On October 30, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter that ended September 30, 2019, and provided an update on recent achievements, events, and its ongoing clinical trials in type 1 diabetes and Alzheimer’s disease (Press release, vTv Therapeutics, OCT 30, 2019, View Source [SID1234550092]).
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"We hosted an informative type 1 diabetes key opinion leader event with JDRF this quarter where two prominent KOLs, Drs. John Buse and Kevan Herold, shared important information including that, despite the increasingly widespread use of improved technologies like continuous glucose monitoring, nearly 80% of individuals with type 1 diabetes fail to achieve the American Diabetes Association’s target goals for HbA1c," said Steve Holcombe, chief executive officer, vTv Therapeutics. "Based on the data we’ve seen to date in our trial of TTP399 in patients with type 1 diabetes, we believe our glucokinase activator could eventually provide a meaningful treatment option to patients with type 1 diabetes that would lower A1c, improve glycemic control and reduce daily insulin use, without increasing hypoglycemic events."
"We are also pleased that we are continuing to make progress with the Elevage Study of azeliragon in patients with mild Alzheimer’s disease with type 2 diabetes that is expected to read-out in late 2020 or early 2021."
Recent Achievements and Outlook
Type 1 Diabetes Study
Completed enrollment for Part 2 of the Simplici-T1 Study. In September 2019, we completed enrollment of patients in part 2 of the phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an adjunct to insulin therapy for patients with type 1 diabetes. We expect to report results in the latter part of the first quarter of 2020.
Presented Additional Positive Data from Part 1 of the Simplici-T1 Study. In September 2019, we presented positive continuous glucose monitor (CGM) and insulin dose data from the patients with complete CGM profiles from part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes. In addition to the previously presented topline improvement in HbA1c of 0.7% relative to placebo, key results from this presentation included:
Patients taking TTP399 treatment (n=6) had increased "Time in Range" from baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day (24 hours), and by 12% (1.7 hours) (p=0.04) during the critical waking hours (7am-9pm) relative to placebo (n=9).
Patients taking TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving glycemic control.
Patients in the TTP399 treatment group experienced fewer Level 1 (≥54-70 mg/dl) and Level 2 (<54 mg/dl) hypoglycemic events than patients in the placebo group.
Alzheimer’s Disease Study
Enrollment continues for Phase 2/3 Elevage Study of azeliragon. We began enrolling 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.
The Elevage Study is designed to confirm the positive post-hoc subgroup results from the previous phase 3 study of azeliragon in patients with mild Alzheimer’s disease in which the subgroup of AD patients with type 2 diabetes (defined by an HbA1c of greater than 6.5% at any time in the study) treated with azeliragon demonstrated a potential benefit in both cognition and function relative to those treated with placebo.
The phase 2 part of the Elevage Study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive). We expect to report topline results from the phase 2 proof of concept study by late 2020 or early 2021.
Recent Events
Hosted Key Opinion Leader (KOL) Event to Discuss the Type 1 Diabetes Landscape and Emerging Therapies as Adjuncts to Insulin. In October, vTv hosted a KOL event to provide an opportunity to learn more about type 1 diabetes. Dr. John Buse, UNC-CH; Dr. Kevan Herold, Yale University; Dr. Esther Latres, JDRF International; and Dr. Carmen Valcarce, vTv Therapeutics, presented to a diverse audience of analysts, investors, and members of the type 1 diabetes community. The KOLs reported that patients with type 1 diabetes have a serious, unmet need for an adjunct to insulin treatment.
An archived version of the event can be found here.
Second Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents as of September 30, 2019, were $2.4 million compared to $1.5 million as of June 30, 2019.
Revenue: Revenues were not material for the third quarter of 2019 versus $1.8 million in the second quarter of 2019. Revenue recognized in the second quarter of 2019 was due to a milestone recognized under our license agreement with Newsoara and the continued amortization of revenue from our license agreement with Reneo over the transfer services period.
R&D Expenses: Research and development expenses were $3.7 million in the third quarter of 2019 and $4.2 million in the second quarter of 2019. The decrease in these costs
was driven primarily by the decreases in costs for the Elevage Study. Such costs were higher in the second quarter of 2019 as we were performing startup activities related to the sites and initiation of patient enrollment.
G&A Expenses: General and administrative expenses were $1.8 million and $2.4 million in each of the third and second quarters of 2019, respectively. The decrease in these costs is related to the recognition of a gain on the sale of laboratory equipment in the third quarter of 2019 as well as overall lower spending in the quarter.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $6.0 million for the third quarter of 2019 compared to net loss before non-controlling interest of $5.1 million for the second quarter of 2019.
Net Loss Per Share: GAAP net loss per share was $0.13 and $0.10 for the three months ended September 30, 2019 and June 30, 2019, respectively, based on weighted-average shares of 32.1 million and 28.0 million for the three month periods ended September 30, 2019 and June 30, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.10 and $0.09 for the three months ended September 30, 2019 and June 30, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 55.2 million and 51.1 million for the three months ended September 30, 2019 and June 30, 2019, respectively.