Bone Biologics Corp
For the period ended Mar 31, 2025. Filed May 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 12, 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-Q
Period ended 2024-09-30; filed 2024-11-14.
0001493152-24-046020
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001641172-25-009746
Item 2. 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 72 previous paragraphs and 38 current paragraphs.
21 unchanged; 11 reworded; 6 added; 36 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 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 (6)
Current report
Recent Developments
Current report
Nasdaq Deficiency Notice
Current report
On April 7, 2025, we received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based on the closing bid price of our common stock for 30 consecutive business days, we no longer meet Nasdaq Listing Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price of at least $1 per share (the “Bid Price Rule”). The Nasdaq Listing Rules provide a compliance period of 180 calendar days, or until October 6, 2025, in which to regain compliance with the Bid Price Rule. If we evidence a closing bid price of at least $1 per share for a minimum of 10 consecutive business days during the 180-day compliance period, we will automatically regain compliance. If we fail to regain compliance with the Bid Price Rule, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. This notification has no immediate effect on the listing of our common stock on Nasdaq.
Current report
The notification has no immediate effect on the listing of our common stock on Nasdaq. We intend to seek stockholder approval of a reverse stock split of our outstanding common stock in a range of 1-for-2.5 to 1-for-10, at the discretion of our Board of Directors (the “Reverse Stock Split”) at our upcoming annual meeting of stockholders to be held on May 30, 2025.
Current report
Available cash is expected to fund our operations into the fourth quarter of 2025.
Current report
During the three months ended March 31, 2025 and 2024, cash used in operating activities was $926,125 and $1,303,411, respectively. Cash expenditures for the three months ended March 31, 2025 decreased due to the legal settlement payment in January 2024 that did not reoccur during the current period.
Removed paragraphs (36)
Previous report
UCLA TDG Exclusive License Agreement
Previous report
Effective April 9, 2019, we entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019, which was subsequently amended through three sets of amendments (as so amended the “Amended License Agreement”) with the UCLA TDG. The Amended License Agreement amends and restates the Amended and Restated Exclusive License Agreement, dated as of June 19, 2017 (the “2017 Agreement”). The 2017 Agreement amended and restated the Exclusive License Agreement, effective March 15, 2006, between the Company and UCLA TDG, as amended by ten amendments. Under the terms of the Amended License Agreement, the Regents have continued to grant us exclusive rights to develop and commercialize NELL-1 (the “Licensed Product”) for spinal fusion by local administration, osteoporosis and trauma applications. The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.
Previous report
We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as pay certain royalties to UCLA TDG under the Amended License Agreement at the rate of 3.0% of net sales of licensed products or licensed methods. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay a minimum annual royalty between $50,000 and $250,000, depending on the calendar year which is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.
Previous report
We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:
Previous report
We are also obligated pay to UCLA TDG a fee (the “Diligence Fee”) of $8,000,000 upon the sale of any Licensed Product (the “Triggering Sale Date”) in accordance with the payment schedule below:
Previous report
Our obligation to pay the Diligence Fee will survive termination or expiration of the Amended License Agreement and we are prohibited from assigning, selling, or otherwise transferring any of its assets related to any Licensed Product unless our Diligence Fee obligation is assigned, sold, or transferred along with such assets, or unless we pay UCLA TDG the Diligence Fee within ten (10) days of such assignment, sale or other transfer of such rights to any Licensed Product.
Previous report
We are also obligated to pay UCLA TDG a cash milestone payment within thirty (30) days of a Liquidity Event (including a Change of Control Transaction and a payment election by UCLA TDG exercisable after December 22, 2016) such payment to equal the greater of:
Previous report
During the nine months ended September 30, 2024, the first patients were treated in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device, triggering the payment of the initial $100,000 Feasibility Study milestone.
Previous report
We are obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in the Amended License Agreement. We are required to meet certain diligence milestone deadlines pursuant to the Amended License Agreement. Applicable for the current year, we are required to spend at least $1,000,000 per calendar year on pre-clinical or clinical development until the date that we complete a Phase III pivotal study. If we fail to meet this or the other diligence milestone deadlines, UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license.
Previous report
We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License Agreement. We have the right to bring infringement actions against third party infringers of the Amended License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Amended License Agreement or any sublicense.
Previous report
Payments to UCLA TDG under the Amended License Agreement for the nine months ended September 30, 2024 and 2023 were $123,058 and $23,238, respectively.
Previous report
Appointment of Director
Previous report
On October 16, 2024, the Company’s Board of Directors appointed Phillip Meikle to the Board of Directors. Don Hankey resigned from the Board of Directors on October 1, 2024, effective immediately. 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.
Previous report
ATM Offering
Previous report
On September 27, 2024, we entered into the ATM Agreement pursuant to which we could sell, at our option, up to an aggregate of $1,143,121 in shares of our common stock through Wainwright through the ATM Facility. Subsequent to September 30, 2024, we sold 366,794 shares of common stock through the ATM Facility for net proceeds of $640,613, after accounting for $131,396 in offering costs.
Previous report
August 2024 Warrant Inducement
Previous 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, Inducement Warrants were issued to the warrant holders for consideration of $0.125 per share, 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.
Previous 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.
Previous 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 expire in five years.
Previous report
Research and Development
Previous report
Our research and development expenditures saw a notable decline, dropping from $6,460,747 for the nine months ending September 30, 2023, to $1,025,814 for the same period in 2024, marking a decrease of $5,434,933. The decrease in costs can be attributed to the significant expenses incurred in 2023 for the production of 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 report
General and Administrative
Previous report
Our general and administrative costs decreased from $1,807,548 for the nine months ending September 30, 2023, to $1,638,409 for the corresponding period in 2024, reflecting a $169,139 decrease. This decrease can mainly be attributed to legal expenses stemming from litigation matters in 2023.
Previous report
March 2024 Offering
Previous 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.
Previous report
The 781,251 warrants have an exercise price of $2.43 per share, and are exercisable immediately for a term of five years. The 662,251 pre-funded warrants have an exercise price of $0.001 per share and are exercisable immediately for a term of five years.
Previous 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.
Previous 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 expire in five years.
Previous report
August 2024 Warrant Inducement
Previous 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, Inducement Warrants were issued to the warrant holders for consideration of $0.125 per share, 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.
Previous 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.
Previous 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 expire in five years.
Previous report
September 2024 ATM Offering
Previous report
On September 27, 2024, the Company entered into the ATM Agreement with Wainwright with respect to the ATM Facility, under which the Company may, from time to time, in its sole discretion, issue and sell through Wainwright, acting as agent or principal, up to approximately$1.1 million of shares of its common stock. Subsequent to September 30, 2024, we sold 366,794 shares of common stock through the ATM Facility for net proceeds of $640,613, after accounting for $131,396 in offering costs.
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.
Previous report
For the nine months ended September 30, 2024, cash used in operating activities was $2,771,438, compared to $7,537,889 for the same period in 2023. The reduction in cash expenditures for 2024 is attributed to the development activities in 2023 related to our NELL-1 protein as we prepared for our pilot clinical study. During the nine months ended September 30, 2024, the first patients were treated in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device.
Reworded paragraphs (11)
Previous wording
We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein known as NELL-1. NELL-1 in combination with DBM, demineralized bone matrix, is an osteopromotive recombinant protein that provides target specific control over bone regeneration. The NELL-1 technology platform has been licensed exclusively for worldwide applications to us through a technology transfer from the UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the Food and Drug Administration (“FDA”) that NELL-1/DBM will be classified as a device/drug combination product that will require an FDA-approved pre-market approval application before it can be commercialized in the United States.
Current wording
We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein known as NELL-1. NELL-1 in combination with DBM, demineralized bone matrix, is an osteopromotive recombinant protein that provides target specific control over bone regeneration. The NELL-1 technology platform has been licensed exclusively for worldwide applications to us through a technology transfer from UCLA TDG. UCLA TDG and the Company received guidance from the FDA that NELL-1/DBM will be classified as a device/drug combination product that will require an FDA-approved PMA before it can be commercialized in the United States.
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
On June 20, 2024, we announced that the first patient had been treated in the multicenter, prospective, randomized pilot clinical study of the Company’s 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 wording
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.
Previous wording
This pilot clinical study will evaluate NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD) and will evaluate safety and effectiveness, fusion success, pain, function improvement and adverse events. 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. Patient treatment is conducted in Australia. The study design was previously reviewed and agreed upon by the U.S. Food and Drug Administration’s Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.
Current wording
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 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.
Previous wording
Our research and development expenditures saw a notable decline, dropping from $1,574,850 for the three months ending September 30, 2023, to $429,747 for the same period in 2024, marking a decrease of $1,145,103. The decrease in costs can be attributed to the significant expenses incurred in 2023 for the production of 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.
Current wording
Our research and development expenditures increased from $245,625 for the three months ending March 31, 2024, to $423,576 for the same period in 2025, marking an increase of $177,951. The increase in costs can be attributed to formulation processes completed with our Contract Development and Manufacturing Organization. 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
Our general and administrative costs increased from $506,040 for the three months ending September 30, 2023, to $521,274 for the corresponding period in 2024, reflecting a $15,234 minimal increase.
Current wording
Our general and administrative costs decreased $43,001 from $657,911 for the three months ending March 31, 2024, to $614,910 for the corresponding period in 2025.
Previous wording
Since inception to September 30, 2024, we have incurred accumulated losses of approximately $83.5 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 million. The accompanying consolidated financial statements for the nine months ended September 30, 2024 have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $2.6 million, and used net cash in operating activities of $2.8 million during the nine months ended September 30, 2024. These factors raise substantial doubt about the Company’s ability to continue as a going concern within a reasonable period of time, which is considered to be one year from the issuance date of these financial statements. In addition, our independent registered public accounting firm, in its audit report to the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, 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 March 31, 2025 have incurred accumulated losses of approximately $86.0 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 $4.9 million. The accompanying consolidated financial statements for the three months ended March 31, 2025 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $1.0 million, and used net cash in operating activities of $0.9 million during the three months ended March 31, 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 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
At September 30, 2024 and December 31, 2023, we had cash of $3,566,426 and $3,026,569, respectively. Available cash is anticipated to cover our operational needs into the second quarter of 2025.
Current wording
At March 31, 2025 and December 31, 2024, we had cash of $2,746,555 and $3,325,131, respectively.
Previous wording
During the nine months ended September 30, 2024, cash provided by financing activities of $3,311,295 resulted from the net proceeds of the March Offering and the Warrant Inducement.
Current wording
During the three months ended March 31, 2025, cash provided by financing activities was $347,549 from the net proceeds of the ATM Offering.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The change in fair value of warrant liability represents the re-measurement of the outstanding warrant liabilities at September 30, 2024.
Previous report — wording carried elsewhere
Nine months ended September 30, 2024 compared to the nine months ended September 30, 2023
Previous report — wording carried elsewhere
Change in fair value of warrant liability
Previous report — wording carried elsewhere
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.