Bone Biologics Corp
For the period ended Jun 30, 2024. Filed Aug 9, 2024.
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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.
Jun 30, 2024 · Filed Aug 9, 2024
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 2024-03-31; filed 2024-05-14.
0001493152-24-019271
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-09.
0001493152-24-030982
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 55 previous paragraphs and 64 current paragraphs.
34 unchanged; 9 reworded; 14 added; 12 removed; 0 previous and 7 current paragraphs rearranged.
Tables are not compared: 4 previous and 5 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 (14)
Current report
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 report
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. These two patients were treated 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 report
During the six months ended June 30, 2024, the first two patients had been treated in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device, triggering the payment of the initial milestone.
Current report
August 2024 Warrant Inducement Transaction
Current report
On August 1, 2024, we entered into warrant inducement letter agreements with holders of the March 2024 Warrants. We offered, to each warrant holder who exercised the March 2024 Warrants, the issuance of two Incentive Warrants. The Incentive Warrants entitle the holders to purchase an aggregate of 781,251 shares of common stock of the Company for a period of 18 months from the date of issuance, and warrants exercisable into an aggregate of 781,251 shares of common stock of the Company for a period of five years from the date of issuance, exercisable immediately, at a price of $2.00 per share. On August 2, 2024, we completed the warrant inducement transaction and received net proceeds to the Company of approximately $1.7 million.
Current report
NASDAQ Panel
Current report
As of June 28, 2024 we are no longer subject to a Nasdaq discretionary panel monitor.
Current report
Research and Development
Current report
General and Administrative
Current report
Our general and administrative costs decreased from $1,301,509 for the six months ending June 30, 2023, to $1,117,135 for the corresponding period in 2024, reflecting an $184,374 decrease. This decrease can mainly be attributed to legal expenses stemming from litigation matters in 2023.
Current report
In addition, we sold pre-funded warrants to purchase 662,251 shares of common stock (exercise price of $0.001 per share), together with warrants to purchase 662,251 shares of common stock (exercised price of $2.43 per share), for a combined public offering price of $2.559 per pre-funded warrant and accompanying warrant. Concurrent with the closing, 225,938 shares of common stock were issued upon the exercise of 225,938 pre-funded warrants.
Current report
The total proceeds received from the sale of common stock and warrants and the exercise of 225,938 pre-funded warrants was approximately $1.5 million.
Current report
On August 1, 2024, we entered into warrant inducement letter agreements with holders of the March 2024 Warrants. We offered, to each warrant holder who exercised the March 2024 Warrants, the issuance of two Incentive Warrants. The Incentive Warrants entitle the holders to purchase an aggregate of 781,251 shares of common stock of the Company for a period of 18 months from the date of issuance, and warrants exercisable into an aggregate of 781,251 shares of common stock of the Company for a period of five years from the date of issuance, exercisable immediately, at a price of $2.00 per share. On August 2, 2024, we completed the warrant inducement transaction and received net proceeds to the Company of approximately $1.7 million.
Current report
Available cash inclusive of the proceeds from the August 2024 Inducement Transaction is anticipated to cover our operational needs into the first quarter of 2025.
Removed paragraphs (12)
Previous report
As of March 31, 2024, none of the above milestones have been met.
Previous report
March 2024 Offering
Previous report
NASDAQ Panel Decision
Previous report
On September 27, 2023, we received a written notice from the Nasdaq notifying us 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 our request for continued listing on Nasdaq subject to the Company demonstrating compliance with the minimum bid price requirement prior to January 12, 2024. We received notice from Nasdaq on January 9, 2024 that we had regained compliance with the minimum bid price requirement. We will remain under a Nasdaq discretionary panel monitor until June 28, 2024.
Previous report
Chief Executive Officer Amended and Restated Letter Agreement
Previous report
On March 12, 2024, we entered into an amended and restated letter agreement with Jeffrey Frelick, effective as of January 1, 2024 (the “Frelick Agreement”). The Frelick Agreement replaces and supersedes the letter agreement entered into between us and Jeffrey Frelick on June 8, 2015 as described in our filings with the Securities and Exchange Commission. Pursuant to the Frelick Agreement, Mr. Frelick will continue to serve as our Chief Executive Officer.
Previous report
The Frelick Agreement continues to be automatically renewable for successive one-year periods on January 1 st of each calendar year, unless either party provides notice of non-renewal to the other no later than July 9 th during any term. The Frelick Agreement continues to provide Mr. Frelick: (i) an annual base salary of $300,000, (ii) the opportunity to earn an annual bonus targeted at 50% of the then-current salary based on reasonably achievable key performance indicators, (iii) eligibility to participate in our benefit plans, and (iv) reimbursement for expenses necessarily and properly incurred in accordance with our policies on the same. Under the terms of the Frelick Agreement, Mr. Frelick is eligible to receive a transaction bonus of 1% to 2% of the transaction value depending on the size of the transaction in the event we are acquired. The Frelick Agreement contains standard restrictive covenants, including non-competition and non-solicitation, and terms and conditions customarily found in similar agreements.
Previous report
Pursuant to the Frelick Agreement, if Mr. Frelick is terminated without cause, he will receive, in addition to any accrued compensation and benefits, a severance payment equal to one year of his then-current base salary, insurance coverage or reimbursement of COBRA payments for a term of one year, and will be eligible, subject to the Board of Directors’ discretion, for a pro-rata annual bonus.
Previous report
Amendment to Chief Financial Officer Letter Agreement
Previous report
On March 12, 2024, we entered into an amendment to the letter agreement between us and Deina Walsh, our Chief Financial Officer, dated December 17, 2021. The amendment became effective as of March 11, 2024. Under the terms of the amendment, Ms. Walsh is eligible to receive a transaction bonus of 0.5% to 1% of the transaction value depending on the size of the transaction in the event we are acquired.
Previous report
On March 6, 2024, we sold and issued, in a public offering (the “March Offering”), 119,000 shares of common stock together with warrants to purchase 119,000 shares of common stock, expiring on March 6, 2029, at a combined public offering price of $2.56 per share of common stock and accompanying warrant, and (ii) pre-funded warrants to purchase 662,251 shares of common stock, together with warrants to purchase 662,251 shares of common stock at a combined public offering price of $2.559 per pre-funded warrant and accompanying warrant. In addition, we issued warrants to purchase up to an aggregate of 46,875 shares of common stock (equal to 6.0% of the aggregate number of shares sold in the March Offering) to H.C. Wainwright & Co., LLC, and its affiliates, as the placement agent, as compensation in connection with the March Offering. The warrants issued to the placement agent in the March Offering have substantially the same terms and conditions as the warrants issued in the March Offering, except that they have an exercise price of $3.20 per share.
Previous report
Available cash is expected to fund our operations through the third quarter of 2024.
Reworded paragraphs (9)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements for the years ended December 31, 2023 and 2022 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2023, with the SEC on February 21, 2024. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements for the years ended December 31, 2023 and 2022 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2023, with the SEC on February 21, 2024. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note on Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors.
Previous wording
Payments to UCLA TDG under the Amended License Agreement for the three months ended March 31, 2024 and 2023 were $10,484 and $16,606, respectively.
Current wording
Payments to UCLA TDG under the Amended License Agreement for the six months ended June 30, 2024 and 2023 were $118,151 and $16,606, respectively.
Previous wording
On March 6, 2024, we sold and issued, in a public offering (the “March Offering”), 119,000 shares of common stock together with warrants to purchase 119,000 shares of common stock, expiring on March 6, 2029, at a combined public offering price of $2.56 per share of common stock and accompanying warrant, and (ii) pre-funded warrants to purchase 662,251 shares of common stock, together with warrants to purchase 662,251 shares of common stock at a combined public offering price of $2.559 per pre-funded warrant and accompanying warrant. In addition, we issued warrants to purchase up to an aggregate of 46,875 shares of common stock (equal to 6.0% of the aggregate number of shares sold in the March Offering) to H.C. Wainwright & Co., LLC, and its affiliates, as the placement agent, as compensation in connection with the March Offering. The warrants issued to the placement agent in the March Offering have substantially the same terms and conditions as the warrants issued in the March Offering, except that they have an exercise price of $3.20 per share.
Current wording
In addition, we issued warrants to purchase up to an aggregate of 46,875 shares of common stock to the placement agent as compensation. The warrants issued to the placement agent have substantially the same terms and conditions as the five-year Incentive Warrants, except the placement agent warrants have an exercise price of $3.35 per share.
Previous wording
Our research and development expenditures saw a notable decline, dropping from $2,590,645 for the three months ending March 31, 2023, to $245,625 for the same period in 2024, marking a decrease of $2,345,020. 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 saw a notable decline, dropping from $2,295,251 for the three months ending June 30, 2023, to $350,442 for the same period in 2024, marking a decrease of $1,944,809. 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 wording
Our general and administrative costs rose from $556,892 for the three months ending March 31, 2023, to $657,911 for the corresponding period in 2024, reflecting a $101,019 increase. This increase can mainly be attributed to legal expenses stemming from settling ongoing litigation.
Current wording
Our general and administrative costs decreased from $744,617 for the three months ending June 30, 2023, to $459,223 for the corresponding period in 2024, reflecting a $285,394 decrease. This decrease can mainly be attributed to legal expenses stemming from litigation matters in 2023.
Previous wording
Since inception to March 31, 2024, we have incurred accumulated losses of approximately $81.8 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 $6.9 million. The accompanying consolidated financial statements for the three months ended March 31, 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 $0.9 million, and used net cash in operating activities of $1.3 million during the three months ended March 31, 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
Since inception to June 30, 2024, we have incurred accumulated losses of approximately $82.6 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 $5.1 million. The accompanying consolidated financial statements for the six months ended June 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 $1.6 million, and used net cash in operating activities of $2.2 million during the six months ended June 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.
Previous wording
At March 31, 2024 and December 31, 2023, we had cash of $3,227,634 and $3,026,569, respectively.
Current wording
At June 30, 2024 and December 31, 2023, we had cash of $2,332,068 and $3,026,569, respectively.
Previous wording
During the three months ended March 31, 2024 and 2023, cash used in operating activities was $1,303,411 and $1,349,993, respectively. Cash expenditures for the three months ended March 31, 2024 decreased as a result of development activities in 2023 for our NELL-1 protein as we prepared for our pilot clinical study. We commenced our first-in-man pilot clinical study in December 2023.
Current wording
For the six months ended June 30, 2024, cash used in operating activities was $2,199,276, compared to $4,982,666 for the same period in 2023. The reduction in cash expenditures for the first half of 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 six months ended June 30, 2024, we implanted our lead product candidate in the first two patients in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device.
Previous wording
During the three months ended March 31, 2024, cash provided by financing activities of $1,504,476 resulted from the net proceeds of the March Offering.
Current wording
During the six months ended June 30, 2024, cash provided by financing activities of $1,504,339 resulted from the net proceeds of the March Offering and $436 from the exercise of pre-funded warrants.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
Six months ended June 30, 2024 compared to the six months ended June 30, 2023
Current report — wording carried from elsewhere
Our research and development expenditures saw a notable decline, dropping from $4,885,896 for the six months ending June 30, 2023, to $596,067 for the same period in 2024, marking a decrease of $4,289,829. 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 report — wording carried from elsewhere
Change in fair value of warrant liability
Current report — wording carried from 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.
Current report — wording carried from elsewhere
The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at June 30, 2024.
Current report — wording carried from elsewhere
On March 6, 2024, we 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.
Current report — wording carried from elsewhere
In addition, we issued warrants to purchase up to an aggregate of 46,875 shares of common stock to the placement agent as compensation. The warrants issued to the placement agent have substantially the same terms and conditions as the five-year Incentive Warrants, except the placement agent warrants have an exercise price of $3.35 per share.