Cerus Corporation (Nasdaq:CERS) today announced the Company’s recent activities related to COVID-19 and efforts to ensure that patients have readily available access to pathogen-reduced blood components, including convalescent plasma.
"As the world endures the impact from the current COVID-19 pandemic, our focused mission of ensuring the availability and safety of the world’s blood supply has never been more relevant. The impact that this pandemic has had on the security of the supply chains for our blood center and hospital customers is unprecedented," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "During this challenging time for our customers, Cerus is focused on helping them maintain the safety and availability of the blood supply, while also providing the assistance they need with regard to standing up programs to produce COVID-19 convalescent plasma in sufficient quantities given the many hospital inquiries globally. We are highly focused on ensuring patients have access to our products and on protecting the health and safety of our employees and the communities in which we operate. Our financial strength prepares us to navigate this pandemic while continuing to execute on the business objectives to support our long-term growth."
Our commitment to blood providers, hospitals and, ultimately, patients:
- Our global supply chain for the INTERCEPT platelet disposable kits is currently intact and at this time, we are confident in our ability to supply INTERCEPT disposable kits. In anticipation of greater demand for INTERCEPT, we increased our inventory levels in 2019 and believe we have ample supply to meet our customers’ needs.
- Fresenius Kabi (FK), our primary manufacturing partner, produces INTERCEPT disposable kits at a facility in France and is classified as an essential business by the French Government. To ensure employee safety and comply with local requirements for social distancing, the FK team recently reconfigured production workflow and the facility continues to produce kits. Going forward, employee absenteeism, at the manufacturing site, is a potential risk that could negatively impact monthly production.
- We and our key suppliers have enacted business continuity measures which are currently in place and have allowed INTERCEPT disposable kit production and business growth to remain unaffected. However, our supply chain is not without vulnerabilities and should the current COVID-19 situation persist beyond the summer or worsen regionally or globally, our business could be adversely impacted.
Our commitment to our employees and their families:
- The safety and well-being of our employees and their families during the pandemic is a top priority. We have taken steps to ensure their safety and minimize the risk of community transmission to help reduce the rate of new infections. Headquartered in Concord, California, we are part of current state-wide orders to "shelter-in-place." Globally, our offices and individual employees are also operating under regional health environments that restrict face-to-face interactions and movement. As a result, most of our employees are working from home to maintain Cerus’ day-to-day operations. However, we continue to work diligently to advance our development portfolio and to expand the label claims and ease of use of the INTERCEPT Blood System.
- Our field team is collaborating with our blood center and hospital customers in new ways including the use of enabling technology such as video conferencing for technical support and training. In situations where our field team needs to be on-site, we will take every necessary travel precaution to keep our employees safe while ensuring our customers can continue to manufacture INTERCEPT treated blood components.
Our commitment to our R&D programs and impact to clinical trials and studies:
- Pathogen-reduced cryoprecipitate: Pathogen-reduced cryo continues to be one of our highest priority R&D programs given the expected clinical utility and potential benefit to patients. For this FDA Breakthrough Device designated program, we do not anticipate disruptions to our activities surrounding data collection and regulatory submission. We continue to expect to file our PMA supplement in the first half of the year.
- U.S. red blood cell (RBC) development program: As a result of COVID-19, many of our participating clinical trial hospital sites have suspended enrollment. In addition, three out of the four blood center partners that produce pathogen-reduced RBCs for these studies have suspended production because of the need to conserve red blood cells to meet hospital demand during the pandemic. While we plan to continue the study enrollment at the sites we can, we will look to reinitiate enrollment at all study sites as quickly as possible. In support of the planned U.S. regulatory filing, we expect to initiate a study in sickle cell chronic exchange transfusion in the U.K., although the timing has been impacted due in part to the COVID-19 pandemic.
- European red blood cell regulatory status: The transition of our CE mark submission from a medical device directive (MDD) filing to a medical device regulation (MDR) filing as a result of the change in European regulatory laws is expected in the second quarter of 2020. However, a recent European Commission letter to the European Parliament and European Council has proposed postponing the MDR compliance date by a year to May of 2021, and it is unknown at this time whether the CE mark submission will continue its review under the MDD pathway or transition at some later point to the MDR pathway.
- U.S. INTERCEPT plasma with DEHP-free plastic disposable kits: The U.S. regulatory filing for INTERCEPT plasma with alternate plastic kits was submitted to the FDA during the fourth quarter of 2019. We anticipate FDA approval during the second quarter of 2020.
- Efficacy of INTERCEPT to pathogen-reduce SARS-CoV-2: To date, there have been no documented cases of COVID-19 as a result of transfusion transmitted infections. However, SARS-CoV-2 has been found in the serum of COVID-19 patients which raises concerns, even though there is no historical evidence of respiratory viruses being associated with transfusion transmitted infectious disease. Building off of our previous studies demonstrating robust inactivation of SARS and MERS in blood components, we are conducting tests to assess the efficacy of INTERCEPT in inactivating SARS-CoV-2. Results of these tests are anticipated in mid-2020.
Our commitment to standing up coronavirus convalescent plasma studies globally :
- In Europe, our deployment team is collaborating with, and supporting blood centers and hospitals interested in processing coronavirus convalescent plasma (CCP) to quickly implement systems to enable blood centers to produce INTERCEPT treated CCP.
- With the aim of optimizing convalescent plasma therapy for COVID-19 patients, Cerus has formed a collaborative research group led by Dr. Laurence Corash, the Company’s chief scientific officer. The research team seeks to define the key characteristics that influence the potential efficacy of convalescent plasma, including the level and nature of anti-COVID-19 antibodies, optimal collection timing, dosing and how these influence responses to the therapy regimen. The research collaboration also plans to explore the further optimization of CCP treatment by pooling units to standardize the antibody profile and by generating a lyophilized product to facilitate ease of use and availability.
- In the U.S., we have developed tools and created standardized protocols to support blood centers and hospitals to quickly implement processes to produce INTERCEPT treated CCP.
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Based in Concord, California, our employees are dedicated to deploying and supplying vital technologies and pathogen-protected blood components for blood centers, hospitals and ultimately patients who rely on safe blood. With the INTERCEPT Blood System, we are focused on protecting patients by delivering the full complement of reliable products and expertise for transfusion medicine. Cerus develops and markets the INTERCEPT Blood System and remains the only company in the blood transfusion space to earn both CE Mark and FDA approval for pathogen reduction of both platelet and plasma components. Cerus currently markets and sells the INTERCEPT Blood System in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Red Blood Cell system is in clinical development. For more information about Cerus, visit www.cerus.com.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements relating to: the Company’s financial strength to continue its business objectives to support long-term growth; the sufficiency of the Company’s business continuity measures to maintain supply of products and ensure production remains unaffected; the therapeutic benefits of pathogen-reduced cryoprecipitate; submission of the Company’s PMA supplement for pathogen-reduced cryoprecipitate; expected timing and delays in enrollment for the Company’s RBC clinical trials; expected timing for initiation of the Company’s sickle cell study in the U.K.; the timing for CE mark submission for the RBC System under the Medical Device Regulation; expected FDA approval of the plasma disposable kits using DEHP-free plastics; the timing and results of the inactivation studies of SARS-CoV-2; and the optimization of CCP treatment and availability of lyophilized CCP. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation risks related to the uncertainty of Cerus’ future capital requirements and its future revenues and other financial performance and results; Cerus’ ability to maintain an effective, secure manufacturing supply chain; the uncertain and time-consuming regulatory process, including the risks (a) that Cerus may be unable to submit its planned PMA supplement to the FDA for pathogen-reduced cryoprecipitate in a timely manner or at all, and even if submitted, such planned PMA supplement may not be accepted or approved in a timely manner or at all and (b) that Cerus may be unable to submit its planned CE Mark application for the RBC System under the Medical Device Regulation in a timely manner or at all, and even if submitted, such planned CE Mark application may not be accepted or approved in a timely manner or at all; the uncertain and time-consuming development process, including the risks that the INTERCEPT Blood System may not inactivate SARS-CoV-2; that anticipated clinical trials of the INTERCEPT Blood System may not be initiated on the anticipated timing or at all, or if initiated, may be extended, delayed, suspended or terminated, including as result of safety concerns; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 21, 2020. To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Tim Lee – Investor Relations Director