[February 27, 2017] |
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vTv Therapeutics Reports 2016 Fourth Quarter and Full Year Financial and Operational Results and Recent Highlights
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 fourth quarter and
full year that ended December 31, 2016.
"2016 marked a year of substantial progress for vTv, as we achieved
numerous milestones in the development of novel therapeutics for
Alzheimer's disease and Type 2 diabetes," said Steve Holcombe, president
and CEO of vTv Therapeutics. "Our Alzheimer's program continues to
advance as planned, and we welcomed positive Phase 2 results from each
of our oral, small molecule drug candidates in Type 2 diabetes."
Recent Highlights
Phase 3 STEADFAST Study with azeliragon in mild Alzheimer's
disease (AD)
Azeliragon: A novel, investigational, oral small molecule antagonist
of the Receptor for Advanced Glycation Endproducts (RAGE) with the
potential to delay progression of AD
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Part A of STEADFAST Study completed enrollment in the third
quarter. The 18-month randomized, double-blind, placebo-controlled
study is evaluating the potential of azeliragon to slow the cognitive
and functional decline of patients with mild Alzheimer's disease.
Based on the completion of enrollment of Part A in September, the
Company anticipates reporting topline data from this part of the study
in early 2018. Enrollment of Part B continues, and is on track to be
completed by mid-year of 2017. The STEADFAST Study is being conducted
under a Special Protocol Assessment. Development of azeliragon has
received fast track designation from the FDA.
Phase 2 LOGRA Study with TTP273 in Type 2 diabetes
TTP273: An investigational, orally-administered small molecule GLP-1R
agonist
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Demonstrated a statistically significant reduction in HbA1c. In
the 12-week LOGRA study conducted in 30 centers in the U.S., 174
patients with Type 2 diabetes on stable doses of metformin were
randomized to receive either placebo or TTP273 at doses of 150 mg once
or twice daily. Patients in each treatment arm had mean
placebo-subtracted HbA1c differences of -0.86 percent and -0.71
percent, respectively. HbA1c increased by 0.15 percent in patients
randomized to placebo. Although the study was not powered to
demonstrate weight loss, trends were observed with patients losing on
average 0.9 kg and 0.6 kg in the once and twice daily arms,
respectively. Additionally, the compound was well-tolerated, with
negligible incidences of nausea and vomiting across all arms of the
study. Analyses of full study results will continue.
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
TTP399: A novel, investigational, oral, liver-selective glucokinase
activator (GKA)
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Topline results showed achievement of the primary endpoint of
statistically significant change from baseline in HbA1c at 6 months
with daily administration of 800 mg of TTP399. The Phase 2b AGATA (Add
Glucokinase Activator to Target (News - Alert) A1c) was a six-month, double-blind,
placebo- and active-controlled parallel group trial in 190 patients
with Type 2 diabetes on a stable dose of metformin. TTP399 was also
found to be well-tolerated without increased incidences of
hypoglycemia and hyperlipidemia compared to placebo. A manuscript with
data from the study is in preparation and will be submitted for
publication during the first quarter of 2017.
Upcoming Anticipated Milestones
STEADFAST Study (azeliragon in Alzheimer's disease): Expect to
complete enrollment in Part B of Phase 3 study in mid-2017.
Fourth Quarter 2016 Financial Results
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Completion of Credit Facility Financing: In October, the
Company closed a $25 million facility, the proceeds of which will be
used to advance its strategic initiatives, as well as to provide
further financial support to ongoing clinical trials.
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Cash Position: Cash, cash equivalents and marketable
securities as of December 31, 2016 were $51.5 million, compared
to $51.1 million as of September 30, 2016. Cash used in the quarter
for operations was offset by the proceeds from the borrowing of the
first tranche under the Company's credit facility received in October.
vTv believes that cash and cash equivalents coupled with funds
available from its credit facility will be sufficient to fund
operations through the first quarter of 2018, which is when topline
results from Part A of the STEADFAST Study are expected.
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R&D Expenses: Research and development expenses
were $11.1 million in the fourth quarter of 2016, compared to $11.2
million in the third quarter of 2016. The decrease in research and
development was primarily driven by decreases in costs associated with
completion of the Company's AGATA and LOGRA studies of $0.8 million
and reduction in compound manufacturing costs for its diabetes and
other programs of $0.6 million. Such decreases were offset by
increases of $1.3 million related to the STEADFAST Study and the
related open-label extension trial for azeliragon.
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G&A Expenses: General and administrative expenses
were $2.3 million in the fourth quarter of 2016, which is relatively
consistent with expenses of $2.4 million in the third quarter of 2016.
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Net Loss: Net loss was $13.7 million for the fourth quarter of
2016 compared to net loss of $13.5 million for the third quarter of
2016.
Full Year 2016 Financial Results
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R&D Expenses: Research and development expenses
were $45.7 million in 2016, compared to $29.6 million in 2015. The
increase in research and development expense was primarily driven by
an increase of $15.4 million in costs related to the Company's
azeliragon program caused by higher enrollment and related activities
for the STEADFAST Study, higher compound manufacturing costs to
support the study and higher costs associated with other supporting
studies. Additionally, there were increases of $0.6 million in costs
related to TTP273, as increases in clinical trial costs outweighed
decreases in compound manufacturing costs, and increases of $1.5
million in other research and development costs driven primarily by
higher compensation costs as headcount was increased in order to
support ongoing clinical trials. Such increases were offset by a
decrease in spending of $1.5 million for TTP399, as the AGATA study
was completed in August 2016 and a decrease in the cost of compound
manufacturing for the study, which primarily occurred in 2015.
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G&A Expenses: General and administrative expenses
were $9.9 million in 2016 compared to $9.1 million in 2015. The
increase was primarily driven by a $2.1 million increase in
compensation costs related to the addition of personnel to support
compliance with public company requirements, offset by a $1.4 million
decrease in legal and professional service expenses incurred in 2015
in connection with the Company's IPO that year.
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Net Loss: Net loss was $55.4 million for 2016 compared to a net
loss of $41.1 million for 2015.
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vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
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December 31,
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September 30,
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2016
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2016
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(Unaudited)
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(Unaudited)
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Assets
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Current assets:
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Cash and cash equivalents
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$
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51,505
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$
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51,058
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Accounts receivable, net
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-
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-
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Prepaid expenses and other current assets
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612
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1,058
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Total current assets
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52,117
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52,116
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Property and equipment, net
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444
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493
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Other long-term assets
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1,934
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2,106
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Total assets
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$
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54,495
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$
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54,715
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Liabilities, Redeemable Noncontrolling Interest and Stockholders'
Deficit
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Current liabilities:
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Accounts payable and accrued expenses
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$
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11,413
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$
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10,156
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Accounts payable and accrued expenses - related party
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-
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406
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Deferred revenue
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21
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21
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Total current liabilities
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11,434
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10,583
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Notes payable
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11,058
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-
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Other liabilities
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433
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225
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Total liabilities
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22,925
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10,808
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Commitments and contingencies
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Redeemable noncontrolling interest
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122,515
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155,147
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Stockholders' deficit:
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Class A Common Stock
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97
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97
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Class B Common Stock
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232
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232
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Additional paid-in capital
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124,212
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122,838
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Accumulated deficit
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(215,486
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)
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(234,407
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)
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Total stockholders' deficit attributable to vTv Therapeutics Inc.
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(90,945
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)
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(111,240
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Total liabilities, redeemable noncontrolling interest and
stockholders' deficit
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$
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54,495
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$
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54,715
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Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
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Three Months Ended
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For the Year Ended December 31,
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December 31, 2016
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September 30, 2016
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2016
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2015
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Revenue
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$
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38
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$
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38
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$
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634
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$
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519
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Operating expenses:
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Research and development
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11,099
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11,165
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45,748
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29,584
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General and administrative
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2,252
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2,401
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9,906
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9,077
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Total operating expenses
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13,351
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13,566
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55,654
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38,661
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Operating loss
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(13,313
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)
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(13,528
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)
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(55,020
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)
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(38,142
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Interest income
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20
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21
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87
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40
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Interest expense
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(394
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)
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(1
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)
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(398
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)
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(108
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)
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Other (expense) income, net
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(24
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)
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3
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(22
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)
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(2,897
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)
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Loss before income taxes and noncontrolling interest
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(13,711
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)
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(13,505
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(55,353
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)
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(41,107
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)
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Income tax provision
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-
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-
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-
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-
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Net loss before noncontrolling interest
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(13,711
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)
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(13,505
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)
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(55,353
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)
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(41,107
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Less: net loss attributable to noncontrolling interest
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(9,661
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)
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(9,512
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)
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(39,001
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)
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(13,609
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Net loss attributable to vTv Therapeutics Inc.
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$
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(4,050
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$
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(3,993
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$
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(16,352
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$
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(27,498
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Net loss per share of vTv Therapeutics Inc. Class A Common Stock,
basic and diluted
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$
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(0.42
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)
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$
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(0.41
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$
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(1.71
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$
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(3.32
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Weighted-average number of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted
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9,693,254
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9,691,362
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9,545,527
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8,276,520
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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 (News - Alert). 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170227006687/en/
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