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News Article | May 3, 2017
Site: www.businesswire.com

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) today announced financial results for the first quarter ended March 31, 2017. “Coming out of our first quarter, we remain optimistic about our growth prospects over the next several years from major markets including the U.S., France and South Africa, but were not able to sign new contracts for the latter two geographies by now as we had previously expected. Therefore, though no less confident in our ability to capture this new business in the near to medium term, we believe it is prudent to adjust our 2017 product revenue guidance to a new range of $43 to 48 million dollars,” said William 'Obi' Greenman, Cerus’ president and chief executive officer. “In the U.S., we are seeing increasing awareness regarding the FDA’s pending final guidance on bacterial safety, and are encouraged by the urgency currently being expressed by blood centers to meet hospital demand for INTERCEPT platelets.” Product revenue recognized during the first quarter of 2017 was $7.0 million compared to $7.6 million during the same period in 2016. The Company experienced strong year-over-year growth for U.S. disposable kits, which was overshadowed by lighter demand for plasma products in EMEA and a weaker Euro compared to the U.S. Dollar. Reported product revenue was negatively affected by an approximate 3% weakening of the Euro compared to the U.S. dollar during the first quarter of 2017 as compared to the same period during 2016. The Company expects 2017 global product revenue in the range of $43 million to $48 million. Gross margins on product revenue for the first quarter of 2017 were 47%, compared to 44% for the first quarter of 2016. Gross margins for the first quarter of 2017 were positively impacted by a more favorable product mix, with higher gross margin platelet kits contributing proportionately more to sales during the first quarter of 2017 than in the prior year period. In addition, the Company realized manufacturing and inventory management efficiencies in the current period compared to the prior year period, which also contributed to the improved gross margins. Total operating expenses for the first quarter of 2017 were $22.8 million, compared to $18.7 million for the first quarter of 2016. Selling, general and administrative expenses increased primarily due to the Company’s increased commercial activity in the U.S. and to a lesser extent, the costs associated with administering the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA) for INTERCEPT red blood cell development. Research and development expenses increased as a result of increased costs associated with clinical development of the red blood cell system, pursuit of supplemental approvals for the platelet and plasma systems, and development activities under the BARDA agreement. Operating losses during the first quarter of 2017 were $18.1 million, compared to $15.3 million for the first quarter of 2016. Net loss for the first quarter of 2017 was $18.6 million, or $0.18 per diluted share, compared to a net loss of $16.9 million, or $0.17 per diluted share, for the first quarter of 2016. Net losses for the first quarter of 2016 were negatively impacted by non-cash income tax expense of $0.8 million. These tax items are largely the result of changes in the fair value of the Company’s marketable equity investment in Aduro Biotech, Inc. At March 31, 2017, the Company had cash, cash equivalents and short-term investments of $53.8 million compared to $71.6 million at December 31, 2016. At March 31, 2017, the Company had approximately $18.2 million in outstanding debt under its loan agreement with Oxford Finance. The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international). A replay will be available on the company’s website, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 41694810. The replay will be available approximately three hours after the call through May 17, 2017. Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma 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. See http://www.cerus.com for information about Cerus. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements concerning Cerus’ 2017 annual product revenue guidance and its expectations for U.S. revenue contribution in 2017 and the timing thereof; Cerus’ expectations regarding increased demand for INTERCEPT components in the U.S.; Cerus’ ability to capture new business in the near to medium; and the timing and likelihood of a future PMA submission to the FDA for the red blood cell system. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not meet its adjusted revenue guidance for 2017 and/or realize meaningful revenue contributions from U.S. customers in 2017 or otherwise, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers; risks associated with Cerus’ lack of commercialization experience in the United States and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System for platelets and plasma in the United States, including as a result of licensure requirements that must be satisfied by U.S. customers prior to their engaging in interstate transport of blood components processed using the INTERCEPT Blood System; risks related to Cerus’ ability to commercialize the INTERCEPT Blood System in the United States without infringing on the intellectual property rights of others; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; the uncertain and time-consuming development and regulatory process, including the risks (a) that Cerus may be unable to comply with the FDA’s post-approval requirements for the INTERCEPT platelet and plasma systems, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval for the INTERCEPT platelet and/or plasma systems, (b) related to Cerus’ ability to expand the label claims and product configurations for the INTERCEPT platelet and plasma systems in the United States, which will require additional regulatory approvals and (c) that Cerus may be unable to file for CE Mark approval of the red blood cell system in Europe in the anticipated timeframe or at all, and even if filed, Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of the red blood cell system in a timely manner or at all; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or weakening economic conditions in the markets where Cerus sells its products; Cerus’ reliance on third parties to market, sell, distribute and maintain its products; Cerus’ ability to maintain an effective manufacturing supply chain, including the ability of its manufacturers to comply with extensive FDA and foreign regulatory agency requirements; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of future revenues and other financial performance and results, 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, 2016, filed with the SEC on March 8, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.


— Increasing incidence of cardiovascular disorders, demand for automated blood component separation procedures, adoption of technologically advanced automated products, government focusing on healthcare infrastructure and rise in the number of platelet donors are fueling the market growth. However, histocompatibility issues, high cost of equipment and lack of trained technicians will hamper market growth. Plasmapheresis segment accounted for the largest market share of the apheresis procedure market due to growing incidence of hematological disorders. Apheresis disposable kits is the largest segment in the total apheresis equipment product market as single use products are in high demand along with high usage volume. Neurology segment is projected to witness the fastest growth under application as individuals are affected with multiple sclerosis. North America is the leading market because of the presence of sophisticated healthcare infrastructure. Asia Pacific is anticipated to be the fastest growing market due to Increasing prevalence of blood disorders and plasma products in China, Japan, Australia, Korea and India. Some of the key players in global Apheresis Equipment market are Asahi Kasei Kuraray Medical Co., Ltd., Fenwal, Inc., Braun Melsungen AG, Cerus Corporation, Fresenius Se & Co. KGAA, Medica SpA, Kaneka Corporation, Nikkiso Co., Ltd, Kawasumi Laboratories Inc, Therakos, Inc., HemaCare Corporation, Haemonetics Corporation and Terumo BCT, Inc. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 8 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements About Stratistics MRC We offer wide spectrum of research and consulting services with in-depth knowledge of different industries. We are known for customized research services, consulting services and Full Time Equivalent (FTE) services in the research world. We explore the market trends and draw our insights with valid assessments and analytical views. We use advanced techniques and tools among the quantitative and qualitative methodologies to identify the market trends. Our research reports and publications are routed to help our clients to design their business models and enhance their business growth in the competitive market scenario. We have a strong team with hand-picked consultants including project managers, implementers, industry experts, researchers, research evaluators and analysts with years of experience in delivering the complex projects. For more information, please visit http://www.strategymrc.com


Patent
Cerus Corporation | Date: 2017-07-26

Provided herein are improved processes for preparing and treating platelet products. The methods are useful in the efficient preparation of platelet products with desirable characteristics, including pathogen inactivated platelet products.


Patent
Cerus Corporation | Date: 2015-07-23

Provided herein are improved processes for preparing and treating platelet products. The methods are useful in the efficient preparation of platelet products with desirable characteristics, including pathogen inactivated platelet products.


News Article | May 23, 2017
Site: www.businesswire.com

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that it received notification last week of a pending U.S. supply shortage of a platelet additive solution (PAS) manufactured and sold by Fresenius Kabi. The pending shortage is due to an unanticipated delay in FDA approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi's supplier. The shortage is expected to temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets. Fresenius Kabi has stated that it is working with its suppliers and the FDA to resolve this delay and minimize any long-term disruption in supply. Cerus is committed to supporting all blood centers, hospitals and patients who rely upon the INTERCEPT system to safeguard their platelet supply. "We believe that access to pathogen reduced platelets is critical for all patients, and are doing everything we can to support impacted blood centers and also their hospital customers who are using or wish to use INTERCEPT platelets," said William 'Obi' Greenman, Cerus' president and CEO. “For our customers who produce INTERCEPT platelets on the Amicus collection platform, availability of this Fresenius Kabi PAS product is essential to their continued production of pathogen reduced platelets. We understand that Fresenius Kabi anticipates the supply shortage will be temporary, and we believe the shortage could adversely affect INTERCEPT platelet production by impacted blood centers through year end," Mr. Greenman continued. As a result of the expected impact of the PAS supply disruption on INTERCEPT platelet production, the Company is updating its 2017 product revenue guidance to a range of $38 million to $46 million compared to the prior range of $43 million to $48 million. In the U.S., INTERCEPT platelets may be produced in a mixture of PAS and plasma (65% PAS and 35% plasma) on platelets collected on the Amicus apheresis platform, or in 100% plasma on platelets collected on the Trima Accel apheresis platform. An individual blood center may have both collection platforms available, or may standardize their production on one platform. Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma 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. See www.cerus.com for information about Cerus. INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation. Amicus is a trademark of Fresenius Kabi. Trima Accel is a trademark of Terumo BCT, Incorporated. Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements concerning Cerus’ 2017 annual product revenue guidance and its expectations for U.S. revenue contribution in 2017 and the timing thereof; and Cerus’ expectations regarding Fresenius Kabi’s ability to remedy the supply shortage of PAS. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not meet its adjusted revenue guidance for 2017 and/or realize meaningful revenue contributions from U.S. customers in 2017 or otherwise, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers; risks associated with Cerus’ lack of commercialization experience in the United States and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System for platelets and plasma in the United States, including as a result of licensure requirements that must be satisfied by U.S. customers prior to their engaging in interstate transport of blood components processed using the INTERCEPT Blood System; risks related to Fresenius Kabi’s efforts to remedy the supply shortage of PAS in a meaningful and timely manner; risks related to how the supply shortage could affect INTERCEPT’s acceptance in the marketplace; risks related to how the supply shortage may effect current commercial contracts; risks related to Cerus’ ability to commercialize the INTERCEPT Blood System in the United States without infringing on the intellectual property rights of others; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; the uncertain and time-consuming development and regulatory process, including the risks (a) that Cerus may be unable to comply with the FDA’s post-approval requirements for the INTERCEPT platelet and plasma systems, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval for the INTERCEPT platelet and/or plasma systems, (b) related to Cerus’ ability to expand the label claims and product configurations for the INTERCEPT platelet and plasma systems in the United States, which will require additional regulatory approvals and (c) that Cerus may be unable to file for CE Mark approval of the red blood cell system in Europe in the anticipated timeframe or at all, and even if filed, Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of the red blood cell system in a timely manner or at all; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or weakening economic conditions in the markets where Cerus sells its products; Cerus’ reliance on third parties to market, sell, distribute and maintain its products; Cerus’ ability to maintain an effective manufacturing supply chain, including the ability of its manufacturers to comply with extensive FDA and foreign regulatory agency requirements; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of future revenues and other financial performance and results, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Annual Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.


Patent
Cerus Corporation | Date: 2016-06-24

Provided herein are compositions and kits including a pathogen-inactivated cryoprecipitate suitable for infusion into a subject at least 1 day after thawing. The methods are useful in the efficient preparation of cryoprecipitates with desirable characteristics, including pathogen-inactivated cryoprecipitates that are suitable for infusion into a subject at least 1 day after thawing.


CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that additional options totaling $46.6 million have been exercised under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. “The allocation of additional options, coupled with recent FDA feedback on the dossier of clinical data required for a possible future red cell PMA submission, confirm our next steps forward for INTERCEPT red blood cells (RBCs) in the U.S.,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Importantly, funds have now been allocated to support our planned Phase III ReCePI study, which is designed to evaluate the efficacy and safety of INTERCEPT RBCs to treat acute anemia in cardiovascular surgery patients.” In addition to funding the proposed Phase III ReCePI study, the newly exercised options include support for a clinical study in the UK to evaluate the efficacy and safety of INTERCEPT red blood cells in patients undergoing exchange transfusion for sickle cell disease. This tranche of funding also allocates funds toward the development of the INTERCEPT RBC System design to enable expanded use and manufacturing scale up of key components. The total value of the full five-year contract is up to $186 million, subject to funding of additional contract options, and provides non-dilutive funding to support a comprehensive development program for the pathogen reduction of RBC components in the U.S. Funding allocated to date, including the latest tranche, totals $88.4 million. Previously allocated funds are already supporting the Phase III RedeS trial to assess the safety and efficacy of INTERCEPT RBCs compared to conventional RBCs in regions at risk for the Zika virus. This contract is being funded in whole or in part with federal funds from the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. HHSO100201600009C. Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma 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. See www.cerus.com for information about Cerus. INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation. Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products and prospects, including statements concerning Cerus’ receipt of funding under the recently exercised funding options in the BARDA contract; Cerus’ expectations with respect to activities that will or may be funded under such recently exercised options and the sufficiency of that funding; and potential future clinical trial activity and regulatory submissions. Actual results could differ materially from these forward-looking statements as a result of certain factors, including without limitation: risks associated with the uncertain nature of funding over which Cerus has no control as well as actions of Congress and governmental agencies which may adversely affect the availability of funding under the contract and/or exercise of any potential subsequent option periods, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted; the uncertain and time-consuming research and development processes that may be necessary prior to the commencement of a Phase III clinical trial; the risks that Cerus may be unable to meet FDA requirements to commence any Phase III clinical studies; the time-consuming clinical trials and regulatory processes that must be completed to obtain regulatory approval of the red blood cell system in a timely manner or at all; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus‘ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.


Patent
Cerus Corporation | Date: 2017-09-13

The present invention relates to the preparation and use in recipients of CAR-T cell-derived effector cells which are modified to limit their proliferation within the recipient. This is accomplished through the introduction of adducts into the nucleic acids of CAR-T cell-derived effector cells following expansion in vitro to provide expanded and activated CAR-T cell-derived effector cells that retain immunologic function, including the expression of one ore more cytokines.


Methods and devices are provided for reducing the concentration of low molecular weight compounds in a biological composition containing cells while substantially maintaining a desired biological activity of the biological composition. The device comprises highly porous adsorbent particles, and the adsorbent particles are immobilized by an inert matrix. The matrix containing the particles is contained in a housing, and the particles range in diameter from about 100 m to about 1500 m. The device can be used to adsorb and remove a pathogen-inactivating compounds from a biological composition such as a blood product.


Patent
Cerus Corporation | Date: 2014-10-31

The present invention provides pathogen-inactivated red blood cell compositions suitable for infusion into a subject.

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