vTv Therapeutics Inc. (Nasdaq: VTVT) today reported financial
results for the third quarter that ended September 30, 2018, and
provided an update on recent achievements and upcoming events.
“We continue to believe in the therapeutic potential of
azeliragon and are committed to finding the optimal development
pathway forward for the program,” said Steve Holcombe, chief
executive officer, vTv Therapeutics. “We are also making progress
with our other programs, either internally in the case of our GKA
program, or through our licensing partners for our GLP-1R agonist,
PPAR-delta, and PDE4 programs. We hope to see milestones achieved
for each of these programs during 2019.”
Recent Achievements and Outlook
- Presentation of data at
11th Clinical Trials on Alzheimer’s Disease.
Presented positive post-hoc subgroup data indicating a potential
benefit of treatment with azeliragon in Alzheimer’s disease
patients with type 2 diabetes. This subgroup included 55 patients
with glycosylated hemoglobin (HbA1c) of greater than 6.5% at
baseline (HbA1c greater than 7.7% was an exclusion criterion at
screening) and a clinical diagnosis of Alzheimer’s disease in the
combined A-Study and B-Study of the STEADFAST trial. The
azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1
point benefit on ADAS-cog relative to the placebo group (n=8),
which was nominally statistically significant (p = 0.005), and a
1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18
months of treatment.
- Meeting with European Medicines
Agency. Met with the Scientific Advice Working Party (SAWP) of
the EMA on October 30, 2018, to discuss future development
requirements in support of seeking regulatory approval of
azeliragon in the European Union. We expect to receive formal
guidance from the SAWP during the fourth quarter of 2018.
- SimplicT-1 Study enrolling patients
with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study
continues to enroll patients with type 1 diabetes in a 12-week
study to evaluate TTP399 as an add-on to insulin therapy. We expect
to have an interim read-out of the results of this study in early
2019. TTP399 has previously demonstrated statistically significant
reductions in HbA1c levels in the AGATA Study, a phase 2 study in
type 2 diabetes.
Upcoming Events
vTv will participate in the following upcoming investor
conferences:
- Piper Jaffray 30th Annual Healthcare
Conference, November 27-29, New York, NY
- J.P. Morgan 37th Annual Healthcare
Conference, January 7-10, San Francisco, CA
Second Quarter 2018 Financial Results
- Cash Position: Cash and
cash equivalents as of September 30, 2018, were $3.8
million compared to $1.2 million as of June 30,
2018.
- R&D Expenses: Research
and development expenses were $2.7 million in the third
quarter of 2018, compared to $8.6 million in the second
quarter of 2018. The decrease in research and development expenses
was primarily driven by the termination of the STEADFAST and open
label extension studies during the second quarter of 2018.
- G&A Expenses: General
and administrative expenses were $2.2 million and $2.7
million, for the third quarter of 2018 and the second quarter of
2018, respectively. General and administrative expenses were lower
due to reduced share-based compensation expense and professional
service fees.
- Net Loss Before Non-Controlling
Interest: Net loss before non-controlling interest
was $2.0 million for the third quarter of 2018 compared to net
loss before non-controlling interest of $9.6 million for the
second quarter of 2018.
- Net Loss Per Share: GAAP
net loss per share was $0.06 and $0.31 for the three months ended
September 30, 2018 and June 30, 2018, respectively, based on
weighted-average shares of 12.3 million and 10.0 million for the
three month periods ended September 30, 2018 and June 30, 2018,
respectively. Non-GAAP net loss per fully exchanged share was $0.06
and $0.29 for the three months ended September 30, 2018 and June
30, 2018, respectively, based on non-GAAP fully exchanged
weighted-average shares of 35.4 million and 33.1 million for the
three months ended September 30, 2018 and June 30, 2018,
respectively.
vTv Therapeutics Inc.Condensed
Consolidated Balance Sheets - Unaudited(in
thousands)
September 30,
June 30, 2018 2018 Assets
Current assets: Cash and cash equivalents $ 3,766 $ 1,163
Restricted cash and cash equivalents — — Accounts receivable, net —
2,270 Prepaid expenses and other current assets 1,006 264 Current
deposits 1,124 2,311 Total current
assets 5,896 6,008 Restricted cash and cash equivalents, long-term
2,500 2,500 Property and equipment, net 177 202 Long-term
investments 2,480 2,480 Long-term deposits 36
36 Total assets $ 11,089 $ 11,226
Liabilities, Redeemable Noncontrolling Interest and
Stockholders’ Deficit Current liabilities: Accounts payable and
accrued expenses $ 8,965 $ 13,144 Current portion of deferred
revenue 6,747 10,114 Current portion of notes payable 9,597
8,229 Total current liabilities 25,309 31,487
Notes payable 8,611 10,863 Deferred revenue, net of current portion
595 603 Warrant liability, related party 382 201 Other liabilities
258 256 Total liabilities 35,155 43,410
Commitments and contingencies Redeemable noncontrolling interest
19,912 39,413 Stockholders’ deficit: Class A Common Stock 158 109
Class B Common Stock 232 232 Additional paid-in capital 144,617
134,587 Accumulated deficit (188,985 ) (206,525 )
Total stockholders’ deficit attributable to vTv Therapeutics Inc.
(43,978 ) (71,597 ) Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit $ 11,089 $
11,226
vTv Therapeutics Inc.Condensed
Consolidated Statements of Operations - Unaudited(in
thousands, except per share data)
Three Months Ended
September 30,
2018
June 30,
2018
Revenue $ 3,375 $ 2,473 Operating expenses: Research and
development 2,698 8,594 General and administrative 2,158
2,737 Total operating expenses 4,856
11,331 Operating loss (1,481 ) (8,858 )
Interest income 13 16 Interest expense (822 ) (870 ) Other income
(expense), net 329 316 Loss before
income taxes and noncontrolling interest (1,961 ) (9,396 ) Income
tax provision — 200 Net loss before
noncontrolling interest (1,961 ) (9,596 ) Less: net loss
attributable to noncontrolling interest (1,165 )
(6,524 )
Net loss attributable to vTv Therapeutics Inc. $
(796 ) $ (3,072 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.06 ) $ (0.31 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
12,305,949 10,049,831
vTv Therapeutics Inc.Condensed
Consolidated Statements of Operations - Unaudited(in
thousands, except per share data)
Three Months Ended
September 30,
For the Nine Months Ended
September 30,
2018 2017 2018
2017 Revenue $ 3,375 $ 15 $ 7,912 $ 58 Operating expenses:
Research and development 2,698 8,989 20,235 29,572 General and
administrative 2,158 2,567 7,150
8,396 Total operating expenses 4,856
11,556 27,385 37,968
Operating loss (1,481 ) (11,541 ) (19,473 ) (37,910 )
Interest income 13 35 47 95 Interest expense (822 ) (849 ) (2,547 )
(2,240 ) Other income (expense), net 329 —
656 — Loss before income taxes
and noncontrolling interest (1,961 ) (12,355 ) (21,317 ) (40,055 )
Income tax provision — — 200
— Net loss before noncontrolling interest
(1,961 ) (12,355 ) (21,517 ) (40,055 ) Less: net loss attributable
to noncontrolling interest (1,165 ) (8,705 )
(14,697 ) (28,222 )
Net loss attributable to vTv
Therapeutics Inc. $ (796 ) $ (3,650 ) $ (6,820 ) $ (11,833 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.06 ) $ (0.38 ) $ (0.64 ) $ (1.22 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
12,305,949 9,693,254 10,701,599
9,693,254
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
diabetes as well as treatment of inflammatory disorders.
About STEADFAST
The STEADFAST study, two independent and identical randomized,
double-blind, placebo-controlled Phase 3 trials (A-Study and
B-Study), was designed to investigate the safety and efficacy of
azeliragon as a potential treatment for patients with mild
Alzheimer’s disease. The 18-month study targeted enrollment of 800
patients (400 in each trial). The first trial enrolled patients in
the United States and Canada who had a clinical diagnosis of mild
Alzheimer’s disease and an MRI consistent with this diagnosis.
Enrollment of the second trial included study sites in the United
Kingdom, Ireland, Australia, New Zealand and South Africa. While in
April and in June 2018 topline results were announced that the
A-Study and the B-Study did not meet the co-primary endpoints and
clinical trials were ended, subsequent post-hoc subgroup analyses
have shown populations that experienced positive benefits.
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 non-GAAP
earnings per fully exchanged share, which is a non-GAAP financial
measure. Non-GAAP earnings per fully exchanged share is defined as
net loss attributable to vTv Therapeutics Inc. 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. 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. 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 non-GAAP earnings per fully
exchanged share, basic and diluted to its most directly comparable
GAAP measure, net loss per share of vTv Therapeutics Class A common
stock, basic and diluted and the computation of the components of
this non-GAAP measure:
Three Months Ended
September 30,
2018
June 30,
2018
Numerator: Net loss attributable to vTv Therapeutics Inc. $ (796 )
$ (3,072 )
Reallocation of net income attributable to
non-controlling interest from the assumed exchange of Class B
shares (1)
(1,165 ) (6,524 ) Net loss before noncontrolling
interest $ (1,961 ) $ (9,596 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
12,305,949 10,049,831 Assumed exchange of Class B Common Stock (1)
23,114,652 23,094,221
Adjusted proforma fully exchanged
weighted-average shares of Class A common stock outstanding, basic
and diluted
35,420,601 33,144,052
Adjusted proforma earnings per fully
exchanged share, basic and diluted
$ (0.06 ) $ (0.29 )
Three Months Ended
September 30,
Nine Months Ended
September 30,
2018 2017 2018 2017
Numerator: Net loss attributable to vTv Therapeutics Inc. $ (796 )
$ (3,650 ) $ (6,820 ) $ (11,833 )
Reallocation of net income attributable to
non-controlling interest from the assumed exchange of Class B
shares (1)
(1,165 ) (8,705 ) (14,697 ) (28,222 )
Net loss before noncontrolling interest $ (1,961 ) $ (12,355 ) $
(21,517 ) $ (40,055 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
12,305,949 9,693,254 10,701,599 9,693,254
Assumed exchange of Class B Common Stock
(1)
23,114,652 23,119,246 23,101,279
23,119,246
Adjusted proforma fully exchanged
weighted-average shares of Class A common stock outstanding, basic
and diluted
35,420,601 32,812,500 33,802,878
32,812,500
Adjusted proforma earnings per fully
exchanged share, basic and diluted
$ (0.06 ) $ (0.38 ) $ (0.64 ) $ (1.22 )
_________________
(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.
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