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vTv Therapeutics Announces 2020 Third Quarter Financial Results and Update
“Following our decision to conclude enrollment in the Elevage Study at the end of September, we look forward to announcing topline results from this phase 2 study of azeliragon in December,” said
Recent Achievements and Outlook
Type 1 Diabetes
- FDA Engagement and Pivotal Study Planning. vTv continued its dialogue with the FDA during the third quarter surrounding the design and endpoints of its planned pivotal studies of TTP399 as an adjunct to insulin therapy for type 1 diabetes. Based upon the FDA’s feedback, the Company plans to conduct a placebo-controlled six-month clinical trial in approximately 400 subjects, followed by a second placebo-controlled six-month clinical trial to be initiated nine to twelve months after initiation of the first pivotal trial. The FDA also confirmed that the effect size of TTP399 on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of a therapy for the treatment of type 1 diabetes.
- Development of Mechanistic Study of Ketoacidosis. To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv plans to conduct a mechanistic study in a small number of patients with type 1 diabetes to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. The Company proposed the mechanistic study to the FDA, and the FDA recommended that the study be performed in support of the planned pivotal trials. vTv expects the mechanistic study to be initiated in the first quarter of 2021 and to report topline results in the second quarter of 2021.
- Two Oral Presentations at EASD of SimpliciT-1 Study Results. Members of vTv’s TTP399 clinical development team, including Chief Scientific Officer Dr.
Carmen Valcarce , presented additional data at the 56th AnnualEuropean Association for the Study of Diabetes on the effects of TTP399 on hypoglycemia and ketone body formation from the positive SimpliciT-1 Study.
Dementia with Diabetes
- Enrollment concluded for Phase 2 Elevage Study of azeliragon. On
September 30 , vTv concluded enrollment of patients in the Elevage Study. Forty-three (43) patients with mild probable Alzheimer’s disease and type 2 diabetes were enrolled in the study. The study is designed to evaluate the effect of six-months of treatment with azeliragon on cognitive performance. The Company plans to report top-line results for substantially all of the enrolled patients duringDecember 2020 , earlier than previously expected. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer’s disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).
- Elevage Study Update to be Presented at CTAD. Dr.
Ann Gooch presented an update on the Elevage Study focusing on the demographic and baseline characteristics data of enrolled subjects at the 13th Clinical Trials on Alzheimer’s Disease conference onNovember 4, 2020 .
Psoriasis
- Multiple Ascending Dose Study with HPP737. The Company is planning a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. vTv expects to initiate the study in the first quarter of 2021 and to report topline results in the second quarter of 2021.
Third Quarter 2020 Financial Results
- Cash Position: The Company’s cash position as of
September 30, 2020 , was$1.8 million compared to$6.4 million as ofJune 30, 2020 .
- Revenue: Revenues were insignificant for both the second and third quarters of 2020.
- R&D Expenses: Research and development expenses were
$1.8 million and$2.5 million for the three months endedSeptember 30, 2020 andJune 30, 2020 , respectively. This decrease of$0.7 million was driven primarily by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.
- G&A Expenses: General and administrative expenses were
$1.1 million for the third quarter of 2020 and$1.7 million for the second quarter, respectively. The decrease of$0.6 million was driven by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.
- Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the third quarter of 2020 compared to $5.0 million for the second quarter of 2020.
- Net Loss Per Share: GAAP net loss per share was
$0.03 and$0.07 for the three months endedSeptember 30, 2020 andJune 30, 2020 , respectively, based on weighted-average shares of 48.2 million and 45.7 million for the three-month periods endedSeptember 30, 2020 andJune 30, 2020 , respectively. Non-GAAP net loss per fully exchanged share was$0.02 and$0.08 for the three months endedSeptember 30, 2020 andJune 30, 2020 , respectively, based on non-GAAP fully exchanged weighted-average shares of 71.3 million and 68.8 million for the three months endedSeptember 30, 2020 andJune 30, 2020 , respectively.
Condensed Consolidated Balance Sheets
(in thousands)
2020 | 2020 | ||||||
(Unaudited) | (Unaudited) | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 1,827 | $ | 6,392 | |||
Accounts receivable, net | 14 | — | |||||
Prepaid expenses and other current assets | 1,306 | 299 | |||||
Current deposits | 531 | 87 | |||||
Total current assets | 3,678 | 6,778 | |||||
Property and equipment, net | 389 | 412 | |||||
Operating lease right-of-use assets | 499 | 514 | |||||
Long-term investments | 2,480 | 2,480 | |||||
Long-term deposits | — | 444 | |||||
Total assets | $ | 7,046 | $ | 10,628 | |||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 5,747 | $ | 6,697 | |||
Operating lease liabilities | 149 | 143 | |||||
Current portion of contract liabilities | 31 | 31 | |||||
Current portion of notes payable | 2,369 | 4,543 | |||||
Total current liabilities | 8,296 | 11,414 | |||||
Contract liabilities, net of current portion | 1,017 | 1,025 | |||||
Operating lease liabilities, net of current portion | 717 | 756 | |||||
Warrant liability, related party | 2,715 | 3,529 | |||||
Other liabilities | 82 | 54 | |||||
Total liabilities | 12,827 | 16,778 | |||||
Commitments and contingencies | |||||||
Redeemable noncontrolling interest | 45,591 | 63,378 | |||||
Stockholders’ deficit: | |||||||
Class A Common Stock | 492 | 479 | |||||
Class B Common Stock | 232 | 232 | |||||
Additional paid-in capital | 201,243 | 198,634 | |||||
Accumulated deficit | (253,339 | ) | (268,873 | ) | |||
Total stockholders’ deficit attributable to |
(51,372 | ) | (69,528 | ) | |||
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 7,046 | $ | 10,628 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
Three Months Ended | |||||||
2020 |
2020 |
||||||
Revenue | $ | 7 | $ | — | |||
Operating expenses: | |||||||
Research and development | 1,768 | 2,509 | |||||
General and administrative | 1,071 | 1,695 | |||||
Total operating expenses | 2,839 | 4,204 | |||||
Operating loss | (2,832 | ) | (4,204 | ) | |||
Interest expense | (235 | ) | (222 | ) | |||
Other income (expense), net | 814 | (565 | ) | ||||
Loss before income taxes and noncontrolling interest | (2,253 | ) | (4,991 | ) | |||
Income tax provision | — | — | |||||
Net loss before noncontrolling interest | (2,253 | ) | (4,991 | ) | |||
Less: net loss attributable to noncontrolling interest | (720 | ) | (1,623 | ) | |||
Net loss attributable to |
$ | (1,533 | ) | $ | (3,368 | ) | |
Net loss attributable to |
$ | (1,533 | ) | $ | (3,368 | ) | |
Net loss per share of Common Stock, basic and diluted |
$ | (0.03 | ) | $ | (0.07 | ) | |
Weighted-average number of Class A Common Stock, basic and diluted |
48,238,285 | 45,661,221 |
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended |
For the Nine Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||
Revenue | $ | 7 | $ | 8 | $ | 15 | $ | 2,757 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 1,768 | 3,663 | 8,481 | 10,713 | |||||||||||
General and administrative | 1,071 | 1,770 | 5,216 | 6,548 | |||||||||||
Total operating expenses | 2,839 | 5,433 | 13,697 | 17,261 | |||||||||||
Operating loss | (2,832 | ) | (5,425 | ) | (13,682 | ) | (14,504 | ) | |||||||
Interest income | — | 15 | 12 | 41 | |||||||||||
Interest expense | (235 | ) | (404 | ) | (625 | ) | (1,544 | ) | |||||||
Other income (expense), net | 814 | (146 | ) | (114 | ) | 1,051 | |||||||||
Loss before income taxes and noncontrolling interest | (2,253 | ) | (5,960 | ) | (14,409 | ) | (14,956 | ) | |||||||
Income tax provision | — | — | — | 100 | |||||||||||
Net loss before noncontrolling interest | (2,253 | ) | (5,960 | ) | (14,409 | ) | (15,056 | ) | |||||||
Less: net loss attributable to noncontrolling interest | (720 | ) | (2,352 | ) | (4,784 | ) | (6,411 | ) | |||||||
Net loss attributable to |
$ | (1,533 | ) | $ | (3,608 | ) | $ | (9,625 | ) | $ | (8,645 | ) | |||
Net loss attributable to |
$ | (1,533 | ) | $ | (3,608 | ) | $ | (9,625 | ) | $ | (12,880 | ) | |||
Net loss per share of |
$ | (0.03 | ) | $ | (0.13 | ) | $ | (0.21 | ) | $ | (0.46 | ) | |||
Weighted-average number of |
48,238,285 | 32,126,130 | 45,796,298 | 27,709,486 |
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 | |||||||
2020 |
2020 |
||||||
Numerator: | |||||||
Net loss attributable to |
$ | (1,533 | ) | $ | (3,368 | ) | |
Other income - related party | 814 | (565 | ) | ||||
Share-based compensation expense | 171 | 186 | |||||
Deemed distribution to related party | — | — | |||||
Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) | (720 | ) | (1,623 | ) | |||
Adjusted net loss before noncontrolling interest | $ | (1,268 | ) | $ | (5,370 | ) | |
Denominator: | |||||||
Weighted-average number of Class A Common Stock, basic and diluted |
48,238,285 | 45,661,221 | |||||
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 |
71,332,506 | 68,755,442 | |||||
Adjusted net loss per fully exchanged share, basic and diluted |
$ | (0.02 | ) | $ | (0.08 | ) |
Three Months Ended |
Nine Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Numerator: | |||||||||||||||
Net loss attributable to |
$ | (1,533 | ) | $ | (4,115 | ) | $ | (9,625 | ) | $ | (12,880 | ) | |||
Other income - related party | 814 | (146 | ) | (114 | ) | 1,050 | |||||||||
Share-based compensation expense | 171 | 413 | 737 | 1,095 | |||||||||||
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) | (720 | ) | (2,352 | ) | (4,784 | ) | (6,411 | ) | |||||||
Adjusted net loss before noncontrolling interest | $ | (1,268 | ) | $ | (5,693 | ) | $ | (13,786 | ) | $ | (12,911 | ) | |||
Denominator: | |||||||||||||||
Weighted-average number of Class A Common Stock, basic and diluted |
48,238,285 | 32,126,130 | 45,796,298 | 27,709,486 | |||||||||||
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 |
71,332,506 | 55,220,351 | 68,890,519 | 50,803,707 | |||||||||||
Adjusted net loss per fully exchanged share, basic and diluted |
$ | (0.02 | ) | $ | (0.10 | ) | $ | (0.20 | ) | $ | (0.25 | ) |
(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.