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Tevogen Bio Holdings Inc

For the period ended Jun 30, 2024. Filed Aug 14, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 14, 2024

TVGN$5.59+0.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-28.

0001493152-24-021650

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-14.

0001493152-24-032294

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 96 previous paragraphs and 112 current paragraphs.

58 unchanged; 26 reworded; 23 added; 12 removed; 0 previous and 5 current paragraphs rearranged.

Tables are not compared: 14 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (23)

Current report

As described in more detail in “Liquidity and Capital Resources – Funding Requirements” below, on June 6, 2024, we entered into a Loan Agreement with The Patel Family, LLP (the “Lender”) providing for (i) an unsecured line of credit facility (the “Facility”), pursuant to which the Lender agreed to lend us up to $36.0 million (the “Maximum Loan Amount”) of term loans in $1.0 million increments on a monthly basis, over a draw period of thirty-six months, and (ii) a contingent option for the Lender to purchase at least $14.0 million of Common Stock in a future private placement (the “Optional PIPE”). The Loan Agreement also contains a contingent option for the lender to purchase at least $14.0 million of our Common Stock plus up to the then-remaining available amount under the Facility, in a future private placement if the ten-day trailing volume weighted average price per share of the Common Stock (the “Trailing VWAP”) reaches $10.00 per share. Pursuant to the terms of the Loan Agreement, the Company also issued to the Lender 1,000,000 shares of Common Stock as a commitment fee (the “Commitment Shares”), subject to forfeiture by the Lender of the Commitment Shares or an equal number of shares of Common Stock in the event the Lender fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date (as defined in the Loan Agreement) in the event the Company has satisfied all applicable closing conditions.

Current report

Change in Fair Value of Written Call Option Derivative Liabilities

Current report

Equity-linked purchase options issued in connection with our debt agreements are assessed to determine whether they are freestanding or embedded with the host instrument under ASC 815. Our embedded and freestanding purchase options were determined to be liability-classified derivative instruments and are measured at fair value both on the date of issuance and at each subsequent balance sheet date, with changes in fair value recorded to “Change in fair value of written call option derivative liabilities” within the consolidated statements of operations.

Current report

Our other expenses consist of losses on the issuance of the Commitment Shares during the three months ended June 30, 2024 associated with the Loan Agreement. Since we intend to elect the fair value option for future draws under the Loan Agreement, we expense all issuance costs associated with the Loan Agreement, which are comprised of the fair value of the Commitment Shares as well as the issuance date fair value of the $14.0 million Purchase Option and Additional Amount Purchase Option. For more information about the Loan Agreement, see “—Liquidity and Capital Resources—Funding Requirements” below.

Current report

General and administrative expenses for the three months ended June 30, 2024 were $4.5 million compared to $1.2 million for the three months ended June 30, 2023. The increase was primarily attributable to increased legal and professional fees of $2.0 million, primarily attributable to additional services incurred as a result of with the Merger, restricted stock compensation expense of $0.7 million related to the RSUs granted to Dr. Saadi, and a non-cash stock-based compensation expense of $0.4 million recognized from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing.

Current report

Change in Fair Value of Written Call Option Derivative Liabilities

Current report

We recognized a non-cash charge of $0.2 million for the fair value of our written call option derivative liabilities associated with our Loan Agreement for the three months ended June 30, 2024.

Current report

We incurred losses on the issuance of Commitment Shares pursuant to the Loan Agreement during the three months ended June 30, 2024.

Current report

Research and development expenses for the six months ended June 30, 2024 were $24.9 million, compared to $2.4 million for the six months ended June 30, 2023. The increase was primarily attributable to a non-cash stock-based compensation expense of $20.5 million recognized from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing and restricted stock compensation expense of $2.3 million related to the RSUs granted to Dr. Saadi.

Current report

The following table summarizes our general and administrative expenses for the six months ended June 30, 2024 and 2023:

Current report

General and administrative expenses for the six months ended June 30, 2024 were $13.2 million compared to $2.1 million for the six months ended June 30, 2023. The increase was primarily attributable to stock-based compensation expense of $7.7 million, of which $6.7 million was recognized as a non-cash stock-based compensation expense from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing, and $1.0 million was recognized as restricted stock compensation expense related to the RSUs granted to Dr. Saadi. The increase of $1.2 million in personnel costs was primarily attributable to an increase in headcount and an increase in premium for the Company’s director and officer insurance policy, and $0.8 million was recognized as a loss from the issuance of Series A Preferred Stock. The increase of $2.2 million in legal and professional fees was primarily attributable to the additional services incurred as a result of the Merger.

Current report

Change in Fair Value of Written Call Option Derivative Liabilities

Current report

We recognized a non-cash loss of $0.2 million for the fair value of our written call option derivative liabilities associated with our Loan Agreement for the three months ended June 30, 2024.

Current report

We incurred losses on the issuance of Commitment Shares during the six months ended June 30, 2024, associated with the Loan Agreement.

Current report

As of June 30, 2024, we had cash of $1.1 million. Our cash balance and the Loan Agreement, which allows us to draw down term loans of $1.0 million per month over thirty-six months, will allow us to have adequate cash and financial resources, to operate for at least the next 12 months from the date of issuance of our unaudited consolidated financial statements included in this Report. We do not plan to initiate a clinical trial until additional funding is received.

Current report

We are currently evaluating different strategies to obtain the additional funding for future operations for subsequent periods. These strategies may include but are not limited to private placements of equity and/or debt, licensing and/or marketing arrangements, and public offerings of equity and/or debt securities. We may not be able to obtain financing on acceptable terms, or at all, and may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect our business prospects.

Current report

We used a Monte Carlo simulation to determine the fair value of the freestanding $14 million purchase option and embedded $36 million purchase option associated with the Loan Agreement at inception and as of June 30, 2024. The Monte Carlo simulation methodology simulates the Company’s future stock price to estimate if and when the Trailing VWAP will reach $10.00 per share, and discounts the resulting payoff back to each valuation date using a present value factor. Significant assumptions used in determining the fair value of these options include volatility and discount rate.
Removed paragraphs (12)

Previous report

As described in more detail in “Liquidity and Capital Resources – Funding Requirements” below, on May 10, 2024, we entered into a binding term sheet with a lender for a unsecured line of credit for up to $36.0 million, as well as for a contingent option for the lender to purchase at least $14.0 million of shares of our common stock in a future private placement (the “Optional PIPE”). We anticipate that this transaction will close during the quarter ending June 30, 2024, but we have not yet entered into a definitive agreement and there is no assurance as to the timing of the closing or the amount of proceeds we will ultimately receive.

Previous report

Since inception, we have generally incurred significant net losses. As of December 31, 2023, we had net operating loss carryforwards, (“NOLs”) for federal and state income tax purposes of $13.9 million and $16.4 million, respectively. We have provided a valuation allowance against the full amount of our net deferred tax assets since, in the opinion of our management, based upon our historical and anticipated future losses, it is more likely than not that the benefits will not be realized.

Previous report

Our utilization of our NOLs may be subject to a substantial annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, respectively, as well as similar state provisions.

Previous report

Research and development expenses for the three months ended March 31, 2024 were $20.8 million, compared to $1.3 million for the three months ended March 31, 2023. The increase was primarily attributable to a non-cash stock-based compensation expense of $19.0 million recognized when the liquidity event condition contained in certain stock-based awards (the “Liquidity Condition”) was satisfied upon the Closing.

Previous report

As of March 31, 2024, we had cash of $1.3 million. Based on our cash balance, as well as our history of operating losses and negative cash flows from operation combined with our anticipated use of cash to, among other things, fund the preclinical and clinical development of our products, identify and develop new product candidates, and seek approval for TVGN 489 and our other product candidates and any other product candidates we may develop, management has concluded that we do not have sufficient cash to fund our operations for 12 months from the date of our unaudited consolidated financial statements included in this Report without additional financing, and as a result, there is substantial doubt about our ability to continue as a going concern. In making this determination, applicable accounting standards prohibited us from considering the potential mitigating effect of plans that have not been fully implemented as of the date of our unaudited consolidated financial statements, including raising additional capital. Our financial information has been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. This financial information and our unaudited consolidated financial statements do not include any adjustments that may result from an unfavorable outcome of this uncertainty.

Previous report

Until such time, if ever, as we can generate substantial revenues from product sales, we expect to finance our cash needs through a combination of public and private equity offerings and debt financings, strategic alliances, collaborations, and marketing, distribution, or licensing arrangements. However, adequate additional financing may not be available to us on acceptable terms, or at all, and may be impacted by the economic climate and market conditions. See the risk factor in our Annual Report captioned*“We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.”*
Reworded paragraphs (26)

Previous wording

In this Quarterly Report on Form 10-Q (this “Report”), “we,” “our,” “us,” “Tevogen,” “the Company” and similar terms refer to Tevogen Bio Holdings Inc. and its subsidiaries collectively unless the context indicates otherwise. All quarterly information in this Management’s Discussion and Analysis is unaudited. The following discussion and analysis of our results of operations and our liquidity and capital resources should be read together with our unaudited consolidated financial statements and the related notes appearing elsewhere this Report and the audited financial information and related notes, as well as the Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”), and in Exhibits 99.1 and 99.2 to our Current Report on Form 8-K/A dated April 29, 2024 (the “Form 8-K”).

Current wording

In this Quarterly Report on Form 10-Q (this “Report”), “we,” “our,” “us,” “Tevogen,” “the Company” and similar terms refer to Tevogen Bio Holdings Inc. and its subsidiaries collectively unless the context indicates otherwise. All quarterly information in this Management’s Discussion and Analysis is unaudited. The following discussion and analysis of our results of operations and our liquidity and capital resources should be read together with our unaudited consolidated financial statements and the related notes appearing elsewhere in this Report and the audited financial information and related notes, as well as the Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”), and in Exhibits 99.1 and 99.2 to our Current Report on Form 8-K/A dated April 29, 2024 (the “Form 8-K”).

Previous wording

Forward-looking statements should be considered in light of these factors and the factors described elsewhere in this Report, including in the “Risk Factors” section, in the “Risk Factors” section of our Annual Report, and in our various filings with the Securities and Exchange Commission (the “SEC”). It is important that you read these factors and the other cautionary statements made in this Report as being applicable to all related forward-looking statements wherever they appear in this Report. If any of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance, or achievements may differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements. You should also read the more detailed description of our business in our Annual Report when considering forward-looking statements. We caution readers not to place undue reliance on any forward-looking statements herein, which speak only as of the date of this Report. We undertake no obligation to publicly update any forward-looking statements, except as required by law.

Current wording

Forward-looking statements should be considered in light of these factors and the factors described elsewhere in this Report, including in the “Risk Factors” section, in the “Risk Factors” section of our Annual Report, and in our various filings with the SEC. It is important that you read these factors and the other cautionary statements made in this Report as being applicable to all related forward-looking statements wherever they appear in this Report. If any of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance, or achievements may differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements. You should also read the more detailed description of our business in our Annual Report when considering forward-looking statements. We caution readers not to place undue reliance on any forward-looking statements herein, which speak only as of the date of this Report. We undertake no obligation to publicly update any forward-looking statements, except as required by law.

Previous wording

We are a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes (“CD8+ CTLs”), to develop off-the-shelf, precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders with the aim of addressing the significant unmet needs of large patient populations. We believe that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility through advanced science, innovative business models, and engagement across the development lifecycle and healthcare system. We aspire to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.

Current wording

We are a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes (“CD8+ CTLs”), to develop off-the-shelf, precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders with the aim of addressing the significant unmet needs of large patient populations. We believe that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility through advanced science, innovative business models, and engagement across the development lifecycle and healthcare system. We believe the full potential of T cell therapies remains largely untapped, and aspire to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.

Previous wording

We believe our allogeneic, precision T cell technology platform, ExacTcell TM, represents a significant scientific breakthrough that has the potential to produce a new class of off the shelf – manufactured and stored for immediate use – drugs with diverse applications spanning virology, oncology, and neurology. ExacTcell is a set of processes and methodologies to develop, enrich, and expand single human leukocyte antigen (“HLA”) restricted CTL therapies with proactively selected, precisely defined targets. HLA molecules are proteins that play an important role in the immune system’s ability to recognize “self” versus “foreign.” There are numerous HLA types that vary from person to person. CD8+ CTLs, also known as killer T cells, are white blood cells that are part of the immune system and destroy infected, malignant, or otherwise damaged cells. We are focused on using ExacTcell to develop allogeneic therapeutics, meaning therapeutics that are intended to be infused in patients other than the original donor.

Current wording

We believe our allogeneic, precision T cell technology platform, ExacTcellTM, represents a significant scientific breakthrough with the potential to mainstream cell therapy with a new class of off the shelf – manufactured and stored for immediate use – T cell therapies with diverse applications across virology, oncology, and neurology. ExacTcell is a set of processes and methodologies to develop, enrich, and expand single human leukocyte antigen (“HLA”) restricted CTL therapies with proactively selected, precisely defined targets. HLA molecules are proteins that play an important role in the immune system’s ability to recognize “self” versus “foreign.” There are numerous HLA types that vary from person to person. CD8+ CTLs, also known as killer T cells, are white blood cells that are part of the immune system and destroy infected, malignant, or otherwise damaged cells. We are focused on using ExacTcell to develop allogeneic therapeutics, meaning therapeutics that are intended to be infused in patients other than the original donor.

Previous wording

The first clinical product of ExacTcell, TVGN 489, is being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention of chronic lingering symptoms of the disease (“Long COVID”). Viruses, including COVID-19, hijack cellular machinery to transform infected cells into virus production plants. Elimination of infected cells is necessary to allow them to be replaced by healthy, uninfected counterparts. TVGN 489 consists of CTLs active against multiple precise, well defined, and well characterized targets across the SARS-CoV-2 genome. The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we completed the Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients. No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm. Secondary endpoints showing a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity were also met. None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period. These clinical observations were mirrored by laboratory evidence of the persistence of TVGN 489 cells for at least six months after treatment. We plan to launch a pivotal trial of TVGN 489 in COVID-19 patients with B cell malignancies, with studies of other highly vulnerable populations thereafter. TVGN 489 is also in preclinical development for treatment and prevention of Long COVID.

Current wording

The first clinical product of ExacTcell, TVGN 489, is being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention of chronic lingering symptoms of the disease (“Long COVID”). Viruses, including COVID-19, hijack cellular machinery to transform infected cells into virus production plants. Elimination of infected cells is necessary to allow them to be replaced by healthy, uninfected counterparts. TVGN 489 consists of CTLs active against multiple precise, well defined, and well characterized targets across the SARS-CoV-2 genome. The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we completed the Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients. No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm. Secondary endpoints showing a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity were also met. None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period. These clinical observations were mirrored by laboratory evidence of the persistence of TVGN 489 cells for at least six months after treatment. The results of the trial were submitted for peer-review and were published inBlood Advancesin June 2024. We believe these findings validate our initiative to develop off-the-shelf T cell therapies for outpatient administration, targeting diseases that affect large patient populations – for the very first time. We plan to launch a pivotal trial of TVGN 489 in COVID-19 patients with B cell malignancies, with studies of other highly vulnerable populations thereafter. TVGN 489 is also in preclinical development for treatment and prevention of Long COVID.

Previous wording

On February 14, 2024 (the “Closing Date”), pursuant to the agreement and plan of merger dated June 28, 2023 (the “Merger Agreement”) by and among Semper Paratus, Semper Merger Sub, Inc., a wholly owned subsidiary of Semper Paratus (“Merger Sub”), SSVK Associates, LLC, Tevogen Bio, and Dr. Ryan Saadi, in his capacity as seller representative, Merger Sub merged with and into Tevogen Bio, with Tevogen Bio being the surviving company and a wholly owned subsidiary of Semper Paratus (the “Merger,” and together with the other transactions contemplated by the Merger Agreement, the “Business Combination”) and Semper Paratus was renamed Tevogen Bio Holdings Inc. (the “Closing”). See Note 4 to our unaudited consolidated financial statements in this quarterly Report 10-Q for additional information regarding the net assets acquired through the Merger. The Merger was accounted for as a reverse recapitalization under U.S. GAAP because the Company was determined to be the accounting acquirer.

Current wording

On February 14, 2024 (the “Closing Date”), pursuant to the agreement and plan of merger dated June 28, 2023 (the “Merger Agreement”) by and among Semper Paratus, Semper Merger Sub, Inc., a wholly owned subsidiary of Semper Paratus (“Merger Sub”), SSVK Associates, LLC, Tevogen Bio, and Dr. Ryan Saadi, in his capacity as seller representative, Merger Sub merged with and into Tevogen Bio, with Tevogen Bio being the surviving company and a wholly owned subsidiary of Semper Paratus (the “Merger,” and together with the other transactions contemplated by the Merger Agreement, the “Business Combination”) and Semper Paratus was renamed Tevogen Bio Holdings Inc. (the “Closing”). See Note 4 to our unaudited consolidated financial statements in this quarterly Report 10-Q for additional information regarding the net assets acquired through the Merger. The Merger was accounted for as a reverse recapitalization under U.S. generally accepted accounting principles (“GAAP”) because the Company was determined to be the accounting acquirer.

Previous wording

To date, we have not generated any revenue. Our net income for the three months ended March 31, 2024, was $11.3 million and our net loss for the three months ended March 31, 2023, was $30.8 million. Net income for the three months ended March 31, 2024, was primarily attributable to a $48.5 million decrease in fair value in the three months ended March 31, 2024 due to the decrease in the fair value of our common stock prior to the Business Combination, partially offset by $7.5 million in transaction costs in connection with the Business Combination and a $29.5 million loss from operations that primarily resulted from non-cash, stock-based compensation expense recognized when the liquidity event condition contained in certain stock-based awards was satisfied upon the Closing. As of March 31, 2024, we had an accumulated deficit of $88.4 million and cash of $1.3 million.

Current wording

To date, we have not generated any revenue. Our net loss for the three months ended June 30, 2024 and 2023 was $9.7 million and $22.2 million, respectively. Net loss for the three months ended June 30, 2024 was primarily attributable to a $8.6 million loss from operations. Our net income (loss) for the six months ended June 30, 2024 and 2023 was $1.6 million and $(52.9) million, respectively. Net income for the six months ended June 30, 2024 was primarily attributable to a decrease in fair value in the six months ended June 30, 2024 due to the decrease in the fair value of our common stock, $0.0001 par value per share (the “Common Stock”), prior to the Business Combination, partially offset by $7.5 million in transaction costs in connection with the Business Combination and a $38.1 million loss from operations that primarily resulted from non-cash, stock-based compensation expense recognized when the liquidity event condition contained in certain stock-based awards was satisfied upon the Closing. As of June 30, 2024, we had an accumulated deficit of $98.1 million and cash of $1.1 million.

Previous wording

On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased 500 shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million. On March 27, 2024, we entered into an Amended and Restated Securities Purchase Agreement with the investor pursuant to which we amended and restated the original agreement and the investor agreed to purchase 600 shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million, of which $0.2 million was received during the three months ended March 31, 2024, and $2.0 million has been received subsequent to March 31, 2024. The remainder is expected to be received in the second quarter of 2024. The shares of Series A Preferred Stock are convertible into a total of 500,000 shares of our common stock at the election of the holder, and the shares of Series A-1 Preferred Stock will be convertible into a total of 600,000 shares of the Company’s common stock. The Series A Preferred Stock is and the Series A-1 Preferred Stock will be subject to a call right providing us the right to call the stock if the volume weighted average price of the common stock for the 20 days prior to delivery of the call notice is greater than $5.00 per share and there is an effective resale registration statement on file covering the underlying common stock. The Series A Preferred Stock is and the Series A-1 Preferred Stock will be non-voting, has or will have no mandatory redemption, and carries or will carry an annual 5% cumulative dividend, increasing by 2% each year, and the dividend on the Series A-1 Preferred Stock is capped at 15% per annum.

Current wording

On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased 500 shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million. On March 27, 2024, we entered into an Amended and Restated Securities Purchase Agreement with the investor pursuant to which we amended and restated the original agreement and the investor agreed to purchase 600 shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million, of which $3.0 million has been received through June 30, 2024. The remainder is expected to be received in the third quarter of 2024.

Previous wording

Based on cash on hand as of the date of this Report, as well as our history of operating losses and negative cash flows from operation combined with our anticipated use of cash, we have concluded that we do not have sufficient cash to fund our operations for 12 months from the issuance date of our unaudited consolidated financial statements, and as a result, under the applicable accounting standards and disclosure rules, there is substantial doubt about our ability to continue as a going concern. In making this determination, applicable accounting standards prohibited us from considering the potential mitigating effect of plans that have not been fully implemented as of the date of our unaudited consolidated financial statements, including without limitation plans to raise additional capital.

Current wording

Based on cash on hand as of the date of this Report, as well as our Loan Agreement, we have concluded that we have sufficient cash to fund our operations for at least the next 12 months from the issuance date of our unaudited consolidated financial statements.

Previous wording

Interest expense, net consists primarily of interest on our convertible promissory notes, partially offset by interest earned on bank deposits. (See “—Sources of Liquidity” below).

Current wording

Interest income (expense), net consists primarily of interest on our convertible promissory notes, partially offset by interest earned on bank deposits. (See “—Sources of Liquidity” below).

Previous wording

U.S. accounting standards provide entities with an option to measure many financial instruments and certain other items at fair value. As a result of us electing this option, we recorded all convertible promissory notes at fair value with changes in fair value reported in our statements of operations at each balance sheet date through the settlement of the convertible promissory notes in connection with the Closing, at which time the convertible promissory notes were converted into our common stock.

Current wording

U.S. accounting standards provide entities with an option to measure many financial instruments and certain other items at fair value. As a result of us electing this option, we recorded all convertible promissory notes at fair value with changes in fair value reported in our statements of operations at each balance sheet date through the settlement of the convertible promissory notes in connection with the Closing, at which time the convertible promissory notes were converted into our common stock and consolidated statements of cash flows.

Previous wording

General and administrative expenses for the three months ended March 31, 2024 were $8.7 million compared to $1.0 million for the three months ended March 31, 2023. The increase was primarily attributable to a non-cash stock-based compensation expense of $6.3 million recognized when the liquidity event condition contained in certain stock-based awards (the “Liquidity Condition”) was satisfied upon the Closing.

Current wording

Research and development expenses for the three months ended June 30, 2024 were $4.1 million, compared to $1.0 million for the three months ended June 30, 2023. The increase was primarily attributable to restricted stock compensation expense of $1.5 million related to the RSUs granted to Dr. Saadi and a non-cash stock-based compensation expense of $1.5 million recognized from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing.

Previous wording

We recognized $0.2 million and $0.3 million in interest expense for the three months ended March 31, 2024 and 2023, respectively, which was attributable primarily to the outstanding principal balance associated with our convertible promissory notes which converted into common stock in connection with the Closing.

Current wording

We recognized $0.2 million and $0.6 million in interest expense for the six months ended June 30, 2024 and 2023, respectively, which was attributable primarily to the outstanding principal balance associated with our convertible promissory notes that converted into common stock in connection with the Closing.

Previous wording

Merger transaction costs in excess of cash received from the Merger of $7.5 million were recognized as period expenses for the three months ended March 31, 2024.

Current wording

Merger transaction costs in excess of cash received from the Merger of $7.5 million were recognized as period expenses for the six months ended June 30, 2024.

Previous wording

We recognized a non-cash gain of $48.5 million and a non-cash loss of $28.1 million for the change in fair value of the convertible promissory notes for the three months ended March 31, 2024 and 2023, respectively. The change was primarily a result of the increase in the underlying estimated fair value of the Company’s common stock during the three months ended March 31, 2023 compared to a decrease in the underlying estimated fair value of the Company’s common stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.

Current wording

We recognized a non-cash gain of $48.5 million and a non-cash loss of $47.8 million for the change in fair value of the convertible promissory notes for the six months ended June 30, 2024 and 2023, respectively. The change was primarily a result of the increase in the underlying estimated fair value of our common stock during the six months ended June 30, 2023 compared to a decrease in the underlying estimated fair value of our common stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.

Previous wording

As of March 31, 2024, we had $1.3 million in cash and an accumulated deficit of $88.4 million compared to $1.1 million in cash and an accumulated deficit of $99.7 million as of December 31, 2023. To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and research tax credits. Since January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, and $1.2 million from the sale of our Series A-1 Preferred Stock.

Current wording

As of June 30, 2024, we had $1.1 million in cash and an accumulated deficit of $98.1 million compared to $1.1 million in cash and an accumulated deficit of $99.7 million as of December 31, 2023. To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and research tax credits. Since January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, and $3.0 million from deposits related to the future sale of our Series A-1 Preferred Stock. In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023:

Current wording

The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023:

Previous wording

During the three months ended March 31, 2024, we used $2.2 million of net cash in operating activities. Cash used in operating activities reflected our net income of $11.3 million offset by $13.9 million of non-cash charges related to the change in the fair value of the convertible promissory notes, stock-based compensation expense, depreciation expense, reductions in the operating right of use (“ROU”) assets, non-cash interest on the convertible promissory notes, offset by a $0.5 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

Current wording

During the six months ended June 30, 2024, we used $5.1 million of net cash in operating activities. Cash used in operating activities reflected our net income of $1.6 million and $1.9 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities, offset by $8.6 million of non-cash charges related to the change in the fair value of the convertible promissory notes, stock-based compensation expense, Merger transaction costs, loss on the issuance of Series A Preferred Stock, loss on issuance of the Commitment Shares, depreciation expense, reductions in the operating right of use (“ROU”) assets, and non-cash interest on the convertible promissory notes.

Previous wording

During the three months ended March 31, 2023, we used $2.2 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $30.8 million offset by $28.5 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation expense, reductions in the operating ROU assets, and a $0.1 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

Current wording

During the six months ended June 30, 2023, we used $4.4 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $52.9 million offset by $48.6 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation expense, and reductions in the operating ROU assets, offset by a $0.1 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

Previous wording

During the three months ended March 31, 2023, the Company purchased $0.1 million of property and equipment.

Current wording

During the six months ended June 30, 2023, we purchased $0.1 million of property and equipment. There was no investing activities during the six months ended June 30, 2024.

Previous wording

During the three months ended March 31, 2024, we received $2.4 million of net cash from financing activities attributable to proceeds from the issuance of $2.0 million Series A Preferred Stock, $0.2 million of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock and $0.2 million of cash in connection with the Merger.

Current wording

During the six months ended June 30, 2024, we received $5.2 million of net cash from financing activities attributable to proceeds from the issuance of $2.0 million Series A Preferred Stock, $3.0 million of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock and $0.2 million of cash in connection with the Merger.

Previous wording

During the three months ended March 31, 2023, we received $2.5 million of net cash from financing activities attributable to the proceeds from the convertible promissory notes.

Current wording

During the six months ended June 30, 2023, we received $2.5 million of net cash from financing activities attributable to the proceeds from the convertible promissory notes.

Previous wording

Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, including the funding we have received from the sale of our Series A Preferred Stock and the funding we expect to receive from the sale of our Series A-1 Preferred Stock. On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which an investor agreed to purchase shares of our Series A Preferred Stock for an aggregate purchase price of $8.0 million. On March 27, 2024, we entered into an agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million. We have not yet received $4.8 million of the $6.0 million purchase price for the Series A-1 Preferred Stock. Even if we receive such proceeds, we will still need additional capital to fully implement our business, operating, and development plans.

Current wording

Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, including the funding we have received from the sale of our Series A Preferred Stock and the funding we expect to receive from the sale of our Series A-1 Preferred Stock, and our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below. On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which an investor agreed to purchase shares of our Series A Preferred Stock for an aggregate purchase price of $8.0 million. On March 27, 2024, we entered into an agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million. We have not yet received $3.0 million of the $6.0 million purchase price for the Series A-1 Preferred Stock. Even if we receive such proceeds, we will still need additional capital to fully implement our business, operating, and development plans.

Previous wording

On May 10, 2024, we entered into a binding term sheet (the “Financing Term Sheet”) with a lender pursuant to which the lender agreed to provide to the Company up to $36.0 million (the “Maximum Loan Amount”) under an unsecured line of credit (the “Facility”). The lender is also the investor in our Series A and Series A-1 Preferred Stock. The Facility would permit us to borrow up to $1.0 million monthly in a single monthly draw over a period of up to three years. Draws would accrue interest at a fixed annual rate of the lower of (i) daily SOFR plus 2.00%, measured on the date we receive the draw (the “Deposit Date”), and (ii) 7.00%, payable quarterly. Interest would be payable in shares of our common stock priced at $1.50 per share, and each draw would mature 48 months after the Deposit Date. Prepayment would be permitted without penalty, and we would be permitted to repay or prepay any amount of outstanding principal balance at our election in cash or in shares of common stock priced at the greater of $1.50 per share and the closing price of the common stock on the day immediately preceding such payment, provided that there is an effective resale registration statement with respect to such shares. Pursuant to the Financing Term Sheet, we would also agree to provide the lender an option to purchase $14.0 million of shares of our common stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum Loan Amount (which amount would cease to be available under the Facility). The Optional PIPE would be priced at a 30% discount to the 10-day trailing volume weighted average price of our common stock on the date such volume weighted average price first reaches at least $10.00 per share. We anticipate that we will enter into a definitive agreement for the financing provided by the Financing Term Sheet during the quarter ending June 30, 2024, but we have not yet entered into such an agreement and there is no assurance as to the timing of closing or the amount of proceeds we will ultimately receive.

Current wording

On June 6, 2024, we entered into the Loan Agreement, pursuant to which the Lender agreed to provide to the Company up to the Maximum Loan Amount of $36.0 million under the Facility. The Lender is also the investor in our Series A and Series A-1 Preferred Stock. The Facility permits us to borrow up to $1.0 million monthly in a single monthly draw over a period of up to three years. Draws will accrue interest at a fixed annual rate of the lower of (i) the daily secured overnight financing rate, measured on the date we receive the draw (the “Deposit Date”), plus 2.00% and (ii) 7.00%, accruing quarterly beginning on the Deposit Date and payable quarterly beginning on the three-month anniversary of the Deposit Date. Interest will be payable in shares of Common Stock with an effective purchase price of $1.50 per share, and each draw will mature 48 months after the Deposit Date. Prepayment will be permitted without penalty. The Company may repay or prepay any amount of outstanding principal balance under the Facility at the Company’s election in cash or in shares of Common Stock with an effective purchase price of the greater of $1.50 per share and the 10-day trailing volume weighted average price of the Common Stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements related to resale registration. Pursuant to the Loan Agreement, we also agreed to provide the Lender an option to purchase $14.0 million of shares of our Common Stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum Loan Amount (which amount would thereafter no longer be available under the Facility). The Optional PIPE would be priced at a 30% discount to the Trailing VWAP on the date such price first reaches at least $10.00 per share (the “Threshold Price Date”) and will be exercisable by the Lender by written notice within three business days after the Company has notified the Lender of the Threshold Price Date (the date of such notice, the “Threshold Price Notice Date”). Pursuant to the terms of the Loan Agreement, we issued to the Lender the Commitment Shares, subject to forfeiture by the Lender of the Commitment Shares or an equal number of shares of Common Stock in the event the Lender fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date in the event the Company has satisfied all applicable closing conditions. There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement. Subsequent to June 30, 2024, the Company drew $1.0 million from the Facility, and $33.5 million remains available to borrow under the Facility for future draws.

Previous wording

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of the financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, the fair value of our common stock, the fair value of our convertible promissory notes, and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions, including those factors set out in the “Risk Factors” section of our Annual Report. See also the section entitled “–Forward-Looking Statements” above.

Current wording

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of the financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, the fair value of our common stock, the fair value of our convertible promissory notes, and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions, including those factors set out in the “Risk Factors” section of our Annual Report. See also the section entitled “–Forward-Looking Statements” above.

Previous wording

Our recurring fair value measurements primarily consist of the convertible promissory notes prior to the Merger, for which we elected the fair value option. As a result of our electing this option, we recorded our convertible promissory notes at fair value.

Current wording

Our recurring fair value measurements primarily consist of the convertible promissory notes prior to the Merger, for which we elected the fair value option, the freestanding $14 million purchase option under the Loan Agreement, and the bifurcated $36 million purchase option that is embedded within the loan commitment under the Loan Agreement.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

We recognized $0.3 million in interest expense for the three months ended June 30, 2023. Interest expense for the three months ended June 30, 2023 was attributable primarily to the outstanding principal balance associated with our convertible promissory notes which converted into common stock in connection with the Closing.

Current report — wording carried from elsewhere

We recognized a non-cash charge of $19.7 million for the change in fair value of the convertible promissory notes for the three months ended June 30, 2023. The change in fair value of the convertible promissory notes was primarily a result of the increase in the underlying estimated fair value of our common stock during the three months ended June 30, 2023. The convertible promissory notes were converted into shares of common stock in connection with the Closing.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:

Current report — wording carried from elsewhere

We do not track our internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:

Current report — wording carried from elsewhere

Change in Fair Value of Convertible Promissory Notes