vTv Therapeutics Announces Q2 2024 Financial Results and Corporate Update

vTv Therapeutics Inc., a late-stage biopharmaceutical company listed on Nasdaq under the ticker VTVT, has reported its financial outcomes for Q2 2024, ending June 30, and provided updates on its corporate progress. The company focuses on innovative small molecule drugs, with a leading program aimed at treating diabetes.

Paul Sekhri, the Chairman, President, and CEO of vTv Therapeutics, highlighted the company's ongoing advancements across both partnered and internally driven programs. A notable development is the amendment of their licensing agreement with Newsoara Biopharma for the PDE4 inhibitor HPP737, which now covers a global scope upon payment of a $20 million upfront fee.

In June, vTv Therapeutics began screening patients for its CATT1 pivotal trial, which evaluates cadisegliatin as an adjunct therapy for type 1 diabetes (T1D). This trial is part of a series intended to support the future regulatory submission of cadisegliatin, an innovative, liver-selective glucokinase activator. However, in July, the FDA placed a clinical hold on the cadisegliatin program due to an unresolved chromatographic signal detected in a recent ADME study. The FDA requires an in vitro study to characterize this signal before the program can continue. No patients had been dosed in the CATT1 study at the time of the hold, and prior studies had shown no significant safety concerns. vTv Therapeutics is actively working with the FDA to resolve the issue. Cadisegliatin has been granted Breakthrough Therapy designation by the FDA for T1D, showing potential to improve glycemic control and reduce hypoglycemia in diabetic patients.

In another significant update, vTv Therapeutics expanded its license agreement with Newsoara Biopharma for HPP737 to a global scale upon the receipt of the $20 million upfront fee. The agreement includes up to $41 million in developmental milestones, $35 million in sales-related milestones, and mid to upper single-digit royalties based on sales.

Additionally, Cantex Pharmaceuticals announced in May that the FDA has granted Orphan Drug Designation to azeliragon, a RAGE antagonist, for treating pancreatic cancer. Azeliragon has also received this designation for glioblastoma treatment. Under its agreement with Cantex, vTv Therapeutics could acquire 20-40% of out-licensing income or the fair value of the program if Cantex is sold, or 20% of Cantex’s net profit from commercial sales. Azeliragon is currently being tested in several Phase 2 cancer trials and a Phase 3 trial for acute kidney injury.

Financial results for Q2 2024 show an increase in the company’s cash position, reaching $45.5 million as of June 30, 2024, up from $9.4 million at the end of 2023. This increase is mainly due to proceeds from private placement financing received on February 27, 2024. Research and Development (R&D) expenses decreased to $3.4 million from $4.7 million in the same period in 2023, primarily due to lower costs related to cadisegliatin. General & Administrative (G&A) expenses rose slightly to $3.7 million from $3.3 million, driven by higher share-based, legal, and payroll costs. Other income for Q2 2024 was $0.2 million, influenced by gains related to warrant value changes. The net loss attributable to vTv shareholders for Q2 2024 was $5.2 million, or $0.81 per basic share, compared to $5.6 million, or $2.69 per basic share, for the same period a year ago.

vTv Therapeutics Inc. continues to focus on developing oral, small molecule drug candidates, with ongoing investigations into treatments for both type 1 and type 2 diabetes and other chronic conditions.