On November 9, 2021 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter ended September 30, 2021, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, NOV 9, 2021, View Source [SID1234594988]).
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"We plan to refocus vTv’s strategy on TTP399. TTP399 is unique and the most important product in our portfolio with strong equity value potential to our shareholders", said Deepa Prasad, president and CEO, vTv Therapeutics. "Biotech is about innovation and meeting the unmet medical needs for patients. TTP399 does exactly this in seeking to solve the unmet need for type 1 diabetic patients experiencing hypoglycemic episodes. We are excited the FDA supports our effort by granting us Breakthrough Therapy Designation. Hypoglycemia is the most common acute complication for type 1 diabetes with onset occurring quickly and often without warning. We believe TTP399 can address this critical unmet need for type 1 diabetic patients worldwide."
Recent Achievements and Outlook
Corporate
Leadership. On October 19, 2021, Deepa Prasad was appointed to the role of President and CEO, and joined the board of directors. Deepa is a recognized healthcare leader with more than 20 years of experience across startup funding, operations, investment banking, and healthcare policy. Most recently, Deepa led investments in innovative life science companies as a managing director at West River Group.
Strategic Focus. We plan to implement a strategy to focus our efforts on the continued development of TTP399 as a potential treatment for patients with type 1 diabetes ("T1D") and TTP273 as a potential treatment for patients with cystic fibrosis related diabetes, as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we plan to pause our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, we are also evaluating cost reductions which may include reductions in our workforce.
Balance Sheet. The Company strengthened its balance sheet during the quarter through utilization of the at-the-market equity program with Cantor Fitzgerald, ending the quarter with $19.6 million of cash, cash equivalents and marketable securities.
Type 1 Diabetes
Mechanistic Study of Ketoacidosis with TTP399. In October 2021, the Company announced positive results from the mechanistic study of TTP399 in people with type 1 diabetes. Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating that treatment with TTP399 presents no increased risk of ketoacidosis. In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 SimpliciT1 Study results.
Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes and is engaged with the FDA on the optimal clinical trial designs for these studies. The Company expects to begin these pivotal studies in the first half of 2022.
Third Quarter 2021 Financial Results
Cash Position: The Company’s cash position as of September 30, 2021, was $19.6 million compared to $10.8 million as of June 30, 2021.
Revenue: Revenue for the third quarter of 2021 was $3.0 million, attributable to the satisfaction of milestones under the license agreements with Newsoara Biopharma Co., Ltd. and Reneo Pharmaceuticals, Inc. Revenue for the second quarter of 2021 was an insignificant amount.
R&D Expenses: Research and development expenses were $2.4 million in each of the three months ended September 30, 2021 and June 30, 2021, respectively.
G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million for each of the three months ended September 30, 2021 and June 30, 2021.
Other Income/(Expense): Other expense for the three months ended September 30, 2021 was $0.2 million and was attributable to the gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the "Related Party Warrants") offset by losses driven by the decrease in the fair value of our investment in Reneo Pharmaceuticals, Inc. (the "Reneo Investment"). Other income for the three months ended June 30, 2021 of $3.8 million was driven by changes in value of the Reneo Investment and gains related to the reduction in fair value of the Related Party Warrants.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $1.5 million for the third quarter of 2021 compared to net loss before non-controlling interest of $0.8 million for the second quarter of 2021.
Net Loss Per Share: Diluted net loss per share was ($0.02) for the three months ended September 30, 2021 compared to diluted net loss per share of ($0.01) for the three months ended June 30, 2021, based on weighted-average diluted shares of 61.1 million and 58.6 million for the three-month periods ended September 30, 2021 and June 30, 2021, respectively.