10q10k10q10k.net

What changed in vTv Therapeutics Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of vTv Therapeutics Inc.'s 2024 and 2025 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 2025 report.

+308 added−302 removedSource: 10-K (2026-03-10) vs 10-K (2025-03-20)

Top changes in vTv Therapeutics Inc.'s 2025 10-K

308 paragraphs added · 302 removed · 206 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

86 edited+64 added−58 removed138 unchanged
Biggest changeOn May 20, 2024, Cantex announced that the FDA granted Orphan Drug Designation to azeliragon, a well-tolerated once-a-day pill, for the treatment of pancreatic cancer. Cantex has an ongoing clinical trial studying the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer.
Biggest changeCantex has completed a clinical trial studying the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer. On December 9, 2024, Cantex announced that the FDA granted Orphan Drug Designation to Cantex’s azeliragon for the treatment of brain metastasis from breast cancer. In February 2025, a Phase 1B clinical trial was initiated by Dr.
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 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, 800 mg cadisegliatin twice daily, or 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.
An applicant seeking approval to market and distribute a new drug in the United States generally must satisfactorily complete each of the following steps before the product candidate will be licensed by the FDA: • preclinical testing including laboratory tests, animal studies and formulation studies, which must be performed in accordance with the FDA’s good laboratory practice (“GLP”), regulations and standards; • submission to the FDA of an Investigational New Drug Application (“IND”) for human clinical testing, which must become effective before human clinical trials may begin; • approval by an independent institutional review board (“IRB”), representing each clinical site before each clinical trial may be initiated; • performance of adequate and well-controlled human clinical trials to establish the safety, potency and efficacy of the product candidate for each proposed indication, in accordance with current good clinical practices (“GCP”); 15 Table of Contents • preparation and submission to the FDA of a new drug application (“NDA”), for a drug product which includes not only the results of the clinical trials, but also, detailed information on the chemistry, manufacture and quality controls for the product candidate and proposed labelling for one or more proposed indication(s); • review of the product candidate by an FDA advisory committee, where appropriate or if applicable; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities, including those of third parties, at which the product candidate or components thereof are manufactured to assess compliance with current good manufacturing practice (“cGMP”) requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; • satisfactory completion of any FDA audits of the non-clinical and clinical trial sites to assure compliance with GCP and the integrity of clinical data in support of the NDA; • payment of user fees and securing FDA approval of the NDA to allow marketing of the new drug product; and • compliance with any post-approval requirements, including the potential requirement to implement a risk evaluation and mitigation strategy (“REMS”) and the potential requirement to conduct any post-approval studies required by the FDA.
An applicant seeking approval to market and distribute a new drug in the United States generally must satisfactorily complete each of the following steps before the product candidate will be licensed by the FDA: • preclinical testing including laboratory tests, animal studies and formulation studies, which must be performed in accordance with the FDA’s good laboratory practice (“GLP”), regulations and standards; • submission to the FDA of an Investigational New Drug Application (“IND”) for human clinical testing, which must become effective before human clinical trials may begin; • approval by an independent institutional review board (“IRB”), representing each clinical site before each clinical trial may be initiated; • performance of adequate and well-controlled human clinical trials to establish the safety, potency and efficacy of the product candidate for each proposed indication, in accordance with current good clinical practices (“GCP”); • preparation and submission to the FDA of a new drug application (“NDA”), for a drug product which includes not only the results of the clinical trials, but also, detailed information on the chemistry, manufacture and quality controls for the product candidate and proposed labelling for one or more proposed indication(s); • review of the product candidate by an FDA advisory committee, where appropriate or if applicable; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities, including those of third parties, at which the product candidate or components thereof are manufactured to assess compliance with current good manufacturing practice (“cGMP”) requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; • satisfactory completion of any FDA audits of the non-clinical and clinical trial sites to assure compliance with GCP and the integrity of clinical data in support of the NDA; • payment of user fees and securing FDA approval of the NDA to allow marketing of the new drug product; and • compliance with any post-approval requirements, including the potential requirement to implement a risk evaluation and mitigation strategy (“REMS”) and the potential requirement to conduct any post-approval studies required by the FDA.
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.
In addition to our clinical development program for cadisegliatin , we continue to advance 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.
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.
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 therapeutic target for improving blood glucose control.
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.
In this trial, treatment with cadisegliatin resulted in a clinically meaningful decrease (40%) in the frequency of severe 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.
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.
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, 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.
These sanctions may include, but are not limited to, the FDA’s refusal to allow an applicant to proceed with clinical trials, refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, warning letters, adverse publicity, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines and civil or criminal investigations and penalties brought by the FDA or Department of Justice (“DOJ”), or other government entities, including state agencies.
These sanctions may include, but are not limited to, the FDA’s refusal to allow an applicant to proceed with clinical trials, refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, warning letters, adverse publicity, product recalls, product seizures, total or partial suspension of production 16 Table of Contents or distribution, injunctions, fines and civil or criminal investigations and penalties brought by the FDA or Department of Justice (“DOJ”), or other government entities, including state agencies.
Mechanistic study We previously conducted a study to evaluate the impact of liver-selective GK activation on the safety and tolerability of cadisegliatin . 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.
Mechanistic study We have conducted a study to evaluate the impact of liver-selective GK activation on the safety and tolerability of cadisegliatin . 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.
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.
Under the terms of the Novo License Agreement, the Company has additional potential developmental and regulatory milestone payments totaling up to $6.0 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.
We do not have multiple sources of supply for the components used in our drug candidates. 12 Table of Contents Intellectual Property Patents We actively protect our commercially important proprietary technology by, among other methods, obtaining, maintaining, and defending our patent rights.
We do not have multiple sources of supply for the components used in our drug candidates. 13 Table of Contents Intellectual Property Patents We actively protect our commercially important proprietary technology by, among other methods, obtaining, maintaining, and defending our patent rights.
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.
Collaboration Revenue and Customers Most of our collaboration revenue for the years ended December 31, 2025, 2024 and 2023 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.
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.
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, 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.
A well-controlled, statistically robust Phase 3 clinical trial may be designed to deliver the data that regulatory authorities will use to decide whether or not to approve, and, if approved, how to appropriately label a drug: such Phase 3 studies are referred to as “pivotal.” In some cases, the FDA may approve an NDA for a product candidate but require the sponsor to conduct additional clinical trials to further assess the product candidate’s safety and effectiveness after approval.
A well-controlled, statistically robust Phase 3 clinical trial may be designed to deliver the data that regulatory authorities will use to decide 18 Table of Contents whether or not to approve, and, if approved, how to appropriately label a drug: such Phase 3 studies are referred to as “pivotal.” In some cases, the FDA may approve an NDA for a product candidate but require the sponsor to conduct additional clinical trials to further assess the product candidate’s safety and effectiveness after approval.
Pursuant to the amendment, on February 28, 2023, the Company received $12.0 million, which reflected the original amount due under the G42 Promissory Note less a 3.75% discount, in full satisfaction of the note. On February 27, 2024, the Company and G42 Investments further amended the G42 Purchase Agreement in connection with the Private Placement.
Pursuant to the amendment, on February 28, 2023, the Company received $12.0 million, which reflected the original amount due under the G42 Promissory Note less a 3.75% discount, in full satisfaction of the note. On February 27, 2024, the Company and G42 Investments further amended the G42 Purchase Agreement in connection with the 2024 Private Placement (as defined below).
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).
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 7 Table of Contents than 54 mg/dL or 3 mmol/L, regardless of symptoms) and Level 3 hypoglycemia ("severe" hypoglycemia e.g., requiring assistance of another person).
The CinRx Purchase Agreement also provides CinRx warrants to purchase up to 30,000 shares of Class A common stock at an initial exercise of price of approximately $28.80 per share (the “CinRx Warrants”).
The CinRx Purchase Agreement also provided CinRx warrants to purchase up to 30,000 shares of Class A common stock at an initial exercise of price of approximately $28.80 per share (the “CinRx Warrants”).
In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, and its implementing regulations, as well as the Drug Supply Chain Security Act (“DSCA”), which regulate the distribution and tracing of prescription drug samples at the federal level and set minimum standards for the regulation of distributors by the states.
In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, and its implementing regulations, as well as the Drug Supply Chain Security Act (“DSCA”), which regulate the distribution and tracing of prescription drug samples at the federal level and set minimum standards for the regulation of 21 Table of Contents distributors by the states.
Partnered Development Programs PDE4 and Newsoara Biopharma On May 31, 2018, we entered into a license agreement with Newsoara (the “Newsoara License Agreement”), under which Newsoara obtained an exclusive and sublicensable license to develop and commercialize our PDE4 program, including the compound HPP737 , in China and other Pacific Rim territories (collectively, the “Newsoara License Territory”).
A HPP737 and Newsoara Biopharma On May 31, 2018, we entered into a license agreement with Newsoara (the “Newsoara License Agreement”), under which Newsoara obtained an exclusive and sublicensable license to develop and commercialize our PDE4 program, including the compound HPP737 , in China and other Pacific Rim territories (collectively, the “Newsoara License Territory”).
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution, or an 17 Table of Contents institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to patients.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to patients.
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.
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, and cadisegliatin was well tolerated.
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 patent portfolio for the Nrf2/Bach1 14 Table of Contents 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.
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.
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.
The Simplici-T1 Study achieved its primary objective by demonstrating statistically significant improvements in HbA1c for cadisegliatin compared to placebo. Moreover, a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia was observed in patients taking cadisegliatin when compared to those taking placebo.
The Simplici-T1 Study achieved its primary objective by demonstrating statistically significant improvements in HbA1c for cadisegliatin compared to placebo. Moreover, a clinically meaningful decrease (40%) in the number of severe and symptomatic hypoglycemia was observed in patients receiving cadisegliatin when compared to those receiving placebo.
The contents of our website are not made a part of this Annual Report on Form 10-K. 20 Table of Contents
The contents of our website are not made a part of this Annual Report on Form 10-K. 22 Table of Contents
In addition to the foregoing IND requirements, an IRB representing each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must conduct 16 Table of Contents continuing review and reapprove the study at least annually.
In addition to the foregoing IND requirements, an IRB representing each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must conduct continuing review and reapprove the study at least annually.
Based on data from Phase 1 and 2 trials to date, we believe that cadisegliatin , if approved, has the potential to be a first-in-class OAD due to its liver-selectivity and novel mechanism of action.
Based on data from Phase 1 and 2 trials to date, we believe that cadisegliatin , if approved, has the potential to be a first-in-class oral anti-diabetic drug due to its liver-selectivity and novel mechanism of action.
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.
The issued patents in this patent family will expire no earlier than 2031, absent any patent term adjustments or extensions in the U.S. and ex-U.S. jurisdictions.
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”).
Activation of GK as a potential treatment of T1D is attractive because it could improve overall blood glucose control and specifically reduce the frequency and severity of low 6 Table of Contents blood glucose (hypoglycemic) episodes through a mechanism of action that is entirely distinct from currently marketed oral anti-diabetic drugs.
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.
In September 2025, we closed (the “Closing”) a private placement (the “2025 Private Placement”) of our Class A common stock and pre-funded warrants, pursuant to which we received aggregate gross proceeds of approximately $80.0 million, before deducting offering expenses payable by us.
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.
In 2021 Cadisegliatin received Breakthrough Therapy designation as an adjunctive therapy to insulin for the treatment of T1D based upon 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.
Two such programs are breakthrough therapy designation and priority review designation, regenerative advanced therapy designation and accelerated approval. 18 Table of Contents Specifically, the FDA may designate a product as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life‑threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Specifically, the FDA may designate a product as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life‑threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
At any time during this 30-day period, or thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.
At any time during this 30-day period, or thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold.
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.
Teplizumab does not address the unmet need of existing patients with diagnosed T1D or those that will eventually develop T1D, and donislecel requires long-term concurrent immunosuppressive therapy and is restricted to T1D patients with recurrent severe hypoglycemic episodes.
An estimated 1.6 million individuals live with T1D in the U.S. as of 2025, a number which is expected to grow to 2.2 million by 2040. Globally, an estimated 9.8 million individuals live with T1D as of 2025.
According to the T1D Index, an estimated 1.5 million individuals live with T1D in the U.S. as of 2026, a number which is expected to grow to 2.0 million by 2040. Globally, an estimated 9.9 million individuals live with T1D as of 2026.
The issuance of the Milestone Shares or the payment of the Milestone Cash Payment, as applicable, are conditioned upon receipt of the FDA Approval and subject to certain limitations and conditions set forth in the G42 Purchase Agreement. There can be no assurance that the FDA Approval will be granted or as to the timing thereof.
The issuance of the Milestone Shares or the payment of the Milestone Cash Payment, as applicable, are conditioned upon receipt of the FDA Approval and subject to certain limitations and conditions set forth in the G42 Purchase Agreement.
The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.
The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
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”).
SGLT-1/2 and SGLT-2 inhibitors were temporarily approved in Europe and are approved in Japan for certain sub-groups of people with T1D; however, they have not been approved in the U.S. for T1D primarily due to safety risks related to increased risk of diabetic ketoacidosis (“DKA”).
Under the terms of the Newsoara License Agreement, Newsoara will be responsible for the development and commercialization of the licensed products in the Newsoara License Territory, at its cost, and is required to use commercially reasonable efforts with respect to such development and commercialization efforts.
Under the terms of the Newsoara License Agreement, Newsoara will be responsible for the development and commercialization of the licensed products at its cost, and is required to use commercially reasonable efforts with respect to such development and commercialization efforts. The Newsoara License Agreement, unless terminated earlier, will continue until expiration of all royalty obligations of Newsoara to us.
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.
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.
The ADME study results included a radiochromatographic signal that, at the time, could not be further characterized, which led the FDA to impose a clinical hold on the cadisegliatin development program.
The ADME study results were consistent with expectations from prior research but also included a radiochromatographic signal that, at the time, could not be further characterized, which led the FDA to impose a clinical hold on the cadisegliatin development program in July 2024.
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.
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.
Following commencement of a clinical trial under an IND, the FDA may also place a clinical hold or partial clinical hold on that trial. In July 2024, the FDA placed the cadisegliatin program on clinical hold based upon a radiochromatographic signal that could not be fully characterized at that time.
In July 2024, the FDA placed the cadisegliatin program on clinical hold based upon a radiochromatographic signal that could not be fully characterized at that time.
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.
There can be no assurance that the FDA Approval will be granted or as to the timing thereof. 8 Table of Contents 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.
The Company, CinPax and CinRx subsequently amended the CinRx Purchase Agreement on February 27, 2024, in connection with the Private Placement. The CinRx Purchase Agreement provides CinPax the right for two years following the Closing to designate a board observer, which has been subsequently approved by the Company’s board.
The Company, CinPax and CinRx subsequently amended the CinRx Purchase Agreement on February 27, 2024, in connection with the Private Placement which removed the right of CinPax to designate a board observer.
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.
Current Treatments for T1D and Their Limitations Patients with T1D have difficulty achieving and maintaining glycemic control, defined as HbA1c ely 75% of Americans living with T1D do not achieve the ADA’s recommended HbA1c level Given the lack of adjunctive treatments for T1D, several existing treatment options for T2D have been investigated in T1D with limited success.
Post-Approval Regulation If regulatory approval for marketing of a product or new indication for an existing product is obtained, the sponsor will be required to comply with all regular post-approval regulatory requirements as well as any post-approval requirements that the FDA may have imposed as part of the approval process.
After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. 20 Table of Contents Post-Approval Regulation If regulatory approval for marketing of a product or new indication for an existing product is obtained, the sponsor will be required to comply with all regular post-approval regulatory requirements as well as any post-approval requirements that the FDA may have imposed as part of the approval process.
The original results indicated the presence of an unexpected radiochromatographic signal which could not be further characterized at the time and led FDA to issue a clinical hold for the cadisegliatin program in July 2024. vTv initiated a series of studies conducted by two independent laboratories to characterize this signal.
Initial results indicated the presence of an unexpected radiochromatographic signal which could not be further characterized at the time and led FDA to issue a clinical hold for the cadisegliatin program in July 2024. Based upon extensive testing by two independent laboratories, the Company determined that the radiochromatographic signal was an experimental artifact (duplicate peak) of a known metabolite.
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).
(“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.
In addition, as a condition of approval, the FDA may require an applicant to develop a REMS. REMS use risk minimization strategies beyond the professional labeling to ensure that the benefits of the product outweigh the potential risks.
REMS use risk minimization strategies beyond the professional labeling to ensure that the benefits of the product outweigh the potential risks.
Finally, the FDA will conduct laboratory research related to the safety, purity, potency and effectiveness of pharmaceutical products. 19 Table of Contents Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
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 principal executive offices are located at 3980 Premier Drive, Suite 110, High Point, NC 27265, and our telephone number is (336) 841-0300.
During 2025, we also will be working on the design and execution of two supportive trials in human volunteers to examine the effects of food on cadisegliatin's pharmacokinetics and the potential effects of cadisegliatin on cardiac function (thorough QT study) as required by FDA guidance. We will also start preparing plans for additional international registrational studies for cadisegliatin in T1D.
We also continue to work on the design and execution of additional supportive trials in human volunteers, including studies to examine the effects of food on cadisegliatin 's pharmacology and the potential effects of cadisegliatin on cardiac function (thorough QT study) as required by FDA.
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.
Cadisegliatin (TTP399) Cadisegliatin (TTP399), is a novel, small-molecule, liver-selective glucokinase activator (GKA) currently being evaluated in a Phase 3 clinical trial as a potential oral adjunctive therapy to insulin for the treatment of T1D. C adisegliatin has a novel mechanism of action: liver-selective activation of GK that could improve glycemic control and reduce the risk of L2 and L3 hypoglycemia.
The FDA may in addition perform certain confirmatory tests on lots of some products before releasing the lots for distribution.
The FDA may in addition perform certain confirmatory tests on lots of some products before releasing the lots for distribution. Finally, the FDA will conduct laboratory research related to the safety, purity, potency and effectiveness of pharmaceutical products.
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").
A Phase 1 mechanistic study of cadisegliatin in patients with T1D showed no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients. Additionally, 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") was conducted.
Following the expiration of a lock up period, from the period May 31, 2022 until December 31, 2024, or if earlier, the date of receipt of FDA approval in the United States for cadisegliatin (the “FDA Approval”), the Company has granted to G42 Investments certain shelf and piggyback registration rights with respect to those shares of Class A common stock issued to G42 Investments pursuant to the G42 Purchase Agreement, including the ability to conduct an underwritten offering to resell such shares under certain circumstances.
As part of the transaction the Company has granted to G42 Investments certain shelf and piggyback registration rights with respect to those shares of Class A common stock issued to G42 Investments pursuant to the G42 Purchase Agreement, including the ability to conduct an underwritten offering to resell such shares under certain circumstances.
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.
We continue to plan for additional registrational studies for cadisegliatin in T1D following the completion of the current CATT1 study. In December 2025, we and our partner, G42 Investments, initiated a double-blind randomized controlled Phase 2 trial in the Middle East region in 300 insulin-dependent people with T2D. The study is expected to start screening patients in 2026.
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.
Under the Second Amendment, the Company is eligible to receive development, regulatory and sales-based milestone payments totaling up to $115.0 million as well as royalties on sales in the mid to upper single digits based on tiers of annual net sales of licensed products.
ITEM 1. BUSINESS Overview We are a clinical stage biopharmaceutical company focused on the development of orally administered treatments for metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients.
ITEM 1. BUSINESS Overview We are a late-stage biopharmaceutical company focused on developing orally administered therapies for metabolic and inflammatory diseases with the goal of improving patient outcomes.
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.
To date, our trials for cadisegliatin suggest a liver-selective approach to GK activation has the potential to avoid the negative properties associated with other nonselective GKAs including: hypoglycemia, increased lipids, tachyphylaxis, and liver toxicity.
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.
Clinical Development Plan Based upon the positive results of our Phase 2 Simplici-T1 Study, we requested Breakthrough Therapy designation (BTD) from th e FDA which was granted in April 2021. Carcinogenicity, long-term toxicology studies, development and reproductive toxicology studies, have been completed with no untoward findings.
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.
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 a randomized, double-blind Phase 2 trial in patients with T2D treated with metformin only, TTP273 showed clinically relevant reductions of glycated hemoglobin (HbA1c) and systolic blood pressure after 3 months of treatment.
In a randomized, double-blind Phase 2 trial in patients with type 2 diabetes (T2D) on background metformin therapy, TTP273 demonstrated statistically significant reductions in glycated hemoglobin (“HbA1c”) after three months of treatment.
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 .
The key components of our business strategy are: • Continuing to advance cadisegliatin (TTP399) as a potential treatment for diabetes .
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.
Despite the availability of these therapies, serious unmet medical need remains for people with T1D which could be addressed by a safe oral treatment option that reduces the incidence of hypoglycemia and improves glycemic control (HbA1c) without the risk of DKA or other serious adverse effects.
The Newsoara License Agreement, unless terminated earlier, will continue until expiration of all royalty obligations of Newsoara to us. Either party may terminate the Newsoara License Agreement for the other party’s uncured material breach. Newsoara may terminate the Newsoara License Agreement at will upon prior written notice.
Either party may terminate the Newsoara License Agreement for the other party’s uncured material breach. 5 Otezla® is trademarked by Amgen. 6 Eucrisa® is trademarked by Pfizer. 12 Table of Contents Newsoara may terminate the Newsoara License Agreement at will upon prior written notice.
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 CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis (50 patients per study arm) to receive 800 mg cadisegliatin daily, 800 mg cadisegliatin twice daily, or placebo. In 2021, the FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D.
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.
Our lead product candidate, cadisegliatin (TTP399) , is a novel, small-molecule, liver-selective glucokinase activator (GKA) currently being evaluated in a Phase 3 clinical trial as a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D).
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.
Human Capital As of December 31, 2025 we had twenty-six employees and 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.
As previously noted, the FDA lifted the clinical hold on March 14, 2025, allowing the Company to resume its clinical development plan for cadisegliatin . We continue to work with our partner, G42 Investments AI Holding RSC Ltd.
As a result, the FDA lifted the clinical hold in March 2025, allowing the Company to resume its clinical development plan for cadisegliatin .
Based upon extensive testing by two independent laboratories, the Company determined that the radiochromatographic signal identified in the ADME study was an experimental artifact and submitted the results of the investigation to the FDA as part of its complete response.
Based upon extensive testing by two independent laboratories, the Company determined that the radiochromatographic signal was an experimental artifact (duplicate peak) of a known metabolite. As a result, the FDA lifted the clinical hold in March 2025, allowing the Company to resume its clinical development plan for cadisegliatin .
The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs.
We 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.
In December 2025, together with our partner, G42 Investments, we initiated a double-blind randomized controlled Phase 2 trial in the Middle East region in 300 insulin-dependent people with T2D.
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.
GLP-1 receptor agonists (“GLP-1RAs”) are established therapies for T2D and, in certain agents, have demonstrated benefits in weight reduction and cardiovascular risk reduction. TTP273 is an orally administered, small-molecule GLP-1RA that has demonstrated reductions in postprandial glucose excursions in response to oral glucose tolerance testing and mixed-meal tolerance testing in preclinical studies and clinical trials.
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 .
We continue to seek additional funding to support the development of our pipeline drug candidates as current internal resources are focused mainly on the development of cadisegliatin . We recently amended our license agreement with our partner, Newsoara BioPharma Co., Ltd.
We continue to seek financing, partnering and licensing transactions for the further development of the pipeline assets which have not been partnered. 5 Table of Contents Our Type 1 Diabetes Program – Cadisegliatin (TTP399) Diabetes Overview Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin.
Our Type 1 Diabetes Program – Cadisegliatin (TTP399) Diabetes Overview Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin. T1D results when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas called beta cells.
HPP737 has shown potent inhibition of IL-17a and TNF-α production in in vitro studies and activity in several animal models of inflammation. HPP737 has completed Phase 1 single-ascending dose and initial multiple-ascending dose studies, in which it was well tolerated at all doses tested in healthy volunteers.
In nonclinical studies, HPP737 has demonstrated inhibition of cytokine production, including IL-17A and TNF-α, in vitro, and activity in multiple animal models of inflammation.
Finally, medical devices such as continuous glucose monitors (CGMs), connected smart insulin pens and automated insulin delivery systems, which tie insulin pumps with CGMs through control algorithm software and allow to constantly adjust insulin delivery in response to changing blood glucose levels, continue to evolve and have already shown to improve glucose control and reduce the risk for hypoglycemia.
Devices such as continuous glucose monitors (“CGMs”), connected insulin pens, and automated insulin delivery systems that integrate insulin pumps with CGMs and control algorithms are widely adopted in T1D and continue to evolve.
We also continue to work on the design for additional international registrational studies for cadisegliatin in T1D.
The study will randomize 300 patients to assess the potential of cadisegliatin as an adjunct therapy to insulin in people with T2D, and is expected to start screening in 2026. We continue to work on the design of additional international registrational studies for cadisegliatin in T1D.

… 128 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

90 edited+26 added−12 removed427 unchanged
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.
Biggest changeThese risks are discussed more fully below and include, but are not limited to, risks related to: 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; 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; 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 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; 23 Table of Contents Risks Relating to Employee Matters and Managing Growth • 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. 24 Table of Contents 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).
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.
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 39 Table of Contents 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.
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.
Given the amount of time required for the 45 Table of Contents 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.
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; • 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 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; 37 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; • 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.
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; 36 Table of Contents • maintaining, protecting and expanding our portfolio of intellectual property rights; and • attracting, hiring and retaining qualified personnel.
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.
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; 28 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.
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.
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.
The market price of shares of our Class A common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: • results and timing of our clinical trials and receipt of data from the trials; • the availability of cash or financing to continue our clinical trials and other operations; • results of clinical trials of our competitors’ products; • failure or discontinuation of any of our research programs; • delays in the development or commercialization of our potential products; • regulatory actions with respect to our products or our competitors’ products; • actual or anticipated fluctuations in our financial condition and operating results; • actual or anticipated changes in our growth rate relative to our competitors; • actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate; • competition from existing products or new products that may emerge; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain, maintain, defend or enforce proprietary rights relating to our products and technologies; • announcement or expectation of additional financing efforts; • sales of our Class A common stock by us, our insiders or our other stockholders; • issues in manufacturing our potential products; • market acceptance of our potential products; • market conditions for biopharmaceutical stocks in general; and • general economic and market conditions.
The market price of shares of our Class A common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: • results and timing of our clinical trials and receipt of data from the trials; • the availability of cash or financing to continue our clinical trials and other operations; • results of clinical trials of our competitors’ products; • failure or discontinuation of any of our research programs; • delays in the development or commercialization of our potential products; • regulatory actions with respect to our products or our competitors’ products; • actual or anticipated fluctuations in our financial condition and operating results; • actual or anticipated changes in our growth rate relative to our competitors; • actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate; • competition from existing products or new products that may emerge; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain, maintain, defend or enforce proprietary rights relating to our products and technologies; • announcement or expectation of additional financing efforts; • sales of our Class A common stock by us, our insiders or our other stockholders; • issues in manufacturing our potential products; • market acceptance of our potential products; 55 Table of Contents • market conditions for biopharmaceutical stocks in general; and • general economic and market conditions.
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.
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; 30 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.
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.
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. 26 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.
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.
The commencement, enrollment and completion of our clinical trials, including our CATT1 Phase 3 clinical trial, can be delayed for a variety of reasons, including: • 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; • 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 in importing and exporting clinical trial materials and study samples; and • 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.
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.
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; 27 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.
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.
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 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 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.
In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a 33 Table of Contents 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.
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.
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.
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.
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 29 Table of Contents time-consuming and could delay any commercial launch of a drug candidate.
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.
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. 60 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 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 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.
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.
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 54 Table of Contents MacAndrews or its affiliates.
Although the actual increase in tax basis and the amount and timing of any payments under the Tax Receivable Agreement will vary depending upon a number of factors, including the timing of exchanges, the price of shares of our Class A common stock at the time of the exchange, the nature of the assets, the extent to which such exchanges are taxable, the tax rates then applicable, and the amount and timing of our income, we expect that the payments that we may make to M&F could be substantial.
Although the actual increase in tax basis and the amount and timing of any payments under the Tax Receivable Agreement will vary depending upon a number of factors, including the timing of exchanges, the price of shares of our Class A common stock at the time of the exchange, 58 Table of Contents the nature of the assets, the extent to which such exchanges are taxable, the tax rates then applicable, and the amount and timing of our income, we expect that the payments that we may make to M&F could be substantial.
Due to the Significant Investors' ownership and rights under the investor rights agreement (as amended the "Investor Rights Agreement") with an affiliate of MacAndrews, the securities purchase agreement (the "Securities Purchase Agreement") and registration rights agreement (the "Registration Rights Agreement) with the Private Placement Investors, our Amended and Restated Certificate of Incorporation, as amended (the "Certificate of Incorporation") and Second Amended and Restated By-laws (the "By-laws"), the Significant Investors have substantial influence over us and our subsidiaries.
Due to the Significant Investors' ownership and rights under the investor rights agreements (as amended the "Investor Rights Agreements") with an affiliate of MacAndrews, the securities purchase agreements (the "Securities Purchase Agreements") and registration rights agreements (the "Registration Rights Agreements") with the Private Placement Investors, our Amended and Restated Certificate of Incorporation, as amended (the "Certificate of Incorporation") and Second Amended and Restated By-laws (the "By-laws"), the Significant Investors have substantial influence over us and our subsidiaries.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could significantly harm our business.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, 34 Table of Contents without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could significantly harm our business.
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.
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.
We have a limited operating history, and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance. We are a clinical stage pharmaceutical company with a limited operating history.
We have a limited operating history, and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance. We are a late-stage pharmaceutical company with a limited operating history.
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.
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 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.
We may never achieve or maintain profitability. We are a clinical stage pharmaceutical company with limited operating history. We have never been profitable and do not expect to be profitable in the foreseeable future.
We may never achieve or maintain profitability. We are a late-stage pharmaceutical company with limited operating history. We have never been profitable and do not expect to be profitable in the foreseeable future.
We expect that our existing and future drug candidates will face competition, and most of our competitors have significantly greater resources than we do. The biopharmaceutical industry is characterized by intense competition and rapid innovation. Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, generic or biosimilar drug companies, universities and other research institutions.
We expect that our existing and future drug candidates will face competition, and most of our competitors have significantly greater resources than we do. The biopharmaceutical industry is characterized by intense competition and rapid technological innovation. Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, generic and biosimilar drug manufacturers, universities, and other research institutions.
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.
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. 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.
For example, M&F may have different tax positions from us, especially in light of the Tax Receivable Agreement, that could influence their decisions regarding whether and when we should dispose of assets, whether and when we should incur new or refinance existing indebtedness, and whether and when we should terminate the Tax Receivable Agreement and accelerate our obligations thereunder.
For example, M&F may have different tax positions from us, especially in light of the Tax Receivable Agreement, that could influence their decisions 59 Table of Contents regarding whether and when we should dispose of assets, whether and when we should incur new or refinance existing indebtedness, and whether and when we should terminate the Tax Receivable Agreement and accelerate our obligations thereunder.
In addition, delays in approvals or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our drug candidates.
In addition, delays in 25 Table of Contents approvals or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our drug candidates.
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.
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.
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.
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.
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.
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.
In addition, any uncertainties resulting from the 44 Table of Contents initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. Our patent rights may prove to be an inadequate barrier to competition.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. Our patent rights may prove to be an inadequate barrier to competition.
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.
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.
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.
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.
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.
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. 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.
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.
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 19,160 shares of our Class A common stock.
We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as cGMPs, for manufacture of both active drug substances and finished drug products.
We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as cGMPs, for manufacture of both active 49 Table of Contents drug substances and finished drug products.
Moreover, it is also possible that prior art may exist that we are aware of, but that we do not believe are relevant to our current or future patents, that could nevertheless be determined to render our patents invalid.
Moreover, it is also possible that prior art may exist that we are aware of, but that we do not believe are 40 Table of Contents relevant to our current or future patents, that could nevertheless be determined to render our patents invalid.
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.
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.
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.
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.
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.
We may 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.
These provisions also may delay, prevent or deter a merger, acquisition, tender offer, proxy contest or other transaction that might otherwise result in our stockholders receiving a premium over the market price for their common stock.
These provisions also may delay, 57 Table of Contents prevent or deter a merger, acquisition, tender offer, proxy contest or other transaction that might otherwise result in our stockholders receiving a premium over the market price for their common stock.
See “—Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates.” We do not presently have the capability to sell, distribute and market our drug candidates.
See “—Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates.” We do not presently 50 Table of Contents have the capability to sell, distribute and market our drug candidates.
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 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.
In that event, we expect that we will be subject to additional risks related to entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • existing tariffs, trade barriers and regulatory requirements and expected or unexpected changes; • economic weakness, including inflation, or political instability in foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where labor unrest is more or less common than in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples.
In that event, we expect that we will be subject to additional risks related to entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • existing tariffs, trade barriers and regulatory requirements and expected or unexpected changes; • economic weakness, including inflation, or political instability in foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where labor unrest is more or less common than in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. 35 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.
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 and price and reimbursement.
We believe the key competitive factors that will affect the development and commercial success of our drug candidates include efficacy, safety and tolerability profile, mechanism of action, predictability and consistency of effect, convenience of dosing, and price and reimbursement.
Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) and the investor that participated in the Private Placement (the "Private Placement Investors," and together with MacAndres, our "Significant Investors") have substantial influence over our business, and their interests may differ from our interests or those of our other stockholders.
Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) and the investors that participated in the 2024 Private Placement and the 2025 Private Placement (together the "Private Placements,"; and such investors, the "Private Placement Investors"; and together with MacAndrews, our "Significant Investors") have substantial influence over our business, and their interests may differ from our interests or those of our other stockholders.
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.
We have incurred net losses in each year since beginning to develop our drug candidates, including net losses of approximately $27.0 million and $18.5 million and for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had a total accumulated deficit of approximately $326.7 million.
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.
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.
The 2024 Plan authorizes us to issue equity awards relating to up to an additional 750,000 shares of our Class A Common Stock.
The 2024 Plan authorizes us to issue equity awards relating to up to an additional 750,000 shares of our Class A Common Stock, subject to automatic annual increases as described in the 2024 Plan.
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.
If we do not apply for patent protection prior to such publication or 46 Table of Contents 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.
Failure to obtain a collaborative relationship for these candidates, particularly in the European Union and for other markets requiring extensive sales efforts, may significantly impair the potential for our drug candidates.
We intend to seek collaborative relationships for the development and/or commercialization of our drug candidates, including cadisegliatin . Failure to obtain a collaborative relationship for these candidates, particularly in the European Union and for other markets requiring extensive sales efforts, may significantly impair the potential for our drug candidates.
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.
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.
It may take several years to establish an alternative source of supply for our drug candidates and to have any such new source approved by the FDA or a foreign regulator. Risks Relating to Our Intellectual Property Our success depends on our ability to protect our intellectual property and our proprietary technologies.
It may take several years to establish an alternative source of supply for our drug candidates and to have any such new source approved by the FDA or a foreign regulator.
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 also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending applications from third parties. 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 also issued pre-funded warrants to purchase up to an aggregate of 3,853,997 shares of Class A common stock.
On February 27, 2024, we also issued pre-funded warrants to purchase up to an aggregate of 3,853,997 shares of Class A common stock in the 2024 Private Placement.
Moreover, we may face IPR proceedings before the USPTO, or patent infringement claims from non-practicing entities that have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect. In the future, we may agree to indemnify our manufacturing partners against certain intellectual property claims brought by third parties.
Moreover, we may face IPR proceedings before the USPTO, or patent infringement claims from non-practicing entities that have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect.
On March 5, 2024, we entered into an exchange agreement pursuant to which the Private Placement Investors exchanged an aggregate of 116,493 shares for pre-funded warrants. As a result, following the exchange, the Private Placement Investors hold shares representing approximately 11.6% of the combined voting power of our outstanding common stock.
On March 5, 2024, we entered into an exchange agreement pursuant to which the 2024 Private Placement Investors exchanged an aggregate of 116,493 shares of our Class A common stock for pre-funded warrants to purchase 116,590 shares of our Class A common stock.
Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage.
Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. 52 Table of Contents Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage.
In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents. If investors perceive these results to be negative, the market price for our common stock could be significantly harmed.
In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents.
Review times can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy as well as personnel changes at the FDA. Moreover, in light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of the U.S.
Review times can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy as well as personnel changes at the FDA. In addition, the current U.S.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations. 51 Table of Contents 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.
Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent.
In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us. 41 Table of Contents Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent.
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 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 Our Dependence on Third Parties We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our drug candidates successfully, if at all.
Some of our competitors may be able to sustain the costs of patent-related disputes, including patent litigation, more effectively than we can because they have substantially greater resources.
If investors perceive these results to be negative, the market price for our common stock could be significantly harmed. 44 Table of Contents Some of our competitors may be able to sustain the costs of patent-related disputes, including patent litigation, more effectively than we can because they have substantially greater resources.
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.
Additionally, we entered into the Securities Purchase Agreements and the Registration Rights Agreements with the Private Placement Investors providing certain governance and registration rights. Pursuant to the Registration Rights Agreements, we filed a shelf registration statement on Form S-3 in October 2025 to register certain shares previously issued to MacAndrews and other of the Private Placement Investors.
Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain pan-European injunction.
Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC.
We and our CROs are required to comply with the FDA’s good clinical practices requirements (“GCPs”) for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected.
Nevertheless, we will be responsible for ensuring that our clinical trials are conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities. 48 Table of Contents We and our CROs are required to comply with the FDA’s good clinical practices requirements (“GCPs”) for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected.
Our drug candidates, if successfully developed and approved, will compete in crowded and competitive markets. In order to compete with approved products, our drug candidates will need to demonstrate compelling advantages.
Our drug candidates, if successfully developed and approved, would compete in highly competitive markets with established therapies. To compete effectively, our drug candidates will need to demonstrate compelling clinical and commercial advantages over existing and emerging alternatives.
Our commercial success will depend in part on our ability to: • apply for, obtain, maintain, and enforce patents; • protect trade secrets and other confidential and proprietary information; and • operate without infringing upon the proprietary rights of others.
Our commercial success will depend in part on our ability to: • apply for, obtain, maintain, and enforce patents; • protect trade secrets and other confidential and proprietary information; and • operate without infringing upon the proprietary rights of others. 38 Table of Contents We generally seek to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates, proprietary technologies, and their uses that are important to our business.
SGLT-2 inhibitors such as dapagliflozin (Farxiga) and ipragliflozin (Suglat) continue to be approved in Japan for T1D but have not been approved for use in the US due to safety risks including those pertaining to diabetic ketoacidosis.
SGLT-2 inhibitors, including dapagliflozin (Farxiga) and ipragliflozin (Suglat), have received approval in Japan for use in T1D but have not been approved in the United States due to safety concerns, including the risk of diabetic ketoacidosis. In late 2024, the U.S.
We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us.
We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents.
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).
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 Our Intellectual Property Our success depends on our ability to protect our intellectual property and our proprietary technologies.
Intellectual property litigation involves many risks and uncertainties, and there is no assurance that we will prevail in any lawsuit brought against us.
In the future, we may agree to indemnify our manufacturing partners against certain intellectual property claims brought by third parties. 43 Table of Contents Intellectual property litigation involves many risks and uncertainties, and there is no assurance that we will prevail in any lawsuit brought against us.
On February 27, 2024, we issued an aggregate of 464,377 shares of our Class A common stock to the Private Placement Investors. As a result, the Private Placement Investors hold shares representing approximately 14.9% of the combined voting power of our outstanding common stock.
On February 27, 2024, we issued an aggregate of 464,377 shares of our Class A common stock to certain investors (the "2024 Private Placement Investors") in the 2024 Private Placement, and in September 2025 we issued an aggregate of 682,018 shares of our Class A common stock to certain investors (the "2025 Private Placement Investors") in the 2025 Private Placement.
Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates dues to increased competition and, resultantly, on our business, financial condition, prospects and results of operations. 42 Table of Contents If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates dues to increased competition and, resultantly, on our business, financial condition, prospects and results of operations.
As a result, MacAndrews and its affiliates held shares representing approximately 46.7% of the combined voting power of our outstanding common stock.
Further, as of December 31, 2025, MacAndrews directly or indirectly holds 1,490,090 shares of the Company’s Class A common stock. As a result, MacAndrews and its affiliates held shares representing approximately 37.8% of the combined voting power of our outstanding common stock.

… 48 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed11 unchanged
Biggest changeWe work with our in-house and cybersecurity vendors on assessing cybersecurity risk and on policies and practices aimed at mitigating these risks. We have engaged third-parties to conduct evaluations of our security controls, including through penetration testing, independent audits, and consulting on best practices to address new challenges.
Biggest changeWe work with our in-house and cybersecurity vendors on assessing cybersecurity risk and on policies and practices aimed at mitigating these risks. We have engaged third-parties to conduct evaluations of our security controls, including penetration testing, independent audits, and consulting on best practices to address new challenges.

Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−1 removed0 unchanged
Biggest changeITEM 2. PROPERTIES Our corporate headquarters is located in High Point, North Carolina, where we lease 8,682 square feet of office space in the Premier Center office park. The term of the lease for this space continues through November 2025. ITEM 3. LEGAL PROCEEDINGS We are not currently a party to any material legal proceedings. ITEM 4.
Biggest changeThe lease for our prior office space at 3980 Premier Drive, Suite 310, High Point, North Carolina expired on November 30, 2025. ITEM 3. LEGAL PROCEEDINGS We are not currently a party to any material legal proceedings. ITEM 4. MINE SAFETY DISCLOSURES None. 61 Table of Contents PART II
Removed
MINE SAFETY DISCLOSURES None. 57 Table of Contents PART II
Added
ITEM 2. PROPERTIES Our corporate headquarters are located in High Point, North Carolina. We operate primarily in a virtual environment and lease office space at 3980 Premier Drive, Suite 110, High Point, North Carolina 27265, within the Premier Center office park.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed1 unchanged
Biggest changeHolders 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.
Biggest changeHolders As of March 10, 2026, there were approximately 43 holders of record of our Class A common stock and 3 holders of record of our Class B common stock.
Because 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.
Because 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 2025.

Item 7. Management's Discussion & Analysis

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

25 edited+11 added−25 removed43 unchanged
Biggest changeIn 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.
Biggest changeAt no time will we sell shares of our Class A common stock under this registration statement in an aggregate amount exceeding one-third of our “public float” (the market value of our outstanding Class A common stock and any other equity securities held by non-affiliates) during any 12-calendar month period, so long as our public float remains below $75.0 million.
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.
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 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 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.
Our future capital requirements will depend on many factors, including: • the progress, costs, results and timing of enrollment and completion of 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 ; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; 68 Table of Contents • 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.
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.
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. 69 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.
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.
As of December 31, 2025, 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.
Financing Activities For the year ended December 31, 2024, net cash provided by financing activities was driven by sales of our Class A common stock and proceeds from pre-funded warrants of $51.0 million from the Private Placement financing and proceeds from the TD Cowen ATM Offering of $2.5 million.
For the year ended December 31, 2024, net cash provided by financing activities was driven by sales of our Class A common stock and pre-funded warrants in the 2024 Private Placement for proceeds of $51.0 million, plus proceeds from the TD Cowen ATM Offering of $2.5 million.
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.
For a discussion of the year ended December 31, 2024 compared to the year ended December 31, 2023, 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, 2024.
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.
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.
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.
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, 2025, we had cash and cash equivalents of $88.9 million.
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.
Since we typically use our employee and infrastructure resources across multiple research and development programs such costs are not allocated to the individual projects. 63 Table of Contents Our research and development expenses by project for the years ended December 31, 2025, 2024 and 2023 were as follows (in thousands): Years Ended December 31, 2025 2024 2023 Direct research and development expense: Cadisegliatin $ 11,434 $ 6,026 $ 10,182 Other projects* (1,258) 490 676 Indirect research and development expense 7,685 5,030 2,737 Total research and development expense $ 17,861 $ 11,546 $ 13,595 * 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.
We do not know when, or if, we will generate any revenue from drug product sales. We do not expect to generate revenue from drug sales unless and until we obtain regulatory approval of and commercialize any of our drug candidates.
Future Funding Requirements To date, we have not generated any revenue from drug product sales. We do not know when, or if, we will generate any revenue from drug product sales. We do not expect to generate revenue from drug sales unless and until we obtain regulatory approval of and commercialize any of our drug candidates.
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.
General and Administrative Expenses General and administrative expenses were $14.9 million and $13.7 million for the years ended December 31, 2025 and 2024, respectively.
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.
The increase in general and administrative expenses during this period of approximately $1.3 million, or 9.5%, was primarily driven by (i) an increase in share-based expense of $0.6 million, (ii) an increase in payroll costs of $0.4 million, (iii) an increase in legal expenses of $0.2 million, and (iv) an increase in other operating costs of $0.1 million.
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.
Other income was immaterial for the year December 31, 2024. Liquidity and Capital Resources Liquidity As of December 31, 2025, we had an accumulated deficit of $326.7 million. Since our inception, we have experienced a history of negative cash flows from operating activities.
We record nonrefundable advance payments we make for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as we receive the related goods or services. Income Taxes In connection with the Initial Public Offering, vTv Therapeutics Inc. was formed.
We record nonrefundable advance payments we make for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as we receive the related goods or services.
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.
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 years ended December 31, 2025 and December 31, 2024 .
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.
The increase in research and development expenses during this period of approximately $6.3 million, or 54.7%, was primarily driven by (i) higher spending on cadisegliatin of $5.4 million, due to increases clinical studies, (ii) an increase in indirect costs of $2.6 million primarily due to increases in payroll and bonus costs and a $1.0 million Novo license milestone payment, partially offset by (iii) a decrease of $1.7 million in other projects primarily related to the write off of an aged accrual.
We also estimate the amount of share-based awards that are expected to be forfeited based on historical employee turnover rates. Effect of Recent Accounting Pronouncements See discussion of recent accounting pronouncements in Note 2, “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K.
Effect of Recent Accounting Pronouncements See discussion of recent accounting pronouncements in Note 2, “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K.
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.
Research and Development Expenses Research and development expenses were $17.9 million and $11.5 million for the years ended December 31, 2025 and 2024, respectively.
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.
We are evaluating several financing strategies to increase our cash reserves, including direct equity investments and the potential licensing and monetization of other Company programs.
Comparison 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.
Comparison of the years ended December 31, 2025 and 2024 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: 2025 2024 Change Revenue $ — $ 1,017 $ (1,017) Operating expenses: Research and development 17,861 11,546 6,315 General and administrative 14,947 13,651 1,296 Total operating expenses 32,808 25,197 7,611 Operating loss (32,808) (24,180) (8,628) Interest income 1,870 1,565 305 Interest expense (6) — (6) Other (expense) income, net (136) 10 (146) Loss before income taxes and noncontrolling interest (31,080) (22,605) (8,475) Income tax provision — 100 (100) Net loss before noncontrolling interest (31,080) (22,705) (8,375) Less: Net loss attributable to noncontrolling interest (4,106) (4,243) 137 Net loss attributable to vTv Therapeutics Inc. $ (26,974) $ (18,462) $ (8,512) Revenue There was no revenue for the year ended December 31, 2025.
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.
Interest Income Interest income for the years ended December 31, 2025 and December 31, 2024 of $1.9 million and $1.6 million, respectively, is related to interest and dividend income from our money market account . 66 Table of Contents Other (Expense) Income, Net Other expense was $0.1 million for the year ended December 31, 2025 and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock.
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.
The Company’s current cash resources are expected to fund operations beyond the anticipated topline data readout from the CATT1 Phase 3 trial. Off-Balance Sheet Arrangements As of December 31, 2025, we do not currently have outstanding any off-balance sheet arrangements as defined under SEC rules.
See the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” Company Overview We are a clinical stage pharmaceutical company focused on treating metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients. We have an innovative pipeline of first-in-class small molecule clinical and preclinical drug candidates.
See the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” Company Overview We are a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases.
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.
Financing Activities For the year ended December 31, 2025, net cash provided by financing activities was driven by sales of Units in the 2025 Private Placement for proceeds of $80.0 million .
Removed
Our lead program is cadisegliatin (TTP399) , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").
Added
The Company’s clinical pipeline is led by cadisegliatin , currently in a Phase 3 trial, a potential first-in-class oral liver-selective glucokinase activator (“GKA”) being investigated as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”). The Company and its development partners are investigating multiple molecules across different indications for chronic diseases.
Removed
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.
Added
Recent Developments In January 2026, the Company received a $20.0 million upfront payment following the amended licensing agreement with Newsoara Biopharma Co., Ltd. for the Company’s highly selective PDE4 inhibitor, HPP737 .
Removed
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 .
Added
Interest Income Interest income represents cash interest income from dividends and interest from our money market accounts, all of which are recognized in our Consolidated Statement of Operations. 64 Table of Contents Other (Expense) Income, Net Other (expense) income primarily consists of the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock. 65 Table of Contents Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Removed
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.
Added
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.
Removed
(“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.
Added
On August 29, 2025, we entered into a securities purchase agreement (the “2025 Securities Purchase Agreement”) with the 2025 Private Placement Investors, pursuant to which we agreed to issue and sell 5,243,732 units (the “Units”) to the 2025 Private Placement Investors (the “2025 Private Placement”).
Removed
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 .
Added
Each Unit includes (i) either (A) one share (the “Shares”) of our Class A common stock at purchase price of $15.265 per share, (the “Common Stock”), or (B) a Pre-Funded Warrant (the “Pre-Funded Warrants”) to purchase one share of Common Stock (the “Pre-Funded Warrant Shares”) at a purchase price of $15.255 per share (representing the per-Share purchase price less the Pre-Funded Warrant's exercise price of $0.01) and (ii) a warrant (the “Common Warrants”) to purchase either (x) one share of Common Stock (the “Warrant Shares”) or (y) a Pre-Funded warrant to purchase one share of Common Stock (the “Replacement Warrants” and, together with the Pre-Funded Warrants and the Common Warrants, the “Warrants”).
Removed
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.
Added
We received aggregate gross proceeds from the 2025 Private Placement of approximately $80.0 million, before deducting offering costs payable by us. The Pre-Funded Warrants are exercisable for $0.01, at any time after their original issuance and will not expire.
Removed
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.
Added
The common warrants are exercisable for (x) $22.71, if exercised for a Share, or (y) $22.70 if exercised for a Pre-Funded Warrant, at any time after their original issuance through their expiration date.
Removed
The financing raised will allow the Company to further advance its lead program for cadisegliatin .
Added
The Common Warrants will expire upon the earlier to occur of (i) the fifth anniversary of the issuance of the Common Warrants and (ii) 90 days following the announcement of positive top-line data from the Company’s ongoing CATT1 clinical trial. On January 30, 2026, the Company entered into a Second Amendment to License Agreement with Newsoara Biopharma Co., Ltd.
Removed
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.
Added
(“Newsoara”) (the “Second Amendment”). Under the Second Amendment, Newsoara's rights in the Company's PDE4 inhibitor, HPP737 , will expand to include all countries of the world upon Newsoara's payment of the upfront fee of $20.0 million. See Note 15 for further details.
Removed
As such, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.
Added
The timing and availability of such additional funding are not yet known and we can provide no assurance that these plans will be successful. 67 Table of Contents Cash Flows Year Ended December 31, 2025 2024 (dollars in thousands) Net cash used in operating activities $ (25,255) $ (25,307) Net cash provided by financing activities 77,441 52,607 Net increase in cash and cash equivalents $ 52,186 $ 27,300 Operating Activities For the year ended December 31, 2025, our net cash used in operating activities decreased by $0.1 million from the prior year.
Removed
In addition to available cash and cash equivalents and available funds discussed above, we are seeking possible additional partnering opportunities for our GKA, GLP-1r and other drug candidates which we believe may provide additional cash for use in our operations and the continuation of the clinical trials for our drug candidates.
Removed
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.
Removed
From August 1, 2015, vTv Therapeutics Inc. has been subject to corporate level income taxes.
Removed
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.
Removed
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.
Removed
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events included in the consolidated financial statements.
Removed
Under this method, we determine deferred tax assets and liabilities on the basis of differences between the consolidated financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse.
Removed
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.
Removed
In making such a determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent results of operations.
Removed
We record uncertain tax positions on the basis of a two-step process in which (1) we determine whether it is more-likely-than-not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions meeting the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.
Removed
Interest and penalties related to income taxes are included in the benefit (provision) for income taxes in our Consolidated Statement of Operations. We have not incurred any significant interest or penalties related to income taxes in any of the periods presented.
Removed
Share-Based Compensation Compensation expense for share-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for those awards earned over the service period. The grant date fair value of stock option awards is estimated using the Black-Scholes option pricing formula.
Removed
Expected volatility is based on the historical volatility of the Company’s Class A common stock over the most recent period commensurate with the estimated expected term of the Company’s stock options offering period which is derived from historical experience. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant.
Removed
Due to a lack of historical exercise data, we estimate the expected life of our outstanding stock options using the simplified method specified under Staff Accounting Bulletin Topic 14.D.2. The fair value of restricted stock units (“RSU”) grants is based on the market value of our Class A common stock on the date of grant.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed3 unchanged
Biggest changeForeign 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.
Biggest changeForeign Currency Risk We do not have any material foreign currency exposure. 70 Table of Contents 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.

Other VTVT 10-K year-over-year comparisons