BBLG 10-K & 10-Q changes, risk factors and insider trading

Our recurring operating losses raise substantial doubt about our ability to continue as a going concern. During the year ended December 31, 31, 2024,2025, we incurred a net loss of $4.1$3.1 million and used net cash in operating activities of $4.1$2.7 million. Our available cash is expected expected to fund our operations up tointo the fourth quarter of 2025.2026. In addition, our independent registered public accounting firm, in its audit report to the financial statements as of and for the year ended December 31, 2024,2025, expressed substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments that might result if we are unable to continue as a going concern and, therefore, be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portion of their investment. In order to have sufficient cash and cash equivalents to fund our operations in the future, we will need to raise additional equity or debt capital and cannot provide any assurance that we will be successful in doing so. The perception of our ability to continue as a going concern may make it more difficult for us to obtain financing for the continuation of our operations and could result in the loss of confidence by investors, suppliers and employees.

We may find it difficult to enroll patientssubjects in our clinical trials which could delay or prevent the start of clinical trials for our product candidate.

Identifying and qualifying patientssubjects to participate in clinical trials of our product candidate is essential to our success. The timing of our clinical trials depends in part on the rate at which we can recruit patientssubjects to participate in clinical trials of our product candidate, and we may experience delays in our clinical trials if we encounter difficulties in enrollment. If we experience delays in our clinical trials, the timeline for obtaining regulatory approval of our product candidate will most likely be delayed.

Many factors may affect our ability to identify, enroll and maintain qualified patients,subjects, including the following:

We may not be able to initiate or continue to support clinical trials of our product candidates, for one or more applications, or any future product candidates if we are unable to locate and enroll a sufficient number of eligible participants in these trials as required by the FDA or other regulatory authorities. Even if we are able to enroll a sufficient number of patientssubjects in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidate may increase and the completion of our trials may be delayed or our trials could become too expensive to complete.

Success in preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the efficacyeffectiveness and safety of a device. A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier preclinical studies or clinical trials.

Despite the results reported in earlier preclinical studies for our lead product candidate, we do not know whether the clinical trials we may conduct will demonstrate adequate efficacyeffectiveness and safety to result in regulatory approval to market our product candidate for a particular indication, in any particular jurisdiction. EfficacyEffectiveness data from prospectively designed trials may differ significantly from those obtained from retrospective subgroup analyses. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for our product candidate may be adversely impacted. Even if we believe that we have adequate data to support an application for regulatory approval to market our current product candidate or any future product candidates, the FDA or other regulatory authorities may not agree and may require that we conduct additional clinical trials.

To date, long-term safety and efficacyeffectiveness have not yet been demonstrated in clinical trials for any of our diagnostic product candidates. Favorable results in early studies or trials, if any, may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned, it cannot be certain that the results will support our product candidate claims. Success in preclinical testing and pilot clinical trials does not ensure that later pilot or pivotal clinical trials will be successful. We cannot be sure that the results of later clinical trials would replicate the results of prior clinical trials and preclinical testing. In particular, the limited results we have obtained for our tests may not predict results from studies in larger numbers of subjects drawn from more diverse populations over a longer period of time. Clinical trials may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. Any such failure could cause us to abandon a product candidate and might delay development of other product candidates. Preclinical and clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our clinical trials would delay us in obtaining FDA approval for the affected product candidate and, ultimately, our ability to commercialize that product candidate.

TheWe patent positions of medical device companies are uncertain and involve complex legal and factual questions. We may incur significant expenses in protecting our intellectual property and defending or assessing claims with respect to intellectual property owned by others. Any patent or other infringement litigation by or against us could cause us to incur significant expenses and divert the attention of our management.

We cannot be certain that all patents applied for will be issued. If a third party has also filed a patent application relating to an invention claimed by us or one or more of our licensors, we may be required to participate in an interference or derivation proceeding declared or instituted by the United States Patent and Trademark Office (the “USPTO”),USPTO, which could result in substantial uncertainties and cost for us, even if the eventual outcome is favorable to us. The degree of future patent protection for our product candidates and technology is uncertain. For example:

We face competition from numerous medical device, pharmaceutical and biotechnology enterprises, as well as from academic institutions, government agencies and private and public research institutions for our current product candidate or future product candidates. Our commercial opportunities will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we may develop. Competition could result in reduced sales and pricing pressure on our current product candidate or future product candidates, if approved, which in turn would reduce our ability to generate meaningful revenues and have a negative impact on our results of operations. In addition, significant delays in the development of our product candidates could allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidates. The biotechnology industry is intensely competitive and involves a high degree of risk. We compete with other companies that have far greater experience and financial, research and technical resources than us. Potential competitors in the U.S. and worldwide are numerous and include medical device, pharmaceutical and biotechnology companies, educational institutions and research foundations, many of which have substantially greater capital resources, marketing experience, research and development staffs and facilities than ours. Some of our competitors may develop and commercialize products that compete directly with those incorporating our technology or may introduce products to market earlier than our product candidates or on a more cost-effective basis. Our competitors compete with us in recruiting and retaining qualified scientific and management personnel as well as in acquiring technologies complementary to our technology. We may face competition with respect to product efficacyeffectiveness and safety, ease of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory approvals, availability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions of others. An inability to successfully complete our product development or commercializing our product candidates could result in our having limited prospects for establishing market share or generating revenue.

The ultimate impact of a public health crisis on our business operations will depend on, among other things, the severity and length of the health crisis, the duration, effectiveness and extent of the mitigation measures and actions designed to contain the outbreak, the emergence, contagiousness and threat of new and different strains of the disease, the availability and efficacyeffectiveness of vaccines and effective treatments, public acceptance of vaccines and treatments for the disease, if any, as well as the resulting economic conditions and how quickly and to what extent normal economic and operating conditions resume, all of which are highly uncertain. Such extraordinary events and their aftermaths can cause investor fear and panic, which could further materially and adversely affect our operations, the economies in which we operate, and the financial markets generally in ways that cannot necessarily be predicted and which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from a public health crisis could materially and adversely affect our business and the value of our common stock.

Future sales and issuances of our common stock or equity-linked securities could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.

Nasdaq requires that the trading price of listed stock remain above $1.00 in order for the stock to remain listed. If a listed stock trades below $1.00 for more than 30 consecutive trading days, then it is subject to delisting from the Nasdaq. In addition, to maintain a listing listing on Nasdaq, we must satisfy minimum financial and other continued listing standards, including those regarding minimum stockholders’ stockholders’ equity, minimum publicly available shares, director independence and independent committee requirements and other corporate governance requirements. We recently regained compliance with Nasdaq’s listing standards, and Nasdaq will continue to monitor our compliance with its requirements. Nasdaq also recently proposed a rule that, if approved, would require companies to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million. If we are unable to satisfy these standards, or if Nasdaq’s proposed rule is approved and we fail to maintain a MVLS of at least $5 million for 30 consecutive trading days, we could be subject to delisting, which would have a negative effect on the price of our common stock, impair your ability to sell or purchase our common stock or warrants when you wish to do so, and potentially cause you to lose the value of your investment in us. In the event of a delisting, we would expect to take actions to restore our compliance with the listing standards, but we can provide no assurance that any action we take to restore our compliance would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the minimum bid price requirement, or prevent future noncompliance with the listing requirements.

If thewe Company isare delisted from Nasdaq, itsour common stock may be eligible for trading on an over-the-counter market. If thewe Company isare not able to obtain a listing on another stock exchange or quotation service for itsour common stock, it may be extremely difficult or impossible for stockholders to sell their shares of common stock. Moreover, if thewe Company isare delisted from Nasdaq, but obtainsobtain a substitute listing for itsour common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result of these factors, if the Company’sour common stock is delisted from Nasdaq, the value and liquidity of the Company’sour common stock would likely be significantly adversely affected. A delisting of the Company’sour common stock from Nasdaq could also adversely affect the Company’sour ability to obtain financing for itsour operations and/or result in a loss of confidence by investors, employees and/or business partners.

Our Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and our Amended and Restated Bylaws,Bylaws (“Bylaws”), and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

During 2024, we announced the treatment of the first patientssubjects in the multicenter, prospective, randomized pilot clinical study of our NB1 bone bone graft device. NB1 is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.

The pilot clinical study will evaluate the safety and effectiveness, fusion success, pain, function improvement and adverse events of NB1 NB1 in up to 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD). To be enrolled in the study, patientssubjects must have DDD at one level from L2-S1 and may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. The study is being conducted in Australia. The study design was previously reviewed and agreed upon by the FDA’s Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.

On In September 27, 2024, wethe Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”). withUnder the respectATM to an “atAgreement, the market” offering program, under which weCompany may, from time to time, in ourits sole discretion, issue and sell through Wainwright, acting as agent or principal,Wainwright up to approximately$1,143,121 $1,143,121of shares of shares of ourits common stockstock. In December 2024, the Company filed a prospectus supplement and increased the aggregate offering that can be sold under the ATM Agreement by $535,000 (the “ATM Facility”).

Subsequent toDuring the year ended December 31, 2024,2025, wethe Company sold 317,06052,843 shares of common stock through the ATM Facility for net proceeds of $347,549, after deducting $13,029 in offering costs.

OurResearch research and development expenses decreased from $6,907,824$2,130,385 during the year ended December 31, 2023,2024 to $2,130,385$1,060,191 during the year ended December 31, 2024.2025, Aa decrease of $4,777,439.$1,070,194. This decreasereduction canresulted be attributed to the significant expenses incurred in the yearfrom ended December 31, 2023 to produce the NELL-1lower protein necessaryneeds forduring our initialpilot clinical study. MovingWe forward,expect weongoing anticipate continued substantialsignificant investment in NELL-1 development activities for NELL-1 as we prepare for our pivotal clinical study in the future.study.

In October 2022, we completed a public equity offering, which included the issuance of 54,1749,029 warrants.warrants to purchase shares of common stock that expire in October 2027. The warrants provide for a Black Black Scholes value calculation in the event of certain transactions (“Fundamental Transactions,” as defined), which includes a floor on volatility utilized in the value calculation at 100% or greater. We have determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815, we have classified the fair value of the warrants as a liability to be re-measured at the end of every reporting period with the change in value reported in the statement of operations.

We have no significant operating history and since inception to December 31, 20242025 have incurred accumulated losses of approximately $85.0$88.1 million. We will continue to incur significant expenses for development activities for our lead product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $4.7$4.9 million. The accompanying consolidated financial statements for the year ended December 31, 20242025 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $4.1$3.1 million, and used net cash in operating activities of $4.1$2.7 million during the year ended December 31, 2024.2025. These factors raise substantial doubt about our ability to continue as a going concern within a reasonable period of time, which is considered to be one year after the date that the financial statements are issued. In addition, our independent registered public accounting firm, in their report on the Company’s audited financial statements for the year ended December 31, 2024, audited financial statements,2025, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

Subsequent toDuring the year ended December 31, 2024,2025, the Companywe sold 317,06052,843 shares of common stock through the ATM Facility for net proceeds of $347,549, after deducting $13,029 in offering costs.

During the year ended December 31, 20242025 and 2023,2024, cash used in operating activities was $4,124,935$2,691,150 and $9,555,904$4,124,935 respectively. Cash expenditures for the year ended December 31, 20242025 decreased primarily due to production in 2023 of our NELL-1reduced proteinresearch asand wedevelopment prepared for our pilot clinical study.activities.

During the year ended December 31, 2025, cash provided by financing activities of $4,700,341 resulted from the net proceeds of our June 2025 public offering of common stock units and proceeds from the ATM Facility. During the year ended December 31, 2024, cash provided by financing activities of $4,423,497 resulted from the net proceeds of our March 2024 public offering of common stock units, units,warrant inducement offering in August Warrant Inducement2024 and proceeds from the ATM Facility. During the year ended December 31, 2023, cash provided by financing activities of $5,044,161 resulted from the net proceeds of our July and November 2023 public offerings of common stock units.

The preparation of the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the valuation of stock options and warrants and income tax valuation allowances. Actual results could differ from those estimates.

In September 2024, we entered into the ATM Agreement with Wainwright. Under the ATM Agreement, we may, from time to time, in our sole discretion, issue and sell through Wainwright up to $1,143,121 of shares of its common stock. In December 2024, we filed a prospectus supplement and increased the aggregate offering that can be sold under the ATM Agreement by $535,000. In March 2026, we filed an additional prospectus supplement and increased the aggregate offering that can be sold under the ATM Facility to $1,064,000.

During the three months ended MarchJune 31,30, 2025,2026, wethe Company sold 52,84315,120 shares of common stock through the ATM Facility for net proceeds of $347,549,$20,180, after after deducting $13,029$2,090 in offering costs. We did not sell any shares of common stock through the ATM Facility during the three months ended March 31, 2026.

Three months ended MarchJune 31,30, 2026 compared to the Three months ended MarchJune 31,30, 2025

Our research and development expenditures decreasedincreased from $423,576$191,608 for the three months ended MarchJune 31,30, 2025, to $141,597$308,747 for the same period in 2026, marking aan decreaseincrease of $281,979.$117,139. The decreaseincrease in costs can be attributed to timingour development activities to extend the shelf-life of our clinical trial.protein. We anticipate continued substantial investment in development activities for NELL-1 as we prepare for our pivotal clinical study in the future.

Our general and administrative expenses increaseddecreased by $48,547, rising$57,108, from $614,910$556,467 for the three months ended MarchJune 31,30, 2025, to $663,457 $499,359 for the same period in 2026.

The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at MarchJune 31,30, 2026.

We have no significant operating history and since inception to MarchJune 31,30, 2026 have incurred accumulated losses of approximately $88.9$89.7 million. We will continue to incur significant expenses for development activities for our lead product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $5.4$6.2 million. The accompanying consolidated financial statements for the threesix months ended MarchJune 31,30, 2026 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $0.8$1.5 million and used net cash in operating activities of $0.8$1.3 million during the threesix months ended MarchJune 31,30, 2026. These factors raise substantial doubt about our ability to continue as a going concern within a reasonable period of time, which is considered to be one year after the date that the financial statements are issued. In addition, our independent registered public accounting firm, in their report on the Company’s audited financial statements for the year ended December 31, 2025, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

WeAvailable expectcash ourincluding availablethe cashJuly 2026 Private Placement is expected to fund ourthe Company’s operations into the fourthsecond quarter of 2026.2027.

For the threesix months ended MarchJune 31,30, 2026 and 2025, cash used in operating activities totaled $804,282$1,322,722 and $926,125,$1,385,004, respectively. The reduction in cash expenditures for the period ended March 31, 2026 is primarily due to decreased research and development costs.

During the threesix months ended MarchJune 31,30, 2026, cash provided by financing activities was $-0-$20,180 from the net proceeds of the ATM Facility compared to $347,549$4,700,341 during the threesix months ended March 31,June 30, 2025. During the threesix months ended MarchJune 31,30, 2025, cash provided by financing activities was from the net proceeds of our the ATM Facility.Facility, the net proceeds of a public offering completed in June 2025 and the exercise of pre-funded warrants.