On November 10, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D) reported financial results for the third quarter ended September 30, 2022, and provided an update on recent corporate developments (Press release, vTv Therapeutics, NOV 10, 2022, View Source [SID1234623829]).
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"During the third quarter, we continued working diligently toward the commencement of TTP399 Phase 3 clinical trials, which we expect to initiate in 1Q2023," said Paul Sekhri, Chief Executive Officer of vTv. "We intend to submit final protocols to the US Food and Drug Administration (FDA) in the coming weeks, with site-specific startup activities and patient enrollment starting the first quarter of 2023. Through our recently signed partnerships with CinRx and G42, I believe that we are well equipped to further advance the clinical development of TTP399 and move closer to realizing our goal of improving care and quality of life for patients with T1D."
Recent Achievements
Leadership. On July 27, 2022, the Company appointed Paul Sekhri as President, Chief Executive Officer (CEO) effective August 1, 2022, and was confirmed as a member of the board of directors on August 9, 2022. Mr. Sekhri brings nearly 30 years of healthcare industry 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.
Partnership. On July 25, 2022, the Company entered into agreements with CinRx Pharma and its subsidiary, CinPax. CinPax agreed to acquire $10.0 million in vTv Class A common stock at approximately $2.41 per share with $6 million paid at closing and the remaining $4.0 million payable on November 22, 2022. vTv will issue warrants to CinRx to acquire 1.2 million additional shares of Class A common stock at an exercise price of approximately $0.72 per share that become exercisable upon agreed vesting triggers. In addition, the agreements set forth terms under which vTv will leverage the CinRx team’s industry experience to collaborate on the oversight of the clinical trials for pharmaceutical products that contain TTP399.
Upcoming Milestones and Events
Pivotal Study Planning. 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. The studies will recruit a total of approximately 1,000 patients and at least one of the studies will be one year of treatment. The FDA and the Company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemic events. These pivotal studies are expected to start in the first quarter of 2023.
Third Quarter 2022 Financial Results
Cash Position: The Company’s cash position as of September 30, 2022, was $15.3 million compared to $13.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $3.1 million and $2.4 million in each of the three months ended September 30, 2022, and 2021, respectively. The increase of $0.7 million is attributable to a decrease in clinical trial costs for azeliragon, which was mainly driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes and a decrease in spending related to a multiple ascending dose study for HPP737, due to its completion in 2021, offset by higher spending on TTP399 due to drug product related costs and trial preparation costs.
General & Administrative (G&A) Expenses: G&A expenses were $2.6 million and $2.2 million for each of the three months ended September 30, 2022, and 2021, respectively. The increase was due to higher legal expense and higher other G&A costs offset by lower payroll costs.
Other (Expense)/Income: Other expense for the three months ended September 30, 2022, was $0.1 million and was driven by an unrealized gain related to the 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 own stock issued to a related party ("Related Party Warrants"). Other income for the three months ended September 30, 2021, was $0.2 million and was related to the unrealized loss recognized related to the investment in Reneo as well as gains related to the change in the fair value of the outstanding warrants in our own stock held by a related party.
Net Loss: Net loss attributable to vTv shareholders for the three months ended September 30, 2022, was $4.3 million or $0.05 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $1.1 million or $0.02 per basic share.