REN-001 IND submission planned for the second
half of 2022
Data from pilot pig study showing successful
cardiac transduction with REN-001 delivered via low-dose retrograde
coronary sinus infusion published in Journal of the American
College of Cardiology: Basic to Translational Science
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 second quarter of 2022 and provided a corporate
update.
“The progress achieved at Renovacor this quarter enabled us to
advance and expand our pipeline of precision AAV gene therapies
that target the underlying drivers of devastating cardiovascular
diseases,” said Magdalene Cook, M.D., Chief Executive Officer of
Renovacor. “Peer-reviewed data published in the prestigious Journal
of American College of Cardiology: Basic to Translational Science
showed what we believe are meaningful levels of cardiac
transduction when REN-001 was delivered locally to the heart of
pigs at doses less than 1e13 vg/kg. We are now working to build
upon these data with an expected IND submission for REN-001 in the
second half of this year, and subsequent initiation of a Phase I/II
clinical study in BAG3-DCM patients.”
Dr. Cook continued, “In addition to the progress made with our
lead candidate, we expanded our pipeline with a new research
program, in collaboration with the University of Utah, targeting
the three largest genetic segments of arrhythmogenic
cardiomyopathy. ACM patients are in urgent need of therapies that
can address the underlying biology of their debilitating disease,
and we are thrilled to be collaborating with the University of Utah
in these efforts. Looking ahead, we believe we are well-positioned
with a pipeline of differentiated precision medicine programs and a
strong team of experienced industry veterans at all levels of the
company.”
Second Quarter 2022 and Recent Highlights
- Continued Advancement of REN-001 Investigational New Drug
(IND)-enabling Studies Supports Planned IND Submission in the
Second Half of 2022: Planned IND submission is expected to
enable the subsequent initiation of a Phase I/II clinical trial in
BAG3-associated dilated cardiomyopathy (BAG3-DCM).
- Announced the Peer-reviewed Publication of Data from a Pilot
Pig Study Showing Robust, Diffuse Cardiac Transduction with REN-001
Delivered via Low-dose Retrograde Coronary Sinus Infusion
(RCSI): In the pilot study featured in a paper, which was
published in Journal of the American College of Cardiology: Basic
to Translational Science, low doses (<1e13 vector genome per
kilogram) of REN-001 delivered locally to the heart of healthy
Yucatan pigs using RCSI resulted in each cardiomyocyte containing,
on average, at least one copy of the vector’s BAG3 payload (i.e.,
vector copy number threshold ≥1). Evaluation of cardiac tissue also
showed diffuse transduction patterns across multiple regions of the
heart and the presence of vector mRNA transcript. All evaluated
animals tolerated the RCSI procedure without evidence of cardiac
injury.
- Expanded Pipeline with New AAV Gene Therapy Research Program
for Multiple Genetic Segments of Arrhythmogenic Cardiomyopathy
(ACM): The program is being developed as a potential precision
therapy for the three largest genetic segments of ACM:
plakophilin-2 (PKP2), desmoglein-2 (DSG2), and desmoplakin (DSP)
associated ACM. To accelerate this program, Renovacor entered into
a research collaboration with the University of Utah’s Nora Eccles
Harrison Cardiovascular Research and Training Institute (CVRTI).
The research program aims to restore gap junction protein
trafficking and gap junction communication between heart muscle
cells to treat life-threatening arrhythmias associated with ACM.
The terms of the research agreement grant Renovacor an option for
an exclusive license to inventions generated from research
conducted under the collaboration.
Second Quarter 2022 Financial Results
Net loss for the three months ended June 30, 2022 was $4.0
million, or $0.23 per basic and diluted share, compared to net loss
of $3.7 million, or $0.59 per basic and diluted share, for the same
period in 2021. Excluding non-cash gains totaling $5.1 million for
the three months ended June 30, 2022 related to the change in fair
value of our warrant and share earnout liabilities, net loss was
$9.1 million, or $0.52 per basic and diluted share.
Research and development expenses were $6.3 million for the
three months ended June 30, 2022, compared to $3.3 million for the
same period in 2021.
General and administrative expenses were $2.8 million for the
three months ended June 30, 2022, compared to $0.4 million for the
same period in 2021.
Cash and cash equivalents as of June 30, 2022, totaled $62.0
million which, based on current projections, Renovacor believes
will be sufficient to fund its operating expenses and capital
expenditure requirements into the fourth quarter 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 and development programs,
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 press release. 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 Company’s ability to submit an IND related to
REN-001 on its anticipated timeline, and any challenges related to
the clearance of such IND by the FDA; 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, including inflationary pressures; 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
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Operating expenses:
Research and development
$
6,289
$
3,333
$
12,219
$
4,488
General and administrative
2,838
385
5,763
912
Loss from operations
(9,127
)
(3,718
)
(17,982
)
(5,400
)
Other income (expense):
Change in fair value of warrant
liability
2,905
—
10,185
—
Change in fair value of share earnout
liability
2,152
—
10,318
—
Other income (expense), net
46
—
49
—
Net income (loss)
$
(4,024
)
$
(3,718
)
$
2,570
$
(5,400
)
Net income (loss) per share - basic and
diluted
$
(0.23
)
$
(0.59
)
$
0.14
$
(0.86
)
Weighted-average number of common shares
used in computing net income (loss) per share
— Basic
17,478,008
6,274,566
17,471,341
6,274,566
— Diluted
17,478,008
6,274,566
17,550,126
6,274,566
Renovacor, Inc. Condensed
Consolidated Balance Sheet Data (In thousands)
June 30,
December 31,
2022
2021
Cash and cash equivalents
$
61,993
$
78,790
Other assets
2,729
2,209
Total assets
$
64,722
$
80,999
Total liabilities
$
7,370
$
27,455
Total stockholders’ equity
57,352
53,544
Total liabilities and stockholders’
equity
$
64,722
$
80,999
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220808005772/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)
Historical Stock Chart
From Oct 2024 to Nov 2024
Renovacor (AMEX:RCOR)
Historical Stock Chart
From Nov 2023 to Nov 2024
