What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2024-03-13 compared with 2023-03-06 · 105 added, 130 removed, 174 unchanged (57% of the section changed)

6 unchanged sentences

We are a clinical stage pharmaceutical company focused on treating metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients.

We have an innovative pipeline of first-in-class small molecule clinical and pre-clinical drug candidates.

Our lead program is TTP399 , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").

We have an innovative pipeline of first-in-class small molecule clinical and preclinical drug candidates.

Our lead program is cadisegliatin (TTP399) , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").

Recent Developments

On July 27, 2022, the Company appointed Paul Sekhri as President and Chief Executive Officer (CEO) effective August 1, 2022, and Mr.

Sekhri was confirmed as a member of the board of directors on August 9, 2022.

Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies, experience in several senior business development and strategy roles and he has been a director on more than 30 private, public company and non-profit boards.

On December 13, 2022.

the Company announced the appointment of Steven Tuch as Chief Financial Officer effective December 8, 2022.

Tuch brings more than 20 years of financial and business development experience with multiple life science companies during various stages of financial planning and development.

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 – TTP399

The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with T1D and has engaged with the FDA on the optimal clinical trial designs for these studies.

The studies will recruit a total of approximately 1,000 patients across two studies, and at least one of the studies will be one year of treatment.

The FDA and the Company

Table of Con tents

have agreed on the primary endpoint for the studies as the difference between placebo and TTP399 -treated group in number of hypoglycemia events.

We expect site-specific startup activities and patient enrollment for these pivotal studies to begin in the second half of 2023.

In October 2021, we announced positive results of a mechanistic study of TTP399 in patients with T1D.

The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis.

Consistent with previous clinical studies, improved fasting plasma glucose levels and fewer hypoglycemic events were observed in the TTP399 treated group during the week of treatment prior to the insulin withdrawal test.

The results of the mechanistic study provided additional evidence to support the idea that treatment with TTP399 will not increase the risk of diabetic ketoacidosis (“DKA”) in patients with T1D.

The data demonstrate that in contrast to agents such as SGLT2 inhibitors and GLP‐1RAs, TTP399 does not increase the risk of ketoacidosis when used as an adjunctive therapy to insulin in individuals with T1D.

Moreover, these findings support prior studies that demonstrate that TTP399 improves glucose control and reduces hypoglycemia and suggests a protective effect of TTP399 against acidosis in people with T1D.

Full study results were published in the Diabetes Obesity and Metabolism journal in conjunction with the 82nd American Diabetes Association Scientific Sessions on June 6, 2022.

In April 2021, we announced that the FDA granted Breakthrough Therapy Designation (“BTD”) for TTP399 as an adjunctive therapy to insulin for the treatment of T1D.

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

G42 Investments

On May 31, 2022, the Company announced entry into agreements that include a $25.0 million investment by G42 Investments AI Holding RSC Ltd.

("G42 Investments").

Under the terms of the agreements, the Company agreed to sell G42 Investments 10,386,274 shares of the Company’s Class A common stock at an issue price of $2.41 per share, with $12.5 million paid in cash at closing, and the remaining amount of $12.5 million payable on May 31, 2023 pursuant to a promissory note (the "G42 Promissory Note").

The agreements also provide for the potential issuance of $30.0 million in additional shares of Class A common stock to G42 Investments (or cash in lieu of such issuance at the option of G42 Investments) if the FDA approves the marketing and sale of a pharmaceutical product containing TTP399 as the active ingredient for treatment of T1D in the United States.

The agreements set forth the terms under which the Company and an affiliate of G42 Investments plan to collaborate on clinical trials for pharmaceutical products that contain TTP399 and grant G42 Investments an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in a specified territory, principally consisting of the Middle East, North Africa and Central Asia.

On February 28, 2023, the Company and G42 Investments amended the G42 Purchase Agreement and modified the G42 Promissory Note to accelerate the payment due under the note.

Pursuant to the amendment, on February 28, 2023, the Company received $12.0 million, which reflected the original amount due under the G42 Promissory Note less a 3.75% discount, in full satisfaction of the note.

CinRx Purchase Agreement

On July 25, 2022, the Company announced entry into agreements that included a $10.0 million investment by CinPax, LLC (“CinPax”), a subsidiary of CinRx Pharma, LLC (“CinRx”).

Under the terms of the agreements, CinPax acquired 4,154,549 shares of Class A common stock of vTv at an issue price of approximately $2.41 per share, with $6.0 million paid in cash at closing, and the remaining amount of $4.0 million was paid to the Company on November 22, 2022.

The agreements also provide for the issuance of 1,200,000 warrants to CinRx to acquire additional shares of Class A common stock that become exercisable upon agreed vesting triggers (including FDA approval of TTP399 ).

In addition to the investment, the Company and CinRx entered into a Master Service Agreement whereby CinRx provides the Company with consulting, preclinical and clinical trial services, as enumerated in project proposals negotiated between the Company and CinRx from time to time.

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.

Holding Company Structure

6 unchanged sentences

has therefore consolidated vTv LLC’s results under the VIE accounting model in its consolidated financial statements.

Table of Con tents

Financial Overview

To date, we have not generated any revenue from drug sales.

Our revenue has been primarily derived from up-front proceeds and research fees under collaboration and license agreements.

Our revenue has been primarily derived from milestone payments, up-front proceeds and research fees under collaboration and license agreements.

In the future, we may generate revenue from a combination of product sales, license fees, milestone payments and royalties from the sales of products developed under licenses of our intellectual property.

4 unchanged sentences

We recognize research and development expenses as they are incurred.

Our direct research and development expenses consist primarily of external costs such as fees paid to investigators, consultants, central laboratories and contract research organizations in connection with our clinical trials, and costs related to acquiring and manufacturing clinical trial materials.

Our direct research and development expenses consist primarily of external costs such as fees paid to investigators, consultants, central laboratories and clinical research organizations in connection with our clinical trials, and costs related to acquiring and manufacturing clinical trial materials.

Our indirect research and development costs consist primarily of cash and share-based compensation costs, the cost of employee benefits and related overhead expenses for personnel in research and development functions.

Since we typically use our employee and infrastructure resources across multiple research and development programs such costs are not allocated to the individual projects.

From our inception, including our predecessor companies, through December 31, 2022, we have incurred approximately $612.5 million in research and development expenses.

Our research and development expenses by project for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands):

2 unchanged sentences

Direct research and development expense:

TTP399 $ 9,611 $ 2,608 $ 917

Cadisegliatin $ 10,182 $ 9,611 $ 2,608

HPP737 — — 2,762

3 unchanged sentences

Total research and development expense $ 13,595 $ 12,357 $ 13,324

We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development of TTP399 and further advance the development of our other drug candidates, subject to the availability of additional funding.

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.

The successful development of our clinical and preclinical drug candidates is highly uncertain.

4 unchanged sentences

• our ability to market, commercialize and achieve market acceptance for any of our drug candidates that we are developing or may develop in the future;

Table of Con tents

• future clinical trial results;

1 unchanged sentence

• the timing and receipt of any regulatory approvals;

• our ability to secure sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer-term cash requirements and other cash needs, at the times and in the amounts needed;

• legislation and regulatory actions and changes in laws or regulations;

• the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.

5 unchanged sentences

Interest Income

Interest income represents non-cash interest income related to the imputed interest from our promissory note receivable, all of which are recognized in our Consolidated Statement of Operations using the effective interest method .

Interest Expense, Net

For periods prior to December 31, 2021, interest expense primarily consisted of cash and non-cash interest expense related to our Venture Loan and Security Agreement (the “Loan Agreement”) with Horizon Technology Finance Corporation and Silicon Valley Bank.

The Loan Agreement was fully repaid and terminated in December 2020.

Cash interest on the Loan Agreement was recognized at a floating interest rate equal to 10.5% plus the amount by which the one-month London Interbank Offer Rate (“LIBOR”) exceeded 0.5%.

Non-cash interest expense represented the amortization of the costs incurred in connection with the Loan Agreement, the allocated fair value of the warrants to purchase shares of our Class A common stock issued in connection with the Loan Agreement (the “Warrants”) and the accretion of the final interest payments (which were required to be paid in cash upon maturity), all of which are recognized in our Consolidated Statement of Operations using the effective interest method.

Other Income (Expense), Net

Other income/expense primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments held in our licensees as well the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock held by related parties.

Table of Con tents

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").

Results of Operations

14 unchanged sentences

Interest expense (13) (15) 2

Other (expense) income, net (2,670) 4,057 (6,727)

Loss before income taxes (24,873) (17,616) (7,257)

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

Loss before income taxes and noncontrolling interest (25,966) (24,873) (1,093)

Income tax provision — 200 (200)

3 unchanged sentences

$ (20,250) $ (19,164) $ (1,086)

Revenues were $2.0 million and $4.0 million for the years ended December 31, 2022 and 2021, respectively.

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.

The revenue recognized in 2021 related to the reallocation of revenue to the license and technology transfer performance obligation made in connection with the First Huadong Amendment as well as increases to the transaction prices for the license performance obligations under the Newsoara License Agreement and the Reneo License Agreement due to the satisfaction of development milestones.

Research and Development Expenses

Research and development expenses were $13.6 million and $12.4 million for the years ended December 31, 2023 and 2022, respectively.

The decrease in research and development expenses during this period of approximately $1.0 million, or 7.3%, was primarily driven by (i) decreased spending of $2.8 million related to the multiple ascending dose study for HPP737 , due to its completion in 2021, (ii) decrease of $2.0 million for a license payment in 2021 to Novo Nordisk for the completion of TTP399 phase 2 studies in 2021, (iii) decreases in indirect and other costs of $2.4 million primarily related to payroll and severance costs due to the reduction in workforce, and (iv) and a decrease in clinical trial costs of $0.8 million for azeliragon which was driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes, partially offset by increases in TTP399 drug related costs of $7.0 million and initial preparatory costs for the upcoming clinical trials.

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.

General and Administrative Expenses

General and administrative expenses were $11.9 million and $12.2 million for the years ended December 31, 2023 and 2022, respectively.

The decrease in general and administrative expenses during this period of approximately $0.1 million, or 1.2%, was primarily driven by (i) a decrease of $2.1 million in payroll costs due to the reduction in workforce, (ii) a decrease of $0.7 million in severance costs, and (iii) a decrease of $0.9 million in share-based expense, partially offset by (iv) an increase in legal expense of $2.3 million, and v) an increase of $1.3 million in other general and administrative costs.

Table of Con tents

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.

Interest Income

Interest income for the year ended December 31, 2022 is related to the imputed interest on the G42 promissory note.

Interest income for the year ended December 31, 2021, was insignificant.

Interest Expense, Net

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 Income / (Expense)

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.

Other income was $4.1 million for the year ended December 31, 2021, and was driven by an unrealized gain recognized related to the Company’s investment in Reneo as well as gains related to the change in fair value of the outstanding warrants held by a related party.

Liquidity and Capital Resources

2 unchanged sentences

Since our inception, we have experienced a history of negative cash flows from operating activities.

We anticipate that we will continue to incur losses for the foreseeable future as we continue our clinical trials.

We anticipate that we will continue to incur losses and negative cash flow from operations for the foreseeable future as we continue our clinical trials.

Further, we expect that we will need additional capital to continue to fund our operations.

As of December 31, 2023, we had cash and cash equivalents of $9.4 million.

In addition to available cash and cash equivalents, we are evaluating several financing strategies to fund the on-going and future clinical trials of TTP399 , including direct equity investments and the potential licensing and monetization of other Company programs.

The Company received proceeds of $12.0 million from the G42 promissory note on February 28, 2023 (See Note 20).

Based on our current operating plan, we may rely on the remaining availability of $37.3 million under our Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.

(“Cantor Fitzgerald”) pursuant to which we could offer and sell, from time to time shares of our Class A common stock (the “ATM Offering”) and our ability to sell approximately 9.4 million shares of Class A common stock to Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant and subject to the limitations of the purchase agreement (the “LPC Purchase Agreement”).

However, the ability to use these sources of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in our Class A common stock.

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) .

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.

We are evaluating several financing strategies to fund our planned and ongoing clinical trials, including direct equity investments and future public offerings of our common stock.

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

We are currently in active discussions with respect to financing, partnering and licensing transactions for the further development of TTP399 , but we may not be successful in completing such transactions.

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

We have entered into the Sales Agreement with Cantor Fitzgerald pursuant to which we may 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.

We are not obligated to sell any shares under the Sales Agreement.

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

As of December 31, 2022, we have sold $31.2 million worth of Class A common stock under the ATM Offering for net proceeds of $30.3 million, leaving $37.3 million available to be sold.

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.

TD Cowen Sales Agreement

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, although we may only offer and sell under the TD Cowen ATM Offering up to one-third of the aggregate market value of our voting and non-voting common equity held by non-affiliates during any 12 calendar month period pursuant to General Instruction I.B.6 of Form S-3 .

We are not obligated to sell any shares under the TD Cowen Sales Agreement.

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 have entered into the LPC Purchase Agreement, pursuant to which we have the right to sell to Lincoln Park shares of the Company’s Class A common stock having an aggregate value of up to $47.0 million.

As of December 31, 2022, we

Table of Con tents

have issued 5,331,306 of these shares for gross proceeds of approximately $11.1 million, leaving $35.9 million available to be sold.

Over the 36-month term of the LPC Purchase Agreement, we have the right, but not the obligation, from time to time, in our sole discretion, to direct Lincoln Park to purchase up to 250,000 shares per day (the “Regular Purchase Share Limit”) of the Class A common stock (each such purchase, a “Regular Purchase”).

The Regular Purchase Share Limit will increase to 275,000 shares per day if the closing price of the Class A common stock on the applicable purchase date is not below $4.00 per share and will further increase to 300,000 shares per day if the closing price of the Class A common stock on the applicable purchase date is not below $5.00 per share.

In any case, Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $2,000,000.

The purchase price for shares of Class A common stock to be purchased by Lincoln Park under a Regular Purchase will be equal to the lower of (in each case, subject to the adjustments described in the LPC Purchase Agreement):

(i) the lowest sale price for the Class A common stock on the applicable purchase date and (ii) the arithmetic average of the three lowest closing sales prices for the Class A common stock during the 10 consecutive trading days prior to the purchase date.

If we direct Lincoln Park to purchase the maximum number of shares of Class A common stock that we may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the LPC Purchase Agreement, we may direct Lincoln Park to make an “accelerated purchase” and an “additional accelerated purchase”, each of an additional number of shares of Class A common stock which may not exceed the lesser of:

(i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase and (ii) 30% of the total number of shares of the common stock traded during a specified period on the applicable purchase date as set forth in the LPC Purchase Agreement.

The purchase price for such shares will be the lesser of (i) 97% of the volume weighted average price of the Class A common stock over a certain portion of the date of sale as set forth in the LPC Purchase Agreement and (ii) the closing sale price of the Class A common stock on the date of sale (an “Accelerated Purchase”).

Under certain circumstances and in accordance with the LPC Purchase Agreement, we may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day.

The LPC Purchase Agreement also prohibits us from directing Lincoln Park to purchase any shares of its Class A common stock if those shares, when aggregated with all other shares of Class A common stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding shares of Class A common stock as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.

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.

Year Ended December 31,

1 unchanged sentence

Net cash used in operating activities $ (19,081) $ (16,022)

Net cash used in investing activities (21) —

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

Net cash provided by financing activities 11,997 14,754

Net (decrease)/increase in cash and cash equivalents $ (1,289) $ 7,668

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

Operating Activities

For the year ended December 31, 2022, our net cash used in operating activities decreased by $3.3 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 as a result from the excess of the fair value of the Class A common stock issued to G42 Investments.

For the year ended December 31, 2023, our net cash used in operating activities increased by $3.1 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.

Investing Activities

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.

No cash was provided by or used in investing activities for the year ended December 31, 2021.

Financing Activities

For the year ended December 31, 2022, net cash provided by financing activities was $14.8 million, consisting primarily of net proceeds from sales of our Class A common stock under the G42 Investments and CinRx Purchase

Table of Con tents

For the year ended December 31, 2021, net cash provided by financing activities was driven by sales of shares of our Class A common stock during the year ended December 31, 2021.

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

5 unchanged sentences

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 and proceeds from the G42 promissory note of $12.0 million which was received on February 28, 2023 (see Note 20) will allow us to meet our liquidity requirements through the end of the second quarter of 2023.

We plan to finance our operations into the first quarter of 2024 through the use of our cash and cash equivalents and based on current operating plans, we are evaluating several financing strategies to fund the on-going and future clinical trials of TTP399 , including direct equity investments and the potential licensing and monetization of other Company programs.

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.

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.

Even if we are able to complete such transactions, it may contain restrictions on our operations or cause substantial dilution to our stockholders.

Even if we are able to complete such transactions, they may contain restrictions on our operations or cause substantial dilution to our stockholders.

We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.

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 and LPC Purchase Agreement.

However, the ability to use these sources 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, and we may use our available capital resources sooner than we currently expect.

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.

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

• The progress, costs, results and timing of our planned trials to evaluate TTP399 as a potential adjunctive therapy for the treatment of type 1 diabetes;

• 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 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 ;

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

5 unchanged sentences

• our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

• our need and ability to hire additional management and scientific and medical personnel;

• our need and ability to hire additional management, scientific, and medical personnel;

• the effect of competing technological and market developments;

2 unchanged sentences

• the amount of any payments we are required to make to M&F TTP Holdings Two LLC in the future under the Tax Receivable Agreement.

Table of Con tents

• the impact and duration of the COVID-19 outbreak / pandemic.

Until such time, if ever, as we can generate substantial revenue from drug sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

We currently have committed external source of funds available through the ATM Offering and LPC Purchase Agreement.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.

1 unchanged sentence

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams or drug candidates or grant licenses on terms that may not be favorable to us.

If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate our research and development programs or commercialization efforts, or pursue one or more alternative strategies, such as restructuring, any of which could adversely affect our business prospects.

Off-Balance Sheet Arrangements

1 unchanged sentence

Discussion of Critical Accounting Policies and Estimates

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

The preparation of our 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 financial statements, as well as the reported revenues and expenses during the reported periods.

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 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.

1 unchanged sentence

Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies,” to our audited financial statements, we believe that the following accounting policies related to revenue recognition, research and development, income taxes, and share-based compensation are the most critical for fully understanding and evaluating our financial condition and results of operations.

Basis of Presentation

The Company is a holding company, and its principal asset is a controlling equity interest in vTv LLC, the Company’s principal operating subsidiary.

The Company has determined that vTv LLC is a VIE for accounting purposes and that the Company is the primary beneficiary of vTv LLC because (through its managing member interest in vTv LLC and the fact that the senior management of the Company is also the senior management of vTv LLC) it has the power to direct all of the activities of vTv LLC, which include those that most significantly impact vTv LLC’s economic performance.

The Company has therefore consolidated vTv LLC’s results under the VIE accounting model in its consolidated financial statements.

While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies,” to our audited consolidated financial statements, we believe that the following accounting policies related to revenue recognition, research and development, income taxes, and share-based compensation are the most critical for fully understanding and evaluating our financial condition and results of operations.

Revenue Recognition

7 unchanged sentences

The amount of variable consideration expected to be received is included in the transaction price when it becomes probable that the milestone will be met.

For contracts with multiple

Table of Con tents

performance obligations, the contract’s transaction price is allocated to each performance obligation using our best estimate of the standalone selling price of each distinct good or service in the contract.

For contracts with multiple performance obligations, the contract’s transaction price is allocated to each performance obligation using our best estimate of the standalone selling price of each distinct good or service in the contract.

The primary method used to estimate standalone selling price is the expected cost plus margin approach.

Revenue is recognized over the related period over which we expect the services to be provided using a proportional performance model or a straight-line method of recognition if there is no discernable pattern over which the services will be provided.

See Note 2 “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K for further information regarding the adoption of ASC 606, “Revenue From Contracts With Customers” and the related changes in the recognition of revenue that were adopted on January 1, 2018.

Revenue is recognized over the related period over which we expect the services to be provided using a proportional performance model or a straight-line method of recognition if there is no discernible pattern over which the services will be provided.

See Note 2 “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K for further information.

Research and Development

Major components of research and development costs include cash compensation, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on our behalf.

Major components of research and development costs include cash compensation to employees, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on our behalf.

Costs incurred in research and development are expensed as incurred.

3 unchanged sentences

Payments under the contracts depend on factors such as the achievement of certain events and the completion of portions of the clinical study or similar conditions.

The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended.

The objective of our accrual policy is to match the recording of expenses in our consolidated financial statements to the actual services received and efforts expended.

As such, expense accruals related to clinical studies are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study.

1 unchanged sentence

Prepaid expenses are recognized as expense in the statements of operations as we receive the related goods or services.

In connection with the IPO, vTv Therapeutics Inc.

In connection with the Initial Public Offering, vTv Therapeutics Inc.

From August 1, 2015, vTv Therapeutics Inc.

6 unchanged sentences

Significant judgments and estimates are required in determining the consolidated income tax expense.

We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events included in the financial statements.

Under this method, we determine deferred tax assets and liabilities on the basis of differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse.

Under this method, we determine deferred tax assets and liabilities on the basis of differences between the consolidated financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse.

The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period in which the enactment date occurs.

2 unchanged sentences

We record uncertain tax positions on the basis of a two-step process in which (1) we determine whether it is more-likely-than-not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions meeting the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.

Table of Con tents

Interest and penalties related to income taxes are included in the benefit (provision) for income taxes in our Consolidated Statement of Operations.

7 unchanged sentences

Due to a lack of historical exercise data, we estimate the expected life of our outstanding stock options using the simplified method specified under Staff Accounting Bulletin Topic 14.D.2.

The fair value of restricted stock units (“RSU”) grants are based on the market value of our Class A common stock on the date of grant.

The fair value of restricted stock units (“RSU”) grants is based on the market value of our Class A common stock on the date of grant.

We also estimate the amount of share-based awards that are expected to be forfeited based on historical employee turnover rates.

2 unchanged sentences

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