vTv Therapeutics Reports Q1 2024 Financial Results and Corporate Update

vTv Therapeutics Inc., a clinical-stage biopharmaceutical company based in HIGH POINT, N.C., recently shared its financial outcomes for the first quarter ending March 31, 2024, along with significant corporate progress. The company, listed on Nasdaq under the ticker VTVT, focuses on developing cadisegliatin, an adjunctive therapy to insulin for treating type 1 diabetes (T1D).

Paul Sekhri, the CEO of vTv, highlighted several milestones achieved during the first quarter of 2024, which he believes will facilitate the company's ongoing corporate and clinical development strategy. A key highlight was the substantial funding from a private placement concluded at the end of February. This funding is projected to support the first Phase 3 study of cadisegliatin in T1D patients, with top-line data expected in early 2026. Preparations for initiating this trial are progressing, with patient enrollment anticipated to start in the second quarter.

The company remains optimistic about cadisegliatin's potential, supported by data from earlier studies, including the Phase 2 SimpliciT-1 study. Alongside the Phase 3 study in the U.S., plans are being laid out for two international registrational trials of cadisegliatin in T1D, expected to commence in 2026. Additionally, vTv is collaborating closely with G42 Investments to launch a Phase 2 trial in the Middle East, targeting 450 type 2 diabetes (T2D) patients on insulin therapy. This trial is on track to begin in the latter half of 2024.

Recent corporate highlights include a $51 million private placement involving healthcare-focused institutional investors and the JDRF T1D Fund. This funding is anticipated to support cadisegliatin's continued development through the first Phase 3 trial's top-line data release in early 2026.

On March 4, 2024, vTv submitted the protocol for the first Phase 3 clinical trial of cadisegliatin to the FDA. This randomized, double-blind, placebo-controlled study aims to enroll about 150 patients across up to 20 U.S. sites. The trial will compare two doses of cadisegliatin against a placebo in T1D patients who are already on multiple daily insulin injections and continuous subcutaneous insulin infusion, using continuous glucose monitoring. The main efficacy endpoint is the incidence of Level 2 or Level 3 hypoglycemic events.

For the first quarter of 2024, vTv reported a cash position of $52.3 million as of March 31, 2024, a significant increase from $9.4 million on December 31, 2023. This improvement is attributed to the private placement financing proceeds received on February 27, 2024.

Research and Development (R&D) expenses for the quarter were $2.6 million, down from $3.9 million in the same period in 2023. This reduction is mainly due to decreased spending on cadisegliatin, particularly in toxicity study costs and drug manufacturing costs, partially offset by higher clinical trial start-up costs and other indirect expenses.

General and Administrative (G&A) expenses rose to $4.0 million from $3.5 million in the previous year, primarily due to increased legal expenses and higher payroll costs, despite lower other G&A costs and share-based expenses.

Other expenses for the quarter amounted to $0.4 million, driven by losses from changes in the fair value of outstanding warrants. Conversely, the same period in 2023 saw an income of $1.6 million, attributed to an unrealized gain from an investment in Reneo and losses related to warrant value changes and a G42 promissory note early redemption.

The net loss attributable to vTv shareholders for Q1 2024 was $4.9 million, equating to $1.17 per basic share, compared to a net loss of $4.5 million or $2.16 per basic share the previous year.

vTv Therapeutics Inc. continues to focus on developing oral, small molecule drug candidates, with a pipeline led by cadisegliatin, a potential adjunctive therapy to insulin for T1D treatment. The company and its development partners are also exploring additional indications, including T2D and other chronic conditions.