| SUBSEQUENT EVENTS | Note 7
– SUBSEQUENT EVENTS On July 13, 2023, the Company
sold an aggregate of 685,033 3.03 1.8 BRTX-100 ThermoStem Program Note
Regarding Forward-Looking Statements This
Quarterly Report on Form 10-Q includes a number of forward-looking statements that reflect management’s current views with respect
to future events and financial performance. Forward-looking statements are projections in respect of future events or our future financial
performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other comparable terminology. These statements include
statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions
on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of
future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by such
forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors,
including the risks set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 27, 2023, any of
which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance or achievements expressed or implied in our forward-looking statements.
These risks and factors include, by way of example and without limitation:
● our
ability to obtain financing needed to complete our clinical trials and implement our business plan;
● our
ability to successfully develop and commercialize BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease,
as well as our metabolic ThermoStem Program;
● our
ability to protect our proprietary rights;
● our
ability to achieve and sustain profitability of the existing lines of business;
● our
ability to attract and retain world-class research and development talent;
● our
ability to attract and retain key science, technology and management personnel and to expand our management team;
● the
accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing;
● business
interruptions resulting from geo-political actions, including war and terrorism or disease outbreaks (such as the recent outbreak
of COVID-19);
● our
ability to attract and retain customers; and
● our
ability to navigate through the increasingly complex therapeutic regulatory environment. Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity or performance. Except as required by applicable law, including the securities laws of the United States, we do not intend
to update any of the forward-looking statements to conform these statements to actual results. Readers
are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the
SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated
events or changes in the future operating results over time, except as required by law. We believe that our assumptions are based upon
reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or
the results of our future activities will not differ materially from our assumptions. As
used in this Quarterly Report on Form 10-Q and unless otherwise indicated, the terms “Company,” “we,” “us”
and “our” refer to BioRestorative Therapies, Inc., a Nevada corporation (“BRT”), and its wholly-owned subsidiary,
Stem Pearls, LLC, a New York limited liability company (“Stem Pearls”). Unless otherwise specified, all dollar amounts are
expressed in United States dollars. Intellectual
Property This
report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly BRTX-100,
ThermoStem, BRTX Dragonfly SM Corporate
History Our
offices are located in Melville, New York where we have established a laboratory facility in order to increase our capabilities for the
further development of possible cellular-based treatments, products and protocols, stem cell-related intellectual property and translational
research applications. As
of June 30, 2023, our accumulated deficit was $161,305,671. We have historically only generated a modest amount of revenue, and our losses
have principally been operating expenses incurred in research and development, marketing and promotional activities in order to commercialize
our products and services, plus costs associated with meeting the requirements of being a public company. We expect to continue to incur
substantial costs for these activities over at least the next year. Business
Overview We
develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult (non-embryonic) stem cells.
We are currently pursuing our Disc/Spine Program BRTX-100 Disc/Spine Program BRTX-100 BRTX-100 We
are also developing our ThermoStem Program ThermoStem Program ThermoStem ThermoStem Program ThermoStem Program ThermoStem Program ThermoStem Program ThermoStem Program ThermoStem We
have licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or
materials to the spine and discs or other potential sites. We anticipate that FDA approval or clearance will be necessary for this device
prior to commercialization. We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 Revenue We
derived all of our revenue pursuant to a license agreement with the SCTC entered into in January 2012, as amended in November 2015 and
November 2022. Pursuant to the license agreement, the SCTC granted to us an exclusive license to use certain intellectual property related
to, among other things, stem cell disc procedures and we have granted to the SCTC a sublicense to use, and the right to sublicense to
third parties the right to use, in certain locations in the United States and the Cayman Islands, certain of the licensed intellectual
property. In consideration of the sublicenses, the SCTC has agreed to pay us royalties on a per disc procedure basis. Results
of Operations Comparison
of the Three Months Ended June 30, 2023 to the Three Months Ended June 30, 2022 Our
financial results for the three months ended June 30, 2023 are summarized as follows in comparison to the three months ended June 30,
2022:
For
the Three Months Ended,
June
30, 2023 June
30, 2022
(unaudited)
Revenues $ 64,500 $ 71,100
Operating
expenses:
Research and development 967,891 1,075,224
General
and administrative 2,213,160 3,624,504
Total
operating expenses 3,181,051 4,699,728
Loss
from operations (3,116,551 ) (4,628,628 )
Other
(income) expense:
Interest (income) expense (96,187 ) 46,613
Other
income, net (39,812 ) -
Total other (income) expense (135,599 ) 46,613
Net
loss $ (2,980,552 ) $ (4,675,241 ) Revenues For
the three months ended June 30, 2023 and 2022, we generated $64,500 and $71,000, respectively, of royalty revenue in connection with
our sublicense agreement. Research
and Development Research
and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific
Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. Research and development
expenses are expensed as they are incurred. For the three months ended June 30, 2023, research and development expenses decreased by
$107,333, or 10.0%, compared to the three months ended June 30, 2022. The decrease was primarily the result of a difference in the timing
of payments made for PRC service expenses. A milestone payment in the amount of $150,000 was paid on June 30, 2022 compared to the three
months ended June 30, 2023 in which no milestone payment was due. We
expect that our research and development expenses will increase in subsequent fiscal periods. General
and Administrative General
and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees, as well
as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses. For the three months ended
June 30, 2023, general and administrative expenses decreased by $1,411,344, or 38.9%, as compared to the three months ended June 30,
2022, primarily driven by a $1,618,481 decrease in stock-based compensation. Interest
(income) expense For
the three months ended June 30, 2023, interest income was $96,187 compared to interest expense of $46,613 for the three months ended
June 30, 2022. The change was primarily due to our investments in marketable securities during the three months ended June 30, 2023,
which generated interest income. During the three months ended June 30, 2022, we did not have any such investments and only incurred
interest expense. Other
income, net For
the three months ended June 30, 2023, Other income, net primarily relates to gains from settlements of certain accrued expenses and realized
and unrealized gain on investments. Comparison
of the Six Months Ended June 30, 2023 to the Six Months Ended June 30, 2022 Our
financial results for the six months ended June 30, 2023 are summarized as follows in comparison to the six months ended June 30, 2022:
For
the Six Months Ended,
June
30, 2023 June
30, 2022
(unaudited)
Revenues $ 95,800 $ 87,100
Operating
expenses:
Research and development 2,479,136 1,850,561
General
and administrative 6,512,313 7,918,960
Total
operating expenses 8,991,449 9,769,521
Loss
from operations (8,895,649 ) (9,682,421 )
Other
(income) expense:
Interest (income) expense (114,403 ) 75,624
Gain on PPP loan forgiveness - (250,000 )
Grant income - (16,654 )
Other
income, net (116,472 ) -
Total other income (230,875 ) (191,030 )
Net
loss $ (8,664,774 ) $ (9,491,391 ) Revenues For
the six months ended June 30, 2023 and 2022, we generated $95,800 and $87,100, respectively, of royalty revenue in connection with our
sublicense agreement. Research
and Development Research
and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific
Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. Research and development
expenses are expensed as they are incurred. For the six months ended June 30, 2023, research and development expenses increased by $628,575,
or 34.0%, compared to the six months ended June 30, 2022. The increase was primarily driven by increased salaries and wages of $836,000,
increased lab site fees of $84,000, and increased consulting fees of 95,000, offset by a decrease in PRC service expenses of $532,000. We
expect that our higher level of research and development expenses will continue in subsequent fiscal periods. General
and Administrative General
and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees, as well
as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses. For the six months ended
June 30, 2023, general and administrative expenses decreased by $1,406,647, compared to the six months ended June 30, 2022. The decrease
was primarily driven by a $1,655,195 decrease in stock-based compensation, offset by an increase in salaries and wages of $167,000. We
expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure and incur additional
costs to support the growth of our business. Interest
(income) expense For
the six months ended June 30, 2023, interest income was $114,403 compared to interest expense of $75,624 for the six months ended June
30, 2022. The change was primarily due to our investments in marketable securities during the six months ended June 30, 2023, which generated
interest income. During the six months ended June 30, 2022, we did not have any such investments and only incurred interest expense. Other
income, net For
the six months ended June 30, 2023, Other income, net primarily relates to gains from settlements of certain accrued expenses and realized
and unrealized gain on investments. Gain
on PPP loan forgiveness Under
the terms of the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”), our $250,000 PPP loan was
forgiven during the six months ended June 30, 2022. Grant
income Grant
income of $16,654 during the six months ended June 30, 2022 consists of funding received under a $256,000 National Institutes of Health
Small Business Technology Transfer (STTR) Phase 1 grant, which we were awarded in September 2021. There was no grant income during the
six months ended June 30, 2023. Liquidity
and Capital Resources Liquidity We
measure our liquidity in a number of ways, including the following:
June 30, December 31,
2023 2022
Cash, Cash
Equivalents, and Investments $ 11,615,365 $ 14,749,408
Working Capital $ 11,231,071 $ 14,688,188 Working
capital decreased by $3,457,117 primarily due to the $3,479,065 of cash used to fund our operations. Availability
of Additional Funds Based
upon our accumulated deficit of $161,305,671 as of June 30, 2023, along with our forecast for continued operating losses and our need
for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing
to continue our operations. However, based on cash on hand as of June 30, 2023 and the recent offerings discussed below, we believe we
have sufficient cash to fund operations for the twelve months subsequent to the filing date of this Form 10-Q. Our
operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital
and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including
our ability to successfully commercialize our products and services, competing technological and market developments, and the need to
enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service
offerings. We
may be unable to raise sufficient additional capital when we need it or raise capital on favorable terms. Future financing may require
us to pledge certain assets and enter into covenants that could restrict certain business activities or our ability to incur further
indebtedness and may contain other terms that are not favorable to our stockholders or us. If we are unable to obtain adequate funds
on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing
agreements on unattractive terms. “At-the-Market”
Offering In
April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC (the “Sales Agent”)
under which we have the ability to issue and sell shares of our Common Stock, from time to time, through the Sales Agent, up to an aggregate
offering price of $4,200,000 in what is commonly referred to as an “at-the-market” (“ATM”) program. During the
three months ended June 30, 2023, we sold 93,551 shares of our Common Stock under the ATM program with the Sales Agent at a weighted-average
gross price of approximately $5.74 per share and raised approximately $536,600 of gross proceeds. The total commissions and related legal
fees were approximately $125,000, and we received net proceeds of approximately $412,000. As of June 30, 2023, we had remaining capacity
to sell up to an additional $3,663,407 of Common Stock under the ATM program. Registered
Direct Offering In
July 2023, we sold an aggregate of 685,033 shares of our Common Stock in a registered direct offering. We received net proceeds of approximately
$1,831,000 from the offering. Cash
Flows During
the six months ended June 30, 2023 and 2022, our sources and uses of cash were as follows:
Six
Months Ended June 30,
2023 2022
Net cash used in operating activities $ (3,479,065 ) $ (2,845,765 )
Net cash provided by (used in) investing activities 3,174,433 (247,247 )
Net cash provided by
financing activities 411,701 -
Net increase (decrease)
in cash $ 107,069 $ (3,093,003 ) Operating
Activities Net
cash used in operating activities was $3,479,065 for the six months ended June 30, 2023, primarily due to cash used to fund the net loss
of $8,664,774, which was partially offset by non-cash expenses of $4,824,865 related primarily to stock-based compensation. Cash flows
were also impacted by routine fluctuations in our operating assets and liabilities. Net cash used in operating activities was $2,845,756
for the six months ended June 30, 2022, primarily due to cash used to fund the net loss of $9,491,391 and a non-cash gain of $250,000
on forgiveness of our PPP loan, which were partially offset by non-cash expenses of $6,480,055 related primarily to stock-based compensation
and $300,032 of cash provided by changes in the levels of operating assets and liabilities. Investing
Activities Net
cash provided by investing activities increased by $3,421,680 for the six months ended June 30, 2023 compared to the six months ended
June 30, 2022, primarily due to a sale of marketable securities, which provided $3,263,504 of cash. Financing
Activities Net
cash provided by financing activities increased by $411,701 for the six months ended June 30, 2023 compared to the six months ended June
30, 2022, due to the net proceeds from the ATM offerings of the Company’s Common Stock. Effects
of Inflation We
do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented. Critical
Accounting Policies and Estimates Our
significant accounting policies are more fully described in the notes to our unaudited condensed consolidated financial statements included
herein for the quarter ended June 30, 2023, and in the notes to our audited consolidated financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023. Not
applicable. As a smaller reporting company, we are not required to provide the information required by this Item. Evaluation
of Disclosure Controls and Procedures We
maintain disclosure controls and procedures as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934, as amended (“the Exchange Act”), that are designed to ensure that information required to be disclosed in our reports
under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and
forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures,
our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls
and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance
of achieving the desired control objectives. Under
the supervision and with the participation of our management, including our principal executive officer and principal financial officer,
we are required to perform an evaluation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the
Exchange Act, as of June 30, 2023. Management
has completed such evaluation and has concluded that our disclosure controls and procedures were not effective to provide reasonable
assurance that information required to be disclosed by us in reports we file or submit under the Exchange Act is appropriate to allow
timely decisions regarding required disclosures. As a result of the material weakness in internal controls over financial reporting described
below, we concluded that our disclosure controls and procedures as of June 30, 2023 were not effective. Material
Weaknesses in Internal Control over Financial Reporting Management
assessed the effectiveness of our internal control over financial reporting as of June 30, 2023 based on the framework established in
Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based
on this assessment, management has determined that our internal control over financial reporting as of June 30, 2023 was not effective. A
material weakness, as defined in the standards established by Sarbanes-Oxley, is a deficiency, or a combination of deficiencies, in internal
control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated
financial statements will not be prevented or detected on a timely basis. The
ineffectiveness of our internal control over financial reporting was due to the following material weaknesses:
● Lack
of adherence to formal policies and procedures;
● Lack
of risk assessment procedures on internal controls to detect financial reporting risks in a timely manner; and
● Lack
of sufficient formal management testing over documented formal procedures and controls, and time to evaluate continuous effectiveness
of controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation
and review of journal entries and account reconciliations. Management’s
Plan to Remediate the Material Weaknesses Management
has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weaknesses
are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions include:
● New
management personnel, including our Chief Financial Officer, who is overseeing the financial reporting process and implementation
of enhanced controls and governance;
● Engagement
of external financial consulting firm to continue to enhance financial reporting, financial operations and internal controls; and
● Documentation
of key procedures and controls using a risk-based approach. Management
is committed to maintaining a strong internal controls environment and implementing measures designed to help ensure that control deficiencies
contributing to the material weaknesses are remediated as soon as possible. We have documented key procedures and controls using a risk-based
approach and have, therefore, made progress toward remediation. We continue to implement our remediation plan, which includes continued
engagement of an external financial consulting firm to enhance financial reporting and operations as well as design and implementation
of controls. We will consider the material weaknesses remediated after the applicable controls operate for a sufficient period of time,
and Management has concluded, through testing, that the controls are operating effectively. Management
will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing
basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow. Changes
in Internal Control Over Financial Reporting Other
than described above, there have been no changes in our internal control over financial reporting that occurred during our second quarter
of 2023 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting. An
investment in our Common Stock involves a number of very significant risks. You should carefully consider the risk factors included in
the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC
on March 27, 2023, in addition to other information contained in that report and in this quarterly report in evaluating the Company and
its business before purchasing shares of our Common Stock. The Company’s business, operating results and financial condition could
be adversely affected due to any of those risks. During
the three months ended June 30, 2023, we did not have any unregistered sales of equity securities.
Incorporated
by Reference
Exhibit Number Exhibit
Description Form Exhibit Filing
Date
3.1 Amended and Restated Articles of Incorporation 8-K 3.3 1/5/2023
3.2 Certificate of Designations of Preferred Stock (Series B) 8-K 3.4 1/5/2023
3.3 Bylaws 8-K 3.5 1/5/2023
31.1* Certification
of Principal Executive Officer
31.2* Certification
of Principal Financial Officer
32.1** Section
1350 Certification of Principal Executive Officer and Principal Financial Officer
101.INS Inline
XBRL Instance Document
101.SCH Inline
XBRL Taxonomy Extension Schema Document
101.CAL Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE Inline
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104 Cover
Page Interactive Date File (embedded within the Inline XBRL document)
* Filed
herewith.
** In
accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed. Pursuant
to the requirements 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.
BIORESTORATIVE
THERAPIES, INC.
By: /s/
Lance Alstodt
Lance
Alstodt
Chief
Executive Officer, President, and Chairman of the Board
(Principal
Executive Officer)
Date: August
11, 2023
By: /s/
Robert E. Kristal
Robert
E. Kristal
Chief
Financial Officer
(Principal
Financial Officer)
Date: August
11, 2023 |
