Bone Biologics Corp
For the period ended Dec 31, 2024. Filed Feb 26, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 26, 2025
BBLG$0.33+3.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-02-21.
0001493152-24-007432
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-02-26.
0001493152-25-008383
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 46 previous paragraphs and 61 current paragraphs.
26 unchanged; 12 reworded; 23 added; 8 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (23)
Current report
During 2024, we announced the treatment of the first patients in the multicenter, prospective, randomized pilot clinical study of our NB1 bone graft device. NB1 is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.
Current report
The pilot clinical study will evaluate the safety and effectiveness, fusion success, pain, function improvement and adverse events of 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, patients 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.
Current report
Appointment of Director
Current report
On October 16, 2024, the Company’s Board of Directors appointed Phillip Meikle to the Board of Directors. Mr. Meikle’s appointment followed Don Hankey’s resignation from the Board of Directors on October 1, 2024. Mr. Meikle received an initial option grant to purchase 9 shares of common stock under the Company’s 2015 Equity Incentive Plan at an exercise price of $1.88 per share. The initial director option grant vests and becomes exercisable on the date of the next annual meeting of the stockholders following the grant date. Mr. Meikle also received an annual director option grant to purchase 28,185 shares of common stock under the 2015 Equity Incentive Plan at an exercise price of $1.88 per share. The annual director option grant vests and becomes exercisable in four equal installments on December 17, 2024, March 19, 2025, June 19, 2025 and September 17, 2025.
Current report
ATM Offering
Current report
On September 27, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) with respect to an “at the market” offering program, under which we may, from time to time, in our sole discretion, issue and sell through Wainwright, acting as agent or principal, up to approximately$1,143,121 of shares of our common stock (the “ATM Facility”).
Current report
On December 13, 2024, we filed a prospectus supplement increasing the aggregate offering price that can be sold under the ATM Agreement by $535,176.
Current report
During the year ended December 31, 2024, we sold 857,242 shares of common stock through the ATM Facility for net proceeds of $1,112,202, after accounting for $205,256 in offering costs.
Current report
Subsequent to December 31, 2024, we sold 317,060 shares of common stock through the ATM Facility for net proceeds of $347,549, after deducting $13,029 in offering costs.
Current report
Our general and administrative expenses decreased from $2,520,479 during the year ended December 31, 2023, to $2,088,776 during the year ended December 31, 2024. A decrease of $431,703. This decrease can mainly be attributed to legal expenses stemming from litigation matters in the year ended December 31, 2023.
Current report
March 2024 Offering
Current report
On March 6, 2024, the Company sold 119,000 shares of common stock together with warrants to purchase 119,000 shares of common stock (exercise price of $2.43 per share), expiring on March 6, 2029, at a combined public offering price of $2.56. In addition, the Company sold pre-funded warrants to purchase 662,251 shares of common stock together with warrants to purchase 662,251 shares of common stock, for a combined price of $2.559. The net proceeds received from the sale of common stock, pre-funded warrants and warrants, net of cash costs of $495,227, was $1,504,113.
Current report
The 781,251 warrants have an exercise price of $2.43 per share, and were exercisable immediately for a term of five years. The 662,251 pre-funded warrants have an exercise price of $0.001 per share and were exercisable immediately until fully exercised.
Current report
During the three months ended March 31, 2024, 363,251 pre-funded warrants were exercised and 363,251 shares of common stock were issued. During the three months ended June 30, 2024, the balance of 299,000 pre-funded warrants were exercised and 299,000 shares of common stock were issued.
Current report
In addition, warrants to purchase 46,875 shares of common stock were issued to Wainwright, in connection with the March 2024 offering. The warrants issued to Wainwright have an exercise price of $3.20 per share and were exercisable immediately upon issuance and for a term of five years.
Current report
August 2024 Warrant Inducement
Current report
On August 2, 2024, existing warrants to purchase 781,251 shares of common stock issued in March 2024, were exercised for cash at the exercise price of $2.43 per share, for gross proceeds of $1,898,440. As an inducement for the warrant holders to exercise the existing warrants for cash, new warrants to purchase 1,562,502 shares of common stock (the “Inducement Warrants”) were issued to the warrant holders for gross proceeds of $195,313. The proceeds received from the exercise of the 781,251 existing warrants, and the issuance of the Inducement Warrants, net of cash costs of $287,233, was $1,806,520.
Current report
The Inducement Warrants have an exercise price of $2.00 per share and were immediately exercisable upon issuance. 781,251 of the Inducement Warrants expire on February 2, 2026, and 781,251 of the Inducement Warrants expire on August 2, 2029.
Current report
In addition, warrants to purchase 46,875 shares of common stock were issued to Wainwright, in connection with the August 2024 warrant inducement. The warrants issued to Wainwright have an exercise price of $3.35 per share and were exercisable immediately upon issuance and for a term of five years.
Current report
September 2024 ATM Offering
Current report
On September 27, 2024, the Company entered into the ATM Agreement with Wainwright with respect to the ATM Facility.
Current report
On December 13, 2024, the Company filed a prospectus supplement increasing the aggregate offering price that can be sold under the ATM Agreement by $535,176.
Current report
During the year ended December 31, 2024, the Company sold 857,242 shares of common stock through the ATM Facility for net proceeds of $1,112,202, after accounting for $205,256 in offering costs.
Removed paragraphs (8)
Previous report
Nasdaq Panel Decision
Previous report
On September 27, 2023, the Company received a written notice from the Nasdaq notifying the Company that it was not in compliance with the $1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and that Nasdaq’s staff had determined to delist the Company’s securities On December 11, 2023, a Nasdaq Hearings Panel granted the Company’s request for continued listing on Nasdaq subject to the Company demonstrating compliance with the minimum bid price requirement prior to January 12, 2024. The Company received notice from Nasdaq on January 9, 2024 that it had regained compliance with the minimum bid price requirement. The Company will remain under a Nasdaq discretionary panel monitor until June 28, 2024.
Previous report
Our general and administrative expenses increased from $2,085,875 during the year ended December 31, 2022 to $2,520,479 during the year ended December 31, 2023. The $434,604 increase was primarily due to consultants for our annual proxy and special meeting and to assist with our NASDAQ notice. We incurred stock based compensation expense for our directors and management team totaling $152,599. The management team incentive bonus accruals were based on performance targets established for each fiscal year.
Previous report
Finance cost related to public offering
Previous report
Finance cost related to public offering of $731,714 represents the excess of the fair value of the derivative warrant instruments issued in our October 2022 offering over the net proceeds from the offering.
Previous report
On June 14, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with EF Hutton, division of Benchmark Investments, LLC (“EF Hutton”) acting as representatives of the several underwriters in connection with a public offering (the “June Offering”) of an aggregate of 317,259 shares of its common stock. The public offering price was $15.76 per share and the underwriters agreed to purchase 317,259 shares at a 7% discount to the public offering price. The Company granted EF Hutton a 45-day option to purchase up to 47,589 additional shares, to cover over-allotments, if any, which was not exercised. The Offering closed on June 16, 2023, resulting in gross proceeds of $5 million, before deducting underwriting discounts and commissions and other offering expenses. The net proceeds in relation to the June Offering were $4,452,163.
Previous report
On November 20, 2023 we sold and issued, in the Registered Direct Offering, 142,384 shares of common stock, at an offering price of $5.12 per share to the Purchasers pursuant to the Purchase Agreement. Pursuant to the Purchase Agreement, in a concurrent private placement, we issued to the Purchasers the November Warrants to purchase up to an aggregate of 142,384 shares of common stock, which represent 100% of the shares of common stock issued and sold in the Registered Direct Offering. The November Warrants are exercisable at an exercise price of $4.16 per share, were exercisable immediately upon issuance, and will expire five and one-half years from the date of issuance. In addition, we issued the placement agent as compensation in connection with the November Offering, the November Placement Agent Warrants to purchase up to an aggregate of 8,543 shares of common stock (equal to 6.0% of the aggregate number of shares sold in the Registered Direct Offering). The November Placement Agent Warrants have substantially the same terms and conditions as the November Warrants, except that the November Placement Agent Warrants have a term of five years from the commencement of sales in the November Offering and an exercise price of $6.40 per share. The net proceeds of the November Offering were $591,998.
Previous report
We anticipate that we will require approximately $5 million to complete first-in-man studies, and an estimated additional $24 million in scientific expenses to achieve FDA approval, if possible, for a spine interbody fusion indication.
Reworded paragraphs (12)
Previous wording
We were founded by University of California professors in collaboration with an Osaka University professor and a University of Southern California surgeon in 2004 as a privately-held company with proprietary, patented technology that has been validated in sheep and non-human primate models to facilitate bone growth. We believe our platform technology has application in delivering improved outcomes in the surgical specialties of spinal, orthopedic, general orthopedic, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Lead product development and clinical studies are targeted on spinal fusion surgery, one of the larger segments in the orthopedic market.
Current wording
We were founded by University of California professors in collaboration with an Osaka University professor and a University of Southern California surgeon in 2004 as a privately-held company with proprietary, patented platform technology. Our platform technology has been validated in sheep and non-human primate models to facilitate bone growth. We believe our platform technology has application in delivering improved outcomes in the surgical specialties of spinal, orthopedic, general orthopedic, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Lead product development and clinical studies are targeted on spinal fusion surgery, one of the larger segments in the orthopedic market.
Previous wording
We are a development stage entity. The production and marketing of our products and ongoing research and development activities are subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by us must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. There can be no assurance that we will not encounter problems in clinical trials that will cause us or the FDA to delay or suspend the clinical trials.
Current wording
We are a clinical-stage entity. The production and marketing of our products and ongoing research and development activities are subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by us must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. There can be no assurance that we will not encounter problems in clinical trials that will cause us or the FDA to delay or suspend clinical trials.
Previous wording
Our success will depend in part on our ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by us will not be challenged, invalidated, rendered unenforceable, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to us.
Current wording
Our success will depend in part on our ability to obtain and retain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by us will not be challenged, invalidated, rendered unenforceable, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to us.
Previous wording
Our research and development expenses increased from $1,579,298 during the year ended December 31, 2022 to $6,907,824 during the year ended December 31, 2023. The increase of $5,328,526 is primarily due to production of our Nell-1 protein as we prepare for our pilot clinical study. We will continue to incur significant expenses for development activities for NELL-1 in the future.
Current wording
Our research and development expenses decreased from $6,907,824 during the year ended December 31, 2023, to $2,130,385 during the year ended December 31, 2024. A decrease of $4,777,439. This decrease can be attributed to the significant expenses incurred in the year ended December 31, 2023 to produce the NELL-1 protein necessary for our initial clinical study. Moving forward, we anticipate continued substantial investment in development activities for NELL-1 as we prepare for our pivotal clinical study in the future.
Previous wording
In October 2022, we completed a public equity offering, which included the issuance of 54,174 warrants. The warrants provide for a 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 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.
Current wording
In October 2022, we completed a public equity offering, which included the issuance of 54,174 warrants. The warrants provide for a 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.
Previous wording
On January 10, 2024 we entered into a Settlement Agreement and Mutual General Release (the “Agreement”) with the Plaintiffs on the one hand, and the Company and LaNeve on the other hand, in settlement of the claims for breach of contract and tortious interference with contract. The Agreement is effective as of January 9, 2024. The parties to the Agreement have filed a joint stipulation to dismiss the action with prejudice with the Court and we expect the action to be dismissed by the Court.
Current wording
On January 10, 2024, we entered into a Settlement Agreement and Mutual General Release (the “Agreement”) with Drs. Bessie (Chia) Soo and Kang (Eric) Ting, on the one hand (the “plaintiffs”), and the Company and Stephen LaNeve on the other hand, in settlement of the claims for breach of contract and tortious interference with contract.
Previous wording
Under the Agreement, the Company agreed to pay the plaintiffs $750,000, and on February 7, 2024, the Company paid $414,989, and the Company’s insurance carrier paid $335,011 for the total settlement.
Current wording
The Agreement was effective as of January 9, 2024. We had certain indemnification obligations to Mr. LaNeve arising out of actions taken in connection with his service to the Company. Under the Agreement, we agreed to pay the plaintiffs $750,000, and on February 7, 2024, we paid $414,989, and our insurance carrier paid $335,011 for the total settlement.
Previous wording
We have no significant operating history and since inception to December 31, 2023 have incurred accumulated losses of approximately $80.9 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 $5.5 million. The accompanying consolidated financial statements for the year ended December 31, 2023 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $8.9 million, and used net cash in operating activities of $9.6 million during the year ended December 31, 2023. 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 December 31, 2023, audited financial statements, 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.
Current wording
We have no significant operating history and since inception to December 31, 2024 have incurred accumulated losses of approximately $85.0 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 million. The accompanying consolidated financial statements for the year ended December 31, 2024 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 million, and used net cash in operating activities of $4.1 million during the year ended December 31, 2024. 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 December 31, 2024, audited financial statements, 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.
Previous wording
As of December 31, 2023 and 2022, we had cash of $3,026,569 and $7,538,312, respectively.
Current wording
As of December 31, 2024 and 2023, we had cash of $3,325,131 and $3,026,569, respectively.
Previous wording
During the year ended December 31, 2023 and 2022, cash used in operating activities was $9,555,904 and $3,566,913 respectively. Cash expenditures for the year ended December 31, 2023 increased primarily due to production of our Nell-1 protein as we prepare for our pilot clinical study.
Current wording
During the year ended December 31, 2024 and 2023, cash used in operating activities was $4,124,935 and $9,555,904 respectively. Cash expenditures for the year ended December 31, 2024 decreased primarily due to production in 2023 of our NELL-1 protein as we prepared for our pilot clinical study.
Previous wording
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. During the year ended December 31, 2022, cash provided by financing activities of $4,429,860 resulted from the net proceeds of our October 2022 public offering of common stock units.
Current wording
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, August Warrant Inducement 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.
Previous wording
Research and development costs include, but are not limited to, payroll and other personnel expenses, consultants, expenses incurred under agreements with contract research and manufacturing organizations and animal clinical investigative sites and the cost to manufacture clinical trial materials. Costs related to research, design and development of products are charged to research and development expense as incurred.
Current wording
Research and development costs related to research, design and development of products are charged to research and development expense as incurred. Research and development costs include, but are not limited to, payroll and other personnel expenses, consultants, expenses incurred under agreements with contract research and manufacturing organizations and animal clinical investigative sites and the cost to manufacture clinical trial materials.