On November 5, 2020 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter ended September 30, 2020, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, NOV 5, 2020, View Source [SID1234570084]).

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"Following our decision to conclude enrollment in the Elevage Study at the end of September, we look forward to announcing topline results from this phase 2 study of azeliragon in December," said Steve Holcombe, president and CEO. "In addition, we are planning a mechanistic study of TTP399 to start early in the new year to better understand its impact on diabetic ketoacidosis. Finally, we are planning a phase 1 study of our PDE4 inhibitor compound, HPP737, as an initial step towards a proof-of-concept study in psoriasis. We expect to report topline results from both the mechanistic study of TTP399 and the phase 1 study of HPP737 during the second quarter of 2021."

Recent Achievements and Outlook

Type 1 Diabetes

FDA Engagement and Pivotal Study Planning. vTv continued its dialogue with the FDA during the third quarter surrounding the design and endpoints of its planned pivotal studies of TTP399 as an adjunct to insulin therapy for type 1 diabetes. Based upon the FDA’s feedback, 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 FDA also 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.

Development of Mechanistic Study of Ketoacidosis. To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv plans to conduct a mechanistic study 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. vTv expects the mechanistic study to be initiated in the first quarter of 2021 and to report topline results in the second quarter of 2021.

Two Oral Presentations at EASD of SimpliciT-1 Study Results. Members of vTv’s TTP399 clinical development team, including Chief Scientific Officer Dr. Carmen Valcarce, presented additional data at the 56th Annual European Association for the Study of Diabetes on the effects of TTP399 on hypoglycemia and ketone body formation from the positive SimpliciT-1 Study.
Dementia with Diabetes

Enrollment concluded for Phase 2 Elevage Study of azeliragon. On September 30, vTv concluded enrollment of patients in the Elevage Study. 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).

Elevage Study Update to be Presented at CTAD. Dr. Ann Gooch presented an update on the Elevage Study focusing on the demographic and baseline characteristics data of enrolled subjects at the 13th Clinical Trials on Alzheimer’s Disease conference on November 4, 2020.
Psoriasis

Multiple Ascending Dose Study with HPP737. The Company is planning a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. vTv expects to initiate the study in the first quarter of 2021 and to report topline results in the second quarter of 2021.
Third Quarter 2020 Financial Results

Cash Position: The Company’s cash position as of September 30, 2020, was $1.8 million compared to $6.4 million as of June 30, 2020.

Revenue: Revenues were insignificant for both the second and third quarters of 2020.

R&D Expenses: Research and development expenses were $1.8 million and $2.5 million for the three months ended September 30, 2020 and June 30, 2020, respectively. This decrease of $0.7 million was driven primarily by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

G&A Expenses: General and administrative expenses were $1.1 million for the third quarter of 2020 and $1.7 million for the second quarter, respectively. The decrease of $0.6 million was driven by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the third quarter of 2020 compared to $5.0 million for the second quarter of 2020.

Net Loss Per Share: GAAP net loss per share was $0.03 and $0.07 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on weighted-average shares of 48.2 million and 45.7 million for the three-month periods ended September 30, 2020 and June 30, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.02 and $0.08 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 71.3 million and 68.8 million for the three months ended September 30, 2020 and June 30, 2020, respectively.