vTv Therapeutics Inc. (NASDAQ:VTVT) Files An 8-K Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition
Information in Item 8.01 under the heading ATM Offering Update regarding our current liquidity is incorporated by reference in this item 2.02.
Item 8.01 Other Events
TTP399 – FDA Type C Meeting Responses and Development Plan Updates
On September 24, 2020, the FDA provided additional written responses to vTv Therapeutics Inc. (the “Company”) in connection with the Company’s pivotal study development plans for TTP399 as an oral adjunct therapy to insulin for people with type 1 diabetes. Based upon the responses provided, the Company plans to conduct a placebo-controlled six-month clinical trial in approximately 400 subjects, followed by a second placebo-controlled six-month clinical trial to be initiated nine to twelve months after initiation of the first pivotal trial. The Company would also include a six-month open label extension in the first clinical trial to provide patient data of the necessary duration to support the safety and efficacy of TTP399. In its response, the FDA confirmed that the effect size of TTP399 on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of a therapy for the treatment of type 1 diabetes. The Company is planning to initiate a mechanistic study of TTP399 in the first quarter of 2021 in a small number of patients with type 1 diabetes to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. The Company proposed the mechanistic study to the FDA, and the FDA recommended that the study be performed in support of the planned pivotal trials. The results of this mechanistic study will provide additional evidence to demonstrate the effects of TTP399 on diabetic ketoacidosis (“DKA”) in patients with type 1 diabetes.
Azeliragon – Elevage Study Update
On September 30, 2020, the Company concluded enrollment of the Elevage Study of azeliragon. Forty-three (43) patients with mild probable Alzheimer’s disease and type 2 diabetes were enrolled in the study. The study is designed to evaluate the effect of six-months of treatment with azeliragon on cognitive performance. The Company plans to report top-line results for substantially all of the enrolled patients during December 2020, earlier than previously expected. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer’s disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).
ATM Offering Update
As previously reported, on April 24, 2020, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), to which the Company may offer and sell, from time to time, through or to Cantor Fitzgerald, as sales agent or principal, shares of the Company’s Class A common stock, par value $0.01 per share, having an aggregate offering price of up to $13.0 million (the “ATM Offering”). During the nine months ended September 30, 2020, the Company sold 3,847,405 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $10.2 million.
In connection with the on-going activities under the ATM Offering, the Company is reporting its estimated liquidity sources as of September 30, 2020. As of the close of the quarter, the Company has estimated liquidity sources that include cash and cash equivalents of $1.8 million and $3.0 million of remaining funds that have not been drawn under the letter agreement dated December 23, 2019 between the Company and MacAndrews and Forbes Group LLC. Further, the Company has remaining availability of approximately $2.8 million under the ATM Offering to which the Company may offer and sell, from time to time, shares of the Company’s Class A Common Stock at then current market prices.
Estimated liquidity is subject to revision as we prepare our financial statements and other disclosures as of and for the quarter ended September 30, 2020, including all disclosures required by GAAP. Because we have not completed our quarterly closing and review procedures for the quarter ended September 30, 2020, and subsequent events may occur that require adjustments to these results, the final results and other disclosures for the quarter ended September 30, 2020 may differ materially from these estimates. These estimates should not be viewed as a substitute for full financial statements prepared in accordance with GAAP.
About vTv Therapeutics Inc. (NASDAQ:VTVT)
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in the discovery and development of orally administered small molecule drug candidates. Its drug candidate for the treatment of Alzheimer’s disease (AD) is azeliragon (TTP488), an orally administered, small molecule antagonist targeting the receptor for advanced glycation endproducts (RAGE), for which it has commenced patient enrollment in a Phase III clinical trial. Its type II diabetes drug candidates include TTP399, an orally administered, liver-selective glucokinase activator (GKA), for which it has completed enrollment in its Phase IIb clinical trial, and TTP273, an orally administered, non-peptide agonist that targets the glucagon-like peptide-1 receptor (GLP-1r), for which it began enrollment in a Phase II clinical trial. It has over three additional programs in various stages of clinical development for the prevention of muscle weakness and the treatment of inflammatory disorders.