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
“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
Added Mr. Holcombe, “In addition, we expanded and strengthened our
leadership team during 2015, welcoming
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
-
vTv continues to enroll its Phase 3 study with lead product
candidate azeliragon. The randomized, double-blind,
placebo-controlled study, which began dosing in
May 2015 , is evaluating whether azeliragon can slow the cognitive and functional decline of patients with mild Alzheimer’s disease. The Company expects to complete enrollment in Part A of the Phase 3 study in mid-2016. The trial is being conducted under a Special Protocol Assessment (SPA) and has Fast Track designation.
- 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).
AGATA Study with TTP399 in Type 2 Diabetes
TTP399: a
novel oral, liver-selective Glucokinase Activator (GKA) with
first-in-class potential
-
The Phase 2b study recently completed patient enrollment and is on
track for a mid-2016 data readout.
AGATA is a randomized, double-blind, placebo- and active-controlled parallel group trial evaluating the safety and efficacy of TTP399 following six months administration of 180 Type 2 diabetic patients on a stable dose of metformin. The trial is designed to demonstrate that TTP399 produces significant and sustainable improvement in glycemic control. - Previous Phase 2a clinical data showed that the drug significantly lowered blood glucose with no evidence of hypoglycemia, increase in lipids or induction of insulin secretion. Within the high-dose arm of the study, approximately 86% of “well-controlled” patients (A1C levels < 7.5) were able to achieve pre-diabetic A1c levels(<6.5%) after only 6 weeks of treatment without any episodes of hypoglycemia following administration of the oral treatment.
LOGRA Study with TTP273 in Type 2 Diabetes
TTP273: an
oral, small molecule GLP-1R agonist with best-in-class potential
- Initiated the LOGRA Phase 2b study, a randomized, double-blind, placebo-controlled, parallel group trial evaluating the safety and efficacy of TTP273 in 156 Type 2 diabetics on stable doses of metformin.
- Previous Phase 1b trial of TTP273 demonstrated robust effects on postprandial and fasting glucose. All doses of TTP273 were safe and well tolerated with no serious adverse events or evidence of gastrointestinal side effects compared to placebo.
- Expect to report study results by year-end 2016.
Corporate Updates:
-
Strengthened balance sheet. vTv completed an initial
public offering in
July 2015 , raising net proceeds of$104 million , after deducting underwriting discounts, commissions and expenses. - Expanded and strengthened leadership team.
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Upcoming Anticipated Milestones:
- STEADFAST Study (azeliragon in Alzheimer’s disease): Expect to complete enrollment in Part A of Phase 3 study in mid-2016.
- AGATA Study (TTP399 GKA in Type 2 diabetes): Expect to report Phase 2b safety and efficacy results in mid-2016.
- LOGRA Study (TTP273 GLP-1R agonist in Type 2 diabetes): Expect to complete enrollment and report Phase 2b safety and efficacy results by year-end 2016.
Fourth Quarter and Full Year 2015 Financial Results
-
Cash Position: Cash, cash equivalents and marketable
securities as of December 31, 2015 were $88.0 million, compared
to $1.4 million as of December 31, 2014. The increase was primarily
driven by the
$104.4 million of proceeds received from the Company’s IPO in August offset by the subsequent use of the proceeds for operations. - R&D Expenses: Research and development expenses were $8.9 million in the fourth quarter of 2015 and $29.6 million for the year ended December 31, 2015, compared to $5.5 million and $18.7 million in the comparable periods in 2014. The increases in research and development expenses for both the three- and twelve-month periods were largely due to higher spending on the clinical trials for azeliragon, TTP399 and TTP273.
-
G&A Expenses: General and administrative expenses
were $2.4 million in the fourth quarter of 2015 and $9.1 million in
the year ended December 31, 2015, compared to $2.1 million and
$11.7 million in the comparable periods in 2014. The increase in general and administrative expenses for the three-month period was primarily due to higher professional fees and insurance costs offset by lower costs for personnel. The decreases in general and administrative expenses for the twelve-month period were primarily driven by the recognition of certain personnel-related expenses recognized in 2014. Such decreases were offset by higher professional fees and insurance costs associated with the Company’s transition to a public company in 2015. - Net Loss: Net loss was $11.1 million for the fourth quarter of 2015 and $41.1 million for the year ended December 31, 2015, compared to net loss of $7.7 million and $36.1 million for the comparable periods in 2014.
-
Financial Guidance:
vTv Therapeutics expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through at least mid-2017.
About vTv
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
| vTv Therapeutics, Inc. | ||||||||||||
| Condensed Combined 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 |
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| (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 | ||||||||||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160301005550/en/
Source:
Investors:
The Trout Group
Adam Krop, 646-378-2963
akrop@troutgroup.com
or
Media:
BMC
Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com