vTv Therapeutics Inc. (vTv Therapeutics) (Nasdaq:VTVT) today
provided a corporate update and reported financial and operational
results for the third quarter ended September 30, 2017.
“We’ve made significant progress in the third quarter of 2017
across our strategic initiatives, and we attribute that to our
ongoing development of innovative therapies, particularly in the
areas of Alzheimer’s and diabetes,” said Steve Holcombe, president
and CEO of vTv Therapeutics. “We look forward to building on this
momentum as we approach several important milestones next year,
including the Part A readout out of our Phase 3 STEADFAST Study of
azeliragon in patients with mild Alzheimer’s disease.”
Third Quarter 2017
Highlights
Issuance of U.S. Patent Covering Methods of Treatment Using
Azeliragon
- The U.S. Patent and Trademark Office
issued patent number 9,717,710 (‘710 Patent) with claims protecting
methods of treatment using azeliragon, vTv Therapeutics’ oral
antagonist of the Receptor for Advanced Glycation Endproducts
(RAGE) for treatment of mild Alzheimer’s disease. The ‘710 Patent,
expiring in October 2034, includes claims covering methods of
treating patients with mild Alzheimer’s disease by administering
about 5 mg per day of azeliragon.
2017 Alzheimer’s Association International Conference
- In two poster presentations titled,
“Assessment of Azeliragon QTc Liability through Integrated,
Model-Based Concentration QTc Analysis” and “Effect of Food on the
Pharmacokinetics of Azeliragon in Healthy Adult Subjects,” vTv
Therapeutics’ researchers reviewed study data that indicated no
deleterious effect of azeliragon on QT at therapeutic and
supra-therapeutic doses and that azeliragon may be given without
regard to meals.
vTv Therapeutics and JDRF Enter Into Industry
Partnership
- JDRF, the leading global organization
funding type 1 diabetes (T1D) research, committed $3 million in
funding, matched by vTv Therapeutics, to support a Phase 2 Proof of
Concept study to explore the effect of vTv Therapeutics’
liver-selective glucokinase activator TTP399 as an oral drug for
the treatment of T1D. The study will evaluate whether TTP399 is
well tolerated when administered as an add-on to insulin therapy
for people with T1D and whether TTP399 has the potential to
significantly improve daily glucose profiles and HbA1c.
53rd European Association for the Study of Diabetes Annual
Meeting
- In a poster presentation titled “Beyond
topline results for the oral (non-peptide) GLP-1R agonist TTP273 in
type 2 diabetes: How much and when?” vTv Therapeutics’ researchers
reviewed results from a concentration/effect analysis on the LOGRA
study showing that lower doses of TTP273 may show more pronounced
effects for key efficacy endpoints, including a reduction in HbA1c,
weight, and fasting plasma glucose.
Upcoming Anticipated
Milestones
STEADFAST Study (azeliragon in patients with mild Alzheimer’s
disease): Expected to report top-line results from each of the
Part A and Part B studies in early 2018 and late 2018,
respectively.
Third Quarter 2017 Financial
Results
- Cash Position: Cash and
cash equivalents as of September 30, 2017 were $20.5
million compared to $32.5 million as of June 30,
2017.
- R&D Expenses: Research
and development expenses were $9.0 million in the third
quarter of 2017, compared to $9.6 million in the second
quarter of 2017. The decrease in research and development expenses
was primarily driven by decreases in spending for the STEADFAST
Study due to the relative costs of patient visits.
- G&A Expenses: General
and administrative expenses were $2.6 million and $3.0
million, for the third and second quarters of 2017, respectively.
The decrease in general and administrative costs was primarily due
to the reduction in professional service fees between the
periods.
- Net Loss Before Non-Controlling
Interest: Net loss before non-controlling interest
was $12.4 million for the third quarter of 2017 compared to
net loss before non-controlling interest of $13.4 million for
the second quarter of 2017.
- Net Loss per Share: GAAP
net loss per share was $0.38 and $0.41 for the three months ended
September 30, 2017 and June 30, 2017, respectively, based on
weighted-average shares of 9.7 million in each period. Non-GAAP net
loss per fully exchanged share was $0.38 and $0.41 for the three
months ended September 30, 2017 and June 30, 2017, respectively,
based on non-GAAP fully exchanged weighted-average shares of 32.8
million in each period.
vTv Therapeutics Inc.Condensed
Consolidated Balance Sheets(in thousands)
September 30,
June 30, 2017 2017 (Unaudited)
(Unaudited) Assets Current assets: Cash and cash
equivalents $ 20,488 $ 32,513 Restricted cash 281 — Prepaid
expenses and other current assets 725 639
Total current assets 21,494 33,152 Property and equipment,
net 310 374 Other long-term assets 2,251 2,253
Total assets $ 24,055 $ 35,779
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’ Deficit
Current liabilities: Accounts payable and accrued expenses $ 10,120
$ 10,734 Deferred revenue — — Current portion of notes payable
2,083 521 Total current liabilities
12,203 11,255 Notes payable 17,228 18,516 Other liabilities
285 273 Total liabilities 29,716 30,044
Commitments and contingencies Redeemable noncontrolling interest
130,642 112,145 Stockholders’ deficit: Class A Common Stock 97 97
Class B Common Stock 232 232 Additional paid-in capital 127,036
126,077 Accumulated deficit (263,668 ) (232,816 )
Total stockholders’ deficit attributable to vTv Therapeutics Inc.
(136,303 ) (106,410 ) Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit $ 24,055 $
35,779
vTv Therapeutics Inc.Condensed
Consolidated Statements of Operations - Unaudited(in
thousands, except per share data)
Three Months Ended
September 30,
2017
June 30,
2017
Revenue $ 15 $ 13 Operating expenses: Research and development
8,989 9,623 General and administrative 2,567
3,005 Total operating expenses 11,556
12,628 Operating loss (11,541 ) (12,615 ) Interest income 35
33 Interest expense (849 ) (832 ) Other income (loss), net —
— Loss before income taxes and noncontrolling
interest (12,355 ) (13,414 ) Income tax provision —
— Net loss before noncontrolling interest (12,355 )
(13,414 ) Less: net loss attributable to noncontrolling interest
(8,705 ) (9,451 )
Net loss attributable to vTv
Therapeutics Inc. $ (3,650 ) $ (3,963 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.38 ) $ (0.41 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,693,254
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,
2017 2016 2017
2016 Revenue $ 15 $ 38 $ 58 $ 596 Operating expenses:
Research and development 8,989 11,165 29,572 34,649 General and
administrative 2,567 2,401 8,396
7,654 Total operating expenses 11,556
13,566 37,968 42,303
Operating loss (11,541 ) (13,528 ) (37,910 ) (41,707 )
Interest income 35 21 95 66 Interest expense (849 ) — (2,240 ) (3 )
Other income (loss), net — 2 —
2 Loss before income taxes and noncontrolling
interest (12,355 ) (13,505 ) (40,055 ) (41,642 ) Income tax
provision — — — —
Net loss before noncontrolling interest (12,355 ) (13,505 )
(40,055 ) (41,642 ) Less: net loss attributable to noncontrolling
interest (8,705 ) (9,512 ) (28,222 )
(29,340 )
Net loss attributable to vTv Therapeutics Inc. $
(3,650 ) $ (3,993 ) $ (11,833 ) $ (12,302 )
Net loss per share of vTv Therapeutics
Inc. Class A Common Stock, basic and diluted
$ (0.38 ) $ (0.41 ) $ (1.22 ) $ (1.30 )
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,691,362 9,693,254
9,495,926
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 Therapeutics 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
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, our most recent Quarterly Report on Form 10-Q 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
accountings principals 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 diluted 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,
2017
June 30,
2017
Numerator: Net loss attributable to vTv Therapeutics Inc. $ (3,650
) $ (3,963 )
Reallocation of net income attributable to
non-controlling interest from the assumed exchange of Class B
shares (1)
(8,705 ) (9,451 ) Net loss before noncontrolling
interest $ (12,355 ) $ (13,414 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,693,254 Assumed exchange of Class B Common Stock (1)
23,119,246 23,119,246
Adjusted proforma fully exchanged
weighted-average shares of Class A common stock outstanding, basic
and diluted
32,812,500 32,812,500
Adjusted proforma earnings per fully
exchanged share, basic and diluted
$ (0.38 ) $ (0.41 )
Three Months Ended
September 30,
2017 2016 Numerator: Net loss attributable to vTv
Therapeutics Inc. $ (3,650 ) $ (3,993 )
Reallocation of net income attributable to
non-controlling interest from the assumed exchange of Class B
shares (1)
(8,705 ) (9,512 ) Net loss before noncontrolling
interest $ (12,355 ) $ (13,505 ) Denominator:
Weighted-average number of vTv
Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,691,362 Assumed exchange of Class B Common Stock (1)
23,119,246 23,121,138
Adjusted proforma fully exchanged
weighted-average shares of Class A common stock outstanding, basic
and diluted
32,812,500 32,812,500
Adjusted proforma earnings per fully
exchanged share, basic and diluted
$ (0.38 ) $ (0.41 )
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Investors:vTv Therapeutics Inc.Mike Biega,
617-221-9660IR@vtvtherapeutics.comorMedia:Pure Communications
Inc.Katie Engleman, 910-509-3977Katie@purecommunications.com
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