vTv Therapeutics Announces 2019 Third Quarter Financial Results and Update
October 30 2019 - 5:30PM
vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial
results for the third quarter that ended September 30, 2019, and
provided an update on recent achievements, events, and its ongoing
clinical trials in type 1 diabetes and Alzheimer’s disease.
“We hosted an informative type 1 diabetes key opinion leader
event with JDRF this quarter where two prominent KOLs, Drs. John
Buse and Kevan Herold, shared important information including that,
despite the increasingly widespread use of improved technologies
like continuous glucose monitoring, nearly 80% of individuals with
type 1 diabetes fail to achieve the American Diabetes Association’s
target goals for HbA1c,” said Steve Holcombe, chief executive
officer, vTv Therapeutics. “Based on the data we’ve seen to date in
our trial of TTP399 in patients with type 1 diabetes, we believe
our glucokinase activator could eventually provide a meaningful
treatment option to patients with type 1 diabetes that would lower
A1c, improve glycemic control and reduce daily insulin use, without
increasing hypoglycemic events.”
“We are also pleased that we are continuing to make progress
with the Elevage Study of azeliragon in patients with mild
Alzheimer’s disease with type 2 diabetes that is expected to
read-out in late 2020 or early 2021.”
Recent Achievements and Outlook
Type 1 Diabetes Study
- Completed enrollment for Part 2 of the Simplici-T1
Study. In September 2019, we completed enrollment of
patients in part 2 of the phase 2 Simplici-T1 Study, a 12-week
study to evaluate TTP399 as an adjunct to insulin therapy for
patients with type 1 diabetes. We expect to report results in the
latter part of the first quarter of 2020.
- Presented Additional Positive Data from Part 1 of the
Simplici-T1 Study. In September 2019, we presented
positive continuous glucose monitor (CGM) and insulin dose data
from the patients with complete CGM profiles from part 1 of the
Simplici-T1 Study at the 55th Annual Meeting of the European
Association for the Study of Diabetes. In addition to the
previously presented topline improvement in HbA1c of 0.7% relative
to placebo, key results from this presentation included:• Patients
taking TTP399 treatment (n=6) had increased “Time in Range” from
baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day
(24 hours), and by 12% (1.7 hours) (p=0.04) during the critical
waking hours (7am-9pm) relative to placebo (n=9).• Patients taking
TTP399 treatment reduced the total daily mealtime bolus insulin
dose by 23% compared to 4% for placebo while significantly
improving glycemic control.• Patients in the TTP399 treatment group
experienced fewer Level 1 (≥54-70 mg/dl) and Level 2 (<54 mg/dl)
hypoglycemic events than patients in the placebo group.
Alzheimer’s Disease Study
- Enrollment continues for Phase 2/3 Elevage Study of
azeliragon. We began enrolling patients in the phase 2
part of the Elevage Study to evaluate the efficacy and safety of
azeliragon in patients with mild Alzheimer's disease (AD) and type
2
diabetes. The
Elevage Study is designed to confirm the positive post-hoc subgroup
results from the previous phase 3 study of azeliragon in patients
with mild Alzheimer’s disease in which the subgroup of AD patients
with type 2 diabetes (defined by an HbA1c of greater than 6.5% at
any time in the study) treated with azeliragon demonstrated a
potential benefit in both cognition and function relative to those
treated with
placebo. The
phase 2 part of the Elevage 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). We expect to report topline results from the phase 2
proof of concept study by late 2020 or early 2021.
Recent Events
- Hosted Key Opinion Leader (KOL) Event to Discuss the
Type 1 Diabetes Landscape and Emerging Therapies as Adjuncts to
Insulin. In October, vTv hosted a KOL event to provide an
opportunity to learn more about type 1 diabetes. Dr. John Buse,
UNC-CH; Dr. Kevan Herold, Yale University; Dr. Esther Latres, JDRF
International; and Dr. Carmen Valcarce, vTv Therapeutics, presented
to a diverse audience of analysts, investors, and members of the
type 1 diabetes community. The KOLs reported that patients with
type 1 diabetes have a serious, unmet need for an adjunct to
insulin
treatment. An
archived version of the event can be found here.
Second Quarter 2019 Financial Results
- Cash Position: Cash and cash equivalents
as of September 30, 2019, were $2.4 million compared
to $1.5 million as of June 30, 2019.
- Revenue: Revenues were not material for the
third quarter of 2019 versus $1.8 million in the second quarter of
2019. Revenue recognized in the second quarter of 2019 was due to a
milestone recognized under our license agreement with Newsoara and
the continued amortization of revenue from our license agreement
with Reneo over the transfer services period.
- R&D Expenses: Research and
development expenses were $3.7 million in the third
quarter of 2019 and $4.2 million in the second quarter of 2019. The
decrease in these costs was driven primarily by the decreases in
costs for the Elevage Study. Such costs were higher in the second
quarter of 2019 as we were performing startup activities related to
the sites and initiation of patient enrollment.
- G&A Expenses: General and
administrative expenses were $1.8 million and $2.4 million in each
of the third and second quarters of 2019, respectively. The
decrease in these costs is related to the recognition of a gain on
the sale of laboratory equipment in the third quarter of 2019 as
well as overall lower spending in the quarter.
- Net Loss Before Non-Controlling
Interest: Net loss before non-controlling interest
was $6.0 million for the third quarter of 2019 compared to net
loss before non-controlling interest of $5.1 million for the
second quarter of 2019.
- Net Loss Per Share: GAAP net loss per
share was $0.13 and $0.10 for the three months ended September 30,
2019 and June 30, 2019, respectively, based on weighted-average
shares of 32.1 million and 28.0 million for the three month periods
ended September 30, 2019 and June 30, 2019, respectively. Non-GAAP
net loss per fully exchanged share was $0.10 and $0.09 for the
three months ended September 30, 2019 and June 30, 2019,
respectively, based on non-GAAP fully exchanged weighted-average
shares of 55.2 million and 51.1 million for the three months ended
September 30, 2019 and June 30, 2019, respectively.
vTv Therapeutics
Inc.Condensed Consolidated Balance
Sheets(in thousands)
|
September 30, |
|
|
June
30 |
|
|
2019 |
|
|
2019 |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
2,436 |
|
|
$ |
1,462 |
|
Accounts receivable, net |
|
10 |
|
|
|
1,822 |
|
Prepaid expenses and other current assets |
|
870 |
|
|
|
145 |
|
Current deposits |
|
251 |
|
|
|
367 |
|
Total current assets |
|
3,567 |
|
|
|
3,796 |
|
Restricted cash and cash
equivalents, long-term |
|
2,500 |
|
|
|
2,500 |
|
Property and equipment,
net |
|
46 |
|
|
|
54 |
|
Operating lease right-of-use
assets |
|
85 |
|
|
|
167 |
|
Long-term investments |
|
2,480 |
|
|
|
2,480 |
|
Long-term deposits |
|
444 |
|
|
|
75 |
|
Total assets |
$ |
9,122 |
|
|
$ |
9,072 |
|
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
6,898 |
|
|
$ |
8,326 |
|
Operating lease liabilities |
|
91 |
|
|
|
178 |
|
Current portion of deferred revenue |
|
31 |
|
|
|
27 |
|
Current portion of notes payable |
|
7,442 |
|
|
|
8,646 |
|
Total current liabilities |
|
14,462 |
|
|
|
17,177 |
|
Notes payable, net of current
portion |
|
1,363 |
|
|
|
2,185 |
|
Deferred revenue, net of
current portion |
|
1,040 |
|
|
|
1,052 |
|
Warrant liability, related
party |
|
1,878 |
|
|
|
1,240 |
|
Other liabilities |
|
260 |
|
|
|
260 |
|
Total liabilities |
|
19,003 |
|
|
|
21,914 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Redeemable noncontrolling
interest |
|
37,268 |
|
|
|
37,060 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
Class A Common Stock |
|
354 |
|
|
|
298 |
|
Class B Common Stock |
|
232 |
|
|
|
232 |
|
Additional paid-in capital |
|
175,990 |
|
|
|
167,125 |
|
Accumulated deficit |
|
(223,725 |
) |
|
|
(217,557 |
) |
Total stockholders’ deficit
attributable to vTv Therapeutics Inc. |
|
(47,149 |
) |
|
|
(49,902 |
) |
Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit |
$ |
9,122 |
|
|
$ |
9,072 |
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations - Unaudited(in thousands, except per
share data)
|
Three Months
Ended |
|
|
September 30, 2019 |
|
|
June 30, 2019 |
|
Revenue |
$ |
8 |
|
|
$ |
1,828 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
3,663 |
|
|
|
4,228 |
|
General and administrative |
|
1,770 |
|
|
|
2,392 |
|
Total operating expenses |
|
5,433 |
|
|
|
6,620 |
|
Operating loss |
|
(5,425 |
) |
|
|
(4,792 |
) |
Interest income |
|
15 |
|
|
|
16 |
|
Interest expense |
|
(404 |
) |
|
|
(514 |
) |
Other (expense) income, net |
|
(146 |
) |
|
|
276 |
|
Loss before income taxes and noncontrolling interest |
|
(5,960 |
) |
|
|
(5,014 |
) |
Income tax provision |
|
— |
|
|
|
100 |
|
Net loss before noncontrolling interest |
|
(5,960 |
) |
|
|
(5,114 |
) |
Less: net loss attributable to noncontrolling
interest |
|
(2,352 |
) |
|
|
(2,232 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(3,608 |
) |
|
$ |
(2,882 |
) |
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,115 |
) |
|
$ |
(2,882 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.10 |
) |
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
32,126,130 |
|
|
|
28,037,628 |
|
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, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue |
$ |
8 |
|
|
$ |
3,375 |
|
|
$ |
2,757 |
|
|
$ |
7,912 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,663 |
|
|
|
2,698 |
|
|
|
10,713 |
|
|
|
20,235 |
|
General and administrative |
|
1,770 |
|
|
|
2,158 |
|
|
|
6,548 |
|
|
|
7,150 |
|
Total operating expenses |
|
5,433 |
|
|
|
4,856 |
|
|
|
17,261 |
|
|
|
27,385 |
|
Operating loss |
|
(5,425 |
) |
|
|
(1,481 |
) |
|
|
(14,504 |
) |
|
|
(19,473 |
) |
Interest income |
|
15 |
|
|
|
13 |
|
|
|
41 |
|
|
|
47 |
|
Interest expense |
|
(404 |
) |
|
|
(822 |
) |
|
|
(1,544 |
) |
|
|
(2,547 |
) |
Other (expense) income, net |
|
(146 |
) |
|
|
329 |
|
|
|
1,051 |
|
|
|
656 |
|
Loss before income taxes and noncontrolling interest |
|
(5,960 |
) |
|
|
(1,961 |
) |
|
|
(14,956 |
) |
|
|
(21,317 |
) |
Income tax provision |
|
— |
|
|
|
— |
|
|
|
100 |
|
|
|
200 |
|
Net loss before noncontrolling interest |
|
(5,960 |
) |
|
|
(1,961 |
) |
|
|
(15,056 |
) |
|
|
(21,517 |
) |
Less: net loss attributable to noncontrolling
interest |
|
(2,352 |
) |
|
|
(1,165 |
) |
|
|
(6,411 |
) |
|
|
(14,697 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(3,608 |
) |
|
$ |
(796 |
) |
|
$ |
(8,645 |
) |
|
$ |
(6,820 |
) |
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,115 |
) |
|
$ |
(796 |
) |
|
$ |
(12,880 |
) |
|
$ |
(6,820 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.64 |
) |
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
32,126,130 |
|
|
|
12,305,949 |
|
|
|
27,709,486 |
|
|
|
10,701,599 |
|
About vTv TherapeuticsvTv Therapeutics Inc. is
a clinical-stage biopharmaceutical company focused on developing
oral small molecule drug candidates. vTv has a pipeline of clinical
drug candidates led by programs for the treatment of type 1
diabetes, Alzheimer’s disease, and inflammatory disorders. vTv’s
development partners are pursuing additional indications in type 2
diabetes, chronic obstructive pulmonary disease (COPD), and genetic
mitochondrial diseases.
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 |
|
|
September 30, 2019 |
|
|
June 30, 2019 |
|
Numerator: |
|
|
|
|
|
|
|
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,115 |
) |
|
$ |
(2,882 |
) |
Other income - related party |
|
(146 |
) |
|
|
275 |
|
Share-based compensation expense |
|
413 |
|
|
|
401 |
|
Deemed distribution to related party |
|
507 |
|
|
|
— |
|
Reallocation of net income attributable to noncontrolling
interest from the assumed exchange of Class B shares (1) |
|
(2,352 |
) |
|
|
(2,232 |
) |
Adjusted net loss before noncontrolling interest |
$ |
(5,693 |
) |
|
$ |
(4,438 |
) |
Denominator: |
|
|
|
|
|
|
|
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
32,126,130 |
|
|
|
28,037,628 |
|
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 |
|
55,220,351 |
|
|
|
51,131,849 |
|
Adjusted net loss per fully
exchanged share, basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.09 |
) |
|
Three Months
Ended September 30, |
|
|
Nine Months
Ended September 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,115 |
) |
|
$ |
(796 |
) |
|
$ |
(12,880 |
) |
|
$ |
(6,820 |
) |
Other income - related party |
|
(146 |
) |
|
|
319 |
|
|
|
1,050 |
|
|
|
610 |
|
Share-based compensation expense |
|
413 |
|
|
|
579 |
|
|
|
1,095 |
|
|
|
2,345 |
|
Deemed distribution to related party |
|
507 |
|
|
|
— |
|
|
|
4,235 |
|
|
|
— |
|
Reallocation of net income attributable to noncontrolling
interest from the assumed exchange of Class B shares (1) |
|
(2,352 |
) |
|
|
(1,165 |
) |
|
|
(6,411 |
) |
|
|
(14,697 |
) |
Adjusted net loss before noncontrolling interest |
$ |
(5,693 |
) |
|
$ |
(1,063 |
) |
|
$ |
(12,911 |
) |
|
$ |
(18,562 |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of vTv Therapeutics Inc. Class A
Common Stock, basic and diluted |
|
32,126,130 |
|
|
|
12,305,949 |
|
|
|
27,709,486 |
|
|
|
10,701,599 |
|
Assumed exchange of Class B Common Stock (1) |
|
23,094,221 |
|
|
|
23,114,652 |
|
|
|
23,094,221 |
|
|
|
23,101,279 |
|
Adjusted proforma fully
exchanged weighted-average shares of Class A common stock
outstanding, basic and diluted |
|
55,220,351 |
|
|
|
35,420,601 |
|
|
|
50,803,707 |
|
|
|
33,802,878 |
|
Adjusted net loss per fully
exchanged share, basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.55 |
) |
(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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