On November 1, 2017 vTv Therapeutics Inc. (vTv Therapeutics) (Nasdaq:VTVT) reported a corporate update and reported financial and operational results for the third quarter ended September 30, 2017 (Press release, vTv Therapeutics, NOV 1, 2017, View Source [SID1234521445]).
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“We’ve made significant progress in the third quarter of 2017 across our strategic initiatives, and we attribute that to our ongoing development of innovative therapies, particularly in the areas of Alzheimer’s and diabetes,” said Steve Holcombe, president and CEO of vTv Therapeutics. “We look forward to building on this momentum as we approach several important milestones next year, including the Part A readout out of our Phase 3 STEADFAST Study of azeliragon in patients with mild Alzheimer’s disease.”
Third Quarter 2017 Highlights
Issuance of U.S. Patent Covering Methods of Treatment Using Azeliragon
The U.S. Patent and Trademark Office issued patent number 9,717,710 (‘710 Patent) with claims protecting methods of treatment using azeliragon, vTv Therapeutics’ oral antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) for treatment of mild Alzheimer’s disease. The ‘710 Patent, expiring in October 2034, includes claims covering methods of treating patients with mild Alzheimer’s disease by administering about 5 mg per day of azeliragon.
2017 Alzheimer’s Association International Conference
In two poster presentations titled, “Assessment of Azeliragon QTc Liability through Integrated, Model-Based Concentration QTc Analysis” and “Effect of Food on the Pharmacokinetics of Azeliragon in Healthy Adult Subjects,” vTv Therapeutics’ researchers reviewed study data that indicated no deleterious effect of azeliragon on QT at therapeutic and supra-therapeutic doses and that azeliragon may be given without regard to meals.
vTv Therapeutics and JDRF Enter Into Industry Partnership
JDRF, the leading global organization funding type 1 diabetes (T1D) research, committed $3 million in funding, matched by vTv Therapeutics, to support a Phase 2 Proof of Concept study to explore the effect of vTv Therapeutics’ liver-selective glucokinase activator TTP399 as an oral drug for the treatment of T1D. The study will evaluate whether TTP399 is well tolerated when administered as an add-on to insulin therapy for people with T1D and whether TTP399 has the potential to significantly improve daily glucose profiles and HbA1c.
53rd European Association for the Study of Diabetes Annual Meeting
In a poster presentation titled “Beyond topline results for the oral (non-peptide) GLP-1R agonist TTP273 in type 2 diabetes: How much and when?” vTv Therapeutics’ researchers reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight, and fasting plasma glucose.
Upcoming Anticipated Milestones
STEADFAST Study (azeliragon in patients with mild Alzheimer’s disease): Expected to report top-line results from each of the Part A and Part B studies in early 2018 and late 2018, respectively.
Third Quarter 2017 Financial Results
Cash Position: Cash and cash equivalents as of September 30, 2017 were $20.5 million compared to $32.5 million as of June 30, 2017.
R&D Expenses: Research and development expenses were $9.0 million in the third quarter of 2017, compared to $9.6 million in the second quarter of 2017. The decrease in research and development expenses was primarily driven by decreases in spending for the STEADFAST Study due to the relative costs of patient visits.
G&A Expenses: General and administrative expenses were $2.6 million and $3.0 million, for the third and second quarters of 2017, respectively. The decrease in general and administrative costs was primarily due to the reduction in professional service fees between the periods.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $12.4 million for the third quarter of 2017 compared to net loss before non-controlling interest of $13.4 million for the second quarter of 2017.
Net Loss per Share: GAAP net loss per share was $0.38 and $0.41 for the three months ended September 30, 2017 and June 30, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP net loss per fully exchanged share was $0.38 and $0.41 for the three months ended September 30, 2017 and June 30, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.