HIGH POINT, N.C.--(BUSINESS WIRE)--vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease (AD) and diabetes, today reported financial results for the third quarter of 2015 and provided an update on recent developments.
“I’m pleased to report that vTv has had a highly productive quarter and 2015. We advanced our pivotal Phase 3 program for our lead product candidate azeliragon, which has demonstrated positive effects treating mild Alzheimer’s disease, and continue to enroll patients in our STEADFAST Study,” said President and CEO Steve Holcombe. “Coming up in 2016, we expect significant data readouts for our two ongoing diabetes programs. Both of these investigational drugs, including our first-in-class liver selective Glucokinase Activator (GKA) that targets the underlying cause of diabetes and our oral GLP-1r, are contenders for best-in-class oral small molecule treatments in a disease with enormous unmet therapeutic needs.”
RECENT HIGHLIGHTS AND EXPECTED MILESTONES FOR 2016
STEADFAST Study in Alzheimer’s Disease
- vTv continues to enroll its Phase 3 study with lead product candidate azeliragon. The randomized, double-blind, placebo-controlled study is evaluating whether the oral, small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) can slow the cognitive and functional decline of patients with mild Alzheimer’s disease. Successful Phase 2b results of 5mg/day over 18 months showed statistically significant efficacy in mild-to-moderate Alzheimer’s patients (+3.1 points on ADAS-Cog standard measure of cognition) and even greater efficacy in mild patients (+4.0). Benefits were shown on CDR-SB and all secondary endpoints, including a significant reduction of psychiatric events (e.g. anxiety).
- Study has received a Special Protocol Assessment (SPA), and azeliragon continues to be developed under Fast Track designation from the U.S. FDA.
- 80 of the targeted 100 clinical sites have been initiated in the United States and Canada.
TTP399 AGATA Study in Type 2 Diabetes
- The Company is enrolling patients into a Phase 2b study of its liver-selective Glucokinase Activator, a novel oral, small molecule product candidate with first-in-class potential. The randomized, double-blind, placebo- and active-controlled parallel group trial is evaluating the safety and efficacy of TTP399 following six months administration of 180 Type 2 diabetic patients on a stable dose of metformin.
- Previous Phase 2 clinical data showed that treatment significantly lowered blood glucose in patients in just six weeks, with no hypoglycemia or increase in lipids and no induction of insulin secretion. Within the high dose arm, patients moved from out-of-control diabetes to glucose measures that are considered pre-diabetic.
- On track for mid-2016 data readout of Phase 2b results.
TTP273 LOGRA Study in Type 2 Diabetes
- Clinical team preparing for first quarter 2016 launch of Phase 2b study of its oral, small molecule GLP-1r agonist with best-in-class potential. The randomized, double-blind, placebo-controlled, parallel group trial is evaluating the safety and efficacy of TTP273 in 156 Type 2 diabetics on stable doses of metformin.
- Expect to report Phase 2b data by the end of 2016.
Third Quarter and Nine Months Ended September 30, 2015
Cash Position: Cash and cash equivalents as of September 30,
2015 were $97.0 million. As of December 31, 2014 the Company had cash
and cash equivalents of $1.4 million. The increased cash balance
reflects net proceeds of approximately $104.4 million received from
the Company’s IPO.
- Research and Development: Expenses were $7.2 million and $20.6 million, respectively, for the three and nine months ended September 30, 2015, compared to $4.3 million and $13.3 million during the comparable periods in 2014. The increases over prior periods were related to increased activity in our clinical trials during the current year.
- General and Administrative: Expenses were $2.4 million and $6.7 million, respectively, for the three and nine months ended September 30, 2015, compared to $1.6 million and $9.6 million during the comparable periods in 2014. G&A expenses were up for the three month period due to increased legal and professional fees coupled with an increase in stock based compensation. G&A costs were down for the nine month period ended September 30, 2105 due to higher compensation costs in 2014 related to the departure of a former officer and director.
- Net Loss: The Company reported a net loss of $9.8 million for the third quarter of 2015 and $30.0 million for the nine months ended September 30, 2015, compared to a net loss of $5.9 million and $28.4 million for the comparable periods in 2014.
About vTv Therapeutics Inc.
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.
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Registration Statement on Form S-1 and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.
|vTv Therapeutics, Inc.|
|Condensed Consolidated Balance Sheets - Unaudited|
|(in thousands except per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$97,010||$1,384|
|Restricted cash and cash equivalents||-||130|
|Prepaid expenses and other current assets||799||97|
|Total current assets||97,809||1,611|
|Property and equipment, net||669||3,778|
|Receivable due from a related party, net||-||800|
|Employee loans receivable - related party||48||58|
|Other long-term assets||1,669||110|
Liabilities Redeemable Convertible Preferred Units, Redeemable
|Accounts payable and accrued expenses||$5,240||$3,079|
|Accounts payable and accrued expenses - related party||516||1,752|
|Total current liabilities||6,076||6,864|
|Debt - related party||-||27,310|
|Debt, net of current portion||-||2,110|
|Fair value of contingent distribution||-||26,359|
|Other liabilities, net of current portion||53||4,434|
|Commitments and contingencies|
|Redeemable convertible preferred units||-||438,086|
|Redeemable noncontrolling interest||188,251||-|
Class A Common stock, $0.01 par value; 100,000,000 shares
Class B Common stock, $0.01 par value; 100,000,000 shares
|Additional paid-in capital||117,131||-|
|Total stockholders' deficit attributable to vTv Therapeutics Inc./members' deficit||(94,185)||(498,806)|
Total liabilities, redeemable convertible preferred units,
|vTv Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations - Unaudited|
|(in thousands, except per share data)|
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Research and development||7,159||4,328||20,638||13,267|
|General and administrative||2,415||1,592||6,707||9,577|
|Total operating expenses||9,574||5,920||27,345||22,844|
|Other expense, net||(381)||(350)||(2,996)||(6,157)|
|Net loss before income taxes||(9,822)||(5,870)||(30,048)||(28,386)|
|Income tax provision||-||-||-||-|
|Net loss before noncontrolling interest||(9,822)||(5,870)||(30,048)||(28,386)|
|Less: net loss attributable to noncontrolling interest||(5,719)||-||(5,719)||-|
|Net loss attributable to vTv Therapeutics Inc.||$(4,103)||$(5,870)||$(24,329)||$(28,386)|
Net loss per share of vTv Therapeutics Inc. Class A
Weighted-average number of vTv Therapeutics Inc.