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vTv Therapeutics Announces 2020 Second Quarter Financial Results and Update
“Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development,” said
Recent Achievements and Outlook
Type 1 Diabetes
- FDA Engagement and Pivotal Study Planning. Following a Type C Meeting request, vTv received written feedback from the FDA in June regarding the design of the Company’s proposed pivotal studies. vTv expects to commence the next study for TTP399 by the end of 2020 with a six-month treatment period and a six-month open label extension. A second study with a 6-month treatment period would be initiated within 12 months after initiation of the first trial.
- Two Presentations at
ADA of Simplici-T1 Study Results. Dr.John Buse ,University of North Carolina at Chapel Hill , and Dr.Carmen Valcarce , chief scientific officer, made separate presentations at the American Diabetes Association’s 80th Scientific Sessions on the results of the Simplici-T1 Study in which TTP399 improved HbA1c in patients with type 1 diabetes, while reducing insulin dose and lowering the incidence of hypoglycemia and diabetic ketoacidosis.
Dementia with Diabetes
- Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv continues to enroll patients in the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with probable mild Alzheimer's disease (AD) and type 2 diabetes. Recruitment for the study will conclude by
September 30, 2020 with a target of approximately 50 patients enrolled. The Company expects to report topline results from this study in the second quarter of 2021.
- Additional Clinical Data from STEADFAST Presented at AAIC. Dr.
Aaron Burstein , SVP clinical development, presented additional clinical data at the Alzheimer’sAssociation International Conference of the impact of azeliragon on the individual components of CDR-sb and ADAS-cog, the two primary instruments used to evaluate Alzheimer’s disease.
Financing Activities
During the second quarter, vTv entered into agreements in order to provide additional financial flexibility and availability of additional capital to fund its near-term operations.
- Amendment to the Loan Agreement. On
July 29, 2020 , vTv entered into the Third Amendment to the Company’s existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for two additional months beginningJuly 1, 2020 and to extend the maturity date of the first tranche fromAugust 1 to September 1, 2020 . The Third Amendment also eliminates the requirement for the Company to maintain a minimum cash balance.
- ATM Sales. Under the Controlled Equity OfferingSM Sales Agreement with
Cantor Fitzgerald , vTv sold shares of its Class A common stock having an aggregate offering price of$7.6 million as of the end of the second quarter.
Second Quarter 2020 Financial Results
- Cash Position: The Company’s cash position as of
June 30, 2020 , was$6.4 million compared to$0.4 million as ofMarch 31, 2020 .
- Revenue: Revenues were insignificant for both the first and second quarter of 2020.
- R&D Expenses: Research and development expenses were
$2.5 million and$4.2 million for the three months endedJune 30, 2020 andMarch 31, 2020 , respectively. This decrease of$1.7 million was driven primarily by a decrease of$0.5 million related to the development of TTP399, as the Simplici-T1 Study was completed in early 2020. Further, costs related to the development of azeliragon decreased approximately$0.8 million related to lower costs incurred for the Elevage Study due to a slowdown in enrollment caused, in part, by COVID-19.
- G&A Expenses: General and administrative expenses were
$1.7 million for the second quarter of 2020 and$2.5 million for the first quarter, respectively. The decrease of$0.8 million was driven by lower professional fees, an adjustment made to the Company’s asset retirement obligation recorded in connection with a leased facility, and overall expense curtailment.
- Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.0 million for the second quarter of 2020 compared to $7.2 million for the first quarter of 2020.
- Net Loss Per Share: GAAP net loss per share was
$0.07 and$0.11 for the three months endedJune 30, 2020 andMarch 31, 2020 , respectively, based on weighted-average shares of 45.7 million and 43.5 million for the three-month periods endedJune 30, 2020 andMarch 31, 2020 , respectively. Non-GAAP net loss per fully exchanged share was$0.08 and$0.11 for the three months endedJune 30, 2020 andMarch 31, 2020 , respectively, based on non-GAAP fully exchanged weighted-average shares of 68.8 million and 66.6 million for the three months endedJune 30, 2020 andMarch 31, 2020 , respectively.
Condensed Consolidated Balance Sheets
(in thousands)
2020 | 2020 | ||||||
(Unaudited) | (Unaudited) | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 6,392 | $ | 406 | |||
Restricted cash and cash equivalents | — | 2,500 | |||||
Accounts receivable, net | — | 5 | |||||
Prepaid expenses and other current assets | 299 | 591 | |||||
Current deposits | 87 | — | |||||
Total current assets | 6,778 | 3,502 | |||||
Property and equipment, net | 412 | 434 | |||||
Operating lease right-of-use assets | 514 | 529 | |||||
Long-term investments | 2,480 | 2,480 | |||||
Long-term deposits | 444 | 444 | |||||
Total assets | $ | 10,628 | $ | 7,389 | |||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 6,697 | $ | 7,395 | |||
Operating lease liabilities | 143 | 136 | |||||
Current portion of contract liabilities | 31 | 31 | |||||
Current portion of notes payable | 4,543 | 4,408 | |||||
Total current liabilities | 11,414 | 11,970 | |||||
Contract liabilities, net of current portion | 1,025 | 1,025 | |||||
Operating lease liabilities, net of current portion | 756 | 795 | |||||
Warrant liability, related party | 3,529 | 2,964 | |||||
Other liabilities | 54 | 260 | |||||
Total liabilities | 16,778 | 17,014 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 63,378 | 52,196 | |||||
Stockholders’ deficit: | |||||||
Class A Common Stock | 479 | 447 | |||||
Class B Common Stock | 232 | 232 | |||||
Additional paid-in capital | 198,634 | 190,200 | |||||
Accumulated deficit | (268,873 | ) | (252,700 | ) | |||
Total stockholders’ deficit attributable to |
(69,528 | ) | (61,821 | ) | |||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 10,628 | $ | 7,389 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
Three Months Ended | |||||||
Revenue | $ | — | $ | 8 | |||
Operating expenses: | |||||||
Research and development | 2,509 | 4,204 | |||||
General and administrative | 1,695 | 2,450 | |||||
Total operating expenses | 4,204 | 6,654 | |||||
Operating loss | (4,204 | ) | (6,646 | ) | |||
Interest income | — | 12 | |||||
Interest expense | (222 | ) | (168 | ) | |||
Other (expense) income, net | (565 | ) | (363 | ) | |||
Loss before income taxes and noncontrolling interest | (4,991 | ) | (7,165 | ) | |||
Income tax provision | — | — | |||||
Net loss before noncontrolling interest | (4,991 | ) | (7,165 | ) | |||
Less: net loss attributable to noncontrolling interest | (1,623 | ) | (2,441 | ) | |||
Net loss attributable to |
$ | (3,368 | ) | $ | (4,724 | ) | |
Net loss attributable to |
$ | (3,368 | ) | $ | (4,724 | ) | |
Net loss per share of Common Stock, basic and diluted |
$ | (0.07 | ) | $ | (0.11 | ) | |
Weighted-average number of Class A Common Stock, basic and diluted |
45,661,221 | 43,462,551 |
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended |
For the Six Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||
Revenue | $ | — | $ | 1,828 | $ | 8 | $ | 2,749 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 2,509 | 4,228 | 6,713 | 7,050 | |||||||||||
General and administrative | 1,695 | 2,392 | 4,145 | 4,778 | |||||||||||
Total operating expenses | 4,204 | 6,620 | 10,858 | 11,828 | |||||||||||
Operating loss | (4,204 | ) | (4,792 | ) | (10,850 | ) | (9,079 | ) | |||||||
Interest income | — | 16 | 12 | 26 | |||||||||||
Interest expense | (222 | ) | (514 | ) | (390 | ) | (1,140 | ) | |||||||
Other (expense) income, net | (565 | ) | 276 | (928 | ) | 1,197 | |||||||||
Loss before income taxes and noncontrolling interest | (4,991 | ) | (5,014 | ) | (12,156 | ) | (8,996 | ) | |||||||
Income tax provision | — | 100 | — | 100 | |||||||||||
Net loss before noncontrolling interest | (4,991 | ) | (5,114 | ) | (12,156 | ) | (9,096 | ) | |||||||
Less: net loss attributable to noncontrolling interest | (1,623 | ) | (2,232 | ) | (4,064 | ) | (4,059 | ) | |||||||
Net loss attributable to |
$ | (3,368 | ) | $ | (2,882 | ) | $ | (8,092 | ) | $ | (5,037 | ) | |||
Net loss attributable to |
$ | (3,368 | ) | $ | (2,882 | ) | $ | (8,092 | ) | $ | (8,765 | ) | |||
Net loss per share of Stock, basic and diluted |
$ | (0.07 | ) | $ | (0.10 | ) | $ | (0.18 | ) | $ | (0.34 | ) | |||
Weighted-average number of Common Stock, basic and diluted |
45,661,221 | 28,037,628 | 44,561,886 | 25,464,562 |
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
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
Three Months Ended | |||||||
Numerator: | |||||||
Net loss attributable to |
$ | (3,368 | ) | $ | (4,724 | ) | |
Other income - related party | (565 | ) | (363 | ) | |||
Share-based compensation expense | 186 | 380 | |||||
Deemed distribution to related party | — | — | |||||
Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) |
(1,623 | ) | (2,441 | ) | |||
Adjusted net loss before noncontrolling interest | $ | (5,370 | ) | $ | (7,148 | ) | |
Denominator: | |||||||
Weighted-average number of Class A Common Stock, basic and diluted |
45,661,221 | 43,462,551 | |||||
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 |
68,755,442 | 66,556,772 | |||||
Adjusted net loss per fully exchanged share, basic and diluted |
$ | (0.08 | ) | $ | (0.11 | ) |
Three Months Ended |
Six Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Numerator: | |||||||||||||||
Net loss attributable to |
$ | (3,368 | ) | $ | (2,882 | ) | $ | (8,092 | ) | $ | (8,765 | ) | |||
Other income - related party | (565 | ) | 275 | (928 | ) | 1,196 | |||||||||
Share-based compensation expense | 186 | 401 | 566 | 682 | |||||||||||
Deemed distribution to related party | — | — | — | 3,728 | |||||||||||
Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) |
(1,623 | ) | (2,232 | ) | (4,064 | ) | (4,059 | ) | |||||||
Adjusted net loss before noncontrolling interest | $ | (5,370 | ) | $ | (4,438 | ) | $ | (12,518 | ) | $ | (7,218 | ) | |||
Denominator: | |||||||||||||||
Weighted-average number of Class A Common Stock, basic and diluted |
45,661,221 | 28,037,628 | 44,561,886 | 25,464,562 | |||||||||||
Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,094,221 | 23,094,221 | 23,094,221 | |||||||||||
Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted |
68,755,442 | 51,131,849 | 67,656,107 | 48,558,783 | |||||||||||
Adjusted net loss per fully exchanged share, basic and diluted |
$ | (0.08 | ) | $ | (0.09 | ) | $ | (0.19 | ) | $ | (0.15 | ) |
(1) | Assumes the exchange of all outstanding Class B common stock, resulting in the elimination of the noncontrolling interest and recognition of the net income attributable to noncontrolling interests. |
Contacts
Investors:
CDavis@LifeSciAdvisors.com
or
Media:
646-871-8485
gsilver@lazarpartners.com
Source: vTv Therapeutics Inc.