10q10k10q10k.net

What changed in vTv Therapeutics Inc.'s 10-K — 2022 vs 2023

vs

Paragraph-level year-over-year comparison of vTv Therapeutics Inc.'s 2022 and 2023 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 2023 report.

+472 added−399 removedSource: 10-K (2024-03-13) vs 10-K (2023-03-06)

Top changes in vTv Therapeutics Inc.'s 2023 10-K

472 paragraphs added · 399 removed · 289 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

114 edited+42 added−31 removed52 unchanged
Biggest changeGiven the current scope of the pandemic, we cannot predict the impact of the progression of the COVID-19 outbreak on future clinical trials and financial results due to a variety of factors, including the continued good health of our employees, the ability of our third-party suppliers, vendors, manufacturers and partners to continue to operate and provide services, the ability of our clinical trial sites to continue or resume operations, any further government and/or public actions taken in response to the pandemic and the ultimate duration of the COVID-19 pandemic. 4 Table of Con tents Our Pipeline The following table summarizes our current drug candidates and their respective stages of development: Our Strategy Our goal is to advance the development of our differentiated pipeline of orally administered, small molecule drug candidates to treat metabolic and inflammatory diseases to minimize their long-term complications and to improve the lives of patients.
Biggest changeIn addition to our clinical development program for cadisegliatin , we continue to further the research and development of our other pipeline candidates through collaborations with academic partners and license agreements. 4 Table of Contents Our Pipeline The following table summarizes our current drug candidates and their respective stages of development: Our Strategy Our goal is to advance the development of our differentiated pipeline of orally administered, small molecule drug candidates to treat metabolic and inflammatory diseases to minimize their long-term complications and to improve the lives of patients.
The G42 Purchase Agreement also provides for, following the receipt of FDA approval of the Licensed Product, at the option of G42 Investments, either (a) the issuance of the Company’s Class A common stock (the “Milestone Shares”) having an aggregate value equal to $30.0 million or (b) the payment by the Company of $30.0 million in cash (the “Milestone Cash Payment”).
The G42 Purchase Agreement also provides for, following the receipt of the FDA Approval of the Licensed Product, at the option of G42 Investments, either (a) the issuance of the Company’s Class A common stock (the “Milestone Shares”) having an aggregate value equal to $30.0 million or (b) the payment by the Company of $30.0 million in cash (the “Milestone Cash Payment”).
If neither of these events happen within five years of the date of the issuance of the CinRx Warrants, the CinRx Warrants will expire and not be exercisable by CinRx.
If neither of these events happen within five years of the date of the issuance of the CinRx Warrants, the CinRx Warrants will expire and will not be exercisable by CinRx.
Such royalties will be payable on a licensed product-by-licensed product and country-by-country basis until the latest of expiration of the licensed patents covering a licensed product in a country, expiration of data exclusivity rights for a licensed product in a country or a specified number of years after the first commercial sale of a licensed product in a country.
Such royalties will be payable on a licensed product-by-licensed product and country-by-country basis until the latest of expiration of the licensed patents covering a licensed product in a 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.
An oral therapy such as TTP273 is needed because the current method of treatment of CFRD is injected insulin, which comes with associated risks of hypoglycemia and poses additional burdens on patients. Other available oral therapies for type 2 diabetes are not recommended for the treatment of CFRD due to side effects such as hypoglycemia, weight loss, or nausea.
An oral therapy such as TTP273 is needed because the current method of treatment of CFRD is injected insulin, which comes with associated risks of hypoglycemia and poses additional burdens on patients. Other available oral therapies for type 2 diabetes ("T2D") are not recommended for the treatment of CFRD due to side effects, such as hypoglycemia, weight loss, or nausea.
The continuous long-term use of glucocorticoids is limited by the risk of skin thinning / atrophy and the potential for systemic absorption. Vitamin D analogs are often added to glucocorticoids to improve glucocorticoid efficacy while allowing for reduction in glucocorticoid dose.
The continuous long-term use of glucocorticoids is limited by the risk of skin thinning and/or atrophy and the potential for systemic absorption. Vitamin D analogs are often added to glucocorticoids to improve glucocorticoid efficacy while allowing for reduction in glucocorticoid dose.
The IP portfolio for TTP273 also includes patent families covering crystalline, non-crystalline, and salt forms of TTP273 , synthetic precursors to, and methods of manufacture of TTP273 , as well as combinations of TTP273 and metformin, and their use in methods of treatment, and dosage regimens of TTP273 .
The IP portfolio for TTP273 also includes patent families covering crystalline, non-crystalline, and salt forms, and formulations of TTP273 , synthetic precursors to, and methods of manufacture of TTP273 , as well as combinations of TTP273 and metformin, and their use in methods of treatment, and dosage regimens of TTP273 .
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 TTP399 (the “FDA Approval”) of TTP399 ), 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.
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.
Contemporaneously with the G42 Purchase Agreement, effective on May 31, 2022, the Company entered into a collaboration and license agreement (the “Cogna Agreement”) with Cogna Technology Solutions LLC, an affiliate of G42 Investments (“Cogna”), which requires Cogna to work with the Company in performing clinical trials for the Company’s TTP399 compound (the “Licensed Product”) as well as jointly creating a global development plan to develop, market, and commercialize TTP399 in certain countries in the Middle East, Africa, and Central Asia (the “Partner Territory”).
Contemporaneously with the G42 Purchase Agreement, effective on May 31, 2022, the Company entered into a collaboration and license agreement (the “Cogna Agreement”) with Cogna Technology Solutions LLC, an affiliate of G42 Investments (“Cogna”), which requires Cogna to work with the Company in performing clinical trials for the Company’s compound cadisegliatin (the “Licensed Product”) as well as jointly creating a global development plan to develop, market, and commercialize cadisegliatin in certain countries in the Middle East, Africa, and Central Asia (the “Partner Territory”).
The CinRx Warrants will become exercisable by CinRx only if (i) the Company receives FDA approval to market and distribute the pharmaceutical product containing the Company’s proprietary candidate, TTP399 , or (ii) the Company is acquired by a third party, sells all or substantially all of its assets related to TTP399 to a third party or grants a third party an exclusive license to develop, commercialize and manufacture TTP399 in the United States.
The CinRx Warrants will become exercisable by CinRx only if (i) the Company receives FDA approval to market and distribute the pharmaceutical product containing the Company’s proprietary candidate, cadisegliatin , or (ii) the Company is acquired by a third party, sells all or substantially all of its assets related to cadisegliatin to a third party or grants a third party an exclusive license to develop, commercialize and manufacture cadisegliatin in the United States.
During the year ended December 31, 2021, the Company made a payment of $2.0 million related to the satisfaction of the milestone to complete the phase 2 trials for TTP399 under this agreement. Third-Party Suppliers and Manufacturers We do not own or operate, and currently have no plans to establish, any manufacturing facilities.
During the year ended December 31, 2021, the Company made a payment of $2.0 million related to the satisfaction of the milestone to complete the Phase 2 trials for cadisegliatin under this agreement. Third-Party Suppliers and Manufacturers We do not own or operate, and currently have no plans to establish, any manufacturing facilities.
In this trial, treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. TTP399 demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking TTP399 than those taking placebo.
In this trial, treatment with cadisegliatin resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. Cadisegliatin demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking cadisegliatin than those taking placebo.
Upon expiration (but not earlier termination) of the Reneo License Agreement, the licenses granted to Reneo will survive on a royalty-free basis in perpetuity. Reneo has continued to progress the development of REN001 for primary mitochondrial myopathy (PMM) and long-chain fatty acid oxidation disorders (LC-FAOD).
Upon expiration (but not earlier termination) of the Reneo License Agreement, the licenses granted to Reneo will survive on a royalty-free basis in perpetuity. Reneo has continued to progress the development of mavodelpar for primary mitochondrial myopathy (PMM) and long-chain fatty acid oxidation disorders (LC-FAOD).
According to the terms of the JDRF Agreement, as amended, JDRF provided research funding of $3.4 million based on the achievement of research and development milestones. Additionally, the Company has the obligation to make certain milestone payments to JDRF upon the commercialization, licensing, sale or transfer of TTP399 as a treatment for type 1 diabetes.
According to the terms of the JDRF Agreement, as amended, JDRF provided research funding of $3.4 million based on the achievement of research and development milestones. Additionally, the Company has the obligation to make certain milestone payments to JDRF upon the commercialization, licensing, sale or transfer of cadisegliatin as a treatment for type 1 diabetes.
The Simplici-T1 Study achieved its primary objective by demonstrating statistically significant improvements in HbA1c for TTP399 compared to placebo. Moreover, a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia was observed in patients taking TTP399 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 frequency of severe and symptomatic hypoglycemia was observed in patients taking cadisegliatin when compared to those taking placebo.
As part of this license grant, we obtained certain worldwide rights to Novo Nordisk’s GKA program, including rights to preclinical and clinical compounds such as TTP399 . This agreement was amended in May 2019 to create milestone payments applicable to certain specific and non-specific areas of therapeutic use.
As part of this license grant, we obtained certain worldwide rights to Novo Nordisk’s GKA program, including rights to preclinical and clinical compounds such as cadisegliatin . This agreement was amended in May 2019 to create milestone payments applicable to certain specific and non-specific areas of therapeutic use.
Further, the Company may supply at cost, or Cogna may manufacture, TTP399 for commercial sale under terms to be agreed upon by the parties at a later date. Separately, the Company will conduct its clinical trials for TTP399 outside of the Partner Territory, at its own cost.
Further, the Company may supply at cost, or Cogna may manufacture, cadisegliatin for commercial sale under terms to be agreed upon by the parties at a later date. Separately, the Company will conduct its clinical trials for cadisegliatin outside of the Partner Territory, at its own cost.
Inbound Partnerships JDRF Agreement In August 2017, we entered into a research and collaboration agreement with JDRF International (the “JDRF Agreement”) to support the funding of the Simplici-T1 Study, a Phase 2 study to explore the effects of TTP399 in patients with type 1 diabetes.
Inbound Partnerships JDRF Agreement In August 2017, we entered into a research and collaboration agreement with JDRF International (the “JDRF Agreement”) to support the funding of the Simplici-T1 Study, a Phase 2 study to explore the effects of cadisegliatin in patients with type 1 diabetes.
The JDRF Agreement was amended in June 2021 to provide additional funding for the Company’s mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes.
The JDRF Agreement was amended in June 2021 to provide additional funding for the Company’s mechanistic study exploring the effects of cadisegliatin on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes.
The issued U.S. patent covering HPP971 and HPP3033 as compositions of matter will expire no earlier than 2031, absent any patent term adjustments or extensions. However, this issued U.S. patent may expire as late as 2037, if after approval by the U.S.
The issued U.S. patent covering HPP971 and HPP3033 as compositions of matter will expire no earlier than 2031, absent any patent term adjustments or extensions. However, this issued U.S. patent may expire as late as 2036, if after approval by the U.S.
In addition, we have received common stock and certain participation rights representing a minority interest in Reneo’s outstanding equity. Under the terms of the Reneo License Agreement, Reneo will be responsible for the worldwide 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.
In addition, we have received common stock and certain participation rights representing a minority interest in Reneo’s outstanding equity. 12 Table of Contents Under the terms of the Reneo License Agreement, Reneo will be responsible for the worldwide 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.
We believe that TTP273 could be used to treat postprandial hyperglycemia in CFRD patients and CF patients with abnormal post-prandial glucose excursions without inducing hypoglycemia or GI side effects.
We believe that TTP273 could be used to treat postprandial hyperglycemia in CFRD patients and CF patients with abnormal postprandial glucose excursions without inducing hypoglycemia or GI side effects.
Our Nrf2/Bach1 Modulator Program The Role of Nrf2/Bach1 Modulators Chronic, unresolved inflammation, oxidative stress, and resulting fibrosis are key features of many diseases. Inflammation is an integral component of the normal immune response that occurs when cells encounter harmful stimuli, such as invading pathogens, damaged cells, or irritants.
The Role of Nrf2/Bach1 Modulators Chronic, unresolved inflammation, oxidative stress, and resulting fibrosis are key features of many diseases. Inflammation is an integral component of the normal immune response that occurs when cells encounter harmful stimuli, such as invading pathogens, damaged cells, or irritants.
In our Phase 1 and Phase 2 clinical trials, TTP273 has been demonstrated to be well-tolerated with lower incidences of GI side effects, such as nausea and vomiting, than placebo with minimal weight loss, especially in non-obese patients.
In our Phase 1 and Phase 2 clinical trials, TTP273 has been demonstrated to be well-tolerated with lower incidences of GI side effects, such as nausea and vomiting, than placebo with minimal weight loss, especially in nonobese patients.
The issued U.S. patent covering the polymorph of azeliragon used in clinical development will expire no earlier than 2028, absent any patent term adjustments or extensions, but may expire as late as 2033 if after approval by the U.S.
The issued U.S. patent covering the polymorph of azeliragon used in clinical development will expire no earlier than 2028, absent any patent term 15 Table of Contents adjustments or extensions, but may expire as late as 2033 if after approval by the U.S.
Specifically, the Company will share various protocols with Cogna related to conducting the clinical trials and will provide the patient dosages and placebo of TTP399 needed to conduct the trials.
Specifically, the Company will share various protocols with Cogna related to conducting the clinical trials and will provide the patient dosages and placebo of cadisegliatin needed to conduct the trials.
The IP portfolio for the GLP-1r program includes issued patents in over 25 countries and regions, including the U.S., Europe, Japan, Canada, Australia, and China, directed to TTP273 as a composition of matter.
The IP portfolio for the GLP-1r program includes issued patents in over 25 countries and regions, including the U.S., over 10 European countries, Japan, Canada, Australia, and China, directed to TTP273 as a composition of matter.
The results of each party’s clinical trials will be combined by the Company to seek FDA approval in the United States for TTP399 .
The results of each party’s clinical trials will be combined by the Company to seek FDA approval in the United States for cadisegliatin .
This results in the proliferation of skin cells and the development of raised, red, silvery scale plaques (i.e., plaque psoriasis, psoriasis vulgaris) that has not only medical implications but an impact on a patient’s quality of life. While the specific inciting events for this pro-inflammatory process are unknown psoriasis may be caused by autoimmunity and genetic predisposition.
This results in the proliferation of skin cells and the development of raised, red, silvery scale plaques (i.e., plaque psoriasis, psoriasis vulgaris) that have not only medical implications but an impact on a patient’s quality of life. While the specific inciting events for this proinflammatory process are unknown, psoriasis may be caused by autoimmunity and genetic predisposition.
Positive Phase 2 Simplici-T1 Study In February 2020, we announced positive results from the Simplici-T1 Study, an adaptive Phase 2 clinical trial of TTP399 , assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of TTP399 in adult patients with T1D over a 12-week period.
Positive Phase 2 Simplici-T1 Study In February 2020, we announced positive results from the Simplici-T1 Study, an adaptive Phase 2 clinical trial of cadisegliatin , assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of cadisegliatin in adult patients with TID over a 12-week period.
The Anteris License Agreement, unless terminated earlier, will continue until expiration of all royalty obligations of Anteris to vTv LLC. Either party may terminate the Anteris License Agreement for the other party’s uncured material breach. 12 Table of Con tents Anteris may terminate the Anteris License Agreement at will upon prior written notice.
The Anteris License Agreement, unless terminated earlier, will continue until expiration of all royalty obligations of Anteris to vTv LLC. Either party may terminate the Anteris License Agreement for the other party’s uncured material breach. Anteris may terminate the Anteris License Agreement at will upon prior written notice.
Under the original Huadong License Agreement, we had the obligation to conduct a Phase 2 multi-region clinical trial (the “Phase 2 MRCT”), should Huadong require us to do so. We were also responsible for contributing up to $3.0 million in 11 Table of Con tents connection with the Phase 2 MRCT, if it occurs.
Under the original Huadong License Agreement, we had the obligation to conduct a Phase 2 multi-region clinical trial (the “Phase 2 MRCT”), should Huadong require us to do so. We were also responsible for contributing up to $3.0 million in connection with the Phase 2 MRCT, if it occurs.
Collaboration Revenue and Customers Most of our collaboration revenue for the years ended December 31, 2022, 2021 and 2020 is related to our licenses of certain compounds in the preclinical stage or clinical stage, including the Cantex License Agreement, Anteris License Agreement, Huadong License Agreement, the Reneo License Agreement, and the Newsoara License Agreement.
Collaboration Revenue and Customers Most of our collaboration revenue for the years ended December 31, 2023, 2022 and 2021 is related to our licenses of certain compounds in the preclinical stage or clinical stage, including the Huadong License Agreement, the Reneo License Agreement, and the Newsoara License Agreement.
The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with compliance with applicable statutes and regulations and other regulatory authorities, require the 15 Table of Con tents expenditure of substantial time and financial resources.
The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
The Breakthrough Therapy designation for TTP399 in type 1 diabetes 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 TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes.
The Breakthrough Therapy designation for cadisegliatin in T1D was supported by the positive results from the Phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of cadisegliatin as an adjunct to insulin therapy in adults with T1D.
The FDA confirmed that the effect size of TTP399 on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of an adjunctive therapy for the treatment of type 1 diabetes.
The FDA confirmed that the effect size of cadisegliatin on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of an adjunctive therapy for the treatment of T1D.
Under the 7 Table of Con tents terms of the Cogna Agreement, Cogna will obtain a license under certain intellectual property controlled by the Company to enable it to fulfill its obligations and exercise its rights under the Cogna Agreement, including to develop and commercialize the Licensed Product in the Partner Territory, but will not have access to the various intellectual property related to the license and TTP399 .
Under the terms of the Cogna Agreement, Cogna will obtain a license under certain intellectual property controlled by the Company to enable it to fulfill its obligations and exercise its rights under the Cogna Agreement, including to develop and commercialize the Licensed Product in the Partner Territory, but will not have access to the various intellectual property related to the license and cadisegliatin .
Moderate to severe disease is treated with systemic therapies including oral PDE4 inhibition, immunosuppressants, retinoids, and biologics (ex: anti-TNF agents, IL-17 inhibitors, IL-23 inhibitors). Biologics, while realizing high efficacy rates in treating psoriasis, are associated with administration by injection, high cost, need for laboratory monitoring and increased risk of infection.
Moderate to severe disease is treated with systemic therapies including oral phosphodiesterase-4 ("PDE4") inhibition, immunosuppressants, retinoids, and biologics (e.g., anti-tumor necrosis factor ("anti-TNF") agents, interleukin-17 ("IL-17") inhibitors, and interleukin-23 ("IL-23") inhibitors). Biologics, while realizing high efficacy rates in treating psoriasis, are associated with administration by injection, high cost, need for laboratory monitoring and increased risk of infection.
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 phosphodiesterase type 4 inhibitors (“PDE4”) program, including the compound HPP737 , in China and other Pacific Rim territories (collectively, the “Newsoara License Territory”).
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”).
The patent applications in these additional patent families, if issued, would be expected to expire between 2031 and 2040, absent any patent term adjustments or extensions. The IP portfolio for HPP737 includes issued patents in the U.S. generically covering HPP737 as a composition of matter and methods of use to treat various indications.
The issued patents and patent applications, if issued in this additional patent family, if issued, would be expected to expire in 2039, absent any patent term adjustments or extensions. The IP portfolio for HPP737 includes issued patents in the U.S. generically covering HPP737 as a composition of matter and methods of use to treat various indications.
Our Cystic Fibrosis Related Diabetes Program – TTP273 - GLP-1r Agonist Cystic Fibrosis Related Diabetes Overview Cystic fibrosis related diabetes (“CFRD”) shares some features with both type 1 and type 2 diabetes but is distinct, and is likewise categorized as diabetes due to other causes, specifically a disease of the exocrine pancreas by the American Diabetes Association.
Cystic Fibrosis Related Diabetes Overview Cystic fibrosis related diabetes (“CFRD”) shares some features with both type 1 and type 2 diabetes but is distinct, and is categorized as diabetes due to other causes, specifically a disease of the exocrine pancreas, by the American Diabetes Association.
Current Treatments for Type 1 Diabetes and Their Limitations Patients with type 1 diabetes have difficulty achieving and maintaining consistent glycemic control, defined as HbA1c Several existing treatment options for type 2 diabetes have been investigated to treat type 1 diabetes, generally without success.
Current Treatments for T1D and Their Limitations Patients with T1D have difficulty achieving and maintaining consistent glycemic control, defined as HbA1c Several existing treatment options for T2D have been investigated to treat T1D, generally without success.
Inhibitors of PDE4 act by increasing intracellular concentrations of cyclic adenosine monophosphate (“cAMP”), which has a broad range of anti-inflammatory effects. PDE4 activity is increased in the skin of patients with psoriasis leading to up-regulation of immune modulatory, pro-inflammatory genes and cytokines including interleukin-17 (IL-17), interleukin-23 (IL-23), and tumor necrosis factor-alpha (TNF-α).
Inhibitors of PDE4 act by increasing intracellular concentrations of cyclic adenosine monophosphate (“cAMP”), which has a broad range of anti-inflammatory effects. PDE4 activity is increased in the skin of patients with psoriasis leading to up-regulation of immune modulatory, proinflammatory genes and cytokines, including IL-17, IL-23, and tumor necrosis factor-alpha (TNF-α). Treatments for psoriasis are aimed at reducing proinflammatory cytokine activity.
Moreover, a Phase 1 mechanistic study of TTP399 in patients with type 1 diabetes to determine the impact of TTP399 on ketone body formation showed no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with type 1 diabetes.
Moreover, a Phase 1 mechanistic study of cadisegliatin in patients with T1D conducted to determine the impact of cadisegliatin on ketone body formation showed no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients with T1D.
The contents of our website are not made a part of this Annual Report on Form 10-K. 16 Table of Con tents
The contents of our website are not made a part of this Annual Report on Form 10-K. 17 Table of Contents
Our trials for TTP399 to date suggest that our liver-selective approach to GK activation has the potential to avoid the tolerability issues associated with other GKAs, such as activation of GK in the pancreas, stimulation of insulin secretion independent of glucose, hypoglycemia, increased lipids, and liver toxicity.
Our trials for cadisegliatin to date also suggest that our liver-selective approach to GK activation has the potential to avoid the tolerability issues associated with other GKAs, such as stimulation of insulin secretion independent of ambient blood glucose causing hypoglycemia, increased lipids, and liver toxicity.
The Breakthrough Therapy designation for TTP399 in type 1 diabetes 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 TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes.
The FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D") in 2021 which was supported by the positive results from the Phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of cadisegliatin as an adjunct to insulin therapy in adults with T1D.
Food and Drug Administration (FDA), we apply for and obtain the maximum possible patent term extension (PTE) that is available under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), and the patent term adjustments calculated by the USPTO are fully applied.
Food and Drug Administration (FDA), we apply for and obtain the maximum possible patent term extension (PTE) that is available under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
Human Capital As of December 31, 2022, we had thirteen employees (all but four of whom work in North Carolina), of which at least eight hold graduate degrees (including six doctorate degrees) and six are engaged in full-time research and development activities.
Human Capital As of December 31, 2023, we had sixteen employees (all but seven of whom work in North Carolina), of which at least ten hold graduate degrees (including eight doctorate degrees) and seven are engaged in full-time research and development activities.
CinPax and CinRx Transaction On July 22, 2022, the Company entered into the CinRx Purchase Agreement with CinPax, LLC (“CinPax”), a subsidiary of CinRx Pharma, LLC (“CinRx”), pursuant to which the Company agreed to sell to CinPax 4,154,549 shares of the Company’s Class A common stock at a price per share of approximately $2.41, 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 at a price per share of approximately $96.40, for an aggregate purchase price of $10.0 million, which was paid (i) $6.0 million in cash at the closing of the transaction and (ii) $4.0 million in the form of a non-interest-bearing promissory note with CinPax and was paid to the Company on November 22, 2022.
Additionally, we have completed nine Phase 1 clinical trials and one Phase 2 clinical trial of TTP054 , a predecessor orally administered GLP-1r agonist.
We have completed two Phase 1 clinical trials and one Phase 2 clinical trial of TTP273 . Additionally, we have completed nine Phase 1 clinical trials and one Phase 2 clinical trial of TTP054 , a predecessor orally administered GLP-1RA.
In September 2021, we announced the results of a multiple ascending dose Phase 1 study of HPP737 , an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy volunteers as part of our psoriasis development program.
In September 2021, we announced the results of a multiple ascending dose Phase 1 study of HPP737 to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy volunteers as part of our psoriasis development program.
The CinRx Purchase Agreement also provides CinRx warrants to purchase up to 1,200,000 shares of Class A common stock at an initial exercise of price of approximately $0.72 per share (the “CinRx Warrants”).
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”).
In people with cystic fibrosis (“CF”), the thick, sticky mucus that is characteristic of the disease causes scarring of the pancreas. This scarring prevents the pancreas from producing normal amounts of insulin. The damaged pancreas also responds to insulin signaling in a delayed manner.
In people with cystic fibrosis (“CF”), the thick, sticky mucus that is characteristic of the disease causes scarring of the pancreas. This scarring prevents the pancreas from producing normal amounts of insulin. The damaged pancreas also responds to insulin signaling in a delayed manner. The delay and blunting of the insulin response in patients with CFRD results in postprandial hyperglycemia.
Intellectual Property Patents The IP portfolio for TTP399 includes issued patents in approximately 35 countries and territories, including the U.S., Europe, Japan, Canada, Australia, and China, directed to TTP399 as a composition of matter.
Intellectual Property Patents The IP portfolio for cadisegliatin (TTP399) includes issued patents in approximately 35 jurisdictions, including the U.S., over 10 European countries, Japan, Canada, Australia, and China, directed to cadisegliatin as a composition of matter, among other things.
Collaboration Agreements G42 Transaction On May 31, 2022, the Company and G42 Investments AI Holding RSC Ltd, a private limited company (“G42 Investments”), entered into a Common Stock Purchase Agreement (the “G42 Purchase Agreement”), pursuant to which the Company sold to G42 Investments 10,386,274 shares of the Company’s Class A common stock at a price per share of approximately $2.41, 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 of G42 Investments to be paid on May 31, 2023 (the "G42 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 at a price per share of approximately $96.40, for an aggregate purchase price of $25.0 million, which was paid (i) $12.5 million in cash at the closing and (ii) $12.5 million in the form of a promissory note.
Preclinical Development Plan Long-term toxicology studies and Development and reproductive toxicology studies, have been completed. Carcinogenecity studies are ongoing and expected to be completed by the second quarter of 2024.
We expect that trial to begin in 2024. Preclinical Development Plan Long-term toxicology studies, development and reproductive toxicology studies, have been completed. Carcinogenicity studies are ongoing and expected to be completed by the second quarter of 2024.
First, its expression is mostly limited to tissues that require glucose-sensing (mainly liver and pancreatic β-cells). Second, GK acts as a biological sensor for changes in serum glucose levels and modulates changes in liver glucose metabolism that in turn regulates the balance between hepatic glucose production and glucose consumption and modulates changes in insulin secretion by the β-cells.
First, its expression is mostly limited to tissues that require glucose-sensing (mainly liver cells and pancreatic β-cells). Second, GK acts as a biological sensor for changes in serum glucose levels and modulates changes in the liver's uptake or release of glucose and changes in insulin secretion by the β-cells.
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.
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.
Based on data from Phase 1 and 2 trials to date, we believe that TTP399 , if approved, has the potential to be a first-in-class OAD due to its liver-selectivity and novel mechanism of action. We have completed ten Phase 1 and three Phase 2 clinical trials of TTP399 , one of which was six months in duration.
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.
We have completed the study conduct for An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]- TTP399 Following Single Dose Oral Administration. Ten participants have been dosed, and analysis is ongoing.
We have also completed a Phase 1 study in healthy male subjects to investigate the absorption, metabolism, and excretion of [ 14 C]- cadisegliatin following single dose oral administration. Ten participants have been dosed and analysis is ongoing.
The Company expects to begin these pivotal studies in 2023. • Seeking additional strategic collaborations and additional funding to support the continued development and commercialization of our development programs . We will continue to seek additional funding to support the further development of our drug candidates.
We expect that trial to begin in 2024. • Seeking additional strategic collaborations and additional funding to support the continued development and commercialization of our development programs . We will continue to seek additional funding to support the further development of our drug candidates.
ITEM 1. BUSINESS Overview We are a clinical stage biopharmaceutical company focused on the development of orally administered treatments for diabetes. We are 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.
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.
With insulin and pramlintide injection as the only treatment options approved in the United States for type 1 diabetes, there is a serious unmet medical need to provide people with type 1 diabetes additional, especially oral, treatment options that can help them to reduce HbA1c, or the incidence of hypoglycemia (blood glucose levels below normal) or DKA.
Thus, there is a serious unmet medical need to provide people with T1D additional, especially oral, treatment options that can help them to reduce HbA1c and the incidence of hypoglycemia (blood glucose levels below normal) or DKA.
We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners.
Trade Secrets In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners.
Government Regulation and Product Approvals Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union (“EU”), extensively regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of biopharmaceutical products.
Revenue recognized in these periods relates to initial consideration received in the form of upfront payments and equity interests, research activities performed by our personnel, and the achievement of development milestones. 16 Table of Contents Government Regulation and Product Approvals Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union (“EU”), extensively regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of biopharmaceutical products.
Genetic knock-out models of Bach1 have shown increased expression of multiple antioxidant proteins such as heme oxygenase-1 (HMOX1), leading to a significant level of cellular, tissue and organ protection in a wide variety 10 Table of Con tents of mouse models.
Bach1 is a transcriptional repressor that controls the expression of certain genes involved in the body’s antioxidant response processes. Genetic knock-out models of Bach1 have shown increased expression of multiple antioxidant proteins such as heme oxygenase-1 (HMOX1), leading to a significant level of cellular, tissue and organ protection in a wide variety of mouse models.
Hemin and the hemin mimetic cobalt protoporphyrin IX (“CoPP”) are Bach1 ligands that have served as useful tool compounds to investigate the role of Bach1 inhibition in a variety of disease settings. Both molecules have been shown to have beneficial effects on oxidative stress and inflammatory-mediated pathologies in several animal models.
Hemin and the hemin mimetic cobalt protoporphyrin IX (“CoPP”) are Bach1 ligands that have served as useful tool compounds to investigate the role of Bach1 inhibition in a variety of disease settings.
On December 21, 2017, we entered into a License Agreement with Reneo Pharmaceuticals, Inc. (“Reneo”) (the “Reneo License Agreement”), under which Reneo obtained an exclusive, worldwide, sublicensable license to develop and commercialize our peroxisome proliferation activated receptor delta (PPAR-δ) agonist program, including the compound HPP593 (REN001), for therapeutic, prophylactic, or diagnostic application in humans.
(“Reneo”) (the “Reneo License Agreement”), under which Reneo obtained an exclusive, worldwide, sublicensable license to develop and commercialize our peroxisome proliferation activated receptor delta (PPAR-δ) agonist program, including the compound HPP593 (REN001, mavodelpar ), for therapeutic, prophylactic, or diagnostic application in humans. Under the terms of the Reneo License Agreement, Reneo paid us an initial license fee of $3.0 million.
Only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method of using it, or a method for manufacturing it may be extended.
Only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method of using it, or a method for manufacturing it may be extended. Similar provisions available in Europe and some other foreign jurisdictions to extend the term of a patent that covers an approved drug.
The IP portfolio for azeliragon also includes patent families covering polymorphs, salt forms, metabolites, degradation products and a synthetic precursor of azeliragon , methods of treatment using select dosage regimens of azeliragon , and methods of treating select patient populations. The patent applications in these additional patent families, if issued, would be expected to expire between 2028 and 2039.
The IP portfolio for azeliragon also includes patent families covering polymorphs, salt forms, metabolites, degradation products and a synthetic precursor of azeliragon , methods of treatment using select dosage regimens of azeliragon , and methods of treating select patient populations, among other things.
As part of the G42 Purchase Agreement, G42 Investments nominated a director as appointee and the Company’s board of directors approved appointing the new director to the Company’s board. G42 Investments has agreed to certain transfer restrictions (including restrictions on short sales or similar transactions) and restrictions on further acquisitions of shares, in each case subject to specified exceptions.
G42 Investments has agreed to certain transfer restrictions (including restrictions on short sales or similar transactions) and restrictions on further acquisitions of shares, in each case subject to specified exceptions.
In addition, Reneo is obligated to pay us royalty payments at mid-single to low-double digit rates, based on tiers of annual net sales of licensed products.
We are eligible to receive additional potential development, regulatory and sales-based milestone payments totaling up to $94.5 million. In addition, Reneo is obligated to pay us royalty payments at mid-single to low-double digit rates, based on tiers of annual net sales of licensed products.
The issued U.S. patent covering azeliragon as a composition of matter will expire no earlier than 2023, absent and patent term adjustments and extensions. However, this issued patent may expire as late as 2029 if, after approval by the U.S.
The issued U.S. patent covering cadisegliatin as a composition of matter will expire no earlier than 2025, 14 Table of Contents absent any patent term adjustments or extensions, but may expire as late as 2030 if, after approval by the U.S.
In December 2021, the Company announced a strategic decision to prioritize the development of its lead program TTP399 , a novel, oral, liver-selective glucokinase activator. This decision included a reduction in the Company’s workforce affecting approximately 65% of its employees. We are also actively seeking licensing deals for our other assets.
In December 2021, the Company announced a strategic decision to prioritize the development of its lead program cadisegliatin , a novel, oral, liver-selective glucokinase activator. The recent successful closing of the Private Placement will allow us to further advance our lead program for cadisegliatin ( TTP399 ). We are also actively seeking licensing deals for our other assets.
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.
Once commercialization takes place in the Partner Territory, the Company will receive royalties in the single digits from Cogna on the net sales of the Licensed Product for a period of at least ten years after the first commercial sale of the Licensed Product in the Partner Territory. 8 Table of Contents On February 28, 2023, the Company and G42 Investments amended the G42 Purchase Agreement and modified the G42 Promissory Note to accelerate the payment due under the note.
Our lead program is TTP399 , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) that is a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. On April 13, 2021, we announced that the U.S.
We anticipate that the financing will enable us to conduct a Phase 3 clinical trial for our lead product candidate, cadisegliatin (TTP399) , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) that is a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. The U.S.
Non-electrophilic activation of the Nrf2 pathway via targeting the Bach1 transcriptional repressor provides an alternative mechanism by which to increase the activation of Nrf2 to reduce the oxidative stress and inflammation associated with many acute and chronic diseases. Bach1 is a transcriptional repressor that controls the expression of certain genes involved in the body’s antioxidant response processes.
Non-electrophilic activation of the Nrf2 pathway via targeting the transcription factor BTB and CNC homology 1 ("Bach1") transcriptional repressor provides an alternative mechanism by which to increase the activation of Nrf2 to reduce the oxidative stress and inflammation associated with many acute and chronic diseases.
Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed.
Dose escalation up to 20mg once per day demonstrated dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety 11 Table of Contents or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events.
Further, the ubiquity of the response suggests that the observed tissue protective effects are not related to the underlying causes of a particular disease, but instead are an intrinsic outcome of Bach1 modulation along with Nrf2 activation.
Both molecules have been shown to have beneficial effects on oxidative stress and inflammatory-mediated pathologies in several animal models. 10 Table of Contents Further, the ubiquity of the response suggests that the observed tissue protective effects are not related to the underlying causes of a particular disease, but instead are an intrinsic outcome of Bach1 modulation along with Nrf2 activation.

… 107 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

111 edited+111 added−28 removed308 unchanged
Biggest changeThe Development and Regulatory Approval of Our Drug Candidates • the potential failure of our clinical trials or our inability to receive regulatory approval for our drug candidates; • the identification of serious adverse or unacceptable side effects which are determined to be drug-related; • the impact of changes in law or regulatory policy on the approval of our drug candidates; • the impact of delays in the commencement, enrollment and completion of our clinical trials; • our ability to submit an NDA for the drug candidates we are developing; Risks Relating to the Commercialization of Our Drug Candidates • the acceptance of drug candidates in the market, if approved by the appropriate regulatory agencies; • our ability to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our drug candidates; • the impact of ongoing obligations and continued regulatory review for our drug candidates post-commercialization; • competition with other products; • the impact of healthcare cost containment initiatives and the growth of managed care; • our ability to obtain marketing approval for our drug candidates and obtain profitable pricing once approved; • the impact of healthcare laws and regulations on our relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors; • our ability to obtain approval to commercialize products outside the United States; Risks Relating to Our Dependence on Third Parties • our ability to establish and maintain collaborative relationships to further the development of our drug candidates; • the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials; • our dependence on limited sources of supply for the components used in TTP399 and our other drug candidates; • our reliance on third-party manufacturers to produce our drug candidates; Risks Relating to Our Intellectual Property • our ability to continue to protect proprietary rights to our intellectual property; • the unauthorized disclosure of our trade secrets or other confidential information; • the impact of changes to the patent laws in the United States and other jurisdictions; • the impact of litigation for infringing intellectual property rights of third parties; • the impact of litigation to protect or enforce our patents or other intellectual property; • our ability to enforce our intellectual property rights throughout the world; • our ability to obtain patent term extensions for our drug candidates; Risks Relating to Employee Matters and Managing Growth • the impact of expanding our operations and managing growth; • our ability to attract and retain key personnel; 17 Table of Con tents • the impact of our employees, independent contractors, principal investigators, CROs, consultants and collaborators in the event that they engage in misconduct or other improper activities; Other Risks Relating to Our Business • the impact of the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; • the impact of COVID-19 on our clinical trials, the operations of our licensees and our financial results; • the impact of using our financial and human resources to pursue a particular research program or drug candidate and failing to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success; • the impact of litigation and government investigations, including product liability lawsuits; • the exposure to uninsured liabilities; • our ability to remain competitive given the rapidly changing market for our proposed drug candidates; • the impact of computer system failures, cyber-attacks or a deficiency in our cyber-security; Risks Related to our Common Stock • our ability to maintain listing of our Class A common stock on Nasdaq • the impact of MacAndrews’ substantial influence over our business; • the potential for conflicts of interest with our directors who have relationships with MacAndrews; • our ability to pay cash dividends; • the potential for securities class action litigation; • the impact of research and reports that equity research analysts publish about us and our business; • the impact of substantial sales of shares into the market at any time; • the dilution created by future sales and issuances of our Class A common stock or rights to purchase Class A common stock; • our reliance upon our “smaller reporting company” status; • our exemption from certain corporate governance requirements since we are a “controlled company”; • the existence of provisions in our governing documents or state law which may delay or prevent our acquisition by a third party; • our obligation to make payments under the Tax Receivable Agreement; • our ability to make distributions from vTv LLC to satisfy our obligations; • the benefits conferred upon M&F that will not benefit Class A common stockholders to the same extent as it will benefit MacAndrews.
Biggest changeThese risks are discussed more fully below and include, but are not limited to, risks related to: Our Financial Position and Need for Additional Capital • our ability to achieve or maintain profitability; • our ability to generate revenue in absence of any products approved for sale; • our need for additional capital to continue the development and commercialization of our drug candidates; • the impact of raising additional capital to our stockholders and the rights of our drug candidates; The Development and Regulatory Approval of Our Drug Candidates • the potential failure of our clinical trials or our inability to receive regulatory approval for our drug candidates; • the identification of serious adverse or unacceptable side effects which are determined to be drug-related; • the impact of changes in law or regulatory policy on the approval of our drug candidates; • the impact of delays in the commencement, enrollment and completion of our clinical trials; • our ability to submit an NDA for the drug candidates we are developing; Risks Relating to the Commercialization of Our Drug Candidates • the acceptance of drug candidates in the market, if approved by the appropriate regulatory agencies; • our ability to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our drug candidates; • the impact of ongoing obligations and continued regulatory review for our drug candidates post-commercialization; • competition with other products; • the impact of healthcare cost containment initiatives and the growth of managed care; • our ability to obtain marketing approval for our drug candidates and obtain profitable pricing once approved; • the impact of healthcare laws and regulations on our relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payors; • our ability to obtain approval to commercialize products outside the United States; Risks Relating to Our Dependence on Third Parties • our ability to establish and maintain collaborative relationships to further the development of our drug candidates; • the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials; • our dependence on limited sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates; • our reliance on third-party manufacturers to produce our drug candidates; Risks Relating to Our Intellectual Property • our ability to continue to protect proprietary rights to our intellectual property; • the unauthorized disclosure of our trade secrets or other confidential information; • the impact of changes to the patent laws in the United States and other jurisdictions; • the impact of litigation for infringing intellectual property rights of third parties; • the impact of litigation to protect or enforce our patents or other intellectual property; • our ability to enforce our intellectual property rights throughout the world; • our ability to obtain patent term extensions for our drug candidates; Risks Relating to Employee Matters and Managing Growth • the impact of expanding our operations and managing growth; 18 Table of Contents • our ability to attract and retain key personnel; • the impact of our employees, independent contractors, principal investigators, CROs, consultants and collaborators in the event that they engage in misconduct or other improper activities; Other Risks Relating to Our Business • the impact of the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; • the impact of using our financial and human resources to pursue a particular research program or drug candidate and failing to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success; • the impact of litigation and government investigations, including product liability lawsuits; • the exposure to uninsured liabilities; • our ability to remain competitive given the rapidly changing market for our proposed drug candidates; • the impact of computer system failures, cyber-attacks or a deficiency in our cyber-security; Risks Related to our Common Stock • our ability to maintain listing of our Class A common stock on Nasdaq • the impact of MacAndrews’ substantial influence over our business; • the potential for conflicts of interest with our directors who have relationships with MacAndrews; • our ability to pay cash dividends; • the potential for securities class action litigation; • the impact of research and reports that equity research analysts publish about us and our business; • the impact of substantial sales of shares into the market at any time; • the dilution created by future sales and issuances of our Class A common stock or rights to purchase Class A common stock; • our reliance upon our “smaller reporting company” status; • the existence of provisions in our governing documents or state law which may delay or prevent our acquisition by a third party; • our obligation to make payments under the Tax Receivable Agreement; • our ability to make distributions from vTv LLC to satisfy our obligations; • the benefits conferred upon M&F that will not benefit Class A common stockholders to the same extent as it will benefit MacAndrews. 19 Table of Contents Risks Relating to Our Financial Position and Need for Additional Capital We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.
The FDCA vests authority with FDA to conduct inspections of sponsors conducting pharmaceutical development, such as vTv, to protect the rights, safety and welfare of clinical trial subjects, ensure the accuracy and reliability of clinical trial data, and verify compliance with FDA regulations.
The FDCA vests authority with the FDA to conduct inspections of sponsors conducting pharmaceutical development, such as vTv, to protect the rights, safety and welfare of clinical trial subjects, ensure the accuracy and reliability of clinical trial data, and verify compliance with FDA regulations.
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.
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; 32 Table of Contents • a dispute may arise between us and a partner concerning the research, development or commercialization of a drug candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and • a partner may use our products or technology in such a way as to invite litigation from a third party.
Any performance failure on the part of our distributors could delay clinical development or marketing approval of our drug candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue. We do not have multiple sources of supply for the components used in TTP399 and our other drug candidates.
Any performance failure on the part of our distributors could delay clinical development or marketing approval of our drug candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue. We do not have multiple sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our drug candidates. We have never submitted an NDA before and may be unable to do so for TTP399 and our other drug candidates we are developing.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our drug candidates. We have never submitted an NDA before and may be unable to do so for cadisegliatin (TTP399) and our other drug candidates we are developing.
Because we have limited financial and human resources, we have here to date focused primarily on the regulatory approval of TTP399 . As a result, we may have foregone or delayed the pursuit of opportunities with other drug candidates or for other indications that could later prove to have had greater commercial potential.
Because we have limited financial and human resources, we have here to date focused primarily on the regulatory approval of cadisegliatin (TTP399) . As a result, we may have foregone or delayed the pursuit of opportunities with other drug candidates or for other indications that could later prove to have had greater commercial potential.
Reliance on third-party manufacturers entails risks to which we might not be subject if we manufactured drug candidates ourselves, including: • the limited number of manufacturers that could produce our drug candidates for us; • the inability to meet our product specifications and quality requirements consistently; • inability to access production facilities on a timely basis; • inability or delay in increasing manufacturing capacity; • manufacturing and product quality issues related to scale-up of manufacturing; • costs and validation of new equipment and facilities required for commercial level activity; • a failure to satisfy the FDA’s cGMP requirements and similar foreign standards on a consistent basis; • the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; • termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; • the reliance on a single source of supply which, if unavailable, would delay our ability to complete our clinical trials or to sell any product for which we have received marketing approval; • the lack of qualified backup suppliers for supplies that are currently purchased from a single source supplier; • carrier disruptions or increased costs that are beyond our control; and • the failure to deliver products under specified storage conditions and in a timely manner.
Reliance on third-party manufacturers entails risks to which we might not be subject if we manufactured drug candidates ourselves, including: • the limited number of manufacturers that could produce our drug candidates for us; • the inability to meet our product specifications and quality requirements consistently; • inability to access production facilities on a timely basis; • inability or delay in increasing manufacturing capacity; • manufacturing and product quality issues related to scale-up of manufacturing; • costs and validation of new equipment and facilities required for commercial level activity; • a failure to satisfy the FDA’s cGMP requirements and similar foreign standards on a consistent basis; • the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; • termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; • the reliance on a single source of supply which, if unavailable, would delay our ability to complete our clinical trials or to sell any product for which we have received marketing approval; 34 Table of Contents • the lack of qualified backup suppliers for supplies that are currently purchased from a single source supplier; • carrier disruptions or increased costs that are beyond our control; and • the failure to deliver products under specified storage conditions and in a timely manner.
As a result, we may never successfully develop and commercialize a product, which could lead to a material adverse effect on the value of any investment in our securities. Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates Our development efforts are focused on the continued development of 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 the Development, Regulatory Approval, and Commercialization of Our Drug Candidates Our development efforts are focused on the continued development of cadisegliatin (TTP399).
The patent applications that we own or license may fail to result in issued patents in the United States or in other countries. Even if patents do issue on such patent applications, third parties may challenge the validity, enforceability, or scope thereof, which may result in such patents being narrowed, invalidated, or held unenforceable.
The patent applications that we own, co-own or license may fail to result in issued patents in the United States or in other countries. Even if patents do issue on such patent applications, third parties may challenge the validity, enforceability, or scope thereof, which may result in such patents being narrowed, invalidated, or held unenforceable.
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; • 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; 20 Table of Contents • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; • maintaining, protecting and expanding our portfolio of intellectual property rights; and • attracting, hiring and retaining qualified personnel.
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 Tax Receivable Agreement provides that, upon a merger, asset sale or other form of business combination or certain other changes of control or if, at any time, we elect an early termination of the Tax Receivable Agreement, our (or our successor’s) obligations under the Tax Receivable Agreement with respect to exchanged or acquired Class B common stock, together with the corresponding number of vTv Units (whether exchanged or acquired before or after such change of control or early termination), would be required to be paid significantly in advance of the actual realization, if any, of any future tax benefits and would be based on certain assumptions, including that we would have sufficient taxable income to fully utilize the deductions arising from the increased 52 Table of Contents tax deductions and tax basis and other benefits related to entering into the Tax Receivable Agreement, and, in the case of certain early termination elections, that any Class B common stock, together with the corresponding number of vTv Units, that have not been exchanged will be deemed exchanged for the market value of the Class A common stock at the time of termination.
In 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; 30 Table of Con tents • 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.
There are significant criminal and civil penalties and fines that attach to violations of the FCPA; • the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent; 29 Table of Con tents • the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
There are significant criminal and civil penalties and fines that attach to violations of the FCPA; • the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent; • the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
If our drug candidates fail to comply with applicable regulatory requirements, a regulatory agency may: • issue warning letters or untitled letters; • mandate modifications to promotional materials or require us to disseminate corrective information to healthcare practitioners or other parties; • require us to enter into a consent decree or permanent injunction, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; • impose other civil or criminal penalties; • suspend or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or • 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; • require us to enter into a consent decree or permanent injunction, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; • impose other civil or criminal penalties; • suspend or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or 28 Table of Contents • seize or detain products or require a product recall.
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 violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; • federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 30 Table of Contents • the Foreign Corrupt Practices Act ("FCPA") that prohibits payments to foreign public officials relating to official acts.
Factors that may inhibit our efforts to commercialize our drugs on our own include: • our inability to recruit and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; • the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; • unforeseen costs and expenses associated with creating an independent sales and marketing organization; and • inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.
Factors that may inhibit our efforts to commercialize our drugs on our own include: • our inability to recruit and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; 27 Table of Contents • the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; • unforeseen costs and expenses associated with creating an independent sales and marketing organization; and • inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.
Our operations to date have been primarily limited to developing our technology and undertaking preclinical studies and clinical trials of TTP399 and our other drug candidates. We have not yet obtained regulatory approvals for any of our drug candidates. Consequently, any statements about our future success or viability are not based on any substantial operating history or commercialized products.
Our operations to date have been primarily limited to developing our technology and undertaking preclinical studies and clinical trials of cadisegliatin and our other drug candidates. We have not yet obtained regulatory approvals for any of our drug candidates. Consequently, any statements about our future success or viability are not based on any substantial operating history or commercialized products.
The degree of market acceptance of our drug candidates will depend on a number of factors, including: • limitations or warnings contained in a product’s FDA-approved labeling; • changes in the standard of care or the availability of alternative therapies for the targeted indications for any of our drug candidates; 25 Table of Con tents • limitations in the approved indications for our drug candidates; • demonstrated clinical safety and efficacy compared to other products; • lack of significant adverse side effects; • education, sales, marketing and distribution support; • availability and degree of coverage and reimbursement from third-party payors; • timing of market introduction and perceived effectiveness of competitive products; • cost-effectiveness; • availability of alternative therapies at similar or lower cost, including generics, biosimilar and over-the-counter products; • adverse publicity about our drug candidates or favorable publicity about competitive products; • convenience and ease of administration of our products; • potential product liability claims; and • government-imposed pricing restrictions.
The degree of market acceptance of our drug candidates will depend on a number of factors, including: • limitations or warnings contained in a product’s FDA-approved labeling; • changes in the standard of care or the availability of alternative therapies for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • demonstrated clinical safety and efficacy compared to other products; • lack of significant adverse side effects; • education, sales, marketing and distribution support; • availability and degree of coverage and reimbursement from third-party payors; • timing of market introduction and perceived effectiveness of competitive products; • cost-effectiveness; • availability of alternative therapies at similar or lower cost, including generics, biosimilar and over-the-counter products; • adverse publicity about our drug candidates or favorable publicity about competitive products; • convenience and ease of administration of our products; • potential product liability claims; and • government-imposed pricing restrictions.
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. We intend to seek collaborative relationships for the development and/or commercialization of our drug candidates, including TTP399 .
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. We intend to seek collaborative relationships for the development and/or commercialization of our drug candidates, including cadisegliatin .
There can be no assurance that we will be able to implement our business strategy successfully . Our development focus is on the continued development of TTP399 as a potential adjunctive treatment for patients with type 1 diabetes and supporting our currently partnered programs.
There can be no assurance that we will be able to implement our business strategy successfully . Our development focus is on the continued development of cadisegliatin as a potential adjunctive treatment for patients with type 1 diabetes and supporting our currently partnered programs.
If we were to lose a supplier, it could have a material adverse effect on our ability to complete the development of TTP399 or our other drug candidates. If we obtain regulatory approval for TTP399 or our other drug candidates, we would need to expand the supply of their components in order to commercialize them.
If we were to lose a supplier, it could have a material adverse effect on our ability to complete the development of cadisegliatin or our other drug candidates. If we obtain regulatory approval for cadisegliatin or our other drug candidates, we would need to expand the supply of their components in order to commercialize them.
Our future capital requirements will depend on many factors, including: • the progress, costs, results and timing of our planned registrational trial(s) for TTP399 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; • 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; 20 Table of Con tents • 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; 21 Table of Contents • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; • our need and ability to hire additional management and scientific and medical personnel; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; and • the amount of any payments we are required to make to M&F TTP Holdings Two LLC in the future under the Tax Receivable Agreement.
We will be able to protect our proprietary technology from unauthorized use by third parties only to the extent that such proprietary rights are covered by regulatory exclusivity, valid and enforceable patents or are effectively maintained as trade secrets.
We will be able to protect our proprietary technologies from unauthorized use by third parties only to the extent that such proprietary rights are covered by regulatory exclusivity, valid and enforceable patents or are effectively maintained as trade secrets.
For example: • we might not have been the first to invent or the first to file the inventions covered by each of our pending patent applications and issued patents; 34 Table of Con tents • others may be able to make, use, sell, offer to sell, or import products that are similar to our products or product candidates but that are not covered by the claims of our patents; others may independently develop similar or alternative technologies or duplicate any of our technologies; • the proprietary rights of others may have an adverse effect on our business; • any proprietary rights we do obtain may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties; • any patents we obtain, or our in-licensed issued patents may not be valid or enforceable; or • we may not develop additional technologies or products that are patentable or suitable to maintain as trade secrets.
For example: • we might not have been the first to invent or the first to file the inventions covered by each of our pending patent applications and issued patents; • others may be able to make, use, sell, offer to sell, or import products that are similar to our products or product candidates but that are not covered by the claims of our patents; others may independently develop similar or alternative technologies or duplicate any of our technologies; • the proprietary rights of others may have an adverse effect on our business; 36 Table of Contents • any proprietary rights we do obtain may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties; • any patents we obtain, or our in-licensed issued patents may not be valid or enforceable; or • we may not develop additional technologies or products that are patentable or suitable to maintain as trade secrets.
Risks Relating to Our Intellectual Property If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our commercial success may be adversely affected.
If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our commercial success may be adversely affected.
If we are not able to successfully execute our business strategy and do not achieve the anticipated benefits, our business, results of operations and financial condition could suffer. Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development.
If we are not able to successfully execute our business strategy and do not achieve the anticipated benefits, our business, results of operations and financial condition could suffer. 22 Table of Contents Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development.
Furthermore, if any of our drug candidates are approved and our third-party manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially 33 Table of Con tents equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue.
Furthermore, if any of our drug candidates are approved and our third-party manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue.
In addition, it may inhibit or preclude our ability to raise additional financing. Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) has substantial influence over our business, and their interests may differ from our interests or those of our other stockholders. MacAndrews holds, directly or indirectly, a majority of our combined voting power.
In addition, it may inhibit or preclude our ability to raise additional financing. Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) has substantial influence over our business, and their interests may differ from our interests or those of our other stockholders. MacAndrews holds, directly or indirectly, a significant percentage of our combined voting power.
Furthermore, regulatory attitudes towards the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on other products, policy changes and agency funding, staffing and leadership.
Furthermore, regulatory attitudes towards the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on other products, policy changes and agency funding, staffing and 23 Table of Contents leadership.
In addition, any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly.
In addition, any delays in completing our clinical trials will increase our costs, slow down 25 Table of Contents our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly.
If any of our drug candidates are approved for commercialization outside of the United States, we intend to enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions.
If any of our drug candidates are 31 Table of Contents approved for commercialization outside of the United States, we intend to enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions.
Nevertheless, the amended and restated certificate of incorporation contains provisions that have the same effect as Section 203 of the Delaware General Corporation Law, except that they provide that MacAndrews and its various successors 45 Table of Con tents and affiliates (and transferees of any of them) will not be deemed to be “interested stockholders,” regardless of the percentage of our stock owned by them, and accordingly will not be subject to such restrictions.
Nevertheless, the amended and restated certificate of incorporation contains provisions that have the same effect as Section 203 of the Delaware General Corporation Law, except that they provide that MacAndrews and its various successors 51 Table of Contents and affiliates (and transferees of any of them) will not be deemed to be “interested stockholders,” regardless of the percentage of our stock owned by them, and accordingly will not be subject to such restrictions.
If we are unable to establish and 31 Table of Con tents maintain collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, we may have to delay or discontinue further development of one or more of our drug candidates, undertake development and commercialization activities at our own expense or find alternative sources of capital.
If we are unable to establish and maintain collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, we may have to delay or discontinue further development of one or more of our drug candidates, undertake development and commercialization activities at our own expense or find alternative sources of capital.
Litigation may be necessary to: • protect and enforce our patents and any future patents issuing on our patent applications; • enforce or clarify the terms of the licenses we have granted or been granted or may grant or be granted in the future; • protect and enforce trade secrets, know-how and other proprietary rights that we own or have licensed, or may license in the future; or 36 Table of Con tents • determine the enforceability, scope, and validity of the proprietary rights of third parties and defend against alleged patent infringement.
Litigation may be necessary to: • protect and enforce our patents and any future patents issuing on our patent applications; • enforce or clarify the terms of the licenses we have granted or been granted or may grant or be granted in the future; 40 Table of Contents • protect and enforce trade secrets, know-how and other proprietary rights that we own or have licensed, or may license in the future; or • determine the enforceability, scope, and validity of the proprietary rights of third parties and defend against alleged patent infringement.
If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to generate revenues and become profitable could be impaired. In the European Union, similar political, 28 Table of Con tents economic and regulatory developments may affect our ability to profitably commercialize our products.
If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to generate revenues and become profitable could be impaired. In the European Union, similar political, economic and regulatory developments may affect our ability to profitably commercialize our products.
Delays in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory approval of our drug candidates. We do not know whether current or future clinical trials of our 23 Table of Con tents drug candidates will begin on time or at all or will be completed on schedule or at all.
Delays in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory approval of our drug candidates. We do not know whether current or future clinical trials of our drug candidates will begin on time or at all or will be completed on schedule or at all.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating 18 Table of Con tents revenue from the commercialization of products or achieve or maintain profitability.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of products or achieve or maintain profitability.
Data from clinical trials may receive greater scrutiny with respect to safety, 22 Table of Con tents which may make the FDA or other regulatory authorities more likely to delay or terminate clinical trials before completion, or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or may result in approval for a more limited indication than originally sought.
Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to delay or terminate clinical trials before completion, or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or may result in approval for a more limited indication than originally sought.
Such amendments to existing protocols or clinical trial applications or the need for new ones, may significantly and adversely affect the cost, timing and completion of the clinical trials for our drug candidates.
Such amendments to existing protocols or clinical trial applications or the need for new ones, may significantly and 24 Table of Contents adversely affect the cost, timing and completion of the clinical trials for our drug candidates.
Failure by any of our suppliers to comply with applicable regulations may result in long delays and interruptions. The number of suppliers of the raw material components of our drug candidates is limited.
Failure by any of our suppliers to comply with applicable regulations may result in long delays and interruptions. 33 Table of Contents The number of suppliers of the raw material components of our drug candidates is limited.
Moreover, we may face Inter Partes Review (“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. In the future, we may agree to indemnify our manufacturing partners against certain intellectual property claims brought by third parties.
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. 43 Table of Con tents 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. 49 Table of Contents The trading market for our Class A common stock will be influenced by the research and reports that equity research analysts publish about us and our business.
Moreover, our competitors may independently develop equivalent knowledge, methods, and 35 Table of Con tents know-how, which would not constitute a violation of our trade secret rights. Enforcing a claim that a third party is engaged in the unlawful use of our trade secrets is expensive, difficult and time consuming, and the outcome is unpredictable.
Moreover, our competitors may independently develop equivalent knowledge, methods, and 37 Table of Contents know-how, which would not constitute a violation of our trade secret rights. Enforcing a claim that a third party is engaged in the unlawful use of our trade secrets is expensive, difficult and time consuming, and the outcome is unpredictable.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed 46 Table of Contents our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
We also will need to raise substantial additional capital in the future to conduct further clinical trials of TTP399 and to continue developing our other drug candidates. Although we are seeking financing, partnering and licensing transactions for the further development of TTP399 , these efforts may not be successful.
We also will need to raise substantial additional capital in the future to conduct further clinical trials of cadisegliatin and to continue developing our other drug candidates. Although we continue to seek financing, partnering and licensing transactions for the further development of cadisegliatin , these efforts may not be successful.
As a result, such circumstances may entail real or apparent conflicts of interest with respect to matters affecting both us and MacAndrews, whose interests, in some circumstances, may be adverse to ours.
As a result, such circumstances may entail real or apparent conflicts of interest with respect to matters affecting both us and MacAndrews or the Private Placement Investors, whose interests, in some circumstances, may be adverse to ours.
If we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected. 38 Table of Con tents We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
If we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected. We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
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. 47 Table of Con tents ITEM 1B. UNRESOLVED STAFF COMMENTS None. ITEM 2.
To the extent that M&F is dissolved or liquidated, MacAndrews and/or its affiliates will succeed to the rights and obligations of M&F under the Tax Receivable Agreement, and the same considerations described above apply to any such successor parties. 53 Table of Contents ITEM 1B. UNRESOLVED STAFF COMMENTS None.
Should we lose these statuses, we may no longer be 44 Table of Con tents exempt from these requirements and expect that compliance with the requirements will increase our legal and financial compliance costs and will make some activities more time consuming and costly.
Should we lose these statuses, we may no longer be exempt from these requirements and expect that compliance with the requirements will increase our legal and financial compliance costs and will make some activities more time consuming and costly.
We expect to continue to incur significant additional expenses as we continue the development of TTP399 .
We expect to continue to incur significant additional expenses as we continue the development of cadisegliatin .
As a result, MacAndrews and its affiliates hold shares representing approximately 57.0% of the combined voting power of our outstanding common stock.
As a result, MacAndrews and its affiliates held shares representing approximately 56.0% of the combined voting power of our outstanding common stock.
Further, if we encounter delays in our clinical trials, the period of time during which we or our collaborators could market our product candidates under patent protection would be reduced. The degree of future protection of our proprietary rights is uncertain.
Further, if we encounter delays in our clinical trials, the period of time during which we or our collaborators could market our product candidates under patent protection would be reduced.
Some of these SGLT-1 and SGLT-2 inhibitors have been approved for certain sub-groups of type 1 diabetics in Europe and Japan, but these therapies have not yet been approved for use in the U.S. due to safety risks including those pertaining to diabetic ketoacidosis.
Some of these SGLT-1 and SGLT-2 inhibitors had been approved for certain sub-groups of type 1 diabetics in Europe and Japan, but are no longer marketed there, and have not been approved for use in the U.S. due to safety risks including those pertaining to diabetic ketoacidosis.
Oral non-insulin agents that are currently being developed to treat type 1 diabetes that may compete with TTP399 include SGLT-1/2 inhibitors, such as sotagliflozin, being developed by Lexicon and SGLT-2 inhibitors such as AstraZeneca’s dapagliflozin and Eli Lilly/Boehringer Ingelheim’s empagliflozin.
Oral non-insulin agents that are currently being developed to treat type 1 diabetes that may compete with cadisegliatin include SGLT-1/2 inhibitors, such as sotagliflozin, being developed by Lexicon and SGLT-2 inhibitors such as AstraZeneca’s dapagliflozin and Eli Lilly/Boehringer Ingelheim’s empagliflozin, and somatostatin type 2 receptor blockers such as Zucara's ZT-01.
Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a drug candidate.
Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a drug candidate. Frequently, drug candidates that have shown promising results in early clinical trials have subsequently suffered significant setbacks in later clinical trials.
Patent protection may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
The degree of future protection of our proprietary rights is uncertain. Patent protection may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
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.
Shares of our Class A common stock issuable upon an exchange of vTv Units as described above would be considered “restricted securities,” as that term is defined in Rule 144 under the Securities Act, unless the exchange is registered under the Securities Act. We also have issued warrants to MacAndrews to purchase 45,595 shares of our Class A common stock.
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. 40 Table of Con tents Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of any products we develop.
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.
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.
Further, it may also slow potential enrollment of our ongoing clinical trials. 45 Table of Contents We may use our financial and human resources to pursue a particular research program or drug candidate and fail to capitalize on programs or drug candidates that may be more profitable or for which there is a greater likelihood of success.
In order to compete with approved products, our drug candidates will need to demonstrate compelling advantages. 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 are efficacy, safety and tolerability profile, mechanism of action, control and predictability, convenience of dosing and price and reimbursement.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We expect to continue to incur significant research and development expenses in connection with our ongoing activities, particularly as we undertake additional clinical trials of TTP399 and our other drug candidates and continue to work on our other research programs.
We expect to continue to incur significant research and development expenses in connection with our ongoing activities, particularly as we undertake additional clinical trials of cadisegliatin and our other drug candidates and continue to work on our other research programs.
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.
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.
We may sell Class A common stock, convertible securities or other equity securities, including under the LPC Purchase Agreement, the ATM Offering, or pursuant to warrants issued to M&F Group and our previous 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, 50 Table of Contents or pursuant to warrants issued to previous investors and lenders, and such sales could result in substantial dilution to existing investors.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. We will need additional capital to complete the development and commercialization of cadisegliatin (TTP399) and our other drug candidate.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability. 27 Table of Con tents We expect that our existing and future drug candidates will face competition, and most of our competitors have significantly greater resources than we do.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
As of December 31, 2022, we had a total accumulated deficit of approximately $265.5 million. In addition, we have not commercialized any products and have never generated any revenue from the commercialization of any product. We have devoted most of our financial resources to research and development, including our preclinical development activities and clinical trials.
In addition, we have not commercialized any products and have never generated any revenue from the commercialization of any product. We have devoted most of our financial resources to research and development, including our preclinical development activities and clinical trials.
Consequently, it is possible that the actual cash tax savings realized by us may be significantly less than the corresponding Tax Receivable Agreement payments. 46 Table of Con tents The only asset of the Company is its interest in vTv LLC, and accordingly it will depend on distributions from vTv LLC to pay taxes and expenses, including payments under the Tax Receivable Agreement. vTv LLC’s ability to make such distributions may be subject to various limitations and restrictions.
The only asset of the Company is its interest in vTv LLC, and accordingly it will depend on distributions from vTv LLC to pay taxes and expenses, including payments under the Tax Receivable Agreement. vTv LLC’s ability to make such distributions may be subject to various limitations and restrictions.
We may not be able to enforce all of our intellectual property rights throughout the world. Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly in developing countries.
Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly in developing countries. Moreover, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.
If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy. Our industry has experienced a high rate of turnover of management personnel in recent years.
If we are 44 Table of Contents not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.
Pursuant to the investor rights agreement, we filed a shelf registration statement on Form S-3 in June 2019 to register certain shares previously issued to MacAndrews.
Further, we have entered into an investor rights agreement with an affiliate of MacAndrews providing certain governance and registration rights. Pursuant to the investor rights agreement, we filed a shelf registration statement on Form S-3 in June 2019 to register certain shares previously issued to MacAndrews.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidates to other available therapies.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidates to other available therapies.
We will be required to pay M&F TTP Holdings Two LLC (“M&F”) for certain tax benefits we may claim. In certain circumstances, payments under the Tax Receivable Agreement may be accelerated and/or significantly exceed the actual tax benefits we realize. The only asset of the Company is its interest in vTv LLC.
In certain circumstances, payments under the Tax Receivable Agreement may be accelerated and/or significantly exceed the actual tax benefits we realize. The only asset of the Company is its interest in vTv LLC.
Our current capital will not be sufficient for us to complete the development of our drug candidates. 19 Table of Con tents As such, we will need to raise additional capital to fund the ongoing and planned trials for our drug candidates and prior to the commercialization of any of our drug candidates.
As such, we will need to raise additional capital to fund the ongoing and planned trials for our drug candidates and prior to the commercialization of any of our drug candidates.
As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
The UPC and Unitary Patent are significant changes in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation in the UPC.
We have no commitments or arrangements for any additional financing to fund our research and development programs other than the funds available to us under our Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
We have no commitments or arrangements for any additional financing to fund our research and development programs other than the funds available to us under our sales agreement (the “TD Cowen Sales Agreement”) with Cowen & Company, LLC (“TD Cowen”) (the “TD Cowen ATM Offering”) .
We are highly dependent on the development, regulatory, commercialization and business development expertise of our executive officers and key employees. If we lose one or more of our executive officers or key personnel, our ability to implement our business strategy successfully could be seriously harmed. Any of our executive officers or key employees may terminate their employment at any time.
Our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on the development, regulatory, commercialization and business development expertise of our executive officers and key employees. If we lose one or more of our executive officers or key personnel, our ability to implement our business strategy successfully could be seriously harmed.
The provisions of our amended and restated certificate of incorporation and amended and restated bylaws, the significant common stock ownership of MacAndrews and the ability of the Board of Directors to create and issue a new series of preferred stock or implement a stockholder rights plan could discourage potential takeover attempts and reduce the price that investors might be willing to pay for shares of our common stock in the future, which could reduce the market price of our common stock.
Further, the Private Placement Investors are also not deemed to be “interested stockholders,” regardless of the percentage of our stock owned by them, and accordingly will not be subject to the restrictions set forth in Section 203 of the Delaware General Corporation Law The provisions of our amended and restated certificate of incorporation and amended and restated bylaws, the significant common stock ownership of MacAndrews and the ability of the Board of Directors to create and issue a new series of preferred stock or implement a stockholder rights plan could discourage potential takeover attempts and reduce the price that investors might be willing to pay for shares of our common stock in the future, which could reduce the market price of our common stock.
Switching vendors may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. 32 Table of Con tents If we are unable to obtain the supplies we need at a reasonable price or on a timely basis, it could have a material adverse effect on our ability to complete the development of our drug candidates or, if we obtain regulatory approval for our drug candidates, to commercialize them.
If we are unable to obtain the supplies we need at a reasonable price or on a timely basis, it could have a material adverse effect on our ability to complete the development of our drug candidates or, if we obtain regulatory approval for our drug candidates, to commercialize them.
Geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors.
In addition, geopolitical actions in the United States and in foreign countries (such as the Russia and Ukraine conflict) could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any future licensors and the maintenance, enforcement or defense of our issued patents which could impair our competitive intellectual property position.

… 170 more changes not shown on this page.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

1 edited+0 added−0 removed0 unchanged
Biggest changeItem 4. Mine Safety Disclosures 48 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 49 Item 6. [Reserved] 49 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 50 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 60
Biggest changeItem 4. Mine Safety Disclosures 54 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 55 Item 6. [Reserved] 55 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 56 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 65 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

1 edited+1 added−2 removed2 unchanged
Biggest changeHolders As of March 6, 2023, there were approximately 24 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 13, 2024, there were approximately 28 holders of record of our Class A common stock and 6 holders of record of our Class B common stock.
Removed
Securities Authorized for Issuance under Equity Compensation Plans The following table summarizes information about our equity compensation plans as of December 31, 2022.
Added
Issuer Purchases of Equity Securities There have been no repurchases of the Company’s common stock during the fourth fiscal quarter of fiscal 2023.
Removed
The only awards that have been granted under the plan below are in the form of option and restricted stock unit awards related to our Class A common stock: Plan Category Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights (a) Weighted average Exercise Price of Outstanding Options, Warrants and Rights (b) Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in column (a)) (c) Equity compensation plans approved by security holders 2015 Omnibus Equity Incentive Plan 5,519,285 $2.81 1,424,882 Inducement Awards 2,824,659 $0.94 — Equity compensation plans not approved by security holders — Total 8,343,944 1,424,882 Issuer Purchases of Equity Securities There have been no repurchases of the Company’s common stock during the fourth fiscal quarter of fiscal 2022.

Item 7. Management's Discussion & Analysis

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

61 edited+28 added−47 removed25 unchanged
Biggest changeThe decrease in research and development expenses during this period of approximately $1.0 million, or 7.3%, was primarily driven by (i) decreased spending of $2.8 million related to the multiple ascending dose study for HPP737 , due to its completion in 2021, (ii) decrease of $2.0 million for a license payment in 2021 to Novo Nordisk for the completion of TTP399 phase 2 studies in 2021, (iii) decreases in indirect and other costs of $2.4 million primarily related to payroll and severance costs due to the reduction in workforce, and (iv) and a decrease in clinical trial costs of $0.8 million for azeliragon which was driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes, partially offset by increases in TTP399 drug related costs of $7.0 million and initial preparatory costs for the upcoming clinical trials.
Biggest changeThe increase in research and development expenses during this period of approximately $1.2 million, or 10.0%, was primarily driven by (i) higher spending on cadisegliatin of $0.6 million due to increases in drug product related costs as well as higher spending on trial preparation costs, and (ii) an increase of $0.6 million in indirect costs and other projects.
Other Income / (Expense) Other expense was $2.7 million for the year ended December 31, 2022 and was driven by an unrealized loss recognized related to the Company’s investment in Reneo as well as the losses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.
Other expense was $2.7 million for the year ended December 31, 2022, and was driven by an unrealized loss recognized related to the Company’s investment in Reneo as well as the losses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.
While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies,” to our audited financial statements, we believe that the following accounting policies related to revenue recognition, research and development, income taxes, and share-based compensation are the most critical for fully understanding and evaluating our financial condition and results of operations.
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.
The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical studies are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study.
The objective of our accrual policy is to match the recording of expenses in our consolidated financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical studies are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study.
Research and Development Major components of research and development costs include cash compensation, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on our behalf.
Research and Development Major components of research and development costs include cash compensation to employees, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on our behalf.
Discussion of Critical Accounting Policies and Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).
Discussion of Critical Accounting Policies and Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).
Under this method, we determine deferred tax assets and liabilities on the basis of differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse.
Under this method, we determine deferred tax assets and liabilities on the basis of differences between the consolidated financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse.
Our direct research and development expenses consist primarily of external costs such as fees paid to investigators, consultants, central laboratories and contract research organizations in connection with our clinical trials, and costs related to acquiring and manufacturing clinical trial materials.
Our direct research and development expenses consist primarily of external costs such as fees paid to investigators, consultants, central laboratories and clinical research organizations in connection with our clinical trials, and costs related to acquiring and manufacturing clinical trial materials.
We are evaluating several financing strategies to fund our planned and ongoing clinical trials, including direct equity investments and future public offerings of our common stock. The timing and availability of such financing are not yet known.
We are evaluating several financing strategies to fund our planned and ongoing clinical trials, including direct equity investments and future public offerings of our common stock. The timing and availability of such additional financing are not yet known.
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events included in the financial statements.
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.
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 pre-clinical drug candidates.
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.
For a discussion of the year ended December 31, 2021, compared to the year ended December 31, 2020, 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, 2021.
For a discussion of the year ended December 31, 2022 compared to the year ended December 31, 2021, please refer to Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022.
The timing of any such transactions is not certain, and we may not be able to complete such transactions on acceptable terms, or at all. Even if we are able to complete such transactions, it may contain restrictions on our operations or cause substantial dilution to our stockholders.
The timing of any such transactions is not certain, and we may not be able to complete such transactions on acceptable terms, or at all. Even if we are able to complete such transactions, they may contain restrictions on our operations or cause substantial dilution to our stockholders.
Off-Balance Sheet Arrangements As of December 31, 2022, we do not currently have outstanding any off-balance sheet arrangements as defined under SEC rules.
Off-Balance Sheet Arrangements As of December 31, 2023, we do not currently have outstanding any off-balance sheet arrangements as defined under SEC rules.
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 IPO, 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. Income Taxes In connection with the Initial Public Offering, vTv Therapeutics Inc. was formed.
ATM Offering We have entered into the Sales Agreement with Cantor Fitzgerald pursuant to which we may offer and sell, from time to time, through or to Cantor Fitzgerald, as sales agent or principal, shares of our Class A common stock having an aggregate offering price of up to $68.5 million.
Cantor Fitzgerald Sales Agreement We previously entered into the Sales Agreement with Cantor Fitzgerald pursuant to which could offer and sell, from time to time, through or to Cantor Fitzgerald, as sales agent or principal, shares of our Class A common stock having an aggregate offering price of up to $68.5 million.
We plan to finance our operations into the first quarter of 2024 through the use of our cash and cash equivalents and based on current operating plans, we are evaluating several financing strategies to fund the on-going and future clinical trials of TTP399 , including direct equity investments and the potential licensing and monetization of other Company programs.
We plan to finance our operations into the first quarter of 2026 through the use of our cash and cash equivalents and based on current operating plans, we are evaluating several financing strategies to fund the ongoing and future clinical trials of cadisegliatin , including direct equity investments and the potential licensing and monetization of other Company programs.
We are not obligated to sell any shares under the Sales Agreement. Under the terms of the Sales Agreement, we will pay Cantor Fitzgerald a commission of up to 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements.
We are not obligated to sell any shares under the TD Cowen Sales Agreement. Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements.
Our future capital requirements will depend on many factors, including: • The progress, costs, results and timing of our planned trials to evaluate TTP399 as a potential adjunctive therapy for the treatment of type 1 diabetes; • the 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; • 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 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; • 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; and 57 Table of Con tents • the impact and duration of the COVID-19 outbreak / pandemic.
Our future capital requirements will depend on many factors, including: • the progress, costs, results and timing of our planned trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes; • the willingness of the FDA to rely upon our completed and planned clinical and preclinical studies and other work, as the basis for review and approval of our drug candidates; • our ability to maintain control over our costs in line with our budget to complete the Phase 3 clinical trial for our lead product candidate, cadisegliatin ; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development; • the ability of our drug candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization capabilities; • the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies; • our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; • our need and ability to hire additional management, scientific, and medical personnel; • the effect of competing technological and market developments; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future; • the amount of any payments we are required to make to M&F TTP Holdings Two LLC in the future under the Tax Receivable Agreement.
We have determined that vTv LLC is a variable-interest entity (“VIE”) for accounting purposes and that vTv Therapeutics Inc. is the primary beneficiary of vTv LLC because (through its managing member interest in vTv LLC and the fact that the senior management of vTv Therapeutics Inc. is also the senior management of vTv LLC) it has the power to direct all of the activities of vTv LLC, which include those that most significantly impact vTv LLC’s economic performance. vTv Therapeutics Inc. has therefore consolidated vTv LLC’s results under the VIE accounting model in its consolidated financial statements. 51 Table of Con tents Financial Overview Revenue To date, we have not generated any revenue from drug sales.
We have determined that vTv LLC is a variable-interest entity (“VIE”) for accounting purposes and that vTv Therapeutics Inc. is the primary beneficiary of vTv LLC because (through its managing member interest in vTv LLC and the fact that the senior management of vTv Therapeutics Inc. is also the senior management of vTv LLC) it has the power to direct all of the activities of vTv LLC, which include those that most significantly impact vTv LLC’s economic performance. vTv Therapeutics Inc. has therefore consolidated vTv LLC’s results under the VIE accounting model in its consolidated financial statements.
Research and Development Expenses Research and development expenses were $12.4 million and $13.3 million for the years ended December 31, 2022 and 2021, respectively.
Research and Development Expenses Research and development expenses were $13.6 million and $12.4 million for the years ended December 31, 2023 and 2022, respectively.
We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
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.
See Note 2 “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K for further information.
For the year ended December 31, 2021, net cash provided by financing activities was driven by sales of shares of our Class A common stock during the year ended December 31, 2021. Future Funding Requirements To date, we have not generated any revenue from drug product sales.
For the year ended December 31, 2022, net cash provided by financing activities was driven by sales of our Class A common stock to a collaboration partner and from the CinRx Purchase Agreement. Future Funding Requirements To date, we have not generated any revenue from drug product sales.
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. 59 Table of Con tents Interest and penalties related to income taxes are included in the benefit (provision) for income taxes in our Consolidated Statement of Operations.
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.
General and Administrative Expenses General and administrative expenses were $12.2 million and $12.3 million for the years ended December 31, 2022 and 2021, respectively.
General and Administrative Expenses General and administrative expenses were $11.9 million and $12.2 million for the years ended December 31, 2023 and 2022, respectively.
The revenue recognized in 2022 related to the increase to the transaction price for the license performance obligations under the amended license agreement with Huadong due to the satisfaction of a development milestone.
Revenue was $2.0 million for the year ended December 31, 2022. The revenue recognized in 2022 related to the increase to the transaction price for the license performance obligations under the amended license agreement with Huadong due to the satisfaction of a development milestone.
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.
Prior to July 30, 2015, our predecessor entities were taxed as partnerships and all their income and deductions flowed through and were subject to tax at the partner level. vTv Therapeutics Inc. holds vTv Units and is required to recognize deferred tax assets and liabilities for the difference between the financial reporting and tax basis of its investment in vTv LLC. 64 Table of Contents Our income tax expense, deferred tax assets and liabilities and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid.
Until such time, if ever, as we can generate substantial revenue from drug sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. We currently have committed external source of funds available through the ATM Offering and LPC Purchase Agreement.
Until such time, if ever, as we can generate substantial revenue from drug sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.
Our revenue has been primarily derived from up-front proceeds and research fees under collaboration and license agreements. In the future, we may generate revenue from a combination of product sales, license fees, milestone payments and royalties from the sales of products developed under licenses of our intellectual property.
In the future, we may generate revenue from a combination of product sales, license fees, milestone payments and royalties from the sales of products developed under licenses of our intellectual property.
The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis.
The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at 63 Table of Contents the date of our consolidated financial statements, as well as the reported revenues and expenses during the reported periods.
Our research and development expenses by project for the years ended December 31, 2022, 2021 and 2020 were as follows (in thousands): Years Ended December 31, 2022 2021 2020 Direct research and development expense: TTP399 $ 9,611 $ 2,608 $ 917 HPP737 — 2,762 493 Azeliragon — 822 6,103 Other projects 563 717 683 Indirect research and development expense 2,183 6,415 2,819 Total research and development expense $ 12,357 $ 13,324 $ 11,015 We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development of TTP399 and further advance the development of our other drug candidates, subject to the availability of additional funding.
Our research and development expenses by project for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Years Ended December 31, 2023 2022 2021 Direct research and development expense: Cadisegliatin $ 10,182 $ 9,611 $ 2,608 HPP737 — — 2,762 Azeliragon — — 822 Other projects 676 563 717 Indirect research and development expense 2,737 2,183 6,415 Total research and development expense $ 13,595 $ 12,357 $ 13,324 We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development of cadisegliatin and further advance the development of our other drug candidates, subject to the availability of additional funding. 58 Table of Contents The successful development of our clinical and preclinical drug candidates is highly uncertain.
In April 2021, we announced that the FDA granted Breakthrough Therapy Designation (“BTD”) for TTP399 as an adjunctive therapy to insulin for the treatment of T1D. This designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.
Food and Drug Administration (FDA) granted Breakthrough Therapy designation in 2021 for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"). The Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.
Revenue is recognized over the related period over which we expect the services to be provided using a proportional performance model or a straight-line method of recognition if there is no discernable pattern over which the services will be provided.
The primary method used to estimate standalone selling price is the expected cost plus margin approach. Revenue is recognized over the related period over which we expect the services to be provided using a proportional performance model or a straight-line method of recognition if there is no discernible pattern over which the services will be provided.
This is due to the numerous risks and uncertainties associated with the development of our drug candidates, including: • the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities; • the potential benefits of our candidates over other therapies; • our ability to market, commercialize and achieve market acceptance for any of our drug candidates that we are developing or may develop in the future; 52 Table of Con tents • future clinical trial results; • our ability to enroll patients in our clinical trials; • the timing and receipt of any regulatory approvals; 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 uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities; • the potential benefits of our candidates over other therapies; • our ability to market, commercialize and achieve market acceptance for any of our drug candidates that we are developing or may develop in the future; • future clinical trial results; • our ability to enroll patients in our clinical trials; • the timing and receipt of any regulatory approvals; • our ability to secure sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer-term cash requirements and other cash needs, at the times and in the amounts needed; • legislation and regulatory actions and changes in laws or regulations; and • the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.
Cash Flows Year Ended December 31, 2022 2021 (dollars in thousands) Net cash used in operating activities $ (16,022) $ (19,308) Net cash used in investing activities (21) — Net cash provided by financing activities 14,754 26,976 Net (decrease)/increase in cash and cash equivalents $ (1,289) $ 7,668 Operating Activities For the year ended December 31, 2022, our net cash used in operating activities decreased by $3.3 million from the prior year.
Cash Flows Year Ended December 31, 2023 2022 (dollars in thousands) Net cash used in operating activities $ (19,081) $ (16,022) Net cash provided by (used in) investing activities 4,404 (21) Net cash provided by financing activities 11,997 14,754 Net decrease in cash and cash equivalents $ (2,680) $ (1,289) Operating Activities For the year ended December 31, 2023, our net cash used in operating activities increased by $3.1 million from the prior year.
Interest Income Interest income represents non-cash interest income related to the imputed interest from our promissory note receivable, all of which are recognized in our Consolidated Statement of Operations using the effective interest method .
Interest Income Interest income represents noncash interest income related to the imputed interest from the G42 Promissory Note receivable using the effective interest method and cash interest income from dividends and interest from our money market account, all of which are recognized in our Consolidated Statement of Operations . Interest Expense The Company’s interest expense is immaterial.
Liquidity and Capital Resources Liquidity and Going Concern As of December 31, 2022, we had an accumulated deficit of $265.5 million. Since our inception, we have experienced a history of negative cash flows from operating activities. We anticipate that we will continue to incur losses for the foreseeable future as we continue our clinical trials.
Liquidity and Capital Resources Liquidity and Going Concern As of December 31, 2023, we had an accumulated deficit of $281.0 million. Since our inception, we have experienced a history of negative cash flows from operating activities.
The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. 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.
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.
However, the ability to use these sources of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in our Class A common stock.
Additionally, we may rely on our ability to sell shares of our Class A 62 Table of Contents common stock pursuant to the ATM Offering. However, the ability to use this source of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in the Company’s Class A common stock.
As of December 31, 2022, we have sold $31.2 million worth of Class A common stock under the ATM Offering for net proceeds of $30.3 million, leaving $37.3 million available to be sold.
As of December 31, 2023, we had sold $31.2 million worth of Class A common stock pursuant to the Sales Agreement for net proceeds of $30.3 million.
Our lead program is TTP399 , an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"). Recent Developments On July 27, 2022, the Company appointed Paul Sekhri as President and Chief Executive Officer (CEO) effective August 1, 2022, and Mr.
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").
The decrease in general and administrative expenses during this period of approximately $0.1 million, or 1.2%, was primarily driven by (i) a decrease of $2.1 million in payroll costs due to the reduction in workforce, (ii) a decrease of $0.7 million in severance costs, and (iii) a decrease of $0.9 million in share-based expense, partially offset by (iv) an increase in legal expense of $2.3 million, and v) an increase of $1.3 million in other general and administrative costs. 54 Table of Con tents Interest Income Interest income for the year ended December 31, 2022 is related to the imputed interest on the G42 promissory note.
The decrease in general and administrative expenses during this period of approximately $0.3 million, or 2.4%, was primarily driven by (i) a decrease of $3.1 million in legal expense, and (ii) a decrease of $0.8 million in severance costs, partially offset by (iii) an increase in payroll costs of $1.8 million, (iv) an increase in other general and administrative costs of $1.5 million, and (v) an increase in share-based compensation expense of $0.3 million.
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.
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.
Comparison of the years ended December 31, 2022 and 2021 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: 2022 2021 Change Revenue $ 2,018 $ 4,005 $ (1,987) Operating expenses: Research and development 12,357 13,324 (967) General and administrative 12,201 12,343 (142) Total operating expenses 24,558 25,667 (1,109) Operating loss (22,540) (21,662) (878) Interest income 352 1 351 Interest expense (15) (12) (3) Other (expense) income, net (2,670) 4,057 (6,727) Loss before income taxes (24,873) (17,616) (7,257) Income tax provision 200 115 85 Net loss before noncontrolling interest (25,073) (17,731) (7,342) Less: Net loss attributable to noncontrolling interest (5,909) (4,744) (1,165) Net loss attributable to vTv Therapeutics Inc. $ (19,164) $ (12,987) $ (6,177) Revenues Revenues were $2.0 million and $4.0 million for the years ended December 31, 2022 and 2021, respectively.
Comparison of the years ended December 31, 2023 and 2022 The following table sets forth certain information concerning our results of operations for the periods shown: (dollars in thousands) Year Ended Statement of operations data: 2023 2022 Change Revenue $ — $ 2,018 $ (2,018) Operating expenses: Research and development 13,595 12,357 1,238 General and administrative 11,907 12,201 (294) Total operating expenses 25,502 24,558 944 Operating loss (25,502) (22,540) (2,962) Interest income 472 352 120 Interest expense (13) (15) 2 Other expense, net (923) (2,670) 1,747 Loss before income taxes and noncontrolling interest (25,966) (24,873) (1,093) Income tax provision — 200 (200) Net loss before noncontrolling interest (25,966) (25,073) (893) Less: Net loss attributable to noncontrolling interest (5,716) (5,909) 193 Net loss attributable to vTv Therapeutics Inc. $ (20,250) $ (19,164) $ (1,086) Revenue There was no revenue for the year ended December 31, 2023.
A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. We then recognize revenue under each contract as the related performance obligations are satisfied. The transaction price under the contract is determined based on the value of the consideration expected to be received in exchange for the transferred assets or services.
For each contract meeting these criteria, we identify the performance obligations included within the contract. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. We then recognize revenue under each contract as the related performance obligations are satisfied.
The grant date fair value of stock option awards is estimated using the Black-Scholes option pricing formula. 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.
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.
Further, we expect that we will need additional capital to continue to fund our operations. As of December 31, 2022, we had cash and cash equivalents of $12.1 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, 2023, we had cash and cash equivalents of $9.4 million.
For contracts with multiple 58 Table of Con tents performance obligations, the contract’s transaction price is allocated to each performance obligation using our best estimate of the standalone selling price of each distinct good or service in the contract. The primary method used to estimate standalone selling price is the expected cost plus margin approach.
The amount of variable consideration expected to be received is included in the transaction price when it becomes probable that the milestone will be met. For contracts with multiple performance obligations, the contract’s transaction price is allocated to each performance obligation using our best estimate of the standalone selling price of each distinct good or service in the contract.
We account for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. For each contract meeting these criteria, we identify the performance obligations included within the contract.
Revenue Recognition The majority of our revenue results from its license and collaboration agreements associated with the development of investigational drug products. We account for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable.
Development, regulatory and sales milestones included in our collaboration agreements are considered to be variable consideration. The amount of variable consideration expected to be received is included in the transaction price when it becomes probable that the milestone will be met.
The transaction price under the contract is determined based on the value of the consideration expected to be received in exchange for the transferred assets or services. Development, regulatory and sales milestones included in our collaboration agreements are considered to be variable consideration.
Other income was $4.1 million for the year ended December 31, 2021, and was driven by an unrealized gain recognized related to the Company’s investment in Reneo as well as gains related to the change in fair value of the outstanding warrants held by a related party.
Other Expense, Net Other expense was $0.9 million for the year ended December 31, 2023 and was driven by the recording of an impairment charge on a cost-method investment of $4.2 million offset by a realized gain recognized related to the Company’s Repurchase Agreement with Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.
The significant contributor to the change in cash used during the year was working capital changes offset by $6.8 million of cash received related to contract liabilities as a result from the excess of the fair value of the Class A common stock issued to G42 Investments.
The significant contributor to the change in cash used during the year was working capital changes offset by $6.8 million of cash received related to contract liabilities. Investing Activities For the year ended December 31, 2023, net cash provided by investing activities was driven by the sale of our investments in Reneo.
We have not incurred any significant interest or penalties related to income taxes in any of the periods presented. 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.
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.
Investing Activities For the year ended December 31, 2022, net cash used in investing activities was insignificant. No cash was provided by or used in investing activities for the year ended December 31, 2021.
For the year ended December 31, 2022, net cash used in investing activities was insignificant. Financing Activities For the year ended December 31, 2023, net cash provided by financing activities was driven by the receipt of proceeds of $12.0 million from the G42 Promissory Note early redemption.
Holding Company Structure vTv Therapeutics Inc. is a holding company, and its principal asset is a controlling equity interest in vTv Therapeutics LLC (“vTv LLC”), the principal operating subsidiary.
(“G42”), to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in 450 insulin-using patients with type 2 diabetes. We expect that trial to begin in 2024. Holding Company Structure vTv Therapeutics Inc. is a holding company and its principal asset is a controlling equity interest in vTv Therapeutics LLC (“vTv LLC”), the principal operating subsidiary.
Interest income for the year ended December 31, 2021, was insignificant. Interest Expense, Net Interest expense for the years ended December 31, 2022 and 2021, was insignificant.
Interest income for the year ended December 31, 2022 of $0.4 million is related to the imputed interest on the G42 Promissory Note. 60 Table of Contents Interest Expense Interest expense for the years ended December 31, 2023 and 2022, was insignificant.
Other Income (Expense), Net Other income/expense primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments held in our licensees as well the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock held by related parties. 53 Table of Con tents Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2022, compared to the year ended December 31, 2021.
Other Expense, Net Other expense primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investment held, the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock held by related parties, the loss from the G42 Promissory Note early redemption on February 28, 2023, the impairment charge from Anteris Bio, Inc.
Based on our current operating plan, we believe that our current cash and cash equivalents and proceeds from the G42 promissory note of $12.0 million which was received on February 28, 2023 (see Note 20) will allow us to meet our liquidity requirements through the end of the second quarter of 2023.
Based on our current operating plan, we believe that our current cash and cash equivalents will allow us to meet our liquidity requirements for at least the next twelve months.
See Note 2 “Summary of Significant Accounting Policies”, to the Consolidated Financial Statements in Item 15 of Part IV of this Annual Report on Form 10-K for further information regarding the adoption of ASC 606, “Revenue From Contracts With Customers” and the related changes in the recognition of revenue that were adopted on January 1, 2018.
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.
Lincoln Park Purchase Agreement We have entered into the LPC Purchase Agreement, pursuant to which we have the right to sell to Lincoln Park shares of the Company’s Class A common stock having an aggregate value of up to $47.0 million.
ATM On February 28, 2024, we entered into a sales agreement (the “TD Cowen Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A common stock, having an aggregate offering price of up to $50.0 million (the “TD Cowen ATM Offering”).
Removed
Sekhri was confirmed as a member of the board of directors on August 9, 2022. Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies, experience in several senior business development and strategy roles and he has been a director on more than 30 private, public company and non-profit boards.
Added
Recent Developments Private Placement of Class A Common Shares and Pre-Funded Warrants On February 27, 2024, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Private Placement Investors”), pursuant to which we agreed to issue and sell to the Private Placement Investors in a private placement (the “Private Placement”) (i) an aggregate of 464,377 shares (the “Private Placement Shares”) of our Class A common stock, at a purchase price of $11.81 per share, and (ii) pre-funded warrants (the “Private Placement Pre-Funded Warrants”) to purchase up to an aggregate of 3,853,997 shares of our Class A common stock (the “Private Placement Warrant Shares”) at a purchase price of $11.80 per Private Placement Pre-Funded Warrant (representing the $11.81 per Private Placement Share purchase price less the exercise price of $0.01 per Private Placement Warrant Share).
Removed
On December 13, 2022. the Company announced the appointment of Steven Tuch as Chief Financial Officer effective December 8, 2022. Mr. Tuch brings more than 20 years of financial and business development experience with multiple life science companies during various stages of financial planning and development.
Added
We received aggregate gross proceeds from the Private Placement of approximately $51.0 million, before deducting offering expenses payable by us. The Private Placement Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.
Removed
The following table summarizes our drug candidates, their partnership status and their respective stages of development: Our Type 1 Diabetes Program – TTP399 The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with T1D and has engaged with the FDA on the optimal clinical trial designs for these studies.
Added
Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities registered on the registration statement relating to the TD Cowen ATM Offering with a value exceeding more than one-third of our public float in any 12-month period so long as our public float remains below $75.0 million.
Removed
The studies will recruit a total of approximately 1,000 patients across two studies, and at least one of the studies will be one year of treatment. The FDA and the Company 50 Table of Con tents have agreed on the primary endpoint for the studies as the difference between placebo and TTP399 -treated group in number of hypoglycemia events.
Added
Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements Reverse Stock Split On November 20, 2023, we filed a Certificate of Amendment to the Company’s amended and restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware, which effected a reverse stock split at a ratio of 1-for-40, such that every 40 shares of our Class A common stock, combined into one issued and outstanding share of Class A common stock, and every 40 shares of our Class B common stock, combined into one issued and outstanding share of Class B Common Stock (the "Reverse Stock Split").
Removed
We expect site-specific startup activities and patient enrollment for these pivotal studies to begin in the second half of 2023. In October 2021, we announced positive results of a mechanistic study of TTP399 in patients with T1D.
Added
No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares of Class A common stock and Class B common stock to which a stockholder was entitled resulting from the Reverse Stock Split were rounded up to the nearest whole share.
Removed
The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis.
Added
The Class A common stock began trading on a reverse split-adjusted basis on the Nasdaq on November 21, 2023.
Removed
Consistent with previous clinical studies, improved fasting plasma glucose levels and fewer hypoglycemic events were observed in the TTP399 treated group during the week of treatment prior to the insulin withdrawal test.
Added
Our Class A common stock will continue trading under the symbol “VTVT,” and the new CUSIP number for the Class A common stock following the Reverse Stock Split is 91835204. 56 Table of Contents Our Product Pipeline The following table summarizes our drug candidates, their partnership status and their respective stages of development: Our Type 1 Diabetes Program – Cadisegliatin (TTP399) The U.S.
Removed
The results of the mechanistic study provided additional evidence to support the idea that treatment with TTP399 will not increase the risk of diabetic ketoacidosis (“DKA”) in patients with T1D.
Added
The Breakthrough Therapy designation for cadisegliatin in T1D was supported by the positive results from the Phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of cadisegliatin as an adjunct to insulin therapy in adults with T1D.
Removed
The data demonstrate that in contrast to agents such as SGLT2 inhibitors and GLP‐1RAs, TTP399 does not increase the risk of ketoacidosis when used as an adjunctive therapy to insulin in individuals with T1D.
Added
In this trial, treatment with cadisegliatin resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. Cadisegliatin demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking cadisegliatin than those taking placebo.
Removed
Moreover, these findings support prior studies that demonstrate that TTP399 improves glucose control and reduces hypoglycemia and suggests a protective effect of TTP399 against acidosis in people with T1D. Full study results were published in the Diabetes Obesity and Metabolism journal in conjunction with the 82nd American Diabetes Association Scientific Sessions on June 6, 2022.

… 56 more changes not shown on this page.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+1 added−2 removed1 unchanged
Biggest changeThe goals of our investment strategy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we maintain cash and cash equivalents in a financial institution that management believes to be of high credit quality.
Biggest changeThe goals of our investment strategy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we maintain cash and cash equivalents with multiple financial institutions that management believes to be of high credit quality.
Removed
Foreign Currency Risk We do not have any material foreign currency exposure. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The information required by this Item is included in our Financial Statements and Supplementary Data listed in Item 15 of Part IV of this Annual Report on Form 10-K. ITEM 9.
Added
Foreign Currency Risk We do not have any material foreign currency exposure.
Removed
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.

Other VTVT 10-K year-over-year comparisons