Full Press Release Details
vTv Therapeutics Announces 2019 Second Quarter Financial Results and Update
HIGH POINT, N.C. - (GLOBE NEWSWIRE) - Jul. 31, 2019 - vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter that ended June 30, 2019, and provided an update on recent achievements and upcoming events.
"We made significant progress during the second quarter," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We reported positive results from part 1 of our phase 2 Simplici-T1 trial in type 1 diabetes and began screening patients for our 488-305 trial evaluating azeliragon in patients with mild Alzheimer's disease and type 2 diabetes. We look forward to continuing to execute successfully on our development plans for each of these drug candidates and advancing them as potential treatments for patients suffering from these diseases."
Recent Achievements and Outlook
In this double-blind, placebo-controlled 12-week trial, the baseline mean HbA1c for the groups treated with TTP399 and placebo was 7.3% and 7.4%, respectively. Patients treated with TTP399 (n=8) showed a statistically significant mean reduction in HbA1c of 0.6% at 12 weeks, while the group treated with placebo (n=11) showed a mean increase in HbA1c of 0.1%, resulting in a mean improvement of 0.7% in the TTP399 group relative to the placebo group (p=0.03).
TTP399 was well tolerated in the study, with no serious adverse event reported, and no report of diabetic ketoacidosis or severe hypoglycemia.
vTv expects to report topline results from the phase 2 proof of concept study by the end of the fourth quarter of 2020.
vTv will present additional results from Part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes in Barcelona Spain, September 16-20, 2019 with a poster entitled "Results from the sentinel and learning phase of the Simplici-T1 study, the first clinical trial to test activation of glucokinase as an adjunctive treatment for type 1 diabetes".
Second Quarter 2019 Financial Results
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
| June 30, | March 31, | ||||||
| 2019 | 2019 | ||||||
| (Unaudited) | (Unaudited) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 1,462 | $ | 4,959 | |||
| Accounts receivable, net | 1,822 | - | |||||
| Prepaid expenses and other current assets | 145 | 419 | |||||
| Current deposits | 367 | 34 | |||||
| Total current assets | 3,796 | 5,412 | |||||
| Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | |||||
| Property and equipment, net | 54 | 62 | |||||
| Operating lease right-of-use assets | 167 | 246 | |||||
| Long-term investments | 2,480 | 2,480 | |||||
| Long-term deposits | 75 | 36 | |||||
| Total assets | $ | 9,072 | $ | 10,736 | |||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 8,326 | $ | 6,244 | |||
| Operating lease liabilities | 178 | 259 | |||||
| Current portion of deferred revenue | 27 | 839 | |||||
| Current portion of notes payable | 8,646 | 9,167 | |||||
| Total current liabilities | 17,177 | 16,509 | |||||
| Notes payable, net of current portion | 2,185 | 4,014 | |||||
| Deferred revenue, net of current portion | 1,052 | 1,067 | |||||
| Warrant liability, related party | 1,240 | 1,515 | |||||
| Other liabilities | 260 | 260 | |||||
| Total liabilities | 21,914 | 23,365 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 37,060 | 45,106 | |||||
| Stockholders' deficit: | |||||||
| Class A Common Stock | 298 | 273 | |||||
| Class B Common Stock | 232 | 232 | |||||
| Additional paid-in capital | 167,125 | 162,249 | |||||
| Accumulated deficit | (217,557 | ) | (220,489 | ) | |||
| Total stockholders' deficit attributable to vTv Therapeutics Inc. | (49,902 | ) | (57,735 | ) | |||
| Total liabilities, redeemable noncontrolling interest and stockholders' deficit | $ | 9,072 | $ | 10,736 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended | |||||||
| June 30, 2019 | March 31, 2019 | ||||||
| Revenue | $ | 1,828 | $ | 921 | |||
| Operating expenses: | |||||||
| Research and development | 4,228 | 2,822 | |||||
| General and administrative | 2,392 | 2,386 | |||||
| Total operating expenses | 6,620 | 5,208 | |||||
| Operating loss | (4,792 | ) | (4,287 | ) | |||
| Interest income | 16 | 10 | |||||
| Interest expense | (514 | ) | (626 | ) | |||
| Other income, net | 276 | 921 | |||||
| Loss before income taxes and noncontrolling interest | (5,014 | ) | (3,982 | ) | |||
| Income tax provision | 100 | - | |||||
| Net loss before noncontrolling interest | (5,114 | ) | (3,982 | ) | |||
| Less: net loss attributable to noncontrolling interest | (2,232 | ) | (1,827 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. | $ | (2,882 | ) | $ | (2,155 | ) | |
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (2,882 | ) | $ | (5,883 | ) | |
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.10 | ) | $ | (0.26 | ) | |
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 28,037,628 | 22,862,907 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | $ | 1,828 | $ | 2,473 | $ | 2,749 | $ | 4,537 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 4,228 | 8,594 | 7,050 | 17,537 | |||||||||||
| General and administrative | 2,392 | 2,737 | 4,778 | 4,992 | |||||||||||
| Total operating expenses | 6,620 | 11,331 | 11,828 | 22,529 | |||||||||||
| Operating loss | (4,792 | ) | (8,858 | ) | (9,079 | ) | (17,992 | ) | |||||||
| Interest income | 16 | 16 | 26 | 34 | |||||||||||
| Interest expense | (514 | ) | (870 | ) | (1,140 | ) | (1,725 | ) | |||||||
| Other income, net | 276 | 316 | 1,197 | 327 | |||||||||||
| Loss before income taxes and noncontrolling interest | (5,014 | ) | (9,396 | ) | (8,996 | ) | (19,356 | ) | |||||||
| Income tax provision | 100 | 200 | 100 | 200 | |||||||||||
| Net loss before noncontrolling interest | (5,114 | ) | (9,596 | ) | (9,096 | ) | (19,556 | ) | |||||||
| Less: net loss attributable to noncontrolling interest | (2,232 | ) | (6,524 | ) | (4,059 | ) | (13,532 | ) | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (2,882 | ) | $ | (3,072 | ) | $ | (5,037 | ) | $ | (6,024 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (2,882 | ) | $ | (3,072 | ) | $ | (8,765 | ) | $ | (6,024 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.10 | ) | $ | (0.31 | ) | $ | (0.34 | ) | $ | (0.61 | ) | |||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 28,037,628 | 10,049,831 | 25,464,562 | 9,875,743 |
About vTv Therapeutics
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, diabetes, and inflammatory disorders.
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 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.
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 adjusted net loss per fully exchanged share, which is a non-GAAP financial measure. Non-GAAP adjusted net loss per fully exchanged share adjusts the net loss attributable to vTv common shareholders for the impact of adjustments related to outstanding warrants, share-based compensation expense and the portion of net loss attributable to the noncontrolling interest. It also assumes the exchange of all the Class B common stock of vTv Therapeutics Inc. and an equal number of non-voting common units of vTv Therapeutics LLC ("vTv Units") for shares of Class A common stock of vTv Therapeutics Inc. We believe that this measure provides useful information to investors as it eliminates the variability of non-controlling interest resulting from the exchanges of Class B common stock and vTv Units into Class A common stock and other items of a non-cash nature. This measure is not intended to be considered in isolation or as a substitute for, or superior to, financial measures prepared and presented in accordance with GAAP.
The following is a reconciliation of non-GAAP adjusted net loss per fully exchanged share, basic and diluted to its most directly comparable GAAP measure, net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted and the computation of the components of this non-GAAP measure:
| Three Months Ended | |||||||
| June 30, 2019 | March 31, 2019 | ||||||
| Numerator: | |||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (2,882 | ) | $ | (5,883 | ) | |
| Other income - related party | 275 | 921 | |||||
| Share-based compensation expense | 401 | 281 | |||||
| Deemed distribution to related party | - | 3,728 | |||||
| Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (2,232 | ) | (1,827 | ) | |||
| Adjusted net loss before noncontrolling interest | $ | (4,438 | ) | $ | (2,780 | ) | |
| Denominator: | |||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 28,037,628 | 22,862,907 | |||||
| Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,094,221 | |||||
| Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted | 51,131,849 | 45,957,128 | |||||
| Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.09 | ) | $ | (0.06 | ) |
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Numerator: | |||||||||||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (2,882 | ) | $ | (3,072 | ) | $ | (8,765 | ) | $ | (6,024 | ) | |||
| Other income - related party | 275 | 316 | 1,196 | 291 | |||||||||||
| Share-based compensation expense | 401 | 803 | 682 | 1,766 | |||||||||||
| Deemed distribution to related party | - | - | 3,728 | - | |||||||||||
| Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (2,232 | ) | (6,524 | ) | (4,059 | ) | (13,532 | ) | |||||||
| Adjusted net loss before noncontrolling interest | $ | (4,438 | ) | $ | (8,477 | ) | $ | (7,218 | ) | $ | (17,499 | ) | |||
| Denominator: | |||||||||||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 28,037,628 | 10,049,831 | 25,464,562 | 9,875,743 | |||||||||||
| Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,094,221 | 23,094,221 | 23,104,867 | |||||||||||
| Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted | 51,131,849 | 33,144,052 | 48,558,783 | 32,980,610 | |||||||||||
| Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.09 | ) | $ | (0.26 | ) | $ | (0.15 | ) | $ | (0.53 | ) |
vTv Therapeutics Inc.
Josh Vlasto, 212-572-5969