What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-20 compared with 2024-03-13 · 39 added, 83 removed, 196 unchanged (38% of the section changed)

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Recent Developments

Private Placement of Class A Common Shares and Pre-Funded Warrants

On February 27, 2024, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Private Placement Investors”), pursuant to which we agreed to issue and sell to the Private Placement Investors in a private placement (the “Private Placement”) (i) an aggregate of 464,377 shares (the “Private Placement Shares”) of our Class A common stock, at a purchase price of $11.81 per share, and (ii) pre-funded warrants (the “Private Placement Pre-Funded Warrants”) to purchase up to an aggregate of 3,853,997 shares of our Class A common stock (the “Private Placement Warrant Shares”) at a purchase price of $11.80 per Private Placement Pre-Funded Warrant (representing the $11.81 per Private Placement Share purchase price less the exercise price of $0.01 per Private Placement Warrant Share).

We received aggregate gross proceeds from the Private Placement of approximately $51.0 million, before deducting offering expenses payable by us.

The Private Placement Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.

On February 28, 2024, we entered into a sales agreement (the “TD Cowen Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A common stock, having an aggregate offering price of up to $50.0 million (the “TD Cowen ATM Offering”).

Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities registered on the registration statement relating to the TD Cowen ATM Offering with a value exceeding more than one-third of our public float in any 12-month period so long as our public float remains below $75.0 million.

Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements

Reverse Stock Split

On November 20, 2023, we filed a Certificate of Amendment to the Company’s amended and restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware, which effected a reverse stock split at a ratio of 1-for-40, such that every 40 shares of our Class A common stock, combined into one issued and outstanding share of Class A common stock, and every 40 shares of our Class B common stock, combined into one issued and outstanding share of Class B Common Stock (the "Reverse Stock Split").

No fractional shares were issued in connection with the Reverse Stock Split.

Any fractional shares of Class A common stock and Class B common stock to which a stockholder was entitled resulting from the Reverse Stock Split were rounded up to the nearest whole share.

The Class A common stock began trading on a reverse split-adjusted basis on the Nasdaq on November 21, 2023.

Our Class A common stock will continue trading under the symbol “VTVT,” and the new CUSIP number for the Class A common stock following the Reverse Stock Split is 91835204.

Our Product Pipeline

The following table summarizes our drug candidates, their partnership status and their respective stages of development:

Our Type 1 Diabetes Program – Cadisegliatin (TTP399)

Food and Drug Administration (FDA) granted Breakthrough Therapy designation in 2021 for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").

The Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.

The Breakthrough Therapy designation for cadisegliatin in T1D was supported by the positive results from the Phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of cadisegliatin as an adjunct to insulin therapy in adults with T1D.

In this trial, treatment with cadisegliatin resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia.

Cadisegliatin demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking cadisegliatin than those taking placebo.

In May of 2023, the FDA issued new draft guidance on "Diabetes Mellitus:

Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products" which, for the first time, permitted the use of hypoglycemia as an endpoint to support a label claim.

Consistent with this guidance and with input from the FDA, we have initiated a Phase 3 double-blind controlled trial to assess the effect of cadisegliatin on reducing the frequency of Level 2 hypoglycemia (blood glucose levels are less than 54 mg/dL or 3 mmol/L, regardless of symptoms) and Level 3 hypoglycemia ("severe" hypoglycemia e.g., requiring assistance of another person) in 150 patients with type 1 diabetes.

Participants in the trial will be randomized to two doses of cadisegliatin or placebo.

Reduction in glycated hemoglobin (HbA1c), a traditional efficacy endpoint in diabetes trials, is a key secondary endpoint to assess the potential of cadisegliatin to reduce hyperglycemia, Following the initial assessment of efficacy after six months of treatment, participants will remain on trial for another six months to assess the durability of potential beneficial effects and safety.

The study protocol was submitted to the FDA on February 29, 2024.

The trial will be conducted in the U.S.

only and is expected to complete enrollment by the fourth quarter in 2024 providing top line 1-year data by the first quarter in 2026.

Concurrently, we will be working on the design for two international registrational studies for cadisegliatin in type 1 diabetes, which we expect to start in 2026.

In addition, we continue to work with our partner, G42 Investments AI Holding RSC Ltd.

(“G42”), to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes.

We expect that trial to begin in 2024.

In March 2025, the Company announced that the clinical hold placed by the FDA in July 2024 on the cadisegliatin clinical program was lifted following the Company’s submission of a complete response letter.

Holding Company Structure

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Cadisegliatin $ 6,026 $ 10,182 $ 9,611

HPP737 — — 2,762

Azeliragon — — 822

Other projects* 490 676 563

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Total research and development expense $ 11,546 $ 13,595 $ 12,357

* Includes HPP737 and azeliragon

We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development of cadisegliatin and further advance the development of our other drug candidates, subject to the availability of additional funding.

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This is due to the numerous risks and uncertainties associated with the development of our drug candidates, including:

• the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

• the scope, rate of progress and expense of our clinical trials once resumed as well as any additional, clinical trials and other research and development activities;

• the potential benefits of our candidates over other therapies;

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General and administrative expenses consist primarily of salaries, benefits and related costs for employees in executive, finance, corporate development, human resources and administrative support functions.

Other significant general and administrative expenses include accounting and legal services, expenses associated with obtaining and maintaining patents, cost of various consultants, occupancy costs and information systems.

Other significant general

and administrative expenses include accounting and legal services, expenses associated with obtaining and maintaining patents, cost of various consultants, occupancy costs and information systems.

Interest Income

Interest income represents noncash interest income related to the imputed interest from the G42 Promissory Note receivable using the effective interest method and cash interest income from dividends and interest from our money market account, all of which are recognized in our Consolidated Statement of Operations .

Interest Expense

The Company’s interest expense is immaterial.

Other Expense, Net

Other expense primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investment held, the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock held by related parties, the loss from the G42 Promissory Note early redemption on February 28, 2023, the impairment charge from Anteris Bio, Inc.

(“Anteris”) liquidation and dissolution and the Common Stock Repurchase Agreement (the "Repurchase Agreement") with Reneo Pharmaceuticals, Inc ("Reneo").

Other Income (Expense), Net

Other Income (Expense), Net primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments, the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock, the loss from the G42 promissory note early redemption on February 28, 2023, the impairment charge from Anteris Bio, Inc.

(“Anteris”) liquidation and dissolution and the Common Stock Repurchase Agreement (the "Repurchase Agreement") with Reneo Pharmaceuticals, Inc ("Reneo"), which was later acquired by OnKure in 2024.

Results of Operations

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Interest expense — (13) 13

Other expense, net (923) (2,670) 1,747

Other income (expense), net 10 (923) 933

Loss before income taxes and noncontrolling interest (22,605) (25,966) 3,361

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$ (18,462) $ (20,250) $ 1,788

Revenue for the year ended December 31, 2024 includes a $1.0 million increase to the transaction price for the license performance obligation under the Newsoara License Agreement due to the satisfaction of a development milestone and recognition of deferred Huadong revenue.

There was no revenue for the year ended December 31, 2023.

Revenue was $2.0 million for the year ended December 31, 2022.

The revenue recognized in 2022 related to the increase to the transaction price for the license performance obligations under the amended license agreement with Huadong due to the satisfaction of a development milestone.

Research and Development Expenses

Research and development expenses were $11.5 million and $13.6 million for the years ended December 31, 2024 and 2023, respectively.

The increase in research and development expenses during this period of approximately $1.2 million, or 10.0%, was primarily driven by (i) higher spending on cadisegliatin of $0.6 million due to increases in drug product related costs as well as higher spending on trial preparation costs, and (ii) an increase of $0.6 million in indirect costs and other projects.

The decrease in research and development expenses during this period of approximately $2.0 million, or 15.1%, was primarily driven by (i) lower spending on cadisegliatin of $4.2 million, due to decreases in toxicity studies and other clinical trial costs, drug manufacturing costs and (ii) other projects of $0.2 million, partially offset by (iii) an increase in indirect costs of $2.2 million due to increases in payroll and bonus costs.

General and Administrative Expenses

General and administrative expenses were $13.7 million and $11.9 million for the years ended December 31, 2024 and 2023, respectively.

The decrease in general and administrative expenses during this period of approximately $0.3 million, or 2.4%, was primarily driven by (i) a decrease of $3.1 million in legal expense, and (ii) a decrease of $0.8 million in severance costs, partially offset by (iii) an increase in payroll costs of $1.8 million, (iv) an increase in other general and administrative costs of $1.5 million, and (v) an increase in share-based compensation expense of $0.3 million.

The increase in general and administrative expenses during this period of approximately $1.7 million, or 14.6%, was primarily driven by (i) an increase in payroll costs of $1.0 million, (ii) an increase in share-based expense of $0.8 million, (iii) an increase in other operating costs of $0.1 million, partially offset by (iv) a decrease of $0.2 million in legal expenses.

Interest Income

Interest income for the year ended December 31, 2023 of $0.5 million is related to imputed interest on the G42 Promissory Note and dividend income from our money market account .

Interest income for the year ended December 31, 2022 of $0.4 million is related to the imputed interest on the G42 Promissory Note.

Interest Expense

Interest expense for the years ended December 31, 2023 and 2022, was insignificant.

Other Expense, Net

Other expense was $0.9 million for the year ended December 31, 2023 and was driven by the recording of an impairment charge on a cost-method investment of $4.2 million offset by a realized gain recognized related to the Company’s Repurchase Agreement with Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.

Other expense was $2.7 million for the year ended December 31, 2022, and was driven by an unrealized loss recognized related to the Company’s investment in Reneo as well as the losses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.

Interest income for the year ended December 31, 2024 of $1.6 million is related to interest and dividend income from our money market account .

Interest income for the year ended December 31, 2023 of $0.5 million is related to the imputed interest on the G42 Promissory Note and dividend income from our money market account.

Other Income (Expense), Net

Other income was immaterial for the year ended December 31, 2024.

Other expense was $0.9 million for the year ended December 31, 2023, and was driven by the recording of an impairment charge on a cost-method investment of $4.2 million offset by a realized gain of $3.1 million related to the Company’s Repurchase Agreement with Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.

Liquidity and Capital Resources

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As of December 31, 2024, we had cash and cash equivalents of $36.7 million.

On February 27, 2024, the Company closed a private placement financing of up to $51.0 million and additionally granting investors the right to purchase up to an additional $30.0 million of common stock 18 months following the closing of the private placement financing.

(See note 20).

The financing raised will allow the Company to further advance its lead program for cadisegliatin (TTP399) .

On February 27, 2024, the Company closed a private placement financing of up to $51.0 million and additionally granted investors the right to purchase up to an additional $30.0 million of common stock up to 18 months following the closing of the private placement financing.

The financing raised will allow the Company to further advance its lead program for cadisegliatin .

To meet our future funding requirements into the first quarter of 2026 , including funding the ongoing and future clinical trials of cadisegliatin ( TTP399 ), we are evaluating several financing strategies, including direct equity investments and the potential licensing and monetization of other Company programs.

The timing and availability of such additional financing are not yet known and we can provide no assurance that these plans will be successful.

If we are unable to raise additional capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition.

As such, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

In addition to available cash and cash equivalents and available funds discussed above, we are seeking possible additional partnering opportunities for our GKA, GLP-1r and other drug candidates which we believe may provide additional cash for use in our operations and the continuation of the clinical trials for our drug candidates.

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The timing and availability of such additional financing are not yet known.

As required by ASC Topic 205-40, Presentation of Financial Statements - Going Concern , management has assessed our ability to continue as a going concern for one year from the consolidated financial statements issuance date for the fiscal year ended December 31, 2023.

Based on the cash and cash equivalents currently available to us as discussed above, we have concluded there is not substantial doubt regarding our ability to continue as a going concern for at least twelve months from the issuance of the December 31, 2023 Form 10-K.

These factors raise substantial doubt about our ability to continue as a going concern.

TD Cowen Sales Agreement

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Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements.

Cantor Fitzgerald Sales Agreement

We previously entered into the Sales Agreement with Cantor Fitzgerald pursuant to which could offer and sell, from time to time, through or to Cantor Fitzgerald, as sales agent or principal, shares of our Class A common stock having an aggregate offering price of up to $68.5 million.

As of December 31, 2023, we had sold $31.2 million worth of Class A common stock pursuant to the Sales Agreement for net proceeds of $30.3 million.

The Sales Agreement with Cantor Fitzgerald was terminated on February 26, 2024.

Lincoln Park Purchase Agreement

We entered into the Purchase Agreement with Lincoln Park ("LPC Purchase Agreement"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, we may sell to Lincoln Park up to $47.0 million of shares of our Class A common stock from time to time over the 36-month term of the LPC Purchase Agreement.

Upon execution of the Purchase Agreement, we issued 10,643 shares of our Class A common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Purchase Agreement.

We have issued 133,282 shares of our Class A common stock to Lincoln Park under the LPC Purchase Agreement through the date of the filing of this Annual Report on Form 10-K.

The LPC Purchase Agreement expired on November 24, 2023.

As of December 31, 2024, we have sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold.

The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

In no event will we sell Class A common stock under this registration statement with a value exceeding more than one-third of the “public float” (the market value of our Class A common stock and any other equity securities that we may issue in the future that are held by non-affiliates) in any 12-calendar month period so long as our public float remains below $75 million.

Year Ended December 31,

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Net cash used in operating activities $ (25,307) $ (19,081)

Net cash provided by (used in) investing activities 4,404 (21)

Net cash provided by investing activities — 4,404

Net cash provided by financing activities 52,607 11,997

Net decrease in cash and cash equivalents $ (2,680) $ (1,289)

Net increase (decrease) in cash and cash equivalents $ 27,300 $ (2,680)

Operating Activities

For the year ended December 31, 2024, our net cash used in operating activities increased by $6.2 million from the prior year.

The significant contributor to the change in cash used during the year was working capital changes offset by $6.8 million of cash received related to contract liabilities.

The significant contributor to the change in cash used during the year was working capital changes.

Investing Activities

There were no cash flows from investing activities for the year ended December 31, 2024 .

For the year ended December 31, 2023, net cash provided by investing activities was driven by the sale of our investments in Reneo.

For the year ended December 31, 2022, net cash used in investing activities was insignificant.

Financing Activities

For the year ended December 31, 2024, net cash provided by financing activities was driven by sales of our Class A common stock and proceeds from pre-funded warrants of $51.0 million from the Private Placement financing and proceeds from the TD Cowen ATM Offering of $2.5 million.

For the year ended December 31, 2023, net cash provided by financing activities was driven by the receipt of proceeds of $12.0 million from the G42 Promissory Note early redemption.

For the year ended December 31, 2022, net cash provided by financing activities was driven by sales of our Class A common stock to a collaboration partner and from the CinRx Purchase Agreement.

Future Funding Requirements

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We anticipate that we will need substantial additional funding in connection with our continuing operations.

Based on our current operating plan, we believe that our current cash and cash equivalents will allow us to meet our liquidity requirements for at least the next twelve months.

We plan to finance our operations into the first quarter of 2026 through the use of our cash and cash equivalents and based on current operating plans, we are evaluating several financing strategies to fund the ongoing and future clinical trials of cadisegliatin , including direct equity investments and the potential licensing and monetization of other Company programs.

We plan to finance our operations through the use of our cash and cash equivalents, including cash received from future funding activities.

We continue to evaluate financing strategies to fund future clinical trials of cadisegliatin , including direct equity investments and the potential licensing and monetization of other Company programs.

The timing of any such transactions is not certain, and we may not be able to complete such transactions on acceptable terms, or at all.

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Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our drug candidates.

Additionally, we may rely on our ability to sell shares of our Class A

common stock pursuant to the ATM Offering.

However, the ability to use this source of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in the Company’s Class A common stock.

Additionally, although we may sell shares of our Class A common stock pursuant to the TD Cowen ATM Offering, our ability to use this source of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in the Company’s Class A common stock.

Our future capital requirements will depend on many factors, including:

• the progress, costs, results and timing of our planned trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes;

• the progress, costs, results and timing of restarting our trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes;

• the willingness of the FDA to rely upon our completed and planned clinical and preclinical studies and other work, as the basis for review and approval of our drug candidates;

• our ability to maintain control over our costs in line with our budget to complete the Phase 3 clinical trial for our lead product candidate, cadisegliatin ;

• our ability to maintain control over our costs in line with our budget for our lead product candidate, cadisegliatin ;

• the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

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Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).

the date of our consolidated financial statements, as well as the reported revenues and expenses during the reported periods.

The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our consolidated financial statements, as well as the reported revenues and expenses during the reported periods.

We evaluate these estimates and judgments on an ongoing basis.

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Revenue Recognition

The majority of our revenue results from its license and collaboration agreements associated with the development of investigational drug products.

The majority of our revenue results from our license and collaboration agreements associated with the development of investigational drug products.

We account for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis