vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT), a clinical-stage
biopharmaceutical company engaged in the discovery and development
of new orally administered treatments for Alzheimer’s disease and
diabetes, among other therapeutic areas, today provided a corporate
update and reported financial and operational results for the first
quarter ended March 31, 2017.
“vTv remains committed to advancing the science behind our
innovative approach to Alzheimer’s disease and type 2 diabetes,”
said Steve Holcombe, president and CEO of vTv Therapeutics. “As we
anticipate completing enrollment of the second and final cohort of
our Phase 3 trial during the second quarter, we are hopeful that
our unique hypothesis in targeting the receptor for advanced
glycation endproducts (RAGE) will position us to be the first
biopharmaceutical company to bring an investigational therapy
before the FDA that could potentially slow the progression of
Alzheimer's disease.”
First Quarter 2017 Recent
Highlights
AD/PD 2017 Panel Participation
AD/PDTM 2017 Alzheimer Clinical Phase 3 Forum: The Race For The
First Disease Modifying Drug For AD: Factors For Success
- During the 13th International
Conference on Alzheimer’s & Parkinson’s Diseases vTv’s Chief
Medical Officer, Larry Altstiel, MD, Ph.D., along with other
leading industry experts, participated in a forum discussion on
Phase 3 clinical trial design for drugs that slow the progression
of Alzheimer’s disease.
ENDO 2017 Annual Meeting
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
- Dr. Adrian Vella of the Mayo Clinic
presented results from the phase 2 AGATA study of vTv Therapeutics’
glucokinase activator (GKA) TTP399, in which the 800 mg dose
demonstrated a reduction in HbA1C as well as a trend in weight loss
for adults with type 2 diabetes.
Upcoming Anticipated
Milestones
STEADFAST Study (azeliragon in Alzheimer’s disease):
Expected to complete enrollment in Part B of Phase 3 study during
the second quarter of 2017.
First Quarter 2017 Financial
Results
- Cash Position: Cash and
cash equivalents as of March 31, 2017 were $45.2 million
compared to $51.5 million as of December 31, 2016. vTv
expects that its cash and cash equivalents will be sufficient to
fund its operations through the receipt of top-line results for
Part A of our STEADFAST Study which are expected in March
2018.
- R&D Expenses: Research
and development expenses were $11.0 million in the first
quarter of 2017, compared to $11.1 million in the fourth
quarter of 2016. The decrease in research and development expense
was primarily driven by decreases in spending for the Phase 2 LOGRA
study which completed in December 2016 offset by increases in
personnel costs and non-cash compensation expense.
- G&A Expenses: General
and administrative expenses were $2.8 million in the first
quarter of 2017, compared to $2.3 million in the fourth
quarter of 2016. The increase in general and administrative
expenses for the quarter was primarily due to increases in
personnel costs, non-cash compensation expense and professional
service expenses.
- Net Loss: Net loss
was $14.3 million for the first quarter of 2017 compared to
net loss of $13.7 million for the fourth quarter of 2016.
vTv Therapeutics, Inc.
Condensed Combined Consolidated Balance
Sheets
(in thousands except per share
data)
March 31, December 31, 2017 2016
(Unaudited) Assets Current assets: Cash and cash
equivalents $ 45,150 $ 51,505 Prepaid expenses and other current
assets 782 612 Total current assets 45,932 52,117
Property and equipment, net 426 444 Other long-term assets
1,971 1,934 Total assets $ 48,329 $ 54,495
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’ Deficit
Current liabilities: Accounts payable and accrued expenses $ 11,105
$ 11,413 Deferred revenue 4 21 Total current
liabilities 11,109 11,434 Notes payable 18,761 11,058 Other
liabilities 269 433 Total liabilities 30,139 22,925
Commitments and contingencies Redeemable noncontrolling interest
141,659 122,515 Stockholders’ deficit: Class A Common Stock 97 97
Class B Common Stock 232 232 Additional paid-in capital 125,118
124,212 Accumulated deficit (248,916 ) (215,486 )
Total stockholders’ deficit attributable to vTv Therapeutics Inc.
(123,469 ) (90,945 ) Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit $ 48,329 $ 54,495
vTv Therapeutics, Inc.
Condensed Combined Consolidated
Statements of Operations - Unaudited
(in thousands, except per share
data)
Three Months Ended
March 31,2017
December 31,2016
Revenue $ 30 $ 38 Operating expenses: Research and development
10,960 11,099 General and administrative 2,824 2,252
Total operating expenses 13,784 13,351 Operating loss
(13,754 ) (13,313 ) Interest income 27 20 Interest expense (559 )
(394 ) Other income (expense), net — (24 ) Loss
before income taxes and noncontrolling interest (14,286 ) (13,711 )
Income tax provision — — Net loss before
noncontrolling interest (14,286 ) (13,711 ) Less: net loss
attributable to noncontrolling interest (10,066 )
(9,661 )
Net loss attributable to vTv Therapeutics Inc. $
(4,220 ) $ (4,050 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.44 ) $ (0.42 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,693,254
vTv Therapeutics, Inc.
Condensed Combined Consolidated
Statements of Operations - Unaudited
(in thousands, except per share
data)
Three Months Ended March 31, 2017
2016 Revenue $ 30 $ 376 Operating expenses: Research and
development 10,960 11,335 General and administrative 2,824
2,581 Total operating expenses 13,784 13,916
Operating loss (13,754 ) (13,540 ) Interest income 27 23 Interest
expense (559 ) (2 ) Other income (loss), net — (1 )
Loss before income taxes and noncontrolling interest (14,286 )
(13,520 ) Income tax provision — — Net loss before
noncontrolling interest (14,286 ) (13,520 ) Less: net loss
attributable to noncontrolling interest (10,066 )
(9,668 )
Net loss attributable to vTv Therapeutics Inc. $
(4,220 ) $ (3,852 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.44 ) $ (0.42 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,229,645
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 and Type 2
diabetes as well as treatment of inflammatory disorders and the
prevention of muscle weakness.
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.
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Investors:vTv Therapeutics Inc.Michael Gibralter,
646-378-2938IR@vtvtherapeutics.comorMedia:Pure Communications
Inc.Katie Engleman, 910-509-3977Katie@purecommunicationsinc.com
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