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, basic and diluted
$ (0.26 ) $ (0.10 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
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, basic and diluted
$ (0.26 ) $ (0.30 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
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 interest from the assumed exchange of Class B
shares (1)
(1,827 ) (1,237 ) Net loss before noncontrolling
interest $ (3,982 ) $ (2,328 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
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 Class A common stock outstanding, basic
and diluted
45,957,128 40,729,380
Adjusted pro forma earnings per fully
exchanged share, basic and diluted
$ (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 interest from the assumed exchange of Class B
shares (1)
(1,827 ) (7,008 ) Net loss before noncontrolling
interest $ (3,982 ) $ (9,960 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
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 Class A common stock outstanding, basic
and diluted
45,957,128 32,815,352
Adjusted pro forma earnings per fully
exchanged share, basic and diluted
$ (0.09 ) $ (0.30 )
(1)
Assumes the exchange of all outstanding
Class B common stock, resulting in the elimination of the
non-controlling interest and recognition of the net income
attributable to non-controlling interests.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190501005900/en/
Investors:vTv Therapeutics Inc.IR@vtvtherapeutics.com
or
Media:Josh Vlasto, 212-572-5969PR@vtvtherapeutics.com
vTv Therapeutics (NASDAQ:VTVT)
Historical Stock Chart
From Mar 2024 to Apr 2024
vTv Therapeutics (NASDAQ:VTVT)
Historical Stock Chart
From Apr 2023 to Apr 2024