CAMBRIDGE, Mass.–(BUSINESS THREAD)–Renovacor, Inc. (NYSE: RCOR), a biotechnology company focused on delivering innovative precision therapies to improve the lives of patients and families battling genetic cardiovascular and mechanical diseases, today reported financial results for the second quarter of 2022 and provided a corporate update.
“The advances made at Renovacor this quarter allowed us to advance and expand our portfolio of precision AAV gene therapies that target the underlying drivers of devastating cardiovascular disease,” said Magdalene Cook, MD, 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 to be significant levels of cardiac transduction when REN-001 was delivered locally to pig hearts at doses below 1e13 vg /kg.. We are now working to capitalize on these data with a planned IND submission for REN-001 in the second half of this year and the subsequent initiation of a phase I/II clinical study in patients with BAG3- DCM”.
Dr. Cook continued: “In addition to the progress made with our lead candidate, we expanded our portfolio with a new research program, in collaboration with the University of Utah, targeting the three largest genetic segments of arrhythmogenic cardiomyopathy . ACM patients urgently need therapies that can address the underlying biology of their debilitating disease, and we are excited to partner with the University of Utah in these efforts. Looking forward, we believe we are well-positioned with a portfolio of differentiated precision medicine programs and a strong team of seasoned industry veterans at all levels of the company.”
Second quarter 2022 and recent highlights
Continued progress of Investigational New Drug (IND) REN-001 studies supports planned IND filing in second half of 2022: Planned IND filing expected to allow later initiation from a phase I/II clinical trial in BAG3-associated dilated cardiomyopathy (BAG3-DCM). Announced the peer-reviewed publication of data from a pig pilot study showing robust and diffuse cardiac transduction with REN-001 delivered via low-dose retrograde coronary sinus infusion (RCSI): In the pilot study presented in a paper, which was published in the 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 hearts of healthy Yucatan pigs via RCSI resulted in each cardiomyocyte contained, on average, at least one copy of the vector BAG3 payload (ie, vector copy number threshold ≥1). Evaluation of cardiac tissue also showed diffuse transduction patterns in various regions of the heart and the presence of vector mRNA transcription. 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-associated ACM (DSP). To accelerate this program, Renovacor entered into a research collaboration with the University of Utah 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 the life-threatening arrhythmias associated with ACM. The terms of the research agreement grant Renovacor an exclusive license option for the inventions generated from the research carried out as part of the collaboration.
Financial results for the second quarter of 2022
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 stock earnings liabilities, the net loss was $9.1 million of dollars, 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 spending requirements of capital during the fourth quarter of 2023.
Renovacor is a biotechnology company focused on providing innovative precision therapies to improve the lives of patients and families battling cardiovascular and mechanical diseases of genetic origin. 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 deliver life-changing therapies to patients suffering from severe genetic cardiovascular disease and related diseases by developing medicines that target the underlying cause of the disease and provide transformative benefit and significant improvement in quality of life. life quality.
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995, as amended, including statements about the expected development of product candidates and development programs of Renovacor, clinical development. deadlines and financial perspectives. These forward-looking statements are generally identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “attempt,” “strategy,” “future,” “opportunity,” “plan,” ” “may”, “should”, “will”, “would”, “will”, “will continue”, “will likely result” and similar expressions. These forward-looking statements are based on current estimates and assumptions of the Company and its management and are subject to a number of risks, uncertainties and important factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statements. research statements contained in this press release. Factors that could cause actual results to differ materially from current expectations include, but are not limited to: competition, the company’s ability to grow and manage growth, maintain relationships with customers and suppliers and retain its management and your key employees; the Company’s ability to successfully advance its current and future product candidates through development activities, preclinical studies and clinical trials and the costs related thereto; the company’s ability to submit an IND related to REN-001 on its expected schedule, and any challenges related to FDA clearance of that IND; the timing, extent and likelihood of regulatory submissions and approvals, including final regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the Company will be adversely affected by other economic, business or competitive factors, including inflationary pressures; the estimates of expenses and profitability of the Company; the evolution of the markets in which the company competes; the company’s ability to implement its strategic initiatives and continue to innovate its existing products; the company’s ability to defend its intellectual property; the impact of the COVID-19 pandemic on the Company’s business, supply chain and workforce; and the risks and uncertainties described in the “Risk Factors” section of the Company’s annual and quarterly reports filed with the Securities Exchange Commission. These documents 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 place undue reliance on forward-looking statements, and Renovacor undertakes no obligation and does not intend to update or revise such forward-looking statements, whether as a result of new information, future events or otherwise. way Renovacor does not guarantee that it will meet your expectations.