Bone Biologics Corp
For the period ended Sep 30, 2024. Filed Nov 14, 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.
Sep 30, 2024 · Filed Nov 14, 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 2024-06-30; filed 2024-08-09.
0001493152-24-030982
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 64 previous paragraphs and 72 current paragraphs.
40 unchanged; 13 reworded; 18 added; 8 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (18)
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. 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.
Current report
ATM Offering
Current 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.
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, 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.
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 expire in five years.
Current report
March 2024 Offering
Current 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.
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 expire in 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, 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.
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 expire in 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, 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.
Removed paragraphs (8)
Previous report
August 2024 Warrant Inducement Transaction
Previous 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.
Previous report
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 report
NASDAQ Panel
Previous report
As of June 28, 2024 we are no longer subject to a Nasdaq discretionary panel monitor.
Previous 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.
Previous 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.
Previous report
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.
Reworded paragraphs (13)
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. 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 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.
Previous wording
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 wording
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 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.
Current wording
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 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.
Current 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.
Previous wording
The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at June 30, 2024.
Current wording
The change in fair value of warrant liability represents the re-measurement of the outstanding warrant liabilities at September 30, 2024.
Previous wording
Six months ended June 30, 2024 compared to the six months ended June 30, 2023
Current wording
Nine months ended September 30, 2024 compared to the nine months ended September 30, 2023
Previous wording
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 wording
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 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.
Current wording
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 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.
Current 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.
Previous wording
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 wording
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 wording
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.
Current 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.
Previous 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.
Current wording
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.
Previous 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.
Current 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
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.
Previous report — wording carried 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.
Previous report — wording carried elsewhere
At June 30, 2024 and December 31, 2023, we had cash of $2,332,068 and $3,026,569, respectively.