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vTv Therapeutics Announces 2022 First Quarter Financial Results and Provides Corporate Update
Recent Achievements and Outlook
Corporate
- Strategic Focus. We are prioritizing the development of our lead program TTP399, a novel, oral liver selective glucokinase activator, as a potential treatment for patients with type 1 diabetes (“T1D”), as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we have paused our development activities in
the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, the Company has reduced its workforce. We are actively seeking to raise capital through licensing TTP399 in regions outside ofNorth America andEurope and are also actively seeking licensing deals for HPP737 and other assets. We are currently in active discussions with respect to financing, partnering, and licensing transactions for the further development of TTP399.
Type 1 Diabetes
- Mechanistic Study of Ketoacidosis with TTP399. In
October 2021 , we announced positive results from the Mechanistic study indicating no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with T1D. Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating that treatment with TTP399 presents no increased risk of ketoacidosis. In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 Simplici-T1 Study results. Full study results will be published in the Diabetes Obesity and Metabolism journal in conjunction with the 82nd American Diabetes Association Scientific Sessions onJune 6 th, 2022. - Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects withT1D and has engaged with the
Food and Drug Administration (“FDA”) on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1000 patients and at least one of the studies will be one year of treatment. The FDA and the company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemia events. These pivotal studies are expected to start in 3Q 2022.
First Quarter 2022 Financial Results
- Cash Position: The Company’s cash position as of
March 31, 2022 , was$12.1 million compared to$13.4 million as ofDecember 31, 2021 . - Revenue: Revenue in first quarter of 2022 was
$2.0 million and relates to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong. The revenue for the fourth quarter of 2021 was immaterial. - R&D Expenses: Research and development expenses were
$3.1 million and$5.4 million in each of the three months endedMarch 31, 2022 andDecember 31, 2021 , respectively. The changes are attributable to (i) decreases of$2.0 million for a license payment to Novo Nordisk for the completion of TTP399 phase 2 studies in Q4 2021, (ii) decreased severance costs of$0.7 million and payroll costs of$0.1 million in connection with the Company's restructuring plan that occurred in Q4 2021, (iii) decreased spending of$0.5 million related to the multiple ascending dose study for HPP737 offset by (iv) increases of$1.3 million due to manufacturing and analytical work related to chemistry manufacturing and control “CMC” for pivotal TTP399 studies, and the progression of TTP399 toxicology studies in Q1 2022. - G&A Expenses: General and administrative expenses were consistent between periods at
$5.3 million and$5.7 million for each of the three months endedMarch 31, 2022 , andDecember 31, 2021 . However, individual changes in the quarters are attributable to (i) lower payroll costs of$0.4 million and lower severance costs of$0.7 million due to the Company's restructuring plan that occurred inDecember 2021 and separation agreement with the Company's former CEO in Q1 2022, (ii) lower shared-based expense of$0.6 million due to the modification of awards related to the retirement and separation agreements with several key employees that occurred in Q4 2021, offset by (iii) higher other G&A operating costs of$0.2 million and (iv) increases of$1.1 million in legal expense. - Other Income/(Expense): Other expense for the three months ended
March 31, 2022 , was$2.7 million and was driven by an unrealized loss related to the Company’s investment in Reneo Pharmaceuticals, Inc. (“Reneo”), as well as gains related to a reduction in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party (“Related Party Warrants”). Other income for the three months endedDecember 31, 2021 , was$1.6 million and was driven by changes in the fair value of our investment in Reneo, as well as the gains related to a reduction in fair value of the Related Party Warrants. - Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.4 million for the first quarter of 2022 compared to net loss before non-controlling interest of
$9.5 million for the fourth quarter of 2021. The decrease in net loss before Non-Controlling Interest was attributable to (i) increases in other expense of$4.3 million driven by changes in the fair value of our investment in Reneo, as well as the gains related to a reduction in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party, offset by (ii) lower R&D expenses of$2.3 million , and (iii) higher revenue of$2.0 million due to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong. - Net Loss Per Share: Diluted net loss per share was (
$0.10 ) for the three months endedMarch 31, 2022 compared to diluted net loss per share of ($0.11 ) for the three months endedDecember 31, 2021 , based on weighted-average diluted shares of 66.9 million and 66.8 million for the three-month periods endedMarch 31, 2022 andDecember 31, 2021 , respectively.
Condensed Consolidated Balance Sheets
(in thousands)
2022 | 2021 | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 12,138 | $ | 13,415 | |||
Accounts receivable | 57 | 57 | |||||
Prepaid expenses and other current assets | 1,387 | 2,049 | |||||
Current deposits | 30 | 100 | |||||
Total current assets | 13,612 | 15,621 | |||||
Property and equipment, net | 255 | 278 | |||||
Operating lease right-of-use assets | 379 | 402 | |||||
Long-term investments | 5,939 | 9,173 | |||||
Total assets | $ | 20,185 | $ | 25,474 | |||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 12,474 | $ | 8,023 | |||
Operating lease liabilities | 191 | 184 | |||||
Current portion of contract liabilities | 35 | 35 | |||||
Current portion of notes payable | — | 256 | |||||
Total current liabilities | 12,700 | 8,498 | |||||
Operating lease liabilities, net of current portion | 441 | 492 | |||||
Warrant liability, related party | 770 | 1,262 | |||||
Total liabilities | 13,911 | 10,252 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 14,367 | 24,962 | |||||
Stockholders’ deficit: | |||||||
Class A Common Stock | 669 | 669 | |||||
Class B Common Stock | 232 | 232 | |||||
Additional paid-in capital | 238,669 | 238,193 | |||||
Accumulated deficit | (247,663 | ) | (248,834 | ) | |||
Total stockholders’ deficit attributable to |
(8,093 | ) | (9,740 | ) | |||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 20,185 | $ | 25,474 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
Three Months Ended | |||||||
Revenue | $ | 2,000 | $ | 9 | |||
Operating expenses: | |||||||
Research and development | 3,133 | 5,402 | |||||
General and administrative | 5,348 | 5,716 | |||||
Total operating expenses | 8,481 | 11,118 | |||||
Operating loss | (6,481 | ) | (11,109 | ) | |||
Interest expense | (1 | ) | (6 | ) | |||
Other (expense) income, net | (2,742 | ) | 1,632 | ||||
Loss before income taxes and noncontrolling interest | (9,224 | ) | (9,483 | ) | |||
Income tax provision | 200 | — | |||||
Net loss before noncontrolling interest | (9,424 | ) | (9,483 | ) | |||
Less: net loss attributable to noncontrolling interest | (2,417 | ) | (2,432 | ) | |||
Net loss attributable to |
$ | (7,007 | ) | $ | (7,051 | ) | |
Net loss attributable to |
$ | (7,007 | ) | $ | (7,051 | ) | |
Net loss per share of Common Stock, basic and diluted |
$ | (0.10 | ) | $ | (0.11 | ) | |
Weighted average number of Class A Common Stock, basic and diluted |
66,942,777 | 66,785,550 |
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended |
|||||||
2022 | 2021 | ||||||
(Unaudited) | |||||||
Revenue | $ | 2,000 | $ | 987 | |||
Operating expenses: | |||||||
Research and development | 3,133 | 3,103 | |||||
General and administrative | 5,348 | 2,164 | |||||
Total operating expenses | 8,481 | 5,267 | |||||
Operating loss | (6,481 | ) | (4,280 | ) | |||
Interest income | — | 1 | |||||
Interest expense | (1 | ) | — | ||||
Other expense, net | (2,742 | ) | (1,648 | ) | |||
Loss before income taxes and noncontrolling interest | (9,224 | ) | (5,927 | ) | |||
Income tax provision | 200 | 15 | |||||
Net loss before noncontrolling interest | (9,424 | ) | (5,942 | ) | |||
Less: net loss attributable to noncontrolling interest | (2,417 | ) | (1,701 | ) | |||
Net loss attributable to |
$ | (7,007 | ) | $ | (4,241 | ) | |
Net loss attributable to |
$ | (7,007 | ) | $ | (4,241 | ) | |
Net loss per share of Stock, basic and diluted |
$ | (0.10 | ) | $ | (0.08 | ) | |
Weighted average number of Common Stock, basic and diluted |
66,942,777 | 56,472,535 |
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
Contacts
Investors:
IR@vtvtherapeutics.com.
or
Media:
PR@vtvtherapeutics.com

Source: vTv Therapeutics Inc.