BNTC

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 and Capital Requirements We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future.
As of June 30, 2026, we had accumulated losses of $273.7 million.
We anticipate that our expenses will increase substantially if and as we: • 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.
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.
Our lead product candidate, BB-301, is in early clinical development.
Our product candidates are subject to the risks of failure typical for development of biologics.
Even if we obtain or a collaborator obtains regulatory approval, the approval may be for disease indications or patient populations that are not as broad as we intended or desired and may require labeling that includes significant use or distribution restrictions or safety warnings.
Also, before a clinical trial can begin at any institution, that institution’s, IRB, and its IBC, if it has one, have to review the proposed clinical trial to assess the safety of the trial.
The FDA has recently required additional and in some cases more stringent clinical trial designs and clinical trial data for gene therapy product candidates, even where companies believed they had previously established alignment with the FDA on their trial designs.
From time to time, the FDA may provide written feedback on clinical trial design elements, including an indication that it would be willing to consider a regulatory pathway based on limited clinical data, such as data from a single pivotal study.
However, even if the FDA initially agrees that a particular data set or development plan could support a marketing application, the agency could later determine that additional or more comprehensive clinical evidence is required, including randomized controlled trials, larger patient populations, longer follow-up periods, different or additional endpoints, or confirmatory studies.
Any unexpected changes to trial design requirements for our ddRNAi-based gene therapy product candidates could require us to conduct additional or modified clinical studies, resulting in increased costs and delays to our development timelines.
The tissue tropism and other physical properties of AAV vectors are limited and may not be effective for other product candidates or delivery into a wide array of tissue types.
Such related diagnostics are subject to regulation by the FDA and typically to comparable foreign regulatory authorities as medical devices and generally require separate regulatory approval or clearance prior to commercialization.
Funding and staffing disruptions at the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
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.
To the extent that academic medical centers, research hospitals, or other institutions that conduct or support our preclinical or clinical programs experience disruptions in federal funding, the pace of our research and development activities could be adversely affected.
While deregulatory initiatives could potentially streamline certain processes, they may result in unpredictable changes to established regulatory pathways, reduced oversight capacity, or shifts in FDA priorities that could delay or complicate our regulatory submissions.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a “rare disease or condition”, which is generally defined as any disease or condition which affects fewer than 200,000 individuals in the United States.
Our ability to recognize revenues from successful potential collaborations may be impaired by multiple factors including that 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; • may cease development in an area that is the subject of a collaboration agreement; • 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; • 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; • may encounter regulatory, resource or quality issues and be unable to meet demand requirements; • may independently develop, or develop with unrelated parties, products that compete directly or indirectly with our product candidates; • may exercise its rights under the agreement to discontinue our collaboration; • may have a dispute 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; • may not adequately protect the intellectual property rights associated with a product candidate; • 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 • 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.
We expect to continue to rely on third-party manufacturers for preclinical and clinical grade product candidates and if we receive regulatory approval for any product candidate, for commercialization and production of commercial quantities of our product candidates.
If we are unable to obtain or maintain third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully.
Our or a third party’s failure to execute on our manufacturing requirements could adversely affect our business in a number of ways, including: • an inability to conduct necessary preclinical studies; • an inability to initiate or continue 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.
Risks Related to Commercialization of Our Product Candidates If we are unable to enter into agreements with third parties to commercialize our product candidates or establish sales and marketing capabilities to market and sell our product candidates, we may be unable to generate any revenues.
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 platform based on modalities and technology similar to ours.
We are aware of multiple companies that are working in the field of RNAi therapeutics.
Legislative and regulatory reforms affecting drug pricing and healthcare reimbursement may adversely affect our ability to commercialize our product candidates profitably.
The U.S. government has pursued, and may continue to pursue, significant legislative and regulatory changes affecting pharmaceutical pricing and reimbursement.
The Inflation Reduction Act of 2022 (“IRA”) authorized Medicare to directly negotiate prices for certain high-expenditure drugs and biologics, imposed inflation-based rebate requirements on drugs covered under Medicare Parts B and D, and capped out-of-pocket costs for Medicare beneficiaries.
The scope of drugs subject to price negotiation is expected to expand in coming years, and any products we develop that receive Medicare reimbursement could become subject to mandatory price negotiations.
In addition, in July 2025, the One Big Beautiful Bill Act was signed into law, which includes significant reductions in Medicaid funding that could reduce the patient population eligible for coverage of our products and put downward pressure on reimbursement levels.
The Centers for Medicare & Medicaid Services (“CMS”) has also introduced new payment models applicable to gene and cell therapies, including the Guaranteeing Uptake and Access to Reimbursement for Durable (GUARD), the Gene-Therapy Ensuring New Efficient Reimbursement Options for Unique Solutions (GENEROUS), and the Gene-Therapy Leveraging Outcomes-Based Engagements (GLOBE) models.
These models may introduce outcomes-based or performance-linked reimbursement for gene therapies, which could create uncertainty about the ultimate price we would receive for our products.
The current U.S. presidential administration has also pursued executive orders establishing Most Favored Nation pricing frameworks, which could limit the prices at which we are able to sell approved products in the United States to levels comparable to those in foreign countries, many of which have established government price controls.
Supreme Court’s decision in Loper Bright Enterprises v.
Raimondo overturned courts’ traditional deference to agency interpretations of ambiguous statutes.
This decision could increase litigation challenging FDA, CMS, and other regulatory agency decisions, create greater uncertainty regarding the regulatory landscape, and make it more difficult to predict how statutes governing drug pricing and market access will be interpreted and applied.
The cumulative effect of these developments could significantly limit the prices we are able to charge for any products that receive marketing approval, reduce patient access to our therapies, and adversely affect our ability to generate revenues.

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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; and • 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.
Risks Related to Our Financial Condition, Capital Requirements We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future.
As of June 30, 2025, we had accumulated losses of $228.2 million.
We anticipate that our expenses will increase substantially if and as we: • continue our research and preclinical development of our product candidates; • expand the scope of our current preclinical and clinical studies for our product candidates or initiate clinical, 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.
Because the length of time and activities associated with 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.
All of our ddRNAi product candidates and our silence and replace product candidates are in preclinical development.
Our current product candidates are subject to the risks of failure typical for development of biologics.
Even if we or a collaborator obtain regulatory approval, the approval may be for disease indications or patient populations that are not as broad as we intended or desired and may require labeling that includes significant use or distribution restrictions or safety warnings.
Also, before a clinical trial can begin at any institution, that institution’s institutional review board, or IRB, and its institutional biosafety committee, or IBC, if it has one, have to review the proposed clinical trial to assess the safety of the trial.
The tissue tropism and other physical properties of AAV vectors are limited and may not be effective for other product candidates or delivery into a wide array of tissues types.
Such related diagnostics are subject to regulation by the FDA and typically to comparable foreign regulatory authorities as medical devices and typically require separate regulatory approval or clearance prior to commercialization.
Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a “rare disease or condition”, which is generally defined as any disease or condition which affects less than 200,000 individuals in the United States.
Our ability to recognize revenues from successful potential collaborations may be impaired by multiple factors including: • 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; • 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.
We expect to continue to rely on third-party manufacturers for preclinical and clinical grade product candidates and if we receive regulatory approval for any product candidate.
If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully.
Our or a third party’s failure to execute on our manufacturing requirements could adversely affect our business in a number of ways, including: • an inability to conduct necessary preclinical studies to progress our product candidates to clinical trials; • an inability to initiate or continue 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.
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.
Because we rely on third parties to manufacture our product candidates, and because we collaborate with various organizations and academic institutions on the advancement of our technology and product candidates, we may, at times, share trade secrets with them.
We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information.
These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets.
Despite these contractual provisions, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by potential competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.
Given that our proprietary position is based, in part, on our know-how and trade secrets, discovery by a third party of our trade secrets or other unauthorized use or disclosure would impair our intellectual property rights and protections in our product candidates.
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.
Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication.
Risks Related to Commercialization of Our Product Candidates 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.
We intend to rely on third-party manufacturers for commercialization and production of commercial quantities of our product candidates.
We may be unable to negotiate agreements with third-party manufacturers to support our commercialization activities on commercially reasonable terms.
We may encounter technical or scientific issues related to manufacturing or development that we may be unable to resolve in a timely manner or with available funds.
If we are unable to engage manufacturing partners to produce our product candidates on a larger scale on reasonable terms, our commercialization efforts will be harmed.
If such third-party manufacturers are unable to produce the necessary quantities of our product candidates, or do so in compliance with cGMP or with pertinent foreign regulatory requirements, and within our planned time frame and cost parameters, the development and sales of our product candidates, if approved, may be impaired.
In some jurisdictions, approval of the manufacturer may be required.
There is no guarantee such approval can be obtained.
If we are unable to enter into agreements with third parties to commercialize our product candidates or establish sales and marketing capabilities to market and sell our product candidates, we may be unable to generate any revenues.
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.
We are aware of multiple companies that are working in the field of RNAi therapeutics, including Alnylam.
The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include, but are not limited to, the following: • 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.
Anew collaboration may be on terms that are not optimal for us and we may not be to maintain any new or existing collaboration if, for example, development or approval of a product candidate is delayed, sales of an approved product candidate do not meet expectations or the collaborator discontinues the collaboration.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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