“We plan to refocus vTv’s strategy on TTP399. TTP399 is unique and the most important product in our portfolio with strong equity value potential to our shareholders”, said
Recent Achievements and Outlook
Corporate
- Leadership. On
October 19, 2021 ,Deepa Prasad was appointed to the role of President and CEO, and joined the board of directors. Deepa is a recognized healthcare leader with more than 20 years of experience across startup funding, operations, investment banking, and healthcare policy. Most recently, Deepa led investments in innovative life science companies as a managing director atWest River Group . - Strategic Focus. We plan to implement a strategy to focus our efforts on the continued development of TTP399 as a potential treatment for patients with type 1 diabetes (“T1D”) and TTP273 as a potential treatment for patients with cystic fibrosis related diabetes, as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we plan to pause our development activities in
the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, we are also evaluating cost reductions which may include reductions in our workforce. - Balance Sheet. The Company strengthened its balance sheet during the quarter through utilization of the at-the-market equity program with
Cantor Fitzgerald , ending the quarter with$19.6 million of cash, cash equivalents and marketable securities.
Type 1 Diabetes
- Mechanistic Study of Ketoacidosis with TTP399. In
October 2021 , the Company announced positive results from the mechanistic study of TTP399 in people with type 1 diabetes. 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 SimpliciT1 Study results. - Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes and is engaged with the FDA on the optimal clinical trial designs for these studies. The Company expects to begin these pivotal studies in the first half of 2022.
Third Quarter 2021 Financial Results
- Cash Position: The Company’s cash position as of
September 30, 2021 , was$19.6 million compared to$10.8 million as ofJune 30, 2021 . - Revenue: Revenue for the third quarter of 2021 was
$3.0 million , attributable to the satisfaction of milestones under the license agreements withNewsoara Biopharma Co., Ltd. and Reneo Pharmaceuticals, Inc. Revenue for the second quarter of 2021 was an insignificant amount. - R&D Expenses: Research and development expenses were
$2.4 million in each of the three months endedSeptember 30, 2021 andJune 30, 2021 , respectively. - G&A Expenses: General and administrative expenses were consistent between periods at
$2.2 million for each of the three months endedSeptember 30, 2021 andJune 30, 2021 . - Other Income/(Expense): Other expense for the three months ended
September 30, 2021 was$0.2 million and was attributable to the gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the “Related Party Warrants”) offset by losses driven by the decrease in the fair value of our investment in Reneo Pharmaceuticals, Inc. (the “Reneo Investment”). Other income for the three months endedJune 30, 2021 of$3.8 million was driven by changes in value of theReneo Investment and gains related to the reduction in fair value of the Related Party Warrants. - Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $1.5 million for the third quarter of 2021 compared to net loss before non-controlling interest of $0.8 million for the second quarter of 2021.
- Net Loss Per Share: Diluted net loss per share was (
$0.02 ) for the three months endedSeptember 30, 2021 compared to diluted net loss per share of ($0.01 ) for the three months endedJune 30, 2021 , based on weighted-average diluted shares of 61.1 million and 58.6 million for the three-month periods endedSeptember 30, 2021 andJune 30, 2021 , respectively.
Condensed Consolidated Balance Sheets
(in thousands)
2021 | 2021 | ||||||
(Unaudited) | (Unaudited) | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 19,566 | $ | 10,835 | |||
Accounts receivable, net | 928 | — | |||||
Prepaid expenses and other current assets | 1,574 | 313 | |||||
Current deposits | 103 | 124 | |||||
Total current assets | 22,171 | 11,272 | |||||
Property and equipment, net | 300 | 322 | |||||
Operating lease right-of-use assets | 424 | 444 | |||||
Long-term investments | 8,539 | 9,622 | |||||
Total assets | $ | 31,434 | $ | 21,660 | |||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 4,663 | $ | 4,855 | |||
Operating lease liabilities | 176 | 169 | |||||
Current portion of contract liabilities | 35 | 35 | |||||
Current portion of notes payable | 636 | — | |||||
Total current liabilities | 5,510 | 5,059 | |||||
Contract liabilities, net of current portion | 9 | 9 | |||||
Operating lease liabilities, net of current portion | 540 | 587 | |||||
Warrant liability, related party | 2,260 | 3,588 | |||||
Other liabilities | 50 | 50 | |||||
Total liabilities | 8,369 | 9,293 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 44,610 | 60,190 | |||||
Stockholders’ deficit: | |||||||
Class A Common Stock | 665 | 602 | |||||
Class B Common Stock | 232 | 232 | |||||
Additional paid-in capital | 236,557 | 224,457 | |||||
Accumulated deficit | (258,999 | ) | (273,114 | ) | |||
Total stockholders’ deficit attributable to | (21,545 | ) | (47,823 | ) | |||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 31,434 | $ | 21,660 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
Three Months Ended | |||||||
2021 | |||||||
Revenue | $ | 3,000 | $ | 9 | |||
Operating expenses: | |||||||
Research and development | 2,382 | 2,437 | |||||
General and administrative | 2,221 | 2,242 | |||||
Total operating expenses | 4,603 | 4,679 | |||||
Operating loss | (1,603 | ) | (4,670 | ) | |||
Interest expense | (6 | ) | — | ||||
Other income, net | 244 | 3,829 | |||||
Loss before income taxes and noncontrolling interest | (1,365 | ) | (841 | ) | |||
Income tax provision | 100 | — | |||||
Net loss before noncontrolling interest | (1,465 | ) | (841 | ) | |||
Less: net loss attributable to noncontrolling interest | (378 | ) | (233 | ) | |||
Net loss attributable to | $ | (1,087 | ) | $ | (608 | ) | |
Net loss attributable to | $ | (1,087 | ) | $ | (608 | ) | |
Net loss per share of Common Stock, basic and diluted | $ | (0.02 | ) | $ | (0.01 | ) | |
Weighted-average number of Class A Common Stock, basic and diluted | 61,073,280 | 58,615,137 | |||||
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended | For the Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||
Revenue | $ | 3,000 | $ | 7 | $ | 3,996 | $ | 15 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 2,382 | 1,768 | 7,922 | 8,481 | |||||||||||
General and administrative | 2,221 | 1,071 | 6,627 | 5,216 | |||||||||||
Total operating expenses | 4,603 | 2,839 | 14,549 | 13,697 | |||||||||||
Operating loss | (1,603 | ) | (2,832 | ) | (10,553 | ) | (13,682 | ) | |||||||
Interest income | — | — | 1 | 12 | |||||||||||
Interest expense | (6 | ) | (235 | ) | (6 | ) | (625 | ) | |||||||
Other income (expense), net | 244 | 814 | 2,425 | (114 | ) | ||||||||||
Loss before income taxes and noncontrolling interest | (1,365 | ) | (2,253 | ) | (8,133 | ) | (14,409 | ) | |||||||
Income tax provision | 100 | — | 115 | — | |||||||||||
Net loss before noncontrolling interest | (1,465 | ) | (2,253 | ) | (8,248 | ) | (14,409 | ) | |||||||
Less: net loss attributable to noncontrolling interest | (378 | ) | (720 | ) | (2,312 | ) | (4,784 | ) | |||||||
Net loss attributable to | $ | (1,087 | ) | $ | (1,533 | ) | $ | (5,936 | ) | $ | (9,625 | ) | |||
Net loss attributable to shareholders | $ | (1,087 | ) | $ | (1,533 | ) | $ | (5,936 | ) | $ | (8,765 | ) | |||
Net loss per share of Common Stock, basic and diluted | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.10 | ) | $ | (0.21 | ) | |||
Weighted-average number of Class A Common Stock, basic and diluted | 61,073,280 | 48,238,285 | 58,737,170 | 45,796,298 |
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:
CDavis@LifeSciAdvisors.com
or
Media:
PR@vtvtherapeutics.com
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