in the fiscal year ended June 30, 2021, computed in accordance with FASB ASC Topic 718. For further information on how we account for stock-based compensation, see Note 10 to the Company’s consolidated financial statements for the year ended June 30, 2021 included in this Annual Report. These amounts reflect the Company’s accounting expense for these awards and do not correspond to the actual amounts, if any, that will be recognized by the NEOs.
|
(4) |
Ms. Boston’s performance-based cash bonus was paid in Australian dollars and has been converted to U.S. dollars using a conversion rate of A$1.00 to $0.671.
|
(5) |
Amounts reflect company-paid health and life insurance premiums.
|
(6) |
Amounts reflect the Company’s compulsory contributions to Ms. Boston’s superannuation account. The superannuation contributions were paid in Australian dollars and were converted to U.S. dollars using a conversion rate of A$1.00 to $0.747, and A$1.00 to $0.671, for the fiscal years ended June 30, 2021 and June 30, 2020, respectively.
|
(7) |
The amounts reported in this table include compensation paid by Benitec Limited prior to the completion of the
Re-domiciliation.
|
Option Awards
|
||||||||||||||||||||
Named Executive Officer
|
Grant Date
|
Number of
Securities Underlying Unexercised Options (#)—Exercisable |
Number of
Securities Underlying Unexercised Options (#)—Unexercisable |
Option
Exercise Price ($) |
Option
Expiration Date |
|||||||||||||||
Dr. Jerel A. Banks, M.D. Ph.D.
|
12/9/2020 | (1)(2) | — | 284,345 | 2.98 | 12/9/2030 | ||||||||||||||
Executive Chairman and Chief Executive Officer
|
6/26/2018 | (2)(3) | 33,333 | — | 50.73 | 6/26/2023 | ||||||||||||||
Megan Boston
|
12/9/2020 | (1)(2) | — | 142,172 | 2.98 | 12/9/2030 | ||||||||||||||
Executive Director
|
3/12/2019 | (2)(3) | 11,111 | 5,555 | 42.33 | 3/12/2024 |
(1) |
The option awards were granted under the 2020 Plan.
|
(2) |
The shares subject to each of the option awards vest in substantially equal installments on each of the first, second and third anniversaries of the grant date, generally subject to continued employment through the applicable vesting date.
|
(3) |
The option awards were granted under the Benitec Officers’ and Employees’ Share Option Plan prior to the
Re-domiciliation.
The share amounts and exercise prices of the awards shown in this table have been adjusted to reflect the terms of the
Re-domiciliation.
|
Name
|
Fees Earned
or Paid in Cash ($)(2) |
Option
Awards
($)(3)
|
All Other
Compensation
($)(4)
|
Total
($) |
||||||||||||
J. Kevin Buchi
|
62,939 | 58,547 | — | 121,486 | ||||||||||||
Peter Francis
|
59,173 | 58,547 | 5,231 | 122,951 | ||||||||||||
Edward F. Smith
|
53,057 | 58,547 | — | 111,604 |
(1) |
For information regarding the compensation of Dr. Banks and Ms. Boston, see “Summary Compensation Table.”
|
(2) |
Fees paid to Mr. Buchi (until February 2021) and Francis were paid in Australian dollars and has been converted to U.S. dollars using a conversion rate of A$1.00 to $0.747 for the fiscal year ended June 30, 2021. Fees paid between February 2021 and June 2021 were paid in USD.
|
(3) |
Amount represents the aggregate grant date fair value of stock and option awards granted by the Company in the fiscal year ended June 30, 2021, computed in accordance with FASB ASC Topic 718. For further information on how we account for stock-based compensation, see Note 10 to the Company’s consolidated financial statements for the year ended June 30, 2021 included in this Annual Report. These amounts reflect the Company’s accounting expense for these awards and do not correspond to the actual amounts, if any, that will be recognized by the directors.
|
(4) |
For information regarding other compensation of all directors, see “Narrative Disclosure to Director Compensation Table”
|
Name
|
Option
Awards (#) |
|||
J. Kevin Buchi
|
23,601 | |||
Peter Francis
|
23,601 | |||
Edward F. Smith
|
23,601 |
• |
an annual cash retainer of $40,000;
|
• |
an additional annual cash retainer of $15,000 to the chair of the Audit Committee;
|
• |
an additional annual cash retainer of $10,000 to the chair of the Compensation Committee;
|
• |
an additional annual cash retainer of $7,500 to the chair of the Nominating Committee;
|
• |
an additional annual cash retainer of $7,500 to a
non-chair
member of the Audit Committee;
|
• |
an additional annual cash retainer of $5,000 to a
non-chair
member of the Compensation Committee; and
|
• |
an additional annual cash retainer of $4,000 to a
non-chair
member of the Nominating Committee.
|
Name of Beneficial Owner
|
Number of
Shares Beneficially Owned |
Percentage
of Shares Beneficially Owned |
||||||
5% or Greater Stockholders:
|
||||||||
Entities affiliated with Suvretta Capital Management, LLC(1)
|
769,000 | 9.4 | % | |||||
Entities affiliated with Lincoln Park Capital, LLC(2)
|
423,529 | 5.1 | % | |||||
Directors and Named Executive Officers:
|
||||||||
Jerel A. Banks(3)
|
33,333 | * | ||||||
Megan Boston(4)
|
11,444 | * | ||||||
Kevin Buchi(5)
|
4,827 | * | ||||||
Peter Francis(6)
|
5,037 | * | ||||||
Edward Smith
|
— | * | ||||||
All Executive Officers and Directors As a Group
|
54,641 |
* |
Represents beneficial ownership of less than one percent of the Company’s outstanding common stock.
|
(1) |
Based on the information included in the Schedule 13G filed by Suvretta Capital Management, LLC (“Suvretta”) on May 7, 2021, Averill Master Fund, Ltd. (“Averill”) and Aaron Cowen. The address of the principal business office of Suvretta and Mr. Cowen is c/o Suvretta Capital Management, LLC, 540 Madison Avenue, 7
th
Floor, New York, New York 10022. The address of the principal business office of Averill is c/o Maples Corporate Services Limited, P.O. Box 309, Ugland House, Grand Cayman
KY1-1104,
Cayman Islands.
|
(2) |
Based on information included in the Schedule 13G filed by Lincoln Park Capital, LLC and its affiliates on April 28, 2021. Represents 423,529 shares held directly by Lincoln Park Capital Fund, LLC (“LPC Fund”). Alex Noah and Joshua B. Scheinfeld have shared voting and shared investment power over the shares held by LPC Fund. The address of the principal business office of Lincoln Park Capital, LLC and its affiliates is 440 North Wells, Suite 410, Chicago, Illinois 60654.
|
(3) |
Represents stock options to acquire 33,333 that have vested or will vest within 60 days of September 7, 2021.
|
(4) |
Includes 333 shares held by Boston Super Invest Pty A/C Boston Family Super that Megan Boston has sole voting power over and stock options to acquire 11,111 shares of common stock that have vested or will vest within 60 days of September 7, 2021.
|
(5) |
Includes 4,827 shares of common stock held by Mr. Buchi.
|
(6) |
Includes 4,737 shares of common stock held by the Francis Family Superannuation Fund and 300 shares held directly by Mr. Francis.
|
(7) |
Includes 10,197 shares of common stock and stock options to acquire 44,444 shares of common stock that have vested or will vest within 60 days of September 7, 2021.
|
Plan category
|
Number of
securities to be issued upon exercise of outstanding options, warrants and rights |
Weighted-
average exercise price of outstanding options, warrants and rights ($) |
Number of
securities remaining available for future issuance under equity compensation plans |
|||||||||
Equity compensation plans approved by security holders
|
702,064 | $ | 7.16 | 59,680 | ||||||||
Equity compensation plans not approved by security holders
|
— | — | — | |||||||||
|
|
|
|
|
|
|||||||
Total
|
702,064 | $ | 7.16 | 59,680 | ||||||||
|
|
|
|
|
|
Fee Category
|
2021
|
2020
|
||||||
Audit Fees(1)
|
$ | 256,500 | $ | 210,140 | ||||
Audit Related Fees(2)
|
$ | 56,500 | $ | 16,200 | ||||
Tax Fees(3)
|
$ | 46,465 | $ | 7,000 | ||||
|
|
|
|
|||||
Total
|
$ | 359,465 | $ | 233,340 | ||||
|
|
|
|
(1) |
Audit Fees consist of fees billed for professional services rendered for the audit of the Company’s consolidated annual financial statements included in the Company’s Annual Report on Form
10-K
and review of the interim consolidated financial statements included in the Company’s Quarterly Reports on Form
10-Q,
and services that are normally provided by independent registered public accounting firms in connection with statutory and regulatory filings or engagements.
|
(2) |
Audit-Related Fees consist of fees billed for assurance and related services rendered that are reasonably related to the performance of the audit or review of the Company’s consolidated financial statements and are not reported under “Audit Fees.”
|
(3) |
Tax Fees were billed for professional services including assistance with tax compliance and the preparation of tax returns, tax consultation services, assistance in connection with tax audits and tax advice related to mergers, acquisitions and dispositions.
|
† |
Indicates a management contract or compensatory plan.
|
* |
Filed or furnished herewith
|
BENITEC BIOPHARMA INC.
|
||
By: |
/s/ Dr. Jerel Banks
|
|
Dr. Jerel Banks | ||
Chief Executive Officer |
Signature
|
Title
|
Date
|
||
/s/ Dr. Jerel Banks
Dr. Jerel Banks
|
Chief Executive Officer, Director
(principal executive officer)
|
September 20, 2021 | ||
/s/ Megan Boston
Megan Boston
|
Executive Director, Director
(principal accounting and financial officer)
|
September 20, 2021 | ||
/s/ J. Kevin Buchi
J. Kevin Buchi
|
Director | September 20, 2021 | ||
/s/ Peter Francis
Peter Francis
|
Director | September 20, 2021 | ||
/s/ Edward Smith
Edward Smith
|
Director | September 20, 2021 |
Exhibit 4.3
Description of the Registrants Securities Registered Pursuant to
Section 12 of the Securities Exchange Act of 1934, as amended
The summary of the general terms and provisions of the registered securities of Benitec Biopharma Inc. (Benitec, we, or our) set forth below does not purport to be complete and is subject to and qualified in its entirety by reference to our Amended and Restated Certificate of Incorporation, as amended (our certificate of incorporation) and our Amended and Restated By-laws (our Bylaws and, together with our certificate of incorporation, our Charter Documents), which are filed as exhibits to this Annual Report on Form 10-K and are incorporated by reference herein. We encourage you to read our Charter Documents and the applicable provisions of the General Corporation Law of the State of Delaware (the DGCL) for additional information.
General
Our authorized capital stock consists of 10,000,000 shares of our common stock, par value $0.0001 per share. During the Re-domiciliation, all of the issued and outstanding ordinary shares of Benitec Limited were exchanged for newly issued shares of common stock of the Company, on the basis of one share of the Companys common stock for every 300 ordinary shares issued and outstanding. As a result of the Re-domiciliation, Benitec Limited is a wholly-owned subsidiary of the Company.
Common Stock
Dividend Rights. Subject to preferences that may be applicable to any then outstanding preferred stock, holders of the Companys common stock are entitled to receive dividends, if any, as may be declared from time to time by the Companys Board out of legally available funds. Dividends may be paid in cash, in property or in shares of common stock, subject to the provisions of the Certificate and applicable law. Declaration and payment of any dividend will be subject to the discretion of the Board. The time and amount of dividends will be dependent upon the Companys financial condition, operations, cash requirements and availability, debt repayment obligations, capital expenditure needs, restrictions in the Companys debt instruments, industry trends, the provisions of Delaware law affecting the payment of distributions to stockholders and any other factors the Board may consider relevant.
Voting Rights. Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. The Companys stockholders do not have cumulative voting rights in the election of directors.
Liquidation Rights. In the event of the Companys liquidation, dissolution or winding up, holders of the Companys common stock are entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Companys debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.
Rights and Preferences. Holders of the Companys common stock have no pre-emptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to the Companys common stock. The rights, preferences and privileges of the holders of the Companys common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that the Company may designate in the future.
Fully Paid and Nonassessable. All outstanding shares of the Companys common stock are fully paid and non-assessable.
Annual Stockholder Meetings. The Certificate and Bylaws provide that annual stockholder meetings will be held at a date, place (if any) and time, as exclusively selected by the Board. To the extent permitted under applicable law, the Company may but is not obligated to conduct meetings by remote communications, including by webcast.
Anti-Takeover Effects of Provisions of the Certificate and Bylaws and DGCL
Some provisions of the DGCL, the Certificate and Bylaws could make the following transactions difficult: (i) acquisition of the Company by means of a tender offer; (ii) acquisition of the Company by means of a proxy contest or otherwise; or (iii) removal of incumbent officers and directors of the Company. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in the best interests of the Company, including transactions that might result in a premium over the market price for the Companys common stock.
These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of the Company to first negotiate with the Board.
Delaware Anti-Takeover Statute. The Company is subject to Section 203 of the DGCL, which prohibits persons deemed interested stockholders from engaging in a business combination with a publicly-held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an interested stockholder is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporations voting stock, and a business combination includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the Board, such as discouraging takeover attempts that might result in a premium over the market price of the Companys common stock.
Special Stockholder Meetings. The Bylaws provide that a special meeting of stockholders may be called by (i) the Chairman of the Board, if any, (ii) the President or Chief Executive Officer, or (iii) the Board pursuant to a resolution adopted by a majority of the total number of directors then in office.
Requirements for Advance Notification of Stockholder Nominations and Proposals. The Bylaws establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors.
Composition of the Board of Directors; Election and Removal of Directors; Filling Vacancies
The Companys Board consists of five directors and the Board may, from time to time, fix the authorized number of directors by resolution of the Board. The Board is divided into three classes, designated Class I, Class II and Class III. Directors need not be stockholders of the Company.
Directors shall serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected. The term of each director shall continue until the election and qualification of his or her successor and be subject to his or her earlier death, disqualification, resignation or removal. Except as otherwise provided by the DGCL, the Certificate or the Bylaws, directors shall be elected by a plurality of the votes of the shares present in person, by remote communication, if applicable, or represented by a duly authorized and executed proxy at the meeting and entitled to vote on the election of directors.
Subject to applicable law or by the Certificate, any director of the entire Board of the Company may be removed without cause by the affirmative vote of a majority of the holders of the Companys then-outstanding common stock entitled to vote generally at an election of directors. Furthermore, any vacancy on the Companys Board, however occurring, including a vacancy resulting from an increase in the size of the board, may be filled only by a majority vote of the Board then in office, even if less than a quorum, or by the sole remaining director.
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Amendment of the Certificate and Bylaws. The Certificate may be amended in any manner permitted under the DGCL and the Bylaws may be amended by the vote or written consent of holders of a majority of the outstanding shares entitled to vote. The Board may also amend the Bylaws, other than a bylaw or amendment thereof specifying or changing a fixed number of directors or the maximum or minimum number or changing from a fixed to a variable board or vice versa.
Limitations of Liability and Indemnification Matters
Each of the Certificate and Bylaws provide that the Company is required to indemnify its directors and officers to the fullest extent not prohibited by Delaware law. The Bylaws also obligates the Company to advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding upon delivery to the Company of an undertaking, by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision, from which there is no further right to appeal, that such indemnitee is not entitled to be indemnified for such expenses.
To the fullest extent permitted by the DGCL, or any other applicable law, the Company, upon approval by the Board, may purchase insurance on behalf of any person required or permitted to be indemnified pursuant to the Bylaws.
Forum for Adjudication of Disputes
The Certificate provides that, unless the Company consents in writing to the selection of an alternative forum, the sole and exclusive forum for (i) derivative actions or proceedings brought on behalf of the Company, (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer or employee of the Company to the Company or the Companys stockholders, (iii) an action asserting a claim arising pursuant to any provision of the DGCL, or (iv) any action asserting a claim governed by the internal affairs doctrine shall be a state or federal court located within the state of Delaware. The Certificate further provides that the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for any complaint asserting a cause of action arising under the Securities Act.
Transfer Agent and Registrar
The transfer agent and registrar for the Companys common stock is Computershare Trust Company, N.A. The transfer agent and registrars address is 250 Royall St., Canton, Massachusetts 02021. Listing. Our common stock is listed on Nasdaq under the symbol BNTC.
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Exhibit 21.1
SUBSIDIARIES OF THE REGISTRANT
Subsidiary |
Jurisdiction of Incorporation or Organization |
|
Benitec Biopharma Proprietary Limited |
Australia | |
Benitec Australia Proprietary Limited |
Australia | |
Benitec Limited |
United Kingdom | |
Benitec, Inc. |
Delaware | |
Benitec LLC |
Delaware | |
RNAi Therapeutics, Inc. |
Delaware | |
Tacere Therapeutics, Inc. |
Delaware | |
Benitec, LLC |
Delaware | |
Benitec IP Holdings, Inc. |
Delaware |
Exhibit 23.1
CONSENT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements (No. 333-253258) on Form S-8 and (No. 333-253259) on Form S-3 of Benitec Biopharma Inc. of our report dated September 20, 2021, relating to the consolidated financial statements of Benitec Biopharma Inc., appearing in this Annual Report on Form 10-K of Benitec Biopharma Inc. for the year ended June 30, 2021.
/s/ BAKER TILLY US, LLP
Campbell, CA
September 20, 2021
Exhibit 31.1
Certification of Principal
Executive Officer Pursuant
to SEC Rule 13a-14(a)/15d-14(a)
I, Dr. Jerel Banks, certify that:
1. |
I have reviewed this annual report on Form 10-K of Benitec Biopharma Inc. for the year ended June 30, 2021; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) |
Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) |
Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Dated: September 20, 2021 | /s/ Dr. Jerel Banks | |||
Name: Dr. Jerel Banks | ||||
Title: Chief Executive Officer (principal executive officer) |
Exhibit 31.2
Certification of Principal
Financial Officer Pursuant
to SEC Rule 13a-14(a)/15d-14(a)
I, Megan Boston, certify that:
1. |
I have reviewed this annual report on Form 10-K of Benitec Biopharma Inc. for the year ended June 30, 2021; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) |
Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) |
Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Dated: September 20, 2021 | /s/ Megan Boston | |||
Name: Megan Boston | ||||
Title: Executive Director (principal financial officer) |
Exhibit 32.1
Certification Pursuant to Section 1350
of Chapter 63 of Title 18 of the United States Code
In connection with the annual report on Form 10-K of Benitec Biopharma Inc. (the Company) for the year ended June 30, 2021, as filed with the Securities and Exchange Commission (the Report), I, Dr. Jerel Banks, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
1. |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934. |
2. |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Dr. Jerel Banks
Dr. Jerel Banks
Chief Executive Officer
September 20, 2021
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification is being furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. This certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
Exhibit 32.2
Certification Pursuant to Section 1350
of Chapter 63 of Title 18 of the United States Code
In connection with the annual report on Form 10-K of Benitec Biopharma Inc. (the Company) for the year ended June 30, 2021, as filed with the Securities and Exchange Commission (the Report), I, Megan Boston, Executive Director of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
1. |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934. |
2. |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Megan Boston
Megan Boston
Executive Director (principal financial officer)
September 20, 2021
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification is being furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. This certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.