Full Press Release Details
vTv Therapeutics Announces 2019 Third Quarter Financial Results and Update
SimpliciT-1 Study of TTP399 in patients with type 1 diabetes fully-enrolled
Elevage Study of azeliragon in patients with mild Alzheimer's disease with type 2 diabetes actively enrolling
HIGH POINT, N.C. - (BUSINESS WIRE) - Oct. 30, 2019 - vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the third quarter that ended September 30, 2019, and provided an update on recent achievements, events, and its ongoing clinical trials in type 1 diabetes and Alzheimer's disease.
"We hosted an informative type 1 diabetes key opinion leader event with JDRF this quarter where two prominent KOLs, Drs. John Buse and Kevan Herold, shared important information including that, despite the increasingly widespread use of improved technologies like continuous glucose monitoring, nearly 80% of individuals with type 1 diabetes fail to achieve the American Diabetes Association's target goals for HbA1c," said Steve Holcombe, chief executive officer, vTv Therapeutics. "Based on the data we've seen to date in our trial of TTP399 in patients with type 1 diabetes, we believe our glucokinase activator could eventually provide a meaningful treatment option to patients with type 1 diabetes that would lower A1c, improve glycemic control and reduce daily insulin use, without increasing hypoglycemic events."
"We are also pleased that we are continuing to make progress with the Elevage Study of azeliragon in patients with mild Alzheimer's disease with type 2 diabetes that is expected to read-out in late 2020 or early 2021."
Recent Achievements and Outlook
Type 1 Diabetes Study
Alzheimer's Disease Study
The Elevage Study is designed to confirm the positive post-hoc subgroup results from the previous phase 3 study of azeliragon in patients with mild Alzheimer's disease in which the subgroup of AD patients with type 2 diabetes (defined by an HbA1c of greater than 6.5% at any time in the study) treated with azeliragon demonstrated a potential benefit in both cognition and function relative to those treated with placebo.
The phase 2 part of the Elevage Study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score 10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive). We expect to report topline results from the phase 2 proof of concept study by late 2020 or early 2021.
An archived version of the event can be found here.
Second Quarter 2019 Financial Results
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
| September 30, | June 30 | ||||||
| 2019 | 2019 | ||||||
| (Unaudited) | (Unaudited) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 2,436 | $ | 1,462 | |||
| Accounts receivable, net | 10 | 1,822 | |||||
| Prepaid expenses and other current assets | 870 | 145 | |||||
| Current deposits | 251 | 367 | |||||
| Total current assets | 3,567 | 3,796 | |||||
| Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | |||||
| Property and equipment, net | 46 | 54 | |||||
| Operating lease right-of-use assets | 85 | 167 | |||||
| Long-term investments | 2,480 | 2,480 | |||||
| Long-term deposits | 444 | 75 | |||||
| Total assets | $ | 9,122 | $ | 9,072 | |||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 6,898 | $ | 8,326 | |||
| Operating lease liabilities | 91 | 178 | |||||
| Current portion of deferred revenue | 31 | 27 | |||||
| Current portion of notes payable | 7,442 | 8,646 | |||||
| Total current liabilities | 14,462 | 17,177 | |||||
| Notes payable, net of current portion | 1,363 | 2,185 | |||||
| Deferred revenue, net of current portion | 1,040 | 1,052 | |||||
| Warrant liability, related party | 1,878 | 1,240 | |||||
| Other liabilities | 260 | 260 | |||||
| Total liabilities | 19,003 | 21,914 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 37,268 | 37,060 | |||||
| Stockholders' deficit: | |||||||
| Class A Common Stock | 354 | 298 | |||||
| Class B Common Stock | 232 | 232 | |||||
| Additional paid-in capital | 175,990 | 167,125 | |||||
| Accumulated deficit | (223,725 | ) | (217,557 | ) | |||
| Total stockholders' deficit attributable to vTv Therapeutics Inc. | (47,149 | ) | (49,902 | ) | |||
| Total liabilities, redeemable noncontrolling interest and stockholders' deficit | $ | 9,122 | $ | 9,072 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended | |||||||
| September 30, 2019 | June 30, 2019 | ||||||
| Revenue | $ | 8 | $ | 1,828 | |||
| Operating expenses: | |||||||
| Research and development | 3,663 | 4,228 | |||||
| General and administrative | 1,770 | 2,392 | |||||
| Total operating expenses | 5,433 | 6,620 | |||||
| Operating loss | (5,425 | ) | (4,792 | ) | |||
| Interest income | 15 | 16 | |||||
| Interest expense | (404 | ) | (514 | ) | |||
| Other (expense) income, net | (146 | ) | 276 | ||||
| Loss before income taxes and noncontrolling interest | (5,960 | ) | (5,014 | ) | |||
| Income tax provision | - | 100 | |||||
| Net loss before noncontrolling interest | (5,960 | ) | (5,114 | ) | |||
| Less: net loss attributable to noncontrolling interest | (2,352 | ) | (2,232 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. | $ | (3,608 | ) | $ | (2,882 | ) | |
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (4,115 | ) | $ | (2,882 | ) | |
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.13 | ) | $ | (0.10 | ) | |
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 32,126,130 | 28,037,628 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended September 30, | For the Nine Months Ended September 30, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | $ | 8 | $ | 3,375 | $ | 2,757 | $ | 7,912 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 3,663 | 2,698 | 10,713 | 20,235 | |||||||||||
| General and administrative | 1,770 | 2,158 | 6,548 | 7,150 | |||||||||||
| Total operating expenses | 5,433 | 4,856 | 17,261 | 27,385 | |||||||||||
| Operating loss | (5,425 | ) | (1,481 | ) | (14,504 | ) | (19,473 | ) | |||||||
| Interest income | 15 | 13 | 41 | 47 | |||||||||||
| Interest expense | (404 | ) | (822 | ) | (1,544 | ) | (2,547 | ) | |||||||
| Other (expense) income, net | (146 | ) | 329 | 1,051 | 656 | ||||||||||
| Loss before income taxes and noncontrolling interest | (5,960 | ) | (1,961 | ) | (14,956 | ) | (21,317 | ) | |||||||
| Income tax provision | - | - | 100 | 200 | |||||||||||
| Net loss before noncontrolling interest | (5,960 | ) | (1,961 | ) | (15,056 | ) | (21,517 | ) | |||||||
| Less: net loss attributable to noncontrolling interest | (2,352 | ) | (1,165 | ) | (6,411 | ) | (14,697 | ) | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (3,608 | ) | $ | (796 | ) | $ | (8,645 | ) | $ | (6,820 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (4,115 | ) | $ | (796 | ) | $ | (12,880 | ) | $ | (6,820 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.13 | ) | $ | (0.06 | ) | $ | (0.46 | ) | $ | (0.64 | ) | |||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 32,126,130 | 12,305,949 | 27,709,486 | 10,701,599 |
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases.
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 | |||||||
| September 30, 2019 | June 30, 2019 | ||||||
| Numerator: | |||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (4,115 | ) | $ | (2,882 | ) | |
| Other income - related party | (146 | ) | 275 | ||||
| Share-based compensation expense | 413 | 401 | |||||
| Deemed distribution to related party | 507 | - | |||||
| Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (2,352 | ) | (2,232 | ) | |||
| Adjusted net loss before noncontrolling interest | $ | (5,693 | ) | $ | (4,438 | ) | |
| Denominator: | |||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 32,126,130 | 28,037,628 | |||||
| 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 | 55,220,351 | 51,131,849 | |||||
| Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.10 | ) | $ | (0.09 | ) |
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Numerator: | |||||||||||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (4,115 | ) | $ | (796 | ) | $ | (12,880 | ) | $ | (6,820 | ) | |||
| Other income - related party | (146 | ) | 319 | 1,050 | 610 | ||||||||||
| Share-based compensation expense | 413 | 579 | 1,095 | 2,345 | |||||||||||
| Deemed distribution to related party | 507 | - | 4,235 | - | |||||||||||
| Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (2,352 | ) | (1,165 | ) | (6,411 | ) | (14,697 | ) | |||||||
| Adjusted net loss before noncontrolling interest | $ | (5,693 | ) | $ | (1,063 | ) | $ | (12,911 | ) | $ | (18,562 | ) | |||
| Denominator: | |||||||||||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 32,126,130 | 12,305,949 | 27,709,486 | 10,701,599 | |||||||||||
| Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,114,652 | 23,094,221 | 23,101,279 | |||||||||||
| Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted | 55,220,351 | 35,420,601 | 50,803,707 | 33,802,878 | |||||||||||
| Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.10 | ) | $ | (0.03 | ) | $ | (0.25 | ) | $ | (0.55 | ) |
vTv Therapeutics Inc.
Josh Vlasto, 212-572-5969