On February 27, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the fourth quarter and year that ended December 31, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, FEB 27, 2019, View Source;p=RssLanding&cat=news&id=2389244 [SID1234533739]).

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"We are excited about the therapeutic potential of azeliragon in patients with mild-Alzheimer’s Disease (AD) and type 2 diabetes and our progress to date with our Simplici-T1 trial in type 1 diabetics," said Steve Holcombe, chief executive officer, vTv Therapeutics. "Our licensing partners also continue to advance our GLP-1R agonist, PPAR-delta, and PDE4 programs and we hope to see progress in each of these programs over the next year."

Recent Achievements and Outlook

Initiated start-up activities for an adaptive Phase 2/3 clinical trial for azeliragon as a potential treatment of mild AD in patients with type 2 diabetes. Post-hoc subgroup analyses of our phase 3 STEADFAST Study identified that a population of mild-AD patients with type 2 diabetes experienced positive benefit. Based on these results, we have initiated start-up activities for an adaptive Phase 2/3 trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes. We are currently finalizing a protocol for the study, negotiating with clinical research organizations to support study conduct activities for the trial and beginning the site selection process. We expect to initiate patient enrollment in this study in mid-2019. We plan to continue to develop azeliragon through internal efforts, based upon receipt of additional funding, or through future partnerships with other life science entities.
Simplic-T1 Study enrolling patients with type 1 diabetes. We have completed enrollment of the part 1 learning phase of the adaptive Phase 1/2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an add-on to insulin therapy for type 1 diabetics, and expect to report results for this portion of the study in June 2019. We have begun the start-up activities for the part 2 confirmatory phase and expect to report results for this portion of the study in the latter part of the first quarter of 2020. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Financing Strategy. We are evaluating several financing strategies to fund the proposed clinical trial of azeliragon for the treatment of mild-AD in patients with type 2 diabetes, including direct equity investment and future public offerings of our common stock. The timing and availability of such financing are not yet known.
Fourth Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of December 31, 2018, were $1.7 million compared to $3.8 million as of September 30, 2018.
R&D Expenses: Research and development expenses were $2.8 million in the fourth quarter of 2018 which were consistent with the $2.7 million of such expenses incurred in the third quarter of 2018.
G&A Expenses: General and administrative expenses were $2.1 million and $2.2 million in the fourth and third quarters of 2018, respectively.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the fourth quarter of 2018 compared to net loss before non-controlling interest of $2.0 million for the third quarter of 2018.
Net Loss Per Share: GAAP net loss per share was $0.10 and $0.06 for the three months ended December 31, 2018 and September 30, 2018, respectively, based on weighted-average shares of 17.6 million and 12.3 million for the three month periods ended December 31, 2018 and September 30, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.08 and $0.06 for the three months ended December 31, 2018 and September 30, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 40.7 million and 35.4 million for the three months ended December 31, 2018 and September 30, 2018, respectively.
Full Year 2018 Financial Results

R&D Expenses: Research and development expenses were $23.0 million and $39.6 million for the years ended December 31, 2018 and 2017, respectively. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies and related activities in the second quarter of 2018.
G&A Expenses: General and administrative expenses were $9.2 million and $11.3 million for the years ended December 31, 2018 and 2017, respectively. The decrease in general and administrative expenses was primarily due to decreases in expenses for share-based awards, incentive-based compensation and professional services.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $23.8 million and $54.6 million for the years ended December 31, 2018 and 2017, respectively.
Net Loss Per Share: GAAP net loss per share was $0.69 and $1.67 for the years ended December 31, 2018 and 2017, respectively, based on weighted-average shares of 12.4 million and 9.7 million for the years ended December 31, 2018 and 2017, respectively. Non-GAAP net loss per fully exchanged share was $0.69 and $1.67 for the year ended December 31, 2018 and 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 35.5 million and 32.8 million for the years ended December 31, 2018 and 2017, respectively.