vTv Therapeutics Announces 2023 First Quarter Financial Results and Provides Corporate Update
11 Mayo 2023 - 3:15PM
vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage
biopharmaceutical company focused on the development of an
adjunctive therapy to insulin for the treatment of type 1 diabetes
("T1D"), today reported financial results for the first quarter
ended March 31, 2023, and provided an update on recent
corporate developments.
“During the first several months of 2023, we
continued making progress to align with the FDA on an efficient
development pathway to support registration of TTP399 as an
adjunctive therapy to insulin for the treatment of type 1 diabetes
and we remain on-track to commence study activities in the second
half of the year,” said Paul Sekhri, Chief Executive Officer of
vTv. “In addition to our ongoing efforts to advance studies of
TTP399 in type 1 diabetes, we continue to work with an affiliate of
G42 Investments in preparation for a phase 2 study comparing TTP399
with placebo in patients with type 2 diabetes on insulin
therapy.”
Recent Company Highlights
- Strengthened the Company’s balance
sheet following receipt of approximately $12.0 million from G42
Investments on February 28, 2023, in satisfaction of the promissory
note issued in connection with the common stock purchase agreement
entered into between vTv and G42 Investments in 2022. As of March
31, 2023, the Company’s cash and cash equivalents totaled
approximately $18.8 million.
- On February 24,
2023, the Company received written confirmation that the FDA is in
agreement with its pediatric study plan for the study of TTP399 in
T1D patients between 2 and 16 years of age.
First Quarter 2023 Financial
Results
-
Cash Position: The Company’s cash position as
of March 31, 2023, was $18.8 million compared to $12.1 million
as of December 31, 2022. The increase is attributed to receipt
of the promissory note from G42 Investments on February 28,
2023.
- Research & Development
(R&D) Expenses: R&D expenses were $3.9
million and $3.1 million in each of the three months ended
March 31, 2023 and 2022, respectively. The increase of $0.8
million is primarily attributable to higher spending on TTP399, due
to increases in drug product related costs, an increase in indirect
costs and other projects related to the development of TTP399.
- General
& Administrative (G&A) Expenses: G&A
expenses were $3.5 million and $5.3 million for each of the three
months ended March 31, 2023 and 2022, respectively. The
decrease of $1.9 million was primarily due to decreases in legal
expense and severance expense, partially offset by higher other
G&A costs.
- Other
Income (Expense): Other income for the three months ended
March 31, 2023, was $1.6 million and was driven by an
unrealized gain related to our investment in Reneo, offset by
losses related to the change in the fair value of the outstanding
warrants to purchase shares of our stock issued to related parties
and the loss from the early redemption of the G42 promissory note.
Other expense for the three months ended March 31, 2022, was
$2.7 million and was related to the unrealized loss recognized
related to our investment in Reneo as well as gains related to the
change in the fair value of the outstanding warrants held by a
related party.
-
Net Loss: Net loss attributable to vTv
shareholders for the three months ended March 31, 2023, was
$4.5 million or $0.06 per basic share. Net loss attributable to vTv
shareholders for the comparable period a year ago was $7.0 million
or $0.10 per basic share.
vTv Therapeutics Inc.Condensed
Consolidated Balance Sheets(in
thousands) |
|
|
March 31,2023 |
|
December 31,2022 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
18,766 |
|
|
$ |
12,126 |
|
Accounts receivable |
|
— |
|
|
|
173 |
|
Promissory note receivable |
|
— |
|
|
|
12,243 |
|
Prepaid expenses and other current assets |
|
1,846 |
|
|
|
2,537 |
|
Current deposits |
|
15 |
|
|
|
15 |
|
Total current assets |
|
20,627 |
|
|
|
27,094 |
|
Property and equipment,
net |
|
185 |
|
|
|
207 |
|
Operating lease right-of-use
assets |
|
324 |
|
|
|
349 |
|
Long-term investments |
|
7,692 |
|
|
|
5,588 |
|
Total assets |
$ |
28,828 |
|
|
$ |
33,238 |
|
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
8,358 |
|
|
$ |
7,313 |
|
Current portion of operating lease liabilities |
|
157 |
|
|
|
154 |
|
Current portion of contract liabilities |
|
17 |
|
|
|
17 |
|
Current portion of notes payable |
|
— |
|
|
|
224 |
|
Total current liabilities |
|
8,532 |
|
|
|
7,708 |
|
Contract liabilities, net of
current portion |
|
18,669 |
|
|
|
18,669 |
|
Operating lease liabilities,
net of current portion |
|
297 |
|
|
|
338 |
|
Warrant liability, related
party |
|
922 |
|
|
|
684 |
|
Total liabilities |
|
28,420 |
|
|
|
27,399 |
|
Commitments and
contingencies |
|
|
|
Redeemable noncontrolling
interest |
|
19,600 |
|
|
|
16,579 |
|
Stockholders’ deficit: |
|
|
|
Class A Common Stock |
|
815 |
|
|
|
815 |
|
Class B Common Stock |
|
232 |
|
|
|
232 |
|
Additional paid-in capital |
|
254,080 |
|
|
|
253,737 |
|
Accumulated deficit |
|
(274,319 |
) |
|
|
(265,524 |
) |
Total stockholders’ deficit
attributable to vTv Therapeutics Inc. |
|
(19,192 |
) |
|
|
(10,740 |
) |
Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit |
$ |
28,828 |
|
|
$ |
33,238 |
|
vTv Therapeutics Inc.Condensed
Consolidated Statements of Operations(in
thousands, except per share data) |
|
|
|
Three Months EndedMarch 31, |
|
|
2023 |
|
|
|
2022 |
|
|
(Unaudited) |
Revenue |
$ |
— |
|
|
$ |
2,000 |
|
Operating expenses: |
|
|
|
Research and development |
|
3,942 |
|
|
|
3,133 |
|
General and administrative |
|
3,485 |
|
|
|
5,348 |
|
Total operating expenses |
|
7,427 |
|
|
|
8,481 |
|
Operating loss |
|
(7,427 |
) |
|
|
(6,481 |
) |
Interest income |
|
100 |
|
|
|
— |
|
Interest expense |
|
— |
|
|
|
(1 |
) |
Other income (expense), net |
|
1,553 |
|
|
|
(2,742 |
) |
Loss before income taxes and noncontrolling interest |
|
(5,774 |
) |
|
|
(9,224 |
) |
Income tax provision |
|
— |
|
|
|
200 |
|
Net loss before noncontrolling interest |
|
(5,774 |
) |
|
|
(9,424 |
) |
Less: net loss attributable to noncontrolling interest |
|
(1,275 |
) |
|
|
(2,417 |
) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(4,499 |
) |
|
$ |
(7,007 |
) |
Net loss attributable to vTv
Therapeutics Inc. common shareholders |
$ |
(4,499 |
) |
|
$ |
(7,007 |
) |
Net loss per share of vTv Therapeutics Inc. Class A common stock,
basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.10 |
) |
Weighted average number of vTv Therapeutics Inc. Class A common
stock, basic and diluted |
|
81,483,600 |
|
|
|
66,942,777 |
|
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 TTP399, a potential
adjunctive therapy to insulin 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 glioblastoma and other
cancers.
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:Selina Husain / Robert Flamm, Ph.D.Burns
McClellan, Inc.shusain@burnsmc.com / rflamm@burnsmc.com
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