On May 7, 2020 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the first quarter ended March 31, 2020, and provided an update on recent clinical achievements (Press release, vTv Therapeutics, MAY 7, 2020, View Source [SID1234557294]).
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"In spite of the challenges presented by the COVID-19 pandemic, we are encouraged by the continued progress we made this past quarter with our two key late stage clinical programs for TTP399 for the treatment of type 1 diabetes and azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes," said Steve Holcombe, chief executive officer. "With respect to TTP399, we are engaging with the FDA regarding our proposed pivotal study development plan to seek regulatory approval for this oral adjunct therapy to insulin. Additionally, we continue to enroll patients in the Elevage study of azeliragon and are considering various strategies to maintain our expected timelines for announcing certain study results in the first half of next year."
Recent Achievements and Outlook
Type 1 Diabetes Study
Full results from the SimpliciT-1 Study to be presented at ADA. We will present posters detailing further results from the phase 2 Simplici-T1 Study of TTP399 in patients with type 1 diabetes at the 80th Scientific Sessions held virtually by the American Diabetes Association, June 12-16th.
Alzheimer’s Disease Study
Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv Therapeutics continues to enroll patients in the Phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (AD) and type 2 diabetes.
Financing Activities
During April, we entered into a pair of agreements in order to provide additional financial flexibility and availability of additional capital to fund our operations.
Amendment to the Loan Agreement. On April 1, 2020, we entered into the Second Amendment to our existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for three months beginning April 1, 2020 before reverting to the previous payment schedule. The Second Amendment also removes the requirement for the Company to maintain a minimum cash balance for the three months beginning April 1, 2020. Thereafter, the Company must maintain a minimum cash balance amount of up to $1.0 million.
ATM Offering. On April 24, 2020, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald under which we may offer and sell, from time to time, shares of our Class A common stock having an aggregate offering price of up to $13.0 million.
First Quarter 2020 Financial Results
Cash Position: The Company’s cash position as of March 31, 2020, was $2.9 million compared to $4.3 million as of December 31, 2019. Of these amounts, $2.5 million was restricted due to the requirements of its Loan Agreement. However, the requirement to maintain this level of minimum cash was temporarily eliminated effective April 1, 2020 in connection with the Second Amendment to the Loan Agreement discussed above.
Revenue: Revenues were insignificant for both the first quarter of 2020 and the fourth quarter of 2019.
R&D Expenses: Research and development expenses were relatively consistent between periods with $4.2 million in the first quarter of 2020 and $4.4 million in the fourth quarter of 2019.
G&A Expenses: General and administrative expenses were $2.5 million for the first quarter of 2020 and $2.0 million for the fourth quarter of 2019, respectively. The increase in these costs was primarily attributable to increased professional and legal fees incurred in the first quarter of 2020.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $7.2 million for the first quarter of 2020 compared to $6.9 million for the fourth quarter of 2019.
Net Loss Per Share: GAAP net loss per share was $0.11 and $0.13 for the three months ended March 31, 2020 and December 31, 2019, respectively, based on weighted-average shares of 43.5 million and 38.0 million for the three-month periods ended March 31, 2020 and December 31, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.11 for each of the three months ended March 31, 2020 and December 31, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 66.6 million and 61.0 million for the three months ended March 31, 2020 and December 31, 2019, respectively.