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vTv Therapeutics Announces 2019 First Quarter Financial Results and Update
“We continue to make significant progress with our operational plans and
look forward to announcing in the second quarter results from part 1 of
our phase 2 Simplici-T1 trial in patients with type 1
diabetes, and the initiation of a phase 2 clinical trial of azeliragon
in patients with mild-Alzheimer’s disease (AD) and type 2 diabetes,”
said
Recent Achievements and Outlook
-
Simplici-T1 Study enrolling patients with
type 1 diabetes. We completed enrollment of part 1 of the phase 2
Simplici-T1 Study, a 12-week study to evaluate TTP399 as an
add-on to insulin therapy for patients with type 1 diabetes, and
expect to report results in
June 2019 . We also began screening patients in the part 2 confirmatory phase 2 and expect to report results for that portion of the study in the latter part of the first quarter of 2020. In the previous AGATA Study, a phase 2 study in type 2 diabetes patients, TTP399 demonstrated statistically significant reductions in HbA1c levels. Importantly, TTP399 has been well tolerated in all clinical studies to date with negligible incidences of hypoglycemia and hyperlipidemia and no occurrences of ketoacidosis. -
Screening for Phase 2 clinical trial of azeliragon expected to
begin in
June 2019 . We are performing start-up activities for a clinical trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes that consists of sequential phase 2 and phase 3 studies operationally conducted under a single clinical trial protocol. The phase 2 study is designed to enroll approximately 100 patients to evaluate the impact of six months of treatment with azeliragon on cognitive performance as measured by the change from baseline in the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (“ADAS-COG14”). We expect to begin screening patients inJune 2019 for the phase 2 clinical trial and to report top-line results from the phase 2 study by the end of the fourth quarter of 2020. The phase 3 study is designed to enroll approximately 200 patients to evaluate the efficacy of 18 months of treatment with azeliragon on cognition and global function as measured by the change from baseline in the ADAS-COG14 and Clinical Dementia Rating Scale Sum of Boxes. The design of the phase 3 study may be adapted based on the results of the phase 2 study. - Publication of paper discussing the discovery and development of TTP399. In the first quarter, we announced the publication of a paper in Science Translational Medicine showcasing the discovery and development of TTP399. The paper reviewed the scientific rationale underpinning the development of TTP399 and detailed its progression from preclinical to clinical development.
First Quarter 2019 Financial Results
-
Cash Position: Cash and cash equivalents as of
March 31, 2019 , were$5.0 million compared to$1.7 million as ofDecember 31, 2018 . -
R&D Expenses: Research and development expenses were
$2.8 million in each of the first quarter of 2019 and the fourth quarter of 2018. -
G&A Expenses: General and administrative expenses were
$2.4 million and$2.1 million in the first quarter of 2019 and the fourth quarter of 2018, respectively. -
Net Loss Before Non-Controlling Interest: Net loss before
non-controlling interest was
$4.0 million for the first quarter of 2019 compared to net loss before non-controlling interest of$2.3 million for the fourth quarter of 2018. -
Net Loss Per Share: GAAP net loss per share was
$0.26 and$0.10 for the three months endedMarch 31, 2019 andDecember 31, 2018 , respectively, based on weighted-average shares of 22.9 million and 17.6 million for the three month periods endedMarch 31, 2019 andDecember 31, 2018 , respectively. Adjusted pro forma net loss per fully exchanged share was$0.09 and$0.06 for the three months endedMarch 31, 2019 andDecember 31, 2018 , respectively, based on adjusted pro forma fully exchanged weighted-average shares of 46.0 million and 40.7 million for the three months endedMarch 31, 2019 andDecember 31, 2018 , respectively.
vTv Therapeutics Inc. Condensed Consolidated Balance Sheets (in thousands) |
||||||||
|
March 31, | December 31, | ||||||
2019 | 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,959 | $ | 1,683 | ||||
Prepaid expenses and other current assets | 419 | 666 | ||||||
Current deposits | 34 | 1,124 | ||||||
Total current assets | 5,412 | 3,473 | ||||||
Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | ||||||
Property and equipment, net | 62 | 70 | ||||||
Operating lease right-of-use assets | 246 | — | ||||||
Long-term investments | 2,480 | 2,480 | ||||||
Long-term deposits | 36 | 36 | ||||||
Total assets | $ | 10,736 | $ | 8,559 | ||||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 6,244 | $ | 7,702 | ||||
Operating lease liabilities | 259 | — | ||||||
Current portion of deferred revenue | 839 | 1,752 | ||||||
Current portion of notes payable | 9,167 | 9,383 | ||||||
Total current liabilities | 16,509 | 18,837 | ||||||
Notes payable, net of current portion | 4,014 | 6,330 | ||||||
Deferred revenue, net of current portion | 1,067 | 1,067 | ||||||
Warrant liability, related party | 1,515 | 2,436 | ||||||
Other liabilities | 260 | 260 | ||||||
Total liabilities | 23,365 | 28,930 | ||||||
Commitments and contingencies | ||||||||
Redeemable noncontrolling interest | 45,106 | 62,482 | ||||||
Stockholders’ deficit: | ||||||||
Class A Common Stock | 273 | 203 | ||||||
Class B Common Stock | 232 | 232 | ||||||
Additional paid-in capital | 162,249 | 150,595 | ||||||
Accumulated deficit | (220,489 | ) | (233,883 | ) | ||||
Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (57,735 | ) | (82,853 | ) | ||||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 10,736 | $ | 8,559 | ||||
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations - Unaudited (in thousands, except per share data) |
||||||||
Three Months Ended | ||||||||
March 31, 2019 | December 31, 2018 | |||||||
Revenue | $ | 921 | $ | 4,522 | ||||
Operating expenses: | ||||||||
Research and development | 2,822 | 2,800 | ||||||
General and administrative | 2,386 | 2,073 | ||||||
Total operating expenses | 5,208 | 4,873 | ||||||
Operating loss | (4,287 | ) | (351 | ) | ||||
Interest income | 10 | 14 | ||||||
Interest expense | (626 | ) | (743 | ) | ||||
Other income (expense), net | 921 | (1,248 | ) | |||||
Loss before income taxes and noncontrolling interest | (3,982 | ) | (2,328 | ) | ||||
Income tax provision | — | — | ||||||
Net loss before noncontrolling interest | (3,982 | ) | (2,328 | ) | ||||
Less: net loss attributable to noncontrolling interest | (1,827 | ) | (1,237 | ) | ||||
Net loss attributable to vTv Therapeutics Inc. | $ | (2,155 | ) | $ | (1,091 | ) | ||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (1,830 | ) | ||
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
$ | (0.26 | ) | $ | (0.10 | ) | ||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
22,862,907 | 17,635,159 | ||||||
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations - Unaudited (in thousands, except per share data) |
||||||||
Three Months Ended March 31, | ||||||||
2019 | 2018 | |||||||
Revenue | $ | 921 | $ | 2,064 | ||||
Operating expenses: | ||||||||
Research and development | 2,822 | 8,943 | ||||||
General and administrative | 2,386 | 2,255 | ||||||
Total operating expenses | 5,208 | 11,198 | ||||||
Operating loss | (4,287 | ) | (9,134 | ) | ||||
Interest income | 10 | 18 | ||||||
Interest expense | (626 | ) | (855 | ) | ||||
Other income (expense), net | 921 | 11 | ||||||
Loss before income taxes and noncontrolling interest | (3,982 | ) | (9,960 | ) | ||||
Income tax provision | — | — | ||||||
Net loss before noncontrolling interest | (3,982 | ) | (9,960 | ) | ||||
Less: net loss attributable to noncontrolling interest | (1,827 | ) | (7,008 | ) | ||||
Net loss attributable to vTv Therapeutics Inc. | $ | (2,155 | ) | $ | (2,952 | ) | ||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (2,952 | ) | ||
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
$ | (0.26 | ) | $ | (0.30 | ) | ||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
22,862,907 | 9,699,721 | ||||||
About
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 Annual Report on Form 10-K and our other filings with the
Non-GAAP Financial Measures
To supplement our consolidated financial statements, which are prepared
and presented in accordance with generally accepted accounting
principles in the U.S. (“GAAP”), we use adjusted pro forma earnings per
fully exchanged share, which is a non-GAAP financial measure. Adjusted
pro forma earnings per fully exchanged share is defined as net loss
attributable to
The following is a reconciliation of adjusted pro forma earnings per
fully exchanged share, basic and diluted to its most directly comparable
GAAP measure, net loss attributable to
Three Months Ended | |||||||||
March 31, 2019 | December 31, 2018 | ||||||||
Numerator: | |||||||||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (1,830 | ) | |||
Deemed distribution to related party | 3,728 | 739 | |||||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,827 | ) | (1,237 | ) | |||||
Net loss before noncontrolling interest | $ | (3,982 | ) | $ | (2,328 | ) | |||
Denominator: | |||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
22,862,907 | 17,635,159 | |||||||
Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,094,221 | |||||||
Adjusted pro forma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
45,957,128 | 40,729,380 | |||||||
Adjusted pro forma earnings per fully exchanged share, basic and diluted |
$ | (0.09 | ) | $ | (0.06 | ) | |||
Three Months Ended March 31, | |||||||||
2019 | 2018 | ||||||||
Numerator: | |||||||||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (2,952 | ) | |||
Deemed distribution to related party | 3,728 | — | |||||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,827 | ) | (7,008 | ) | |||||
Net loss before noncontrolling interest | $ | (3,982 | ) | $ | (9,960 | ) | |||
Denominator: | |||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
22,862,907 | 9,699,721 | |||||||
Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,115,631 | |||||||
Adjusted pro forma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
45,957,128 | 32,815,352 | |||||||
Adjusted pro forma earnings per fully exchanged share, basic and diluted |
$ | (0.09 | ) | $ | (0.30 | ) | |||
(1) |
Assumes the exchange of all outstanding Class B common stock, resulting in the elimination of the non-controlling interest and recognition of the net income attributable to non-controlling interests. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190501005900/en/
Source:
Investors:
vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or
Media:
Josh Vlasto, 212-572-5969
PR@vtvtherapeutics.com