vTv Therapeutics Announces 2019 Second Quarter Financial Results and Update
July 31 2019 - 4:30PM
vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial
results for the second quarter that ended June 30, 2019, and
provided an update on recent achievements and upcoming events.
“We made significant progress during the second quarter,” said
Steve Holcombe, chief executive officer, vTv Therapeutics. “We
reported positive results from part 1 of our phase 2 Simplici-T1
trial in type 1 diabetes and began screening patients for our
488-305 trial evaluating azeliragon in patients with mild
Alzheimer’s disease and type 2 diabetes. We look forward to
continuing to execute successfully on our development plans for
each of these drug candidates and advancing them as potential
treatments for patients suffering from these diseases.”
Recent Achievements and Outlook
- Part 1 of the Simplici-T1 Study achieves positive
topline results in patients with type 1 diabetes. In June
2019, we announced positive topline results from part 1 of the
phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an
add-on to insulin therapy for patients with type 1 diabetes.In this
double-blind, placebo-controlled 12-week trial, the baseline mean
HbA1c for the groups treated with TTP399 and placebo was 7.3% and
7.4%, respectively. Patients treated with TTP399 (n=8) showed a
statistically significant mean reduction in HbA1c of 0.6% at 12
weeks, while the group treated with placebo (n=11) showed a mean
increase in HbA1c of 0.1%, resulting in a mean improvement of 0.7%
in the TTP399 group relative to the placebo group (p=0.03). TTP399
was well tolerated in the study, with no serious adverse event
reported, and no report of diabetic ketoacidosis or severe
hypoglycemia.
- Simplici-T1 Study enrolling patients in Part
2. In May 2019, we began enrolling patients in the part 2
confirmatory phase of the Simplici-T1 Study and expect to report
results for that portion of the study in the latter part of the
first quarter of 2020.
- Screening patients for Phase 2/3 clinical trial of
azeliragon. We began screening patients in June 2019 for a
Phase 2 clinical trial to evaluate azeliragon as a potential
treatment of mild-AD in patients with type 2 diabetes. The
randomized, double-blind, placebo-controlled multicenter trial is
designed as sequential phase 2 and phase 3 studies operationally
conducted under one protocol. Each part of the study will
evaluate the efficacy and safety of azeliragon in patients with
mild Alzheimer's disease (screening MMSE 21 to 26, baseline MMSE 19
to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening
HbA1c 6.5% to 9.5%, inclusive).vTv expects to report topline
results from the phase 2 proof of concept study by the end of the
fourth quarter of 2020.
Upcoming Events
vTv will present additional results from Part 1 of the
Simplici-T1 Study at the 55th Annual Meeting of the European
Association for the Study of Diabetes in Barcelona Spain, September
16–20, 2019 with a poster entitled “Results from the sentinel and
learning phase of the Simplici-T1 study, the first clinical trial
to test activation of glucokinase as an adjunctive treatment for
type 1 diabetes.”
Second Quarter 2019 Financial Results
- Cash Position: Cash and cash equivalents
as of June 30, 2019, were $1.5 million compared
to $5.0 million as of March 31, 2019.
- Revenue: Revenues were $1.8 million for the
second quarter of 2019 versus $0.9 million in the first quarter of
2019. The increase in revenue was driven by the recognition
of $1.0 million for one of our license agreements based on the
satisfaction of a development milestone.
- R&D Expenses: Research and
development expenses were $4.2 million in the second
quarter of 2019 and $2.8 million in the first quarter of
2019. This increase in R&D expenses was driven primarily
by the increase in costs for the 488-305 Study for which we were
performing start-up activities, including site activations, in the
second quarter of 2019.
- G&A Expenses: General and
administrative expenses were $2.4 million in each of the second and
first quarters of 2019.
- Net Loss Before Non-Controlling
Interest: Net loss before non-controlling interest
was $5.1 million for the second quarter of 2019 compared to
net loss before non-controlling interest of $4.0 million for
the first quarter of 2019.
- Net Loss Per Share: GAAP net loss per
share was $0.10 and $0.26 for the three months ended June 30, 2019
and March 31, 2019, respectively, based on weighted-average shares
of 28.0 million and 22.9 million for the three month periods ended
June 30, 2019 and March 31, 2019, respectively. Non-GAAP net loss
per fully exchanged share was $0.09 and $0.06 for the three months
ended June 30, 2019 and March 31, 2019, respectively, based on
non-GAAP fully exchanged weighted-average shares of 51.1 million
and 46.0 million for the three months ended June 30, 2019 and March
31, 2019, respectively.
vTv Therapeutics
Inc.Condensed Consolidated Balance
Sheets(in thousands)
|
June 30, |
|
|
March
31, |
|
|
2019 |
|
|
2019 |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
1,462 |
|
|
$ |
4,959 |
|
Accounts receivable, net |
|
1,822 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
145 |
|
|
|
419 |
|
Current deposits |
|
367 |
|
|
|
34 |
|
Total current assets |
|
3,796 |
|
|
|
5,412 |
|
Restricted cash and cash
equivalents, long-term |
|
2,500 |
|
|
|
2,500 |
|
Property and equipment,
net |
|
54 |
|
|
|
62 |
|
Operating lease right-of-use
assets |
|
167 |
|
|
|
246 |
|
Long-term investments |
|
2,480 |
|
|
|
2,480 |
|
Long-term deposits |
|
75 |
|
|
|
36 |
|
Total assets |
$ |
9,072 |
|
|
$ |
10,736 |
|
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
8,326 |
|
|
$ |
6,244 |
|
Operating lease liabilities |
|
178 |
|
|
|
259 |
|
Current portion of deferred revenue |
|
27 |
|
|
|
839 |
|
Current portion of notes payable |
|
8,646 |
|
|
|
9,167 |
|
Total current liabilities |
|
17,177 |
|
|
|
16,509 |
|
Notes payable, net of current
portion |
|
2,185 |
|
|
|
4,014 |
|
Deferred revenue, net of
current portion |
|
1,052 |
|
|
|
1,067 |
|
Warrant liability, related
party |
|
1,240 |
|
|
|
1,515 |
|
Other liabilities |
|
260 |
|
|
|
260 |
|
Total liabilities |
|
21,914 |
|
|
|
23,365 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Redeemable noncontrolling
interest |
|
37,060 |
|
|
|
45,106 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
Class A Common Stock |
|
298 |
|
|
|
273 |
|
Class B Common Stock |
|
232 |
|
|
|
232 |
|
Additional paid-in capital |
|
167,125 |
|
|
|
162,249 |
|
Accumulated deficit |
|
(217,557 |
) |
|
|
(220,489 |
) |
Total stockholders’ deficit
attributable to vTv Therapeutics Inc. |
|
(49,902 |
) |
|
|
(57,735 |
) |
Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit |
$ |
9,072 |
|
|
$ |
10,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations - Unaudited(in thousands, except per
share data)
|
Three Months
Ended |
|
|
June 30, 2019 |
|
|
March 31, 2019 |
|
Revenue |
$ |
1,828 |
|
|
$ |
921 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
4,228 |
|
|
|
2,822 |
|
General and administrative |
|
2,392 |
|
|
|
2,386 |
|
Total operating expenses |
|
6,620 |
|
|
|
5,208 |
|
Operating loss |
|
(4,792 |
) |
|
|
(4,287 |
) |
Interest income |
|
16 |
|
|
|
10 |
|
Interest expense |
|
(514 |
) |
|
|
(626 |
) |
Other income, net |
|
276 |
|
|
|
921 |
|
Loss before income taxes and noncontrolling interest |
|
(5,014 |
) |
|
|
(3,982 |
) |
Income tax provision |
|
100 |
|
|
|
— |
|
Net loss before noncontrolling interest |
|
(5,114 |
) |
|
|
(3,982 |
) |
Less: net loss attributable to noncontrolling
interest |
|
(2,232 |
) |
|
|
(1,827 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(2,882 |
) |
|
$ |
(2,155 |
) |
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(2,882 |
) |
|
$ |
(5,883 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.26 |
) |
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
28,037,628 |
|
|
|
22,862,907 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations - Unaudited(in thousands, except per
share data)
|
Three Months
Ended June 30, |
|
|
For the Six
Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue |
$ |
1,828 |
|
|
$ |
2,473 |
|
|
$ |
2,749 |
|
|
$ |
4,537 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
4,228 |
|
|
|
8,594 |
|
|
|
7,050 |
|
|
|
17,537 |
|
General and administrative |
|
2,392 |
|
|
|
2,737 |
|
|
|
4,778 |
|
|
|
4,992 |
|
Total operating expenses |
|
6,620 |
|
|
|
11,331 |
|
|
|
11,828 |
|
|
|
22,529 |
|
Operating loss |
|
(4,792 |
) |
|
|
(8,858 |
) |
|
|
(9,079 |
) |
|
|
(17,992 |
) |
Interest income |
|
16 |
|
|
|
16 |
|
|
|
26 |
|
|
|
34 |
|
Interest expense |
|
(514 |
) |
|
|
(870 |
) |
|
|
(1,140 |
) |
|
|
(1,725 |
) |
Other income, net |
|
276 |
|
|
|
316 |
|
|
|
1,197 |
|
|
|
327 |
|
Loss before income taxes and noncontrolling interest |
|
(5,014 |
) |
|
|
(9,396 |
) |
|
|
(8,996 |
) |
|
|
(19,356 |
) |
Income tax provision |
|
100 |
|
|
|
200 |
|
|
|
100 |
|
|
|
200 |
|
Net loss before noncontrolling interest |
|
(5,114 |
) |
|
|
(9,596 |
) |
|
|
(9,096 |
) |
|
|
(19,556 |
) |
Less: net loss attributable to noncontrolling
interest |
|
(2,232 |
) |
|
|
(6,524 |
) |
|
|
(4,059 |
) |
|
|
(13,532 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(2,882 |
) |
|
$ |
(3,072 |
) |
|
$ |
(5,037 |
) |
|
$ |
(6,024 |
) |
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(2,882 |
) |
|
$ |
(3,072 |
) |
|
$ |
(8,765 |
) |
|
$ |
(6,024 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.61 |
) |
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
28,037,628 |
|
|
|
10,049,831 |
|
|
|
25,464,562 |
|
|
|
9,875,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About vTv TherapeuticsvTv 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, diabetes, and inflammatory
disorders.
Forward-Looking StatementsThis 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 MeasuresTo 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 adjusted net loss per fully
exchanged share, which is a non-GAAP financial measure. Non-GAAP
adjusted net loss per fully exchanged share adjusts the net loss
attributable to vTv common shareholders for the impact of
adjustments related to outstanding warrants, share-based
compensation expense and the portion of net loss attributable to
the noncontrolling interest. It also assumes 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 and other items of a non-cash
nature. 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 adjusted net loss
per fully exchanged share, basic and diluted to its most directly
comparable GAAP measure, net loss per share of vTv Therapeutics
Inc. Class A common stock, basic and diluted and the computation of
the components of this non-GAAP measure:
|
Three Months
Ended |
|
|
June 30, 2019 |
|
|
March 31, 2019 |
|
Numerator: |
|
|
|
|
|
|
|
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(2,882 |
) |
|
$ |
(5,883 |
) |
Other income - related party |
|
275 |
|
|
|
921 |
|
Share-based compensation expense |
|
401 |
|
|
|
281 |
|
Deemed distribution to related party |
|
— |
|
|
|
3,728 |
|
Reallocation of net income attributable to noncontrolling
interest from the assumed exchange of Class B shares (1) |
|
(2,232 |
) |
|
|
(1,827 |
) |
Adjusted net loss before noncontrolling interest |
$ |
(4,438 |
) |
|
$ |
(2,780 |
) |
Denominator: |
|
|
|
|
|
|
|
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
28,037,628 |
|
|
|
22,862,907 |
|
Assumed exchange of Class B Common Stock (1) |
|
23,094,221 |
|
|
|
23,094,221 |
|
Adjusted proforma fully
exchanged weighted-average shares of Class A common stock
outstanding, basic and diluted |
|
51,131,849 |
|
|
|
45,957,128 |
|
Adjusted net loss per fully
exchanged share, basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
|
Six Months
Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(2,882 |
) |
|
$ |
(3,072 |
) |
|
$ |
(8,765 |
) |
|
$ |
(6,024 |
) |
Other income - related party |
|
275 |
|
|
|
316 |
|
|
|
1,196 |
|
|
|
291 |
|
Share-based compensation expense |
|
401 |
|
|
|
803 |
|
|
|
682 |
|
|
|
1,766 |
|
Deemed distribution to related party |
|
— |
|
|
|
— |
|
|
|
3,728 |
|
|
|
— |
|
Reallocation of net income attributable to noncontrolling
interest from the assumed exchange of Class B shares (1) |
|
(2,232 |
) |
|
|
(6,524 |
) |
|
|
(4,059 |
) |
|
|
(13,532 |
) |
Adjusted net loss before noncontrolling interest |
$ |
(4,438 |
) |
|
$ |
(8,477 |
) |
|
$ |
(7,218 |
) |
|
$ |
(17,499 |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
28,037,628 |
|
|
|
10,049,831 |
|
|
|
25,464,562 |
|
|
|
9,875,743 |
|
Assumed exchange of Class B Common Stock (1) |
|
23,094,221 |
|
|
|
23,094,221 |
|
|
|
23,094,221 |
|
|
|
23,104,867 |
|
Adjusted proforma fully
exchanged weighted-average shares of Class A common stock
outstanding, basic and diluted |
|
51,131,849 |
|
|
|
33,144,052 |
|
|
|
48,558,783 |
|
|
|
32,980,610 |
|
Adjusted net loss per fully
exchanged share, basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.53 |
) |
(1) Assumes the exchange of all outstanding Class B common
stock, resulting in the elimination of the noncontrolling interest
and recognition of the net income attributable to noncontrolling
interests.
ContactsInvestors: vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or Media: Josh Vlasto, 212-572-5969
PR@vtvtherapeutics.com
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