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What changed in vTv Therapeutics Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of vTv Therapeutics Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+394 added−342 removedSource: 10-K (2025-03-20) vs 10-K (2024-03-13)

Top changes in vTv Therapeutics Inc.'s 2024 10-K

394 paragraphs added · 342 removed · 228 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

84 edited+139 added−65 removed59 unchanged
Biggest changeConcurrently, we will be working on the design for two international registrational studies for cadisegliatin in T1D, which we expect to start in 2026. 5 Table of Contents In addition, we continue to work with our partner, G42 Investments, to initiate a double-blind randomized controlled Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes ("T2D").
Biggest changeWe also will continue to work with our partner, G42 Investments to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in patients with T2D. We expect that trial to begin in 2025. Preclinical Development Long-term toxicology studies, development and reproductive toxicology studies, have been completed.
We believe the key competitive factors that will affect the development and commercial success of our drug candidates are efficacy, safety and tolerability profile, mechanism of action, control and predictability, convenience of dosing, price and reimbursement, and availability of comparable alternative therapies.
Competition We believe the key competitive factors that will affect the development and commercial success of our drug candidates are efficacy, safety and tolerability profile, mechanism of action, control and predictability, convenience of dosing, price and reimbursement, and availability of comparable alternative therapies.
The IP portfolio for azeliragon also includes patent families covering polymorphs, salt forms, metabolites, degradation products and a synthetic precursor of azeliragon , methods of treatment using select dosage regimens of azeliragon , and methods of treating select patient populations, among other things.
The patent portfolio for azeliragon also includes patent families covering polymorphs, salt forms, metabolites, degradation products and a synthetic precursor of azeliragon , methods of treatment using select dosage regimens of azeliragon , and methods of treating select patient populations, among other things.
Novo Nordisk In February 2007, we entered into an Agreement Concerning Glucokinase Activator Project with Novo Nordisk A/S (the “Novo License Agreement”) whereby we obtained an exclusive, worldwide, sublicensable license under certain Novo Nordisk intellectual property rights to discover, develop, manufacture, have manufactured, use, and commercialize products for the prevention, treatment, control, mitigation, or palliation of human or animal diseases or conditions.
Inbound Partnerships Novo Nordisk In February 2007, we entered into an Agreement Concerning Glucokinase Activator Project with Novo Nordisk A/S (the “Novo License Agreement”) whereby we obtained an exclusive, worldwide, sublicensable license under certain Novo Nordisk intellectual property rights to discover, develop, manufacture, have manufactured, use, and commercialize products for the prevention, treatment, control, mitigation, or palliation of human or animal diseases or conditions.
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 this trial, treatment with cadisegliatin resulted in a clinically meaningful decrease (40%) in the frequency of sever and symptomatic hypoglycemia and in a statistically significant improvement in HbA1c relative to placebo. 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.
The FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D") in 2021 which 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.
The FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D in 2021 which 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.
Cadisegliatin (TTP399) Cadisegliatin is an orally administered, small molecule, liver-selective GKA in development as an adjunctive therapy to insulin for the treatment of TID. C adisegliatin has a novel mechanism of action: liver-selective activation of GK that seeks to provide improved glycemic control and a reduction in the risk of hypoglycemia.
Cadisegliatin (TTP399) Cadisegliatin is an orally administered, small molecule, liver-selective GKA in development as an adjunctive therapy to insulin for the treatment of T1D. C adisegliatin has a novel mechanism of action: liver-selective activation of GK that seeks to provide improved glycemic control and a reduction in the risk of hypoglycemia.
Under the terms of the Novo License Agreement, the Company has additional potential developmental and regulatory milestone payments totaling up to $9.0 million for approval of a product for the treatment of type 1 diabetes, $50.5 million for approval of a product for the treatment of type 2 diabetes, or $115.0 million for approval of a product in any other indication.
Under the terms of the Novo License Agreement, the Company has additional potential developmental and regulatory milestone payments totaling up to $7.0 million for approval of a product for the treatment of type 1 diabetes, $50.5 million for approval of a product for the treatment of type 2 diabetes, or $115.0 million for approval of a product in any other indication.
Positive Phase 2 Simplici-T1 Study In February 2020, we announced positive results from the Simplici-T1 Study, an adaptive Phase 2 clinical trial of cadisegliatin , assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of cadisegliatin in adult patients with TID over a 12-week period.
Positive Phase 2 Simplici-T1 Study In February 2020, we announced positive results from the Simplici-T1 Study, an adaptive Phase 2 clinical trial of cadisegliatin , assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of cadisegliatin in adult patients with T1D over a 12-week period.
GK activation is attractive as a potential therapy for the treatment of T1D because it may improve 6 Table of Contents overall glucose control and specifically reduce the frequency and severity of low blood glucose (hypoglycemic) episodes through a mechanism of action that is entirely distinct from currently marketed oral anti-diabetic drugs (“OAD”).
Activation of GK is attractive as a potential therapy for the treatment of T1D because it may improve overall blood glucose control and specifically reduce the frequency and severity of low blood glucose (hypoglycemic) episodes through a mechanism of action that is entirely distinct from currently marketed oral anti-diabetic drugs (“OAD”).
Our trials for cadisegliatin to date also suggest that our liver-selective approach to GK activation has the potential to avoid the tolerability issues associated with other GKAs, such as stimulation of insulin secretion independent of ambient blood glucose causing hypoglycemia, increased lipids, and liver toxicity.
Our trials for cadisegliatin to date also suggest that our liver-selective approach to GK activation has the potential to avoid the tolerability issues associated with other GKAs, such as stimulation of insulin secretion independent of ambient blood glucose causing hypoglycemia, increased 6 Table of Contents lipids, and liver toxicity.
On February 27, 2024, we closed (the “Closing”) a private placement (the “Private Placement”) of our Class A common stock and pre-funded warrants, pursuant to which we received aggregate gross proceeds of approximately $51.0 million, before deducting offering expenses payable by us.
In February 2024, we closed (the “Closing”) a private placement (the “Private Placement”) of our Class A common stock and pre-funded warrants, pursuant to which we received aggregate gross proceeds of approximately $51.0 million, before deducting offering expenses payable by us.
Such royalties will be payable on a licensed product-by-licensed product and country-by-country basis until the latest of expiration of the licensed patents covering a licensed product in a country, expiration of data exclusivity rights for a licensed product in a country or a specified number of years after the first commercial sale of a licensed product in a country.
Such royalties will be payable on a licensed product-by-licensed product and country-by-country basis until the latest of expiration of the licensed patents covering a licensed product in a 11 Table of Contents country, expiration of data exclusivity rights for a licensed product in a country or a specified number of years after the first commercial sale of a licensed product in a country.
The results of each party’s clinical trials will be combined by the Company to seek FDA approval in the United States for cadisegliatin .
The results of each party’s clinical trials may be combined by the Company to seek FDA approval in the United States for cadisegliatin .
The IP portfolio for TTP273 also includes patent families covering crystalline, non-crystalline, and salt forms, and formulations of TTP273 , synthetic precursors to, and methods of manufacture of TTP273 , as well as combinations of TTP273 and metformin, and their use in methods of treatment, and dosage regimens of TTP273 .
The patent portfolio for TTP273 also includes patent families directed to crystalline, non-crystalline, and crystalline salt forms, and formulations of TTP273 , synthetic precursors to, and methods of manufacture of TTP273 , as well as combinations of TTP273 and metformin, and their use in methods of treatment, and dosage regimens of TTP273 .
In 2022, the FDA approved Teplizumab (Tzield), a humanized anti-CD3 monoclonal antibody for the treatment of patients with two or more diabetes-related auto-antibodies to delay onset of full-blown disease, and Donislecel (Lantidra), an allogeneic (donor) pancreatic islet cellular therapy for the treatment of patients with T1D who are in poor glycemic control because of recurrent severe hypoglycemia.
In 2022, the FDA approved teplizumab (Tzield ® ), a humanized anti-CD3 monoclonal antibody for the treatment of patients with two or more diabetes-related auto-antibodies to delay onset of Stage 3 T1D, and donislecel (Lantidra™), an allogeneic (donor) pancreatic islet cellular therapy for the treatment of patients with T1D who are in poor glycemic control because of recurrent severe hypoglycemia.
The contents of our website are not made a part of this Annual Report on Form 10-K. 17 Table of Contents
The contents of our website are not made a part of this Annual Report on Form 10-K. 20 Table of Contents
The IP portfolio for the Nrf2/Bach1 program also includes patent families covering backup compounds, methods of use in combination with other Nrf2 activator compounds such as dimethyl fumarate and bardoxolone, and methods to treat sickle cell diseases, osteoporosis, and refractive ocular disorders.
The patent portfolio for the Nrf2/Bach1 program also includes patent families directed to methods of use in combination with other Nrf2 activator compounds such as dimethyl fumarate and bardoxolone, and methods to treat sickle cell diseases, osteoporosis, and refractive ocular disorders.
The Role of Glucokinase Activation in Diabetes Glucokinase (“GK”) is a key regulator of glucose homeostasis and acts as the physiological glucose sensor, changing its conformation, activity, and/or intracellular location in parallel with changes in glucose concentrations. GK has two distinctive characteristics that make it a good choice for blood glucose control.
The Role of Glucokinase Activation in Diabetes Glucokinase (“GK”) is a key regulator of glucose homeostasis and acts as the physiological glucose sensor, changing its conformation, activity, and/or intracellular location commensurate with changes in blood glucose concentrations. GK has two distinctive characteristics that make it a good choice for a therapeutic target for improving blood glucose control.
In these trials, cadisegliatin was well tolerated with negligible incidence of hypoglycemia in the T2D studies and a significant reduction of hypoglycemia observed in the Phase 2 study in TID.
In these trials, cadisegliatin was well tolerated with a significant reduction or hypoglycemia observed in the Phase 2 study in T1D and a negligible incidence of hypoglycemia in the T2D studies .
CinPax and CinRx Transaction On July 22, 2022, the Company entered into a Common Stock and Warrant Purchase Agreement (as amended, the "CinRx Purchase Agreement") with CinPax, LLC (“CinPax”), a subsidiary of CinRx Pharma, LLC (“CinRx”), pursuant to which the Company sold to CinPax 103,864 shares of the Company’s Class A common stock at a price per share of approximately $96.40, for an aggregate purchase price of $10.0 million, which was paid (i) $6.0 million in cash at the closing of the transaction and (ii) $4.0 million in the form of a non-interest-bearing promissory note with CinPax and was paid to the Company on November 22, 2022.
CinPax and CinRx Transaction On July 22, 2022, the Company entered into a Common Stock and Warrant Purchase Agreement (as amended, the "CinRx Purchase Agreement") with CinPax, LLC (“CinPax”), a subsidiary of CinRx Pharma, LLC (“CinRx”), pursuant to 8 Table of Contents which the Company sold to CinPax 103,864 shares of the Company’s Class A common stock, for an aggregate purchase price of $10.0 million, which was paid (i) $6.0 million in cash at the closing of the transaction and (ii) $4.0 million in the form of a non-interest-bearing promissory note with CinPax and was paid to the Company on November 22, 2022.
Collaboration Agreements G42 Transaction The Company and G42 Investments, entered into a Common Stock Purchase Agreement (the “G42 Purchase Agreement”) on May 31, 2022, pursuant to which the Company sold to G42 Investments 259,657 shares of the Company’s Class A common stock at a price per share of approximately $96.40, for an aggregate purchase price of $25.0 million, which was paid (i) $12.5 million in cash at the closing and (ii) $12.5 million in the form of a promissory note.
Collaboration Agreements 7 Table of Contents G42 Transaction The Company and G42 Investments, entered into a Common Stock Purchase Agreement (the “G42 Purchase Agreement”) on May 31, 2022, pursuant to which the Company sold to G42 Investments 259,657 shares of the Company’s Class A common stock, for an aggregate purchase price of $25.0 million, which was paid (i) $12.5 million in cash at the closing and (ii) $12.5 million in the form of a promissory note.
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 FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D in 2021. 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.
In our Phase 1 and Phase 2 clinical trials, TTP273 has been demonstrated to be well-tolerated with lower incidences of GI side effects, such as nausea and vomiting, than placebo with minimal weight loss, especially in nonobese patients.
In these trials, TTP273 has been demonstrated to be well-tolerated with lower incidences of GI side effects, such as nausea and vomiting, than placebo with minimal weight loss, especially in nonobese patients.
First, its expression is mostly limited to tissues that require glucose-sensing (mainly liver cells and pancreatic β-cells). Second, GK acts as a biological sensor for changes in serum glucose levels and modulates changes in the liver's uptake or release of glucose and changes in insulin secretion by the β-cells.
First, its expression is mostly limited to glucose-sensing tissues (mainly liver cells and pancreatic β-cells), allowing for a focused therapeutic effect. Second, GK acts as a biological sensor for changes in serum glucose levels, modulating changes in the liver's uptake or release of glucose and changes in insulin secretion by β-cells.
HPP3033 Oxidative stress plays an important role in the degeneration of dopaminergic neurons in Parkinson’s disease (PD). In a model of Parkinson's disease, oral administration of HPP3033 attenuated 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine ("MPTP") neurotoxicity in pre- and post-treatment paradigms. Bach1 inhibitor-induced neuroprotection was associated with the up regulation of Bach1 targeted pathways in concurrence with the results from Bach knock-out ("KO") mice.
In a model of Parkinson's disease, oral administration of HPP3033 attenuated 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine ("MPTP") neurotoxicity in pre- and post-treatment paradigms. Bach1 inhibitor-induced neuroprotection was associated with the up regulation of Bach1 targeted pathways in concurrence with the results from Bach knock-out ("KO") mice.
However, Teplizumab does not address the unmet need of existing patients with T1D or those that are eventually at risk to become patients with T1D following any therapeutic delay in disease onset. The use of Donislecel, on the other hand, is restricted to patients with T1D and recurrent severe hypoglycemic episodes, and requires long-term concurrent immunosuppressive therapy.
However, teplizumab does not address the unmet need of existing patients with T1D or those that will eventually develop T1D following any therapeutic delay in disease onset. The use of donislecel is restricted to patients with T1D and recurrent severe hypoglycemic episodes, and requires long-term concurrent immunosuppressive therapy.
We are eligible to receive additional potential development, regulatory and sales-based milestone payments totaling up to $58.5 million. In addition, Newsoara is obligated to pay us royalty payments at high-single to low-double digit rates, based on tiers of annual net sales of licensed products.
We are eligible to receive additional potential development, regulatory and sales-based milestone payments totaling up to $76.5 million. In addition, Newsoara is obligated to pay the Company royalty payments at mid to upper single digit rates, based on tiers of annual net sales of licensed products.
The IP portfolio for HPP737 also includes a patent family specifically covering HPP737 and another patent family covering a crystalline form of HPP737 . Any patents issuing from these two patent families will expire in 2040, absent any patent term adjustments or extensions.
The patent portfolio for HPP737 also includes a patent family specifically covering HPP737 and another patent family directed to a crystalline form of HPP737 . Any patents issuing from the pending patent applications in these two patent families will expire in 2040, absent any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
Collaboration Revenue and Customers Most of our collaboration revenue for the years ended December 31, 2023, 2022 and 2021 is related to our licenses of certain compounds in the preclinical stage or clinical stage, including the Huadong License Agreement, the Reneo License Agreement, and the Newsoara License Agreement.
Collaboration Revenue and Customers Most of our collaboration revenue for the years ended December 31, 2024, 2023 and 2022 is related to our licenses of certain compounds in the preclinical stage or clinical stage, including the Huadong License Agreement, which was terminated effective September 1, 2024, and the Newsoara License Agreement.
We have also completed a Phase 1 study in healthy male subjects to investigate the absorption, metabolism, and excretion of [ 14 C]- cadisegliatin following single dose oral administration. Ten participants have been dosed and analysis is ongoing.
We also completed a Phase 1 study in healthy male subjects to investigate the absorption, metabolism, and excretion of [ 14 C]- cadisegliatin following single dose oral administration (the "ADME study").
We now 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 of hypoglycemia) and Level 3 hypoglycemia ("severe" hypoglycemia e.g., requiring assistance of another person) in 150 patients with T1D.
The CATT1 trial is a double-blind, randomized 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).
None of our employees are represented by a labor union, and we consider our employee relations to be good. Our Corporate Information We were incorporated under the laws of the State of Delaware in 2015. Our principal executive offices are located at 3980 Premier Drive, Suite 310, High Point, NC 27265, and our telephone number is (336) 841-0300.
Our Corporate Information We were incorporated under the laws of the State of Delaware in 2015. Our principal executive offices are located at 3980 Premier Drive, Suite 310, High Point, NC 27265, and our telephone number is (336) 841-0300.
Current Treatments for T1D and Their Limitations Patients with T1D have difficulty achieving and maintaining consistent glycemic control, defined as HbA1c Several existing treatment options for T2D have been investigated to treat T1D, generally without success.
Current Treatments for T1D and Their Limitations Patients with T1D have difficulty achieving and maintaining glycemic control, defined as HbA1c Facing a lack of adjunctive treatments for T1D, several existing treatment options for T2D have been investigated in T1D without success.
Thus, there is a serious unmet medical need to provide people with T1D additional, especially oral, treatment options that can help them to reduce HbA1c and the incidence of hypoglycemia (blood glucose levels below normal) or DKA.
Thus, there is a serious unmet medical need to provide people with T1D additional, especially oral, treatment options that can help them to reduce the incidence of hypoglycemia and improve glycemic control (HbA1c) without the risk of DKA or other serious adverse effects.
Importantly, patients taking cadisegliatin reported no events of hypoglycemia, while four events of hypoglycemia were reported in the placebo group. ADME study In August 2023, we completed an Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [ 14 C]- cadisegliatin (TTP399) Following Single Dose Oral Administration.
ADME study In August 2023, we completed an Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [ 14 C]- cadisegliatin (TTP399) Following Single Dose Oral Administration. Ten participants were dosed.
Upon expiration (but not earlier termination) of the Newsoara License Agreement the licenses granted to Newsoara will survive on a royalty-free basis in perpetuity. Azeliragon and Cantex Pharmaceuticals, Inc. On June 22, 2021, vTv Therapeutics Inc. and Cantex Pharmaceuticals, Inc.
Upon expiration (but not earlier termination) of the Newsoara License Agreement the licenses granted to Newsoara will survive on a royalty-free basis in perpetuity.
While SGLT-1/2 and SGLT-2 inhibitors were initially approved in Europe and Japan with label restrictions to certain sub-groups of people with T1D, and continue to be approved for patients with T2D, these therapies have since been withdrawn from the European market and never received regulatory approval in the U.S. for T1D due to safety risks primarily relating to the risk of diabetic ketoacidosis (“DKA”).
SGLT-1/2 and SGLT-2 inhibitors were temporarily approved in Europe and Japan for certain sub-groups of people with T1D; however, they never received regulatory approval in the U.S. for T1D and were withdrawn from the European market due to safety risks primarily relating to increased risk of diabetic ketoacidosis (“DKA”).
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
We currently rely, and expect to continue to rely, on third parties to manufacture clinical supplies of our drug candidates and for our other research and discovery programs. We do not have multiple sources of supply for the components used in our drug candidates.
We currently rely, and expect to continue to rely, on third parties to manufacture clinical supplies of our drug candidates and for our other research and discovery programs.
We expect that trial to begin in 2024. • Seeking additional strategic collaborations and additional funding to support the continued development and commercialization of our development programs . We will continue to seek additional funding to support the further development of our drug candidates.
We expect that trial to begin in 2025. • Seeking additional strategic collaborations and additional funding to support the continued development and commercialization of our pipeline development programs . We continue to seek additional funding to support the further development of our drug candidates because internal resources are solely focused on the development of cadisegliatin .
Trade Secrets In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners.
We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners.
Revenue recognized in these periods relates to initial consideration received in the form of upfront payments and equity interests, research activities performed by our personnel, and the achievement of development milestones. 16 Table of Contents Government Regulation and Product Approvals Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union (“EU”), extensively regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of biopharmaceutical products.
Government Regulation and Product Approvals Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union (“EU”), extensively regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of biopharmaceutical products.
The issued patents and patent applications, if issued in this additional patent family, if issued, would be expected to expire in 2039, absent any patent term adjustments or extensions. The IP portfolio for HPP737 includes issued patents in the U.S. generically covering HPP737 as a composition of matter and methods of use to treat various indications.
The patent portfolio for HPP737 includes issued patents in the U.S. generically covering HPP737 as a composition of matter and methods of use to treat various indications. The issued U.S. patent generically covering HPP737 as a composition of matter will expire no earlier than 2029, absent any patent term adjustments or extensions.
Many of the companies against which we may compete have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.
Many of the companies against which we may compete have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.
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 T1D.
The CATT1 trial is a double-blind, randomized 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).
(“G42 Investments”), to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes ("T2D"). We expect that trial to begin in 2024.
(“G42 Investments”), to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in patients with type 2 diabetes ("T2D"). The study will randomize 450 patients to assess the potential of cadisegliatin as an adjunct therapy to insulin in patients with T2D. We expect that trial to begin in 2025.
As key components of our strategy, we are focused on: • Continuing to advance cadisegliatin (TTP399) as a potential treatment for type 1 diabetes .
We are also actively seeking licensing deals for our pipeline assets that are not currently partnered. As key components of our strategy, we are focused on: • Continuing to advance cadisegliatin (TTP399) as a potential treatment for type 1 diabetes .
While the causes of TID are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. The onset of T1D is not believed to be affected by diet or lifestyle.
T1D results when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas called beta cells. While the causes of T1D are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. The onset of T1D is not believed to be affected by diet or lifestyle.
We believe that TTP273 could be used to treat postprandial hyperglycemia in CFRD patients and CF patients with abnormal postprandial glucose excursions without inducing hypoglycemia or GI side effects.
We believe that TTP273 could be used to treat postprandial hyperglycemia in CFRD patients and CF patients with abnormal postprandial glucose excursions without inducing hypoglycemia or GI side effects. 9 Table of Contents We have completed two Phase 1 clinical trials and one Phase 2 clinical trial of TTP273 .
Concurrently, we will be working on the design for two international registrational studies for cadisegliatin in T1D, which we expect to start in 2026. 7 Table of Contents In addition, we continue to work with our partner, G42 Investments, to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in 450 insulin-using patients with T2D.
We will also start preparing plans for additional international registrational studies for cadisegliatin in T1D. In addition, we continue to work with our partner, G42 Investments, to initiate a double-blind randomized controlled Phase 2 trial in the Middle East region in 450 insulin-dependent patients with T2D.
Hemin and the hemin mimetic cobalt protoporphyrin IX (“CoPP”) are Bach1 ligands that have served as useful tool compounds to investigate the role of Bach1 inhibition in a variety of disease settings.
Hemin and the hemin mimetic cobalt protoporphyrin IX (“CoPP”) are Bach1 ligands that have served as useful tool compounds to investigate the role of Bach1 inhibition in a variety of disease settings. Both molecules have been shown to have beneficial effects on oxidative stress and inflammatory-mediated pathologies in several animal models.
TTP273 is an orally available, small molecule GLP-1RA which has been demonstrated to reduce postprandial glucose excursion in response to an oral glucose test or mixed meal tolerance test in both preclinical and clinical studies. We are currently exploring options to study the therapeutic potential of TTP273 in patients with cystic fibrosis related diabetes ("CFRD").
TTP273 TTP273 is an orally available, small molecule GLP-1RA, which has been demonstrated to reduce postprandial glucose excursion in response to an oral glucose test or mixed meal tolerance test in both preclinical and clinical studies.
The Company may also be obligated to pay an additional $75.0 million in potential sales-based milestones, as well as royalty payments, at mid-single digit royalty rates, based on tiered sales of commercialized licensed products.
The Company may also be obligated to pay an additional $75.0 million in potential sales-based milestones, as well as royalty payments, at mid-single digit royalty rates, based on tiered sales of commercialized licensed products. Third-Party Suppliers and Manufacturers We do not own or operate, and currently have no plans to establish, any manufacturing facilities.
HPP737 - PDE4 Inhibitor Psoriasis Overview Psoriasis is a chronic autoimmune inflammatory disease in which the growth cycle of skin is accelerated due to an imbalance in proinflammatory and anti-inflammatory cytokines.
Therefore, the results obtained with HPP3033 in this study hold promise for the future development of this compound. 10 Table of Contents HPP737 - PDE4 Inhibitor Psoriasis Overview Psoriasis is a chronic autoimmune inflammatory disease in which the growth cycle of skin is accelerated due to an imbalance in proinflammatory and anti-inflammatory cytokines.
Once commercialization takes place in the Partner Territory, the Company will receive royalties in the single digits from Cogna on the net sales of the Licensed Product for a period of at least ten years after the first commercial sale of the Licensed Product in the Partner Territory. 8 Table of Contents 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.
Once commercialization takes place in the Partner Territory, the Company will receive royalties in the single digits from Cogna on the net sales of the Licensed Product for a period of at least ten years after the first commercial sale of the Licensed Product in the Partner Territory.
Nrf2 activators are known to exert protection in the pre-treatment paradigm, but the benefits of pharmacological Nrf2 activation are rarely observed in post-treatment models. Therefore, the results obtained with HPP3033 in this study hold promise for the future development of this compound.
Nrf2 activators are known to exert protection in the pre-treatment paradigm, but the benefits of pharmacological Nrf2 activation are rarely observed in post-treatment models.
In addition to our clinical development program for cadisegliatin , we continue to further the research and development of our other pipeline candidates through collaborations with academic partners and license agreements. 4 Table of Contents Our Pipeline The following table summarizes our current drug candidates and their respective stages of development: Our Strategy Our goal is to advance the development of our differentiated pipeline of orally administered, small molecule drug candidates to treat metabolic and inflammatory diseases to minimize their long-term complications and to improve the lives of patients.
In addition to our clinical development program for cadisegliatin , we continue to further the research and development of our other pipeline candidates through collaborations with academic partners and license agreements. 4 Table of Contents Our Pipeline The following table summarizes our current drug candidates and their respective stages of development: Our Strategy Our primary goal is to advance the development of our lead program cadisegliatin , a novel, oral, liver-selective glucokinase activator.
(“Cantex”) entered into a licensing agreement under which Cantex obtained exclusive worldwide rights to develop and commercialize azeliragon , vTv’s novel antagonist of RAGE (the receptor for advanced glycation end products). Under the terms of the agreement, Cantex will be responsible for the development and commercialization of azeliragon, and the companies will allocate downstream profits under a tiered arrangement.
On June 22, 2021, vTv Therapeutics Inc. and Cantex Pharmaceuticals, Inc. (“Cantex”) entered into a licensing agreement under which Cantex obtained exclusive worldwide rights to develop and commercialize azeliragon , vTv’s novel antagonist of RAGE (the receptor for advanced glycation end products).
We anticipate that the financing will enable us to conduct a Phase 3 clinical trial for our lead product candidate, cadisegliatin (TTP399) , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) that is a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. The U.S.
Our lead product candidate, cadisegliatin (TTP399) , is an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) that is a potential adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"). On March 14, 2025, based upon the Company's submission of a complete response letter, the U.S.
The patent applications in these additional patent families, if issued, would be expected to expire between 2035 and 2041, absent any patent term adjustments or extensions.
The issued patents and patents issuing from pending patent applications in these additional patent families are projected to expire between 2035 and 2041, absent any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days.
The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg once per day demonstrated dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed.
In addition, Diasome Pharmaceuticals has started a new Phase 2 study in February 2024 to assess the effects of their Hepatic Directed Vesicle (HDV)-based insulin lispro formulation ("HDV Insulin lispro") on the incidence of nocturnal hypoglycemia in patients with T1D. However, none of these treatments are currently approved or marketed for the treatment of type 1 diabetes.
In addition, in 2024 Diasome Pharmaceuticals began a Phase 2b study to assess the effects of their hepatic directed vesicle (HDV)-based insulin lispro formulation on the incidence of nocturnal hypoglycemia in patients with T1D.
Both molecules have been shown to have beneficial effects on oxidative stress and inflammatory-mediated pathologies in several animal models. 10 Table of Contents Further, the ubiquity of the response suggests that the observed tissue protective effects are not related to the underlying causes of a particular disease, but instead are an intrinsic outcome of Bach1 modulation along with Nrf2 activation.
Further, the ubiquity of the response suggests that the observed tissue protective effects are not related to the underlying causes of a particular disease, but instead are an intrinsic outcome of Bach1 modulation along with Nrf2 activation. HPP3033 Oxidative stress plays an important role in the degeneration of dopaminergic neurons in Parkinson’s disease (PD).
Patents covering TTP273 as a composition of matter outside the United States will expire no earlier than 2030, absent any patent term adjustments or extensions. Provisions that are similar to the U.S. PTE under the Hatch-Waxman Act are available in Europe and some other foreign jurisdictions to extend the term of the patent covering TTP273 as a composition of matter.
The issued patents covering TTP273 as a composition of matter will expire no earlier than 2030, absent any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
The securities purchase agreement for the Private Placement, among other things, grants the investors the right to purchase up to an additional $30.0 million of Class A common stock 18 months following the Closing.
The securities purchase agreement for the Private Placement, among other things, grants the investors the right to purchase up to an additional $30.0 million of Class A common stock on or before August 27, 2025. The Private Placement will allow us to continue to advance our lead program for cadisegliatin ( TTP399 ).
The issued patents and patent applications, if issued, in these additional patent families would be expected to expire between 2034 and 2041, absent any patent term adjustments or extensions. The IP portfolio for cadisegliatin further includes additional patent families covering combinations of cadisegliatin with metformin, DPP-4 inhibitors, or GLP-1r agonists, and their use in methods of treatment.
The patent portfolio for cadisegliatin further includes patent families directed to combinations of cadisegliatin with metformin, DPP-4 inhibitors, or GLP-1r agonists, and their use in methods of treatment.
The patent applications in these additional patent families, if issued, would be expected to expire between 2034 and 2042, absent any patent term adjustments or extensions.
The issued patents and patents issuing from pending patent applications in these additional patent families are projected expected to expire between 2031 and 2033, absent any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
Mechanistic study In October 2021, we announced positive results from the mechanistic study indicating no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients with T1D. Consistent with previous clinical studies of cadisegliatin , the drug was well tolerated with fewer subjects reporting treatment-emergent adverse events in the group taking cadisegliatin than in the placebo group.
Consistent with previous clinical studies of cadisegliatin , the drug was well tolerated with fewer subjects reporting treatment-emergent adverse events in the group taking cadisegliatin than in the placebo group. Importantly, patients taking cadisegliatin reported no events of hypoglycemia, while four events of hypoglycemia were reported in the placebo group.
Ten participants have been dosed, and analysis is ongoing. Clinical Development Plan Based upon the positive results of our Phase 2 Simplici-T1 Study, we requested breakthrough treatment designation (BTD) with the FDA which was granted in April 2021.
Clinical Development Plan Based upon the positive results of our Phase 2 Simplici-T1 Study, we requested breakthrough treatment designation (BTD) from th e FDA which was granted in April 2021. • Based upon the lifting of the clinical hold imposed in July 2024, we plan to resume our Phase 3 CATT1 trial in the second quarter of 2025.
Although existing GLP-1 mimetics are available for the treatment of CFRD, their use is limited by the gastrointestinal ("GI") side effects and undesired weight loss associated with these agents. 9 Table of Contents TTP273 TTP273 is an orally available, small molecule GLP-1RA, which has been demonstrated to reduce postprandial glucose excursion in response to an oral glucose test or mixed meal tolerance test in both preclinical and clinical studies.
TTP273 is an orally available, small molecule GLP-1RA which has been demonstrated to reduce postprandial glucose excursion in response to an oral glucose test or mixed meal tolerance test in both preclinical and clinical studies. Therapeutic use of GLP1-RAs overview GLP-1 RAs were initially developed to treat T2D but have demonstrated effectiveness in promoting weight loss.
On January 9, 2023, Cantex announced that the FDA has granted Orphan Drug Designation to azeliragon for the treatment of glioblastoma. In addition, a Phase 2 trial of azeliragon is in progress in women receiving “neoadjuvant chemotherapy” of breast cancer, which is chemotherapy to prevent cancer from returning after initial potentially curative treatment.
In addition, a Phase 2 trial of azeliragon is in progress in women receiving “neoadjuvant chemotherapy” of breast cancer, which is chemotherapy to prevent cancer from returning after initial potentially curative treatment. In February 2022, Cantex secured a global license from Harvard University to further develop azeliragon as a treatment for inflammatory lung diseases, including COVID-19.
The key competitive factors affecting the success of all our programs are likely to be their efficacy, safety, convenience, and availability of reimbursement. Potential Competing Products – Type 1 Diabetes If approved, we expect that our type 1 diabetes investigational drug candidate will compete with oral non-insulin agents and new insulin formulations or devices that are currently being developed.
Potential Competing Products – Type 1 Diabetes If approved, we expect that our type 1 diabetes investigational drug candidate will compete with oral or injectable non-insulin agents, new insulin formulations or medical devices that are currently marketed or being developed. An injectable somatostatin type 2 receptor blocker is being developed by Zucara Therapeutics to treat nocturnal hypoglycemia.
Human Capital As of December 31, 2023, we had sixteen employees (all but seven of whom work in North Carolina), of which at least ten hold graduate degrees (including eight doctorate degrees) and seven are engaged in full-time research and development activities.
Human Capital As of December 31, 2024, we had twenty-three employees (eight of whom work in North Carolina), of which at least thirteen hold graduate degrees (including ten doctorate degrees). None of our employees are represented by a labor union, and we consider our employee relations to be good.
Pramlintide (Symlin), an amylin peptide analog approved for meal time injections, has been approved for use in both T1D and T2D since 2005 but has not been adopted widely. Alternative therapeutic modalities, including monoclonal antibodies, are under clinical investigation and have demonstrated evidence of the potential to delay the onset of T1D.
Pramlintide (Symlin), an amylin peptide analog approved for mealtime injections, was approved for use in both T1D and T2D in 2005 but has not been adopted widely.
The issued U.S. patent covering HPP971 and HPP3033 as compositions of matter will expire no earlier than 2031, absent any patent term adjustments or extensions. However, this issued U.S. patent may expire as late as 2036, if after approval by the U.S.
The issued patents in this patent family will expire no earlier than 2031, absent 13 Table of Contents any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
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 in reducing hyperglycemia.
The CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis (i.e., 50 patients for each study arm) to receive 800 mg cadisegliatin daily or twice daily or to receive placebo. A key secondary endpoint is reduction in glycated hemoglobin (HbA1c), a traditional efficacy endpoint in diabetes trials, to assess the potential of cadisegliatin to reduce hyperglycemia.
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 in reducing hyperglycemia.
The CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis (i.e., 50 patients for each study arm) to receive 800 mg cadisegliatin daily or twice daily or to receive placebo. A key secondary endpoint is reduction in glycated hemoglobin (HbA1c), a traditional efficacy endpoint in diabetes trials, to assess the potential of cadisegliatin to reduce hyperglycemia.
The Role of GLP-1r Activation in Cystic Fibrosis Related Diabetes GLP-1 is released by the gut in response to nutrients and lowers postprandial glucose by promoting insulin secretion. Abnormally low postprandial stimulation of incretin hormones like GLP-1 has been described in CF patients and improvement in postprandial hyperglycemia has been demonstrated following prandial administration of GLP-1 agonists or dipeptidyl peptidase-4.
Additionally, in cystic fibrosis related diabetes (“CFRD”) which presents with abnormally low postprandial stimulation of incretin hormones like GLP-1, an improvement in postprandial hyperglycemia has been demonstrated following prandial administration of GLP-1 agonists.
The issued patents and patent applications, if issued, in these additional patent families would be expected to expire between 2031 and 2033, absent any patent term adjustments or extensions. In addition, the IP portfolio also includes a patent family covering methods of treating patients with type 1 diabetes using cadisegliatin in combination with insulin.
For example, the patent portfolio for cadisegliatin includes a patent family directed to methods of treating patients with type 1 diabetes using cadisegliatin in combination with insulin.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThese risks are discussed more fully below and include, but are not limited to, risks related to: Our Financial Position and Need for Additional Capital • our ability to achieve or maintain profitability; • our ability to generate revenue in absence of any products approved for sale; • our need for additional capital to continue the development and commercialization of our drug candidates; • the impact of raising additional capital to our stockholders and the rights of our drug candidates; The Development and Regulatory Approval of Our Drug Candidates • the potential failure of our clinical trials or our inability to receive regulatory approval for our drug candidates; • the identification of serious adverse or unacceptable side effects which are determined to be drug-related; • the impact of changes in law or regulatory policy on the approval of our drug candidates; • the impact of delays in the commencement, enrollment and completion of our clinical trials; • our ability to submit an NDA for the drug candidates we are developing; Risks Relating to the Commercialization of Our Drug Candidates • the acceptance of drug candidates in the market, if approved by the appropriate regulatory agencies; • our ability to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our drug candidates; • the impact of ongoing obligations and continued regulatory review for our drug candidates post-commercialization; • competition with other products; • the impact of healthcare cost containment initiatives and the growth of managed care; • our ability to obtain marketing approval for our drug candidates and obtain profitable pricing once approved; • the impact of healthcare laws and regulations on our relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors; • our ability to obtain approval to commercialize products outside the United States; Risks Relating to Our Dependence on Third Parties • our ability to establish and maintain collaborative relationships to further the development of our drug candidates; • the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials; • our dependence on limited sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates; • our reliance on third-party manufacturers to produce our drug candidates; Risks Relating to Our Intellectual Property • our ability to continue to protect proprietary rights to our intellectual property; • the unauthorized disclosure of our trade secrets or other confidential information; • the impact of changes to the patent laws in the United States and other jurisdictions; • the impact of litigation for infringing intellectual property rights of third parties; • the impact of litigation to protect or enforce our patents or other intellectual property; • our ability to enforce our intellectual property rights throughout the world; • our ability to obtain patent term extensions for our drug candidates; Risks Relating to Employee Matters and Managing Growth • the impact of expanding our operations and managing growth; 18 Table of Contents • our ability to attract and retain key personnel; • the impact of our employees, independent contractors, principal investigators, CROs, consultants and collaborators in the event that they engage in misconduct or other improper activities; Other Risks Relating to Our Business • the impact of the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; • the impact of using our financial and human resources to pursue a particular research program or drug candidate and failing to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success; • the impact of litigation and government investigations, including product liability lawsuits; • the exposure to uninsured liabilities; • our ability to remain competitive given the rapidly changing market for our proposed drug candidates; • the impact of computer system failures, cyber-attacks or a deficiency in our cyber-security; Risks Related to our Common Stock • our ability to maintain listing of our Class A common stock on Nasdaq • the impact of MacAndrews’ substantial influence over our business; • the potential for conflicts of interest with our directors who have relationships with MacAndrews; • our ability to pay cash dividends; • the potential for securities class action litigation; • the impact of research and reports that equity research analysts publish about us and our business; • the impact of substantial sales of shares into the market at any time; • the dilution created by future sales and issuances of our Class A common stock or rights to purchase Class A common stock; • our reliance upon our “smaller reporting company” status; • the existence of provisions in our governing documents or state law which may delay or prevent our acquisition by a third party; • our obligation to make payments under the Tax Receivable Agreement; • our ability to make distributions from vTv LLC to satisfy our obligations; • the benefits conferred upon M&F that will not benefit Class A common stockholders to the same extent as it will benefit MacAndrews. 19 Table of Contents Risks Relating to Our Financial Position and Need for Additional Capital We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.
Biggest changeThese risks are discussed more fully below and include, but are not limited to, risks related to: Our Financial Position and Need for Additional Capital • our need for additional capital to continue the development and commercialization of our drug candidates; • the impact of raising additional capital to our stockholders and the rights of our drug candidates; • our ability to achieve or maintain profitability; • our financial condition and ability to continue as a going concern: • our ability to generate revenue in absence of any products approved for sale; The Development and Regulatory Approval of Our Drug Candidates • the impact of delays in the commencement, enrollment and completion of our clinical trials, including clinical holds or other regulatory limitations on our clinical development programs; • potential failure of our clinical trials or our inability to receive regulatory approval for our drug candidates; • the identification of serious adverse or unacceptable side effects which are determined to be drug-related; • the impact of changes in law or regulatory policy on the approval of our drug candidates; • our ability to submit an NDA for the drug candidates we are developing; Risks Relating to the Commercialization of Our Drug Candidates • the acceptance of drug candidates in the market, if approved by the appropriate regulatory agencies; • our ability to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our drug candidates; • the impact of ongoing obligations and continued regulatory review for our drug candidates post-commercialization; • competition with other products; • the impact of healthcare cost containment initiatives and the growth of managed care; • our ability to obtain marketing approval for our drug candidates and obtain profitable pricing once approved; • the impact of healthcare laws and regulations on our relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors; • our ability to obtain approval to commercialize products outside the United States; Risks Relating to Our Dependence on Third Parties • our ability to establish and maintain collaborative relationships to further the development of our drug candidates; • the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials; • our dependence on limited sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates; • our reliance on third-party manufacturers to produce our drug candidates; Risks Relating to Our Intellectual Property • our ability to continue to protect proprietary rights to our intellectual property; • the unauthorized disclosure of our trade secrets or other confidential information; • the impact of changes to the patent laws in the United States and other jurisdictions; • the impact of litigation for infringing intellectual property rights of third parties; • the impact of litigation to protect or enforce our patents or other intellectual property; • our ability to enforce our intellectual property rights throughout the world; • our ability to obtain patent term extensions for our drug candidates; Risks Relating to Employee Matters and Managing Growth 21 Table of Contents • the impact of expanding our operations and managing growth; • our ability to attract and retain key personnel; • the impact of our employees, independent contractors, principal investigators, CROs, consultants and collaborators in the event that they engage in misconduct or other improper activities; Other Risks Relating to Our Business • our ability to remain competitive given the rapidly changing market for our proposed drug candidates; • the impact of computer system failures, cyberattacks or a deficiency in our cybersecurity; • the impact of using our financial and human resources to pursue a particular research program or drug candidate and failing to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success; • the impact of litigation and government investigations, including product liability lawsuits; • the exposure to uninsured liabilities; Risks Related to our Common Stock • our ability to maintain listing of our Class A common stock on Nasdaq • the potential for conflicts of interest with our directors who have relationships with major investors; • our ability to pay cash dividends; • the potential for securities class action litigation; • the impact of research and reports that equity research analysts publish about us and our business; • the impact of substantial sales of shares into the market at any time; • the dilution created by future sales and issuances of our Class A common stock or rights to purchase Class A common stock; • our reliance upon our “smaller reporting company” status; • the existence of provisions in our governing documents or state law which may delay or prevent our acquisition by a third party; • our obligation to make payments under the Tax Receivable Agreement; • our ability to make distributions from vTv LLC to satisfy our obligations. 22 Table of Contents Risks Relating to Our Financial Position and Need for Additional Capital We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.
Further, we have entered into an investor rights agreement with an affiliate of MacAndrews providing certain governance and registration rights. Pursuant to the investor rights agreement, we filed a shelf registration statement on Form S-3 in June 2019 to register certain shares previously issued to MacAndrews.
Further, we have entered into the Investor Rights Agreement with an affiliate of MacAndrews providing certain governance and registration rights. Pursuant to the Investor Rights Agreement, we filed a shelf registration statement on Form S-3 in June 2019 to register certain shares previously issued to MacAndrews.
To the extent that we are unable to make payments under the Tax Receivable Agreement for any reason, such payments will be deferred and will accrue interest until paid.
To the extent that we are unable to make payments under the Tax Receivable Agreement for any reason, such payments will be deferred and will accrue interest until paid.
Our future capital requirements will depend on many factors, including: • the progress, costs, results and timing of our planned registrational trial(s) for cadisegliatin as a potential adjunctive therapy to insulin for the treatment of type 1 diabetes; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development; 21 Table of Contents • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • 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; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; and • 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.
Our future capital requirements will depend on many factors, including: • the progress, costs, results and timing of our planned registrational trial(s) for cadisegliatin as a potential adjunctive therapy to insulin for the treatment of type 1 diabetes; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development; • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; 24 Table of Contents • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • 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; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; and • 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.
Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to: • completing research and nonclinical and clinical development of our product candidates; • obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies; • establishing collaborations for the development of certain of our drug candidates; • establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for our product candidates, if approved; • launching and commercializing product candidates for which we obtain regulatory and marketing approval, either directly or with a collaborator or distributor; • obtaining market acceptance of our product candidates as viable treatment options; • obtaining favorable formulary placement with government and third-party payors that allows for favorable reimbursement; • addressing any competing technological and market developments; 20 Table of Contents • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; • maintaining, protecting and expanding our portfolio of intellectual property rights; and • attracting, hiring and retaining qualified personnel.
Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to: • completing research and nonclinical and clinical development of our product candidates; • obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies; • establishing collaborations for the development of certain of our drug candidates; • establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for our product candidates, if approved; • launching and commercializing product candidates for which we obtain regulatory and marketing approval, either directly or with a collaborator or distributor; • obtaining market acceptance of our product candidates as viable treatment options; • obtaining favorable formulary placement with government and third-party payors that allows for favorable reimbursement; • addressing any competing technological and market developments; • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; 23 Table of Contents • maintaining, protecting and expanding our portfolio of intellectual property rights; and • attracting, hiring and retaining qualified personnel.
A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; • HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act (HITECH), and their respective implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; • the federal Physician Payments Sunshine Act and its implementing regulations, which imposed annual reporting requirements for certain manufacturers of drugs, devices, biological products and medical supplies for payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; • HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act (HITECH), and their respective implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; • the federal Physician Payments Sunshine Act and its implementing regulations, which imposed annual reporting requirements for certain manufacturers of drugs, devices, biological products and medical supplies for payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental 34 Table of Contents third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
In addition, the Tax Receivable Agreement provides that, upon a merger, asset sale or other form of business combination or certain other changes of control or if, at any time, we elect an early termination of the Tax Receivable Agreement, our (or our successor’s) obligations under the Tax Receivable Agreement with respect to exchanged or acquired Class B common stock, together with the corresponding number of vTv Units (whether exchanged or acquired before or after such change of control or early termination), would be required to be paid significantly in advance of the actual realization, if any, of any future tax benefits and would be based on certain assumptions, including that we would have sufficient taxable income to fully utilize the deductions arising from the increased 52 Table of Contents tax deductions and tax basis and other benefits related to entering into the Tax Receivable Agreement, and, in the case of certain early termination elections, that any Class B common stock, together with the corresponding number of vTv Units, that have not been exchanged will be deemed exchanged for the market value of the Class A common stock at the time of termination.
In addition, the Tax Receivable Agreement provides that, upon a merger, asset sale or other form of business combination or certain other changes of control or if, at any time, we elect an early termination of the Tax Receivable Agreement, our (or our successor’s) obligations under the Tax Receivable Agreement with respect to exchanged or acquired Class B common stock, together with the corresponding number of vTv Units (whether exchanged or acquired before or after such change of control or early termination), would be required to be paid significantly in advance of the actual realization, if any, of any future tax benefits and would be based on certain assumptions, including that we would have sufficient taxable income to fully utilize the deductions arising from the increased tax deductions and tax basis and other benefits related to entering into the Tax Receivable Agreement, and, in the case of 55 Table of Contents certain early termination elections, that any Class B common stock, together with the corresponding number of vTv Units, that have not been exchanged will be deemed exchanged for the market value of the Class A common stock at the time of termination.
These risks and uncertainties include the following: • the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; • patent applications may not result in any patents being issued; • patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; • our competitors, many of whom may have substantially greater resources than we do and many of whom may have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates; • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and • countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.
These risks and uncertainties include the following: • the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; • patent applications may not result in any patents being issued; 39 Table of Contents • patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; • our competitors, many of whom may have substantially greater resources than we do and many of whom may have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates; • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and • countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.
If our drug candidates fail to comply with applicable regulatory requirements, a regulatory agency may: • issue warning letters or untitled letters; • mandate modifications to promotional materials or require us to disseminate corrective information to healthcare practitioners or other parties; • require us to enter into a consent decree or permanent injunction, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; • impose other civil or criminal penalties; • suspend or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or 28 Table of Contents • seize or detain products or require a product recall.
If our drug candidates fail to comply with applicable regulatory requirements, a regulatory agency may: • issue warning letters or untitled letters; • mandate modifications to promotional materials or require us to disseminate corrective information to healthcare practitioners or other parties; 31 Table of Contents • require us to enter into a consent decree or permanent injunction, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; • impose other civil or criminal penalties; • suspend or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or • seize or detain products or require a product recall.
Reliance on third-party manufacturers entails risks to which we might not be subject if we manufactured drug candidates ourselves, including: • the limited number of manufacturers that could produce our drug candidates for us; • the inability to meet our product specifications and quality requirements consistently; • inability to access production facilities on a timely basis; • inability or delay in increasing manufacturing capacity; • manufacturing and product quality issues related to scale-up of manufacturing; • costs and validation of new equipment and facilities required for commercial level activity; • a failure to satisfy the FDA’s cGMP requirements and similar foreign standards on a consistent basis; • the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; • termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; • the reliance on a single source of supply which, if unavailable, would delay our ability to complete our clinical trials or to sell any product for which we have received marketing approval; 34 Table of Contents • the lack of qualified backup suppliers for supplies that are currently purchased from a single source supplier; • carrier disruptions or increased costs that are beyond our control; and • the failure to deliver products under specified storage conditions and in a timely manner.
Reliance on third-party manufacturers entails risks to which we might not be subject if we manufactured drug candidates ourselves, including: • the limited number of manufacturers that could produce our drug candidates for us; • the inability to meet our product specifications and quality requirements consistently; • inability to access production facilities on a timely basis; • inability or delay in increasing manufacturing capacity; • manufacturing and product quality issues related to scale-up of manufacturing; • costs and validation of new equipment and facilities required for commercial level activity; • a failure to satisfy the FDA’s cGMP requirements and similar foreign standards on a consistent basis; • the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; • termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; • the reliance on a single source of supply which, if unavailable, would delay our ability to complete our clinical trials or to sell any product for which we have received marketing approval; • the lack of qualified backup suppliers for supplies that are currently purchased from a single source supplier; • carrier disruptions or increased costs that are beyond our control; and • the failure to deliver products under specified storage conditions and in a timely manner.
We are seeking possible additional partnering opportunities and grants 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 also continue to evaluate other financing strategies to fund our ongoing trials.
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 also continue to evaluate other financing strategies to fund our ongoing trials.
The commencement, enrollment and completion of our clinical trials can be delayed for a variety of reasons, including: • inability to reach agreements on acceptable terms with prospective contract research organizations (CRO) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • regulatory objections to commencing a clinical trial; • inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our drug candidates; • withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; • inability to obtain institutional review board (“IRB”), approval to conduct a clinical trial; • difficulty recruiting and enrolling subjects to participate in clinical trials for a variety of reasons, including willingness of subjects to undergo required study procedures, meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our drug candidates; • inability to recruit and retain subjects in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy; and • difficulty in importing and exporting clinical trial materials and study samples.
The commencement, enrollment and completion of our clinical trials can be delayed for a variety of reasons, including: • inability to reach agreements on acceptable terms with prospective contract research organizations (CRO) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • regulatory objections to commencing or continuing a clinical trial, including the imposition of a clinical hold; • inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our drug candidates; • withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; • inability to obtain institutional review board (“IRB”), approval to conduct a clinical trial; • difficulty recruiting and enrolling subjects to participate in clinical trials for a variety of reasons, including willingness of subjects to undergo required study procedures, meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our drug candidates; • inability to recruit and retain subjects in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy; and • difficulty in importing and exporting clinical trial materials and study samples.
If any of our drug candidates cause serious adverse events or undesirable side effects either during clinical development, or after marketing approval, if obtained: • regulatory authorities, IRBs, or the DSMB may impose a clinical hold, or we may decide on our own to suspend or terminate a study, which could result in substantial delays and adversely impact our ability to continue development of the product; • regulatory authorities may require the addition of labeling statements, specific warnings, contraindications or field alerts to study subjects, investigators, physicians or pharmacies; • we may be required to change the product design or the way the product is administered, conduct additional clinical trials or change the labeling of the product; • we may be required to implement a REMS, which could result in substantial cost increases or signification limitations on distribution or have a negative impact on our ability to successfully commercialize the product; • we may be required to limit the patients who can receive the product; • we may be subject to limitations on how we promote the product; • sales of the product may decrease significantly; • regulatory authorities may require us to take our approved product off the market; • we may be subject to litigation or product liability claims; and • our reputation may suffer.
If any of our drug candidates cause serious adverse events or undesirable side effects either during clinical development, or after marketing approval, if obtained: • regulatory authorities, IRBs, or the DSMB may impose a clinical hold, or we may decide on our own to suspend or terminate a study, which could result in substantial delays and adversely impact our ability to continue development of the product; • regulatory authorities may require the addition of labeling statements, specific warnings, contraindications or field alerts to study subjects, investigators, physicians or pharmacies; • we may be required to change the product design or the way the product is administered, conduct additional clinical trials or change the labeling of the product; • we may be required to implement a REMS, which could result in substantial cost increases or signification limitations on distribution or have a negative impact on our ability to successfully commercialize the product; • we may be required to limit the patients who can receive the product; 29 Table of Contents • we may be subject to limitations on how we promote the product; • sales of the product may decrease significantly; • regulatory authorities may require us to take our approved product off the market; • we may be subject to litigation or product liability claims; and • our reputation may suffer.
The investor rights agreement was amended on February 27, 2024 to alter MacAndrews' governance rights. Additionally, we entered into a securities purchase agreement and a registration rights agreement with the Private Placement Investors providing certain governance and registration rights.
The Investor Rights Agreement was amended on February 27, 2024 to alter MacAndrews' governance rights. Additionally, we entered into the Securities Purchase Agreement and the Registration Rights Agreement with the Private Placement Investors providing certain governance and registration rights.
For example: • we might not have been the first to invent or the first to file the inventions covered by each of our pending patent applications and issued patents; • others may be able to make, use, sell, offer to sell, or import products that are similar to our products or product candidates but that are not covered by the claims of our patents; others may independently develop similar or alternative technologies or duplicate any of our technologies; • the proprietary rights of others may have an adverse effect on our business; 36 Table of Contents • any proprietary rights we do obtain may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties; • any patents we obtain, or our in-licensed issued patents may not be valid or enforceable; or • we may not develop additional technologies or products that are patentable or suitable to maintain as trade secrets.
For example: • we might not have been the first to invent or the first to file the inventions covered by each of our pending patent applications and issued patents; • others may be able to make, use, sell, offer to sell, or import products that are similar to our products or product candidates but that are not covered by the claims of our patents; others may independently develop similar or alternative technologies or duplicate any of our technologies; • the proprietary rights of others may have an adverse effect on our business; • any proprietary rights we do obtain may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties; • any patents we obtain, or our in-licensed issued patents may not be valid or enforceable; or • we may not develop additional technologies or products that are patentable or suitable to maintain as trade secrets.
In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; • federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 30 Table of Contents • the Foreign Corrupt Practices Act ("FCPA") that prohibits payments to foreign public officials relating to official acts.
In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; • federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the Foreign Corrupt Practices Act ("FCPA") that prohibits payments to foreign public officials relating to official acts.
Conversely, if the Private Placement Investors decline to exercise their participation rights it may adversely affect the way the market and potential investors view the Company. 48 Table of Contents We do not anticipate paying cash dividends on our Class A common stock, and accordingly, stockholders must rely on stock appreciation for any return on their investment.
Conversely, if the Private Placement Investors decline to exercise their participation rights it may adversely affect the way the market and potential investors view the Company. 51 Table of Contents We do not anticipate paying cash dividends on our Class A common stock, and accordingly, stockholders must rely on stock appreciation for any return on their investment.
Factors that may inhibit our efforts to commercialize our drugs on our own include: • our inability to recruit and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; 27 Table of Contents • the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; • unforeseen costs and expenses associated with creating an independent sales and marketing organization; and • inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.
Factors that may inhibit our efforts to commercialize our drugs on our own include: • our inability to recruit and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; • the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; • unforeseen costs and expenses associated with creating an independent sales and marketing organization; and • inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.
As a result of this volatility, our stockholders may not be able to sell their common stock at or above the price at which they purchased their shares. 49 Table of Contents The trading market for our Class A common stock will be influenced by the research and reports that equity research analysts publish about us and our business.
As a result of this volatility, our stockholders may not be able to sell their common stock at or above the price at which they purchased their shares. 52 Table of Contents The trading market for our Class A common stock will be influenced by the research and reports that equity research analysts publish about us and our business.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for any drug candidates or products we develop; • injury to our reputation and significant negative media attention; • withdrawal of clinical trial participants or delay or cancellation of clinical trials; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; • the inability or delay in our ability to commercialize any products we develop; and • a decline in our share price.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for any drug candidates or products we develop; • injury to our reputation and significant negative media attention; • withdrawal of clinical trial participants or delay or cancellation of clinical trials; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; 49 Table of Contents • the inability or delay in our ability to commercialize any products we develop; and • a decline in our share price.
In addition, we may not be able to enter into any collaborations that will generate significant cash. If we are unable to develop and commercialize one or more of our drug candidates either alone or with collaborators, or if revenues from any drug candidate that receives marketing approval are insufficient, we will not achieve profitability.
In addition, we may not be able to enter into any collaborations that will generate significant cash. If we are unable to develop and commercialize one or more of our drug candidates either alone or with collaborators, or if revenues from any drug candidate that receives regulatory approval are insufficient, we will not achieve profitability.
Such authorities may impose such a suspension or termination due to a number of factors, including: • failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; • failure to pass inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities; • failure of any contract manufacturing organizations (“CMOs”), that we use to comply with current Good Manufacturing Practices (“cGMPs”); • unforeseen safety issues or any determination that a clinical trial presents unacceptable health risks; • failure to demonstrate benefit from using the drug; or • changes in the regulatory requirement and guidance.
Such authorities may impose such a suspension or termination due to a number of factors, including: • failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; 28 Table of Contents • failure to pass inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities; • failure of any contract manufacturing organizations (“CMOs”), that we use to comply with current Good Manufacturing Practices (“cGMPs”); • unforeseen safety issues or any determination that a clinical trial presents unacceptable health risks; • failure to demonstrate benefit from using the drug; or • changes in the regulatory requirement and guidance.
To the extent that M&F is dissolved or liquidated, MacAndrews and/or its affiliates will succeed to the rights and obligations of M&F under the Tax Receivable Agreement, and the same considerations described above apply to any such successor parties. 53 Table of Contents ITEM 1B. UNRESOLVED STAFF COMMENTS None.
To the extent that M&F is dissolved or liquidated, MacAndrews and/or its affiliates will succeed to the rights and obligations of M&F under the Tax Receivable Agreement, and the same considerations described above apply to any such successor parties. 56 Table of Contents ITEM 1B. UNRESOLVED STAFF COMMENTS None.
We have adopted new comprehensive compliance policies, and revised our code of conduct, but it is not always possible to identify and deter employee or non-employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
We have adopted new comprehensive compliance policies, and revised our code of conduct, but it is not always possible to identify and deter 48 Table of Contents employee or non-employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
We may sell Class A common stock, convertible securities or other equity securities, including under the TD Cowen ATM Offering, 50 Table of Contents or pursuant to warrants issued to previous investors and lenders, and such sales could result in substantial dilution to existing investors.
We may 53 Table of Contents sell Class A common stock, convertible securities or other equity securities, including under the TD Cowen ATM Offering, or pursuant to warrants issued to previous investors and lenders, and such sales could result in substantial dilution to existing investors.
In addition, our amended and restated certificate of incorporation provides that none of MacAndrews, any of our non-employee directors who are employees, affiliates or consultants of MacAndrews or its affiliates (other than us or our subsidiaries) or any of their respective affiliates will be liable to us or our stockholders for breach of any fiduciary duty by reason of the fact that any such individual directs a corporate opportunity to MacAndrews or its affiliates instead of us, or does not communicate information regarding a corporate opportunity to us that such person or affiliate has directed to MacAndrews or its affiliates.
In addition, our Certificate of Incorporation provides that none of MacAndrews, any of our non-employee directors who are employees, affiliates or consultants of MacAndrews or its affiliates (other than us or our subsidiaries) or any of their respective affiliates will be liable to us or our stockholders for breach of any fiduciary duty by reason of the fact that any such individual directs a corporate opportunity to MacAndrews or its affiliates instead of us, or does not communicate information regarding a corporate opportunity to us that such person or affiliate has directed to MacAndrews or its affiliates.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. We will need additional capital to complete the development and commercialization of cadisegliatin (TTP399) and our other drug candidate.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. We will need additional capital to complete the development and commercialization of cadisegliatin (TTP399) and our other drug candidates.
As of December 31, 2023, MacAndrews and its affiliat es held 577,108 non-voting common units of vTv LLC (“vTv Units”) and the same number of shares of vTv Therapeutics Inc. Class B common stock as well as an aggregate of 912,982 shares of our Class A common stock.
As of December 31, 2024, MacAndrews and its affiliat es held 577,108 non-voting common units of vTv LLC (“vTv Units”) and the same number of shares of vTv Therapeutics Inc. Class B common stock as well as an aggregate of 912,982 shares of our Class A common stock.
After March 2013, under the Leahy-Smith America Invents Act (the “America Invents Act”) enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application would be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
After March 2013, under the Leahy-Smith America Invents Act (the “America Invents Act”) enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other 41 Table of Contents requirements for patentability are met, the first inventor to file a patent application would be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
Litigation may be necessary to: • protect and enforce our patents and any future patents issuing on our patent applications; • enforce or clarify the terms of the licenses we have granted or been granted or may grant or be granted in the future; 40 Table of Contents • protect and enforce trade secrets, know-how and other proprietary rights that we own or have licensed, or may license in the future; or • determine the enforceability, scope, and validity of the proprietary rights of third parties and defend against alleged patent infringement.
Litigation may be necessary to: • protect and enforce our patents and any future patents issuing on our patent applications; • enforce or clarify the terms of the licenses we have granted or been granted or may grant or be granted in the future; • protect and enforce trade secrets, know-how and other proprietary rights that we own or have licensed, or may license in the future; or • determine the enforceability, scope, and validity of the proprietary rights of third parties and defend against alleged patent infringement.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with 45 Table of Contents sufficient rights to exclude others from commercializing products similar or identical to ours.
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • a collaboration partner may shift its priorities and resources away from our drug candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing; • a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration; • a collaboration partner may not devote sufficient capital or resources towards our drug candidates; • a collaboration partner may change the success criteria for a drug candidate thereby delaying or ceasing development of such candidate; • a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; • a collaboration partner could develop a product that competes, either directly or indirectly, with our drug candidate; • a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product; • a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements; • a partner may exercise a contractual right to terminate a strategic alliance; 32 Table of Contents • a dispute may arise between us and a partner concerning the research, development or commercialization of a drug candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and • a partner may use our products or technology in such a way as to invite litigation from a third party.
We also will need to enter into collaborative relationships to provide funding to support our other research and development programs. 35 Table of Contents The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • a collaboration partner may shift its priorities and resources away from our drug candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing; • a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration; • a collaboration partner may not devote sufficient capital or resources towards our drug candidates; • a collaboration partner may change the success criteria for a drug candidate thereby delaying or ceasing development of such candidate; • a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; • a collaboration partner could develop a product that competes, either directly or indirectly, with our drug candidate; • a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product; • a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements; • a partner may exercise a contractual right to terminate a strategic alliance; • a dispute may arise between us and a partner concerning the research, development or commercialization of a drug candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and • a partner may use our products or technology in such a way as to invite litigation from a third party.
If we are not able to successfully execute our business strategy and do not achieve the anticipated benefits, our business, results of operations and financial condition could suffer. 22 Table of Contents Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development.
If we are not able to successfully execute our business strategy and do not achieve the anticipated benefits, our business, results of operations and financial condition could suffer. Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development.
As a result, we may never successfully develop and commercialize a product, which could lead to a material adverse effect on the value of any investment in our securities. Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates Our development efforts are focused on the continued development of cadisegliatin (TTP399).
As a result, we may 25 Table of Contents never successfully develop and commercialize a product, which could lead to a material adverse effect on the value of any investment in our securities. Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates Our development efforts are focused on the continued development of cadisegliatin (TTP399).
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to 39 Table of Contents commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Also, confidential patient and other information may be compromised in a cyber-attack or cyber-intrusion.
For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the 50 Table of Contents data. Also, confidential patient and other information may be compromised in a cyber-attack or cyber-intrusion.
The concentration of voting power with MacAndrews may have an adverse effect on the price of our Class A common stock. Our company may take actions that our other stockholders do not view as beneficial, which may adversely affect our results of operations and financial condition and cause the value of our Class A common stock to decline.
The concentration of voting power with our Significant Investors may have an adverse effect on the price of our Class A common stock. Our company may take actions that our other stockholders do not view as beneficial, which may adversely affect our results of operations and financial condition and cause the value of our Class A common stock to decline.
There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any commercial launch of a drug candidate.
There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and 30 Table of Contents time-consuming and could delay any commercial launch of a drug candidate.
Furthermore, regulatory attitudes towards the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on other products, policy changes and agency funding, staffing and 23 Table of Contents leadership.
Furthermore, regulatory attitudes towards the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on other products, policy changes and agency funding, staffing and leadership.
There can be no assurance that our patent applications or the patent applications of our future licensors will result 35 Table of Contents in patents being issued or that issued patents will afford sufficient protection against competitors with similar technologies, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.
There can be no assurance that our patent applications or the patent applications of our future licensors will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technologies, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.
Nevertheless, the amended and restated certificate of incorporation contains provisions that have the same effect as Section 203 of the Delaware General Corporation Law, except that they provide that MacAndrews and its various successors 51 Table of Contents and affiliates (and transferees of any of them) will not be deemed to be “interested stockholders,” regardless of the percentage of our stock owned by them, and accordingly will not be subject to such restrictions.
Nevertheless, the Certificate of Incorporation contains provisions that have the same effect as Section 203 of the Delaware General Corporation Law, except that they provide that MacAndrews and its various successors and affiliates (and transferees of any 54 Table of Contents of them) will not be deemed to be “interested stockholders,” regardless of the percentage of our stock owned by them, and accordingly will not be subject to such restrictions.
In addition, any delays in completing our clinical trials will increase our costs, slow down 25 Table of Contents our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly.
In addition, any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly.
Supreme Court and federal courts have ruled on several patent cases in recent years that impact the scope of patentability of certain inventions or discoveries related to the life, including both narrowing the scope of patent protection available in certain circumstances or 38 Table of Contents weakening the rights of patent owners in certain situations.
Supreme Court and federal courts have ruled on several patent cases in recent years that impact the scope of patentability of certain inventions or discoveries related to the life, including both narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
As is common in the biotechnology and pharmaceutical industry, we employ individuals and engage the service of consultants, who were previously employed at, may have previously provided, or may be currently providing consulting 43 Table of Contents services to, other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
As is common in the biotechnology and pharmaceutical industry, we employ individuals and engage the service of consultants, who were previously employed at, may have previously provided, or may be currently providing consulting services to, other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
Third parties making claims against us for infringement, violation or misappropriation of their intellectual property rights may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates.
Third parties making claims against us for infringement, violation or misappropriation of their intellectual property rights may seek and obtain injunctive or other equitable relief, which could effectively block our ability 43 Table of Contents to further develop and commercialize our product candidates.
If any of our drug candidates are 31 Table of Contents approved for commercialization outside of the United States, we intend to enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions.
If any of our drug candidates are approved for commercialization outside of the United States, we intend to enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions.
Many of our potential competitors have substantially greater: • resources, including capital, personnel and technology; • research and development capability; • clinical trial expertise; • regulatory expertise; • intellectual property rights, including patent rights; • expertise in obtaining, maintaining, defending and enforcing intellectual property rights, including patent rights; • manufacturing and distribution expertise; and • sales and marketing expertise.
Many of our potential competitors have substantially greater: • resources, including capital, personnel and technology; • research and development capability; • clinical trial expertise; • regulatory expertise; • intellectual property rights, including patent rights; 32 Table of Contents • expertise in obtaining, maintaining, defending and enforcing intellectual property rights, including patent rights; • manufacturing and distribution expertise; and • sales and marketing expertise.
Accordingly, if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, our clinical trials may be delayed or we may be required to repeat such clinical trials, which would delay the regulatory approval process.
Accordingly, 36 Table of Contents if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, our clinical trials may be delayed or we may be required to repeat such clinical trials, which would delay the regulatory approval process.
Shares of our Class A common stock issuable upon an exchange of vTv Units as described above would be considered “restricted securities,” as that term is defined in Rule 144 under the Securities Act, unless the exchange is registered under the Securities Act. We also have issued warrants to MacAndrews to purchase 45,595 shares of our Class A common stock.
Shares of our Class A common stock issuable upon an exchange of vTv Units as described above would be considered “restricted securities,” as that term is defined in Rule 144 under the Securities Act, unless the exchange is registered under the Securities Act. We also have issued warrants to MacAndrews to purchase 40,639 shares of our Class A common stock.
The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property rights. This could make it difficult for us to stop the infringement of our patents or the misappropriation 41 Table of Contents of our other intellectual property rights.
The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property rights. This could make it difficult for us to stop the infringement of our patents or the misappropriation of our other intellectual property rights.
The concentration of ownership and voting power with MacAndrews may also delay, defer or even prevent an acquisition by a third party or other change of control of our company and may make some transactions more difficult or impossible without the support of MacAndrews, even if such events are in the best interests of our other stockholders.
The concentration of ownership and voting power of our Significant Investors may also delay, defer or even prevent an acquisition by a third party or other change of control of our company and may make some transactions more difficult or impossible without the support of our Significant Investors, even if such events are in the best interests of our other stockholders.
The FDCA sets forth the standards for approval of new and generic drugs, as well as setting forth the prohibition on marketing investigational products that have not been approved by the FDA as safe and effective.
The FDCA sets forth the standards for approval of new and generic drugs, as well as setting forth the prohibition on marketing investigational products that have not been approved by the FDA as safe and 33 Table of Contents effective.
Moreover, our competitors could counterclaim in any suit to enforce our patents that we infringe their intellectual property. Furthermore, some of our competitors have substantially greater intellectual property portfolios, and resources, than we do.
Moreover, our competitors could counterclaim in any suit to enforce our patents 40 Table of Contents that we infringe their intellectual property. Furthermore, some of our competitors have substantially greater intellectual property portfolios, and resources, than we do.
Such amendments to existing protocols or clinical trial applications or the need for new ones, may significantly and 24 Table of Contents adversely affect the cost, timing and completion of the clinical trials for our drug candidates.
Such amendments to existing protocols or clinical trial applications or the need for new ones, may significantly and adversely affect the cost, timing and completion of the clinical trials for our drug candidates.
Failure by any of our suppliers to comply with applicable regulations may result in long delays and interruptions. 33 Table of Contents The number of suppliers of the raw material components of our drug candidates is limited.
Failure by any of our suppliers to comply with applicable regulations may result in long delays and interruptions. The number of suppliers of the raw material components of our drug candidates is limited.
Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.
Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cybersecurity.
We will be able to protect our proprietary technologies from unauthorized use by third parties only to the extent that such proprietary rights are covered by regulatory exclusivity, valid and enforceable patents or are effectively maintained as trade secrets.
We will be able to protect our proprietary technologies from unauthorized use by third parties only to the extent that such proprietary rights are covered by regulatory exclusivity, valid and enforceable patents or are effectively maintained as trade 38 Table of Contents secrets.
We intend to take advantage of these reporting exemptions as long as we remain eligible to do so under the related rules. Provisions in our charter and bylaws and investor agreements, and provisions of Delaware law may delay or prevent our acquisition by a third party, which might diminish the value of our common stock.
We intend to take advantage of these reporting exemptions as long as we remain eligible to do so under the related rules. Provisions in our Certificate of Incorporation and By-laws and investor agreements, and provisions of Delaware law may delay or prevent our acquisition by a third party, which might diminish the value of our common stock.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed 46 Table of Contents our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
The interests of MacAndrews may differ from our interests or those of our other stockholders and the concentration of control in MacAndrews will limit other stockholders’ ability to influence corporate matters.
The interests of our Significant Investors may differ from our interests or those of our other stockholders and the concentration of control in our Significant Investors will limit other stockholders’ ability to influence corporate matters.
As of March 13, 2024, there remains $50.0 million of availability under the TD Cowen ATM Offering, although the amount of our Class A common stock that we may offer and sell under the TD Cowen ATM Offering during any 12 calendar month period is currently limited to one-third of the aggregate market value of our voting and non-voting common equity held by non-affiliates pursuant to General Instruction I.B.6 of Form S-3.
As of March 20, 2025, there remains $47.5 million of availability under the TD Cowen ATM Offering, although the amount of our Class A common stock that we may offer and sell under the TD Cowen ATM Offering during any 12 calendar month period is currently limited to one-third of the aggregate market value of our voting and non-voting common equity held by non-affiliates pursuant to General Instruction I.B.6 of Form S-3.
We cannot be certain that we will be able to respond to any regulatory requests during the review period in a timely manner, or at all, without delaying potential regulatory action.
We cannot be certain that we will be able to respond to any regulatory 26 Table of Contents requests during the review period in a timely manner, or at all, without delaying potential regulatory action.
We have elected in our amended and restated certificate of incorporation not to be subject to Section 203 of the Delaware General Corporation Law.
We have elected in our Certificate of Incorporation not to be subject to Section 203 of the Delaware General Corporation Law.
Our amended and restated certificate of incorporation and amended and restated bylaws contain several provisions that may make it more difficult or expensive for a third party to acquire control of us without the approval of the Board of Directors.
Our Certificate of Incorporation and By-laws contain several provisions that may make it more difficult or expensive for a third party to acquire control of us without the approval of the Board of Directors.
As a result, MacAndrews and its affiliates held shares representing approximately 56.0% of the combined voting power of our outstanding common stock.
As a result, MacAndrews and its affiliates held shares representing approximately 46.7% of the combined voting power of our outstanding common stock.
Our directors who have relationships with MacAndrews and the investors that participated in the Private Placement (the “Private Placement Investors”) may have conflicts of interest with respect to matters involving our company. One of our directors is affiliated with MacAndrews and two of our directors are associated with the Private Placement Investors.
Our directors who have relationships with the Significant Investors may have conflicts of interest with respect to matters involving our company. One of our directors is affiliated with MacAndrews and two of our directors are associated with the Private Placement Investors.
We have incurred net losses in each year since beginning to develop our drug candidates, including net losses of approximately $20.3 million, $19.2 million and $13.0 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, we had a total accumulated deficit of approximately $281.0 million.
We have incurred net losses in each year since beginning to develop our drug candidates, including net losses of approximately $18.5 million, $20.3 million and $19.2 million for the years ended December 31, 2024, 2023 and 2022, respectively. As of December 31, 2024, we had a total accumulated deficit of approximately $299.7 million.
Until such time, if ever, as we can generate substantial revenue, we may 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 do not currently have any committed external source of funds other than those available to us under the TD Cowen ATM Offering.
Until such time, if ever, as we can generate substantial revenue, we may 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 do not currently have any committed external source of funds.
Our patent rights may prove to be an inadequate barrier to competition. The lifespan of any one patent is limited, and each of these patents will ultimately expire and we cannot be sure that pending applications will be granted, or that we will discover new inventions which we can successfully patent.
The lifespan of any one patent is limited, and each of these patents will ultimately expire and we cannot be sure that pending applications will be granted, or that we will discover new inventions which we can successfully patent.
If we are unable to arrange for third-party manufacturing of our drug candidates on a timely basis, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them.
As a result, we may have difficulty finding manufacturers for our drug candidates with adequate capacity for our needs. If we are unable to arrange for third-party manufacturing of our drug candidates on a timely basis, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them.
We have no commitments or arrangements for any additional financing to fund our research and development programs other than the funds available to us under our sales agreement (the “TD Cowen Sales Agreement”) with Cowen & Company, LLC (“TD Cowen”) (the “TD Cowen ATM Offering”) .
We have no commitments or arrangements for any additional financing to fund our research and development programs other than the funds we may raise through the sale of our Class A common stock under our sales agreement (the “TD Cowen Sales Agreement”) with Cowen & Company, LLC (“TD Cowen”) (the “TD Cowen ATM Offering”).
If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our drug candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates, if approved.
If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our drug candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates, if approved. 37 Table of Contents In addition, there are a limited number of manufacturers that operate under the FDA’s cGMP regulations capable of manufacturing our drug candidates.
In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.
In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution. 47 Table of Contents Risks Relating to Employee Matters and Managing Growth We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.
In addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate.
This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our drug candidates, which would significantly harm our business, results of operations and prospects. 27 Table of Contents In addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate.
In addition, we have not commercialized any products and have never generated any revenue from the commercialization of any product. We have devoted most of our financial resources to research and development, including our preclinical development activities and clinical trials.
We have not commercialized any products and have devoted most of our financial resources to research and development, including our preclinical development activities and clinical trials.
If we are 44 Table of Contents not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.
If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy. Our industry has experienced a high rate of turnover of management personnel in recent years.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidates to other available therapies.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidates to other available therapies.
If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.
If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized. 46 Table of Contents We may be subject to claims that we or our employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets.
In addition, recognition of rights in trade secrets and a willingness to enforce trade secrets differs in certain jurisdictions. Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Further, it may also slow potential enrollment of our ongoing clinical trials. 45 Table of Contents We may use our financial and human resources to pursue a particular research program or drug candidate and fail to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success.
Other Risks Relating to Our Business We may use our financial and human resources to pursue a particular research program or drug candidate and fail to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed11 unchanged
Biggest changeFor additional information regarding the risks we face from cybersecurity threats, please see the risk factor titled “Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security” included in Part I, Item 1A, Risk Factors of this Annual Report on Form 10-K.
Biggest changeFor additional information regarding the risks we face from cybersecurity threats, please see the risk factor titled “Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cybersecurity” included in Part I, Item 1A, Risk Factors of this Annual Report on Form 10-K.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed1 unchanged
Biggest changeMINE SAFETY DISCLOSURES None. 54 Table of Contents PART II
Biggest changeMINE SAFETY DISCLOSURES None. 57 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−1 removed1 unchanged
Biggest changeBecause almost all of the shares of our Class A common stock are held by brokers, nominees and other institutions on behalf of shareholders, we are unable to estimate the total number of shareholders represented by these record holders.
Biggest changeBecause almost all of the shares of our Class A common stock are held by brokers, nominees and other institutions, we are unable to estimate the total number of beneficial owners represented by these record holders. Issuer Purchases of Equity Securities There have been no repurchases of the Company’s common stock during the fourth fiscal quarter of fiscal 2024.
Holders As of March 13, 2024, there were approximately 28 holders of record of our Class A common stock and 6 holders of record of our Class B common stock.
Holders As of March 20, 2025, there were approximately 41 holders of record of our Class A common stock and 6 holders of record of our Class B common stock.
Removed
Issuer Purchases of Equity Securities There have been no repurchases of the Company’s common stock during the fourth fiscal quarter of fiscal 2023.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

41 edited+6 added−27 removed46 unchanged
Biggest changeComparison of the years ended December 31, 2023 and 2022 The following table sets forth certain information concerning our results of operations for the periods shown: (dollars in thousands) Year Ended Statement of operations data: 2023 2022 Change Revenue $ — $ 2,018 $ (2,018) Operating expenses: Research and development 13,595 12,357 1,238 General and administrative 11,907 12,201 (294) Total operating expenses 25,502 24,558 944 Operating loss (25,502) (22,540) (2,962) Interest income 472 352 120 Interest expense (13) (15) 2 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) Net loss before noncontrolling interest (25,966) (25,073) (893) Less: Net loss attributable to noncontrolling interest (5,716) (5,909) 193 Net loss attributable to vTv Therapeutics Inc. $ (20,250) $ (19,164) $ (1,086) Revenue There was no revenue for the year ended December 31, 2023.
Biggest changeComparison of the years ended December 31, 2024 and 2023 The following table sets forth certain information concerning our results of operations for the periods shown: (dollars in thousands) Year Ended Statement of operations data: 2024 2023 Change Revenue $ 1,017 $ — $ 1,017 Operating expenses: Research and development 11,546 13,595 (2,049) General and administrative 13,651 11,907 1,744 Total operating expenses 25,197 25,502 (305) Operating loss (24,180) (25,502) 1,322 Interest income 1,565 472 1,093 Interest expense — (13) 13 Other income (expense), net 10 (923) 933 Loss before income taxes and noncontrolling interest (22,605) (25,966) 3,361 Income tax provision 100 — 100 Net loss before noncontrolling interest (22,705) (25,966) 3,261 Less: Net loss attributable to noncontrolling interest (4,243) (5,716) 1,473 Net loss attributable to vTv Therapeutics Inc. $ (18,462) $ (20,250) $ 1,788 Revenue 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.
ATM 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 .
ATM Offering 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 .
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 potential benefits of our candidates over other therapies; • 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; • future clinical trial results; • our ability to enroll patients in our clinical trials; • 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; and • the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.
This is due to the numerous risks and uncertainties associated with the development of our drug candidates, including: • 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; • 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; • future clinical trial results; • our ability to enroll patients in our clinical trials; • 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; and • the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.
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 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; • the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development; • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • 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, scientific, and medical personnel; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; • 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.
Our future capital requirements will depend on many factors, including: • 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 for our lead product candidate, cadisegliatin ; 64 Table of Contents • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development; • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • 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, scientific, and medical personnel; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; and • 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.
For a discussion of the year ended December 31, 2022 compared to the year ended December 31, 2021, please refer to Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022.
For a discussion of the year ended December 31, 2023 compared to the year ended December 31, 2022, please refer to Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.
The financing raised will allow the Company to further advance its lead program for cadisegliatin (TTP399) .
The financing raised will allow the Company to further advance its lead program for cadisegliatin .
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 $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.
General and Administrative Expenses 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.
General and Administrative Expenses 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 60 Table of Contents and administrative expenses include accounting and legal services, expenses associated with obtaining and maintaining patents, cost of various consultants, occupancy costs and information systems.
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. We recognize deferred tax assets to the extent we believe these assets are more-likely-than-not to be realized.
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. 66 Table of Contents We recognize deferred tax assets to the extent we believe these assets are more-likely-than-not to be realized.
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 63 Table of Contents 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.
Off-Balance Sheet Arrangements As of December 31, 2023, we do not currently have outstanding any off-balance sheet arrangements as defined under SEC rules.
Off-Balance Sheet Arrangements As of December 31, 2024, we do not currently have outstanding any off-balance sheet arrangements as defined under SEC rules.
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.
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 .
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).
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.
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.
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.
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.
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, 2024, we had cash and cash equivalents of $36.7 million.
Liquidity and Capital Resources Liquidity and Going Concern As of December 31, 2023, we had an accumulated deficit of $281.0 million. Since our inception, we have experienced a history of negative cash flows from operating activities.
Liquidity and Capital Resources Liquidity and Going Concern As of December 31, 2024, we had an accumulated deficit of $299.7 million. Since our inception, we have experienced a history of negative cash flows from operating activities.
Additionally, we may rely on our ability to sell shares of our Class A 62 Table of Contents 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.
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.
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.
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. 65 Table of Contents Revenue Recognition The majority of our revenue results from our license and collaboration agreements associated with the development of investigational drug products.
(“Anteris”) liquidation and dissolution and the Common Stock Repurchase Agreement (the "Repurchase Agreement") with Reneo Pharmaceuticals, Inc ("Reneo"). 59 Table of Contents Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2023 compared to the year ended December 31, 2022.
(“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. 61 Table of Contents Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023.
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, 2023 of $0.5 million is related to the imputed interest on the G42 Promissory Note and dividend income from our money market account. 62 Table of Contents Other Income (Expense), Net Other income was immaterial for the year ended December 31, 2024.
Prior to July 30, 2015, our predecessor entities were taxed as partnerships and all their income and deductions flowed through and were subject to tax at the partner level. vTv Therapeutics Inc. holds vTv Units and is required to recognize deferred tax assets and liabilities for the difference between the financial reporting and tax basis of its investment in vTv LLC. 64 Table of Contents Our income tax expense, deferred tax assets and liabilities and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid.
Prior to July 30, 2015, our predecessor entities were taxed as partnerships and all their income and deductions flowed through and were subject to tax at the partner level. vTv Therapeutics Inc. holds vTv Units and is required to recognize deferred tax assets and liabilities for the difference between the financial reporting and tax basis of its investment in vTv LLC.
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 discernible pattern over which the services will be provided.
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.
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.
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.
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 additional financing are not yet known.
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 additional financing are not yet known. These factors raise substantial doubt about our ability to continue as a going concern.
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.
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.
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.
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 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.
Our research and development expenses by project for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Years Ended December 31, 2023 2022 2021 Direct research and development expense: Cadisegliatin $ 10,182 $ 9,611 $ 2,608 HPP737 — — 2,762 Azeliragon — — 822 Other projects 676 563 717 Indirect research and development expense 2,737 2,183 6,415 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 cadisegliatin and further advance the development of our other drug candidates, subject to the availability of additional funding. 58 Table of Contents The successful development of our clinical and preclinical drug candidates is highly uncertain.
Since we typically use our employee and infrastructure resources across multiple research and development programs such costs are not allocated to the individual projects. 59 Table of Contents Our research and development expenses by project for the years ended December 31, 2024, 2023 and 2022 were as follows (in thousands): Years Ended December 31, 2024 2023 2022 Direct research and development expense: Cadisegliatin $ 6,026 $ 10,182 $ 9,611 Other projects* 490 676 563 Indirect research and development expense 5,030 2,737 2,183 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.
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.
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.
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.
There was no revenue for the year ended December 31, 2023. 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.
For the year ended December 31, 2022, net cash used in investing activities was insignificant. Financing Activities 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, 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. Future Funding Requirements To date, we have not generated any revenue from drug product sales.
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 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.
We are subject to income taxes in both the United States and various state jurisdictions. Significant judgments and estimates are required in determining the consolidated income tax expense.
Our income tax expense, deferred tax assets and liabilities and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the United States and various state jurisdictions. Significant judgments and estimates are required in determining the consolidated income tax expense.
For each contract meeting these criteria, we identify the performance obligations included within the contract. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. We then recognize revenue under each contract as the related performance obligations are satisfied.
A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. We then recognize revenue under each contract as the related performance obligations are satisfied. The transaction price under the contract is determined based on the value of the consideration expected to be received in exchange for the transferred assets or services.
Revenue Recognition The majority of our revenue results from its 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.
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. For each contract meeting these criteria, we identify the performance obligations included within the contract.
The transaction price under the contract is determined based on the value of the consideration expected to be received in exchange for the transferred assets or services. Development, regulatory and sales milestones included in our collaboration agreements are considered to be variable consideration.
Development, regulatory and sales milestones included in our collaboration agreements are considered to be variable consideration. 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.
(“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 vTv Therapeutics Inc. is a holding company and its principal asset is a controlling equity interest in vTv Therapeutics LLC (“vTv LLC”), the principal operating subsidiary.
Holding Company Structure vTv Therapeutics Inc. is a holding company and its principal asset is a controlling equity interest in vTv Therapeutics LLC (“vTv LLC”), the principal operating subsidiary.
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 To date, we have not generated any revenue from drug product sales.
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.
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.
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.
Interest income for the year ended December 31, 2022 of $0.4 million is related to the imputed interest on the G42 Promissory Note. 60 Table of Contents Interest Expense Interest expense for the years ended December 31, 2023 and 2022, was insignificant.
Interest Income 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 .
Removed
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).
Added
Recent Developments 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.
Removed
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.
Added
The successful development of our clinical and preclinical drug candidates is highly uncertain.
Removed
ATM 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”).
Added
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.
Removed
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.
Added
As such, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.
Removed
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").
Added
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. 63 Table of Contents Cash Flows Year Ended December 31, 2024 2023 (dollars in thousands) Net cash used in operating activities $ (25,307) $ (19,081) Net cash provided by investing activities — 4,404 Net cash provided by financing activities 52,607 11,997 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.
Removed
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.
Added
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.
Removed
The Class A common stock began trading on a reverse split-adjusted basis on the Nasdaq on November 21, 2023.
Removed
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. 56 Table of Contents 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) The U.S.
Removed
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.
Removed
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.
Removed
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.
Removed
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.
Removed
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.
Removed
Participants in the trial will be randomized to two doses of cadisegliatin or placebo.
Removed
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.
Removed
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.
Removed
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. 57 Table of Contents In addition, we continue to work with our partner, G42 Investments AI Holding RSC Ltd.
Removed
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.
Removed
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.
Removed
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.
Removed
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.
Removed
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.
Removed
The Sales Agreement with Cantor Fitzgerald was terminated on February 26, 2024. 61 Table of Contents 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.
Removed
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.
Removed
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.
Removed
Cash Flows Year Ended December 31, 2023 2022 (dollars in thousands) Net cash used in operating activities $ (19,081) $ (16,022) Net cash provided by (used in) investing activities 4,404 (21) Net cash provided by financing activities 11,997 14,754 Net decrease in cash and cash equivalents $ (2,680) $ (1,289) Operating Activities For the year ended December 31, 2023, our net cash used in operating activities increased by $3.1 million from the prior year.
Removed
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.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

0 edited+2 added−1 removed2 unchanged
Removed
Foreign Currency Risk We do not have any material foreign currency exposure.
Added
Foreign Currency Risk We do not have any material foreign currency exposure. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The information required by this Item is included in our Consolidated Financial Statements and Supplementary Data listed in Item 15 of Part IV of this Annual Report on Form 10-K. ITEM 9.
Added
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.

Other VTVT 10-K year-over-year comparisons