Press Release
View printer-friendly version << Back
vTv Therapeutics Announces 2018 Fourth Quarter and Full Year Financial Results and Update
“We are excited about the therapeutic potential of azeliragon in
patients with mild-Alzheimer’s Disease (AD) and type 2 diabetes and our
progress to date with our Simplici-T1 trial in type 1 diabetics,” said
Recent Achievements and Outlook
- Initiated start-up activities for an adaptive Phase 2/3 clinical trial for azeliragon as a potential treatment of mild AD in patients with type 2 diabetes. Post-hoc subgroup analyses of our phase 3 STEADFAST Study identified that a population of mild-AD patients with type 2 diabetes experienced positive benefit. Based on these results, we have initiated start-up activities for an adaptive Phase 2/3 trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes. We are currently finalizing a protocol for the study, negotiating with clinical research organizations to support study conduct activities for the trial and beginning the site selection process. We expect to initiate patient enrollment in this study in mid-2019. We plan to continue to develop azeliragon through internal efforts, based upon receipt of additional funding, or through future partnerships with other life science entities.
-
Simplic-T1 Study enrolling patients with type 1 diabetes. We
have completed enrollment of the part 1 learning phase of the adaptive
Phase 1/2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an
add-on to insulin therapy for type 1 diabetics, and expect to report
results for this portion of the study in
June 2019 . We have begun the start-up activities for the part 2 confirmatory phase and expect to report results for this portion of the study in the latter part of the first quarter of 2020. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes. - Financing Strategy. We are evaluating several financing strategies to fund the proposed clinical trial of azeliragon for the treatment of mild-AD in patients with type 2 diabetes, including direct equity investment and future public offerings of our common stock. The timing and availability of such financing are not yet known.
Fourth Quarter 2018 Financial Results
-
Cash Position: Cash and cash equivalents as of
December 31, 2018 , were$1.7 million compared to$3.8 million as ofSeptember 30, 2018 . -
R&D Expenses: Research and development expenses were
$2.8 million in the fourth quarter of 2018 which were consistent with the$2.7 million of such expenses incurred in the third quarter of 2018. -
G&A Expenses: General and administrative expenses were
$2.1 million and$2.2 million in the fourth and third quarters of 2018, respectively. -
Net Loss Before Non-Controlling Interest: Net loss before
non-controlling interest was
$2.3 million for the fourth quarter of 2018 compared to net loss before non-controlling interest of$2.0 million for the third quarter of 2018. -
Net Loss Per Share: GAAP net loss per share was
$0.10 and$0.06 for the three months endedDecember 31, 2018 andSeptember 30, 2018 , respectively, based on weighted-average shares of 17.6 million and 12.3 million for the three month periods endedDecember 31, 2018 andSeptember 30, 2018 , respectively. Non-GAAP net loss per fully exchanged share was$0.08 and$0.06 for the three months endedDecember 31, 2018 andSeptember 30, 2018 , respectively, based on non-GAAP fully exchanged weighted-average shares of 40.7 million and 35.4 million for the three months endedDecember 31, 2018 andSeptember 30, 2018 , respectively.
Full Year 2018 Financial Results
-
R&D Expenses: Research and development expenses were
$23.0 million and$39.6 million for the years endedDecember 31, 2018 and 2017, respectively. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies and related activities in the second quarter of 2018. -
G&A Expenses: General and administrative expenses were
$9.2 million and$11.3 million for the years endedDecember 31, 2018 and 2017, respectively. The decrease in general and administrative expenses was primarily due to decreases in expenses for share-based awards, incentive-based compensation and professional services. -
Net Loss Before Non-Controlling Interest: Net loss before
non-controlling interest was
$23.8 million and$54.6 million for the years endedDecember 31, 2018 and 2017, respectively. -
Net Loss Per Share: GAAP net loss per share was
$0.69 and$1.67 for the years endedDecember 31, 2018 and 2017, respectively, based on weighted-average shares of 12.4 million and 9.7 million for the years endedDecember 31, 2018 and 2017, respectively. Non-GAAP net loss per fully exchanged share was$0.69 and$1.67 for the year endedDecember 31, 2018 and 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 35.5 million and 32.8 million for the years endedDecember 31, 2018 and 2017, respectively.
vTv Therapeutics Inc. Condensed Consolidated Balance Sheets (in thousands) |
||||||||||
December 31, | September 30, | |||||||||
2018 | 2018 | |||||||||
(Unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 1,683 | $ | 3,766 | ||||||
Prepaid expenses and other current assets | 666 | 1,006 | ||||||||
Current deposits | 1,124 | 1,124 | ||||||||
Total current assets | 3,473 | 5,896 | ||||||||
Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | ||||||||
Property and equipment, net | 70 | 177 | ||||||||
Long-term investments | 2,480 | 2,480 | ||||||||
Long-term deposits | 36 | 36 | ||||||||
Total assets | $ | 8,559 | $ | 11,089 | ||||||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | ||||||||||
Current liabilities: | ||||||||||
Accounts payable and accrued expenses | $ | 7,702 | $ | 8,965 | ||||||
Current portion of deferred revenue | 1,752 | 6,747 | ||||||||
Current portion of notes payable | 9,383 | 9,597 | ||||||||
Total current liabilities | 18,837 | 25,309 | ||||||||
Notes payable | 6,330 | 8,611 | ||||||||
Deferred revenue, net of current portion | 1,067 | 595 | ||||||||
Warrant liability, related party | 2,436 | 382 | ||||||||
Other liabilities | 260 | 258 | ||||||||
Total liabilities | 28,930 | 35,155 | ||||||||
Commitments and contingencies | ||||||||||
Redeemable noncontrolling interest | 62,482 | 19,912 | ||||||||
Stockholders’ deficit: | ||||||||||
Class A Common Stock | 203 | 158 | ||||||||
Class B Common Stock | 232 | 232 | ||||||||
Additional paid-in capital | 150,595 | 144,617 | ||||||||
Accumulated deficit | (233,883 | ) | (188,985 | ) | ||||||
Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (82,853 | ) | (43,978 | ) | ||||||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 8,559 | $ | 11,089 | ||||||
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations - Unaudited (in thousands, except per share data) |
||||||||||
Three Months Ended | ||||||||||
December 31, 2018 | September 30, 2018 | |||||||||
Revenue | $ | 4,522 | $ | 3,375 | ||||||
Operating expenses: | ||||||||||
Research and development | 2,800 | 2,698 | ||||||||
General and administrative | 2,073 | 2,158 | ||||||||
Total operating expenses | 4,873 | 4,856 | ||||||||
Operating loss | (351 | ) | (1,481 | ) | ||||||
Interest income | 14 | 13 | ||||||||
Interest expense | (743 | ) | (822 | ) | ||||||
Other (expense) income, net | (1,248 | ) | 329 | |||||||
Loss before income taxes and noncontrolling interest | (2,328 | ) | (1,961 | ) | ||||||
Income tax provision | — | — | ||||||||
Net loss before noncontrolling interest | (2,328 | ) | (1,961 | ) | ||||||
Less: net loss attributable to noncontrolling interest | (1,237 | ) | (1,165 | ) | ||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (1,091 | ) | $ | (796 | ) | ||||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (1,830 | ) | $ | (796 | ) | ||||
Net loss per share of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
$ | (0.10 | ) | $ | (0.06 | ) | ||||
Weighted-average number of vTv Therapeutics Inc.
Class A Common Stock, basic and diluted |
17,635,159 | 12,305,949 | ||||||||
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations (in thousands, except per share data) |
||||||||||||||||||||
Three Months Ended |
For the Year Ended |
|||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenue | $ | 4,522 | $ | 233 | $ | 12,434 | $ | 291 | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 2,800 | 10,068 | 23,035 | 39,640 | ||||||||||||||||
General and administrative | 2,073 | 2,937 | 9,223 | 11,333 | ||||||||||||||||
Total operating expenses | 4,873 | 13,005 | 32,258 | 50,973 | ||||||||||||||||
Operating loss | (351 | ) | (12,772 | ) | (19,824 | ) | (50,682 | ) | ||||||||||||
Interest income | 14 | 22 | 61 | 117 | ||||||||||||||||
Interest expense | (743 | ) | (852 | ) | (3,290 | ) | (3,092 | ) | ||||||||||||
Other expense, net | (1,248 | ) | (190 | ) | (592 | ) | (190 | ) | ||||||||||||
Loss before income taxes and noncontrolling interest | (2,328 | ) | (13,792 | ) | (23,645 | ) | (53,847 | ) | ||||||||||||
Income tax provision | — | 800 | 200 | 800 | ||||||||||||||||
Net loss before noncontrolling interest | (2,328 | ) | (14,592 | ) | (23,845 | ) | (54,647 | ) | ||||||||||||
Less: net loss attributable to noncontrolling interest | (1,237 | ) | (10,281 | ) | (15,934 | ) | (38,503 | ) | ||||||||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (1,091 | ) | $ | (4,311 | ) | $ | (7,911 | ) | $ | (16,144 | ) | ||||||||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (1,830 | ) | $ | (4,311 | ) | $ | (8,650 | ) | $ | (16,144 | ) | ||||||||
Net loss per share of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
$ | (0.10 | ) | $ | (0.44 | ) | $ | (0.69 | ) | $ | (1.67 | ) | ||||||||
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
17,635,159 | 9,693,254 | 12,449,236 | 9,693,254 | ||||||||||||||||
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 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 | ||||||||
December 31, |
September 30, |
|||||||
Numerator: | ||||||||
Net loss attributable to vTv Therapeutics Inc. common shareholders |
$ | (1,830) | $ | (796) | ||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,237) | (1,165) | ||||||
Net loss before noncontrolling interest | $ | (3,067) | $ | (1,961) | ||||
Denominator: | ||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
17,635,159 | 12,305,949 | ||||||
Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,114,652 | ||||||
Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
40,729,380 | 35,420,601 | ||||||
Adjusted proforma earnings per fully exchanged share, basic and diluted |
$ | (0.08) | $ | (0.06) | ||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Numerator: | ||||||||||||||||||||
Net loss attributable to vTv Therapeutics Inc. common Shareholders |
$ | (1,830 | ) | $ | (4,311 | ) | $ | (8,650 | ) | $ | (16,144 | ) | ||||||||
Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) |
(1,237 | ) | (10,281 | ) | (15,934 | ) | (38,503 | ) | ||||||||||||
Net loss before noncontrolling interest | $ | (3,067 | ) | $ | (14,592 | ) | $ | (24,584 | ) | $ | (54,647 | ) | ||||||||
Denominator: | ||||||||||||||||||||
Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted |
17,635,159 | 9,693,254 | 12,449,236 | 9,693,254 | ||||||||||||||||
Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,119,246 | 23,099,500 | 23,119,246 | ||||||||||||||||
Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
40,729,380 | 32,812,500 | 35,548,736 | 32,812,500 | ||||||||||||||||
Adjusted proforma earnings per fully exchanged share, basic and diluted |
$ | (0.08 | ) | $ | (0.44 | ) | $ | (0.69 | ) | $ | (1.67 | ) | ||||||||
(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/20190227005239/en/
Source:
Investors:
vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or
Media:
Josh
Vlasto, 212-572-5969
PR@vtvtherapeutics.com