REN-001 advancing toward IND submission in the
second half of 2022 with the initiation of a Phase I/II clinical
trial in BAG3-DCM expected thereafter
Strengthened executive team with appointment of
Fred Driscoll as CFO
Renovacor, Inc. (NYSE: RCOR), a biotechnology company focused on
delivering innovative precision therapies to improve the lives of
patients and families battling genetically-driven cardiovascular
and mechanistically-related diseases, today reported financial
results for the first quarter of 2022 and provided a corporate
update.
“Our first quarter progress was highlighted by REN-001’s
continued advancement towards the clinic and by the addition of
industry veteran Fred Driscoll as CFO to our executive team,” said
Magdalene Cook, M.D., Chief Executive Officer of Renovacor.
“Preclinical studies have demonstrated REN-001’s potential to
address the underlying cause of BAG3-DCM and provided important
learnings that are informing our planned IND package. We intend to
present additional results from these studies later this year,
prior to the planned IND application submission in the second half,
which is expected to enable the subsequent initiation of a Phase
I/II clinical trial in BAG3-DCM patients, bringing us closer to our
goal of transforming the treatment paradigm for this devastating
disease.”
First Quarter 2022 and Recent Highlights
- Continued Progress in REN-001 IND-enabling Studies with an
IND Submission Planned for the Second Half of 2022: Renovacor
expects this planned IND submission to enable the subsequent
initiation of a Phase I/II clinical trial in BAG3-associated
dilated cardiomyopathy (BAG3-DCM) patients.
- Strengthened Executive Team with the Appointment of Fred
Driscoll as Chief Financial Officer (CFO): Mr. Driscoll joined
Renovacor with over 25 years of executive experience in the biotech
industry. Most recently, he served as CFO of Flexion Therapeutics,
where he led the company through a successful $75 million initial
public offering in 2014 and was a member of the mergers and
acquisitions team that executed the 2021 sale of the company to
Pacira BioSciences for up to $1 billion in enterprise value.
- Opened New Company Headquarters in Cambridge,
Massachusetts: New space supports company’s growth and provides
access to strong regional talent pool.
First Quarter 2022 Financial Results
Net income for the three months ended March 31, 2022 was $6.6
million, compared to net loss of $1.7 million for the same period
in 2021. Excluding non-cash gains totaling $15.4 million for the
three months ended March 31, 2022 related to the change in fair
value of our warrant and share earnout liabilities, net loss was
$8.8 million, or $0.51 per basic and diluted share, compared to a
net loss of $0.27 per basic and diluted share for the same period
in 2021.
Research and development expenses were $5.9 million for the
three months ended March 31, 2022, compared to $1.2 million for the
same period in 2021.
General and administrative expenses were $2.9 million for the
three months ended March 31, 2022, compared to $0.5 million for the
same period in 2021.
Cash and cash equivalents as of March 31, 2022, totaled $70.1
million which, based on current projections, Renovacor believes
will be sufficient to fund its operating expenses and capital
expenditures requirements into the second half of 2023.
About Renovacor
Renovacor is a biotechnology company focused on delivering
innovative precision therapies to improve the lives of patients and
families battling genetically-driven cardiovascular and
mechanistically-related diseases. The company’s lead program in
BAG3-associated dilated cardiomyopathy (DCM) uses gene transfer
technology to address the monogenic cause of this severe form of
heart failure. Renovacor’s vision is to bring life-changing
therapies to patients living with serious genetic cardiovascular
and related diseases, by developing medicines that target the
underlying cause of disease and provide a transformative benefit
and significant improvement to quality of life.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of the “safe harbor” provisions of the United
States Private Securities Litigation Reform Act of 1995, as
amended, including statements regarding the anticipated development
of Renovacor’s product candidates, clinical development timelines
and financial outlook. These forward-looking statements generally
are identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions.
These forward-looking statements are based upon current estimates
and assumptions of the Company and its management and are subject
to a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this presentation. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: competition, the ability of the company to grow and manage
growth, maintain relationships with customers and suppliers and
retain its management and key employees; the Company's ability to
successfully advance its current and future product candidates
through development activities, preclinical studies and clinical
trials and costs related thereto; the timing, scope and likelihood
of regulatory filings and approvals, including final regulatory
approval of our product candidates; changes in applicable laws or
regulations; the possibility that the Company may be adversely
affected by other economic, business or competitive factors; the
Company’s estimates of expenses and profitability; the evolution of
the markets in which the Company competes; the ability of the
Company to implement its strategic initiatives and continue to
innovate its existing products; the ability of the Company to
defend its intellectual property; the impact of the COVID-19
pandemic on the Company’s business, supply chain and labor force;
and the risks and uncertainties described in the “Risk Factors”
section of the Company's annual and quarterly and reports filed the
Securities Exchange Commission. These filings identify and address
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and Renovacor assumes
no obligation and does not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. Renovacor gives no assurance that it
will achieve its expectations.
Renovacor, Inc.
Condensed Consolidated Statements
of Operations
(In thousands, except share and
per share data)
Three Months Ended
March 31,
2022
2021
Operating expenses:
Research and development
$
5,930
$
1,155
General and administrative
2,925
526
Loss from operations
(8,855
)
(1,681
)
Other income (expense):
Change in fair value of warrant
liability
7,280
—
Change in fair value of share earnout
liability
8,166
—
Other income (expense), net
3
—
Net income (loss)
$
6,594
$
(1,681
)
Net income (loss) per share
— Basic
$
0.37
$
(0.27
)
— Diluted
$
0.36
$
(0.27
)
Weighted-average number of common shares
used in computing net income (loss) per share
— Basic
17,471,266
6,274,566
— Diluted
17,628,835
6,274,566
Renovacor, Inc.
Condensed Consolidated Balance
Sheet Data
(In thousands)
March 31,
December 31,
2022
2021
Cash and cash equivalents
$
70,084
$
78,790
Other assets
2,027
2,209
Total assets
$
72,111
$
80,999
Total liabilities
$
11,372
$
27,455
Total stockholders’ equity
60,739
53,544
Total liabilities and stockholders’
equity
$
72,111
$
80,999
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version on businesswire.com: https://www.businesswire.com/news/home/20220512006043/en/
Investors: Brooks Rahmer Renovacor, Inc 610-424-2627
ir@renovacor.com Media: Patrick Bursey LifeSci
Communications 646-970-4688 pbursey@lifescicomms.com
Renovacor (AMEX:RCOR)
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Renovacor (AMEX:RCOR)
過去 株価チャート
から 11 2023 まで 11 2024