BNTC 10-K & 10-Q changes, risk factors and insider trading
Benitec Biopharma Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1808898 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Legislative and regulatory reforms affecting drug pricing and healthcare reimbursement may adversely affect our ability to commercialize our product candidates profitably.”
Removed heading “Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.”
Removed heading “If we are unable to enter into agreements with third-party manufacturers on commercially reasonable terms, the commercialization of our product candidates may be adversely affected.”
Largest changes
“Despite the implementation of security measures, our internal computer and information technology systems and those of our current and any future CROs and other contractors, consultants and collaborators are vulnerable to damage from computer viruses, cyber-attacks, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such events could cause interruptions of our operations. …”see in full comparison
“Any failure to remediate the identified material weakness, or to develop or maintain effective controls, or any difficulties encountered in the implementation or improvement of such controls, could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods, such as the restatement of our previously issued unaudited condensed consolidated financial statements described in more detail in this Annual Report on Form 10-K. …”see in full comparison
“Cyber-attacks, breaches, interruptions or other data security incidents could result in legal claims or proceedings, liability under federal or state laws that protect the privacy of personal information, regulatory penalties, significant remediation costs, disrupt key business operations and divert attention of management and key information technology resources. In the United States, notice of breaches must be made to affected individuals, the U.S. Secretary of the Department of Health and Human Services, or HHS, and for extensive breaches, notice may need to be made to the media or U.S. …”see in full comparison
“The current U.S. presidential administration has implemented significant workforce reductions across federal agencies, including the FDA, and the administration’s efforts to reduce federal spending have affected FDA staffing and operations, including the departure of key leadership and other experienced personnel. Efforts by the current administration to substantially reduce or delay federal research funding could have substantial direct or indirect impacts on our research activities and on research institutions with which we collaborate. …”see in full comparison
see in full comparisonDespite the implementation of security measures, our internal computer and information technology systems and those of our current and any future CROs and other contractors, consultants and collaborators are vulnerable to damage from computer viruses, cyber-attacks, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such events could cause interruptions of our operations.While we have not experienced any material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it couldresult in a disruption ofdisrupt our development programs andourbusiness operations,whetherresultdue to a loss of our trade secrets or other similar disruptions. For example, thein loss of clinical trialdataorfrompreclinicalongoingdata, delay regulatory approval efforts, increase recovery orfuturereproductionclinicalcosts,trialsexpose confidential ordataproprietaryfrominformationpreclinical studies couldand result indelayslegalin ourclaims, regulatoryapprovalpenalties,effortssignificant remediation costs or reputational harm. Similar events affecting third parties on which we rely, including manufacturers, CROs, vendors andsignificantlycollaborators,increaseandourthirdcostspartiesto recover or reproduce the data. Likewise,that we rely onthird partiesto manufacture our product candidates andwill rely on third partiesto conduct future clinicaltrials, and similar events relating to their computer systemstrials couldalsohave similarconsequences to our business.consequences. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed and become more expensive. We may face increased cybersecurity risks due to our reliance on internet technology and the number of our employees that are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
“In addition, these agreements typically restrict the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by us or we may share these rights with other parties. …”see in full comparison
Full comparison: every changed paragraph (234)
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;
We have never generated any revenue from product sales and may never be profitable;
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;
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;
We are early in our product development efforts, and our current product candidate is in early clinical stage. We may not be able to obtain regulatory approvals for the commercialization of our product candidates;
Issues that may impact delivery of our therapeutics to the cell could adversely affect or limit our ability to develop and commercialize product candidates;
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;
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.
We rely on third parties for the manufacture and supply of our product candidates, and any disruption in these relationships or in the manufacturing process could adversely affect our ability to develop and commercialize our product candidates;
Physicians, patients, third-party payers, or others in the medical community may not be receptive to our product candidates, and we may not generate any future revenue from the sale or licensing of our product candidates;
Legislative and regulatory reforms affecting drug pricing and healthcare reimbursement, including Medicare drug-price negotiation and Medicaid funding changes, may adversely affect our ability to commercialize our product candidates profitably;
Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan;
Our internal computer and information technology systems, or those of our third parties, may fail or suffer security breaches, which could result in a disruption of our product development programs;
We could face potential product liability claims and, if successful claims are brought against us, we may incur substantial liability and costs; and Funding and staffing disruptions at the FDA and other government agencies could hinder their ability to perform normal business functions on which the operation of our business may rely.
Risks Related to Our Financial Condition,Condition and Capital Requirements
continue our research and preclinical development of our product candidates;
expand the scope of our current preclinical and clinical studies or initiate additional preclinical or other studies for product candidates;
seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
further develop the manufacturing process for our product candidates;
change or add additional manufacturers or suppliers;
seek to identify and validate additional product candidates;
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;
maintain, protect and expand our intellectual property portfolio;
create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and experience any delays or encounter issues with any of the above.
establishing proof of concept in preclinical studies and clinical trials for our product candidates;
successfully initiating and completing clinical trials of our product candidates;
obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;
maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties;
establishing and maintaining successful licenses, collaborations and alliances with third parties;
developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;
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;
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;
obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options;
obtaining favorable coverage and reimbursement rates for our products from third-party payers;
addressing any competing technological and market developments;
identifying and validating new product candidates; and negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.
Because the length of time and activities associated with the successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. In any event, we will require additional capital to obtain regulatory approval for our product candidates and to commercialize any product candidates that receive regulatory approval. We estimate that our cash and cash equivalents will be sufficient to fund the Company’s operations for at least the next twelve months after the date that this Annual Report is filed.
Any additional fundraising efforts may divert our management from their day-to-day activities, which may compromise our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders, and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our common stock to decline. If we incur indebtedness we may be required to agree to restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could compromise our ability to conduct our business. We could also seek financing through arrangements with collaborative partners at an earlier stage than would otherwise be desirabledesirable, and we may be required to relinquish rights to some or all of our technologies or product candidates or otherwise agree to terms unfavorable to us.
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 salesale, and our approach to the development of ddRNAi technology and silence and replace technology may not result in safe, effective or marketable products.
We are early in our product development effortsefforts, 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.
The research, testing, manufacturing, labeling, approval, selling, marketing and distribution of biologics is subject to extensive regulation by the FDA and other regulatory authorities, and these regulations differ from country to country. We do not have any products on the market and are early in our development efforts. AllOur of our ddRNAilead product candidatescandidate, andBB-301, our silence and replace product candidates areis in preclinicalearly clinical development. Our current product candidates are subject to the risks of failure typical for development of biologics. The development and approval process is expensive and can take many years to complete, and its outcome is inherently uncertain. In addition, the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of any future clinical trials;
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;
the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for approval;
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;
the results of clinical trials may not confirm the positive results from earlier preclinical studies or clinical trials;
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
the data collected from 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;
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;
regulatory agencies might not approve or might require changes to our manufacturing processes or facilities; or regulatory agencies may change their approval policies or adopt new regulations in a manner rendering our clinical data insufficient for approval.
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
restrictions on the products, manufacturers, or manufacturing process;
warning letters;
civil and criminal penalties;
injunctions;
suspension or withdrawal of regulatory approvals;
product seizures, detentions or import bans;
voluntary or mandatory product recalls and publicity requirements;
total or partial suspension of production;
Management's Discussion & Analysis (MD&A)
Removed heading “Restatement of Prior Period Financial Statements”
Removed heading “Quarterly Financial Information (Unaudited)”
Removed heading “Years Ended June 30, 2025 and 2024”
Largest changes
“Restatement of Prior Period Financial Statements”see in full comparison
“On October 11, 2024, we entered into a Sales Agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering amount of up to $75 million from time to time through the Agent. The Agent will use its commercially reasonable efforts, as the agent and subject to the terms of the Sales Agreement, to sell the shares offered. …”see in full comparison
“We have restated our previously issued unaudited condensed consolidated financial statements for the quarterly periods and year-to-date periods ended March 31, 2025 and December 31, 2024, as contained in this Annual Report on Form 10-K. Refer to the “Explanatory Note” Preceding Item 1, Business, for background on the restatement, the periods impacted, control considerations, and other information. …”see in full comparison
“As a result of the restatement described above, we are restating our comparisons of expenses for the impacted periods as follows:”see in full comparison
Full comparison: every changed paragraph (58)
Restatement of Prior Period Financial Statements
We have restated our previously issued unaudited condensed consolidated financial statements for the quarterly periods and year-to-date periods ended March 31, 2025 and December 31, 2024, as contained in this Annual Report on Form 10-K. Refer to the “Explanatory Note” Preceding Item 1, Business, for background on the restatement, the periods impacted, control considerations, and other information. In addition, we have restated certain previously reported financial information for the quarterly periods and year-to-date periods ended March 31, 2025 and December 31, 2024 in this Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including but not limited to information within the Results of Operations section. See Note 3, Restatement of Prior Period Financial Statements, in the notes to the consolidated financial statements in this Annual Report on Form 10-K, for additional information related to the restatement, including descriptions of the misstatements and the impacts on our consolidated financial statements.
We endeavor to become the leader in discovery, development, and commercialization of therapeutic agents capable of addressing significant unmet medical need via the application of the silence and replace approach to the treatment of genetic disorders.
Benitec Biopharma Inc. (“Benitec” or the “Company” or in the thirdfirst person, “we” or “our”) is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary platform, called DNA-directed RNA interference, or ddRNAi, combines RNA interference, or RNAi, with gene therapy to create medicines that facilitate sustained silencing of disease-causing genes following a single administration. The unique therapeutic constructs also enable the simultaneous delivery of wildtype replacement genes, facilitating the proprietary “silence and replace” approach to the treatment of genetically defined diseases. We are developing a silence and replace-based therapeutic (BB-301) for the treatment of Oculopharyngeal Muscular Dystrophy ("OPMD"), a chronic, life-threatening genetic disorder.
BB-301 is a silence and replace-based genetic medicine currently under development by Benitec. BB-301 is an AAV-based gene therapy designed to permanently silence the expression of the disease-causing gene (to slow, or halt, the biological mechanisms underlying disease progression in OPMD) and to simultaneously replace the mutant gene with a wildtypefunctional gene (to drive restoration of function in diseased cells). This fundamental therapeutic approach to disease management is called “silence and replace.” The silence and replace mechanism offers the potential to restore the normative physiology of diseased cells and tissues and to improve treatment outcomes for patients suffering from the chronic, and potentially fatal, effects of OPMD. BB-301 has been granted Orphan Drug Designation in the UnitedEuropean StatesUnion and Orphan Drug Designation and Fast Track Designation in the EuropeanUnited Union.States.
The targeted gene silencing effects of RNAi, in conjunction with the durable transgene expression achievable via the use of modified viral vectors, imbues the silence and replace approach with the potential to produce permanent silencing of disease-causing genes along with simultaneous replacement of the wild type gene function following a single administration of the proprietary genetic medicine. We believe that this novel mechanistic profile of the current and future investigational agents developed by Benitec could facilitate the achievement of robust and durable clinical activity while greatly reducing the frequency of drug administration traditionally expected for medicines employed for the management of chronic diseases. Additionally, the achievement of permanent gene silencing and gene replacement may significantly reduce the risk of patient non-compliance during the course of medical management of potentially fatal clinical disorders. We will require additional financing to progress our product candidates through future inflection points.
Royalties, milestone payments and other license fees
We have been and in the future may be required to pay royalties, milestone payments and other license fees in connection with our licensing of intellectual property from third parties, including as discussed below.
Foreign Currency Translation and Other Comprehensive Income (Loss) The Company’s functional currency and reporting currency is the United States dollar. BBL’s functional currency is the Australian dollar (AUD). Assets and liabilities are translated at the exchange rate in effect at the balance sheet date. Revenues and expenses are translated at the average rate of exchange prevailing during the reporting period. Equity transactions are translated at each historical transaction date spot rate. Translation adjustments arising from the use of different exchange rates from period to period are included as a component of stockholders’ equity as “Accumulated other comprehensive income (loss).” Gains and losses resulting from foreign currency translation are included in the consolidated statements of operations and comprehensive income (loss) as other comprehensive income (loss).
ATM Agreement
On October 11, 2024, we entered into a Sales Agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering amount of up to $75 million from time to time through the Agent. The Agent will use its commercially reasonable efforts, as the agent and subject to the terms of the Sales Agreement, to sell the shares offered. Sales of the shares, if any, may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. We may also agree to sell shares to the Agent as principal for its own account on terms agreed to by us and the Agent. The Agent will be entitled to a commission from us of 3.0% of the gross proceeds from the sale of shares sold under the Sales Agreement. In addition, we have agreed to reimburse certain expenses incurred by the Agent in connection with the offering. Shares sold pursuant to the Sales Agreement, if any, will be sold pursuant to our shelf registration statement on Form S-3 (File No. 333-277310), that was filed with the Securities and Exchange Commission, including the related prospectus, dated March 5, 2024, as supplemented by a prospectus supplement. As of June 30, 2025, we have not sold any shares of common stock pursuant to the Sales Agreement.
MarchNovember 2025 Capital Raise
On MarchNovember 25,5, 2025, we entered into an Underwriting Agreement with Leerink Partners LLC and TD Securities (USA) LLC,LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein, pursuant to which we agreed to issue and sell, in ana firm commitment underwritten offering by us (the “November 2025 Underwritten Offering”), (i) 1,143,0005,930,000 shares of ourthe Company’s common stock, par value $0.0001 per share (the “Common Stock”). atIn addition, we granted the Underwriters a purchase30-day price to investors of $13.00 per share, and (ii) pre-funded warrantsoption to purchase 300,000up to an additional 889,500 shares of Common StockStock. atThe anpublic exerciseoffering price offor $0.0001 pereach share at a purchase price to investors of $12.999Common perStock warrant.is $13.50. In connection with their services, the Underwrittenunderwriters Offering,received wean enteredunderwriting intodiscount aequal Securitiesto Purchase Agreement with entities affiliated with each6.0% of Suvretta Capital, a greater than 5% beneficial owner prior to the offering (together, the “Purchasers”), pursuant to which we agreed to issue and sell to the Purchasers an aggregate of 900,000 shares of Common Stock at a purchase price of $13.00 per share in a registered direct offering (the “Direct Offering,” and together with the Underwritten Offering, the “Offerings”), the same price per share as the offering price in the Underwritten Offering. We received gross proceeds of approximately $30.5 million and net proceeds of approximately $28.2 million from the Offerings.November 2025 Underwritten Offering.
Concurrently with the November 2025 Underwritten Offering, on November 5, 2025, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with affiliates of Suvretta Capital (now Montanova Capital), Averill Master Fund, Ltd. and Averill Madison Master Fund, Ltd. (together, the “Purchasers” and the “Suvretta Funds”), pursuant to which the Company agreed to issue and sell to the Purchasers an aggregate of 1,481,481 shares of Common Stock at a purchase price of $13.50 per share in a registered direct offering (the “Direct Offering,” and together with the November 2025 Underwritten Offering, the “Offerings”), the same price per share as the price to the public in the November 2025 Underwritten Offering. In connection with their services, we entered into a Placement Agency Agreement with Leerink Partners, TD Securities and Evercore ISI pursuant to which we agreed to pay such placement agents a fee in an amount equal to 6.0% of the gross proceeds received by the Company from the Direct Offering, subject to the placement agents reimbursing the Company for certain of its expenses. Pursuant to the Purchase Agreement, the Company and the Purchasers entered into a Registration Rights Agreement pursuant to which the Company agreed to register for resale the shares of Common Stock sold in the Direct Offering.
Total gross proceeds received by the Company during the year ended June 30, 2026 from the issuance of Common Stock totaled $104.5 million, less underwriter issuance costs of $5.7 million and other incidental costs of $0.6 million.
We did not generate or recognize any revenue during the years ended June 30, 2026 and 2025.
Quarterly Financial Information (Unaudited)
As a result of the restatement described above, we are restating our comparisons of expenses for the impacted periods as follows:
The following table sets forth a summary of our expenses for each of the periods:
During the three and nine months ended March 31, 2025, respectively, we incurred $6.5 million and $15.5 million in research and development expenses, respectively, as compared to $2.6 million and $12.1 million for the comparable periods ended March 31, 2024. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. The year-over-year increase for the three and nine months ended March 31, 2025, reflects the timing of contract manufacturing activity and the timing of payments for the OPMD Natural History and Dosing study.
General and administrative expense totaled $8.8 million and $16.5 million for the three and nine months ended March 31, 2025, compared to $1.6 million and $5.0 million for the comparable periods ended March 31, 2024. The increase for the three month period, 2025 relates primarily to an increase in share-based compensation of $7.4 million, travel expenses of $176 thousand and salaries and wages of $254 thousand. The increase in the nine month period relates to an increase in share-based compensation of $10.9 million, and higher corporate costs related to an increase in legal fees, and higher travel expenses as well as an increase in salaries and wages.
The following table sets forth a summary of our expenses for each of the periods:
During the three and six months ended December 31, 2024, respectively, we incurred $5.4 million and $9.0 million in research and development expenses, respectively, as compared to $5.1 million and $9.5 million for the comparable periods ended December 31, 2023. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. The year-over-year decrease for the three and six-month periods ended December 31, 2024 reflects the timing of contract manufacturing activity and the timing of payments for the OPMD Natural History and Dosing study.
General and administrative expense totaled $5.4 million and $7.6 million for the three and six months ended December 31, 2024, compared to $1.8 million and $3.4 million for the comparable periods ended December 31, 2023. The increase for the three and six-month period ended December 31, 2024 relates primarily to an increase in share-based compensation of $2.7 million and $3.4 million and corporate costs related to the filing of an At-the-Market offering and related legal fees of $643 thousand and $945 thousand, respectively.
Years Ended June 30, 2025 and 2024
We did not generate or recognize any revenue during the years ended June 30, 2025 and 2024.
Royalties and License Fees
Royalties and license fees consist primarily of payments we are required to remit for royalties and other payments related to in-licensed intellectual property. We cannot precisely predict the amount, if any, of royalties we will owe in the future, and if our calculations of royalty payments are incorrect, we may owe additional royalties, which could negatively affect our results of operations. Furthermore, we may enter into additional license agreements in the future, which may also include royalty, milestone, and other payments.
General and administrative expenses consist primarily of salaries, related benefits, travel, and equity-basedshare-based compensation expense. General and administrative expenses also include facility expenses, professional fees for legal, consulting, accounting and audit services and other related costs.
We anticipate that our generalresearch and administrativedevelopment expenses may increase as we focus on the continued development of the clinical OPMD program. We also anticipate an increase in expenses relating to accounting, legal and regulatory-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and other similar costs.
Ms. Boston was appointed as our Chief Financial Officer effective January 1, 2025. On December 9, 2024, the Compensation Committee approved increases of the base salaries of Dr. Jerel Banks and Megan Boston to $667,000 and $415,000, respectively, each adjustment being effective as of January 1, 2025. The Compensation Committee further determined that the target annual discretionary bonus with respect to our 2025 fiscal year for Dr. Jerel Banks and Megan Boston will be 55% and 40% of their base salary, respectively. On December 9, 2024, the Board of Directors appointed Sophie Mukadam as Chief Operating Officer, effective as of January 1, 2025. Sophie Mukadam will receive a base salary of $500,000 and a target annual bonus of 40% of base salary. On February 13, 2025, the Compensation Committee of our board of directors approved a change to the base salary of Megan Boston, CFO, from USD$415,000 to USD$531,900 to be effective March 1, 2025. The base salary change was approved in anticipation of Ms. Boston relocating from Australia to Los Angeles, California.
In connection with such relocation, the Compensation Committee also approved moving and transitional housing allowances in aggregate amounts of approximately $5,000 and $18,000, respectively.
Operating Expenses
During the years ended June 30, 2025 and 2024, we incurred royalties and license fees expenses of zero and $(108) thousand, respectively. The credits to expense during the year ended June 30, 2024, relates to the reversal of accruals for license fees no longer due.
During the year ended June 30, 2025,2026, we incurred $18.3$23.4 million in research and development expenses, as compared to $15.6$18.3 million for the comparable year ended June 30, 2024.2025. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. The year-over-year increase for the year ended June 30, 2025,2026, primarily reflects thean timingincrease in share-based compensation expense of $6.3 million and an increase in payroll of $2.2 million, offset by a reduction in contract manufacturing activity and the timing of payments$3.8 for the OPMD Natural History and Dosing study.million.
General and administrative expenses totaled $23.4$27.8 million for the year ended June 30, 2025,2026, compared to $7.0$23.4 million for the comparable year ended June 30, 2024.2025. The increase for the year ended June 30, 2025,2026, relates primarily to increases in share-based compensation of $14.5$2.7 million,million legaland feesan increase in payroll of $492$0.8 thousand, consulting fees of $605 thousand, travel expenses of $219 thousand, and salaries and wages of $685 thousand.million.
Other Income (ExpenseLoss)
Other income (loss), net during the year ended June 30, 2025,2026, which mainly consists of foreign currency transaction gain (loss), and interest income other expense, net, gain on extinguishment of liabilities, and unrealized loss on investment,which totaled $3,848$5.6 thousand. Other income (loss), net during the year ended June 30, 2024, which consists of foreign currency transaction gain (loss), interest expense, other income (expense), and unrealized loss on investment, totaled $739. Foreign currency transaction gains and losses reflect changes in foreign exchange rates.million. Net interest income increased by $2.3 million for year ended June 30, 2025,2026, in comparison the year ended June 30, 2024,2025, reflectsreflecting thean increase in our cash and cash equivalent balances. Other expense, net recognized duringIn the yearsyear ended June 30, 20252025, andthere 2024 relate to recognition ofwas a franchise tax expenses. Gaingain on extinguishment of liabilities is due to usa settlingsettlement of an outstanding trade payables balance and accrued clinical development project costs of $1.2 million with a vendor for $495$0.5 thousandmillion due to a contractual dispute regarding contract performance and deliverables. This settlement resulted in a gain of $764$0.8 thousandmillion in fiscal year 2025. No comparable settlements occurred during the currentyear year.ended June 30, 2026.
We have incurred cumulative losses and negative cash flows from operations since our predecessor’s inception in 1995. We had accumulated losses of $218$273.7 million as of June 30, 2025.2026. We expect that our research and development expenses will increase due to the continued development of the OPMD program. It is also likely that there will be an increase in the general and administrative expenses due to thecompliance obligationsrequirements of being a domestic public company in the United States.
We had no borrowings as of June 30, 20252026 and do not currently have a credit facility. As of June 30, 2026 and 2025, we had outstanding warrants to purchase 20,017,501 and 20,443,496 shares respectively, of Common Stock consisting of the following:
As of June 30, 2025,2026, we had cash and cash equivalents of approximately $97.7$180.0 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts. On October 11, 2024, we entered into the Sales Agreement as discussed above, which provides for the sale of up to $75 million of our common stock from time-to-time in “at-the-market offerings”. On March 25, 2025, we completed a financing which raised $30.5 million.
On November 5, 2025, we sold 5.9 million shares of common stock in an offering, and concurrently sold 1.5 million shares to affiliates of Suvretta Capital (now Montanova Capital) in a registered direct offering. Total gross proceeds from the common stock issuances during the year ended June 30, 2026 was $104.5 million, less underwriter issuance costs of $5.7 million and other incidental costs of $0.6 million.
Net cash used in operating activities for the years ended June 30, 20252026 and 20242025 was $23.6$16.5 million and $19.4$23.6 million, respectively. Net cash used in operating activities was primarily the result of our net loss, partially offset by non-cash expenses,expenses. andOther factors included changes in working capital,capital including— primarily an increase in payables offset by a decrease in payablesprepaid assets and tradelease and other receivables and increases in prepaids.liabilities.
Net cash used in investing activities for the years ended June 30, 20252026 and 20242025 was $18not thousandsignificant and $179 thousand, respectively. Cash used in investing activities in the years ended June 30, 2025 and 2024 was related to the purchase of furniture and fixtures and lab equipment, respectively.equipment.
Net cash provided by financing activities was $99.0 million and $70.5 million for the years ended June 30, 2026 and 2025, respectively. Cash from financing activities in the year ended June 30, 2026 was mostly related to the issuance of common stock from the November 2025 offering, and the exercise of pre-funded warrants, Series 2 warrants, and common warrants, partially offset by share issuance costs. Cash from financing activities in the year ended June 30, 2025 was related to the March 2025 underwritten and direct offering with gross proceeds of $42.3 million, partially offset by share issuance costs of $2.3 million, resulting in net cash provided by financing activities of $70.5 million, and the issuance of common stock from the exercise of pre-funded warrants, Series 2 warrants, and common warrants.
Net cash provided by financing activities was $70.5 million and $68.0 million for the years ended June 30, 2025 and 2024, respectively. Cash from financing activities in the year ended June 30, 2025 was related to the issuance of common stock from the exercise of pre-funded warrants, Series 2 warrants, and common warrants, and an underwritten and direct offering with net proceeds of $72.8 million, partially offset by $2.3 million in share issuance costs. Cash from financing activities in the year ended June 30, 2024 was related to the issuance of common stock, pre-funded warrants, and common warrants, with gross proceeds of $73.9 million, partially offset by $5.9 million in share issuance costs.
The future of usthe Company as an operating business will depend on its ability to manage operating costs and budgeted amounts and obtain adequate financing.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrectincorrect, and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
the timing and costs of our clinical trials for our ddRNAi and silence and replace product candidates;
the timing and costs of our 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.
On October 1, 2016, wethe Company entered into an operating lease for office space in Hayward, California thatwith originally expired in April 2018. We have entered into leasemultiple amendments that extendedextending the lease through December 2027. WeThe Company also entered into a new lease in Los Angeles, California,California whichfor hasoffice space with an initial expiration date in July 2026. The Company entered into a lease amendment for the Los Angeles office that extended the lease through January 2028. See Note 98 of the Notes to Consolidated Financial Statements included in this Annual Report on Form 10-K.
We record share-based compensation in accordance with ASC 718, Stock Compensation. ASC 718 requires the fair value of all share-based employee compensation awarded to employees and non-employees to be recorded as an expense over the shorter of the service period or the vesting period. We determine employee and non-employee share-based compensation based on grant-date fair value using the Black-Scholes Option Pricing Model and allocate the resulting compensation expense over the corresponding requisite service period using the graded vesting attribution method. We account for forfeitures of share-based awards as they occur.
What changed in the latest 10-Q
Risk Factors
There have been no material changes to the risk factors disclosed in Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
“Interim Clinical Study Results and FDA Fast Track Designation On January 11, 2026, we announced updated positive long-term clinical results for BB-301 Phase 1b/2a Clinical Trial. The first patient treated in Cohort 1 of the trial has completed the 24-month post-treatment assessment. …”see in full comparison
General and administrative expense totaledsee in full comparison$7.5$7.3 million and$14.0$21.3 million for the three andsixnine months endedDecemberMarch 31,2025,2026, compared to$5.4$8.8 million and$7.6$16.5 million for the comparable period endedDecemberMarch 31,2024.2025. Theincreasedecrease for the threeand sixmonths endedDecemberMarch 31,2025,2026 relates primarily toanaincreasedecrease in share based compensation of$2.0$2.1millionmillion, partially offset by increases in salaries and$6.0wages of $0.4 million. The increase for the nine months ended March 31, 2026 primarily related to increases in share based compensation of $3.9 million and salaries and wages of$0.6$0.8million and $0.9 million, offset by a decrease in legal fees of $0.4 million and $0.5 million, respectively.million.
During the three andsee in full comparisonsixnine months endedDecemberMarch 31,2025,2026, we incurred$5.8$6.3 million and$9.2$15.5 million in research and development expenses, respectively, as compared to$5.4$6.5 million and$9.0$15.5 million for the comparable period endedDecemberMarch 31,2024.2025. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. Theincreasedecrease for the threeand sixmonths endedDecemberMarch 31,20252026reflectswasincreaseduein share based compensation of $2.2 million and $3.0 million, respectively, offset byto the timing of contract manufacturing activity and the timing of payments for the OPMD Natural History and Dosingstudy.study, partially offset by an increase in share based compensation of $2.0 million. In the nine months ended March 31, 2026 and 2025, research and development expense remained flat.
Other income (loss), net during the three andsee in full comparisonsixnine months endedDecemberMarch 31,2025, which2026, consists of foreign currency transaction gain (loss), interest income, net, and otherincome (expense),expense, net, totaled$1.5$1.6 million and$2.4$4.0 million, respectively. Other income (loss), net during the three andsixnine months endedDecemberMarch 31, 2025, consists of foreign currency transaction gain (loss), interest income, net, gain on extinguishment of liabilities, and other expense, net, totaled$1.3$0.8 million and$2.0$2.8 million, respectively. Foreign currency transaction gains and losses reflect changes in foreign exchange rates.NetThe increase in net interest income for the three andsixnine months endedDecemberMarch 31,2025,2026, in comparison to the three andsixnine months endedDecemberMarch 31,2024,2025, reflects the increase in the Company’s cash and cash equivalent balances. Gain on extinguishment of liabilities in the prior period is due to the settlement with a vendor of an outstanding trade payable balance and an accrued clinical development project cost balance totaling $1.3 million for $0.5 million due to a dispute regarding contract performance and deliverables. This settlement resulted in a gain of $0.8 million in thethree and sixnine months endedDecemberMarch 31,2024.2025.
Net cash provided by financing activities wassee in full comparison$98.2$98.7 million and$39.5$67.7 million for thesixnine months endedDecemberMarch 31,20252026 and2024,2025, respectively. The financing activities for thesixnine months endedDecemberMarch 31,20252026 primarily related to the issuance of common stock with gross proceeds of $104.5 million and from the exercise of common stock warrants with gross proceeds of $0.5 million, offset by $6.3 million in share issuance costs. Cash from financing activities in thesixnine months endedDecemberMarch 31,20242025 was related to the issuance of common stock with gross proceeds of $30.5 million and issuance of common stock from the exercise of Series 2 warrants and common stock warrants with gross proceeds of $39.5million.million, offset by $2.2 million in share issuance costs.
The Investigational New Drug (IND) application for BB-301 was approved to proceed by the U.S. Food and Drug Administration in June 2023. The first study subject was safely treated in Cohort 1 of the BB-301 Phase 1b/2a clinical trial (NCT06185673) in November 2023. All Cohort 1see in full comparisondosingsubjectswashave safely completedinthesecond12-monthcalendarpost-BB-301-treatmentquarterfollow-upofperiod.2025.The first two Cohort 2dosingsubjectswashave been safelyinitiatedtreated.inNothetreatment-relatedfourthseverecalendaradversequartereventsofhave2025been.observed. BB-301 is the lead investigational gene therapy agent under development by Benitec. BB-301 has been granted Orphan Drug Designation in theUnitedEuropeanStatesUnion and Orphan Drug Designation and Fast Track Designation in theEuropeanUnitedUnionStates, and the key attributes of BB-301 are outlined in Figure 3.
Full comparison: every changed paragraph (30)
You should read the following discussion and analysis of financial condition and operating results together with our consolidated financial statements and the related notes and other financial information included elsewhere in this document. See also “Special Note Regarding Forward-Looking Statements” immediately prior to Part I, Item 1 in this Quarterly Report on Form 10-Q.
Benitec Biopharma Inc. (“Benitec” or the “Company” or in the third person, “we” or “our”) is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary platform, called DNA-directed RNA interference, or ddRNAi, combines RNA interference, or RNAi, with gene therapy to create medicines that facilitate sustained silencing of disease-causing genes following a single administration. The unique therapeutic constructs also enable the simultaneous delivery of functional replacement genes, facilitating the proprietary “silence and replace” approach to the treatment of genetically defined diseases. The Company is developing a silence and replace-based therapeutic (BB-301) for the treatment of Oculopharyngeal Muscular Dystrophy ("OPMD"), a chronic, life-threatening genetic disorder.
BB-301 is a silence and replace-based genetic medicine currently under development by Benitec. BB-301 uses DNA-directed RNA interference ("ddRNAi") to simultaneously silence the mutant gene and replace it with a functional gene, potentially providing a permanent solution with a single administration. This fundamental therapeutic approach to disease management is called “silence and replace.” The silence and replace mechanism offers the potential to restore the normative physiology of diseased cells and tissues and to improve treatment outcomes for patients suffering from the chronic, and potentially fatal, effects of OPMD. BB-301 has been granted Orphan Drug Designation in the UnitedEuropean StatesUnion and Orphan Drug Designation and Fast Track Designation in the EuropeanUnited Union.States.
ddRNAi is designed to produce permanent silencing of disease-causing genes, by combining RNA interference, or RNAi, with viral delivery agents typically associated with the field of gene therapy (i.e., viral vectors). Modified adeno-associated viral (“AAV”) vectors are employed to deliver genetic constructs which encode short hairpin RNAs that are, then, serially expressed and processed to produce siRNA molecules within the transduced cell for the duration of the life of the target cell. These newly introduced siRNA molecules drive permanent silencing of the expression of the disease-causing gene. The silence and replace approach further bolsters the biological benefits of permanent silencing of disease-causing genes by incorporating multifunctional genetic constructs within the modified AAV vectors to create an AAV-based gene therapy agent that is designed to silence the expression of disease-causing genes (to slow, or halt, the underlying mechanism of disease progression) and to simultaneously replace the mutant genes with normal, functional genes (to drive restoration of function in diseased cells). This fundamentally distinct therapeutic approach to disease management offers the potential to restore the underlying physiology of the treated tissues and, in the process, improve treatment outcomes for patients suffering from the chronic and, potentially, fatal effects of diseases like Oculopharyngeal Muscular Dystrophy (OPMD).OPMD.
The mutation of a single gene can cause a chronic disease via the resulting intracellular production of a disease-causing protein (i.e., an abnormal form of the protein of interest), and many chronic and/or fatal disorders are known to result from the inappropriate expression of a single gene or multiple genes. In some cases, genetic disorders of this type can be treated exclusively by “silencing” the intracellular production of the disease-causing protein through well-validated biological approaches like RNA interference (“RNAi”).RNAi. RNAi employs small nucleic acid molecules to activate an intracellular enzyme complex, and this biological pathway temporarily reduces the production of the disease-causing protein. In the absence of the disease-causing protein, normal cellular function is restored and the chronic disease that initially resulted from the presence of the mutant protein is partially or completely resolved. RNAi is potentially applicable to over 20,000 human genes and a large number of disease-causing microorganism-specific genes.
A small double stranded RNA, or dsRNA, molecule (A, Figure 1), comprising one strand known as the sense strand and another strand known as the antisense strand, which are complementary to each other, is synthesized in the laboratory. These small dsRNAs are called small interfering RNAs, or siRNAs. The sequence of the sense strand corresponds to a short region of the target gene mRNA. The siRNA is delivered to the target cell (B, Figure 1), where a group of enzymes, referred to as the RNA-Induced Silencing Complex, or RISC, process the siRNA (C, Figure 1), where one of the strands (usually the sense strand) is released (D, Figure 1). RISC uses the antisense strand to find the mRNA that has a complementary sequence (E, Figure 1) leading to the cleavage of the target mRNA (F, Figure 1). As a consequence, the output of the mRNA (protein production) does not occur (G, Figure 1). Several companies, including Alnylam Pharmaceuticals Inc. (“Alnylam”),Inc., utilize this approach in their RNAi product candidates.
The silence and replace approach to the treatment of genetic disorders employs adeno-associated viral vectors (“AAVs”) vectors to deliver genetic constructs which may, after a single administration to the target tissues:
Chronically express RNAi molecules inside of the target, diseased, cells (to serially silence the intracellular production of mutant, disease-causing, protein and the functional protein of interest);
The Investigational New Drug (IND) application for BB-301 was approved to proceed by the U.S. Food and Drug Administration in June 2023. The first study subject was safely treated in Cohort 1 of the BB-301 Phase 1b/2a clinical trial (NCT06185673) in November 2023. All Cohort 1 dosingsubjects washave safely completed in the second12-month calendarpost-BB-301-treatment quarterfollow-up ofperiod. 2025.The first two Cohort 2 dosingsubjects washave been safely initiatedtreated. inNo thetreatment-related fourthsevere calendaradverse quarterevents ofhave 2025been .observed. BB-301 is the lead investigational gene therapy agent under development by Benitec. BB-301 has been granted Orphan Drug Designation in the UnitedEuropean StatesUnion and Orphan Drug Designation and Fast Track Designation in the EuropeanUnited UnionStates, and the key attributes of BB-301 are outlined in Figure 3.
There are currently no therapeutic interventions approved for OPMD. BB-301 is the only clinical-stage therapeutic agent in development designed to treat dysphagia in patients with OPMD. Additionally, there are no surgical interventions available to OPMD patients that modify the natural history of the disease, which is principally comprised of chronic deterioration of swallowing function. BB-301 has received Orphan Drug Designation in the European Union and Orphan Drug Designation and Fast Track Designation in the United States and the European Union and, upon achievement of regulatory approval for BB-301 in these respective jurisdictions, the Orphan Drug Designations would provide commercial exclusivity independent of intellectual property protection. While OPMD is a rare disorder, we believe the commercial opportunity for a safe and efficacious therapeutic agent in this clinical indication exceeds $1 billion over the course of the commercial life of the product.
The BB-301 clinical development program is being conducted in the United States, and the primary elements of the program are summarized below:below.
The first study subject was safely treated in Cohort 1 of the BB-301 Phase 1b/2a clinical trial (NCT06185673) in November 2023. All six Cohort 1 subjects have safely completed the 12-month post-BB-301-treatment follow-up period. The first two Cohort 2 subjects have been safely treated with BB-301. No treatment-related severe adverse events have been observed.
All six subjects in Cohort 1 have been safely treated with BB-301, and the first subject of Cohort 2 has been safely treated with BB-301.No treatment-related Severe Adverse Events have been observed for the Subjects treated with BB-301.
Interim Clinical Study Results and FDA Fast Track Designation On January 11, 2026, we announced updated positive long-term clinical results for BB-301 Phase 1b/2a Clinical Trial. The first patient treated in Cohort 1 of the trial has completed the 24-month post-treatment assessment. These results serve as an update to the interim clinical results shared on November 3, 2025 that announced Cohort 1 patients demonstrated significant and sustained improvements across multiple clinical measures including dysphagic symptom burden, post-swallow residue accumulation, time required to consume fixed volumes of liquid, as well as improved pharyngeal closure during swallowing. The update provided in January 2026, shows that following the administration of BB-301, patient 1 in Cohort 1 continued to demonstrate robust, disease-modifying outcomes across multiple clinical measures including post-swallow residue at 24 months. Additionally, the first 4 patients in Cohort 1 have now completed the 12-month statistical follow-up period and continued to demonstrate durable response to BB-301. We look forward to engaging the U.S. Food and Drug Administration mid-2026 to confirm the BB-301 pivotal study design. BB-301 was previously granted fast track and Orphan Drug Designation in the U.S. and Orphan Drug Designation in the European Union (EU) for the treatment of OPMD with dysphagia.
Foreign Currency Translation and Other Comprehensive Income (Loss) The Company’s functional currency and reporting currency is the United States dollar. BBL’s functional currency is the Australian dollar (AUD). Assets and liabilities are translated at the exchange rate in effect at the balance sheet date. Revenues and expenses are translated at the average rate of exchange prevailing during the reporting period. Equity transactions are translated at each historical transaction date spot rate. Translation adjustments arising from the use of different exchange rates from period to period are included as a component of stockholders’ equity in accumulated other comprehensive income (loss) and the Consolidated Statements of Comprehensive Income (Loss).Loss. Other comprehensive income (loss) for all periods presented consists entirely of foreign currency translation gains and losses.
We anticipate that our general and administrative expenses may increase as we focus on the continued development of the clinical OPMD program. We also anticipate an increase in expenses relating to accounting, legal and regulatory-related services associated with maintaining compliance with stock exchange listing and SEC requirements, director and officer insurance premiums and other similar costs.
The following tables setsset forth a summary of our expenses for each of the periods:
During the three and sixnine months ended DecemberMarch 31, 2025,2026, we incurred $5.8$6.3 million and $9.2$15.5 million in research and development expenses, respectively, as compared to $5.4$6.5 million and $9.0$15.5 million for the comparable period ended DecemberMarch 31, 2024.2025. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. The increasedecrease for the three and six months ended DecemberMarch 31, 20252026 reflectswas increasedue in share based compensation of $2.2 million and $3.0 million, respectively, offset byto the timing of contract manufacturing activity and the timing of payments for the OPMD Natural History and Dosing study.study, partially offset by an increase in share based compensation of $2.0 million. In the nine months ended March 31, 2026 and 2025, research and development expense remained flat.
General and administrative expense totaled $7.5$7.3 million and $14.0$21.3 million for the three and sixnine months ended DecemberMarch 31, 2025,2026, compared to $5.4$8.8 million and $7.6$16.5 million for the comparable period ended DecemberMarch 31, 2024.2025. The increasedecrease for the three and six months ended DecemberMarch 31, 2025,2026 relates primarily to ana increasedecrease in share based compensation of $2.0$2.1 millionmillion, partially offset by increases in salaries and $6.0wages of $0.4 million. The increase for the nine months ended March 31, 2026 primarily related to increases in share based compensation of $3.9 million and salaries and wages of $0.6$0.8 million and $0.9 million, offset by a decrease in legal fees of $0.4 million and $0.5 million, respectively.million.
The following tables setsset forth a summary of our other income (loss) for each of the periods:
Other income (loss), net during the three and sixnine months ended DecemberMarch 31, 2025, which2026, consists of foreign currency transaction gain (loss), interest income, net, and other income (expense),expense, net, totaled $1.5$1.6 million and $2.4$4.0 million, respectively. Other income (loss), net during the three and sixnine months ended DecemberMarch 31, 2025, consists of foreign currency transaction gain (loss), interest income, net, gain on extinguishment of liabilities, and other expense, net, totaled $1.3$0.8 million and $2.0$2.8 million, respectively. Foreign currency transaction gains and losses reflect changes in foreign exchange rates. NetThe increase in net interest income for the three and sixnine months ended DecemberMarch 31, 2025,2026, in comparison to the three and sixnine months ended DecemberMarch 31, 2024,2025, reflects the increase in the Company’s cash and cash equivalent balances. Gain on extinguishment of liabilities in the prior period is due to the settlement with a vendor of an outstanding trade payable balance and an accrued clinical development project cost balance totaling $1.3 million for $0.5 million due to a dispute regarding contract performance and deliverables. This settlement resulted in a gain of $0.8 million in the three and sixnine months ended DecemberMarch 31, 2024.2025.
The Company has incurred cumulative losses and negative cash flows from operations since our predecessor’s inception in 1995. The Company had accumulated losses of $249$261 million as of DecemberMarch 31, 2025.2026. We expect that our research and development expenses will increase due to the continued development of the OPMD program.
As of DecemberMarch 31, 2025,2026, we do not have outstanding borrowings or credit facilities.
As of DecemberMarch 31, 2025,2026, the Company has issued warrants allowing holders to purchase 20,179,42820,080,001 shares of Common Stock, consisting of the following:
As of DecemberMarch 31, 2025,2026, we had cash and cash equivalents of approximately $188.8$184.8 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts.
Net cash used in operating activities for the sixnine months ended DecemberMarch 31, 20252026 and 20242025 was $7.1$11.6 million and $12.3$15.4 million, respectively. Net cash used in operating activities was primarily the result of our net loss, partially offset by non-cash expenses, and changes in working capital primarily in trade and other payables.
Net cash used in investing activities sixnine months ended DecemberMarch 31, 20252026 and 20242025 was $11$26 thousand and $12$18 thousand, respectively.
Net cash provided by financing activities was $98.2$98.7 million and $39.5$67.7 million for the sixnine months ended DecemberMarch 31, 20252026 and 2024,2025, respectively. The financing activities for the sixnine months ended DecemberMarch 31, 20252026 primarily related to the issuance of common stock with gross proceeds of $104.5 million and from the exercise of common stock warrants with gross proceeds of $0.5 million, offset by $6.3 million in share issuance costs. Cash from financing activities in the sixnine months ended DecemberMarch 31, 20242025 was related to the issuance of common stock with gross proceeds of $30.5 million and issuance of common stock from the exercise of Series 2 warrants and common stock warrants with gross proceeds of $39.5 million.million, offset by $2.2 million in share issuance costs.
On October 1, 2016, the Company entered into an operating lease for office space in Hayward, California with multiple amendments extending the lease through December 2027. The Company also entered into a new lease in Los Angeles, California for office space with an initial expiration date in July 2026. The Company entered into a lease amendment for the Los Angeles office that extended the lease through January 2028. See Note 8 of the Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.10-Q for additional information.
Estimates and assumptions about future events and their effects cannot be determined with certainty. The Company bases its estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as the Company’s operating environment changes. These changes have historically been minor and have been included in the consolidated financial statements as soon as they became known. In addition, management is periodically faced with uncertainties, the outcomes of which are not within its control and will not be known for prolonged periods of time. These uncertainties are discussed in the section above entitled “Risk Factors.Factors” in our Annual Report on Form 10-K for the year ended June 30, 2025. Based on a critical assessment of its accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that the Company’s consolidated financial statements are fairly stated in accordance with accounting principles generally accepted in the United States of America and provide a meaningful presentation of the Company’s financial condition and results of operations.
BNTC insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-29 | Buchi J Kevin |
Gift | 51,813 | — | — |
Well-known investors holding BNTC (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 921,299 | $12.3M | 0.01% | Added 41% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 81,466 | $1.1M | 0.0% | Reduced 53% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 22,481 | $300.8K | 0.0% | New position |