vTv Therapeutics Inc. (NASDAQ: VTVT) is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and diabetes as well as the treatment of inflammatory disorders.

 

Driven by its favorable fundamentals, VtVt has become a momentum stock in the recent past. As per its recently filed 8-K, the company’ Large shareholders continue to add the position in the company.

Before this, on Aug 3, 2018, the company reported financial results for the second quarter that ended June 30, 2018 and provided an update on recent achievements and upcoming events.

Since its announcement regarding the topline results from Part B of the STEADFAST Study, VTVT has continued to analyze the results from Parts A and B and are encouraged by its findings. Additionally, the company’ other programs, including its glucokinase activator currently in clinical development for type 1 diabetes and its GLP-1R program that is being developed in partnership with Huadong Medicine for type 2 diabetes, continue to make steady progress.

 

Recent Achievements and Outlook

• Azeliragon data analysis continues in order to move development of the therapy forward in consultation with the company’ scientific advisory board and the FDA.
• SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study has begun dosing patients with type 1 diabetes in a 12-week study to evaluate TTP399 as an add-on to insulin therapy. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
• Advancing PDE4 program with Newsoara. During the second quarter, vTv licensed rights to its PDE4 program to Newsoara Biopharma Co., Ltd. to further its development and potential commercialization in China and other Pacific Rim countries. Newsoara is developing vTv’s PDE4 compounds as a potential therapeutic for COPD, a chronic illness affecting nearly 100 million people in China.
• Additional Investment by MacAndrews & Forbes Incorporated. MacAndrews & Forbes provided vTv an additional $10 million capital line.

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Upcoming near-term events:

• STEADFAST Part A & B Combined Results Serve as Basis for FDA and EMA Discussions Regarding Regulatory Pathways. vTvT will be meeting with FDA and EMA (in Q4’18) to discuss regulatory approval pathways
• vTvT will also participate in the following upcoming scientific conferences:  11th Clinical Trials on Alzheimer’s Disease (CTAD), October 24-27, Barcelona.

The company is continuously progressing towards approval stage with significant upside potential. Moreover, increasing position of institutional investors on the stock has reinforced market confidence and positioned the company as an attractive emerging player in the space. Furthermore, 2019 is expected to be a remarkable year for biotech space and Alzheimer’s disease, and diabetes segment will likely continue to dominate the industry.

 

The market cap of just $133.7 million and share now ruling at $3.40, can move to a level of $15 -$16 in the next six months or so. Per www.marketbeat.com, the average twelve-month price target is $15.00, suggesting that the stock has a possible upside of ~340%. Considering all this, the company is in an extremely favorable risk-reward position, and value investors should consider exposure in this sector as the backdrop remains favorable.

Description & about the Company: vTv Therapeutics LLC (vTv) is a clinical-stage pharmaceutical company focused on the discovery and development of human therapeutics to fill unmet medical needs. The company’ mission is to advance clinical drug candidates discovered with its innovative technology into safe and effective medicines.

vTv has a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases including Alzheimer’s disease, diabetes, and inflammation.  The company has built its product candidate portfolio through internal discovery and is advancing its product candidates through in-house research and development efforts. The quality and breadth of vTv’s product candidate pipeline, platform technology, scientific team, and strategic collaborations have enabled it to become a fully integrated pharmaceutical development company.

 

Robust Pipeline of Novel Product Candidates:

Unique differentiating features:

Second Quarter 2018 Financial Results (in, thousands):

• Cash Position: Cash and cash equivalents as of June 30, 2018, were $1.2 million compared to $6.5 million as of March 31, 2018.
• R&D Expenses: Research and development expenses were $8.6 million in the second quarter of 2018, compared to $8.9 million in the first quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open-label extension studies during the second quarter of fiscal 2018.
• Net Loss per Share: GAAP net loss per share was $0.31 and $0.30 for the three months ended June 30, 2018, and March 31, 2018, respectively, based on weighted-average shares of 10.0 million and 9.7 million for the three-month periods ended June 30, 2018, and March 31, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.29 and $0.30 for the three months ended June 30, 2018, and March 31, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 33.1 million and 32.8 million for the three months ended June 30, 2018, and March 31, 2018, respectively.

 

Key risk factors and potential stock drivers:

• Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.
• VTVT is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
• VTVT has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.

 

Stock Performance

Comments:

• On Friday, Oct 12th, 2018, VTVT is trading at $3.43, with a robust average volume of 2.3 million shares exchanging hands. Market capitalization is $133.701 million. The current RSI is 72.26
• At $3.40, shares of VTVT are trading above its 50-day moving average (MA) at $1.40 and above its 200-day moving average (MA) at $3.03
• The present support and resistance levels for the stock are at $2.81 & $4.23 respectively.

 

 

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