MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
+Added: condensed consolidated interim financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited
+Added: consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s
+Added: Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Amendment No.
+Added: 1 to the Annual
+Added: Report on Form 10-K/A, which was filed on June 11, 2024.
Regarding Forward-Looking Statements
−Removed: Quarterly Report on Form 10-Q includes a number of forward-looking statements that reflect management’s current views with respect
−Removed: to future events and financial performance.
−Removed: Forward-looking statements are projections in respect of future events or our future financial
−Removed: In some cases, you can identify forward-looking statements by terminology such as “may,” “should,”
−Removed: “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,”
−Removed: “potential” or “continue” or the negative of these terms or other comparable terminology.
−Removed: These statements include
−Removed: statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions
−Removed: on which such statements are based.
−Removed: Prospective investors are cautioned that any such forward-looking statements are not guarantees of
−Removed: future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by such
−Removed: forward-looking statements.
−Removed: These statements are only predictions and involve known and unknown risks, uncertainties and other factors,
−Removed: including the risks set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year
−Removed: ended December 31, 2022, as filed with the U.S.
−Removed: Securities and Exchange Commission (the “SEC”) on March 27, 2023, any of
−Removed: which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially
−Removed: different from any future results, levels of activity, performance or achievements expressed or implied in our forward-looking statements.
−Removed: These risks and factors include, by way of example and without limitation:
−Removed: our ability to obtain financing
−Removed: needed to complete our clinical trials and implement our business plan;
−Removed: our ability to successfully
−Removed: develop and commercialize BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease, as well as our metabolic
−Removed: ThermoStem Program;
−Removed: our ability to protect
−Removed: our proprietary rights;
−Removed: our ability to achieve
−Removed: and sustain profitability of the existing lines of business;
−Removed: our ability to attract
−Removed: and retain world-class research and development talent;
−Removed: our ability to attract
−Removed: and retain key science, technology and management personnel and to expand our management team;
−Removed: the accuracy of estimates
−Removed: regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing;
−Removed: business interruptions
−Removed: resulting from geo-political actions, including war and terrorism or disease outbreaks (such as the recent outbreak of COVID-19);
−Removed: our ability to attract
−Removed: and retain customers;
−Removed: our ability to navigate
−Removed: through the increasingly complex therapeutic regulatory environment.
+Added: Quarterly Report on Form 10-Q includes a number of forward-looking statements that reflect management’s current views with
+Added: respect to future events and financial performance.
+Added: Forward-looking statements are projections in respect of future events or our
+Added: future financial performance.
+Added: In some cases, you can identify forward-looking statements by terminology such as “may,”
+Added: “should,” “expects,” “plans,” “anticipates,” “believes,”
+Added: “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
+Added: other comparable terminology.
+Added: These statements include statements regarding the intent, belief or current expectations of us and
+Added: members of our management team, as well as the assumptions on which such statements are based.
+Added: Prospective investors are cautioned
+Added: that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, and that
+Added: actual results may differ materially from those contemplated by such forward-looking statements.
+Added: These statements are only
+Added: predictions and involve known and unknown risks, uncertainties and other factors, including the risks set forth in the section
+Added: entitled “Risk Factors” in our Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, as filed with
+Added: Securities and Exchange Commission (the “SEC”) on June 11, 2024, any of which may cause our company’s or
+Added: our industry’s actual results, levels of activity, performance or achievements to be materially different from any future
+Added: results, levels of activity, performance or achievements expressed or implied in our forward-looking statements.
+Added: These risks and
+Added: factors include, by way of example and without limitation:
+Added: ability to obtain financing needed to complete our clinical trials and implement our business plan;
+Added: ability to successfully develop and commercialize BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease,
+Added: as well as our metabolic ThermoStem Program;
+Added: ability to protect our proprietary rights;
+Added: ability to achieve and sustain profitability of the existing lines of business;
+Added: ability to attract and retain world-class research and development talent;
+Added: ability to attract and retain key science, technology and management personnel and to expand our management team;
+Added: accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing;
+Added: interruptions resulting from geo-political actions, including war and terrorism or disease outbreaks (such as the recent outbreak
+Added: of COVID-19);
+Added: ability to attract and retain customers;
+Added: ability to navigate through the increasingly complex therapeutic regulatory environment;
+Added: ability to successfully engage in any new business lines that we pursue;
+Added: risks related to the restatement of our previously issued financial statements.
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
27 unchanged sentences
research applications.
−Removed: of September 30, 2023, our accumulated deficit was $164,231,163.
−Removed: We have historically only generated a modest amount of revenue, and
−Removed: our losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order
−Removed: to commercialize our products and services, plus costs associated with meeting the requirements of being a public company.
−Removed: to continue to incur substantial costs for these activities over at least the next year.
−Removed: develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult (non-embryonic) stem cells.
−Removed: We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 .
−Removed: In March 2022, a United States patent was issued in our Disc/Spine Program .
−Removed: We submitted an IND application to the FDA to obtain
−Removed: authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100 , our lead cell therapy candidate, in the
−Removed: treatment of chronic lower back pain arising from degenerative disc disease.
−Removed: We have received such authorization from the FDA and have
−Removed: commenced such clinical trial through the execution of a CRO agreement with Professional Research Consulting, Inc., d/b/a PRC Clinical
−Removed: (“PRC”), the execution of clinical trial site agreements, patient enrollment, the commencement of patient procedures, the
+Added: of March 31, 2024, our accumulated deficit was $148,922,589.
+Added: We have historically only generated a modest amount of revenue, and our
+Added: losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order to
+Added: commercialize our products and services, plus costs associated with meeting the requirements of being a public company.
+Added: continue to incur substantial costs for these activities over at least the next year.
+Added: develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.
+Added: are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 .
+Added: In March 2022, a United States patent issued in our Disc/Spine Program .
+Added: We have received authorization from the FDA to commence
+Added: a Phase 2 clinical trial investigating the use of BRTX-100 in the treatment of chronic lower back pain arising from degenerative
+Added: disc disease.
+Added: We have commenced such clinical trial through the execution of a CRO agreement with Professional Research Consulting, Inc.,
+Added: d/b/a PRC Clinical, the execution of clinical trial site agreements, patient enrollment, the commencement of patient procedures, the
purchase of manufacturing equipment and the expansion of our laboratory to include capabilities for clinical production.
2 unchanged sentences
In June 2023, we
−Removed: received a unanimous recommendation from the Data Safety Monitoring Board (“DSMB”) to continue our Phase 2 clinical trial
−Removed: without any changes.
−Removed: We have obtained a worldwide (excluding Asia and Argentina) exclusive license to use technology for investigational
−Removed: adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs.
−Removed: The technology is an advanced
−Removed: stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg
−Removed: We are investigating the expansion of the clinic application of BRTX-100 to other indications within the body.
+Added: received a unanimous recommendation from the Data Safety Monitoring Board to continue our Phase 2 clinical trial without any changes.
+Added: We have obtained a worldwide (excluding Asia and Argentina) exclusive license to use technology for investigational adult stem cell treatment
+Added: of disc and spine conditions, including protruding and bulging lumbar discs.
+Added: The technology is an advanced stem cell injection procedure
+Added: that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot.
+Added: We are investigating
+Added: the expansion of the clinic application of BRTX-100 to other indications within the body.
are also developing our ThermoStem Program .
−Removed: This pre-clinical program involves the use of brown adipose (fat) in connection
−Removed: with the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac
−Removed: deficiencies.
−Removed: United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March
−Removed: 2020, March 2021, July 2021, and June 2023;
−Removed: Australian patents related to the ThermoStem Program were issued in April 2017,
−Removed: October 2019, and August 2021;
−Removed: Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021,
−Removed: February 2022 and June 2023;
−Removed: Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, and
−Removed: and European patents related to the ThermoStem Program were issued in April 2020, January 2021, and July
−Removed: have obtained a license for a patented curved needle device that is a needle system designed to deliver cells and/or other
−Removed: therapeutic products or materials to the spine and discs or other potential sites.
−Removed: We anticipate that FDA approval or clearance will
−Removed: be necessary for this device prior to commercialization.
−Removed: We do not intend to utilize this device in connection with our Phase 2 clinical
−Removed: trial with regard to BRTX-100 .
−Removed: September 2023, we announced that we had entered into a supply agreement with a supplier of biologic-based cosmetics pursuant to which
−Removed: we will manufacture tissue-based biologics for use in the production of cosmetic and aesthetic applications.
+Added: This pre-clinical program involves the use of brown adipose (fat) in connection with
+Added: the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac deficiencies.
+Added: United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, July
+Added: 2021, June 2023 and December 2023;
+Added: Australian patents related to the ThermoStem Program were issued in April 2017, October 2019,
+Added: and August 2021;
+Added: Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022 and
+Added: Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, and March 2022;
+Added: European patents
+Added: related to the ThermoStem Program were issued in April 2020, January 2021, and July 2023 .
+Added: have obtained a license for a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic
+Added: products or materials to the spine and discs or other potential sites.
+Added: We anticipate that FDA approval or clearance will be necessary
+Added: for this device prior to commercialization.
+Added: We do not intend to utilize this device in connection with our Phase 2 clinical trial with
+Added: regard to BRTX-100 .
+Added: addition, in continuation of our mission of developing and commercializing cell-based biologics, we are seeking to develop a biologics-based
+Added: cosmetic products business.
+Added: Pursuant to such business, we would formulate, manufacture and sell products designed for cosmetic and aesthetic
+Added: In April 2024.
+Added: we announced that we have entered into a five-year exclusive supply agreement with Cartessa Aesthetics, LLC (“Cartessa”),
+Added: a leading North American based aesthetic company, to supply to Cartessa our first commercial product.
derived all of our revenue pursuant to a license agreement with the SCTC entered into in January 2012, as amended in November 2015 and
5 unchanged sentences
of Operations
−Removed: of the Three Months Ended September 30, 2023 to the Three Months Ended September 30, 2022
−Removed: financial results for the three months ended September 30, 2023 are summarized as follows in comparison to the three months ended September
+Added: of the Three Months Ended March 31, 2024 to the Three Months Ended March 31, 2023
+Added: financial results for the three months ended March 31, 2024 are summarized as follows in comparison to the three months ended March 31,
For the Three Months Ended
−Removed: September 30, 2023
−Removed: September 30, 2022
+Added: (As Restated)
Operating Expenses:
4 unchanged sentences
Other (Income) Expense:
−Removed: Interest (income) expense
−Removed: Grant income, net
−Removed: Other income, net
+Added: Interest income
+Added: Gain on exchange of warrants
+Added: Change in fair value of derivative liabilities
Total Other (Income) Expense
1 unchanged sentence
$ (7,172,572 )
−Removed: the three months ended September 30, 2023 and 2022, we generated $30,700 and $29,000, respectively, of royalty revenue in connection
−Removed: with our sublicense agreement.
−Removed: and Development
−Removed: and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development;
−Removed: (b) our Scientific
−Removed: Advisory Board members;
−Removed: and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives.
−Removed: Research and development
−Removed: expenses are expensed as they are incurred.
−Removed: For the three months ended September 30, 2023, research and development expenses decreased
−Removed: by $114,346, or 11.6%, compared to the three months ended September 30, 2022.
−Removed: The decrease was primarily the result of a decrease in
−Removed: contract research fees of $228,683 and a decrease in other fees of $117,138 that were the result of start-up and execution expenses incurred
−Removed: during the three months ended September 30, 2022 that did not occur in the same period of 2023, offset by an increase in salaries
−Removed: and wages of $214,021 due to salary increases.
−Removed: expect that our research and development expenses will increase in subsequent fiscal periods.
−Removed: and Administrative
−Removed: and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees, as well
−Removed: as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses.
−Removed: For the three months ended
−Removed: September 30, 2023, general and administrative expenses decreased by $1,389,211, or 38.1%, as compared to the three months ended September
−Removed: 30, 2022, primarily driven by a $1,580,822 decrease in stock-based compensation.
−Removed: (income) expense
−Removed: the three months ended September 30, 2023, interest income was $61,667 compared to interest expense of $28,841 for the three months ended
−Removed: September 30, 2022.
−Removed: The change was primarily due to our investments in marketable securities during the three months ended September
−Removed: 30, 2023, which generated interest income.
−Removed: During the three months ended September 30, 2022, we did not have any such investments and
−Removed: only incurred interest expense.
−Removed: income of $83,333 during the three months ended September 30, 2023 consists of funding received under a National Institutes of
−Removed: Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.
−Removed: There was no grant income received
−Removed: during the three months ended September 30, 2022.
−Removed: the three months ended September 30, 2023, Other income, net primarily relates to an Employee Retention Tax Credit (“ERTC”),
−Removed: gains from settlements of certain accrued expenses and realized and unrealized gain on investments.
−Removed: of the Nine Months Ended September 30, 2023 to the Nine Months Ended September 30, 2022
−Removed: financial results for the nine months ended September 30, 2023 are summarized as follows in comparison to the nine months ended September
−Removed: For the Nine Months Ended,
−Removed: September 30, 2023
−Removed: September 30, 2022
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: (12,000,092 )
−Removed: (14,292,121 )
−Removed: Other (income) expense:
−Removed: Interest (income) expense
−Removed: Gain on PPP loan forgiveness
−Removed: Other (income) expense, net
−Removed: Total other income
−Removed: $ (11,590,266 )
−Removed: $ (14,147,216 )
−Removed: the nine months ended September 30, 2023 and 2022, we generated $126,500 and $116,100, respectively, of royalty revenue in connection
−Removed: with our sublicense agreement.
+Added: the three months ended March 31, 2024 and 2023, we generated $35,000 and $31,300, respectively, of royalty revenue in connection with
+Added: our sublicense agreement.
and Development
5 unchanged sentences
expenses are expensed as they are incurred.
−Removed: For the nine months ended September 30, 2023, research and development expenses increased
−Removed: by $514,229 or 18.1%, compared to the nine months ended September 30, 2022.
−Removed: The increase was primarily driven by increased salaries and
−Removed: wages of $1,050,221 due to salary increases and bonuses, increased lab site fees of $104,000, and increased consulting fees of $93,000,
−Removed: offset by a decrease in PRC service expenses of $733,000 as the result of non-recurring start-up and execution expenses
−Removed: incurred during the nine months ended September 30, 2022.
−Removed: expect that our higher level of research and development expenses will continue in subsequent fiscal periods.
+Added: For the three months ended March 31, 2024, research and development expenses decreased by
+Added: $173,614, or 14%, compared to the three months ended March 31, 2023.
+Added: The decrease was primarily the result of a decrease in compensation
+Added: costs of $237,383 related to a discretionary bonus during the 2023 period partially offset by an increase in laboratory expenses related
+Added: to our Phase II clinical trial of $74,005.
+Added: We expect that our research and development expenses will increase in subsequent fiscal periods.
and Administrative
1 unchanged sentence
as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses.
−Removed: For the nine months ended
−Removed: September 30, 2023, general and administrative expenses decreased by $2,795,858, or 24.2%, compared to the nine months ended
−Removed: September 30, 2022.
−Removed: The decrease was primarily driven by a $3,236,017 decrease in stock-based compensation, offset by an increase in
−Removed: salaries and wages of $235,000 due to salary increases and bonuses paid during the nine months ended September 30, 2023.
−Removed: expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure and incur additional
−Removed: costs to support the growth of our business.
−Removed: (income) expense
−Removed: the nine months ended September 30, 2023, interest income was $176,070 compared to interest expense of $104,465 for the nine months ended
−Removed: September 30, 2022.
−Removed: The change was primarily due to our investments in marketable securities during the nine months ended September 30,
−Removed: 2023, which generated interest income.
−Removed: During the nine months ended September 30, 2022, we did not have any such investments and only
−Removed: incurred interest expense.
−Removed: the nine months ended September 30, 2023, Other income, net primarily relates to the ERTC refundable tax credit, gains from settlements
−Removed: of certain accrued expenses and realized and unrealized gain on investments.
−Removed: on PPP loan forgiveness
−Removed: the terms of the U.S.
−Removed: Small Business Administration’s Paycheck Protection Program (“PPP”), our $250,000 PPP loan was
−Removed: forgiven during the nine months ended September 30, 2022.
−Removed: income of $83,333 during the nine months ended September 30, 2023 consists of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.
−Removed: Grant income of $16,654 during the nine months ended September 30, 2022 consists of
−Removed: funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, which we were
−Removed: awarded in September 2021.
+Added: For the three months
+Added: ended March 31, 2024, general and administrative expenses decreased by $1,492,532, or 33%, as compared to the three months ended
+Added: March 31, 2023, primarily driven by a decrease in stock-based compensation expense of $1,350,121 due to options granted in 2021 and
+Added: 2022 that became fully vested in 2023 and a decrease in headcount costs of $243,171, partially offset by an increase in legal and
+Added: professional fees expense of $64,628 primarily related to our warrant exercise program.
+Added: the three months ended March 31, 2024, interest income was $162,597, compared to interest income of $18,216 for the three months ended
+Added: March 31, 2023.
+Added: The change was primarily due to interest and dividend income on the investments held in marketable securities.
+Added: the three months ended March 31, 2024, other income primarily related to gains from settlements of certain accrued expenses and realized
+Added: and unrealized gain on investments.
+Added: For the three months ended March 31, 2023, other income primarily related to gains from settlements
+Added: of certain accrued expenses and unrealized gain on investments.
+Added: on Exchange of Warrants
+Added: For the three months ended March 31, 2024, we recognized a gain on exchange of $1,711,698 related to the issuance
+Added: of warrants and common stock in exchange for the cancellation of existing warrants.
+Added: in Fair Value of Derivative Liabilities
+Added: the three months ended March 31, 2024 and 2023, we recognized a loss on the change in fair value of derivative liabilities of $137,319
+Added: and $1,488,350, respectively, related to the increase in fair value of warrants that are accounted for as derivative liabilities.
and Capital Resources
measure our liquidity in a number of ways, including the following:
−Removed: September 30,
−Removed: Cash, Cash Equivalents, and Investments
+Added: (As Restated)
+Added: Cash and cash equivalents
+Added: Investments held in marketable securities
Working capital
−Removed: capital decreased by $3,016,870 primarily due to the $4,656,785 of cash used to fund our operations.
+Added: capital increased by $4,538,943 primarily due to the $7,518,489 of cash provided by financing activities which was partially offset by
+Added: $2,317,780 of cash used to fund our operations.
of Additional Funds
−Removed: upon our accumulated deficit of $164,231,163 as of September 30, 2023, along with our forecast for continued operating losses and our
−Removed: need for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing
+Added: upon our accumulated deficit of $148,922,589 as of March 31, 2024, along with our forecast for continued operating losses and our need
+Added: for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing
to continue our operations.
−Removed: However, based on cash on hand and investments as of September 30, 2023, we believe
−Removed: we have sufficient cash to fund operations for the twelve months subsequent to the filing date of this Form 10-Q.
+Added: However, based on cash and cash equivalents and investments on hand, we believe we have sufficient cash to
+Added: fund operations for at least 12 months after the issuance date of these financial statements.
operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital
10 unchanged sentences
agreements on unattractive terms.
−Removed: “At-the-Market”
−Removed: April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC (the “Sales
−Removed: Agent”) under which we currently have the ability to issue and sell shares of our Common Stock, from time to time,
−Removed: through the Sales Agent, up to an aggregate offering price of approximately $5,486,000 in what is commonly referred to as an
−Removed: “at-the-market” (“ATM”) program.
−Removed: During the nine months ended September 30, 2023, we sold 93,551
−Removed: shares of our Common Stock under the ATM program with the Sales Agent at a weighted-average gross price of approximately $5.74 per
−Removed: share and raised approximately $536,600 of gross proceeds.
−Removed: The total commissions and related legal fees were approximately $125,000,
−Removed: and we received net proceeds of approximately $412,000.
−Removed: As of September 30, 2023, we had remaining capacity to sell up
−Removed: to an additional $3,663,407 of Common Stock under the ATM program.
−Removed: October 2023, we sold an additional 39,276 shares of our Common Stock at an average price of $2.17 per share and raised approximately
−Removed: $86,000 in gross proceeds under the ATM program.
−Removed: Direct Offering
−Removed: July 2023, we sold an aggregate of 685,033 shares of our Common Stock in a registered direct offering.
−Removed: We received net proceeds of approximately
−Removed: $1,831,000 from the offering.
−Removed: the nine months ended September 30, 2023 and 2022, our sources and uses of cash were as follows:
−Removed: Nine Months Ended September 30,
+Added: the three months ended March 31, 2024 and 2023, our sources and uses of cash were as follows:
+Added: Three months Ended March 31,
+Added: (As Restated)
Net cash used in operating activities
1 unchanged sentence
$ (2,379,277 )
−Removed: Net cash provided by (used in) investing activities
−Removed: (10,156,204 )
+Added: Net cash (used in) provided by investing activities
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash
−Removed: $ (14,453,616 )
−Removed: cash used in operating activities was $4,656,785 for the nine months ended September 30, 2023, primarily due to cash used to fund the
−Removed: net loss of $11,590,266, which was partially offset by non-cash expenses of $6,547,216 related primarily to stock-based compensation.
−Removed: Cash flows were also impacted by routine fluctuations in our operating assets and liabilities.
−Removed: cash used in operating activities was $4,297,412 for the nine months ended September 30, 2022, primarily due to cash used to fund the
−Removed: net loss of $14,147,216 and a non-cash gain of $250,000 on forgiveness of our PPP loan ,
−Removed: which was partially offset by non-cash expenses of $9,554,582 related primarily to stock-based compensation and $349,543 of cash provided
−Removed: by changes in operating assets and liabilities.
−Removed: cash provided by investing activities increased by $13,307,581 for the nine months ended September 30, 2023 compared to the nine months
−Removed: ended September 30, 2022, primarily due to the initial purchase of investments held in marketable securities of $9,933,562
−Removed: made in the prior year, compared to sales of marketable securities of $3,690,238 in the current year.
−Removed: cash provided by financing activities increased by $2,265,700 for the nine months ended September 30, 2023 compared to the nine months
−Removed: ended September 30, 2022, due to the net proceeds from the ATM and registered direct offerings of the Company’s Common Stock.
+Added: Net increase in cash
+Added: cash used in operating activities was $2,317,780 for the three months ended March 31, 2024, primarily due to cash used to fund the
+Added: net loss of $2,223,255, adjusted for net non-cash expenses of $381,174, and $475,699 of cash used in changes in operating assets and
+Added: Net cash used in operating activities was $2,379,277 for the three months ended
+Added: March 31, 2023, primarily due to cash used to fund the net loss of $7,172,572, adjusted for net non-cash expenses of $4,871,267, and
+Added: $77,972 of cash used in changes in operating assets and liabilities.
+Added: cash used in investing activities was $4,928,006 for the three months ended March 31, 2024 compared to net cash provided by investing
+Added: activities of $2,539,169 for the three months ended March 31, 2023, primarily due to a sale of marketable securities, which provided
+Added: $5,800,00 of cash and a purchase of marketable securities which used $10,728,006 of cash.
+Added: cash provided by financing activities was $7,518,489 for the three months ended March 31, 2024 compared to no cash provided by financing
+Added: activities for the three months ended March 31, 2023, due to net proceeds received in connection with the exercise and issuance of warrants.
do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented.
−Removed: Accounting Policies and Estimates
−Removed: significant accounting policies are more fully described in the notes to our unaudited condensed consolidated financial statements included
−Removed: herein for the quarter ended September 30, 2023, and in the notes to our audited consolidated financial statements included in our Annual
−Removed: Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023.
+Added: Accounting Estimates
+Added: prepare our consolidated financial statements in accordance with U.S.
+Added: generally accepted accounting principles, which require our management
+Added: to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the
+Added: balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods.
+Added: To the extent that there
+Added: are material differences between these estimates and actual results, our financial condition or results of operations would be affected.
+Added: We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our
+Added: circumstances and expectations for the future based on available information.
+Added: We evaluate these estimates on an ongoing basis.
+Added: consider an accounting estimate to be critical if:
+Added: (i) the accounting estimate requires us to make assumptions about matters that were
+Added: highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
+Added: period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact
+Added: on our financial condition or results of operations.
+Added: There are items within our unaudited condensed consolidated financial statements
+Added: that require estimation but are not deemed critical, as defined above.
+Added: a detailed discussion of our significant accounting policies and related judgments, see Note 2 of the Notes to Unaudited Condensed Consolidated
+Added: Financial Statements in “Item 1.
+Added: Financial Statements” of this report.
Quantitative and Qualitative Disclosures about Market Risk
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