vTv Therapeutics Announces 2022 First Quarter Financial Results and Provides Corporate Update
May 12 2022 - 7:45AM
vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial
results for the first quarter ended March 31, 2022, and provided an
update on the progress of its clinical programs.
Recent Achievements and Outlook
Corporate
- Strategic Focus. We are prioritizing the
development of our lead program TTP399, a novel, oral liver
selective glucokinase activator, as a potential treatment for
patients with type 1 diabetes (“T1D”), as well as continuing to
support our currently partnered programs. Given the strategic focus
on these programs, we have paused our development activities in the
United States on HPP737 while we evaluate strategic options for it.
As part of this planned strategic focus, the Company has reduced
its workforce. We are actively seeking to raise capital through
licensing TTP399 in regions outside of North America and Europe and
are also actively seeking licensing deals for HPP737 and other
assets. We are currently in active discussions with respect to
financing, partnering, and licensing transactions for the further
development of TTP399.
Type 1 Diabetes
- Mechanistic Study of Ketoacidosis with
TTP399. In October 2021, we
announced positive results from the Mechanistic study indicating no
increased risk of ketoacidosis with TTP399 during acute insulin
withdrawal in patients with T1D. Patients with type 1 diabetes
taking TTP399 experienced no increase in ketone levels relative to
placebo during a period of acute insulin withdrawal, indicating
that treatment with TTP399 presents no increased risk of
ketoacidosis. In addition, patients taking TTP399 had improved
fasting plasma glucose levels and experienced fewer hypoglycemic
events relative to those taking placebo, consistent and supportive
of the previously announced phase 2 Simplici-T1 Study results. Full
study results will be published in the Diabetes Obesity and
Metabolism journal in conjunction with the 82nd American Diabetes
Association Scientific Sessions on June 6th, 2022.
- Pivotal Study Planning. The Company is
planning two pivotal, placebo-controlled clinical trials of TTP399
in subjects withT1D and has engaged with the Food and Drug
Administration (“FDA”) on the optimal clinical trial designs for
these studies. The studies will recruit a total of approximately
1000 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 3Q 2022.
First Quarter 2022 Financial Results
- Cash Position: The Company’s cash
position as of March 31, 2022, was $12.1 million compared to $13.4
million as of December 31, 2021.
- Revenue: Revenue in first quarter of 2022 was
$2.0 million and relates to an increase in the transaction price
for a license performance obligation, that was fully recognized due
to the satisfaction of a development milestone under the amended
license agreement with Huadong. The revenue for the fourth quarter
of 2021 was immaterial.
- R&D Expenses: Research and
development expenses were $3.1 million and $5.4 million in each of
the three months ended March 31, 2022 and December 31, 2021,
respectively. The changes are attributable to (i) decreases of $2.0
million for a license payment to Novo Nordisk for the completion of
TTP399 phase 2 studies in Q4 2021, (ii) decreased severance costs
of $0.7 million and payroll costs of $0.1 million in connection
with the Company's restructuring plan that occurred in Q4 2021,
(iii) decreased spending of $0.5 million related to the multiple
ascending dose study for HPP737 offset by (iv) increases of $1.3
million due to manufacturing and analytical work related to
chemistry manufacturing and control “CMC” for pivotal TTP399
studies, and the progression of TTP399 toxicology studies in Q1
2022.
- G&A Expenses: General and
administrative expenses were consistent between periods at $5.3
million and $5.7 million for each of the three months ended March
31, 2022, and December 31, 2021. However, individual changes in the
quarters are attributable to (i) lower payroll costs of $0.4
million and lower severance costs of $0.7 million due to the
Company's restructuring plan that occurred in December 2021 and
separation agreement with the Company's former CEO in Q1 2022, (ii)
lower shared-based expense of $0.6 million due to the modification
of awards related to the retirement and separation agreements with
several key employees that occurred in Q4 2021, offset by (iii)
higher other G&A operating costs of $0.2 million and (iv)
increases of $1.1 million in legal expense.
- Other Income/(Expense): Other expense for the
three months ended March 31, 2022, was $2.7 million and was driven
by an unrealized loss related to the Company’s investment in Reneo
Pharmaceuticals, Inc. (“Reneo”), as well as gains related to a
reduction 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 December 31,
2021, was $1.6 million and was driven by changes in the fair value
of our investment in Reneo, as well as the gains related to a
reduction in fair value of the Related Party Warrants.
- Net Loss Before
Non-Controlling Interest: Net loss before
non-controlling interest was $9.4 million for the first
quarter of 2022 compared to net loss before non-controlling
interest of $9.5 million for the fourth quarter of 2021. The
decrease in net loss before Non-Controlling Interest was
attributable to (i) increases in other expense of $4.3 million
driven by changes in the fair value of our investment in Reneo, as
well as the gains related to a reduction in the fair value of the
outstanding warrants to purchase shares of our own stock issued to
a related party, offset by (ii) lower R&D expenses of $2.3
million, and (iii) higher revenue of $2.0 million due to an
increase in the transaction price for a license performance
obligation, that was fully recognized due to the satisfaction of a
development milestone under the amended license agreement with
Huadong.
- Net Loss Per
Share: Diluted net loss per share was ($0.10) for the
three months ended March 31, 2022 compared to diluted net loss per
share of ($0.11) for the three months ended December 31, 2021,
based on weighted-average diluted shares of 66.9 million and 66.8
million for the three-month periods ended March 31, 2022 and
December 31, 2021, respectively.
vTv Therapeutics
Inc.Condensed Consolidated Balance
Sheets(in thousands)
|
March 31, |
|
|
December 30, |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
12,138 |
|
|
$ |
13,415 |
|
Accounts receivable |
|
57 |
|
|
|
57 |
|
Prepaid expenses and other current assets |
|
1,387 |
|
|
|
2,049 |
|
Current deposits |
|
30 |
|
|
|
100 |
|
Total current assets |
|
13,612 |
|
|
|
15,621 |
|
Property and equipment,
net |
|
255 |
|
|
|
278 |
|
Operating lease right-of-use
assets |
|
379 |
|
|
|
402 |
|
Long-term investments |
|
5,939 |
|
|
|
9,173 |
|
Total assets |
$ |
20,185 |
|
|
$ |
25,474 |
|
Liabilities,
Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
12,474 |
|
|
$ |
8,023 |
|
Operating lease liabilities |
|
191 |
|
|
|
184 |
|
Current portion of contract liabilities |
|
35 |
|
|
|
35 |
|
Current portion of notes payable |
|
— |
|
|
|
256 |
|
Total current liabilities |
|
12,700 |
|
|
|
8,498 |
|
Operating lease liabilities,
net of current portion |
|
441 |
|
|
|
492 |
|
Warrant liability, related
party |
|
770 |
|
|
|
1,262 |
|
Total liabilities |
|
13,911 |
|
|
|
10,252 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Redeemable noncontrolling
interest |
|
14,367 |
|
|
|
24,962 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
Class A Common Stock |
|
669 |
|
|
|
669 |
|
Class B Common Stock |
|
232 |
|
|
|
232 |
|
Additional paid-in capital |
|
238,669 |
|
|
|
238,193 |
|
Accumulated deficit |
|
(247,663 |
) |
|
|
(248,834 |
) |
Total stockholders’ deficit
attributable to vTv Therapeutics Inc. |
|
(8,093 |
) |
|
|
(9,740 |
) |
Total liabilities, redeemable
noncontrolling interest and stockholders’ deficit |
$ |
20,185 |
|
|
$ |
25,474 |
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations - Unaudited(in thousands, except per
share data)
|
Three Months Ended |
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Revenue |
$ |
2,000 |
|
|
$ |
9 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
3,133 |
|
|
|
5,402 |
|
General and administrative |
|
5,348 |
|
|
|
5,716 |
|
Total operating expenses |
|
8,481 |
|
|
|
11,118 |
|
Operating loss |
|
(6,481 |
) |
|
|
(11,109 |
) |
Interest expense |
|
(1 |
) |
|
|
(6 |
) |
Other (expense) income,
net |
|
(2,742 |
) |
|
|
1,632 |
|
Loss before income taxes and
noncontrolling interest |
|
(9,224 |
) |
|
|
(9,483 |
) |
Income tax provision |
|
200 |
|
|
|
— |
|
Net loss before noncontrolling
interest |
|
(9,424 |
) |
|
|
(9,483 |
) |
Less: net loss attributable to
noncontrolling interest |
|
(2,417 |
) |
|
|
(2,432 |
) |
Net loss attributable to vTv
Therapeutics Inc. |
$ |
(7,007 |
) |
|
$ |
(7,051 |
) |
Net loss attributable to vTv
Therapeutics Inc. common shareholders |
$ |
(7,007 |
) |
|
$ |
(7,051 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common Stock,
basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.11 |
) |
Weighted average number of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
|
66,942,777 |
|
|
|
66,785,550 |
|
vTv Therapeutics
Inc.Condensed Consolidated Statements of
Operations(in thousands, except per share
data)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
Revenue |
$ |
2,000 |
|
|
$ |
987 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
3,133 |
|
|
|
3,103 |
|
General and administrative |
|
5,348 |
|
|
|
2,164 |
|
Total operating expenses |
|
8,481 |
|
|
|
5,267 |
|
Operating loss |
|
(6,481 |
) |
|
|
(4,280 |
) |
Interest income |
|
— |
|
|
|
1 |
|
Interest expense |
|
(1 |
) |
|
|
— |
|
Other expense, net |
|
(2,742 |
) |
|
|
(1,648 |
) |
Loss before income taxes and
noncontrolling interest |
|
(9,224 |
) |
|
|
(5,927 |
) |
Income tax provision |
|
200 |
|
|
|
15 |
|
Net loss before noncontrolling
interest |
|
(9,424 |
) |
|
|
(5,942 |
) |
Less: net loss attributable to
noncontrolling interest |
|
(2,417 |
) |
|
|
(1,701 |
) |
Net loss attributable to vTv
Therapeutics Inc. |
$ |
(7,007 |
) |
|
$ |
(4,241 |
) |
Net loss attributable to vTv
Therapeutics Inc. common shareholders |
$ |
(7,007 |
) |
|
$ |
(4,241 |
) |
Net loss per share of vTv Therapeutics Inc. Class A Common Stock,
basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.08 |
) |
Weighted average number of vTv Therapeutics Inc. Class A Common
Stock, basic and diluted |
|
66,942,777 |
|
|
|
56,472,535 |
|
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:IR@vtvtherapeutics.com.
orMedia:PR@vtvtherapeutics.com
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