BPTH 10-K & 10-Q changes, risk factors and insider trading
Bio-path Holdings, Inc. · OTC · Pharmaceutical Preparations · CIK 1133818 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Even if we are successful in obtaining regulatory approval to market a drug candidate, we, and our third-party manufacturer(s) will be, subject to extensive regulation by the FDA.”
New heading “Even if we receive regulatory approval of any product candidate or therapy that we may develop, we will be subject to ongoing regulatory obligations, reporting requirements and continued regulatory review, which may result in significant additional expenses. If we fail to comply with regulatory requirements or experience unanticipated problems with our products or product candidates, we may be subject to substantial penalties, fines, delays, suspensions, refusals and withdrawals of approvals.”
New heading “We may be subject to claims that our employees and contractors have wrongfully used or disclosed alleged trade secrets of their former employers.”
New heading “Our common stock has been delisted from The Nasdaq Capital Market and there is no guarantee that our common stock will be regularly traded on the OTCQB Venture Market or other over-the-counter markets.”
New heading “Recent and future reverse stock splits may decrease the liquidity of our common stock and result in higher transaction costs.”
New heading “Following a reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.”
New heading “If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.”
Removed heading “Claims Related to DNAbilize®”
Removed heading “Compositions and Methods of Use for Specific Drug Targets”
Removed heading “Our common stock may be delisted from The Nasdaq Capital Market which could negatively impact the price of our common stock and our ability to access the capital markets.”
Largest changes
“Even if we receive regulatory approval of any product candidate or therapy that we may develop, we will be subject to ongoing regulatory obligations, reporting requirements and continued regulatory review, which may result in significant additional expenses. If we fail to comply with regulatory requirements or experience unanticipated problems with our products or product candidates, we may be subject to substantial penalties, fines, delays, suspensions, refusals and withdrawals of approvals.”see in full comparison
“Our common stock has been delisted from The Nasdaq Capital Market and there is no guarantee that our common stock will be regularly traded on the OTCQB Venture Market or other over-the-counter markets.”see in full comparison
“Our common stock may be delisted from The Nasdaq Capital Market which could negatively impact the price of our common stock and our ability to access the capital markets.”see in full comparison
“If we fail to comply with all listing standards applicable to issuers listed on The Nasdaq Capital Market, our common stock may be delisted. If our common stock is delisted, it could reduce the price of our common stock and the levels of liquidity available to our stockholders. In addition, the delisting of our common stock could materially adversely affect our access to the capital markets and any limitation on liquidity or reduction in the price of our common stock could materially adversely affect our ability to raise capital. …”see in full comparison
“Following a reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.”see in full comparison
“Recent and future reverse stock splits may decrease the liquidity of our common stock and result in higher transaction costs.”see in full comparison
Full comparison: every changed paragraph (42)
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. For example, overin the last severalrecent years, including December 22, 2018 to January 25, 2019, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough employees and stop critical activities. If a prolonged government shutdown or a series of shutdowns occurs, it could significantly affect the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to gain access to the public markets and obtain necessary capital in order to properly capitalize and continue our operations, which could have a material adverse effect on our business and financial condition.
We must complete extensive clinical trials to demonstrate the safety and efficacy of our drug candidates. If we are unable to demonstrate the safety and efficacy of our drug candidates, we will not beobtain successful.the regulatory approval necessary to market our drug candidates, which would have an adverse effect on our business.
To date, none of our drug candidates have been approved for sale in the U.S. or any foreign country. Before a new drug product can be marketed, it must obtain clearance from the FDA by submitting an investigational new drug application (“IND”), then by successfully completing human testing under three phases of clinical trials, and finally by submitting a new drug application (“NDA”).
Before an entity can begin clinical trials for a product candidate in the U.S., they must complete extensive nonclinical and preclinical studies that support their planned and future INDs. We cannot be certain of the timely completion or outcome of ongoing and future nonclinical and preclinical studies and cannot predict if the FDA will allow our future proposed clinical programs to proceed or if the outcome of their nonclinical and preclinical studies will ultimately support further development of our programs. We also cannot be sure that we will be able to submit INDs or similar applications with respect to our future product candidates on the timelines we expect, if at all, and we cannot be sure that submission of IND or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin. With respect to INDs we have already obtained or are able to obtain in the future, we cannot be sure that our clinical trials will be successful to the satisfaction of the FDA.
For purposes of NDA approval by the FDA, human clinical trials are typically conducted in the following phases (which may overlap):
All clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be considered reliable for regulatory purposes. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. These government regulations may delay or prevent approval of product candidates for a considerable period of time and impose costly procedures upon our business operations.
The FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved. Such trials may be made a condition to be satisfied for continuing drug approval. The results of Phase 4 clinical trials can confirm the effectiveness of a product candidate and can provide important safety information. In addition, the FDA has authority to require sponsors to conduct post-marketing trials to specifically address safety issues identified by the agency.
To date, none of our drug candidates have been approved for sale in the U.S. or any foreign country. While antisense therapeutics have been in development for over 20 years, only a limited number of antisense drugs have been successfully developed to date. Further, the development of liposomal antisense therapeutics, which comprise our drug therapeutics technology, has faced many challenges and generally remains unproven in the treatment of cancers. The success of our business depends primarily on our ability to develop and commercialize our drug candidates successfully. OurIn order to obtain FDA approval to market a new drug in the U.S., our drug candidates must satisfy rigorous standards of safety and efficacy to the satisfaction of the FDA before they canmay be approved for sale. ToIn an effort to satisfy these standards, we must engage in expensive and lengthy testing of our drug candidates.
We may not be able to obtain authority from the FDA or other equivalent foreign regulatory agencies to move on to further efficacy segments of our ongoing clinical trials or commence and complete any other clinical trials for any of our drug candidates. Positive results in preclinical studies of a drug candidate may not be predictive of similar results in human clinical trials, and promising results from early clinical trials of a drug candidate may not be replicated in later clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development. Accordingly, the results from the preclinical tests or clinical trials for our drug candidates may not be predictive of the results we may obtain in later stage trials. The failure of clinical trials to demonstrate safety and efficacy of one or more of our drug candidates will have a material adverse effect on our business and financial condition.condition for any number of reasons including delays in development, additional unanticipated studies required by the FDA, or an ultimate inability to market a product candidate and generate a profit.
Even if we are successful in obtaining regulatory approval to market a drug candidate, we, and our third-party manufacturer(s) will be, subject to extensive regulation by the FDA.
Changes to some of the conditions established in an approved application, including changes in indications, labeling, manufacturing processes or facilities, require submission and FDA approval of a new NDA, or an NDA supplement, before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.
Drug products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet. Although physicians may, in their independent professional medical judgment, prescribe legally available drugs for off-label uses, manufacturers typically may not market or promote such off-label uses.
Prexigebersen has received orphan drug designations for the treatment of AML in the U.S. Orphan designation is available to drugs intended to treat, diagnose or prevent a rare disease or condition that affects fewer than 200,000 people in the U.S. at the time of application for orphan designation. Orphan drug designation must be requested before submitting an application for marketing authorization. Orphan designation qualifies the sponsor of the product for a tax credit and marketing incentives. The first sponsor to receive FDA marketing approval for a drug with an orphan designation is entitled to a seven-year exclusive marketing period in the U.S. for that product for that indication and, typically, a waiver of the prescription drug user fee for its marketing application. However, aorphan drug thatexclusivity may not effectively protect the FDAproduct considerscandidate tofrom competition for several reasons including different drugs with different active ingredients may be clinically superior to, or different from, the approved orphan drug, even though for the same indication,conditions mayand competitors also obtainpotentially could secure approval inof the U.S.same drug for different non-orphan conditions. Even after an orphan drug is approved, the FDA can subsequently approve the same drug during the seven-year exclusive marketing period.period for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusive marketing rights may also be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug.
Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the product candidate any advantage in the regulatory review or approval process. Orphan drug designation in no way ensures ultimate regulatory approval.
Identification of previously unknown problems with respect to a drug candidate,candidate and/or a commercial product(s) with which any of our candidates are being tested or a manufacturer or facility involved in the production of any such candidate or commercial product may result in restrictions on the drug candidate, product, manufacturer or facility.facility that could have a material adverse effect on the development of our drug candidate(s).
In addition, because we are developing at least one of our drug candidates in combination with one or more third-party commercial products, we could also be subject to delays, difficulties, and other adverse effects if any such commercial products (or the companies and/or facilities involved in their marketing and/or production) experience safety, efficacy, compliance, or other issues. For example, one of the therapies with which BP1001 is being studied as a combination therapy candidate may have unexpected safety issues that are improperly attributed to BP1001, or the administration of BP1001 with such other therapies may result in safety issues or adverse events that may not have been present if such other therapies or BP1001 would have been used alone. And, the commercial drug(s) with which any of our candidates is being developed could become unavailable due to any number of circumstances beyond our control. This could delay or prevent our ability to complete the affected clinical studies and/or pursue, obtain, or maintain FDA approval, as applicable.
Even if we receive regulatory approval of any product candidate or therapy that we may develop, we will be subject to ongoing regulatory obligations, reporting requirements and continued regulatory review, which may result in significant additional expenses. If we fail to comply with regulatory requirements or experience unanticipated problems with our products or product candidates, we may be subject to substantial penalties, fines, delays, suspensions, refusals and withdrawals of approvals.
If BP1001 or any other product candidates that we are developing or may in the future are approved, they will be subject to ongoing regulatory requirements and reporting requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, recordkeeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the U.S. and requirements of comparable non-U.S. regulatory authorities. In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that we conduct post-approval.
Facilities of CMOs and testing laboratories are required to comply with extensive FDA, and non-U.S. regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP, and in certain cases, current Good Tissue Practices (“cGTP”), regulations. As a result, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any NDA, other marketing application, and previous responses to inspection observations. Accordingly, we and others with whom we work with must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
Additionally, the FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses and a company that is found to have improperly promoted off-label uses may be subject to significant liability. The policies of the FDA and of other regulatory authorities may change and additional government regulations maybe enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
The FDA may seek consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers, manufacturing processes or testing laboratories, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
Our patent portfolio currently includes five issued patents in the U.S. and 17 issued patents in foreign jurisdictions:
Claims Related to DNAbilize®
Compositions and Methods of Use for Specific Drug Targets
Our patent portfolio currently includes seven issued patents in the U.S. and 61 issued patents in foreign jurisdictions. We have sixthree additional pending patent applications in the U.S. and sevenfive additional allowed patent application in a foreign jurisdiction. Further, we have pending patent applications in key foreign jurisdictions across our six families of applications. Our success depends in large part on our ability to obtain and maintain patent protection both in the U.S. and in other countries for our drug candidates. Our ability to protect our drug candidates from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, our ability to maintain, obtain and enforce patents is uncertain and involves complex legal and factual questions. Accordingly, rights under any issued patents may not provide us with sufficient protection for our drug candidates or provide sufficient protection to afford us a commercial advantage against competitive products or processes. We cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us.
We may be subject to claims that our employees and contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, or we, have used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Our common stock has been delisted from The Nasdaq Capital Market and there is no guarantee that our common stock will be regularly traded on the OTCQB Venture Market or other over-the-counter markets.
On February 14, 2025, Nasdaq notified the Company that the Panel determined to delist the Company’s common stock. On February 19, 2025, trading of our common stock was suspended on The Nasdaq Capital Market and trading of our common stock commenced on the OTCQB Venture Market under the ticker symbol “BPTH.”
The OTCQB Venture Market is a significantly more limited market than The Nasdaq Capital Market, and quotation on the OTC Venture Market has resulted in a less liquid market for existing and potential holders of our common stock which could further depress the trading price of our common stock. There is no guarantee that our common stock will continue to be traded on the OTCQB Venture Market or on other over-the-counter markets, and accordingly, our common stock may become illiquid. We can provide no assurance as to whether broker-dealers will continue to provide public quotes of the common stock on the OTCQB Venture Market, or whether the trading volume of the common stock will be sufficient to provide for an efficient trading market.
To date, we have a low volume of daily trades in our common stock on The Nasdaq Capital Market.stock. Our stockholders may be unable to sell their common stock at or near their asking prices or at all, which may result in substantial losses to our stockholders.
As a public reporting company, we are subject to the Sarbanes-Oxley Act of 2002, as well as to the information and reporting requirements of the SEC and other federal securities laws. We are also subject to the rules of Thethe NasdaqOTCQB StockVenture Market. As a result, we incur significant legal, accounting, and other expenses that we would not incur as a private company, including costs associated with our public company reporting requirements and corporate governance requirements. Compliance with these public company obligations places significant additional demands on our limited number of finance and accounting staff and on our financial, accounting and information systems.
Recent and future reverse stock splits may decrease the liquidity of our common stock and result in higher transaction costs.
Our stockholders approved a reverse stock split at our 2024 Annual Meeting which may be effected in the sole discretion of the Board of Directors, at a ratio of up to 1-for-30, and may be abandoned in the sole discretion of the Board of Directors. The liquidity of our common stock may be negatively impacted by any such reverse stock split, given the reduced number of shares that are outstanding after such a reverse stock split, particularly if the stock price does not increase as a result of such reverse stock split. Additionally, if the reverse stock split is implemented, it will increase the number of our stockholders who own “odd lots” of fewer than 100 shares of common stock. Brokerage commissions and other costs of transactions in odd lots are generally higher than the costs of transactions of more than 100 shares of common stock. Accordingly, a reverse stock split may not achieve the desired results of increasing the stock price of our common stock.
Following a reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.
Although we believe that a higher market price of our common stock may help generate greater or broader investor interest, there can be no assurance that a reverse stock split, will result in a share price that will attract new investors, including institutional investors. In addition, there can be no assurance that the market price of our common stock will satisfy the investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve. If we effect the reverse stock split approved at the 2024 Annual Meeting, the primary intent will be the anticipated increase in the price of our common stock immediately following and resulting from a reverse stock split due to the reduction in the number of issued and outstanding shares of common stock. It cannot be assured that a reverse stock split will result in any sustained proportionate increase in the market price of our common stock, which is dependent upon many factors, including our business and financial performance, general market conditions, and prospects for future success, which are unrelated to the number of shares of our common stock outstanding. It is not uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split.
If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us, our industry and our market. If no analyst elects to cover us and publish research or reports about us, the market for our common stock could be severely limited and our stock price could be adversely affected. As a small-cap company, we are more likely than our larger competitors to lack coverage from securities analysts. In addition, even if we receive analyst coverage, if one or more analysts ceases coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. If one or more analysts who elect to cover us issue negative reports or adversely change their recommendations regarding our common stock, our stock price could decline.
Our common stock may be delisted from The Nasdaq Capital Market which could negatively impact the price of our common stock and our ability to access the capital markets.
The listing standards of The Nasdaq Capital Market provide that a company, in order to qualify for continued listing, must maintain (1) a board of directors comprised of a majority of Independent Directors (as defined in Nasdaq Listing Rule 5605(a)(2)) and an audit committee of the board of directors comprised of at least three members, each of whom must be an Independent Director, and (2) a minimum stock price of $1.00 and satisfy standards relative to minimum stockholders’ equity, minimum market value of publicly held shares and various additional requirements.
If we fail to comply with all listing standards applicable to issuers listed on The Nasdaq Capital Market, our common stock may be delisted. If our common stock is delisted, it could reduce the price of our common stock and the levels of liquidity available to our stockholders. In addition, the delisting of our common stock could materially adversely affect our access to the capital markets and any limitation on liquidity or reduction in the price of our common stock could materially adversely affect our ability to raise capital. Delisting from The Nasdaq Capital Market could also result in other negative consequences, including the potential loss of confidence by suppliers, customers and employees, the loss of institutional investor interest and fewer business development opportunities.
In the past, we have received a notice of non-compliance from the Listing Qualifications Department of The Nasdaq Stock Market LLC with respect to the $1.00 minimum closing bid price requirement. Although we have effected a reverse stock split in an effort to regained compliance with the minimum closing bid price requirement, there can be no assurance that we will be able to meet the minimum closing bid price requirement or other listing requirements in the future.
Management's Discussion & Analysis (MD&A)
New heading “Development and Treatment for Obesity”
New heading “For the Year Ended December 31, 2024”
New heading “March 2024 Registered Direct Offering and March 2024 Private Placement”
New heading “At the Market Offering”
New heading “April 2024 Registered Direct Offering and April 2024 Private Placement”
New heading “June 2024 Private Placement”
New heading “October 2024 Private Placement”
New heading “March 2025 Promissory Note”
Removed heading “For the Year Ended December 31, 2022”
Removed heading “2022 Registered Direct Offering and 2022 Private Placement”
Largest changes
“On March 6, 2025, we entered into a securities purchase agreement with 1800 Diagonal Lending LLC, a Virginia limited liability company (the “Lender”), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “Promissory Note”) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The Promissory Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, March 6, 2025. …”see in full comparison
“On April 4, 2024, we entered into the At The Market Offering Agreement with Wainwright, as sales agent, pursuant to which we may offer and sell, from time to time, through Wainwright, shares of our common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method permitted by law, including in privately negotiated transactions. …”see in full comparison
“March 2024 Registered Direct Offering and March 2024 Private Placement”see in full comparison
“April 2024 Registered Direct Offering and April 2024 Private Placement”see in full comparison
Full comparison: every changed paragraph (50)
We are a clinical and preclinical stage oncology-focusedoncology and obesity-focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, our DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.
Using DNAbilize® as a platform for drug development and manufacturing, we currently have four drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersenBP1001, (pronouncedor prex” i je ber’ sen),prexigebersen, which targets Grb2, initially started the efficacy portion of a Phase 2 clinical trial for untreated AML patients in combination with LDAC. The interim data presented inHowever, the 2018changing ASH Annual Meeting showed that 11 (65%)landscape of the 17 evaluable patients had a response, including five (29%) who achieved CR, inclusive of one CR with CRi and one morphologic leukemia-free state, and six (35%) stable disease responses, including two patients who had greater than a 50% reduction in bone marrow blasts. However, DNA hypomethylating agents are now the most frequently used agents in theAML treatment ofhas elderlyled AMLto patients in the U.S. and Europe. As a result, Stage 2amendment of the Phase 2 trialclinical instudy AMLby was amended to removeremoving the combination treatment of prexigebersen and LDAC and replacereplacing it with the combination treatment of prexigebersen and decitabine, a DNA hypomethylating agent, for treatment of a second cohort of untreated AML patients. Since decitabine is also used as a treatment for relapsed/refractory AML patients, a cohort of relapsed/refractory AML patients was also added to the study.decitabine.
The FDA granted approval of venetoclaxVenetoclax in combination with LDAC, decitabine or azacytidine (the latter two drugs are DNA hypomethylating agents) is approved as frontline therapy for newly diagnosed AML in adults who are 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. We believe this approval of the frontline venetoclax and decitabine combination therapy provides an opportunity for combiningdeveloping prexigebersen withas an addition to the combination therapy for the treatment of newly diagnosed AML patients. Preclinical efficacy studies for the triple combination treatment of prexigebersen, decitabine and venetoclax in AML have been successfully completed. In the preclinical efficacy studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen. Decrease in AML cell viability was the primary measure of efficacy. The triple combination of decitabine, venetoclax and prexigebersen showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, we believe that adding prexigebersen to the treatment combination of decitabine and venetoclax could lead to improved efficacy in AML patients. Accordingly, we further amended Stage 2 of this Phase 2 clinical trial to add the triple combination treatment comprised of prexigebersen, decitabine and venetoclax.
Our approved amended Stage 2 for this Phase 2 clinical trial currently has three cohorts of patients.subjects. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort willincludes includenewly untreateddiagnosed AML patients, and the second cohort will includeincludes relapsed/refractory AML patients. Finally, the third cohort will treattreats relapsed/refractory AML patients, who are venetoclax-resistant or -intolerant, with the two-drug combination of prexigebersen and decitabine. The full trial design plans have approximately 98 evaluable patients for the first cohort having untreatednewly diagnosed AML patients with a preliminary review performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The full trial design plans have approximately 54 evaluable patients for each of the second cohort, having relapsed/refractory AML patients, and the third cohort, having AML patients who are venetoclax-resistant or -intolerant, in each case with a review performed after 19 evaluable patients. The study is anticipated to be conducted at up to ten clinical sites in the U.S., and Gail J. Roboz, MD, is the national coordinating Principal Investigator for the Phase 2 trial. Dr. Roboz is a professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University (the “Weill Medical College”) and the New York-Presbyterian Hospital in New York City. On August 13, 2020, we announced the enrollment and dosing of the first patient in this approved amended Stage 2 of the Phase 2 clinical trial.
The safety run-in of the triple combination of prexigebersen, decitabine and venetoclax for the Phase 2 clinical study was successfully completed. The preliminary data, presented at the 2021 ASH Annual Meeting, showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen.
On June 3, 2024, we announced additional interim data for the first two cohorts of the Phase 2 clinical trial. In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients with a median age of 75 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML evolved from myelodysplastic syndromes, chronic myelomonocytic leukemia or treatment-related AML. Fifteen patients (75%) achieved CR/CRi/CRh. One patient achieved partial remission (“PR”), three patients achieved stable disease, and one patient had toxicity attributed to decitabine and venetoclax treatment. In Cohort 2, 40 relapsed/refractory patients were enrolled; 23 evaluable patients with a median age of 63 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML. Twelve patients (55%) achieved CR/CRi/CRh, one patient achieved PR, eight patients achieved stable disease and two patients had progressive disease or treatment failure. Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue (72%), anemia (60%) and neutropenia (49%), while the most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%). The interim analysis data was selected as an oral presentation in the 2024 ASCO Annual Meeting and as a poster presentation in the 2024 EHA Annual Meeting. Based on this interim data, we expect to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively and plan to pursue FDA expedited programs for Fast Track designation. We are evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial in Europe. We plan to complete enrollment in cohorts 1 and 2 in 2026.
The safety run-in of Stage 2 of the Phase 2 clinical study was successfully completed, and the preliminary data was presented at the 2021 ASH Annual Meeting. In the safety run-in of the triple combination, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. Five patients (83%) responded to treatment, including four (67%) achieving CR and one (17%) achieving CRi. Recent publications provide that response (CR + CRi) rates to combination treatment with decitabine and venetoclax (but without prexigebersen) are 42 to 52% for relapsed/refractory AML patients and 0 to 39% for relapsed/refractory secondary AML patients. Response rates to frontline treatment with decitabine and venetoclax (but without prexigebersen) are 62 to 71% for newly diagnosed AML patients. These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle.
On August 1, 2023, we announced interim data for the first two cohorts of the amended Stage 2 of the Phase 2 clinical trial. Fourteen newly diagnosed patients were evaluable in the first cohort and treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in the first cohort (median age 75) were adverse risk by 2017 ELN guidelines (n=10) or secondary AML (n=4). Prexigebersen was well-tolerated, and AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Twelve of the 14 evaluable patients (86%) achieved CR/CRi and two (14%) achieved PR. In total, 100% of the evaluable patients had a response to treatment. The CR/CRi rates of 86% for the evaluable patients in the first cohort is significantly higher than the CR/CRi rates of 62% for newly diagnosed patients treated with the frontline combination treatment of decitabine and venetoclax. Fourteen refractory/relapsed evaluable AML patients in the second cohort were treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. Substantially all of the patients in the second cohort (median age 56.5) were adverse risk by 2017 ELN guidelines (n=11) or secondary AML (n=2). Prexigebersen was well-tolerated, and AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Eight of the 14 evaluable refractory/relapsed patients (57%) achieved CR/CRi, two (14%) achieved PR and two (22%) achieved stable disease. In total, 93% of the evaluable patients in the second cohort had a response to treatment. The CR/CRi rates of 57% for the evaluable refractory and relapsed patients in the second cohort is significantly higher than the CR/CRi) rates of 21% for refractory/relapsed patients treated with the combination treatment of decitabine and venetoclax. Based on this interim data, we currently plan to pursue FDA expedited programs for Fast Track designation, and we are evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial in Europe.
Our second drug candidate, BP1002,Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed CLL patients has been initiated. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center while two additional clinical trial sites are currently being activated for inclusion in the study,Center, The University of Texas Southwestern and New York Medical College. On January 10, 2024, we announced the successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design,design. unlessEnrollment therehas isbeen asuccessfully completed for both dose limitingcohorts, toxicity20 whichand would40 require an additional three patients to be tested.mg/m2. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment is now open for patients for the second BP1002 dose cohort of 40 mg/m2.toxicities.
On December 11, 2024, we announced that the Phase 1 clinical trial evaluating BP1002 as a treatment for refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia has discontinued enrollment. This decision was based on enrollment challenges in these niche indications, particularly given the crowded development landscape that includes multiple competing trials and to reallocate resources towards advancing our metabolic program.
Additionally, preclinical studies suggest that the combination of BP1002 with decitabine is efficacious in venetoclax-resistant leukemia and lymphoma cells. An abstract of the preclinical study was presented at the 2021 American Association for Cancer Research (“AACR”) Annual Meeting. A Phase 1/1b clinical trial to investigate the ability of BP1002 to treat refractory/relapsed AML patients, including venetoclax-resistant patients, is being studied. A recent study6study found that AML patients who had relapsed from frontline venetoclax-based treatment had a very poor prognosis, with a median survival of less than 3three months. Since venetoclax and BP1002 utilize different mechanisms of action, we believe that BP1002 may be a potential treatment for venetoclax-relapsed AML patients. The Phase 1/1b clinical trial is being 6conducted (Maitiat A,several Ruaschleading C,cancer Cortescenters JE,in et.al.the OutcomesUnited States, including the Weill Medical College, MD Anderson, Scripps Health and The University of relapsedCalifornia orat refractoryLos acuteAngeles myeloidCancer leukemiaCenter. On October 7, 2024, we announced that the FDA had completed its review of PK/PD data from the first two dosing cohorts (20 and 40 mg/m2) and that the enrollment for the third dosing cohort (60 mg/m2) is complete and we are now enrolling cohort four, which is the higher dose of 90 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after frontlinecompletion hypomethylatingof agentBP1002 monotherapy cohorts and venetoclaxwill regimens.assess Haematologicathe 2021;safety 106:and 894-898.)efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
conducted at several leading cancer centers in the United States, including the Weill Medical College, MD Anderson, Scripps Cancer Center and The University of California at Los Angeles Cancer Center.
On December 14, 2023, we announced the successful completion of the first dose cohort of the dose escalation portion of the Phase 1/1b clinical trial of BP1002. A total of three evaluable patients per dosing cohort are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Enrollment is now open for patients for the second BP1002 dose cohort of 40 mg/m2. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and is intended to assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
Our third drug candidate, BP1003,Liposomal STAT3 (“BP1003”), targets the STAT3 protein and is currently in IND enabling studies as a potential treatment of pancreatic cancer, NSCLC and AML. Preclinical modelsstudies haveshowing shownBP1003’s BP1003ability to inhibit cell viability and STAT3 protein expression in NSCLC and AMLcancer cell lines.viability Further,had BP1003 successfully penetrated pancreatic tumors ex vivo and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic cancer patient derived tumor model. An abstract of the preclinical study wasbeen presented at the 2019 AACR Annual Meeting.Meetings. OurOn September 16, 2024, we announced a publication in the peer-reviewed journal, Biomedicines, which highlights the therapeutic potential and broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models, including breast, ovarian, and pancreatic cancer. The lead indication for which we intend to develop BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. For example, pancreatic adenocarcinoma is projected to be the second most lethal cancer behind lung cancer by 2030. Typical survival for a metastatic pancreatic cancer patient is about three to six months from diagnosis. Additionally, an abstract of the preclinical study demonstrating that BP1003 enhanced the sensitivity of breast and ovarian cancer cells to chemotherapy was presented at the 2022 AACR Annual Meeting. We have successfully completed several IND enabling studies of BP1003 and have one additional IND enabling study to complete. Once the additional study is successfully completed, our goal is to file an IND application and initiate the first-in-humans Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors, including pancreatic cancer and NSCLC.
In addition, a modified product named BP1001-A, our fourth drug candidate, has shown to enhance chemotherapy efficacy in a preclinical study involving solid tumor models. Results of the preclinical study were published in the scientific journal Oncotarget in July 2020. BP1001-A incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. A BP1001-A Phase 1/1b clinical trial in patients with advanced or recurrent solid tumors has been initiated. The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including MD Anderson, Karmanos Cancer Institute, Mary Crowley Cancer Research and Holy Cross Hospital, Maryland. On July 17, 2023, we announced completion of the first cohort of the dose escalation portion of the Phase 1/1b clinical trial. A total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy over three dose levels in a standard 3+3 dose escalation design. The first dose cohort consisted of a starting dose of 60 mg/m2,m2 had been completed, and there were no dose limiting toxicities. Enrollment is now open for patients for the second dose cohort of 90 mg/m2.m2 which we expect to be complete in the second quarter of 2025 in order to advance to dose level 3. The Phase 1B1b portion of the study is expected to commence after successful completion of BP1001-A monotherapy cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in Stage 4 pancreatic cancer and combination therapy in breast cancer.
Development and Treatment for Obesity
Insulin resistance is a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Insulin lowers blood glucose level by activating the PI3K/AKT pathway. However, this insulin pathway is dysfunctional in obese patients who have Type 2 diabetes. Literature suggests that Grb2 is an inhibitor of the insulin/PI3K/AKT pathway. Upregulation of the Grb2 gene has been reported for patients with Type 2 diabetes. Knockdown of Grb2 expression enhanced insulin-induced AKT activity and glucose uptake in myoblast and hepatoma cells. Furthermore, insulin sensitivity was restored in Grb2 heterozygous knockout mice fed on high fat-induced diet. We are currently exploring the development of BP1001-A as a drug candidate to target insulin resistance. We hypothesize that by downregulating Grb2 expression, BP1001-A could potentially lower blood glucose level by enhancing insulin-mediated AKT activation and glucose uptake and storage and are pursuing studies to test such hypothesis.
On December 19, 2024, we announced the results of our initial preclinical work; BP1001-A, by downregulating Grb2 expression, increased the levels of phosphorylated AKT and phosphorylated FOXO-1 (a downstream AKT effector) in myoblast and hepatoma cells in the presence of insulin. Furthermore, high fat diet rich in saturated fatty acids can lead to insulin resistance. Palmitic acid, the most common saturated fatty acid in a high fat diet, has been shown to impair insulin signaling. On March 18, 2025, we announced preclinical results that BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models. These preliminary data confirmed that BP1001-A could affect the insulin/PI3K/AKT pathway and increase insulin sensitivity, thus validating BP1001-A as a potential candidate to target obesity in Type 2 diabetes patients. We have initiated animal studies to evaluate the efficacy of BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients. If successful, we intend to initiate a first-in-human Phase 1 clinical trial in 2025 to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials.
We are developing a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to the investigational treatment and improve the probability of success for this program as a result. The emerging role of biomarkers has been enhancing cancer development over the past decade and has become a more common companion to many cancer development programs. We expect to develop molecular biomarker packages to accompany our new programs.
We have certain intellectual property as the basis for our current drug products in clinical development, prexigebersen, BP1002, BP1003 and BP1001-A. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancercancer, obesity and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.
Research and Development Expenses. Our research and development expense was $11.6$7.3 million for the year ended December 31, 2023,2024, ana increasedecrease of $2.4$4.3 million compared to the year ended December 31, 2022.2023. The increasedecrease in research and development expense was primarily due to decreased manufacturing expenses related to drug product releases in 20232024 as well as an increase in expense relatedcompared to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023. The following table sets forth our research and development expenses (in thousands):
General and Administrative Expenses. Our general and administrative expense was $4.2$4.7 million for the year ended December 31, 2023,2024, aan decreaseincrease of $0.5 million compared to the year ended December 31, 2022.2023. The decreaseincrease in general and administrative expense was primarily due to decreasedincreased salaries and benefits expense as well as Delawareexpenses franchiserelated taxto expense.our special shareholder meeting in 2024. The following table sets forth our general and administrative expenses (in thousands):
Net Operating Loss. Our net loss from operations was $15.8$12.0 million for the year ended December 31, 2023,2024, ana increasedecrease of $1.9$3.8 million compared to the year ended December 31, 2022.2023.
Change in Fair Value of Warrant Liability. The change in fair value of the warrant liability for the year ended December 31, 20232024 resulted in non-cash expenseincome of $0.3$2.1 million.
Net Loss. Our net loss was $16.1$9.9 million for the year ended December 31, 2023,2024, ana increasedecrease of $2.2$6.2 million compared to the year ended December 31, 2022.2023.
We had a cash balance of $1.1$1.2 million at December 31, 2023,2024, aan decreaseincrease of $9.3$0.1 million compared to December 31, 2022.2023. We do not believe that our available cash at December 31, 20232024 will be sufficient to fund current liabilities and capital expenditure requirements. The Company’s ability to continue as a going concern is dependent upon obtaining funding through one or more sources as described above to meet its planned obligations and pay its liabilities.
For the Year Ended December 31, 2024
Operating Activities. Net cash used in operating activities for the year ended December 31, 2024 was $10.6 million. Excluding non-cash stock-based compensation expense of $0.6 million, change in fair value of the warrant liability of $2.1 million and depreciation and amortization expenses of $0.2 million, net cash used in operating activities consisted primarily of the net loss for the period of $9.9 million, an increase in operating assets of $0.6 million and a decrease in lease liabilities of $0.1 million. These are partially offset by an increase in accounts payable and accrued expenses of $1.4 million.
Investing Activities. There were no investing activities for the year ended December 31, 2024.
Financing Activities. Net cash provided by financing activities for the year ended December 31, 2024 consisted of $10.7 million from the March 2024 Registered Direct Offering, the April 2024 Registered Direct Offering, the At The Market Offering Agreement, the June 2024 Private Placement and the October 2024 Private Placement (each as defined below).
For the Year Ended December 31, 2022
Operating Activities. Net cash used in operating activities for the year ended December 31, 2022 was $15.1 million. Excluding non-cash stock-based compensation expense of $0.9 million and depreciation and amortization expenses of $0.2 million, net cash used in operating activities consisted primarily of the net loss for the period of $13.9 million and an increase in current assets of $2.9 million which was partially offset by an increase in accounts payable and accrued expenses of $0.7 million.
Investing Activities. Net cash used in investing activities for the year ended December 31, 2022 consisted of a capital expenditure totaling $21,000 which was related to a research and development equipment purchase.
Financing Activities. Net cash provided by financing activities for the year ended December 31, 2022 consisted of net proceeds of $1.7 million from the 2022 Registered Direct Offering and the 2022 Private Placement, each as described below.
On May 27, 2022, we filed a shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC on June 14, 2022 (File No. 333-265282) (the “2022 Shelf Registration Statement”), at which time the offering of unsold securities under a previous shelf registration statement on Form S-3 filed with the SEC, which was declared effective by the SEC on June 5, 2019 (File No. 333-231537) (the “2019 Shelf Registration Statement”), was deemed terminated pursuant to Rule 415(a)(6) under the Securities Act. The 2022 Shelf Registration Statement was filed to register the offering, issuance and sale of (i) up to $110.0 million of our common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination thereof, either individually or in units, (ii) up to $9.0 million of our common stock under the Offering Agreement (as defined below), which $9.0 million was subsequently reduced to $3.0 million pursuant to a prospectus supplement filed with the SEC on July 29, 2022, and (iii) up to 11,895 shares of our common stock pursuant to the exercise of warrants outstanding on May 27, 2022. The $3.0 million of our common stock that could previously be offered, issued and sold under the Offering Agreement was included in the $110.0 million of our securities that may be offered, issued and sold. On December 7, 2022, we received written notice from Wainwright (as defined below) that Wainwright had elected, pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7, 2022. As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of our common stock remained available for sale pursuant to the ATM Prospectus (as defined below) and the Offering Agreement. As a result of the termination of the Offering Agreement, we will not offer or sell any additional shares of our common stock under the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of our common stock included in the ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement. BecauseAs ourof publicthe floatdate ishereof, lesswe thanare $75.0not million, our abilityeligible to offer and sell any securities underutilize the 2022 Shelf Registration Statement is currently limited pursuant to Instruction I.B.6 to Form S-3. For so long as our public float is less than $75.0 million, the aggregate market value of securities we sell pursuant to Instruction I.B.6 to Form S-3 during any 12 consecutive months may not exceed one-third of our public float.Statement. The foregoing does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
2022 Registered Direct Offering and 2022 Private Placement
On November 6, 2022, we entered into a placement agency agreement with Roth Capital Partners, LLC relating to the 2022 Registered Direct Offering and the 2022 Private Placement. In addition, on November 6, 2022, we entered into securities purchase agreements with several institutional and accredited investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 40,000 shares of our common stock for gross proceeds of approximately $2.0 million under the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on November 9, 2022 (the “2022 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreements to issue to such investors warrants to purchase up to 40,000 shares of our common stock (the “2022 Private Placement”). The 2022 Registered Direct Offering and the 2022 Private Placement closed on November 9, 2022. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.7 million.
March 2024 Registered Direct Offering and March 2024 Private Placement
On March 25, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 75,000 shares of our common stock for gross proceeds of approximately $0.3 million under the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on March 27, 2024 (the “March 2024 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investor warrants to purchase up to 75,000 shares of our common stock at an exercise price of $3.865 per share (the “March 2024 Private Placement”). The March 2024 Registered Direct Offering and the March 2024 Private Placement closed on March 27, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $0.2 million.
At the Market Offering
On April 4, 2024, we entered into the At The Market Offering Agreement with Wainwright, as sales agent, pursuant to which we may offer and sell, from time to time, through Wainwright, shares of our common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method permitted by law, including in privately negotiated transactions. We or Wainwright may suspend or terminate the offering of shares upon notice to the other party and subject to other conditions. We will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of shares under the At The Market Offering Agreement and have agreed to provide Wainwright with customary indemnification and contribution rights. We have also agreed to reimburse Wainwright for certain specified expenses. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the At The Market Offering Agreement. On April 4, 2024, in connection with the execution of the At The Market Offering Agreement, we filed with the SEC a prospectus supplement (the “Initial ATM Prospectus Supplement”) to the base prospectus contained in the 2022 Shelf Registration Statement, which Initial ATM Prospectus Supplement related to the offering of up to $2.0 million of shares of the Company’s common stock under the At The Market Offering Agreement. Subsequent to entering into the Offering Agreement, we offered and sold 436,511 shares of common stock for gross proceeds of approximately $2.0 million and terminated the offering under the Initial ATM Prospectus Supplement on April 19, 2024. The net proceeds from such offering, after deducting commissions and our offering expenses, were approximately $1.8 million.
On April 19, 2024, we determined to increase the number of shares available for sale under the At The Market Offering Agreement, up to an additional aggregate offering price of approximately $1.1 million, which shares are being offered and sold pursuant to the 2022 Shelf Registration Statement and a prospectus supplement and accompanying prospectus filed with the SEC on April 19, 2024 (the “Subsequent ATM Prospectus Supplement”). As of December 31, 2024, we have offered and sold 334,929 shares of common stock under the Subsequent ATM Prospectus Supplement for gross proceeds of approximately $1.1 million and after deducting commissions and the Company’s offering expenses, the net proceeds from such offering were approximately $1.0 million.
April 2024 Registered Direct Offering and April 2024 Private Placement
On April 18, 2024, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 375,000 shares of our common stock for gross proceeds of approximately $1.2 million under the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on April 19, 2024 (the “April 2024 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors warrants to purchase up to 375,000 shares of our common stock at an exercise price of $3.10 per share (the “April 2024 Private Placement”). The April 2024 Registered Direct Offering and the April 2024 Private Placement closed on April 19, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $0.9 million.
June 2024 Private Placement
On June 3, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private placement, an aggregate of (i) 180,000 shares of our common stock, (ii) pre-funded warrants to purchase up to 1,629,955 shares of our common stock at an exercise price of $0.001 per share, (iii) series A warrants to purchase up to 1,809,955 shares of our common stock at an exercise price of $2.00 per share and (iv) series B warrants to purchase up to 1,809,955 shares of our common stock at an exercise price of $2.00 per share for gross proceeds of approximately $4.0 million (the “June 2024 Private Placement”). The June 2024 Private Placement closed on June 5, 2024. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.3 million.
October 2024 Private Placement
On October 8, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private placement, an aggregate of (i) pre-funded warrants to purchase up to 4,597,702 shares of our common stock at an exercise price of $0.001 per share, (ii) series A warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share and (iii) series B warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share for gross proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with the June 2024 Private Placement, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.5 million.
March 2025 Promissory Note
On March 6, 2025, we entered into a securities purchase agreement with 1800 Diagonal Lending LLC, a Virginia limited liability company (the “Lender”), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “Promissory Note”) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The Promissory Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, March 6, 2025. The Promissory Note shall be paid in five payments with the first payment of $90,160 due on August 30, 2025 and each subsequent payment shall be equal to $22,540 which are due on September 30, 2025, October 30, 2025, November 30, 2025 and December 30, 2025. Upon the occurrence and during any continuation of any Event of Default (as defined in the Promissory Note), the Promissory Note shall become immediately due and payable and the Company shall pay to the Lender, in full satisfaction, an amount equal to 150% times the sum of (i) the then outstanding principal amount of the Promissory Note plus (ii) accrued and unpaid interest on the unpaid principal amount of the Promissory Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Lender pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Lender may elect to convert all or any part of the outstanding principal and interest on the Promissory Note in fully paid and non-assessable shares of the Company’s Common Stock at a conversion price per share equal to 65% of the lowest closing bid price of the Common Stock for the ten trading days prior to the date of conversion (the “Conversion Right”).
What changed in the latest 10-Q
Risk Factors
The operational pause, furlough of employees or other actions we take to conserve cash and fund our operations may not achieve our intended outcome
On June 24, 2025, we implemented an operational pause in order to conserve capital while we seek potential fundraising transactions. As a result of our inability to secure meaningful funding prior to such operational pause, we also announced the furlough of most of our employees, in order to reduce expenses. These or other actions we may take may result in unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, decreased morale among our remaining employees, and the risk that we may not achieve the anticipated benefits of the operational pause. In addition, while most employees have been furloughed, certain functions necessary to our operations remain, and we may be unsuccessful in distributing the duties and obligations of furloughed employees. The operational pause could also make it difficult for us to pursue, or prevent us from pursuing, new opportunities and initiatives due to insufficient personnel, or require us to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives. If we are unable to realize the anticipated benefits from the operational pause, or if we experience significant adverse consequences from the operational pause, our business, financial condition, and results of operations may be materially adversely affected.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “January 2026 Promissory Notes”
Removed heading “Comparisons of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024”
Removed heading “2022 Shelf Registration Statement”
Removed heading “March 2024 Registered Direct Offering and March 2024 Private Placement”
Removed heading “At the Market Offering”
Removed heading “April 2024 Registered Direct Offering and April 2024 Private Placement”
Removed heading “October 2024 Private Placement”
Largest changes
“Upon the occurrence and during any continuation of any Event of Default (as defined in the Promissory Notes), the Promissory Notes shall become immediately due and payable and, with respect to each Promissory note, the Company shall pay to the Lenders, in full satisfaction of such Promissory Note, an amount equal to 150% times the sum of (i) the then outstanding principal amount of such applicable Promissory Notes plus (ii) accrued and unpaid interest on the unpaid principal amount of such applicable Promissory Notes to the date of payment plus (iii) default interest, if any, at a rate of 22% …”see in full comparison
“Upon the occurrence and during any continuation of any Event of Default (as defined in the April 2025 Promissory Note), the April 2025 Promissory Note shall become immediately due and payable and we shall pay to the Second Lender, in full satisfaction, an amount equal to 150% times the sum of (i) the then outstanding principal amount of the April 2025 Promissory Note plus (ii) accrued and unpaid interest on the unpaid principal amount of the April 2025 Promissory Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses …”see in full comparison
“Comparisons of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024”see in full comparison
“On April 4, 2024, we entered into the At The Market Offering Agreement with Wainwright, as sales agent, pursuant to which we may offer and sell, from time to time, through Wainwright, shares of our common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method permitted by law, including in privately negotiated transactions. …”see in full comparison
“March 2024 Registered Direct Offering and March 2024 Private Placement”see in full comparison
“April 2024 Registered Direct Offering and April 2024 Private Placement”see in full comparison
Full comparison: every changed paragraph (45)
When you read this Item of this Quarterly
Report on Form 10-Q, it is important that you also read the unaudited financial statements and related notes included elsewhere in this
Quarterly Report on Form 10-Q and our audited financial statements and notes thereto included in our Annual Report on Form 10-K1-K as of
the fiscal
year ended December 31, 2024.2025. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties,
uncertainties, such as statements of our plans, objectives, expectations and intentions. We use words such as “anticipate,”
“estimate,”
“plan,” “project,” “continuing,” “ongoing,” “expect,”
“believe,”
“intend,” “may,” “will,” “should,” “could,” and similar
expressions to identify
forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking
statements for
many reasons, including the matters discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on
Form 10-K1-K as of
the fiscal year ended December 31, 2024,2025, the matters discussed in “Item 1A. Risk Factors” to Part II of this
Quarterly Report
on Form 10-Q and other risks and uncertainties discussed in filings made with the SEC. See “Cautionary Note Regarding Forward-Looking
Forward-Looking Statements” in this Quarterly Report on Form 10-Q for additional discussion regarding risks associated with forward-looking
statements.
As of SeptemberMarch 30,31, 2025,2026, we
we had an accumulated deficit of $126.0 million. Our net loss was $1.0 million and $2.1 million for the three months ended SeptemberMarch 30,31, 2026
2025 and 2024,2025, respectively. Our net loss was $8.4 million and $7.1 million for the nine months ended September 30, 2025 and 2024, respectively.
We expect to continue to incur significant operating losses, and we anticipate that our losses may increase substantially
as we expand
our drug development programs and commercialization efforts. To achieve profitability, we must enter into license or development
agreements agreements
with third parties or successfully develop and obtain regulatory approval for one or more of our drug candidates and effectively
commercialize commercialize
any drug candidates we develop. In addition, if we obtain regulatory approval of one or more of our drug candidates, we
expect to incur
significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Even if we
succeed in developing
and commercializing one or more of our drug candidates, we may not be able to generate sufficient revenue and we
may never be able to
achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand, cash
from operations, debt
financings and public or private equity offerings. We may seek to access the public or private equity markets whenever
conditions are
favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms
that are favorable
to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently
have no lines
of credit or other arranged access to debt financing.
Comparisons of the Three Months Ended March 31,
September 30, 20252026 to the Three Months Ended SeptemberMarch 30,31, 20242025
Revenue. We had no revenue for each of
the three
months ended SeptemberMarch 30,31, 20252026 and 2024.2025.
Research and Development Expense.
Expense. Our research and development expense for the three months ended SeptemberMarch 30,31, 20252026 was $0.3$0.1 million, a decrease of $1.0$1.9 million
compared to
the three months ended SeptemberMarch 30,31, 2024.2025. The decrease in research and development expense was primarily due to cash flow
constraints and
related pausing our clinical trials for BP1001 and BP1001-A. TheOur followingclinical tabletrials setsare forthcurrently ouron research and development
expenses (in thousands):hold.
General and Administrative
Expense. Our general and administrative expense for the three months ended SeptemberMarch 30,31, 20252026 was $0.2$0.3 million, a decrease of $1.1$1 million
million compared to the three months ended SeptemberMarch 30,31, 2024.2025. The decrease in general and administrative expense was primarily due to
decreased salaries
and benefits expenses due to the curtailment of the Company’s activities, including the resignations and terminations
of employment
of corporate overhead.
Net Operating Loss. Our
net loss from
operations for the three months ended SeptemberMarch 30,31, 20252026 was $0.5$0.3 million, a decrease of $2.1$2.9 million compared to the three
months ended
September 30,March 2024.31, 2025.
Other Income (Expense) The
The Company recognized lossesincome of $0.3$0.1 million on the change in value of the warrant liability and derivative liabilities, compared
to gains
of $0.5$0.4 for the three months ended SeptemberMarch 30,31, 2024. The Company incurred interest expense of $0.1 compared to income of $0.0
for the three months ended September 30, 2024.2025.
Net Loss. Our net loss
loss for the three months ended SeptemberMarch 30,31, 20252026 was $1.0$0.3 million, a decrease of $1.1$2.6 million compared to the three months ended September
30,March 2024.31, 2025.
Net Loss per Share. Net
loss per share, both basic and diluted, for the three months ended SeptemberMarch 30,31, 20252026 was $0.11,$(0.03), compared to $1.70$(0.40) for the three months
ended SeptemberMarch 30,31, 2024.2025. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during
the applicable periods and excludes stock options and warrants because they are antidilutive.
Comparisons of the Nine Months Ended September
30, 2025 to the Nine Months Ended September 30, 2024
Revenue. We had no revenue for each of the
nine months ended September 30, 2025 and 2024.
Research and Development
Expense. Our research and development expense for the nine months ended September 30, 2025 was $6.3 million, an increase of $0.8
million compared to the nine months ended September 30, 2025. The increase in research and development expense was primarily due to expenses
related to pausing our clinical trials for BP1001 and BP1001-A as well as increased manufacturing expenses related to drug product releases
in 2025, prior to our cash flow restraints in the 3rd Quarter.
General and Administrative
Expense. Our general and administrative expense for the nine months ended September 30, 2025 was $2.0 million, a decrease of $1.9
million compared to the nine months ended September 30, 2024. The decrease in general and administrative expense was primarily due to
decreased salaries and benefits expense, professional and consulting fees and shareholder meeting expenses related to our special shareholder
meeting held in the first quarter of 2024, as well as the curtailment of the Company’s activities, including the resignations and
terminations of employment of corporate overhead in the 3rd Quarter.
Net Operating Loss. Our net loss from
operations for the nine months ended September 30, 2025 was $8.3 million, a decrease of $1.1 million compared to the nine months ended
September 30, 2024.
Other Income (Expense) The Company recognized
losses of $0.0 million on the change in value of the warrant liability and derivative liabilities, compared to gains of $2.2 for the nine
months ended September 30, 2024. The Company incurred interest expense of $0.1 compared to income of $0.0 for the nine months ended September
30, 2024.
Net Loss. Our net loss for the nine months
ended June 30, 2025 was $8.4 million, a decrease of $1.3 million compared to the nine months ended September 30, 2024.
Net Loss per Share. Net
loss per share, both basic and diluted, for the nine months ended September 30, 2025 was $1.06, compared to $4.05 for the nine months
ended September 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during
the applicable periods and excludes stock options and warrants because they are antidilutive.
We had a cash balance of $0.0$0.1 million as of
SeptemberMarch 30,31, 2025,2026, aan decreaseincrease of $1.2$0.1 million compared to December 31, 2024.2025. We do not believe that our available cash at SeptemberMarch 30,31, 2026
2025 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for the next 12 months from the date
date of this Quarterly Report on Form 10-Q. The Company’s ability to continue as a going concern is dependent upon obtaining funding
through one or more sources as described above to meet its planned obligations and pay its liabilities.
Operating Activities. Net
cash used in operating activities for the ninethree months ended SeptemberMarch 30,31, 20252026 was $1.6$0.1 million. Excluding non-cash expenses of $0.4$0.1 million,
net cash used in operating activities for the nine months ended September 30, 2025 consisted primarily of the net loss for the period
of $8.4$0.3 million, an increase in accounts payable and accrued expenses of $4.6$0.3 million, and a decrease in other current assets of $1.3 million$0.2
and a decrease in prepaid drug product of $0.6 million.
Net cash used in operating activities for the three months ended March 31, 2025 was $1.3 million. Excluding non-cash change in fair value of the warrant liability of $0.4 million and stock-based compensation expense of $0.1 million,. net cash used in operating activities for the three months ended March 31, 2025 consisted primarily of the net loss for the period of $2.9 million, an increase in accounts payable and accrued expenses of $1.2 million and a decrease in prepaid drug product of $0.6 million. Net cash used in operating activities for the three months ended March 31, 2024 was $1.0 million. Excluding non-cash change in fair value of the warrant liability of $0.5 million and stock-based compensation expense of $0.2 million, net cash used in operating activities for the three months ended March 31, 2024 consisted primarily of the net loss for the period of $3.2 million and a decrease of $0.5 million in other current assets. These are partially offset by an increase of $1.9 million in operating liabilities.
Net cash used in operating
activities for the nine months ended September 30, 2024 was $7.7 million. Excluding non-cash gains of $1.7 million, net cash used in
operating activities for the nine months ended June 30, 2024 consisted primarily of the net loss for the period of $7.1 million and an
increase in other current assets of $0.5 million. These are partially offset by an increase in accounts payable and accrued expenses
of $1.6 million and a decrease in prepaid drug product of $0.1 million.
Financing Activities. Net
cash provided by financing activities for the ninethree months ended SeptemberMarch 30,31, 20252026 was $0.4$0.1 million from theproceeds Warrant Exercises (as defined
below), the March 2025of Promissory Notes and the April Promissory Note.Notes.
Net cash provided by financing activities for the three months ended March 31, 2025 was $0.3 million from the Warrant Exercises and the March 2025 Promissory Notes (each as defined below). Net cash provided by financing activities for the three months ended March 31, 2024 was $0.2 million from the March 2024 Registered Direct Offering .
Net cash provided by financing
activities for the nine months ended September 30, 2024 was $7.2 million from the March 2024 Registered Direct Offering, the April 2024
Registered Direct Offering, the Offering Agreement (as defined below) and the June 2024 PIPE.
2022 Shelf Registration Statement
On May 27, 2022, we filed
a shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC on June 14, 2022 (File No. 333-265282)
(the “2022 Shelf Registration Statement”), at which time the offering of unsold securities under a previous shelf registration
statement on Form S-3 filed with the SEC, which was declared effective by the SEC on June 5, 2019 (File No. 333-231537) (the “2019
Shelf Registration Statement”), was deemed terminated pursuant to Rule 415(a)(6) under the Securities Act. The 2022 Shelf Registration
Statement was filed to register the offering, issuance and sale of (i) up to $110.0 million of our common stock, preferred stock, warrants
to purchase common stock or preferred stock or any combination thereof, either individually or in units, (ii) up to $9.0 million of our
common stock under our At The Market Offering Agreement (the “Offering Agreement”), dated as of July 13, 2020, with H. C.
Wainwright & Co., LLC (“Wainwright”), pursuant to which we could offer and sell, from time to time, through or to Wainwright,
shares of our common stock, which $9.0 million was subsequently reduced to $3.0 million pursuant to a prospectus supplement filed with
the SEC on July 29, 2022, and (iii) up to 11,895 shares of our common stock pursuant to the exercise of warrants outstanding on May 27,
2022. The $3.0 million of our common stock that could previously be offered, issued and sold under the Offering Agreement was included
in the $110.0 million of our securities that may be offered, issued and sold. On December 7, 2022, we received written notice from Wainwright
that Wainwright had elected, pursuant to Section 8(b) of the Offering Agreement to terminate the Offering Agreement effective as of December
7, 2022. As of the date hereof, we are not eligible to utilize the 2022 Shelf Registration Statement. The foregoing does not constitute
an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction
in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
March 2024 Registered Direct Offering
and March 2024 Private Placement
On March 25, 2024, we
entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell,
in a registered direct offering, an aggregate of 75,000 shares of our common stock for gross proceeds of approximately $0.3 million under
the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on March
27, 2024 (the “March 2024 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the
securities purchase agreement to issue to such investor warrants to purchase up to 75,000 shares of our common stock at an exercise price
of $3.865 per share (the “March 2024 Private Placement”). The March 2024 Registered Direct Offering and the March 2024 Private
Placement closed on March 27, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses
and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately
$0.2 million.
At the Market Offering
On April 4, 2024, we entered into
the At The Market Offering Agreement with Wainwright, as sales agent, pursuant to which we may offer and sell, from time to time, through
Wainwright, shares of our common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to
be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method
permitted by law, including in privately negotiated transactions. We or Wainwright may suspend or terminate the offering of shares upon
notice to the other party and subject to other conditions. We will pay Wainwright a commission of 3.0% of the aggregate gross proceeds
from each sale of shares under the At The Market Offering Agreement and have agreed to provide Wainwright with customary indemnification
and contribution rights. We have also agreed to reimburse Wainwright for certain specified expenses. We are subject to certain restrictions
on our ability to offer and sell shares of our common stock under the At The Market Offering Agreement. On April 4, 2024, in connection
with the execution of the At The Market Offering Agreement, we filed with the SEC a prospectus supplement (the “Initial ATM Prospectus
Supplement”) to the base prospectus contained in the 2022 Shelf Registration Statement, which Initial ATM Prospectus Supplement
related to the offering of up to $2.0 million of shares of the Company’s common stock
under the At The Market Offering Agreement. Subsequent to entering into the Offering Agreement, we offered and sold 436,511
shares of common stock for gross proceeds of approximately $2.0 million and terminated the offering under the Initial ATM Prospectus Supplement
on April 19, 2024. The net proceeds from such offering, after deducting commissions and our offering expenses, were approximately $1.8
million.
On April 19, 2024, we determined
to increase the number of shares available for sale under the At The Market Offering Agreement, up to an additional aggregate offering
price of approximately $1.1 million, which shares are being offered and sold pursuant to the 2022 Shelf Registration Statement and a prospectus
supplement and accompanying prospectus filed with the SEC on April 19, 2024 (the “Subsequent ATM Prospectus Supplement”).
As of June 30, 2025, we have offered and sold 334,929 shares of common stock under the Subsequent ATM Prospectus Supplement for gross
proceeds of approximately $1.1 million and after deducting commissions and the Company’s offering expenses, the net proceeds from
such offering were approximately $1.0 million.
April 2024 Registered Direct Offering
and April 2024 Private Placement
On April 18, 2024, we entered
into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to sell, in a registered
direct offering, an aggregate of 375,000 shares of our common stock for gross proceeds of approximately $1.2 million under the base prospectus
contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on April 19, 2024 (the “April
2024 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement
to issue to such investors warrants to purchase up to 375,000 shares of our common stock at an exercise price of $3.10 per share (the
“April 2024 Private Placement”). The April 2024 Registered Direct Offering and the April 2024 Private Placement closed on
April 19, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses,
and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $0.9 million.
June 2024 PIPE
On June 3, 2024, we entered
into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private
placement, an aggregate of (i) 180,000 shares of our common stock, (ii) pre-funded warrants to purchase up to 1,629,955 shares of our
common stock at an exercise price of $0.001 per share, (iii) series A warrants to purchase up to 1,809,955 shares of our common stock
at an exercise price of $2.00 per share and (iv) series B warrants to purchase up to 1,809,955 shares of our common stock at an exercise
price of $2.00 per share for gross proceeds of approximately $4.0 million (the “June 2024 PIPE”). The June 2024 PIPE closed
on June 5, 2024. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses,
and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.3 million.
October 2024 Private Placement
On October 8, 2024, we entered
into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private
placement, an aggregate of (i) pre-funded warrants to purchase up to 4,597,702 shares of our common stock at an exercise price of $0.001
per share, (ii) series A warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share and
(iii) series B warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share for gross
proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on
October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor
agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and
series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with
the June 2024 PIPE, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s
fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering,
were approximately $3.5 million.
Upon the occurrence and
during any continuation of any Event of Default (as defined in the April 2025 Promissory Note), the April 2025 Promissory Note shall become
immediately due and payable and we shall pay to the Second Lender, in full satisfaction, an amount equal to 150% times the sum of (i)
the then outstanding principal amount of the April 2025 Promissory Note plus (ii) accrued and unpaid interest on the unpaid principal
amount of the April 2025 Promissory Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the
amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Second Lender pursuant to the Conversion Right (as defined
below). In addition, only upon an Event of Default and during any continuation thereof, the Second Lender may elect to convert all or
any part of the outstanding principal and interest on the April 2025 Promissory Note in fully paid and non-assessable shares of the Company’s
common stock at a conversion price per share equal to 65% of the lowest closing bid price of the common stock for the ten trading days
prior to the date of conversion (the “Conversion Right”). The Second Lender, together with its affiliates, may not convert
any portion of the April 2025 Promissory Note to the extent that the Second Lender would own more than 4.99% of the Company’s outstanding
common stock immediately after the conversion.
As of SeptemberMarch 30,31, 2025,2026, the
the March 2025 Promissory Notes and April 2025 Promissory Note were in default and became convertible under the default provisions.
January 2026 Promissory Notes
On December 29. 2025, the Company entered into a securities purchase agreement with Vanquish Funding Group, Inc. (the “Third Lender” and together with the First Lender and Second Lender, the “Lenders”),, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,500, which was funded on January 8, 2026 for a purchase price of $32,000 after deducting the original issue discount of $6,400. The Third Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, January 8, 2026. The Third Promissory Note shall be paid in four payments with the first payment of $22,080 due on June 30, 2026 and subsequent payments of $7,360 due on July 30, 2026, August 30, 2026, and September 30, 2026.
On January 2, 2026, the Company entered into a securities purchase agreement with the Second Lender. (together with the First Lender, Second Lender and Third Lender, the “Lenders”),, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,500 (together with the December 29, 2025 promissory note, the “January 2026 Promissory Notes, and together with the March 2025 Promissory Notes and the April 2025 Promissory Notes, the “Promissory Notes”)), which was funded on January 8, 2026 for a purchase price of $32,000 after deducting the original issue discount of $6,400. The Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, January 8, 2026. The Promissory Note shall be paid in four payments with the first payment of $22,080 due on July 2, 2026 and subsequent payments of $7,360 due on August 2, 2026, September 2, 2026, and October 2, 2026.
Upon the occurrence and during any continuation of any Event of Default (as defined in the Promissory Notes), the Promissory Notes shall become immediately due and payable and, with respect to each Promissory note, the Company shall pay to the Lenders, in full satisfaction of such Promissory Note, an amount equal to 150% times the sum of (i) the then outstanding principal amount of such applicable Promissory Notes plus (ii) accrued and unpaid interest on the unpaid principal amount of such applicable Promissory Notes to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Lenders, as applicable, pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Lenders may elect to convert all or any part of the outstanding principal and interest on the Promissory Notes, as applicable, in fully paid and non-assessable shares of the Company’s common stock at a conversion price per share equal to 65% of the lowest closing bid price of the Company’s common stock for the ten trading days prior to the date of conversion (the “Conversion Right”). The Lenders, together with their affiliates, may not convert any portion of such Promissory Notes to the extent that the Lenders would own more than 4.99% of the Company’s outstanding common stock immediately after the conversion
As of SeptemberMarch 30,31, 2025,2026, we did not have any material
material off-balance sheet arrangements.
BPTH 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.
No Form 4 stock transactions in this period.
Well-known investors holding BPTH (13F)
None of the 59 investors we track reported a position in their latest 13F.