HIGH POINT, N.C., May 09, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT), a clinical stage biopharmaceutical company focused on the development of an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today reported financial results for the first quarter ended March 31, 2024, and provided an update on recent corporate developments. "The first quarter of 2024 saw us reach several important milestones, which we believe position vTv well for continued execution of our corporate and clinical development strategy," said Paul Sekhri, Chief Executive Officer of vTv. "The proceeds of the private placement we announced at the end of February are expected to fully fund the first Phase 3 study of cadisegliatin in patients with T1D, for which we expect to report top line data in the first quarter of 2026. Site activation activities for this trial are well underway and we continue to expect enrollment of the first patient during the second quarter. We believe that the body of evidence generated to-date, including the data from the Phase 2 SimpliciT-1 study provides a compelling scientific rationale supporting the potential of cadisegliatin as an adjunctive therapy to insulin for the treatment of this highly prevalent disease. In parallel with the upcoming launch of this Phase 3 study, we are in the planning stages for two international registrational trials of cadisegliatin in T1D which we expect to initiate in 2026. We are also continuing our close collaboration with G42 Investments to support the launch of the planned Phase 2 trial in the Middle East, evaluating cadisegliatin in 450 T2D patients currently on insulin therapy. That trial remains on-track to commence in the second half of 2024." Recent Company Highlights Significantly strengthened the Company's balance sheet through a $51 million private placement with healthcare-focused institutional investors and the JDRF T1D Fund. The proceeds of the private placement are expected to fund the continued development of cadisegliatin through top-line data from the first Phase 3 study, which is anticipated by the first quarter of 2026. On March 4, 2024, the Company announced the submission to the FDA of the protocol for the first Phase 3 clinical trial of cadisegliatin in patients with T1D. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 150 patients at up to 20 sites in the U.S., with the first patient expected to be enrolled in the second quarter. It will assess two doses of cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use continuous glucose monitoring. The primary efficacy endpoint of the study is the incidence of Level 2 or Level 3 hypoglycemic events. First Quarter 2024 Financial Results Cash Position: The Company's cash position as of March 31, 2024, was $52.3 million compared to $9.4 million as of December 31, 2023. The increase is attributed to receipt of the proceeds from the private placement financing on February 27, 2024. Research & Development (R&D) Expenses: R&D expenses were $2.6 million and $3.9 million in each of the three months ended March 31, 2024, and 2023, respectively. The decrease of $1.3 million is primarily attributable to lower spending on cadisegliatin, due to decreases in i) toxicity study costs and drug manufacturing related costs, partially offset by increases in clinical trial start-up costs and ii) an increase in indirect costs and other projects. General & Administrative (G&A) Expenses: G&A expenses were $4.0 million and $3.5 million for each of the three months ended March 31, 2024, and 2023, respectively. The increase of $0.5 million was primarily due to increases in legal expense and higher payroll costs offset by lower other G&A costs and share-based expense. Other (Expense)/Income: Other expense for the three months ended March 31, 2024, was $0.4 million and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties. Other income for the three months ended March 31, 2023, was $1.6 million and was driven by an unrealized gain related to our investment in Reneo, losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties and the loss from the G42 promissory note early redemption. Net Loss: Net loss attributable to vTv shareholders for the three months ended March 31, 2024, was $4.9 million or $1.17 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $4.5 million or $2.16 per basic share. vTv Therapeutics Inc.Condensed Consolidated Balance Sheets(in thousands)   March 31,2024   December 31,2023   (Unaudited)     Assets       Current assets:       Cash and cash equivalents $ 52,255     $ 9,446   Accounts receivable   981       102   Prepaid expenses and other current assets   571       1,044   Current deposits   65       65   Total current assets   53,872       10,657   Property and equipment, net   95       117   Operating lease right-of-use assets   216       244   Total assets $ 54,183     $ 11,018   Liabilities, Redeemable Noncontrolling Interest and Stockholders' Equity (Deficit)       Current liabilities:       Accounts payable and accrued expenses $ 8,731     $ 10,242   Current portion of operating lease liabilities   173       169   Current portion of contract liabilities