HIGH POINT, N.C.--(BUSINESS WIRE)--vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, among other therapeutic areas, today provided a corporate update and reported financial and operational results for the fourth quarter and full year that ended December 31, 2016.
“2016 marked a year of substantial progress for vTv, as we achieved numerous milestones in the development of novel therapeutics for Alzheimer’s disease and Type 2 diabetes,” said Steve Holcombe, president and CEO of vTv Therapeutics. “Our Alzheimer’s program continues to advance as planned, and we welcomed positive Phase 2 results from each of our oral, small molecule drug candidates in Type 2 diabetes.”
Phase 3 STEADFAST Study with azeliragon in mild Alzheimer’s disease (AD)
Azeliragon: A novel, investigational, oral small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) with the potential to delay progression of AD
- Part A of STEADFAST Study completed enrollment in the third quarter. The 18-month randomized, double-blind, placebo-controlled study is evaluating the potential of azeliragon to slow the cognitive and functional decline of patients with mild Alzheimer’s disease. Based on the completion of enrollment of Part A in September, the Company anticipates reporting topline data from this part of the study in early 2018. Enrollment of Part B continues, and is on track to be completed by mid-year of 2017. The STEADFAST Study is being conducted under a Special Protocol Assessment. Development of azeliragon has received fast track designation from the FDA.
Phase 2 LOGRA Study with TTP273 in Type 2 diabetes
TTP273: An investigational, orally-administered small molecule GLP-1R agonist
- Demonstrated a statistically significant reduction in HbA1c. In the 12-week LOGRA study conducted in 30 centers in the U.S., 174 patients with Type 2 diabetes on stable doses of metformin were randomized to receive either placebo or TTP273 at doses of 150 mg once or twice daily. Patients in each treatment arm had mean placebo-subtracted HbA1c differences of -0.86 percent and -0.71 percent, respectively. HbA1c increased by 0.15 percent in patients randomized to placebo. Although the study was not powered to demonstrate weight loss, trends were observed with patients losing on average 0.9 kg and 0.6 kg in the once and twice daily arms, respectively. Additionally, the compound was well-tolerated, with negligible incidences of nausea and vomiting across all arms of the study. Analyses of full study results will continue.
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
TTP399: A novel, investigational, oral, liver-selective glucokinase activator (GKA)
- Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months with daily administration of 800 mg of TTP399. The Phase 2b AGATA (Add Glucokinase Activator to Target A1c) was a six-month, double-blind, placebo- and active-controlled parallel group trial in 190 patients with Type 2 diabetes on a stable dose of metformin. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo. A manuscript with data from the study is in preparation and will be submitted for publication during the first quarter of 2017.
Upcoming Anticipated Milestones
STEADFAST Study (azeliragon in Alzheimer’s disease): Expect to complete enrollment in Part B of Phase 3 study in mid-2017.
Fourth Quarter 2016 Financial Results
- Completion of Credit Facility Financing: In October, the Company closed a $25 million facility, the proceeds of which will be used to advance its strategic initiatives, as well as to provide further financial support to ongoing clinical trials.
- Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2016 were $51.5 million, compared to $51.1 million as of September 30, 2016. Cash used in the quarter for operations was offset by the proceeds from the borrowing of the first tranche under the Company’s credit facility received in October. vTv believes that cash and cash equivalents coupled with funds available from its credit facility will be sufficient to fund operations through the first quarter of 2018, which is when topline results from Part A of the STEADFAST Study are expected.
- R&D Expenses: Research and development expenses were $11.1 million in the fourth quarter of 2016, compared to $11.2 million in the third quarter of 2016. The decrease in research and development was primarily driven by decreases in costs associated with completion of the Company’s AGATA and LOGRA studies of $0.8 million and reduction in compound manufacturing costs for its diabetes and other programs of $0.6 million. Such decreases were offset by increases of $1.3 million related to the STEADFAST Study and the related open-label extension trial for azeliragon.
- G&A Expenses: General and administrative expenses were $2.3 million in the fourth quarter of 2016, which is relatively consistent with expenses of $2.4 million in the third quarter of 2016.
- Net Loss: Net loss was $13.7 million for the fourth quarter of 2016 compared to net loss of $13.5 million for the third quarter of 2016.
Full Year 2016 Financial Results
- R&D Expenses: Research and development expenses were $45.7 million in 2016, compared to $29.6 million in 2015. The increase in research and development expense was primarily driven by an increase of $15.4 million in costs related to the Company’s azeliragon program caused by higher enrollment and related activities for the STEADFAST Study, higher compound manufacturing costs to support the study and higher costs associated with other supporting studies. Additionally, there were increases of $0.6 million in costs related to TTP273, as increases in clinical trial costs outweighed decreases in compound manufacturing costs, and increases of $1.5 million in other research and development costs driven primarily by higher compensation costs as headcount was increased in order to support ongoing clinical trials. Such increases were offset by a decrease in spending of $1.5 million for TTP399, as the AGATA study was completed in August 2016 and a decrease in the cost of compound manufacturing for the study, which primarily occurred in 2015.
- G&A Expenses: General and administrative expenses were $9.9 million in 2016 compared to $9.1 million in 2015. The increase was primarily driven by a $2.1 million increase in compensation costs related to the addition of personnel to support compliance with public company requirements, offset by a $1.4 million decrease in legal and professional service expenses incurred in 2015 in connection with the Company’s IPO that year.
- Net Loss: Net loss was $55.4 million for 2016 compared to a net loss of $41.1 million for 2015.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
|December 31,||September 30,|
|Cash and cash equivalents||$||51,505||$||51,058|
|Accounts receivable, net||—||—|
|Prepaid expenses and other current assets||612||1,058|
|Total current assets||52,117||52,116|
|Property and equipment, net||444||493|
|Other long-term assets||1,934||2,106|
|Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit|
|Accounts payable and accrued expenses||$||11,413||$||10,156|
|Accounts payable and accrued expenses - related party||—||406|
|Total current liabilities||11,434||10,583|
|Commitments and contingencies|
|Redeemable noncontrolling interest||122,515||155,147|
|Class A Common Stock||97||97|
|Class B Common Stock||232||232|
|Additional paid-in capital||124,212||122,838|
|Total stockholders’ deficit attributable to vTv Therapeutics Inc.||(90,945||)||(111,240||)|
|Total liabilities, redeemable noncontrolling interest and stockholders’ deficit||$||54,495||$||54,715|
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
|Three Months Ended||
For the Year Ended
|Research and development||11,099||11,165||45,748||29,584|
|General and administrative||2,252||2,401||9,906||9,077|
|Total operating expenses||13,351||13,566||55,654||38,661|
|Other (expense) income, net||(24||)||3||(22||)||(2,897||)|
|Loss before income taxes and noncontrolling interest||(13,711||)||(13,505||)||(55,353||)||(41,107||)|
|Income tax provision||—||—||—||—|
|Net loss before noncontrolling interest||(13,711||)||(13,505||)||(55,353||)||(41,107||)|
|Less: net loss attributable to noncontrolling interest||(9,661||)||(9,512||)||(39,001||)||(13,609||)|
|Net loss attributable to vTv Therapeutics Inc.||$||(4,050||)||$||(3,993||)||$||(16,352||)||$||(27,498||)|
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
About vTv Therapeutics
vTv Therapeutics Inc. 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 Type 2 diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness.
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