On August 15, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on second quarter ended June 30, 2022, and provided an update on recent corporate developments (Press release, vTv Therapeutics, AUG 15, 2022, View Source [SID1234618363]).
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"I have been with vTv for only about two weeks but the strategic steps that have been taken toward initiating the TTP399 pivotal study and the energy displayed by the team to execute on that program have been truly impressive," said Paul Sekhri, newly appointed Chief Executive Officer of vTv. "I am looking forward to working with our management team and with our new partners, G42 Healthcare and CinRx Pharma, to accomplish our objective of improving the care and quality of life for T1D patients."
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, 2002, 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 $6.0 million paid at closing and the remaining $4.0 million payable on November 22, 2022. vTv will issue a warrant 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 will 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.
Publication. In June, results of a Phase 1 trial that assessed the effects of TTP399 on ketoacidosis risk in individuals with T1D on insulin pump therapy during acute insulin withdrawal was published in Diabetes Obesity and Metabolism (View Source) and presented at The American Diabetes Association’s 82nd Scientific Sessions on June 5, 2022. The results suggested that TTP399 does not increase, and may decrease, the risk of diabetic ketoacidosis (DKA) in subjects with T1D.
Partnership. On May 31, 2022, the Company entered into agreements with G42 Healthcare ("G42") and an affiliate. G42 agreed to acquire $25.0 million in vTv Class A common stock at approximately $2.41 per share with $12.5 million paid at closing and the remaining $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30.0 million in additional shares of Class A common stock to G42 (or cash in lieu of such issuance at the option of G42) if the U.S. Food and Drug Administration (FDA) approves the marketing and sale of a pharmaceutical product containing TTP399. vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories in the Middle East, Africa, and Central Asia.
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 hypoglycemia events. These pivotal studies are expected to start in the fourth quarter of 2022.
Second Quarter 2022 Financial Results
Cash Position: The Company’s cash position as of June 30, 2022, was $17.9 million compared to $13.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $2.2 million and $2.4 million in each of the three months ended June 30, 2022, and 2021, respectively. The decrease of $0.2 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 trial preparation costs.
General & Administrative (G&A) Expenses: G&A expenses were $1.8 million and $2.2 million for each of the three months ended June 30, 2022, and 2021, respectively. The decrease was due to lower payroll costs and lower share-based expense partially offset by higher legal expense and higher other G&A costs.
Other (Expense)/Income: Other expense for the three months ended June 30, 2022, was $0.1 million and was driven by an unrealized loss related to the investment in Reneo as well as the gains 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 June 30, 2021, was $3.8 million and was related to the unrealized gain 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 June 30, 2022, was $3.2 million or $0.04 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $0.6 million or $0.01 per basic share.