TTP273 is an oral, small molecule GLP-1R
agonist with best-in-class potential
Company Releases Q2 Earnings Results and
Details Upcoming Program Milestones
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, today announced the completion of enrollment of the
company’s Phase 2 LOGRA (aLlosteric Oral Glp1
Receptor Agonist) study, a randomized, double-blind,
placebo-controlled, parallel group trial of TTP273. TTP273 is an
oral, small molecule GLP-1R agonist with best-in-class
potential.
The previous Phase 1b trial of TTP273 showed robust effects on
postprandial and fasting glucose. In this study, all doses of
TTP273 were well tolerated with no serious adverse events or
evidence of significant gastrointestinal side effects.
Last week, vTv announced positive topline results from a placebo
and active-comparator-controlled Phase 2b clinical study of TTP399,
a liver-selective glucokinase activator (GKA) under development for
the treatment of Type 2 diabetes.
“Coming off the announcement of positive topline results from
our GKA trial, we are pleased to report that enrollment of our
GLP-1 trial has been completed,” said Steve Holcombe, President and
CEO of vTv. “Earlier studies of this compound showed that TTP273
has the potential to provide enhanced glycemic control and weight
loss without the burden of injections or gastrointestinal side
effects seen with other GLP-1 biologic agents. We look forward to
completing this trial and reporting results at the end of this
year.”
The LOGRA study is assessing the safety and efficacy of TTP273
in Type 2 diabetic subjects on stable doses of metformin. The
study’s primary endpoint is the change from baseline in HbA1c at 3
months, with secondary endpoints including body weight, plasma
glucose, lipids insulin, lactate, C-peptide, glucagon and GLP.
Topline results are expected late this year.
Second Quarter Financials, Recent
Highlights, and Upcoming Milestones
“We’re on the threshold of several important clinical milestones
including completing enrollment in the next few weeks of Part A of
our pivotal Phase 3 azeliragon trial in mild Alzheimer’s subjects.
We will begin discussions with pharmaceutical companies regarding
possible partnering opportunities for our successful GKA program
while continuing to advance TTP399. We also expect to complete and
then report the topline results of our phase 2 GLP-1R trial by the
end of the year. This has been an exciting year as we continue to
meet the key goals for our Alzheimer’s and diabetes programs,”
Holcombe added.
Phase 3 STEADFAST Study with azeliragon in mild Alzheimer’s
disease (AD)
Azeliragon: A novel, oral small molecule antagonist of the
Receptor for Advanced Glycation Endproducts (RAGE) with
best-in-class potential
- On track to complete enrollment in
Part A of STEADFAST trial in the third quarter. The randomized,
double-blind, placebo-controlled study is evaluating whether
azeliragon can effectively slow the cognitive and functional
decline of patients with mild Alzheimer’s disease at 18 months of
treatment. The Company anticipates reporting topline data from the
first of the two Phase 3 arms in early 2018. The STEADFAST Study is
being conducted under a Special Protocol Assessment and has Fast
Track designation from the FDA.
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
TTP399: A novel oral, liver-selective Glucokinase Activator
(GKA) with first-in-class potential
- Topline results showed achievement
of the primary endpoint of statistically significant change
from baseline in HbA1c at 6 months of daily administration of 800
mg of TTP399. The reduction in HbA1c was dose-dependent and
sustained throughout the duration of the study. TTP399 was also
found to be well-tolerated without increased incidences of
hypoglycemia and hyperlipidemia compared to placebo. A manuscript
with more details is in preparation and will be submitted for
publication to a major medical journal.
Second Quarter 2016 Financial
Results
- Cash Position: Cash, cash
equivalents and marketable securities as of June 30, 2016
were $63.8 million, compared to $88.0 million as
of December 31, 2015. The Company expects that its cash, cash
equivalents and marketable securities will be sufficient to fund
its operations through at least mid-2017.
- R&D Expenses: Research
and development expenses were $12.1 million in the second
quarter of 2016, compared to $5.7 million in the same period
in 2015. The increase in research and development was primarily
driven by increased costs of $5.3 million for our azeliragon
program due to continued enrollment of the STEADFAST study, higher
compound manufacturing costs and the costs of a drug - drug
interaction study which began in 2016. Additionally, we saw an
increase in costs of $0.6 million related to our TTP273 program as
our Phase 2b LOGRA study continues to enroll and a $0.7 million
increase in personnel costs related to share-based compensation
expense recognized in 2016 and increases in headcount to support
the management of the ongoing clinical trials.
- G&A Expenses: General
and administrative expenses were $2.7 million in the second
quarter of 2016, compared to $2.3 million in the same period
in 2015. The increase in general and administrative expenses for
the quarter was primarily due to an increase of $0.6 million
related to compensation expense from share-based awards in 2016 and
increases in headcount to support our compliance with public
company requirements. Additionally, we saw an increase of $0.3
million in costs related to our transition to a public company.
These increases were offset by a decrease in legal and professional
service expenses of $0.5 million which were higher in the 2015
period as we prepared for our initial public offering.
- Net Loss: Net loss
was $14.6 million for the second quarter of 2016 compared to
net loss of $10.4 million for the same period in 2015.
vTv Therapeutics, Inc. Condensed Combined
Consolidated Balance Sheets (in thousands except per share
data) June 30, December
31, 2016 2015 (Unaudited) Assets
Current assets: Cash and cash equivalents $ 63,841 $ 88,003 Account
receivable, net — 69 Prepaid expenses and other current assets
423 1,114 Total current assets 64,264 89,186 Property
and equipment, net 561 624 Employee loans receivable - related
party 24 49 Other long-term assets 1,934 1,673 Total
assets $ 66,783 $ 91,532
Liabilities, Redeemable Noncontrolling
Interest and Stockholders’ Deficit Current liabilities:
Accounts payable and accrued expenses $ 9,490 $ 6,627 Accounts
payable and accrued expenses - related party 312 880 Deferred
revenue 21 219 Total current liabilities 9,823 7,726
Other liabilities 230 245 Total liabilities 10,053
7,971 Commitments and contingencies Redeemable noncontrolling
interest 136,250 161,531 Stockholders’ deficit: Class A Common
Stock, $0.01 par value; 100,000,000 shares authorized, 9,689,924
and
9,156,686 shares outstanding as of June
30, 2016 and December 31, 2015,
respectively
97 92 Class B Common Stock, $0.01 par value; 100,000,000 shares
authorized, 23,122,576
and 23,655,814 shares outstanding as of
June 30, 2016 and December 31, 2015,
respectively
232 237 Additional paid-in capital 122,137 117,686 Accumulated
deficit (201,986) (195,985) Total stockholders’
deficit attributable to vTv Therapeutics Inc. (79,520)
(77,970) Total liabilities, redeemable noncontrolling
interest and stockholders’ deficit $ 66,783 $ 91,532
vTv Therapeutics, Inc. Condensed Combined Consolidated
Statements of Operations - Unaudited (in thousands, except
per share data) Three
Months Ended June 30, For the Six Months Ended June 30,
2016 2015 2016 2015 Revenue $ 182 $ 110
$ 558 $ 160 Operating expenses: Research and development 12,149
5,702 23,484 13,478 General and administrative 2,672
2,297 5,253 4,292 Total operating expenses
14,821 7,999 28,737 17,770 Operating loss
(14,639) (7,889) (28,179) (17,610) Other income (expense), net
22 (2,523) 42 (2,615) Loss before
income taxes and noncontrolling interest (14,617) (10,412) (28,137)
(20,225) Income tax provision — — — —
Net loss before noncontrolling interest (14,617) (10,412) (28,137)
(20,225) Less: net loss attributable to noncontrolling interest
(10,160) — (19,828) —
Net loss
attributable to vTv Therapeutics Inc. $ (4,457) $ (10,412) $
(8,309) $ (20,225) Net loss per share of vTv Therapeutics Inc.
Class A Common
Stock, basic and diluted
$ (0.47) $ (0.88) $ — Weighted-average number of vTv Therapeutics
Inc. Class A
Common Stock, basic and diluted
9,564,623 9,397,134 —
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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