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vTv Therapeutics Announces Third Quarter 2018 Results and Update
“We continue to believe in the therapeutic potential of azeliragon
and are committed to finding the optimal development pathway forward for
the program,” said
Recent Achievements and Outlook
- Presentation of data at 11th Clinical Trials on Alzheimer’s Disease. Presented positive post-hoc subgroup data indicating a potential benefit of treatment with azeliragon in Alzheimer’s disease patients with type 2 diabetes. This subgroup included 55 patients with glycosylated hemoglobin (HbA1c) of greater than 6.5% at baseline (HbA1c greater than 7.7% was an exclusion criterion at screening) and a clinical diagnosis of Alzheimer’s disease in the combined A-Study and B-Study of the STEADFAST trial. The azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1 point benefit on ADAS-cog relative to the placebo group (n=8), which was nominally statistically significant (p = 0.005), and a 1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18 months of treatment.
-
Meeting with
European Medicines Agency . Met with theScientific Advice Working Party (SAWP) of the EMA onOctober 30, 2018 , to discuss future development requirements in support of seeking regulatory approval of azeliragon in theEuropean Union . We expect to receive formal guidance from the SAWP during the fourth quarter of 2018. - SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study continues to enroll patients with type 1 diabetes in a 12-week study to evaluate TTP399 as an add-on to insulin therapy. We expect to have an interim read-out of the results of this study in early 2019. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Upcoming Events
vTv will participate in the following upcoming investor conferences:
-
Piper Jaffray 30th Annual Healthcare Conference,November 27-29 ,New York, NY -
J.P. Morgan 37th Annual Healthcare Conference,
January 7-10 ,San Francisco, CA
Second Quarter 2018 Financial Results
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Cash Position: Cash and cash equivalents as of
September 30, 2018 , were$3.8 million compared to$1.2 million as ofJune 30, 2018 . -
R&D Expenses: Research and development expenses were
$2.7 million in the third quarter of 2018, compared to$8.6 million in the second quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of 2018. -
G&A Expenses: General and administrative expenses were
$2.2 million and$2.7 million , for the third quarter of 2018 and the second quarter of 2018, respectively. General and administrative expenses were lower due to reduced share-based compensation expense and professional service fees. -
Net Loss Before Non-Controlling Interest: Net loss before
non-controlling interest was
$2.0 million for the third quarter of 2018 compared to net loss before non-controlling interest of$9.6 million for the second quarter of 2018. -
Net Loss Per Share: GAAP net loss per share was
$0.06 and$0.31 for the three months endedSeptember 30, 2018 andJune 30, 2018 , respectively, based on weighted-average shares of 12.3 million and 10.0 million for the three month periods endedSeptember 30, 2018 andJune 30, 2018 , respectively. Non-GAAP net loss per fully exchanged share was$0.06 and$0.29 for the three months endedSeptember 30, 2018 andJune 30, 2018 , respectively, based on non-GAAP fully exchanged weighted-average shares of 35.4 million and 33.1 million for the three months endedSeptember 30, 2018 andJune 30, 2018 , respectively.
vTv Therapeutics Inc. |
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September 30, | June 30, | |||||||||||
2018 | 2018 | |||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 3,766 | $ | 1,163 | ||||||||
Restricted cash and cash equivalents | — | — | ||||||||||
Accounts receivable, net | — | 2,270 | ||||||||||
Prepaid expenses and other current assets | 1,006 | 264 | ||||||||||
Current deposits | 1,124 | 2,311 | ||||||||||
Total current assets | 5,896 | 6,008 | ||||||||||
Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | ||||||||||
Property and equipment, net | 177 | 202 | ||||||||||
Long-term investments | 2,480 | 2,480 | ||||||||||
Long-term deposits | 36 | 36 | ||||||||||
Total assets | $ | 11,089 | $ | 11,226 | ||||||||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable and accrued expenses | $ | 8,965 | $ | 13,144 | ||||||||
Current portion of deferred revenue | 6,747 | 10,114 | ||||||||||
Current portion of notes payable | 9,597 | 8,229 | ||||||||||
Total current liabilities | 25,309 | 31,487 | ||||||||||
Notes payable | 8,611 | 10,863 | ||||||||||
Deferred revenue, net of current portion | 595 | 603 | ||||||||||
Warrant liability, related party | 382 | 201 | ||||||||||
Other liabilities | 258 | 256 | ||||||||||
Total liabilities | 35,155 | 43,410 | ||||||||||
Commitments and contingencies | ||||||||||||
Redeemable noncontrolling interest | 19,912 | 39,413 | ||||||||||
Stockholders’ deficit: | ||||||||||||
Class A Common Stock | 158 | 109 | ||||||||||
Class B Common Stock | 232 | 232 | ||||||||||
Additional paid-in capital | 144,617 | 134,587 | ||||||||||
Accumulated deficit | (188,985 | ) | (206,525 | ) | ||||||||
Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (43,978 | ) | (71,597 | ) | ||||||||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 11,089 | $ | 11,226 |
vTv Therapeutics Inc. |
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Three Months Ended | ||||||||||||
September 30, 2018 |
June 30, 2018 |
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Revenue | $ | 3,375 | $ | 2,473 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 2,698 | 8,594 | ||||||||||
General and administrative | 2,158 | 2,737 | ||||||||||
Total operating expenses | 4,856 | 11,331 | ||||||||||
Operating loss | (1,481 | ) | (8,858 | ) | ||||||||
Interest income | 13 | 16 | ||||||||||
Interest expense | (822 | ) | (870 | ) | ||||||||
Other income (expense), net | 329 | 316 | ||||||||||
Loss before income taxes and noncontrolling interest | (1,961 | ) | (9,396 | ) | ||||||||
Income tax provision | — | 200 | ||||||||||
Net loss before noncontrolling interest | (1,961 | ) | (9,596 | ) | ||||||||
Less: net loss attributable to noncontrolling interest | (1,165 | ) | (6,524 | ) | ||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (796 | ) | $ | (3,072 | ) | ||||||
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
$ | (0.06 | ) | $ | (0.31 | ) | ||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
12,305,949 | 10,049,831 |
vTv Therapeutics Inc. |
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Three Months Ended September 30, |
For the Nine Months Ended September 30, |
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2018 | 2017 | 2018 | 2017 | |||||||||||||||||||
Revenue | $ | 3,375 | $ | 15 | $ | 7,912 | $ | 58 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 2,698 | 8,989 | 20,235 | 29,572 | ||||||||||||||||||
General and administrative | 2,158 | 2,567 | 7,150 | 8,396 | ||||||||||||||||||
Total operating expenses | 4,856 | 11,556 | 27,385 | 37,968 | ||||||||||||||||||
Operating loss | (1,481 | ) | (11,541 | ) | (19,473 | ) | (37,910 | ) | ||||||||||||||
Interest income | 13 | 35 | 47 | 95 | ||||||||||||||||||
Interest expense | (822 | ) | (849 | ) | (2,547 | ) | (2,240 | ) | ||||||||||||||
Other income (expense), net | 329 | — | 656 | — | ||||||||||||||||||
Loss before income taxes and noncontrolling interest | (1,961 | ) | (12,355 | ) | (21,317 | ) | (40,055 | ) | ||||||||||||||
Income tax provision | — | — | 200 | — | ||||||||||||||||||
Net loss before noncontrolling interest | (1,961 | ) | (12,355 | ) | (21,517 | ) | (40,055 | ) | ||||||||||||||
Less: net loss attributable to noncontrolling interest | (1,165 | ) | (8,705 | ) | (14,697 | ) | (28,222 | ) | ||||||||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (796 | ) | $ | (3,650 | ) | $ | (6,820 | ) | $ | (11,833 | ) | ||||||||||
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
$ | (0.06 | ) | $ | (0.38 | ) | $ | (0.64 | ) | $ | (1.22 | ) | ||||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
12,305,949 | 9,693,254 | 10,701,599 | 9,693,254 | ||||||||||||||||||
About
About STEADFAST
The STEADFAST study, two independent and identical randomized,
double-blind, placebo-controlled Phase 3 trials (A-Study and B-Study),
was designed to investigate the safety and efficacy of azeliragon
as a potential treatment for patients with mild Alzheimer’s disease. The
18-month study targeted enrollment of 800 patients (400 in each trial).
The first trial enrolled patients in
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 non-GAAP earnings per fully
exchanged share, which is a non-GAAP financial measure. Non-GAAP
earnings per fully exchanged share is defined as net loss attributable
to
The following is a reconciliation of non-GAAP earnings per fully exchanged share, basic and diluted to its most directly comparable GAAP measure, net loss per share of vTv Therapeutics Class A common stock, basic and diluted and the computation of the components of this non-GAAP measure:
Three Months Ended | ||||||||||||
September 30, 2018 |
June 30, 2018 |
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Numerator: | ||||||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (796 | ) | $ | (3,072 | ) | ||||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,165 | ) | (6,524 | ) | ||||||||
Net loss before noncontrolling interest | $ | (1,961 | ) | $ | (9,596 | ) | ||||||
Denominator: | ||||||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
12,305,949 | 10,049,831 | ||||||||||
Assumed exchange of Class B Common Stock (1) | 23,114,652 | 23,094,221 | ||||||||||
Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
35,420,601 | 33,144,052 | ||||||||||
Adjusted proforma earnings per fully exchanged share, basic and diluted |
$ | (0.06 | ) | $ | (0.29 | ) |
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2018 | 2017 | 2018 | 2017 | ||||||||||||||
Numerator: | |||||||||||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (796 | ) | $ | (3,650 | ) | $ | (6,820 | ) | $ | (11,833 | ) | |||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,165 | ) | (8,705 | ) | (14,697 | ) | (28,222 | ) | |||||||||
Net loss before noncontrolling interest | $ | (1,961 | ) | $ | (12,355 | ) | $ | (21,517 | ) | $ | (40,055 | ) | |||||
Denominator: | |||||||||||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
12,305,949 | 9,693,254 | 10,701,599 | 9,693,254 | |||||||||||||
Assumed exchange of Class B Common Stock (1) |
23,114,652 | 23,119,246 | 23,101,279 | 23,119,246 | |||||||||||||
Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
35,420,601 | 32,812,500 | 33,802,878 | 32,812,500 | |||||||||||||
Adjusted proforma earnings per fully exchanged share, basic and diluted |
$ | (0.06 | ) | $ | (0.38 | ) | $ | (0.64 | ) | $ | (1.22 | ) | |||||
_________________ |
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(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. |
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Source:
vTv Therapeutics Inc.
Investors:
IR@vtvtherapeutics.com
or
Media:
Josh
Vlasto, 212-572-5969
PR@vtvtherapeutics.com