Full Press Release Details
vTv Therapeutics Reports Fourth Quarter and Full Year 2015 Financial and Operational Results and Recent Highlights
- Launched pivotal Phase 3 STEADFAST study with azeliragon in Alzheimer's disease
- Completed enrollment of AGATA Phase 2b study with liver-selective Glucokinase Activator in Type 2 diabetes, with expected data readout in mid-2016
- Initiated LOGRA Phase 2b study with oral GLP-1R agonist in Type 2 diabetes, with expected data readout by year-end 2016
- Raised $104 million in net proceeds from IPO
HIGH POINT, NC - March 1, 2016 - 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 and diabetes, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2015. In addition, vTv provided an update on recent developments and upcoming milestones for its lead clinical development programs.
"Over the past year, we have made significant progress advancing our mission to develop first- and best-in-class therapies for Alzheimer's disease and diabetes," said President and CEO Steve Holcombe. "We initiated our pivotal Phase 3 STEADFAST study of azeliragon, a novel product candidate which has demonstrated unprecedented positive effects in treating mild Alzheimer's disease. We also advanced two mid-stage clinical studies with oral, small molecule drug candidates in Type 2 diabetes, both of which have demonstrated sustained glucose control without the side effects seen with other current or investigational agents. We look forward to expected data readouts in mid-2016 for the fully enrolled Phase 2b study with TTP399, a liver-selective Glucokinase Activator, and at year-end for our Phase 2b study with TTP273, our oral, small molecule GLP-1R agonist. We believe our Alzheimer's and diabetes product candidates have disruptive potential, and could vastly improve the lives of millions of patients around the world for whom there are no adequate therapeutic options."
Added Mr. Holcombe, "In addition, we expanded and strengthened our leadership team during 2015, welcoming Jeffrey Kindler as Executive Chairman of the Board of Directors, Dr. Larry Altstiel as Chief Medical Officer, and Rudy Howard as Chief Financial Officer. We also raised over $100 million in an initial public offering, fueling our ability to invest in these important clinical programs."
2015 AND RECENT HIGHLIGHTS
Development Programs:
STEADFAST Study with azeliragon in Alzheimer's disease
Azeliragon: a novel, oral small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) with best-in-class potential
AGATA Study with TTP399 in Type 2 Diabetes
TTP399: a novel oral, liver-selective Glucokinase Activator (GKA) with first-in-class potential
LOGRA Study with TTP273 in Type 2 Diabetes
TTP273: an oral, small molecule GLP-1R agonist with best-in-class potential
--Jeffrey Kindler joined as Executive Chairman of Board of Directors. Mr. Kindler, the former Chairman & CEO of Pfizer, has over 25 years of executive management experience in the pharmaceutical and consumer products industries.
--Larry Altstiel, M.D., Ph.D., joined as Chief Medical Officer. Dr. Altstiel, a former Pfizer and Eli Lilly senior executive, brings 20 years of senior clinical research and management experience in neurodegenerative diseases.
--Rudy Howard was appointed Chief Financial Officer. Mr. Howard joins with 30 years of senior financial executive roles, last serving as CFO of SciQuest.
Upcoming Anticipated Milestones:
Fourth Quarter and Full Year 2015 Financial Results
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.
Forward-Looking Statements
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.
Consolidated Balance Sheets
(in thousands except per share data)
| December 31, | |||||||
| 2015 | 2014 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 88,003 | $ | 1,384 | |||
| Restricted cash and cash equivalents | - | 130 | |||||
| Account receivable, net | 69 | - | |||||
| Prepaid expenses and other current assets | 1,114 | 97 | |||||
| Total current assets | 89,186 | 1,611 | |||||
| Note receivable | - | 6,594 | |||||
| Property and equipment, net | 624 | 3,778 | |||||
| Receivable due from a related party, net | - | 800 | |||||
| Employee loans receivable - related party | 49 | 58 | |||||
| Other long-term assets | 1,673 | 110 | |||||
| Total assets | $ | 91,532 | $ | 12,951 | |||
| Liabilities Redeemable Convertible Preferred Units, Redeemable Noncontrolling Interest, Stockholders' and Members' Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 6,627 | $ | 3,079 | |||
| Accounts payable and accrued expenses - related party | 880 | 1,752 | |||||
| Deferred revenue | 219 | - | |||||
| Short-term debt | - | 155 | |||||
| Other liabilities | - | 1,878 | |||||
| Total current liabilities | 7,726 | 6,864 | |||||
| Debt - related party | - | 27,310 | |||||
| Debt, net of current portion | - | 2,110 | |||||
| Fair value of contingent distribution | - | 26,359 | |||||
| Note payable | - | 6,594 | |||||
| Other liabilities, net of current portion | 245 | 4,434 | |||||
| Total liabilities | 7,971 | 73,671 | |||||
| Commitments and contingencies | |||||||
| Redeemable convertible preferred units | - | 438,086 | |||||
| Redeemable noncontrolling interest | 161,531 | - | |||||
| Stockholders'/members' deficit: | |||||||
| Members' deficit | - | (498,806 | ) | ||||
| Class A Common Stock, $0.01 par value; 100,000,000 shares authorized, 9,156,686 shares outstanding as of December 31, 2015 | 92 | - | |||||
| Class B Common Stock, $0.01 par value; 100,000,000 shares authorized, 23,655,814 shares outstanding as of December 31, 2015 | 237 | - | |||||
| Additional paid-in capital | 117,686 | - | |||||
| Accumulated deficit | (195,985 | ) | - | ||||
| Total stockholders' deficit attributable to vTv Therapeutics Inc./members' deficit | (77,970 | ) | (498,806 | ) | |||
| Total liabilities, redeemable convertible preferred units, redeemable noncontrolling interest, stockholders' and members' deficit | $ | 91,532 | $ | 12,951 |
vTv Therapeutics Inc.
Consolidated Statements of Operations
(in thousands except per share data)
| Three months ended | Year Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||
| Revenue | $ | 226 | $ | 934 | $ | 519 | $ | 1,549 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 8,946 | 5,462 | 29,584 | 18,729 | |||||||||||
| General and administrative | 2,370 | 2,140 | 9,077 | 11,717 | |||||||||||
| Total operating expenses | 11,316 | 7,602 | 38,661 | 30,446 | |||||||||||
| Operating loss | (11,090 | ) | (6,668 | ) | (38,142 | ) | (28,897 | ) | |||||||
| Other expense, net | 31 | (1,047 | ) | (2,965 | ) | (7,204 | ) | ||||||||
| Net loss before income taxes | (11,059 | ) | (7,715 | ) | (41,107 | ) | (36,101 | ) | |||||||
| Income tax provision | - | - | - | - | |||||||||||
| Net loss before noncontrolling interest | (11,059 | ) | (7,715 | ) | (41,107 | ) | (36,101 | ) | |||||||
| Less: net loss attributable to noncontrolling interest | (7,890 | ) | - | (13,609 | ) | - | |||||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (3,169 | ) | $ | (7,715 | ) | $ | (27,498 | ) | $ | (36,101 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.35 | ) | $ | (3.32 | ) | |||||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,156,686 | 8,276,520 |