vTv Therapeutics Inc. (NASDAQ:VTVT) is a clinical-stage pharmaceutical company focused on treating metabolic and inflammatory diseases. The company has an innovative pipeline of first-in-class small molecule drug candidates, with its lead program being 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).
Business Overview
vTv Therapeutics was incorporated in the state of Delaware in April 2015 and is the principal operating subsidiary of vTv Therapeutics Inc., the publicly traded holding company. The company is engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs.vTv's lead program, cadisegliatin (TTP399), has received Breakthrough Therapy designation from the FDA for use as an adjunctive therapy to insulin for the treatment of T1D. This designation provides the company with added support and the potential to expedite development and review timelines. The positive results from the Phase 2 SimpliciT-1 study, which showed a statistically significant improvement in HbA1c and a clinically meaningful decrease in the frequency of severe and symptomatic hypoglycemia, supported the Breakthrough Therapy designation.
Encouraged by the FDA's recent draft guidance permitting the use of hypoglycemia as an endpoint to support a label claim, vTv has initiated a Phase 3 trial to assess the effect of cadisegliatin on reducing the frequency of Level 2 and Level 3 hypoglycemia in patients with T1D. The company expects to complete enrollment for this trial by the fourth quarter of 2024 and report top-line 1-year data by the first quarter of 2026. Concurrently, vTv is working on the design for two international registrational studies for cadisegliatin in T1D, which are expected to start in 2026.
In addition to the T1D program, vTv is collaborating with its partner, G42 Investments AI Holding RSC Ltd., to initiate a double-blind, randomized, controlled Phase 2 trial of cadisegliatin in insulin-using patients with type 2 diabetes in the Middle East region. That trial is expected to begin in 2024.
Financials
To date, vTv Therapeutics has not generated any revenue from drug sales. The company's revenue has been primarily derived from milestone payments, upfront proceeds, and research fees under collaboration and license agreements. For the year ended December 31, 2023, the company reported annual net income of -$20.25 million, annual revenue of $0, annual operating cash flow of -$18.515 million, and annual free cash flow of -$18.515 million.For the three months ended March 31, 2024, vTv reported revenue of $1.0 million, which included a $1.0 million increase to the transaction price for the license performance obligation under the Newsoara License Agreement due to the satisfaction of a development milestone. The company's research and development expenses for the quarter were $2.6 million, while general and administrative expenses were $4.0 million, resulting in a net loss of $4.9 million.
Liquidity
As of March 31, 2024, vTv Therapeutics had cash and cash equivalents of $52.3 million. The company believes its current cash and cash equivalents will allow it to meet its liquidity requirements for at least the next twelve months.In February 2024, vTv closed a private placement financing of up to $51.0 million, which will allow the company to further advance its lead program, cadisegliatin. Additionally, in February 2024, the company entered into a sales agreement with Cowen and Company, LLC, under which it may offer and sell up to $50.0 million of its Class A common stock, subject to certain limitations.
Risks and Challenges
As a clinical-stage pharmaceutical company, vTv Therapeutics faces several risks and challenges, including the uncertainty of the success and timing of its clinical trials, the ability to obtain regulatory approvals, the potential for competition from other therapies, and the need for additional capital to fund its operations and development activities.The company's ability to generate revenue is dependent on the successful development and commercialization of its drug candidates, particularly cadisegliatin. Any delays or setbacks in the clinical development of cadisegliatin could have a material adverse impact on the company's financial condition and results of operations.
Additionally, vTv Therapeutics operates in a highly competitive industry, and it may face competition from larger, more established pharmaceutical companies with greater resources and expertise. The company's success will depend on its ability to differentiate its drug candidates and demonstrate their superiority over existing or future treatments.