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vTv Therapeutics Announces 2020 First Quarter Financial Results and Update
“In spite of the challenges presented by the COVID-19 pandemic, we are encouraged by the continued progress we made this past quarter with our two key late stage clinical programs for TTP399 for the treatment of type 1 diabetes and azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes,” said
Recent Achievements and Outlook
Type 1 Diabetes Study
- Full results from the SimpliciT-1 Study to be presented at
ADA . We will present posters detailing further results from the phase 2 Simplici-T1 Study of TTP399 in patients with type 1 diabetes at the 80th Scientific Sessions held virtually by theAmerican Diabetes Association ,June 12-16 th.
Alzheimer’s Disease Study
- Enrollment continues for Phase 2 Elevage Study of azeliragon.
vTv Therapeutics continues to enroll patients in the Phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease (AD) and type 2 diabetes.
Financing Activities
During April, we entered into a pair of agreements in order to provide additional financial flexibility and availability of additional capital to fund our operations.
- Amendment to the Loan Agreement. On
April 1, 2020 , we entered into the Second Amendment to our existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for three months beginningApril 1, 2020 before reverting to the previous payment schedule. The Second Amendment also removes the requirement for the Company to maintain a minimum cash balance for the three months beginningApril 1, 2020 . Thereafter, the Company must maintain a minimum cash balance amount of up to$1.0 million .
- ATM Offering. On
April 24, 2020 , we entered into a Controlled Equity OfferingSM Sales Agreement withCantor Fitzgerald under which we may offer and sell, from time to time, shares of our Class A common stock having an aggregate offering price of up to$13.0 million .
First Quarter 2020 Financial Results
- Cash Position: The Company’s cash position as of
March 31, 2020 , was$2.9 million compared to$4.3 million as ofDecember 31, 2019 . Of these amounts,$2.5 million was restricted due to the requirements of its Loan Agreement. However, the requirement to maintain this level of minimum cash was temporarily eliminated effectiveApril 1, 2020 in connection with the Second Amendment to the Loan Agreement discussed above.
- Revenue: Revenues were insignificant for both the first quarter of 2020 and the fourth quarter of 2019.
- R&D Expenses: Research and development expenses were relatively consistent between periods with
$4.2 million in the first quarter of 2020 and$4.4 million in the fourth quarter of 2019.
- G&A Expenses: General and administrative expenses were
$2.5 million for the first quarter of 2020 and$2.0 million for the fourth quarter of 2019, respectively. The increase in these costs was primarily attributable to increased professional and legal fees incurred in the first quarter of 2020.
- Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $7.2 million for the first quarter of 2020 compared to $6.9 million for the fourth quarter of 2019.
- Net Loss Per Share: GAAP net loss per share was
$0.11 and$0.13 for the three months endedMarch 31, 2020 andDecember 31, 2019 , respectively, based on weighted-average shares of 43.5 million and 38.0 million for the three-month periods endedMarch 31, 2020 andDecember 31, 2019 , respectively. Non-GAAP net loss per fully exchanged share was$0.11 for each of the three months endedMarch 31, 2020 andDecember 31, 2019 , respectively, based on non-GAAP fully exchanged weighted-average shares of 66.6 million and 61.0 million for the three months endedMarch 31, 2020 andDecember 31, 2019 , respectively.
Condensed Consolidated Balance Sheets
(in thousands)
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 406 | $ | 1,777 | ||||
Restricted cash and cash equivalents | 2,500 | — | ||||||
Accounts receivable, net | 5 | 5 | ||||||
Prepaid expenses and other current assets | 591 | 806 | ||||||
Current deposits | — | 250 | ||||||
Total current assets | 3,502 | 2,838 | ||||||
Restricted cash and cash equivalents, long-term | — | 2,500 | ||||||
Property and equipment, net | 434 | 461 | ||||||
Operating lease right-of-use assets | 529 | 543 | ||||||
Long-term investments | 2,480 | 2,480 | ||||||
Long-term deposits | 444 | 444 | ||||||
Total assets | $ | 7,389 | $ | 9,266 | ||||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 7,395 | $ | 7,068 | ||||
Operating lease liabilities | 136 | 110 | ||||||
Current portion of contract liabilities | 31 | 31 | ||||||
Current portion of notes payable | 4,408 | 6,172 | ||||||
Total current liabilities | 11,970 | 13,381 | ||||||
Contract liabilities, net of current portion | 1,025 | 1,033 | ||||||
Operating lease liabilities, net of current portion | 795 | 831 | ||||||
Warrant liability, related party | 2,964 | 2,601 | ||||||
Other liabilities | 260 | 260 | ||||||
Total liabilities | 17,014 | 18,106 | ||||||
Commitments and contingencies | ||||||||
Redeemable noncontrolling interest | 52,196 | 40,183 | ||||||
Stockholders’ deficit: | ||||||||
Class A Common Stock | 447 | 409 | ||||||
Class B Common Stock | 232 | 232 | ||||||
Additional paid-in capital | 190,200 | 183,858 | ||||||
Accumulated deficit | (252,700 | ) | (233,522 | ) | ||||
Total stockholders’ deficit attributable to |
(61,821 | ) | (49,023 | ) | ||||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 7,389 | $ | 9,266 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
Three Months Ended | ||||||||
Revenue | $ | 8 | $ | 7 | ||||
Operating expenses: | ||||||||
Research and development | 4,204 | 4,406 | ||||||
General and administrative | 2,450 | 1,989 | ||||||
Total operating expenses | 6,654 | 6,395 | ||||||
Operating loss | (6,646 | ) | (6,388 | ) | ||||
Interest income | 12 | 12 | ||||||
Interest expense | (168 | ) | (283 | ) | ||||
Other (expense) income, net | (363 | ) | (223 | ) | ||||
Loss before income taxes and noncontrolling interest | (7,165 | ) | (6,882 | ) | ||||
Income tax provision | — | — | ||||||
Net loss before noncontrolling interest | (7,165 | ) | (6,882 | ) | ||||
Less: net loss attributable to noncontrolling interest | (2,441 | ) | (2,483 | ) | ||||
Net loss attributable to |
$ | (4,724 | ) | $ | (4,399 | ) | ||
Net loss attributable to |
$ | (4,724 | ) | $ | (5,033 | ) | ||
Net loss per share of |
$ | (0.11 | ) | $ | (0.13 | ) | ||
Weighted-average number of |
43,462,551 | 37,955,449 |
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended |
||||||||
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Revenue | $ | 8 | $ | 921 | ||||
Operating expenses: | ||||||||
Research and development | 4,204 | 2,822 | ||||||
General and administrative | 2,450 | 2,386 | ||||||
Total operating expenses | 6,654 | 5,208 | ||||||
Operating loss | (6,646 | ) | (4,287 | ) | ||||
Interest income | 12 | 10 | ||||||
Interest expense | (168 | ) | (626 | ) | ||||
Other (expense) income, net | (363 | ) | 921 | |||||
Loss before income taxes and noncontrolling interest | (7,165 | ) | (3,982 | ) | ||||
Income tax provision | — | — | ||||||
Net loss before noncontrolling interest | (7,165 | ) | (3,982 | ) | ||||
Less: net loss attributable to noncontrolling interest | (2,441 | ) | (1,827 | ) | ||||
Net loss attributable to |
$ | (4,724 | ) | $ | (2,155 | ) | ||
Net loss attributable to |
$ | (4,724 | ) | $ | (2,155 | ) | ||
Net loss per share of |
$ | (0.11 | ) | $ | (0.26 | ) | ||
Weighted-average number of |
43,462,551 | 22,862,907 |
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 |
$ | (4,724 | ) | $ | (5,033 | ) | ||
Other income - related party | (363 | ) | (223 | ) | ||||
Share-based compensation expense | 380 | 423 | ||||||
Deemed distribution to related party | — | 634 | ||||||
Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (2,441 | ) | (2,483 | ) | ||||
Adjusted net loss before noncontrolling interest | $ | (7,148 | ) | $ | (6,682 | ) | ||
Denominator: | ||||||||
Weighted-average number of |
43,462,551 | 37,955,449 | ||||||
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 | 66,556,772 | 61,049,670 | ||||||
Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) |
Three Months Ended |
||||||||
2020 | 2019 | |||||||
Numerator: | ||||||||
Net loss attributable to |
$ | (4,724 | ) | $ | (5,883 | ) | ||
Other income - related party | (363 | ) | 921 | |||||
Share-based compensation expense | 380 | 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) | (2,441 | ) | (1,827 | ) | ||||
Adjusted net loss before noncontrolling interest | $ | (7,148 | ) | $ | (2,780 | ) | ||
Denominator: | ||||||||
Weighted-average number of |
43,462,551 | 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 | 66,556,772 | 45,957,128 | ||||||
Adjusted net loss per fully exchanged share, basic and diluted | $ | (0.11 | ) | $ | (0.06 | ) |
(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.