HIGH POINT, N.C.–(BUSINESS WIRE)–vTv
Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for
the first quarter that ended March 31, 2019, and provided an update on
recent achievements and upcoming events.
“We continue to make significant progress with our operational plans and
look forward to announcing in the second quarter results from part 1 of
our phase 2 Simplici-T1 trial in patients with type 1
diabetes, and the initiation of a phase 2 clinical trial of azeliragon
in patients with mild-Alzheimer’s disease (AD) and type 2 diabetes,”
said Steve Holcombe, chief executive officer, vTv Therapeutics.
Recent Achievements and Outlook
-
Simplici-T1 Study enrolling patients with
type 1 diabetes. We completed enrollment of part 1 of the phase 2
Simplici-T1 Study, a 12-week study to evaluate TTP399 as an
add-on to insulin therapy for patients with type 1 diabetes, and
expect to report results in June 2019. We also began screening
patients in the part 2 confirmatory phase 2 and expect to report
results for that portion of the study in the latter part of the first
quarter of 2020. In the previous AGATA Study, a phase 2 study in type
2 diabetes patients, TTP399 demonstrated statistically significant
reductions in HbA1c levels. Importantly, TTP399 has been well
tolerated in all clinical studies to date with negligible incidences
of hypoglycemia and hyperlipidemia and no occurrences of ketoacidosis. -
Screening for Phase 2 clinical trial of azeliragon expected to
begin in June 2019. We are performing start-up activities for a
clinical trial to evaluate azeliragon as a potential treatment of
mild-AD in patients with type 2 diabetes that consists of sequential
phase 2 and phase 3 studies operationally conducted under a single
clinical trial protocol. The phase 2 study is designed to enroll
approximately 100 patients to evaluate the impact of six months of
treatment with azeliragon on cognitive performance as measured by the
change from baseline in the Alzheimer’s Disease Assessment Scale –
Cognitive Subscale (“ADAS-COG14”). We expect to begin
screening patients in June 2019 for the phase 2 clinical trial and to
report top-line results from the phase 2 study by the end of the
fourth quarter of 2020. The phase 3 study is designed to enroll
approximately 200 patients to evaluate the efficacy of 18 months of
treatment with azeliragon on cognition and global function as measured
by the change from baseline in the ADAS-COG14 and Clinical
Dementia Rating Scale Sum of Boxes. The design of the phase 3 study
may be adapted based on the results of the phase 2 study. -
Publication of paper discussing the discovery and development of
TTP399. In the first quarter, we announced the publication of a
paper in Science Translational Medicine showcasing the
discovery and development of TTP399. The paper reviewed the scientific
rationale underpinning the development of TTP399 and detailed its
progression from preclinical to clinical development.
First Quarter 2019 Financial Results
-
Cash Position: Cash and cash equivalents as of March 31, 2019,
were $5.0 million compared to $1.7 million as of December 31, 2018. -
R&D Expenses: Research and development expenses were $2.8
million in each of the first quarter of 2019 and the fourth quarter of
2018. -
G&A Expenses: General and administrative expenses were $2.4
million and $2.1 million in the first quarter of 2019 and the fourth
quarter of 2018, respectively. -
Net Loss Before Non-Controlling Interest: Net loss before
non-controlling interest was $4.0 million for the first quarter of
2019 compared to net loss before non-controlling interest of $2.3
million for the fourth quarter of 2018. -
Net Loss Per Share: GAAP net loss per share was $0.26 and $0.10
for the three months ended March 31, 2019 and December 31, 2018,
respectively, based on weighted-average shares of 22.9 million and
17.6 million for the three month periods ended March 31, 2019 and
December 31, 2018, respectively. Adjusted pro forma net loss per fully
exchanged share was $0.09 and $0.06 for the three months ended March
31, 2019 and December 31, 2018, respectively, based on adjusted pro
forma fully exchanged weighted-average shares of 46.0 million and 40.7
million for the three months ended March 31, 2019 and December 31,
2018, respectively.
|
vTv Therapeutics Inc. Condensed Consolidated Balance Sheets (in thousands) |
||||||||
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,959 | $ | 1,683 | ||||
| Prepaid expenses and other current assets | 419 | 666 | ||||||
| Current deposits | 34 | 1,124 | ||||||
| Total current assets | 5,412 | 3,473 | ||||||
| Restricted cash and cash equivalents, long-term | 2,500 | 2,500 | ||||||
| Property and equipment, net | 62 | 70 | ||||||
| Operating lease right-of-use assets | 246 | — | ||||||
| Long-term investments | 2,480 | 2,480 | ||||||
| Long-term deposits | 36 | 36 | ||||||
| Total assets | $ | 10,736 | $ | 8,559 | ||||
|
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit |
||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 6,244 | $ | 7,702 | ||||
| Operating lease liabilities | 259 | — | ||||||
| Current portion of deferred revenue | 839 | 1,752 | ||||||
| Current portion of notes payable | 9,167 | 9,383 | ||||||
| Total current liabilities | 16,509 | 18,837 | ||||||
| Notes payable, net of current portion | 4,014 | 6,330 | ||||||
| Deferred revenue, net of current portion | 1,067 | 1,067 | ||||||
| Warrant liability, related party | 1,515 | 2,436 | ||||||
| Other liabilities | 260 | 260 | ||||||
| Total liabilities | 23,365 | 28,930 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable noncontrolling interest | 45,106 | 62,482 | ||||||
| Stockholders’ deficit: | ||||||||
| Class A Common Stock | 273 | 203 | ||||||
| Class B Common Stock | 232 | 232 | ||||||
| Additional paid-in capital | 162,249 | 150,595 | ||||||
| Accumulated deficit | (220,489 | ) | (233,883 | ) | ||||
| Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (57,735 | ) | (82,853 | ) | ||||
|
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit |
$ | 10,736 | $ | 8,559 | ||||
|
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations – Unaudited (in thousands, except per share data) |
||||||||
| Three Months Ended | ||||||||
| March 31, 2019 | December 31, 2018 | |||||||
| Revenue | $ | 921 | $ | 4,522 | ||||
| Operating expenses: | ||||||||
| Research and development | 2,822 | 2,800 | ||||||
| General and administrative | 2,386 | 2,073 | ||||||
| Total operating expenses | 5,208 | 4,873 | ||||||
| Operating loss | (4,287 | ) | (351 | ) | ||||
| Interest income | 10 | 14 | ||||||
| Interest expense | (626 | ) | (743 | ) | ||||
| Other income (expense), net | 921 | (1,248 | ) | |||||
| Loss before income taxes and noncontrolling interest | (3,982 | ) | (2,328 | ) | ||||
| Income tax provision | — | — | ||||||
| Net loss before noncontrolling interest | (3,982 | ) | (2,328 | ) | ||||
| Less: net loss attributable to noncontrolling interest | (1,827 | ) | (1,237 | ) | ||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (2,155 | ) | $ | (1,091 | ) | ||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (1,830 | ) | ||
|
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, |
$ | (0.26 | ) | $ | (0.10 | ) | ||
|
Weighted-average number of vTv Therapeutics Inc. Class A Common |
22,862,907 | 17,635,159 | ||||||
|
vTv Therapeutics Inc. Condensed Consolidated Statements of Operations – Unaudited (in thousands, except per share data) |
||||||||
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | $ | 921 | $ | 2,064 | ||||
| Operating expenses: | ||||||||
| Research and development | 2,822 | 8,943 | ||||||
| General and administrative | 2,386 | 2,255 | ||||||
| Total operating expenses | 5,208 | 11,198 | ||||||
| Operating loss | (4,287 | ) | (9,134 | ) | ||||
| Interest income | 10 | 18 | ||||||
| Interest expense | (626 | ) | (855 | ) | ||||
| Other income (expense), net | 921 | 11 | ||||||
| Loss before income taxes and noncontrolling interest | (3,982 | ) | (9,960 | ) | ||||
| Income tax provision | — | — | ||||||
| Net loss before noncontrolling interest | (3,982 | ) | (9,960 | ) | ||||
| Less: net loss attributable to noncontrolling interest | (1,827 | ) | (7,008 | ) | ||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (2,155 | ) | $ | (2,952 | ) | ||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (2,952 | ) | ||
|
Net loss per share of vTv Therapeutics Inc. Class A Common Stock, |
$ | (0.26 | ) | $ | (0.30 | ) | ||
|
Weighted-average number of vTv Therapeutics Inc. Class A Common |
22,862,907 | 9,699,721 | ||||||
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company
engaged in the discovery and development of orally administered small
molecule drug candidates to fill significant unmet medical needs. vTv
has a pipeline of clinical drug candidates led by programs for the
treatment of Alzheimer’s disease, diabetes, and inflammatory disorders.
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 SEC. These
forward-looking statements reflect our views with respect to future
events as of the date of this release and are based on assumptions and
subject to risks and uncertainties. Given these uncertainties, you
should not place undue reliance on these forward-looking statements.
These forward-looking statements represent our estimates and assumptions
only as of the date of this release and, except as required by law, we
undertake no obligation to update or review publicly any forward-looking
statements, whether as a result of new information, future events or
otherwise after the date of this release. We anticipate that subsequent
events and developments will cause our views to change. Our
forward-looking statements do not reflect the potential impact of any
future acquisitions, merger, dispositions, joint ventures or investments
we may undertake. We qualify all of our forward-looking statements by
these cautionary statements.
Non-GAAP Financial Measures
To supplement our consolidated financial statements, which are prepared
and presented in accordance with generally accepted accounting
principles in the U.S. (“GAAP”), we use adjusted pro forma earnings per
fully exchanged share, which is a non-GAAP financial measure. Adjusted
pro forma earnings per fully exchanged share is defined as net loss
attributable to vTv Therapeutics Inc. common shareholders including the
loss attributable to the non-controlling interest and assuming the
exchange of all the Class B common stock of vTv Therapeutics Inc. and an
equal number of non-voting common units of vTv Therapeutics LLC (“vTv
Units”) for shares of Class A common stock of vTv Therapeutics Inc.
Additionally, we have adjusted this metric for the non-cash deemed
distributions that were made in connection with our letter agreements
with MacAndrews & Forbes Group LLC. We believe that this measure
provides useful information to investors as it eliminates the
variability of non-controlling interest resulting from the exchanges of
Class B common stock and vTv Units into Class A common stock and
excludes the impact of the non-cash deemed distribution. This measure is
not intended to be considered in isolation or as a substitute for, or
superior to, financial measures prepared and presented in accordance
with GAAP.
The following is a reconciliation of adjusted pro forma earnings per
fully exchanged share, basic and diluted to its most directly comparable
GAAP measure, net loss attributable to vTv Therapeutics Inc. common
shareholders, basic and diluted and the computation of the components of
this non-GAAP measure:
| Three Months Ended | |||||||||
| March 31, 2019 | December 31, 2018 | ||||||||
| Numerator: | |||||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (1,830 | ) | |||
| Deemed distribution to related party | 3,728 | 739 | |||||||
|
Reallocation of net income attributable to non-controlling |
(1,827 | ) | (1,237 | ) | |||||
| Net loss before noncontrolling interest | $ | (3,982 | ) | $ | (2,328 | ) | |||
| Denominator: | |||||||||
|
Weighted-average number of vTv Therapeutics Inc. Class A Common |
22,862,907 | 17,635,159 | |||||||
| Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,094,221 | |||||||
|
Adjusted pro forma fully exchanged weighted-average shares of |
45,957,128 | 40,729,380 | |||||||
|
Adjusted pro forma earnings per fully exchanged share, basic and |
$ | (0.09 | ) | $ | (0.06 | ) | |||
| Three Months Ended March 31, | |||||||||
| 2019 | 2018 | ||||||||
| Numerator: | |||||||||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (5,883 | ) | $ | (2,952 | ) | |||
| Deemed distribution to related party | 3,728 | — | |||||||
|
Reallocation of net income attributable to non-controlling |
(1,827 | ) | (7,008 | ) | |||||
| Net loss before noncontrolling interest | $ | (3,982 | ) | $ | (9,960 | ) | |||
| Denominator: | |||||||||
|
Weighted-average number of vTv Therapeutics Inc. Class A Common |
22,862,907 | 9,699,721 | |||||||
| Assumed exchange of Class B Common Stock (1) | 23,094,221 | 23,115,631 | |||||||
|
Adjusted pro forma fully exchanged weighted-average shares of |
45,957,128 | 32,815,352 | |||||||
|
Adjusted pro forma earnings per fully exchanged share, basic and |
$ | (0.09 | ) | $ | (0.30 | ) | |||
|
(1) |
Assumes the exchange of all outstanding Class B common stock, |
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Contacts
Investors:
vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or
Media:
Josh Vlasto, 212-572-5969
PR@vtvtherapeutics.com