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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________ to _________
Commission
File No. 001-40899
Bone
Biologics Corporation
(Exact
name of registrant as specified in its charter)
Delaware |
|
42-1743430 |
(State
or other jurisdiction of
incorporation
or formation) |
|
(I.R.S.
employer
identification
number) |
2
Burlington Woods Drive, Ste 100, Burlington, MA 01803
(Address
of principal executive offices and Zip Code)
(781)
552-4452
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, $0.001 par value per share |
|
BBLG |
|
The
Nasdaq Capital Market |
Warrants
to Purchase Common stock, $0.001 par value per share |
|
BBLGW |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
☒
Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files).
☒
Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐
Yes ☒ No
As
of August 9, 2024, there were 1,801,427 shares of the issuer’s common stock, $0.001 par value, outstanding.
Bone
Biologics Corporation
-
INDEX -
NOTE
ON FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements. Such forward-looking statements include
those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements
of historical fact. These forward-looking statements are based on our current expectations and projections about future events and they
are subject to risks and uncertainties known and unknown that could cause actual results and developments to differ materially from those
expressed or implied in such statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
For a more detailed listing of some of the risks and uncertainties facing the Company, please see our Current Report on Form 10-K for
the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on February 21, 2024 and
subsequent Quarterly Reports on Form 10-Q or other reports filed with the SEC.
All
statements other than historical facts contained in this report, including statements regarding our future financial position, capital
expenditures, cash flows, business strategy and plans and objectives of management for future operations are forward-looking statements.
The words “anticipate,” “believe,” “expect,” “plan,” “estimate,” “could,” “may,” “will,” and similar expressions are intended to identify forward-looking statements.
These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow.
Such statements reflect our management’s current views with respect to future events and financial performance and involve risks
and uncertainties, including, without limitation, our ability to raise additional capital to fund our operations, inflation, rising interest
rates, governmental responses there to and possible recession caused thereby, obtaining Food and Drug Administration and other regulatory authorization to market our drug and biological products, successful completion of our clinical trials, our ability
to achieve regulatory authorization to market our lead product NELL-1/DBM, our reliance on third party manufacturers for our drug products,
market acceptance of our products, our dependence on licenses for certain of our products, our reliance on the expected growth in demand
for our products, exposure to product liability and defect claims, development of a public trading market for our securities, and various
other matters, many of which are beyond our control.
Should
one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially
and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all of the forward-looking statements
made in this Form 10-Q are qualified by these cautionary statements and accordingly there can be no assurances made with respect to the
actual results or developments. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking
statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements.
Unless
expressly indicated or the context requires otherwise, the terms “Company,” “we,” “us,” and “our”
in this document refer to Bone Biologics Corporation, a Delaware corporation and its wholly owned subsidiary as defined under the heading
“Management’s Discussion and Analysis” in this Form 10-Q.
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
Bone
Biologics Corporation
Condensed
Consolidated Balance Sheets
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash | |
$ | 2,332,068 | | |
$ | 3,026,569 | |
Advances on research and development contract services | |
| 650,275 | | |
| 328,844 | |
Prepaid insurance | |
| 192,691 | | |
| 372,350 | |
Prepaid expenses | |
| 18,430 | | |
| 10,000 | |
Total current assets | |
| 3,193,464 | | |
| 3,737,763 | |
Total assets | |
$ | 3,193,464 | | |
$ | 3,737,763 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 231,872 | | |
$ | 360,662 | |
Research and development contract liabilities | |
| 44,980 | | |
| - | |
Accrued legal settlement | |
| - | | |
| 414,989 | |
Warrant liability | |
| 7,655 | | |
| 55,751 | |
| |
| | | |
| | |
Total current liabilities | |
| 284,507 | | |
| 831,402 | |
Total liabilities | |
| 284,507 | | |
| 831,402 | |
| |
| | | |
| | |
Commitments and Contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ Equity | |
| | | |
| | |
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023 | |
| - | | |
| - | |
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 1,315,489 and 534,238 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 1,315 | | |
| 534 | |
Additional paid-in capital | |
| 85,466,303 | | |
| 83,814,785 | |
Accumulated deficit | |
| (82,558,661 | ) | |
| (80,908,958 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 2,908,957 | | |
| 2,906,361 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 3,193,464 | | |
$ | 3,737,763 | |
See
accompanying notes to unaudited condensed consolidated financial statements.
Bone
Biologics Corporation
Condensed
Consolidated Statements of Operations
| |
Three
Months
Ended
June
30, 2024 | | |
Three Months
Ended
June 30, 2023 | | |
Six
Months
Ended
June
30, 2024 | | |
Six Months
Ended
June 30, 2023 | |
| |
(unaudited) | | |
(unaudited) | | |
(unaudited) | | |
(unaudited) | |
Revenues | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 350,442 | | |
| 2,295,251 | | |
| 596,067 | | |
| 4,885,896 | |
General and administrative | |
| 459,223 | | |
| 744,617 | | |
| 1,117,135 | | |
| 1,301,509 | |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 809,665 | | |
| 3,039,868 | | |
| 1,713,202 | | |
| 6,187,405 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (809,665 | ) | |
| (3,039,868 | ) | |
| (1,713,202 | ) | |
| (6,187,405 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other expenses | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liability | |
| 10,785 | | |
| 1,270,202 | | |
| 48,096 | | |
| 707,284 | |
Interest income | |
| 15,147 | | |
| 428 | | |
| 15,403 | | |
| 984 | |
Total other income (expenses) | |
| 25,932 | | |
| 1,270,630 | | |
| 63,499 | | |
| 708,268 | |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (783,733 | ) | |
$ | (1,769,238 | ) | |
$ | (1,649,703 | ) | |
$ | (5,479,137 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average shares outstanding – basic and diluted | |
| 1,168,423 | | |
| 339,308 | | |
| 915,931 | | |
| 295,031 | |
| |
| | | |
| | | |
| | | |
| | |
Loss per share – basic and diluted | |
$ | (0.67 | ) | |
$ | (5.21 | ) | |
$ | (1.80 | ) | |
$ | (18.57 | ) |
See
accompanying notes to unaudited condensed consolidated financial statements.
Bone
Biologics Corporation
Consolidated
Statement of Stockholders’ Equity
For
the Six Months ended June 30, 2024
(unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Equity | | |
Equity | |
| |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Equity | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2023 | |
| 534,238 | | |
$ | 534 | | |
$ | 83,814,785 | | |
$ | (80,908,958 | ) | |
$ | 2,906,361 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Fair value of vested stock options | |
| - | | |
| - | | |
| 52,681 | | |
| - | | |
| 52,681 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Options issued to settle accrued bonus | |
| - | | |
| - | | |
| 77,400 | | |
| - | | |
| 77,400 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from sale of common stock in public offering, net of offering costs of $490,227 | |
| 344,938 | | |
| 345 | | |
| 1,503,994 | | |
| - | | |
| 1,504,339 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of pre-funded warrants | |
| 137,313 | | |
| 137 | | |
| - | | |
| - | | |
| 137 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| (865,970 | ) | |
| (865,970 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2024 | |
| 1,016,489 | | |
| 1,016 | | |
| 85,448,860 | | |
| (81,774,928 | ) | |
| 3,674,948 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Fair value of vested stock options | |
| - | | |
| - | | |
| 17,443 | | |
| - | | |
| 17,443 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of pre-funded warrants | |
| 299,000 | | |
| 299 | | |
| - | | |
| - | | |
| 299 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| (783,733 | ) | |
| (783,733 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2024 | |
| 1,315,489 | | |
$ | 1,315 | | |
$ | 85,466,303 | | |
$ | (82,558,661 | ) | |
$ | 2,908,957 | |
See
accompanying notes to unaudited condensed consolidated financial statements.
Bone
Biologics Corporation
Consolidated
Statement of Stockholders’ Equity
For
the Six Months ended June 30, 2023
(unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Equity | | |
Equity | |
| |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Equity | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2022 | |
| 63,820 | | |
$ | 64 | | |
$ | 77,907,471 | | |
$ | (71,960,227 | ) | |
$ | 5,947,308 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Fair value of vested stock options issued to employees and directors | |
| - | | |
| - | | |
| 44,764 | | |
| - | | |
| 44,764 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of warrants | |
| 5,837 | | |
| 6 | | |
| (6 | ) | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Extinguishment of warrant liability upon exercise of warrants | |
| - | | |
| - | | |
| 490,226 | | |
| - | | |
| 490,226 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| (3,709,899 | ) | |
| (3,709,899 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2023 | |
| 69,657 | | |
$ | 70 | | |
$ | 78,442,455 | | |
$ | (75,670,126 | ) | |
$ | 2,772,399 | |
Balance | |
| 69,657 | | |
$ | 70 | | |
$ | 78,442,455 | | |
$ | (75,670,126 | ) | |
$ | 2,772,399 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Fair value of vested stock options issued to employees and directors | |
| - | | |
| - | | |
| 16,670 | | |
| - | | |
| 16,670 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of warrants | |
| 4,938 | | |
| 5 | | |
| (5 | ) | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Extinguishment of warrant liability upon exercise of warrants | |
| - | | |
| - | | |
| 220,798 | | |
| - | | |
| 220,798 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from sale of common stock in public offering, net of offering costs $547,837 | |
| 317,259 | | |
| 317 | | |
| 4,451,846 | | |
| - | | |
| 4,452,163 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| (1,769,238 | ) | |
| (1,769,238 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2023 | |
| 391,854 | | |
$ | 392 | | |
$ | 83,131,764 | | |
$ | (77,439,364 | ) | |
$ | 5,692,792 | |
Balance | |
| 391,854 | | |
$ | 392 | | |
$ | 83,131,764 | | |
$ | (77,439,364 | ) | |
$ | 5,692,792 | |
See
accompanying notes to unaudited condensed consolidated financial statements.
Bone
Biologics Corporation
Condensed
Consolidated Statements of Cash Flows
| |
Six months Ended June 30, 2024 | | |
Six months Ended June 30, 2023 | |
| |
(unaudited) | | |
(unaudited) | |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (1,649,703 | ) | |
$ | (5,479,137 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 70,124 | | |
| 61,434 | |
Change in fair value of warrant liability | |
| (48,096 | ) | |
| (707,284 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Advances on research and development contract services | |
| (321,431 | ) | |
| 170,205 | |
Prepaid insurance and prepaid expenses | |
| 171,229 | | |
| 171,482 | |
Accounts payable and accrued expenses | |
| (51,390 | ) | |
| 706,881 | |
Research and development contract liabilities | |
| 44,980 | | |
| 93,753 | |
Accrued legal settlement | |
| (414,989 | ) | |
| - | |
| |
| | | |
| | |
Net cash used in operating activities | |
| (2,199,276 | ) | |
| (4,982,666 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from sale of common stock in public offering, net of offering costs | |
| 1,504,339 | | |
| 4,452,163 | |
Exercise of pre-funded warrants | |
| 436 | | |
| - | |
| |
| | | |
| | |
Net cash provided by financing activities | |
| 1,504,775 | | |
| 4,452,163 | |
| |
| | | |
| | |
Net decrease in cash | |
| (694,501 | ) | |
| (530,503 | ) |
| |
| | | |
| | |
Cash, beginning of period | |
| 3,026,569 | | |
| 7,538,312 | |
Cash, end of period | |
$ | 2,332,068 | | |
$ | 7,007,809 | |
| |
| | | |
| | |
Supplemental information | |
| | | |
| | |
Income taxes paid | |
$ | - | | |
$ | - | |
Noncash investing and financing activities | |
| | | |
| | |
Options issued to settle accrued bonus | |
$ | 77,400 | | |
| - | |
See
accompanying notes to unaudited condensed consolidated financial statements.
Bone
Biologics Corporation
Notes
to Unaudited Condensed Consolidated Financial Statements
For
the Six months ended June 30, 2024 and 2023
1.
The Company
Bone
Biologics Corporation (the “Company”) was incorporated under the laws of the State of Delaware on October 18, 2007 as AFH
Acquisition X, Inc. Pursuant to a Merger Agreement, dated September 19, 2014, by and among the Company, its wholly-owned subsidiary,
Bone Biologics Acquisition Corp., (“Merger Sub”), and Bone Biologics, Inc., Merger Sub merged with and into Bone Biologics
Inc., with Bone Biologics Inc. remaining as the surviving corporation. On September 22, 2014, the Company changed its name to “Bone
Biologics Corporation” and Bone Biologics, Inc. became a wholly owned subsidiary of the Company. Bone Biologics, Inc. was incorporated
in California on September 9, 2004.
The
Company is 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 the
Company 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.
The
production and marketing of the Company’s products and its ongoing research and development activities will be subject to extensive
regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product
developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval
process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems
in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.
The
Company’s success will depend in part on its 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 the Company will not be challenged, invalidated, or circumvented, or that the rights granted thereunder
will provide proprietary protection or competitive advantages to the Company.
Going
Concern and Liquidity
The
Company has not generated revenue from operations and since inception to June 30, 2024 has incurred accumulated losses of
approximately $82.6
million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBM.
Operating expenditures for the next twelve months are estimated at $5.1
million. The accompanying unaudited condensed 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, the Company 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 one year after the date that the financial statements are issued. In addition, our independent
registered public accounting firm, in its audit report to the financial statements included in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2023, expressed substantial doubt about the Company’s 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.
As
of June 30, 2024, the Company had $2.3 million in cash on hand.
On August 2, 2024, the Company
completed a warrant inducement transaction generating net proceeds to the Company of approximately $1.7
million (see Note 8).
Available cash inclusive of the
proceeds from the August 2024 warrant inducement transaction is anticipated to cover our operational needs into the first quarter of
2025.
The
Company will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional
working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to
meet the Company’s needs. If cash resources are insufficient to satisfy the Company’s on-going cash requirements, the Company
will be required to scale back or discontinue its product development programs, or obtain funds if available (although there can be no
certainties) through strategic alliances that may require the Company to relinquish rights to its technology, or substantially reduce
or discontinue its operations entirely. No assurance can be given that any future financing will be available or, if available, that
it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain
undue restrictions on the Company’s operations, in the case of debt financing, or cause substantial dilution for its stockholders,
in the case of equity financing.
Reverse
stock splits
On
June 5, 2023, the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-30 reverse stock split of its outstanding common stock and warrants. The amendment was
authorized by the Company’s stockholders on May 1, 2023, and was effective on June 5, 2023.
On
December 14, 2023, the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-8 reverse stock split of its outstanding common stock and warrants. The amendment was
authorized by the Company’s stockholders on December 12, 2023, and was effective on December 20, 2023.
All
share and per share amounts have been retro-actively restated as if the reverse splits occurred at the beginning of the earliest period
presented.
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring
adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for
a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles
generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations
of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the
information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2023 was derived from the
audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on February 21,
2024 (the “2023 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the
Company’s audited financial statements for the year ended December 31, 2023 and notes thereto included in the 2023 Annual Report.
The
results of operations for the six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the entire
fiscal year ended December 31, 2024 or for any other period.
Segment
Information
The
Company operates and reports in one segment, which focuses on bone regeneration in spinal fusion using the recombinant human protein
known as NELL-1. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the
Chief Operating Decision Maker, which is the Company’s Chief Executive Officer and President.
Use
of Estimates
The
preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include
the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity
instruments, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could
differ from those estimates.
Inflation
Macroeconomic
factors such as inflation, rising interest rates, governmental responses there to and possible recession caused thereby also add significant
uncertainty to the Company’s operations and possible effects to the amount and type of financing available to the Company in the
future.
Cash
Cash
primarily consists of bank demand deposits maintained by a major financial institution. The Company’s policy is to maintain its
cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation
(the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically
have cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively.
The Company has not experienced any losses to date resulting from this policy.
Research
and Development Costs
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. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless
the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that
a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined
as non-refundable are charged to operations as incurred.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheets and are then charged to research and development costs in the Company’s consolidated statements of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheets, with a corresponding charge to research and development costs
in the Company’s consolidated statements of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Fair
Value of Financial Instruments
Accounting
standards require certain assets and liabilities be reported at fair value in the financial statements and provide a framework for establishing
that fair value. The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the
use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which
the first two are considered observable and the last is considered unobservable:
Level
1: Quoted prices in active markets for identical assets or liabilities.
Level
2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.
The
fair value of financial instruments measured on a recurring basis was as follows as of June 30, 2024:
Schedule of Fair Value Liabilities Measured on Recurring Basic
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
Total liabilities at fair value | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
The
following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level
3 inputs for the six month period ended June 30, 2024 as follows:
Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable
| |
June 30, 2024 | |
Warrant liability | |
| | |
Balance as of beginning of period – December 31, 2023 | |
$ | 55,751 | |
Change in fair value | |
| (48,096 | ) |
Balance as of June 30, 2024 | |
$ | 7,655 | |
The
Company believes the carrying amount of certain financial instruments, including cash and accounts payable approximate their values based
on their short-term nature and are excluded from the fair value tables above.
Stock
Based Compensation
ASC
718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions
to employees and non-employees. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other
equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including
grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair
values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award,
known as the requisite service period (usually the vesting period). Recognition of compensation expense for non-employees is in the same
period and manner as if the Company had paid cash for the services.
Loss
per Common Share
Basic
loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding
during the period. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include
the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional
common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if options and warrants were
to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.
Since
the effects of outstanding options and warrants are anti-dilutive for the six months ended June 30, 2024 and 2023, shares of common stock
underlying these instruments have been excluded from the computation of loss per common share.
The
following sets forth the number of shares of common stock underlying outstanding options and warrants as of June 30, 2024 and 2023:
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 1,025,970 | | |
| 46,912 | |
Stock options | |
| 74,151 | | |
| 2,125 | |
Anti
dilutive securities | |
| 1,100,121 | | |
| 49,037 | |
New
Accounting Standards
The
Company’s management has evaluated all the recently issued, but not yet effective, accounting standards and guidance that have
been issued or proposed by the Financial Accounting Standards Board or other standards-setting bodies through the filing date of
these financial statements and does not believe the future adoption of any such pronouncements will have a material effect on the
Company’s financial position and results of operations.
3.
Warrant Liability
In
October 2022, the Company completed a public equity offering, which included the issuance of 54,174 warrants. The warrants provide for
a Black Scholes value calculation, as defined, in the event of certain transactions (“Fundamental Transactions,” as defined),
which includes a floor on volatility utilized in the Black Scholes value calculation at 100% or greater. The Company has 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, the Company has 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.
The
warrant liability was valued at the following dates using a Black-Scholes model with the following assumptions:
Schedule of Warrant Liability Black-Scholes Model
| |
June 30, 2024 | | |
December 31, 2023 | |
Warrant liability: | |
| | | |
| | |
Risk-free interest rate | |
| 4.49 | % | |
| 3.94 | % |
Expected volatility | |
| 134.22 | % | |
| 136.25 | % |
Expected life (in years) | |
| 3.28 | | |
| 3.78 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair Value of warrant liability | |
$ | 7,655 | | |
$ | 55,751 | |
The
risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. The Company determines expected volatility based
upon the historical volatility of the Company’s common stock. The Company does not believe that the future volatility of its common
stock over an option’s expected term is likely to differ significantly from the past. The expected term of the warrants granted
are determined based on the duration of time the warrants are expected to be outstanding. The dividend yield on the Company’s warrants
is assumed to be zero as the Company has not historically paid dividends.
4.
Stockholders’ Equity
Preferred
Stock
The
Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue a total of 20,000,000 shares of preferred
stock. No shares have been issued as of June 30, 2024 and December 31, 2023.
Common
Stock
The
Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue a total of 100,000,000 shares of common
stock. As of June 30, 2024 and December 31, 2023, the Company had an aggregate of 1,315,489 and 534,238 shares of common stock outstanding,
respectively.
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 (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.
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.
In
March 2024, 137,313 shares of common stock were issued upon the exercise of 137,313 pre-funded warrants, for proceeds of $137.
During
the three months ended June 30, 2024, 299,000 shares of common stock were issued upon the exercise of 299,000 pre-funded warrants, for proceeds of $299.
The Company issued warrants to purchase up to an aggregate
of 46,875 shares of common stock to the placement agent, as compensation in connection with the March 2024 offering. The warrants issued
to the placement agent have substantially the same terms and conditions as the warrants issued to investors, except that the placement
agent warrants have an exercise price of $3.20 per share.
5.
Common Stock Warrants
A
summary of warrant activity for the six months ended June 30, 2024 is presented below:
Schedule of Warrant Activity
Subject to Exercise | |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | |
Outstanding as of December 31, 2023 | |
| 197,844 | | |
$ | 127.86 | | |
| 4.95 | |
Granted – 2024 | |
| 1,490,377 | | |
| 1.44 | | |
| 5.00 | |
Forfeited/Expired – 2024 | |
| - | | |
| - | | |
| - | |
Exercised – 2024 | |
| (662,251 | ) | |
| 0.001 | | |
| 4.68 | |
Outstanding as of June 30, 2024 | |
| 1,025,970 | | |
$ | 26.65 | | |
| 4.64 | |
As
of June 30, 2024, the Company had outstanding exercisable, but unexercised Common Stock Warrants as follows:
Schedule of Outstanding Vested and Unexercised Common Stock Warrants
Date Issued | |
Exercise Price | | |
Number of Warrants | | |
Expiration date |
|
October 2021 | |
$ | 1,512.00 | | |
| 7,620 | | |
October 13, 2026 |
|
October 2022 | |
$ | 388.80 | | |
| 18,058 | | |
October 12, 2027 |
|
October 2022 | |
$ | 324.00 | | |
| 18,846 | | |
October 12, 2027 |
|
October 2022 | |
$ | 0.00 | | |
| 2,393 | | |
October 12, 2027 |
|
November 2023 | |
$ | 6.40 | | |
| 8,543 | | |
November 16, 2028 |
|
November 2023 | |
$ | 4.16 | | |
| 142,384 | | |
May 21, 2029 |
|
March 2024 | |
$ | 2.43 | | |
| 781,251 | | |
March 6, 2029 |
|
March 2024 | |
$ | 3.20 | | |
| 46,875 | | |
March 6, 2029 |
|
Total outstanding warrants at June 30, 2024 | |
| | | |
| 1,025,970 | | |
|
|
Based
on a fair market value of $1.22 per share on June 30, 2024, there 2,393 exercisable but unexercised in-the-money common stock warrants
on that date. Accordingly, the intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2024 was $2,919.
Please see Note 8 Subsequent Events for disclose of a warrant inducement entered into on August 1, 2024.
6.
Stock-based Compensation
2015
Equity Incentive Plan
The
Company has 629,489 shares of common stock authorized and reserved for issuance under its 2015 Equity Incentive Plan for option awards.
This reserve may be increased by the Board each year by up to the number of shares of stock equal to 5% of the number of shares of stock
issued and outstanding on the immediately preceding December 31. Shares subject to awards granted under the 2015 Equity Incentive Plan
which expire, are repurchased or are cancelled or forfeited will again become available for issuance under the 2015 Equity Incentive
Plan. The shares available will not be reduced by awards settled in cash. Shares withheld to satisfy tax withholding obligations will
not again become available for grant. The gross number of shares issued upon the exercise of stock appreciation rights or options exercised
by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under the 2015 Equity Incentive
Plan.
Awards
may be granted under the 2015 Equity Incentive Plan to the Company’s employees, including officers, director or consultants, and
its present or future affiliated entities. While the Company may grant incentive stock options only to employees, it may grant non-statutory
stock options, stock appreciation rights, restricted stock purchase rights or bonuses, restricted stock units, performance shares, performance
units and cash-based awards or other stock based awards to any eligible participant.
The
2015 Equity Incentive Plan is administered by the Company’s compensation committee. Subject to the provisions of the 2015 Equity
Incentive Plan, the compensation committee determines, in its discretion, the persons to whom, and the times at which, awards are granted,
as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between the Company and the
holder of the award. The compensation committee has the authority to construe and interpret the terms of the 2015 Equity Incentive Plan
and awards granted under the 2015 Equity Incentive Plan.
A
summary of stock option activity for the six months ended June 30, 2024 is presented below:
Schedule of Stock Option Activity
Subject to Exercise | |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2023 | |
| 34,310 | | |
$ | 236.70 | | |
| 8.62 | | |
$ | - | |
Granted – 2024 | |
| 45,515 | | |
| 3.72 | | |
| 3.41 | | |
| - | |
Forfeited/Expired – 2024 | |
| (5,674 | ) | |
| 54.24 | | |
| 7.94 | | |
| - | |
Exercised – 2024 | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 74,151 | | |
$ | 107.65 | | |
| 4.87 | | |
$ | - | |
Options vested and exercisable at June 30, 2024 | |
| 59,419 | | |
$ | 133.13 | | |
| 3.96 | | |
$ | - | |
As
of June 30, 2024, the Company had outstanding stock options as follows:
Schedule of Outstanding Stock Options
Date Issued | |
Exercise Price | | |
Number of Options | | |
Expiration date |
|
August 2015 | |
$ | 9,540.00 | | |
| 174 | | |
December 27, 2025 |
|
September 2015 | |
$ | 9,540.00 | | |
| 36 | | |
December 27, 2025 |
|
November 2015 | |
$ | 9,540.00 | | |
| 205 | | |
December 27, 2025 |
|
December 2015 | |
$ | 9,540.00 | | |
| 12 | | |
December 27, 2025 |
|
January 2016 | |
$ | 9,540.00 | | |
| 213 | | |
January 9, 2026 |
|
May 2016 | |
$ | 12,300.00 | | |
| 45 | | |
May 26, 2026 |
|
September 2016 | |
$ | 12,300.00 | | |
| 21 | | |
May 31, 2026 |
|
January 2017 | |
$ | 12,300.00 | | |
| 10 | | |
January 1, 2027 |
|
January 2018 | |
$ | 11,820.00 | | |
| 8 | | |
January 1, 2028 |
|
January 2019 | |
$ | 564.00 | | |
| 92 | | |
January 1, 2029 |
|
October 2021 | |
$ | 1,260.00 | | |
| 207 | | |
October 26, 2031 |
|
January 2022 | |
$ | 844.80 | | |
| 111 | | |
January 1, 2032 |
|
August 2022 | |
$ | 387.26 | | |
| 462 | | |
August 23, 2032 |
|
January 2023 | |
$ | 57.60 | | |
| 237 | | |
January 25, 2025 |
|
September 2023 | |
$ | 5.12 | | |
| 26,803 | | |
September 12, 2033 |
|
January 2024 | |
$ | 4.68 | | |
| 8,015 | | |
January 8, 2034 |
|
January 2024 | |
$ | 3.61 | | |
| 37,500 | | |
January 17, 2026 |
|
| |
| | | |
| | | |
|
|
Total outstanding options at June 30, 2024 | |
| | | |
| 74,151 | | |
|
|
Based
on a fair value of $1.22 per share on June 30, 2024. There were no exercisable but unexercised in-the-money common stock warrants on
that date.
During
the six months ended June 30, 2024, options exercisable into 8,015 shares of common stock were granted with a fair value of $34,039.
Vesting of options differs based on the terms of each option. During the six months ended June 30, 2024 and 2023, the Company had stock-based
compensation expense of $70,124 and $61,434, respectively, related to the vesting of stock options granted to the Company’s employees
and directors included in our reported net loss. In addition, during the six months ended June 30, 2024, options exercisable into 37,500
shares of common stock were issued to employees in settlement of previously accrued bonuses of $77,400.
In
January 2024, options exercisable into 5,674 shares of common stock were forfeited upon the resignation of a director. The Company’s
policy is to account for forfeitures of the unvested portion of option grants when they occur; therefore, these forfeitures are recorded
as a reversal to expense, which can result in a credit balance in the statement of operations.
The
Company utilized the Black-Scholes option-pricing model. The assumptions used for the six months ended June 30, 2024 are as follows:
Schedule of Assumptions Using Black-Scholes Option Pricing Mode
| |
June 30, 2024 | |
Risk free interest rate | |
| 3.97 | % |
Expected Volatility | |
| 137.91 | % |
Expected life (in years) | |
| 5.58 | |
Expected dividend yield | |
| 0 | % |
The
expected volatility is a measure of the amount by which the Company stock price is expected to fluctuate during the expected term of
options granted. The Company determines the expected volatility based upon the historical volatility of our common stock since listing
on The Nasdaq Capital Market. The Company does not believe that the future volatility of its common stock over an option’s expected
term is likely to differ significantly from the past. The risk-free interest rate used in the calculations is based on the implied yield
available on U.S. Treasury issues with an equivalent term approximating the expected life of the options as calculated using the simplified
method. The expected life of the options used was based on the contractual life of the option granted. Stock-based compensation is a
non-cash expense because the Company settles these obligations by issuing shares of its common stock from its authorized shares instead
of settling such obligations with cash payments.
As
of June 30, 2024, total unrecognized compensation cost related to unvested stock options was $6,811. The cost is expected to be recognized
over a weighted average period of 0.03 years.
7.
Commitments and Contingencies
UCLA
TDG Exclusive License Agreement
Effective
April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019 and 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 the Company 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.
The
Company has 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. The Company must pay the royalties to UCLA
TDG on a quarterly basis. Upon a first commercial sale, the Company 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 the Company is required to pay any third party any royalties
as a result of it making use of UCLA TDG patents, then it may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point
paid to a third party. If the Company grants sublicense rights to a third party to use the UCLA TDG patent, then it will pay UCLA TDG
10% to 20% of the sublicensing income it receives from such sublicense.
The
Company is obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:
|
● |
$100,000
upon enrollment of the first subject in a Feasibility Study; |
|
|
|
|
● |
$250,000
upon enrollment of the first subject in a Pivotal Study: |
|
|
|
|
● |
$
upon Pre-Market Approval of a Licensed Product or Licensed Method; and |
|
|
|
|
● |
$1,000,000
upon the First Commercial Sale of a Licensed Product or Licensed Method. |
The
Company is 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:
|
● |
Due
upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000; |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000. |
The
Company’s obligation to pay the Diligence Fee will survive termination or expiration of the agreement and it is prohibited from
assigning, selling, or otherwise transferring any of its assets related to any Licensed Product unless its Diligence Fee obligation is
assigned, sold, or transferred along with such assets, or unless it pays UCLA TDG the Diligence Fee within ten (10) days of such assignment,
sale or other transfer of such rights to any Licensed Product.
The
Company is 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:
|
● |
$500,000;
or |
|
|
|
|
● |
2%
of all proceeds in connection with a Change of Control Transaction. |
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.
The
Company is obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in
the Amended License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license
if it does not meet certain diligence milestone deadlines set forth in the Amended License Agreement.
The
Company must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License
Agreement. The Company has 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 the Company’s expense, be joined involuntarily to the action. The Company
is required to indemnify UCLA TDG against any third party claims arising out of its exercise of the rights under the Amended License
Agreement or any sublicense.
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.
Contingencies
The
Company is subject to claims and assessments from time to time in the ordinary course of business. The Company’s management does
not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business,
financial condition, results of operations or cash flows.
8.
Subsequent Events
On August 1, 2024, the Company entered into warrant inducement letter agreements
with holders of the March 2024 Warrants. The Company 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, the Company completed the warrant inducement transaction and received net proceeds to the Company of approximately $1.7 million.
In addition, the Company 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.
Due
to certain beneficial ownership limitations set forth in the March 2024 Warrants, the Company issued the number of shares that would
not cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of common stock in
abeyance. Of March 2024 Warrants exercised, an aggregate of 560,251 shares
of common stock were held in abeyance. The abeyance shares will be held until notice is received
by the holder that the shares of common stock may be issued in compliance with such beneficial ownership limitations. Until such time, the abeyance shares are evidenced
through the holder's existing warrants and will continue to be included in the Company's table of outstanding warrants. The abeyance
shares are not considered issued or outstanding in our consolidated balance sheets.
As
of August 6, 2024, 264,938
Abeyance Shares were released and issued.
Item
2. Management’s Discussion and Analysis.
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.
Company
Overview
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.
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.
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.
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.
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.
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.
UCLA
TDG Exclusive License Agreement
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.
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.
We
are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:
|
● |
$100,000
upon enrollment of the first subject in a Feasibility Study; |
|
|
|
|
● |
$250,000
upon enrollment of the first subject in a Pivotal Study: |
|
|
|
|
● |
$500,000
upon Pre-Market Approval of a Licensed Product or Licensed Method; and |
|
|
|
|
● |
$1,000,000
upon the First Commercial Sale of a Licensed Product or Licensed Method. |
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:
|
● |
Due
upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000; |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000. |
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.
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:
|
● |
$500,000;
or |
|
|
|
|
● |
2%
of all proceeds in connection with a Change of Control Transaction. |
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.
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.
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.
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.
August
2024 Warrant Inducement Transaction
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.
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.
NASDAQ
Panel
As of June 28, 2024 we are no longer subject to a Nasdaq discretionary panel monitor.
Results
of Operations
Since
our inception, we devoted substantially all of our efforts and funding to the development of the NELL-1 protein and raising capital.
We have not yet generated revenues from our planned operations.
Three
months ended June 30, 2024 compared to the three months ended June 30, 2023
| |
Three-months ended June 30, 2024 | | |
Three-months ended June 30, 2023 | | |
% Change | |
Operating expenses | |
| | | |
| | | |
| | |
Research and development | |
$ | 350,442 | | |
$ | 2,295,251 | | |
| (84.73 | )% |
General and administrative | |
| 459,223 | | |
| 744,617 | | |
| (38.33 | )% |
| |
| | | |
| | | |
| | |
Total operating expenses | |
| 809,665 | | |
| 3,039,868 | | |
| (73.37 | )% |
| |
| | | |
| | | |
| | |
Loss from operations | |
| (809,665 | ) | |
| (3,039,868 | ) | |
| (73.37 | )% |
| |
| | | |
| | | |
| | |
Change in fair value of warrant liability | |
| 10,785 | | |
| 1,270,202 | | |
| (99.15 | )% |
| |
| | | |
| | | |
| | |
Interest income | |
| 15,147 | | |
| 428 | | |
| 3439.02 | % |
| |
| | | |
| | | |
| | |
Net loss | |
$ | (783,733 | ) | |
$ | (1,769,238 | ) | |
| (55.70 | )% |
Research
and Development
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.
General
and Administrative
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.
Change
in fair value of warrant liability
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.
The
change in fair value of warrant liability represents the re-measurement of the outstanding warrants at June 30, 2024.
Six
months ended June 30, 2024 compared to the six months ended June 30, 2023
| |
Six-months ended June 30, 2024 | | |
Six-months ended June 30, 2023 | | |
% Change | |
Operating expenses | |
| | | |
| | | |
| | |
Research and development | |
$ | 596,067 | | |
$ | 4,885,896 | | |
| (87.80 | )% |
General and administrative | |
| 1,117,135 | | |
| 1,301,509 | | |
| (14.17 | )% |
| |
| | | |
| | | |
| | |
Total operating expenses | |
| 1,713,202 | | |
| 6,187,405 | | |
| (72.31 | )% |
| |
| | | |
| | | |
| | |
Loss from operations | |
| (1,713,202 | ) | |
| (6,187,405 | ) | |
| (72.31 | )% |
| |
| | | |
| | | |
| | |
Change in fair value of warrant liability | |
| 48,096 | | |
| 707,284 | | |
| (93.20 | )% |
| |
| | | |
| | | |
| | |
Interest income | |
| 15,403 | | |
| 984 | | |
| 1465.35 | % |
| |
| | | |
| | | |
| | |
Net loss | |
$ | (1,649,703 | ) | |
$ | (5,479,137 | ) | |
| (69.89 | )% |
Research
and Development
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.
General
and Administrative
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.
Change
in fair value of warrant liability
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.
The
change in fair value of warrant liability represents the re-measurement of the outstanding warrants at June 30, 2024.
Liquidity
and Capital Resources
Going
Concern and Liquidity
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.
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.
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.
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.
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.
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.
We
will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional working
capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet our
needs. If cash resources are insufficient to satisfy our on-going cash requirements, we will be required to scale back or discontinue
our product development programs, or obtain funds if available (although there can be no certainties) through strategic alliances that
may require us to relinquish rights to our technology or substantially reduce or discontinue our operations entirely. No assurance can
be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us. Even if
we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause
substantial dilution for our stockholders, in the case of equity financing.
At
June 30, 2024 and December 31, 2023, we had cash of $2,332,068 and $3,026,569, respectively.
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.
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.
Cash
Flows
Operating
activities
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.
Financing
activities
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.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the
Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital
expenditures or capital resources that is material to investors.
Critical
Accounting Policies and Use of Estimates
See
our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for a discussion of our critical accounting policies
and use of estimates. There have been no material changes to our critical accounting policies and use of estimates discussed in such
report.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not
applicable.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management, including our Chief Financial Officer and Chief Executive Officer, we evaluated
the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of June 30, 2024. Based upon that evaluation,
our Chief Financial Officer and Chief Executive Officer concluded that as of June 30, 2024, our disclosure controls and procedures were
effective.
Changes
in Internal Controls
There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(d) and 15d-15(d) under the Exchange Act)
that occurred during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings.
There
are no material updates to the matters previously disclosed in “Part I—Item 3—Legal Proceedings” of our Annual
Report on Form 10-K for the fiscal year ended December 31, 2023 and "Part II—Item 1—Legal Proceedings" of our Quarterly
Report on Form 10-Q for the period ended March 31, 2024.
Item
1A. Risk Factors.
For
a discussion of the Company’s potential risks or uncertainties, please see “Part I—Item 1A—Risk Factors”
and “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations”
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC, and “Part I—Item
2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” herein. There have been no
material changes from the risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023
except as noted herein.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None
Item
3. Defaults Upon Senior Securities.
None
Item
4. Mine Safety Disclosures.
Not
Applicable
Item
5. Other Information.
During
the three months ended June 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement”
or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Item
6. Exhibits.
|
(a) |
Exhibits
required by Item 601 of Regulation S-K. |
*
Filed Herewith
+
Management contract or compensatory arrangement.
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
|
BONE
BIOLOGICS CORPORATION |
|
|
|
Dated:
August 9, 2024 |
By: |
/s/
Jeffrey Frelick |
|
Name: |
Jeffrey
Frelick |
|
Title: |
Chief
Executive Officer |
Exhibit
31.1
Certification
of Principal Executive Officer
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
and
Securities and Exchange Commission Release 34-46427
I,
Jeffrey Frelick, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Bone Biologics Corporation;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 9, 2024 |
/s/
Jeffrey Frelick |
|
Jeffrey
Frelick |
|
Principal
Executive Officer |
Exhibit
31.2
Certification
of Principal Financial Officer
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
and
Securities and Exchange Commission Release 34-46427
I,
Deina H. Walsh, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Bone Biologics Corporation;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 9, 2024 |
/s/
Deina H. Walsh |
|
Deina
H. Walsh |
|
Principal
Financial Officer |
Exhibit
32.1
Certification
of Principal Executive Officer
Pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to
Section
906 of the Sarbanes-Oxley Act of 2002
In
connection with the Report of Bone Biologics Corporation (the “Company”) on Form 10-Q for the period ended June 30, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jeffrey Frelick, Principal Executive
Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that, to the best of my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
|
/s/
Jeffrey Frelick |
|
Jeffrey
Frelick |
|
Principal
Executive Officer |
|
|
|
August
9, 2024 |
Exhibit
32.2
Certification
of Principal Financial Officer
Pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to
Section
906 of the Sarbanes-Oxley Act of 2002
In
connection with the Report of Bone Biologics Corporation (the “Company”) on Form 10-Q for the period ended June 30, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Deina H. Walsh, Principal Financial
Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that, to the best of my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
|
/s/
Deina H. Walsh |
|
Deina
H. Walsh |
|
Principal
Financial Officer |
|
|
|
August
9, 2024 |
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Entity File Number |
001-40899
|
|
Entity Registrant Name |
Bone
Biologics Corporation
|
|
Entity Central Index Key |
0001419554
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Entity Tax Identification Number |
42-1743430
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Entity Incorporation, State or Country Code |
DE
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Entity Address, Address Line One |
2
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552-4452
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current Assets |
|
|
Cash |
$ 2,332,068
|
$ 3,026,569
|
Advances on research and development contract services |
650,275
|
328,844
|
Prepaid insurance |
192,691
|
372,350
|
Prepaid expenses |
18,430
|
10,000
|
Total current assets |
3,193,464
|
3,737,763
|
Total assets |
3,193,464
|
3,737,763
|
Current Liabilities |
|
|
Accounts payable and accrued expenses |
231,872
|
360,662
|
Research and development contract liabilities |
44,980
|
|
Accrued legal settlement |
|
414,989
|
Warrant liability |
7,655
|
55,751
|
Total current liabilities |
284,507
|
831,402
|
Total liabilities |
284,507
|
831,402
|
Commitments and Contingencies |
|
|
Stockholders’ Equity |
|
|
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023 |
|
|
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 1,315,489 and 534,238 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
1,315
|
534
|
Additional paid-in capital |
85,466,303
|
83,814,785
|
Accumulated deficit |
(82,558,661)
|
(80,908,958)
|
Total stockholders’ equity |
2,908,957
|
2,906,361
|
Total liabilities and stockholders’ equity |
$ 3,193,464
|
$ 3,737,763
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
1,315,489
|
534,238
|
Common stock, shares outstanding |
1,315,489
|
534,238
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
350,442
|
2,295,251
|
596,067
|
4,885,896
|
General and administrative |
459,223
|
744,617
|
1,117,135
|
1,301,509
|
Total operating expenses |
809,665
|
3,039,868
|
1,713,202
|
6,187,405
|
Loss from operations |
(809,665)
|
(3,039,868)
|
(1,713,202)
|
(6,187,405)
|
Other expenses |
|
|
|
|
Change in fair value of warrant liability |
10,785
|
1,270,202
|
48,096
|
707,284
|
Interest income |
15,147
|
428
|
15,403
|
984
|
Total other income (expenses) |
25,932
|
1,270,630
|
63,499
|
708,268
|
Net Loss |
$ (783,733)
|
$ (1,769,238)
|
$ (1,649,703)
|
$ (5,479,137)
|
Weighted average shares outstanding - basic |
1,168,423
|
339,308
|
915,931
|
295,031
|
Weighted average shares outstanding - diluted |
1,168,423
|
339,308
|
915,931
|
295,031
|
Loss per share - basic |
$ 0.67
|
$ (5.21)
|
$ (1.80)
|
$ (18.57)
|
Loss per share - diluted |
$ 0.67
|
$ (5.21)
|
$ (1.80)
|
$ (18.57)
|
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v3.24.2.u1
Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 64
|
$ 77,907,471
|
$ (71,960,227)
|
$ 5,947,308
|
Balance, shares at Dec. 31, 2022 |
63,820
|
|
|
|
Fair value of vested stock options issued to employees and directors |
|
44,764
|
|
44,764
|
Net Loss |
|
|
(3,709,899)
|
(3,709,899)
|
Exercise of warrants |
$ 6
|
(6)
|
|
|
Exercise of warrants, shares |
5,837
|
|
|
|
Extinguishment of warrant liability upon exercise of warrants |
|
490,226
|
|
490,226
|
Balance at Mar. 31, 2023 |
$ 70
|
78,442,455
|
(75,670,126)
|
2,772,399
|
Balance, shares at Mar. 31, 2023 |
69,657
|
|
|
|
Balance at Dec. 31, 2022 |
$ 64
|
77,907,471
|
(71,960,227)
|
5,947,308
|
Balance, shares at Dec. 31, 2022 |
63,820
|
|
|
|
Net Loss |
|
|
|
(5,479,137)
|
Balance at Jun. 30, 2023 |
$ 392
|
83,131,764
|
(77,439,364)
|
5,692,792
|
Balance, shares at Jun. 30, 2023 |
391,854
|
|
|
|
Balance at Mar. 31, 2023 |
$ 70
|
78,442,455
|
(75,670,126)
|
2,772,399
|
Balance, shares at Mar. 31, 2023 |
69,657
|
|
|
|
Fair value of vested stock options issued to employees and directors |
|
16,670
|
|
16,670
|
Proceeds from sale of common stock in public offering, net of offering costs $547,837 |
$ 317
|
4,451,846
|
|
4,452,163
|
Proceeds from sale of common stock in public offering, net of offering costs, shares |
317,259
|
|
|
|
Net Loss |
|
|
(1,769,238)
|
(1,769,238)
|
Exercise of warrants |
$ 5
|
(5)
|
|
|
Exercise of warrants, shares |
4,938
|
|
|
|
Extinguishment of warrant liability upon exercise of warrants |
|
220,798
|
|
220,798
|
Balance at Jun. 30, 2023 |
$ 392
|
83,131,764
|
(77,439,364)
|
5,692,792
|
Balance, shares at Jun. 30, 2023 |
391,854
|
|
|
|
Balance at Dec. 31, 2023 |
$ 534
|
83,814,785
|
(80,908,958)
|
2,906,361
|
Balance, shares at Dec. 31, 2023 |
534,238
|
|
|
|
Fair value of vested stock options issued to employees and directors |
|
52,681
|
|
52,681
|
Options issued to settle accrued bonus |
|
77,400
|
|
77,400
|
Proceeds from sale of common stock in public offering, net of offering costs $547,837 |
$ 345
|
1,503,994
|
|
1,504,339
|
Proceeds from sale of common stock in public offering, net of offering costs, shares |
344,938
|
|
|
|
Exercise of pre-funded warrants |
$ 137
|
|
|
137
|
Exercise of prefunded warrants, shares |
137,313
|
|
|
|
Net Loss |
|
|
(865,970)
|
(865,970)
|
Balance at Mar. 31, 2024 |
$ 1,016
|
85,448,860
|
(81,774,928)
|
3,674,948
|
Balance, shares at Mar. 31, 2024 |
1,016,489
|
|
|
|
Balance at Dec. 31, 2023 |
$ 534
|
83,814,785
|
(80,908,958)
|
2,906,361
|
Balance, shares at Dec. 31, 2023 |
534,238
|
|
|
|
Net Loss |
|
|
|
(1,649,703)
|
Balance at Jun. 30, 2024 |
$ 1,315
|
85,466,303
|
(82,558,661)
|
2,908,957
|
Balance, shares at Jun. 30, 2024 |
1,315,489
|
|
|
|
Balance at Mar. 31, 2024 |
$ 1,016
|
85,448,860
|
(81,774,928)
|
3,674,948
|
Balance, shares at Mar. 31, 2024 |
1,016,489
|
|
|
|
Fair value of vested stock options issued to employees and directors |
|
17,443
|
|
17,443
|
Exercise of pre-funded warrants |
$ 299
|
|
|
299
|
Exercise of prefunded warrants, shares |
299,000
|
|
|
|
Net Loss |
|
|
(783,733)
|
(783,733)
|
Balance at Jun. 30, 2024 |
$ 1,315
|
$ 85,466,303
|
$ (82,558,661)
|
$ 2,908,957
|
Balance, shares at Jun. 30, 2024 |
1,315,489
|
|
|
|
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|
3 Months Ended |
Mar. 31, 2024 |
Jun. 30, 2023 |
Common Stock [Member] |
|
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Offering costs |
$ 490,227
|
$ 547,837
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6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities |
|
|
Net loss |
$ (1,649,703)
|
$ (5,479,137)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Stock-based compensation |
70,124
|
61,434
|
Change in fair value of warrant liability |
(48,096)
|
(707,284)
|
Changes in operating assets and liabilities: |
|
|
Advances on research and development contract services |
(321,431)
|
170,205
|
Prepaid insurance and prepaid expenses |
171,229
|
171,482
|
Accounts payable and accrued expenses |
(51,390)
|
706,881
|
Research and development contract liabilities |
44,980
|
93,753
|
Accrued legal settlement |
(414,989)
|
|
Net cash used in operating activities |
(2,199,276)
|
(4,982,666)
|
Cash flows from financing activities |
|
|
Proceeds from sale of common stock in public offering, net of offering costs |
1,504,339
|
4,452,163
|
Exercise of pre-funded warrants |
436
|
|
Net cash provided by financing activities |
1,504,775
|
4,452,163
|
Net decrease in cash |
(694,501)
|
(530,503)
|
Cash, beginning of period |
3,026,569
|
7,538,312
|
Cash, end of period |
2,332,068
|
7,007,809
|
Supplemental information |
|
|
Income taxes paid |
|
|
Noncash investing and financing activities |
|
|
Options issued to settle accrued bonus |
$ 77,400
|
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
Net Income (Loss) |
$ (783,733)
|
$ (865,970)
|
$ (1,769,238)
|
$ (3,709,899)
|
$ (1,649,703)
|
$ (5,479,137)
|
X |
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v3.24.2.u1
The Company
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The Company |
1.
The Company
Bone
Biologics Corporation (the “Company”) was incorporated under the laws of the State of Delaware on October 18, 2007 as AFH
Acquisition X, Inc. Pursuant to a Merger Agreement, dated September 19, 2014, by and among the Company, its wholly-owned subsidiary,
Bone Biologics Acquisition Corp., (“Merger Sub”), and Bone Biologics, Inc., Merger Sub merged with and into Bone Biologics
Inc., with Bone Biologics Inc. remaining as the surviving corporation. On September 22, 2014, the Company changed its name to “Bone
Biologics Corporation” and Bone Biologics, Inc. became a wholly owned subsidiary of the Company. Bone Biologics, Inc. was incorporated
in California on September 9, 2004.
The
Company is 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 the
Company 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.
The
production and marketing of the Company’s products and its ongoing research and development activities will be subject to extensive
regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product
developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval
process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems
in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.
The
Company’s success will depend in part on its 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 the Company will not be challenged, invalidated, or circumvented, or that the rights granted thereunder
will provide proprietary protection or competitive advantages to the Company.
Going
Concern and Liquidity
The
Company has not generated revenue from operations and since inception to June 30, 2024 has incurred accumulated losses of
approximately $82.6
million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBM.
Operating expenditures for the next twelve months are estimated at $5.1
million. The accompanying unaudited condensed 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, the Company 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 one year after the date that the financial statements are issued. In addition, our independent
registered public accounting firm, in its audit report to the financial statements included in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2023, expressed substantial doubt about the Company’s 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.
As
of June 30, 2024, the Company had $2.3 million in cash on hand.
On August 2, 2024, the Company
completed a warrant inducement transaction generating net proceeds to the Company of approximately $1.7
million (see Note 8).
Available cash inclusive of the
proceeds from the August 2024 warrant inducement transaction is anticipated to cover our operational needs into the first quarter of
2025.
The
Company will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional
working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to
meet the Company’s needs. If cash resources are insufficient to satisfy the Company’s on-going cash requirements, the Company
will be required to scale back or discontinue its product development programs, or obtain funds if available (although there can be no
certainties) through strategic alliances that may require the Company to relinquish rights to its technology, or substantially reduce
or discontinue its operations entirely. No assurance can be given that any future financing will be available or, if available, that
it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain
undue restrictions on the Company’s operations, in the case of debt financing, or cause substantial dilution for its stockholders,
in the case of equity financing.
Reverse
stock splits
On
June 5, 2023, the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-30 reverse stock split of its outstanding common stock and warrants. The amendment was
authorized by the Company’s stockholders on May 1, 2023, and was effective on June 5, 2023.
On
December 14, 2023, the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-8 reverse stock split of its outstanding common stock and warrants. The amendment was
authorized by the Company’s stockholders on December 12, 2023, and was effective on December 20, 2023.
All
share and per share amounts have been retro-actively restated as if the reverse splits occurred at the beginning of the earliest period
presented.
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring
adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for
a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles
generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations
of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the
information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2023 was derived from the
audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on February 21,
2024 (the “2023 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the
Company’s audited financial statements for the year ended December 31, 2023 and notes thereto included in the 2023 Annual Report.
The
results of operations for the six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the entire
fiscal year ended December 31, 2024 or for any other period.
Segment
Information
The
Company operates and reports in one segment, which focuses on bone regeneration in spinal fusion using the recombinant human protein
known as NELL-1. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the
Chief Operating Decision Maker, which is the Company’s Chief Executive Officer and President.
Use
of Estimates
The
preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include
the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity
instruments, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could
differ from those estimates.
Inflation
Macroeconomic
factors such as inflation, rising interest rates, governmental responses there to and possible recession caused thereby also add significant
uncertainty to the Company’s operations and possible effects to the amount and type of financing available to the Company in the
future.
Cash
Cash
primarily consists of bank demand deposits maintained by a major financial institution. The Company’s policy is to maintain its
cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation
(the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically
have cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively.
The Company has not experienced any losses to date resulting from this policy.
Research
and Development Costs
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. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless
the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that
a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined
as non-refundable are charged to operations as incurred.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheets and are then charged to research and development costs in the Company’s consolidated statements of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheets, with a corresponding charge to research and development costs
in the Company’s consolidated statements of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Fair
Value of Financial Instruments
Accounting
standards require certain assets and liabilities be reported at fair value in the financial statements and provide a framework for establishing
that fair value. The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the
use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which
the first two are considered observable and the last is considered unobservable:
Level
1: Quoted prices in active markets for identical assets or liabilities.
Level
2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.
The
fair value of financial instruments measured on a recurring basis was as follows as of June 30, 2024:
Schedule of Fair Value Liabilities Measured on Recurring Basic
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
Total liabilities at fair value | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
The
following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level
3 inputs for the six month period ended June 30, 2024 as follows:
Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable
| |
June 30, 2024 | |
Warrant liability | |
| | |
Balance as of beginning of period – December 31, 2023 | |
$ | 55,751 | |
Change in fair value | |
| (48,096 | ) |
Balance as of June 30, 2024 | |
$ | 7,655 | |
The
Company believes the carrying amount of certain financial instruments, including cash and accounts payable approximate their values based
on their short-term nature and are excluded from the fair value tables above.
Stock
Based Compensation
ASC
718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions
to employees and non-employees. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other
equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including
grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair
values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award,
known as the requisite service period (usually the vesting period). Recognition of compensation expense for non-employees is in the same
period and manner as if the Company had paid cash for the services.
Loss
per Common Share
Basic
loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding
during the period. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include
the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional
common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if options and warrants were
to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.
Since
the effects of outstanding options and warrants are anti-dilutive for the six months ended June 30, 2024 and 2023, shares of common stock
underlying these instruments have been excluded from the computation of loss per common share.
The
following sets forth the number of shares of common stock underlying outstanding options and warrants as of June 30, 2024 and 2023:
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 1,025,970 | | |
| 46,912 | |
Stock options | |
| 74,151 | | |
| 2,125 | |
Anti
dilutive securities | |
| 1,100,121 | | |
| 49,037 | |
New
Accounting Standards
The
Company’s management has evaluated all the recently issued, but not yet effective, accounting standards and guidance that have
been issued or proposed by the Financial Accounting Standards Board or other standards-setting bodies through the filing date of
these financial statements and does not believe the future adoption of any such pronouncements will have a material effect on the
Company’s financial position and results of operations.
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v3.24.2.u1
Warrant Liability
|
6 Months Ended |
Jun. 30, 2024 |
Warrant Liability |
|
Warrant Liability |
3.
Warrant Liability
In
October 2022, the Company completed a public equity offering, which included the issuance of 54,174 warrants. The warrants provide for
a Black Scholes value calculation, as defined, in the event of certain transactions (“Fundamental Transactions,” as defined),
which includes a floor on volatility utilized in the Black Scholes value calculation at 100% or greater. The Company has 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, the Company has 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.
The
warrant liability was valued at the following dates using a Black-Scholes model with the following assumptions:
Schedule of Warrant Liability Black-Scholes Model
| |
June 30, 2024 | | |
December 31, 2023 | |
Warrant liability: | |
| | | |
| | |
Risk-free interest rate | |
| 4.49 | % | |
| 3.94 | % |
Expected volatility | |
| 134.22 | % | |
| 136.25 | % |
Expected life (in years) | |
| 3.28 | | |
| 3.78 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair Value of warrant liability | |
$ | 7,655 | | |
$ | 55,751 | |
The
risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. The Company determines expected volatility based
upon the historical volatility of the Company’s common stock. The Company does not believe that the future volatility of its common
stock over an option’s expected term is likely to differ significantly from the past. The expected term of the warrants granted
are determined based on the duration of time the warrants are expected to be outstanding. The dividend yield on the Company’s warrants
is assumed to be zero as the Company has not historically paid dividends.
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Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
4.
Stockholders’ Equity
Preferred
Stock
The
Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue a total of 20,000,000 shares of preferred
stock. No shares have been issued as of June 30, 2024 and December 31, 2023.
Common
Stock
The
Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue a total of 100,000,000 shares of common
stock. As of June 30, 2024 and December 31, 2023, the Company had an aggregate of 1,315,489 and 534,238 shares of common stock outstanding,
respectively.
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 (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.
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.
In
March 2024, 137,313 shares of common stock were issued upon the exercise of 137,313 pre-funded warrants, for proceeds of $137.
During
the three months ended June 30, 2024, 299,000 shares of common stock were issued upon the exercise of 299,000 pre-funded warrants, for proceeds of $299.
The Company issued warrants to purchase up to an aggregate
of 46,875 shares of common stock to the placement agent, as compensation in connection with the March 2024 offering. The warrants issued
to the placement agent have substantially the same terms and conditions as the warrants issued to investors, except that the placement
agent warrants have an exercise price of $3.20 per share.
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v3.24.2.u1
Common Stock Warrants
|
6 Months Ended |
Jun. 30, 2024 |
Common Stock Warrants |
|
Common Stock Warrants |
5.
Common Stock Warrants
A
summary of warrant activity for the six months ended June 30, 2024 is presented below:
Schedule of Warrant Activity
Subject to Exercise | |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | |
Outstanding as of December 31, 2023 | |
| 197,844 | | |
$ | 127.86 | | |
| 4.95 | |
Granted – 2024 | |
| 1,490,377 | | |
| 1.44 | | |
| 5.00 | |
Forfeited/Expired – 2024 | |
| - | | |
| - | | |
| - | |
Exercised – 2024 | |
| (662,251 | ) | |
| 0.001 | | |
| 4.68 | |
Outstanding as of June 30, 2024 | |
| 1,025,970 | | |
$ | 26.65 | | |
| 4.64 | |
As
of June 30, 2024, the Company had outstanding exercisable, but unexercised Common Stock Warrants as follows:
Schedule of Outstanding Vested and Unexercised Common Stock Warrants
Date Issued | |
Exercise Price | | |
Number of Warrants | | |
Expiration date |
|
October 2021 | |
$ | 1,512.00 | | |
| 7,620 | | |
October 13, 2026 |
|
October 2022 | |
$ | 388.80 | | |
| 18,058 | | |
October 12, 2027 |
|
October 2022 | |
$ | 324.00 | | |
| 18,846 | | |
October 12, 2027 |
|
October 2022 | |
$ | 0.00 | | |
| 2,393 | | |
October 12, 2027 |
|
November 2023 | |
$ | 6.40 | | |
| 8,543 | | |
November 16, 2028 |
|
November 2023 | |
$ | 4.16 | | |
| 142,384 | | |
May 21, 2029 |
|
March 2024 | |
$ | 2.43 | | |
| 781,251 | | |
March 6, 2029 |
|
March 2024 | |
$ | 3.20 | | |
| 46,875 | | |
March 6, 2029 |
|
Total outstanding warrants at June 30, 2024 | |
| | | |
| 1,025,970 | | |
|
|
Based
on a fair market value of $1.22 per share on June 30, 2024, there 2,393 exercisable but unexercised in-the-money common stock warrants
on that date. Accordingly, the intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2024 was $2,919.
Please see Note 8 Subsequent Events for disclose of a warrant inducement entered into on August 1, 2024.
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v3.24.2.u1
Stock-based Compensation
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based Compensation |
6.
Stock-based Compensation
2015
Equity Incentive Plan
The
Company has 629,489 shares of common stock authorized and reserved for issuance under its 2015 Equity Incentive Plan for option awards.
This reserve may be increased by the Board each year by up to the number of shares of stock equal to 5% of the number of shares of stock
issued and outstanding on the immediately preceding December 31. Shares subject to awards granted under the 2015 Equity Incentive Plan
which expire, are repurchased or are cancelled or forfeited will again become available for issuance under the 2015 Equity Incentive
Plan. The shares available will not be reduced by awards settled in cash. Shares withheld to satisfy tax withholding obligations will
not again become available for grant. The gross number of shares issued upon the exercise of stock appreciation rights or options exercised
by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under the 2015 Equity Incentive
Plan.
Awards
may be granted under the 2015 Equity Incentive Plan to the Company’s employees, including officers, director or consultants, and
its present or future affiliated entities. While the Company may grant incentive stock options only to employees, it may grant non-statutory
stock options, stock appreciation rights, restricted stock purchase rights or bonuses, restricted stock units, performance shares, performance
units and cash-based awards or other stock based awards to any eligible participant.
The
2015 Equity Incentive Plan is administered by the Company’s compensation committee. Subject to the provisions of the 2015 Equity
Incentive Plan, the compensation committee determines, in its discretion, the persons to whom, and the times at which, awards are granted,
as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between the Company and the
holder of the award. The compensation committee has the authority to construe and interpret the terms of the 2015 Equity Incentive Plan
and awards granted under the 2015 Equity Incentive Plan.
A
summary of stock option activity for the six months ended June 30, 2024 is presented below:
Schedule of Stock Option Activity
Subject to Exercise | |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2023 | |
| 34,310 | | |
$ | 236.70 | | |
| 8.62 | | |
$ | - | |
Granted – 2024 | |
| 45,515 | | |
| 3.72 | | |
| 3.41 | | |
| - | |
Forfeited/Expired – 2024 | |
| (5,674 | ) | |
| 54.24 | | |
| 7.94 | | |
| - | |
Exercised – 2024 | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 74,151 | | |
$ | 107.65 | | |
| 4.87 | | |
$ | - | |
Options vested and exercisable at June 30, 2024 | |
| 59,419 | | |
$ | 133.13 | | |
| 3.96 | | |
$ | - | |
As
of June 30, 2024, the Company had outstanding stock options as follows:
Schedule of Outstanding Stock Options
Date Issued | |
Exercise Price | | |
Number of Options | | |
Expiration date |
|
August 2015 | |
$ | 9,540.00 | | |
| 174 | | |
December 27, 2025 |
|
September 2015 | |
$ | 9,540.00 | | |
| 36 | | |
December 27, 2025 |
|
November 2015 | |
$ | 9,540.00 | | |
| 205 | | |
December 27, 2025 |
|
December 2015 | |
$ | 9,540.00 | | |
| 12 | | |
December 27, 2025 |
|
January 2016 | |
$ | 9,540.00 | | |
| 213 | | |
January 9, 2026 |
|
May 2016 | |
$ | 12,300.00 | | |
| 45 | | |
May 26, 2026 |
|
September 2016 | |
$ | 12,300.00 | | |
| 21 | | |
May 31, 2026 |
|
January 2017 | |
$ | 12,300.00 | | |
| 10 | | |
January 1, 2027 |
|
January 2018 | |
$ | 11,820.00 | | |
| 8 | | |
January 1, 2028 |
|
January 2019 | |
$ | 564.00 | | |
| 92 | | |
January 1, 2029 |
|
October 2021 | |
$ | 1,260.00 | | |
| 207 | | |
October 26, 2031 |
|
January 2022 | |
$ | 844.80 | | |
| 111 | | |
January 1, 2032 |
|
August 2022 | |
$ | 387.26 | | |
| 462 | | |
August 23, 2032 |
|
January 2023 | |
$ | 57.60 | | |
| 237 | | |
January 25, 2025 |
|
September 2023 | |
$ | 5.12 | | |
| 26,803 | | |
September 12, 2033 |
|
January 2024 | |
$ | 4.68 | | |
| 8,015 | | |
January 8, 2034 |
|
January 2024 | |
$ | 3.61 | | |
| 37,500 | | |
January 17, 2026 |
|
| |
| | | |
| | | |
|
|
Total outstanding options at June 30, 2024 | |
| | | |
| 74,151 | | |
|
|
Based
on a fair value of $1.22 per share on June 30, 2024. There were no exercisable but unexercised in-the-money common stock warrants on
that date.
During
the six months ended June 30, 2024, options exercisable into 8,015 shares of common stock were granted with a fair value of $34,039.
Vesting of options differs based on the terms of each option. During the six months ended June 30, 2024 and 2023, the Company had stock-based
compensation expense of $70,124 and $61,434, respectively, related to the vesting of stock options granted to the Company’s employees
and directors included in our reported net loss. In addition, during the six months ended June 30, 2024, options exercisable into 37,500
shares of common stock were issued to employees in settlement of previously accrued bonuses of $77,400.
In
January 2024, options exercisable into 5,674 shares of common stock were forfeited upon the resignation of a director. The Company’s
policy is to account for forfeitures of the unvested portion of option grants when they occur; therefore, these forfeitures are recorded
as a reversal to expense, which can result in a credit balance in the statement of operations.
The
Company utilized the Black-Scholes option-pricing model. The assumptions used for the six months ended June 30, 2024 are as follows:
Schedule of Assumptions Using Black-Scholes Option Pricing Mode
| |
June 30, 2024 | |
Risk free interest rate | |
| 3.97 | % |
Expected Volatility | |
| 137.91 | % |
Expected life (in years) | |
| 5.58 | |
Expected dividend yield | |
| 0 | % |
The
expected volatility is a measure of the amount by which the Company stock price is expected to fluctuate during the expected term of
options granted. The Company determines the expected volatility based upon the historical volatility of our common stock since listing
on The Nasdaq Capital Market. The Company does not believe that the future volatility of its common stock over an option’s expected
term is likely to differ significantly from the past. The risk-free interest rate used in the calculations is based on the implied yield
available on U.S. Treasury issues with an equivalent term approximating the expected life of the options as calculated using the simplified
method. The expected life of the options used was based on the contractual life of the option granted. Stock-based compensation is a
non-cash expense because the Company settles these obligations by issuing shares of its common stock from its authorized shares instead
of settling such obligations with cash payments.
As
of June 30, 2024, total unrecognized compensation cost related to unvested stock options was $6,811. The cost is expected to be recognized
over a weighted average period of 0.03 years.
|
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
7.
Commitments and Contingencies
UCLA
TDG Exclusive License Agreement
Effective
April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019 and 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 the Company 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.
The
Company has 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. The Company must pay the royalties to UCLA
TDG on a quarterly basis. Upon a first commercial sale, the Company 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 the Company is required to pay any third party any royalties
as a result of it making use of UCLA TDG patents, then it may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point
paid to a third party. If the Company grants sublicense rights to a third party to use the UCLA TDG patent, then it will pay UCLA TDG
10% to 20% of the sublicensing income it receives from such sublicense.
The
Company is obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:
|
● |
$100,000
upon enrollment of the first subject in a Feasibility Study; |
|
|
|
|
● |
$250,000
upon enrollment of the first subject in a Pivotal Study: |
|
|
|
|
● |
$
upon Pre-Market Approval of a Licensed Product or Licensed Method; and |
|
|
|
|
● |
$1,000,000
upon the First Commercial Sale of a Licensed Product or Licensed Method. |
The
Company is 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:
|
● |
Due
upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000; |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and |
|
|
|
|
● |
Due
upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000. |
The
Company’s obligation to pay the Diligence Fee will survive termination or expiration of the agreement and it is prohibited from
assigning, selling, or otherwise transferring any of its assets related to any Licensed Product unless its Diligence Fee obligation is
assigned, sold, or transferred along with such assets, or unless it pays UCLA TDG the Diligence Fee within ten (10) days of such assignment,
sale or other transfer of such rights to any Licensed Product.
The
Company is 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:
|
● |
$500,000;
or |
|
|
|
|
● |
2%
of all proceeds in connection with a Change of Control Transaction. |
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.
The
Company is obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in
the Amended License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license
if it does not meet certain diligence milestone deadlines set forth in the Amended License Agreement.
The
Company must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License
Agreement. The Company has 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 the Company’s expense, be joined involuntarily to the action. The Company
is required to indemnify UCLA TDG against any third party claims arising out of its exercise of the rights under the Amended License
Agreement or any sublicense.
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.
Contingencies
The
Company is subject to claims and assessments from time to time in the ordinary course of business. The Company’s management does
not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business,
financial condition, results of operations or cash flows.
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v3.24.2.u1
Subsequent Events
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
8.
Subsequent Events
On August 1, 2024, the Company entered into warrant inducement letter agreements
with holders of the March 2024 Warrants. The Company 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, the Company completed the warrant inducement transaction and received net proceeds to the Company of approximately $1.7 million.
In addition, the Company 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.
Due
to certain beneficial ownership limitations set forth in the March 2024 Warrants, the Company issued the number of shares that would
not cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of common stock in
abeyance. Of March 2024 Warrants exercised, an aggregate of 560,251 shares
of common stock were held in abeyance. The abeyance shares will be held until notice is received
by the holder that the shares of common stock may be issued in compliance with such beneficial ownership limitations. Until such time, the abeyance shares are evidenced
through the holder's existing warrants and will continue to be included in the Company's table of outstanding warrants. The abeyance
shares are not considered issued or outstanding in our consolidated balance sheets.
As
of August 6, 2024, 264,938
Abeyance Shares were released and issued.
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring
adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for
a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles
generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations
of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the
information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2023 was derived from the
audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on February 21,
2024 (the “2023 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the
Company’s audited financial statements for the year ended December 31, 2023 and notes thereto included in the 2023 Annual Report.
The
results of operations for the six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the entire
fiscal year ended December 31, 2024 or for any other period.
|
Segment Information |
Segment
Information
The
Company operates and reports in one segment, which focuses on bone regeneration in spinal fusion using the recombinant human protein
known as NELL-1. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the
Chief Operating Decision Maker, which is the Company’s Chief Executive Officer and President.
|
Use of Estimates |
Use
of Estimates
The
preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include
the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity
instruments, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could
differ from those estimates.
|
Inflation |
Inflation
Macroeconomic
factors such as inflation, rising interest rates, governmental responses there to and possible recession caused thereby also add significant
uncertainty to the Company’s operations and possible effects to the amount and type of financing available to the Company in the
future.
|
Cash |
Cash
Cash
primarily consists of bank demand deposits maintained by a major financial institution. The Company’s policy is to maintain its
cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation
(the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically
have cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively.
The Company has not experienced any losses to date resulting from this policy.
|
Research and Development Costs |
Research
and Development Costs
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. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless
the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that
a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined
as non-refundable are charged to operations as incurred.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheets and are then charged to research and development costs in the Company’s consolidated statements of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheets, with a corresponding charge to research and development costs
in the Company’s consolidated statements of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
Accounting
standards require certain assets and liabilities be reported at fair value in the financial statements and provide a framework for establishing
that fair value. The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the
use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which
the first two are considered observable and the last is considered unobservable:
Level
1: Quoted prices in active markets for identical assets or liabilities.
Level
2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.
The
fair value of financial instruments measured on a recurring basis was as follows as of June 30, 2024:
Schedule of Fair Value Liabilities Measured on Recurring Basic
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
Total liabilities at fair value | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
The
following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level
3 inputs for the six month period ended June 30, 2024 as follows:
Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable
| |
June 30, 2024 | |
Warrant liability | |
| | |
Balance as of beginning of period – December 31, 2023 | |
$ | 55,751 | |
Change in fair value | |
| (48,096 | ) |
Balance as of June 30, 2024 | |
$ | 7,655 | |
The
Company believes the carrying amount of certain financial instruments, including cash and accounts payable approximate their values based
on their short-term nature and are excluded from the fair value tables above.
|
Stock Based Compensation |
Stock
Based Compensation
ASC
718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions
to employees and non-employees. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other
equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including
grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair
values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award,
known as the requisite service period (usually the vesting period). Recognition of compensation expense for non-employees is in the same
period and manner as if the Company had paid cash for the services.
|
Loss per Common Share |
Loss
per Common Share
Basic
loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding
during the period. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include
the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional
common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if options and warrants were
to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.
Since
the effects of outstanding options and warrants are anti-dilutive for the six months ended June 30, 2024 and 2023, shares of common stock
underlying these instruments have been excluded from the computation of loss per common share.
The
following sets forth the number of shares of common stock underlying outstanding options and warrants as of June 30, 2024 and 2023:
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 1,025,970 | | |
| 46,912 | |
Stock options | |
| 74,151 | | |
| 2,125 | |
Anti
dilutive securities | |
| 1,100,121 | | |
| 49,037 | |
|
New Accounting Standards |
New
Accounting Standards
The
Company’s management has evaluated all the recently issued, but not yet effective, accounting standards and guidance that have
been issued or proposed by the Financial Accounting Standards Board or other standards-setting bodies through the filing date of
these financial statements and does not believe the future adoption of any such pronouncements will have a material effect on the
Company’s financial position and results of operations.
|
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v3.24.2.u1
Summary of Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Fair Value Liabilities Measured on Recurring Basic |
The
fair value of financial instruments measured on a recurring basis was as follows as of June 30, 2024:
Schedule of Fair Value Liabilities Measured on Recurring Basic
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
Total liabilities at fair value | |
$ | 7,655 | | |
| — | | |
| — | | |
$ | 7,655 | |
|
Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable |
The
following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level
3 inputs for the six month period ended June 30, 2024 as follows:
Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable
| |
June 30, 2024 | |
Warrant liability | |
| | |
Balance as of beginning of period – December 31, 2023 | |
$ | 55,751 | |
Change in fair value | |
| (48,096 | ) |
Balance as of June 30, 2024 | |
$ | 7,655 | |
|
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share |
The
following sets forth the number of shares of common stock underlying outstanding options and warrants as of June 30, 2024 and 2023:
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 1,025,970 | | |
| 46,912 | |
Stock options | |
| 74,151 | | |
| 2,125 | |
Anti
dilutive securities | |
| 1,100,121 | | |
| 49,037 | |
|
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- DefinitionTabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities.
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v3.24.2.u1
Warrant Liability (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Warrant Liability |
|
Schedule of Warrant Liability Black-Scholes Model |
The
warrant liability was valued at the following dates using a Black-Scholes model with the following assumptions:
Schedule of Warrant Liability Black-Scholes Model
| |
June 30, 2024 | | |
December 31, 2023 | |
Warrant liability: | |
| | | |
| | |
Risk-free interest rate | |
| 4.49 | % | |
| 3.94 | % |
Expected volatility | |
| 134.22 | % | |
| 136.25 | % |
Expected life (in years) | |
| 3.28 | | |
| 3.78 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair Value of warrant liability | |
$ | 7,655 | | |
$ | 55,751 | |
|
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v3.24.2.u1
Common Stock Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Common Stock Warrants |
|
Schedule of Warrant Activity |
A
summary of warrant activity for the six months ended June 30, 2024 is presented below:
Schedule of Warrant Activity
Subject to Exercise | |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | |
Outstanding as of December 31, 2023 | |
| 197,844 | | |
$ | 127.86 | | |
| 4.95 | |
Granted – 2024 | |
| 1,490,377 | | |
| 1.44 | | |
| 5.00 | |
Forfeited/Expired – 2024 | |
| - | | |
| - | | |
| - | |
Exercised – 2024 | |
| (662,251 | ) | |
| 0.001 | | |
| 4.68 | |
Outstanding as of June 30, 2024 | |
| 1,025,970 | | |
$ | 26.65 | | |
| 4.64 | |
|
Schedule of Outstanding Vested and Unexercised Common Stock Warrants |
As
of June 30, 2024, the Company had outstanding exercisable, but unexercised Common Stock Warrants as follows:
Schedule of Outstanding Vested and Unexercised Common Stock Warrants
Date Issued | |
Exercise Price | | |
Number of Warrants | | |
Expiration date |
|
October 2021 | |
$ | 1,512.00 | | |
| 7,620 | | |
October 13, 2026 |
|
October 2022 | |
$ | 388.80 | | |
| 18,058 | | |
October 12, 2027 |
|
October 2022 | |
$ | 324.00 | | |
| 18,846 | | |
October 12, 2027 |
|
October 2022 | |
$ | 0.00 | | |
| 2,393 | | |
October 12, 2027 |
|
November 2023 | |
$ | 6.40 | | |
| 8,543 | | |
November 16, 2028 |
|
November 2023 | |
$ | 4.16 | | |
| 142,384 | | |
May 21, 2029 |
|
March 2024 | |
$ | 2.43 | | |
| 781,251 | | |
March 6, 2029 |
|
March 2024 | |
$ | 3.20 | | |
| 46,875 | | |
March 6, 2029 |
|
Total outstanding warrants at June 30, 2024 | |
| | | |
| 1,025,970 | | |
|
|
|
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v3.24.2.u1
Stock-based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Option Activity |
A
summary of stock option activity for the six months ended June 30, 2024 is presented below:
Schedule of Stock Option Activity
Subject to Exercise | |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Life (Years) | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2023 | |
| 34,310 | | |
$ | 236.70 | | |
| 8.62 | | |
$ | - | |
Granted – 2024 | |
| 45,515 | | |
| 3.72 | | |
| 3.41 | | |
| - | |
Forfeited/Expired – 2024 | |
| (5,674 | ) | |
| 54.24 | | |
| 7.94 | | |
| - | |
Exercised – 2024 | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 74,151 | | |
$ | 107.65 | | |
| 4.87 | | |
$ | - | |
Options vested and exercisable at June 30, 2024 | |
| 59,419 | | |
$ | 133.13 | | |
| 3.96 | | |
$ | - | |
|
Schedule of Outstanding Stock Options |
As
of June 30, 2024, the Company had outstanding stock options as follows:
Schedule of Outstanding Stock Options
Date Issued | |
Exercise Price | | |
Number of Options | | |
Expiration date |
|
August 2015 | |
$ | 9,540.00 | | |
| 174 | | |
December 27, 2025 |
|
September 2015 | |
$ | 9,540.00 | | |
| 36 | | |
December 27, 2025 |
|
November 2015 | |
$ | 9,540.00 | | |
| 205 | | |
December 27, 2025 |
|
December 2015 | |
$ | 9,540.00 | | |
| 12 | | |
December 27, 2025 |
|
January 2016 | |
$ | 9,540.00 | | |
| 213 | | |
January 9, 2026 |
|
May 2016 | |
$ | 12,300.00 | | |
| 45 | | |
May 26, 2026 |
|
September 2016 | |
$ | 12,300.00 | | |
| 21 | | |
May 31, 2026 |
|
January 2017 | |
$ | 12,300.00 | | |
| 10 | | |
January 1, 2027 |
|
January 2018 | |
$ | 11,820.00 | | |
| 8 | | |
January 1, 2028 |
|
January 2019 | |
$ | 564.00 | | |
| 92 | | |
January 1, 2029 |
|
October 2021 | |
$ | 1,260.00 | | |
| 207 | | |
October 26, 2031 |
|
January 2022 | |
$ | 844.80 | | |
| 111 | | |
January 1, 2032 |
|
August 2022 | |
$ | 387.26 | | |
| 462 | | |
August 23, 2032 |
|
January 2023 | |
$ | 57.60 | | |
| 237 | | |
January 25, 2025 |
|
September 2023 | |
$ | 5.12 | | |
| 26,803 | | |
September 12, 2033 |
|
January 2024 | |
$ | 4.68 | | |
| 8,015 | | |
January 8, 2034 |
|
January 2024 | |
$ | 3.61 | | |
| 37,500 | | |
January 17, 2026 |
|
| |
| | | |
| | | |
|
|
Total outstanding options at June 30, 2024 | |
| | | |
| 74,151 | | |
|
|
|
Schedule of Assumptions Using Black-Scholes Option Pricing Mode |
The
Company utilized the Black-Scholes option-pricing model. The assumptions used for the six months ended June 30, 2024 are as follows:
Schedule of Assumptions Using Black-Scholes Option Pricing Mode
| |
June 30, 2024 | |
Risk free interest rate | |
| 3.97 | % |
Expected Volatility | |
| 137.91 | % |
Expected life (in years) | |
| 5.58 | |
Expected dividend yield | |
| 0 | % |
|
X |
- DefinitionTabular disclosure of option exercise prices, by grouped ranges, including the upper and lower limits of the price range, the number of shares under option, weighted average exercise price and remaining contractual option terms.
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v3.24.2.u1
The Company (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
|
Aug. 02, 2024 |
Dec. 14, 2023 |
Jun. 05, 2023 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
|
$ 82,558,661
|
|
|
|
$ 82,558,661
|
|
$ 80,908,958
|
Operating expenses |
|
|
|
|
|
|
|
5,100,000
|
|
|
Net loss |
|
|
|
783,733
|
$ 865,970
|
$ 1,769,238
|
$ 3,709,899
|
1,649,703
|
$ 5,479,137
|
|
Net cash used in operating activities |
|
|
|
|
|
|
|
2,199,276
|
4,982,666
|
|
Cash |
|
|
|
$ 2,332,068
|
|
|
|
2,332,068
|
|
$ 3,026,569
|
Proceeds from warrant exercises |
$ 1,700,000
|
|
|
|
|
|
|
$ 436
|
|
|
Stockholders' equity, reverse stock split |
|
the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-8 reverse stock split of its outstanding common stock and warrants
|
the
Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary of State of the
State of Delaware to effect a 1-for-30 reverse stock split of its outstanding common stock and warrants
|
|
|
|
|
|
|
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Schedule of Fair Value Liabilities Measured on Recurring Basic (Details) - Fair Value, Recurring [Member]
|
Jun. 30, 2024
USD ($)
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Warrant liability |
$ 7,655
|
Total liabilities at fair value |
7,655
|
Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Warrant liability |
|
Total liabilities at fair value |
|
Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Warrant liability |
|
Total liabilities at fair value |
|
Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Warrant liability |
7,655
|
Total liabilities at fair value |
$ 7,655
|
X |
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v3.24.2.u1
Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti dilutive securities |
1,100,121
|
49,037
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti dilutive securities |
1,025,970
|
46,912
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti dilutive securities |
74,151
|
2,125
|
X |
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Schedule of Warrant Liability Black-Scholes Model (Details) - Warrant [Member]
|
Jun. 30, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value of warrant liability |
$ 7,655
|
$ 55,751
|
Measurement Input, Risk Free Interest Rate [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
4.49
|
3.94
|
Measurement Input Expected Volatility [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
134.22
|
136.25
|
Measurement Input, Expected Term [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
3.28
|
3.78
|
Measurement Input Expected Dividend Yield [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
|
|
X |
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
|
|
Mar. 06, 2024 |
Mar. 31, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Oct. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
20,000,000
|
|
|
20,000,000
|
|
Preferred stock, shares issued |
|
|
0
|
|
|
0
|
|
Common stock, shares authorized |
|
|
100,000,000
|
|
|
100,000,000
|
|
Common stock, shares outstanding |
|
|
1,315,489
|
|
|
534,238
|
|
Warrants to purchase |
|
|
|
|
|
|
54,174
|
Exercise of warrants |
|
|
|
$ 1,504,339
|
$ 4,452,163
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Proceeds from sale of common stock in public offering, shares |
|
|
|
344,938
|
317,259
|
|
|
Warrants to purchase |
225,938
|
|
|
|
|
|
|
Exercise of warrants |
|
|
|
$ 345
|
$ 317
|
|
|
Common Stock [Member] | March Offering [Member] |
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Proceeds from sale of common stock in public offering, shares |
119,000
|
|
|
|
|
|
|
Warrants to purchase |
119,000
|
|
|
|
|
|
|
Exercise price |
$ 2.43
|
|
$ 3.20
|
|
|
|
|
Public offering price |
$ 2.56
|
|
|
|
|
|
|
Warrants to purchase |
|
|
46,875
|
|
|
|
|
Prefunded Warrant [Member] | March Offering [Member] |
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Proceeds from sale of common stock in public offering, shares |
662,251
|
|
|
|
|
|
|
Exercise price |
$ 0.001
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase |
|
137,313
|
299,000
|
137,313
|
|
|
|
Exercise of warrants |
225,938
|
137,313
|
299,000
|
|
|
|
|
Exercise of warrants |
$ 1,500,000
|
$ 137
|
$ 299
|
|
|
|
|
Warrant [Member] | March Offering [Member] |
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase |
662,251
|
|
|
|
|
|
|
Exercise price |
$ 2.43
|
|
|
|
|
|
|
Public offering price |
$ 2.559
|
|
|
|
|
|
|
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Schedule of Warrant Activity (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Common Stock Warrants |
|
|
Number of Warrants, Outstanding |
197,844
|
|
Weighted Average Exercise Price, Outstanding |
$ 127.86
|
|
Weighted Average Life (Years), Outstanding |
4 years 7 months 20 days
|
4 years 11 months 12 days
|
Number of Warrants, Granted |
1,490,377
|
|
Weighted Average Exercise Price, Granted |
$ 1.44
|
|
Weighted Average Life (Years), Granted |
5 years
|
|
Number of Warrants, Forfeited/Expired |
|
|
Weighted Average Exercise Price ,Forfeited/Expired |
|
|
Number of Warrants, Exercised |
(662,251)
|
|
Weighted Average Exercise Price, Exercised |
$ 0.001
|
|
Weighted Average Life (Years), Exercised |
4 years 8 months 4 days
|
|
Number of Warrants, Outstanding |
1,025,970
|
197,844
|
Weighted Average Exercise Price, Outstanding |
$ 26.65
|
$ 127.86
|
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v3.24.2.u1
Schedule of Outstanding Vested and Unexercised Common Stock Warrants (Details) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Total outstanding warrants |
1,025,970
|
197,844
|
October 2021 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 1,512.00
|
|
Total outstanding warrants |
7,620
|
|
Expiration date |
Oct. 13, 2026
|
|
October 2022 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 388.80
|
|
Total outstanding warrants |
18,058
|
|
Expiration date |
Oct. 12, 2027
|
|
October 2022-1 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 324.00
|
|
Total outstanding warrants |
18,846
|
|
Expiration date |
Oct. 12, 2027
|
|
October 2022-2 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 0.00
|
|
Total outstanding warrants |
2,393
|
|
Expiration date |
Oct. 12, 2027
|
|
November 2023 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 6.40
|
|
Total outstanding warrants |
8,543
|
|
Expiration date |
Nov. 16, 2028
|
|
November 2023-1 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 4.16
|
|
Total outstanding warrants |
142,384
|
|
Expiration date |
May 21, 2029
|
|
March 2024 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 2.43
|
|
Total outstanding warrants |
781,251
|
|
Expiration date |
Mar. 06, 2029
|
|
March 2024-1 [Member] | Vested and Unexercised Common Stock Warrants [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Exercise price |
$ 3.20
|
|
Total outstanding warrants |
46,875
|
|
Expiration date |
Mar. 06, 2029
|
|
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Schedule of Stock Option Activity (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
Number of Options Outstanding, Beginning balance |
34,310
|
|
Weighted Average Exercise Price, Outstanding, Beginning balance |
$ 236.70
|
|
Weighted Average Life (Years), Outstanding |
4 years 10 months 13 days
|
8 years 7 months 13 days
|
Aggregate Intrinsic Value, Outstanding, Beginning balance |
|
|
Number of Options, Granted |
45,515
|
|
Weighted Average Exercise Price, Granted |
$ 3.72
|
|
Weighted Average Life (Years), Granted |
3 years 4 months 28 days
|
|
Number of Options, Forfeited/Expired |
(5,674)
|
|
Weighted Average Exercise Price, Forfeited/Expired |
$ 54.24
|
|
Weighted Average Life (Years), Forfeited/Expired |
7 years 11 months 8 days
|
|
Number of Options, Exercised |
|
|
Weighted Average Exercise Price, Exercised |
|
|
Number of Options Outstanding, Ending balance |
74,151
|
34,310
|
Weighted Average Exercise Price, Outstanding, Ending balance |
$ 107.65
|
$ 236.70
|
Aggregate Intrinsic Value, Outstanding, Ending balance |
|
|
Number of Options, Options Vested and Exercisable |
59,419
|
|
Weighted Average Exercise Price, Options Vested and Exercisable |
$ 133.13
|
|
Weighted Average Life (Years), Options Vested and Exercisable |
3 years 11 months 15 days
|
|
Aggregate Intrinsic Value, Options Vested and Exercisable |
|
|
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v3.24.2.u1
Schedule of Outstanding Stock Options (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Total outstanding options |
74,151
|
August 2015 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 9,540.00
|
Total outstanding options |
174
|
Expiration date |
Dec. 27, 2025
|
September 2015 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 9,540.00
|
Total outstanding options |
36
|
Expiration date |
Dec. 27, 2025
|
November 2015 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 9,540.00
|
Total outstanding options |
205
|
Expiration date |
Dec. 27, 2025
|
December 2015 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 9,540.00
|
Total outstanding options |
12
|
Expiration date |
Dec. 27, 2025
|
January 2016 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 9,540.00
|
Total outstanding options |
213
|
Expiration date |
Jan. 09, 2026
|
May 2016 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 12,300.00
|
Total outstanding options |
45
|
Expiration date |
May 26, 2026
|
September 2016 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 12,300.00
|
Total outstanding options |
21
|
Expiration date |
May 31, 2026
|
January 2017 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 12,300.00
|
Total outstanding options |
10
|
Expiration date |
Jan. 01, 2027
|
January 2018 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 11,820.00
|
Total outstanding options |
8
|
Expiration date |
Jan. 01, 2028
|
January 2019 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 564.00
|
Total outstanding options |
92
|
Expiration date |
Jan. 01, 2029
|
October 2021 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 1,260.00
|
Total outstanding options |
207
|
Expiration date |
Oct. 26, 2031
|
January 2022 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 844.80
|
Total outstanding options |
111
|
Expiration date |
Jan. 01, 2032
|
August 2022 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 387.26
|
Total outstanding options |
462
|
Expiration date |
Aug. 23, 2032
|
January 2023 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 57.60
|
Total outstanding options |
237
|
Expiration date |
Jan. 25, 2025
|
September 2023 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 5.12
|
Total outstanding options |
26,803
|
Expiration date |
Sep. 12, 2033
|
January 2024 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 4.68
|
Total outstanding options |
8,015
|
Expiration date |
Jan. 08, 2034
|
January 2024-1 [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Exercise price | $ / shares |
$ 3.61
|
Total outstanding options |
37,500
|
Expiration date |
Jan. 17, 2026
|
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v3.24.2.u1
Stock-based Compensation (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Jan. 31, 2024 |
Mar. 31, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Fair value, per share |
|
|
$ 1.22
|
|
Options exerciseable |
|
|
|
|
Fair value |
|
|
$ 34,039
|
|
Share-Based Payment Arrangement, Noncash Expense |
|
|
$ 70,124
|
$ 61,434
|
Options exerciseable value |
|
$ 77,400
|
|
|
Common Stock [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options exerciseable |
|
|
8,015
|
|
Options exerciseable value |
|
|
|
|
Common Stock [Member] | Employees [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options exerciseable |
|
|
37,500
|
|
Options exerciseable value |
|
|
$ 77,400
|
|
Common Stock [Member] | Director [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Shares forfeited |
5,674
|
|
|
|
2015 Equity Incentive Plan [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock, capital shares reserved for future issuance |
|
|
629,489
|
|
Percentage of stock issued and outstanding |
|
|
5.00%
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Unrecognized compensation cost |
|
|
$ 6,811
|
|
Weighted average period (in years) |
|
|
10 days
|
|
X |
- DefinitionPercentage of stock issued and outstanding.
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v3.24.2.u1
Commitments and Contingencies (Details Narrative) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
UCLA TDG [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
$ 500,000
|
|
Proceeds from private placement percentage |
2.00%
|
|
License Agreement [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Maintenance fees |
$ 10,000
|
|
Licensed sales net |
3.00%
|
|
License Agreement [Member] | UCLA TDG [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
$ 118,151
|
$ 16,606
|
Diligence fee |
8,000,000
|
|
License Agreement [Member] | UCLA TDG [Member] | First Subject in Feasibility Study [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
100,000
|
|
License Agreement [Member] | UCLA TDG [Member] | First Subject in Pivotal Study [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
250,000
|
|
License Agreement [Member] | UCLA TDG [Member] | Pre Market Approval of Licensed Product Or Licensed Method [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
500,000
|
|
License Agreement [Member] | UCLA TDG [Member] | First Commercial Sale of Licensed Product or Licensed Method [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
License commitment fee |
$ 1,000,000
|
|
License Agreement [Member] | UCLA TDG [Member] | Minimum [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Percentage of commercial sale of product |
10.00%
|
|
License Agreement [Member] | UCLA TDG [Member] | Maximum [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Percentage of commercial sale of product |
20.00%
|
|
License Agreement [Member] | Third Party [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Royalty percentage reduced |
0.333%
|
|
License Agreement [Member] | First Commercial Sale [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Royalty expenses |
$ 50,000
|
|
License Agreement [Member] | After First Commercial Sale [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Royalty expenses |
$ 250,000
|
|
License Agreement [Member] | Scenario 1 [Member] | UCLA TDG [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Cumulative net sales description |
Due
upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000;
|
|
License Agreement [Member] | Scenario 2 [Member] | UCLA TDG [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Cumulative net sales description |
Due
upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and
|
|
License Agreement [Member] | Scenario 3 [Member] | UCLA TDG [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Cumulative net sales description |
Due
upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000.
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v3.24.2.u1
Subsequent Events (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
|
|
3 Months Ended |
|
|
|
Aug. 06, 2024 |
Aug. 02, 2024 |
Aug. 01, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Mar. 06, 2024 |
Oct. 31, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase |
|
|
|
|
|
|
|
54,174
|
Warrant [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase |
|
|
|
137,313
|
|
299,000
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase |
|
|
|
|
|
|
225,938
|
|
Number of new stock issued |
|
|
|
344,938
|
317,259
|
|
|
|
Subsequent Event [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants and rights outstanding term |
|
|
5 years
|
|
|
|
|
|
Exercise price |
|
|
$ 3.35
|
|
|
|
|
|
Number of new stock issued |
|
|
46,875
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Number of new stock issued |
|
560,251
|
|
|
|
|
|
|
Subsequent Event [Member] | Inducement Letter Agreements [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase |
|
|
781,251
|
|
|
|
|
|
Warrants and rights outstanding term |
|
|
5 years
|
|
|
|
|
|
Exercise price |
|
|
$ 2.00
|
|
|
|
|
|
Net proceeds |
|
$ 1.7
|
|
|
|
|
|
|
Number of new stock issued |
264,938
|
|
|
|
|
|
|
|
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