- Launched pivotal Phase 3 STEADFAST study with azeliragon in
Alzheimer’s disease
- Completed enrollment of AGATA Phase 2b study with liver-selective
Glucokinase Activator in Type 2 diabetes, with expected data readout in
mid-2016
- Initiated LOGRA Phase 2b study with oral GLP-1R agonist in Type 2
diabetes, with expected data readout by year-end 2016
- Raised $104 million in net proceeds from IPO
vTv Therapeutics Inc. (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
reported business highlights and financial results for the fourth
quarter and year ended December 31, 2015. In addition, vTv provided an
update on recent developments and upcoming milestones for its lead
clinical development programs.
“Over the past year, we have made significant progress advancing our
mission to develop first- and best-in-class therapies for Alzheimer’s
disease and diabetes,” said President and CEO Steve Holcombe. “We
initiated our pivotal Phase 3 STEADFAST study of azeliragon, a novel
product candidate which has demonstrated unprecedented positive effects
in treating mild Alzheimer’s disease. We also advanced two mid-stage
clinical studies with oral, small molecule drug candidates in Type 2
diabetes, both of which have demonstrated sustained glucose control
without the side effects seen with other current or investigational
agents. We look forward to expected data readouts in mid-2016 for the
fully enrolled Phase 2b study with TTP399, a liver-selective Glucokinase
Activator, and at year-end for our Phase 2b study with TTP273, our oral,
small molecule GLP-1R agonist. We believe our Alzheimer’s and diabetes
product candidates have disruptive potential, and could vastly improve
the lives of millions of patients around the world for whom there are no
adequate therapeutic options.”
Added Mr. Holcombe, “In addition, we expanded and strengthened our
leadership team during 2015, welcoming Jeffrey Kindler as Executive
Chairman of the Board of Directors, Dr. Larry Altstiel as Chief Medical
Officer, and Rudy Howard as Chief Financial Officer. We also raised over
$100 million in an initial public offering, fueling our ability to
invest in these important clinical programs.”
2015 AND RECENT HIGHLIGHTS
Development Programs:
STEADFAST Study with azeliragon in Alzheimer’s disease
Azeliragon:
a novel, oral small molecule antagonist of the Receptor for Advanced
Glycation Endproducts (RAGE) with best-in-class potential
-
vTv continues to enroll its Phase 3 study with lead product
candidate azeliragon. The randomized, double-blind,
placebo-controlled study, which began dosing in May 2015, is
evaluating whether azeliragon can slow the cognitive and functional
decline of patients with mild Alzheimer’s disease. The Company expects
to complete enrollment in Part A of the Phase 3 study in mid-2016. The
trial is being conducted under a Special Protocol Assessment (SPA) and
has Fast Track designation.
-
Successful Phase 2b results of 5mg/day over 18 months showed
statistically significant efficacy in mild-to-moderate Alzheimer’s
patients (+3.1 points on ADAS-Cog standard measure of cognition) and
even greater efficacy in mild patients (+4.0). Benefits were shown on
CDR-SB and all secondary endpoints, including a significant reduction
of psychiatric events (e.g. anxiety).
AGATA Study with TTP399 in Type 2 Diabetes
TTP399: a
novel oral, liver-selective Glucokinase Activator (GKA) with
first-in-class potential
-
The Phase 2b study recently completed patient enrollment and is on
track for a mid-2016 data readout. AGATA is a randomized,
double-blind, placebo- and active-controlled parallel group trial
evaluating the safety and efficacy of TTP399 following six months
administration of 180 Type 2 diabetic patients on a stable dose of
metformin. The trial is designed to demonstrate that TTP399 produces
significant and sustainable improvement in glycemic control.
-
Previous Phase 2a clinical data showed that the drug significantly
lowered blood glucose with no evidence of hypoglycemia, increase in
lipids or induction of insulin secretion. Within the high-dose arm
of the study, approximately 86% of “well-controlled” patients (A1C
levels < 7.5) were able to achieve pre-diabetic A1c levels(<6.5%)
after only 6 weeks of treatment without any episodes of hypoglycemia
following administration of the oral treatment.
LOGRA Study with TTP273 in Type 2 Diabetes
TTP273: an
oral, small molecule GLP-1R agonist with best-in-class potential
-
Initiated the LOGRA Phase 2b study, a randomized, double-blind,
placebo-controlled, parallel group trial evaluating the safety and
efficacy of TTP273 in 156 Type 2 diabetics on stable doses of
metformin.
-
Previous Phase 1b trial of TTP273 demonstrated robust effects on
postprandial and fasting glucose. All doses of TTP273 were safe
and well tolerated with no serious adverse events or evidence of
gastrointestinal side effects compared to placebo.
-
Expect to report study results by year-end 2016.
Corporate Updates:
-
Strengthened balance sheet. vTv completed an initial
public offering in July 2015, raising net proceeds of $104 million,
after deducting underwriting discounts, commissions and expenses.
-
Expanded and strengthened leadership team.
--Jeffrey Kindler joined as Executive Chairman of Board of Directors. Mr.
Kindler, the former Chairman & CEO of Pfizer, has over 25 years of
executive management experience in the pharmaceutical and consumer
products industries.
--Larry Altstiel, M.D., Ph.D., joined as Chief Medical Officer. Dr.
Altstiel, a former Pfizer and Eli Lilly senior executive, brings 20
years of senior clinical research and management experience in
neurodegenerative diseases.
--Rudy Howard was appointed Chief Financial Officer. Mr. Howard
joins with 30 years of senior financial executive roles, last serving as
CFO of SciQuest.
Upcoming Anticipated Milestones:
-
STEADFAST Study (azeliragon in Alzheimer’s disease): Expect to
complete enrollment in Part A of Phase 3 study in mid-2016.
-
AGATA Study (TTP399 GKA in Type 2 diabetes): Expect to report
Phase 2b safety and efficacy results in mid-2016.
-
LOGRA Study (TTP273 GLP-1R agonist in Type 2 diabetes): Expect
to complete enrollment and report Phase 2b safety and efficacy results
by year-end 2016.
Fourth Quarter and Full Year 2015 Financial
Results
-
Cash Position: Cash, cash equivalents and marketable
securities as of December 31, 2015 were $88.0 million, compared
to $1.4 million as of December 31, 2014. The increase was primarily
driven by the $104.4 million of proceeds received from the Company’s
IPO in August offset by the subsequent use of the proceeds for
operations.
-
R&D Expenses: Research and development expenses
were $8.9 million in the fourth quarter of 2015 and $29.6 million for
the year ended December 31, 2015, compared to $5.5 million and $18.7
million in the comparable periods in 2014. The increases in research
and development expenses for both the three- and twelve-month periods
were largely due to higher spending on the clinical trials for azeliragon,
TTP399 and TTP273.
-
G&A Expenses: General and administrative expenses
were $2.4 million in the fourth quarter of 2015 and $9.1 million in
the year ended December 31, 2015, compared to $2.1 million and $11.7
million in the comparable periods in 2014. The increase in general and
administrative expenses for the three-month period was primarily due
to higher professional fees and insurance costs offset by lower costs
for personnel. The decreases in general and administrative expenses
for the twelve-month period were primarily driven by the recognition
of certain personnel-related expenses recognized in 2014. Such
decreases were offset by higher professional fees and insurance costs
associated with the Company’s transition to a public company in 2015.
-
Net Loss: Net loss was $11.1 million for the fourth quarter of
2015 and $41.1 million for the year ended December 31, 2015, compared
to net loss of $7.7 million and $36.1 million for the comparable
periods in 2014.
-
Financial Guidance: vTv Therapeutics expects that its
cash, cash equivalents and marketable securities will be sufficient to
fund its operations through at least mid-2017.
About vTv Therapeutics Inc.
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 Registration Statement on Form S-1 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.
|
|
|
|
|
|
|
|
|
vTv Therapeutics, Inc.
|
Condensed Combined Consolidated Balance Sheets
|
(in thousands except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
|
$
|
88,003
|
|
|
$
|
1,384
|
|
Restricted cash and cash equivalents
|
|
|
|
|
|
|
—
|
|
|
|
130
|
|
Account receivable, net
|
|
|
|
|
|
|
69
|
|
|
|
—
|
|
Prepaid expenses and other current assets
|
|
|
|
|
|
|
1,114
|
|
|
|
97
|
|
Total current assets
|
|
|
|
|
|
|
89,186
|
|
|
|
1,611
|
|
Note receivable
|
|
|
|
|
|
|
—
|
|
|
|
6,594
|
|
Property and equipment, net
|
|
|
|
|
|
|
624
|
|
|
|
3,778
|
|
Receivable due from a related party, net
|
|
|
|
|
|
|
—
|
|
|
|
800
|
|
Employee loans receivable - related party
|
|
|
|
|
|
|
49
|
|
|
|
58
|
|
Other long-term assets
|
|
|
|
|
|
|
1,673
|
|
|
|
110
|
|
Total assets
|
|
|
|
|
|
$
|
91,532
|
|
|
$
|
12,951
|
|
Liabilities Redeemable Convertible Preferred Units, Redeemable
Noncontrolling
|
Interest, Stockholders’ and Members’ Deficit
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
|
|
|
$
|
6,627
|
|
|
$
|
3,079
|
|
Accounts payable and accrued expenses - related party
|
|
|
|
|
|
|
880
|
|
|
|
1,752
|
|
Deferred revenue
|
|
|
|
|
|
|
219
|
|
|
|
—
|
|
Short-term debt
|
|
|
|
|
|
|
—
|
|
|
|
155
|
|
Other liabilities
|
|
|
|
|
|
|
—
|
|
|
|
1,878
|
|
Total current liabilities
|
|
|
|
|
|
|
7,726
|
|
|
|
6,864
|
|
Debt - related party
|
|
|
|
|
|
|
—
|
|
|
|
27,310
|
|
Debt, net of current portion
|
|
|
|
|
|
|
—
|
|
|
|
2,110
|
|
Fair value of contingent distribution
|
|
|
|
|
|
|
—
|
|
|
|
26,359
|
|
Note payable
|
|
|
|
|
|
|
—
|
|
|
|
6,594
|
|
Other liabilities, net of current portion
|
|
|
|
|
|
|
245
|
|
|
|
4,434
|
|
Total liabilities
|
|
|
|
|
|
|
7,971
|
|
|
|
73,671
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred units
|
|
|
|
|
|
|
—
|
|
|
|
438,086
|
|
Redeemable noncontrolling interest
|
|
|
|
|
|
|
161,531
|
|
|
|
—
|
|
Stockholders’/members’ deficit:
|
|
|
|
|
|
|
|
|
Members' deficit
|
|
|
|
|
|
|
—
|
|
|
|
(498,806
|
)
|
Class A Common Stock, $0.01 par value; 100,000,000 shares
authorized, 9,156,686
|
|
|
|
|
|
|
|
|
|
|
|
|
shares outstanding as of December 31, 2015
|
|
|
|
|
|
|
92
|
|
|
|
—
|
|
Class B Common Stock, $0.01 par value; 100,000,000 shares
authorized, 23,655,814
|
|
|
|
|
|
|
|
|
|
|
|
|
shares outstanding as of December 31, 2015
|
|
|
|
|
|
|
237
|
|
|
|
—
|
|
Additional paid-in capital
|
|
|
|
|
|
|
117,686
|
|
|
|
—
|
|
Accumulated deficit
|
|
|
|
|
|
|
(195,985
|
)
|
|
|
—
|
|
Total stockholders’ deficit attributable to vTv Therapeutics
Inc./members’ deficit
|
|
|
|
|
|
|
(77,970
|
)
|
|
|
(498,806
|
)
|
Total liabilities, redeemable convertible preferred units,
redeemable noncontrolling
|
|
|
|
|
|
|
|
|
|
|
|
|
interest, stockholders’ and members’ deficit
|
|
|
|
|
|
$
|
91,532
|
|
|
$
|
12,951
|
|
|
|
|
|
|
|
|
|
|
|
vTv Therapeutics, Inc.
|
Consolidated Statements of Operations
|
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Year Ended
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
$
|
226
|
|
|
$
|
934
|
|
|
$
|
519
|
|
|
$
|
1,549
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
8,946
|
|
|
|
5,462
|
|
|
|
29,584
|
|
|
|
18,729
|
|
General and administrative
|
|
|
|
|
|
|
2,370
|
|
|
|
2,140
|
|
|
|
9,077
|
|
|
|
11,717
|
|
Total operating expenses
|
|
|
|
|
|
|
11,316
|
|
|
|
7,602
|
|
|
|
38,661
|
|
|
|
30,446
|
|
Operating loss
|
|
|
|
|
|
|
(11,090
|
)
|
|
|
(6,668
|
)
|
|
|
(38,142
|
)
|
|
|
(28,897
|
)
|
Other expense, net
|
|
|
|
|
|
|
31
|
|
|
|
(1,047
|
)
|
|
|
(2,965
|
)
|
|
|
(7,204
|
)
|
Net loss before income taxes
|
|
|
|
|
|
|
(11,059
|
)
|
|
|
(7,715
|
)
|
|
|
(41,107
|
)
|
|
|
(36,101
|
)
|
Income tax provision
|
|
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Net loss before noncontrolling interest
|
|
|
|
|
|
|
(11,059
|
)
|
|
|
(7,715
|
)
|
|
|
(41,107
|
)
|
|
|
(36,101
|
)
|
Less: net loss attributable to noncontrolling interest
|
|
|
|
|
|
|
(7,890
|
)
|
|
|
—
|
|
|
|
(13,609
|
)
|
|
|
—
|
|
Net loss attributable to vTv Therapeutics Inc.
|
|
|
|
|
|
$
|
(3,169
|
)
|
|
$
|
(7,715
|
)
|
|
$
|
(27,498
|
)
|
|
$
|
(36,101
|
)
|
Net loss per share of vTv Therapeutics Inc. Class A Common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock, basic and diluted
|
|
|
|
|
|
$
|
(0.35
|
)
|
|
|
|
$
|
(3.32
|
)
|
|
|
Weighted-average number of vTv Therapeutics Inc. Class A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock, basic and diluted
|
|
|
|
|
|
|
9,156,686
|
|
|
|
|
|
8,276,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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