vTv Therapeutics Announces 2022 Second Quarter Financial Results and Provides Corporate Update
16 August 2022 - 8:43AM
vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage
biopharmaceutical company focused on the development of orally
administered treatments for type 1 diabetes (T1D) today reported
financial results for the second quarter ended June 30, 2022,
and provided an update on recent corporate developments.
“I have been with vTv for only about two weeks
but the strategic steps that have been taken toward initiating the
TTP399 pivotal study and the energy displayed by the team to
execute on that program have been truly impressive,” said Paul
Sekhri, newly appointed Chief Executive Officer of vTv. “I am
looking forward to working with our management team and with our
new partners, G42 Healthcare and CinRx Pharma, to accomplish our
objective of improving the care and quality of life for T1D
patients.”
Recent Achievements
-
Leadership. On July 27, 2022, the Company
appointed Paul Sekhri as President, Chief Executive Officer (CEO)
effective August 1, 2022, and was confirmed as a member of the
board of directors on August 9, 2022. Mr. Sekhri brings nearly 30
years of healthcare industry experience, including serving as
President and CEO of several healthcare companies, experience in
several senior business development and strategy roles and he has
been a director on more than 30 private, public company and
non-profit boards.
-
Partnership. On July 25, 2002, the Company entered
into agreements with CinRx Pharma and its subsidiary, CinPax.
CinPax agreed to acquire $10.0 million in vTv Class A common stock
at approximately $2.41 per share with $6.0 million paid at closing
and the remaining $4.0 million payable on November 22, 2022. vTv
will issue a warrant to CinRx to acquire 1.2 million additional
shares of Class A common stock at an exercise price of
approximately $0.72 per share that will become exercisable upon
agreed vesting triggers. In addition, the agreements set forth
terms under which vTv will leverage the CinRx team’s industry
experience to collaborate on the oversight of the clinical trials
for pharmaceutical products that contain TTP399.
-
Publication. In June, results of a Phase 1 trial
that assessed the effects of TTP399 on ketoacidosis risk in
individuals with T1D on insulin pump therapy during acute insulin
withdrawal was published in Diabetes Obesity and Metabolism
(https://doi.org/10.1111/dom.14697) and presented at The American
Diabetes Association's 82nd Scientific Sessions on June 5, 2022.
The results suggested that TTP399 does not increase, and may
decrease, the risk of diabetic ketoacidosis (DKA) in subjects with
T1D.
-
Partnership. On May 31, 2022, the Company entered
into agreements with G42 Healthcare ("G42") and an affiliate. G42
agreed to acquire $25.0 million in vTv Class A common stock at
approximately $2.41 per share with $12.5 million paid at closing
and the remaining $12.5 million payable on May 31, 2023. The
agreements also provide for the potential issuance of $30.0 million
in additional shares of Class A common stock to G42 (or cash in
lieu of such issuance at the option of G42) if the U.S. Food and
Drug Administration (FDA) approves the marketing and sale of a
pharmaceutical product containing TTP399. vTv and an affiliate of
G42 plan to collaborate on clinical trials for pharmaceutical
products that contain TTP399, including G42’s affiliate funding a
portion of the Phase 3 clinical trials for TTP399, and vTv granting
G42’s affiliate an exclusive license to develop and commercialize
pharmaceutical products containing TTP399 in certain territories in
the Middle East, Africa, and Central Asia.
Upcoming Milestones and
Events
-
Pivotal Study Planning. The Company is planning
two pivotal, placebo-controlled clinical trials of TTP399 in
subjects with T1D and has engaged with the FDA on the optimal
clinical trial designs for these studies. The studies will recruit
a total of approximately 1,000 patients and at least one of the
studies will be one year of treatment. The FDA and the Company have
agreed on the primary endpoint for the studies as the difference
between placebo and TTP399-treated group in number of hypoglycemia
events. These pivotal studies are expected to start in the fourth
quarter of 2022.
Second Quarter 2022 Financial
Results
- Cash
Position: The Company’s cash position as of
June 30, 2022, was $17.9 million compared to $13.4 million as
of December 31, 2021.
- Research & Development
(R&D) Expenses: R&D expenses were $2.2
million and $2.4 million in each of the three months ended
June 30, 2022, and 2021, respectively. The decrease of $0.2
million is attributable to a decrease in clinical trial costs for
azeliragon, which was mainly driven by discontinuance of its
development as a potential treatment of Alzheimer’s disease in
patients with type 2 diabetes and a decrease in spending related to
a multiple ascending dose study for HPP737, due to its completion
in 2021, offset by higher spending on TTP399 due to trial
preparation costs.
- General
& Administrative (G&A) Expenses: G&A
expenses were $1.8 million and $2.2 million for each of the three
months ended June 30, 2022, and 2021, respectively. The
decrease was due to lower payroll costs and lower share-based
expense partially offset by higher legal expense and higher other
G&A costs.
- Other
(Expense)/Income: Other expense for the three months ended
June 30, 2022, was $0.1 million and was driven by an
unrealized loss related to the investment in Reneo as well as the
gains related to the change in the fair value of the outstanding
warrants to purchase shares of our own stock issued to a related
party (“Related Party Warrants”). Other income for the three months
ended June 30, 2021, was $3.8 million and was related to the
unrealized gain recognized related to the investment in Reneo as
well as gains related to the change in the fair value of the
outstanding warrants in our own stock held by a related party.
- Net
Loss: Net loss attributable to vTv shareholders for
the three months ended June 30, 2022, was $3.2 million or
$0.04 per basic share. Net loss attributable to vTv shareholders
for the comparable period a year ago was $0.6 million or $0.01 per
basic share.
vTv Therapeutics
Inc.Condensed Consolidated Balance
Sheets(in thousands)
|
June 30,2022 |
|
December 31,2021 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
17,863 |
|
|
$ |
13,415 |
|
Accounts receivable |
|
77 |
|
|
|
57 |
|
Promissory note receivable |
|
11,941 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
643 |
|
|
|
2,049 |
|
Current deposits |
|
85 |
|
|
|
100 |
|
Total current assets |
|
30,609 |
|
|
|
15,621 |
|
Property and equipment,
net |
|
254 |
|
|
|
278 |
|
Operating lease right-of-use
assets |
|
354 |
|
|
|
402 |
|
Long-term investments |
|
5,772 |
|
|
|
9,173 |
|
Total assets |
$ |
36,989 |
|
|
$ |
25,474 |
|
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
9,600 |
|
|
$ |
8,023 |
|
Current portion of operating lease liabilities |
|
199 |
|
|
|
184 |
|
Current portion of contract liabilities |
|
26 |
|
|
|
35 |
|
Current portion of notes payable |
|
— |
|
|
|
256 |
|
Total current liabilities |
|
9,825 |
|
|
|
8,498 |
|
Contract liabilities, net of
current portion |
|
18,669 |
|
|
|
— |
|
Operating lease liabilities,
net of current portion |
|
388 |
|
|
|
492 |
|
Warrant liability, related
party |
|
717 |
|
|
|
1,262 |
|
Total liabilities |
|
29,599 |
|
|
|
10,252 |
|
Commitments and
contingencies |
|
|
|
Redeemable noncontrolling
interest |
|
15,916 |
|
|
|
24,962 |
|
Stockholders’ deficit: |
|
|
|
Class A Common Stock |
|
773 |
|
|
|
669 |
|
Class B Common Stock |
|
232 |
|
|
|
232 |
|
Additional paid-in capital |
|
243,772 |
|
|
|
238,193 |
|
Accumulated deficit |
|
(253,303 |
) |
|
|
(248,834 |
) |
Total stockholders’ deficit
attributable to vTv Therapeutics Inc. |
|
(8,526 |
) |
|
|
(9,740 |
) |
Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit |
$ |
36,989 |
|
|
$ |
25,474 |
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations(in thousands, except per share
data)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(Unaudited) |
|
|
Revenue |
$ |
9 |
|
|
$ |
9 |
|
|
$ |
2,009 |
|
|
$ |
996 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,205 |
|
|
|
2,437 |
|
|
|
5,338 |
|
|
|
5,540 |
|
General and administrative |
|
1,831 |
|
|
|
2,242 |
|
|
|
7,179 |
|
|
|
4,406 |
|
Total operating expenses |
|
4,036 |
|
|
|
4,679 |
|
|
|
12,517 |
|
|
|
9,946 |
|
Operating loss |
|
(4,027 |
) |
|
|
(4,670 |
) |
|
|
(10,508 |
) |
|
|
(8,950 |
) |
Interest income |
|
50 |
|
|
|
— |
|
|
|
50 |
|
|
|
1 |
|
Interest expense |
|
— |
|
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
Other (expense) income, net |
|
(114 |
) |
|
|
3,829 |
|
|
|
(2,856 |
) |
|
|
2,181 |
|
Loss before income taxes |
|
(4,091 |
) |
|
|
(841 |
) |
|
|
(13,315 |
) |
|
|
(6,768 |
) |
Income tax provision |
|
— |
|
|
|
— |
|
|
|
200 |
|
|
|
15 |
|
Net loss before noncontrolling interest |
|
(4,091 |
) |
|
|
(841 |
) |
|
|
(13,515 |
) |
|
|
(6,783 |
) |
Less: Net loss attributable to noncontrolling interest |
|
(940 |
) |
|
|
(233 |
) |
|
|
(3,357 |
) |
|
|
(1,934 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(3,151 |
) |
|
$ |
(608 |
) |
|
$ |
(10,158 |
) |
|
$ |
(4,849 |
) |
Net loss attributable to vTv
Therapeutics Inc. common shareholders |
$ |
(3,151 |
) |
|
$ |
(608 |
) |
|
$ |
(10,158 |
) |
|
$ |
(4,849 |
) |
Net loss per share of vTv Therapeutics Inc. Class A common stock,
basic and diluted |
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.08 |
) |
Weighted average number of vTv Therapeutics Inc. Class A common
stock, basic and diluted |
|
70,366,823 |
|
|
|
58,615,137 |
|
|
|
68,664,259 |
|
|
|
57,549,755 |
|
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. vTv’s development partners are
pursuing additional indications in type 2 diabetes, chronic
obstructive pulmonary disease, renal disease, primary mitochondrial
myopathy, and pancreatic cancer.
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. In addition, we may not be able to
successfully complete a successful financing, partnering or
licensing transactions with respect to TTP399. 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.
Contacts:
Investors:Lee RothBurns
McClellanlroth@burnsmc.com
Media:Katie Larch / Robert Flamm, Ph.D.Burns
McClellan, Inc.klarch@burnsmc.com / rflamm@burnsmc.com
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