CERS Cerus Corporation

7.04
-0.02  -0%
Previous Close 7.06
Open 7.01
52 Week Low 2.71
52 Week High 7.56
Market Cap $1,169,846,149
Shares 166,171,328
Float 162,063,919
Enterprise Value $1,100,553,575
Volume 1,693,522
Av. Daily Volume 1,992,421
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Drug Pipeline

Drug Stage Notes
INTERCEPT
Plasma / COVID-19
Approved
Approved
PMA approved Dec 16 2014. Two COVID-19 patients were transfused with INTERCEPT treated coronavirus convalescent plasma (CCP) - noted April 2, 2020.
INTERCEPT (ReCePI)
Patients undergoing complex cardiac surgery procedures
Phase 3
Phase 3
Phase 3 initiation announced December 19, 2018.
INTERCEPT
Platelets
Approved
Approved
PMA approved Dec 18 2014
INTERCEPT
Chronic anemia in thalassemia patients
Phase 3
Phase 3
Phase 3 trial met endpoints - January 23, 2018. CE mark submission due 2H 2018.

Latest News

  1. Cerus Corporation (NASDAQ:CERS) announced today that INTERCEPT Blood Systems disposable kit shipments have surpassed 7.5 million treatable platelet and plasma doses globally since commercial launch.

    "This is a significant milestone for Cerus and highlights the scope our technology has had within the transfusion industry and on the millions of patients worldwide transfused with INTERCEPT treated platelet and plasma components," said William ‘Obi' Greenman, Cerus' president and chief executive officer. "We have a solid track record with the safety and efficacy of our INTERCEPT products, which now surpasses more than 7.5 million treatable doses."

    The INTERCEPT Blood System for platelets and plasma provides a proactive approach to reduce the…

    Cerus Corporation (NASDAQ:CERS) announced today that INTERCEPT Blood Systems disposable kit shipments have surpassed 7.5 million treatable platelet and plasma doses globally since commercial launch.

    "This is a significant milestone for Cerus and highlights the scope our technology has had within the transfusion industry and on the millions of patients worldwide transfused with INTERCEPT treated platelet and plasma components," said William ‘Obi' Greenman, Cerus' president and chief executive officer. "We have a solid track record with the safety and efficacy of our INTERCEPT products, which now surpasses more than 7.5 million treatable doses."

    The INTERCEPT Blood System for platelets and plasma provides a proactive approach to reduce the risk of transfusion-transmitted infectious disease (TTID). Cerus' proprietary pathogen-reduction technology provides a foundational strategy for safeguarding the blood supply against a broad spectrum of known and emerging pathogens. Annually, over 115 million units of blood are donated worldwide and there is no therapeutic alternative for patients who need blood1.

    About the Cerus INTERCEPT Blood System:

    • Provides robust, broad-spectrum reduction of the risks of TTID, including sepsis, and can be used to replace bacterial detection, cytomegalovirus (CMV) and Babesia testing and gamma irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD).
    • INTERCEPT Blood System for platelets and plasma utilizes amotosalen, a photoactive compound activated with ultra-violet light that specifically targets DNA and RNA, irreversibly cross-linking nucleic acids, which blocks the replication of viruses, bacteria, and parasites.
    • Over a decade of national hemovigilance data on INTERCEPT treated platelets establishing a proven track record of safety and clinical utility . The INTERCEPT Blood System for platelets is now the standard of care in nine countries including France, Switzerland, Belgium, and Austria.
    • INTERCEPT complies with the FDA guidance on bacterial safety in platelets and also provides a proactive solution to address pandemic preparedness.
    • A recent study conducted at the King Abdulaziz University in Jeddah Saudi Arabia demonstrated that INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components.
    • The use of INTERCEPT provides an alternative to the three-month donor deferral period for residents of non-malaria endemic countries after traveling to malaria-endemic regions, thereby potentially improving blood component availability for hospitals, blood banks, and ultimately, patients in need.

    Standard of care defined as treating greater than 50% of platelets

    1. World Health Organization, https://www.who.int/news-room/facts-in-pictures/detail/blood-transfusion

    ABOUT CERUS

    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 and follow us on LinkedIn.

    INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

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  2. Cerus Corporation (NASDAQ:CERS) today announced financial results for the second quarter ended June 30, 2020.

    Recent developments and highlights include:

    • Q2 2020 Total Revenue of $26.8 million - driven by robust year-over-year platelet kit sales growth in the U.S. and strong plasma and illuminator sales in our EMEA region. Total revenue comprised of (in millions, except %):

     

    Q2 2020

    Q2 2019

    Change $

    Change%

    Product Revenue

    $ 21.5

    $ 18.2

    $ 3.3

    18.1%

    Government Contract Revenue

    5.3

    4.3

    1.0

    23.3%

    Total Revenue

    $ 26.8

    $ 22.5

    $ 4.3

    19.1%

    • Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million - an approximately 20% to 25% increase over 2019…

    Cerus Corporation (NASDAQ:CERS) today announced financial results for the second quarter ended June 30, 2020.

    Recent developments and highlights include:

    • Q2 2020 Total Revenue of $26.8 million - driven by robust year-over-year platelet kit sales growth in the U.S. and strong plasma and illuminator sales in our EMEA region. Total revenue comprised of (in millions, except %):

     

    Q2 2020

    Q2 2019

    Change $

    Change%

    Product Revenue

    $ 21.5

    $ 18.2

    $ 3.3

    18.1%

    Government Contract Revenue

    5.3

    4.3

    1.0

    23.3%

    Total Revenue

    $ 26.8

    $ 22.5

    $ 4.3

    19.1%

    • Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million - an approximately 20% to 25% increase over 2019 reported product revenue.
    • Submitted a pre-market approval supplement (PMA-S) to the FDA for pathogen reduced cryoprecipitated fibrinogen complex with 5-day post-thaw storage.
    • Finalized INTERCEPT Red Cell CE Mark modular submission schedule, in agreement with our notified body, under new MDR submission pathway, providing clarity on the timing and pathway for red blood cells, the most frequently transfused blood component globally.
    • Reached agreement with FDA on chronic transfusion clinical data required for PMA submission and submitted clinical protocol amendment for the existing Phase 3 RedeS study to allow for enrollment of sickle cell and thalassemia patients.
    • Announced study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion.
    • Awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services for INTERCEPT Blood System for platelets.
    • Cash, cash equivalents, and short-term investments of $136.5 million at June 30, 2020.

    "The benefits of pathogen reduced blood products have never been so prominent as they are now during the COVID-19 pandemic. Our Q2 results reflect the highest quarterly product revenue we have recorded to date at $21.5 million. This pandemic has made clear to us not only the resilience of our business during this time, but also the essential role that pathogen inactivation plays in helping ensure the security and safety of the blood supply chain. It has also resulted in greater focus on strategic planning and pandemic preparedness by blood centers," said William ‘Obi' Greenman, Cerus' president and chief executive officer. "Demand for INTERCEPT platelet kits continued to be strong in the U.S. as blood centers and hospitals adopt pathogen reduction to be compliant with the FDA guidance document on platelet safety, which has a compliance deadline that is now less than 8 months away."

    "Our development programs continued to make progress during the quarter. In May, we submitted our PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex, which could result in potential FDA approval by the end of this year. In addition, meetings with the European and U.S. regulatory agencies in the quarter resulted in more expedited and clear pathways to potentially gain regulatory approvals of the INTERCEPT red blood cell system," continued Greenman.

    Revenue

    Product revenue during the second quarter of 2020 was $21.5 million, compared to $18.2 million during the same period in 2019. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand and an increase in illuminator sales in our EMEA region. Year-to-date product revenue totaled $40.1 million, an increase of 12% compared to the same period in 2019.

    Government contract revenue from the Company's Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.3 million during the second quarter of 2020, compared to $4.3 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $11.4 million, compared to $8.7 million in the first half of 2019. The total potential value of the current BARDA agreement is $214 million with $55 million recognized as revenue to date.

    BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded partially 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.

    Gross Margins

    Gross margins on product revenue during the second quarter of 2020 were 55% and consistent with the prior year period. Gross margins during the first half of 2020 were 55% compared to 54% reported in the first half of 2019.

    Operating Expenses

    Total operating expenses for the second quarter of 2020 were $31.7 million compared to $31.2 million for the same period the prior year. Year-to-date, operating expenses totaled $63.5 million compared to $60.8 million for the first half of 2019.

    Selling, general, and administrative (SG&A) expenses for the second quarter of 2020 totaled $16.1 million, compared to $16.7 million for the second quarter of 2019. The year-over-year decline was due to lower travel and marketing related expenses as a result of the COVID-19 pandemic. Year-to-date SG&A expenses totaled $32.0 million compared to $32.9 million for the first half of 2019.

    Research and development (R&D) expenses for the second quarter of 2020 were $15.6 million, compared to $14.4 million for the second quarter of 2019. The increase in year-over-year R&D expenses was due to higher expenses associated with initiatives to expand platelet label claims and development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $31.4 million compared to $27.9 million for the first half of 2019.

    Net Loss

    Net loss for the second quarter of 2020 was $14.9 million, or $0.09 per diluted share, compared to a net loss of $17.6 million, or $0.13 per diluted share, for the second quarter of 2019. Year-to-date net loss was $31.3 million, or $0.19 per diluted share, compared to $36.4 million, or $0.26 per diluted share, in the first half of 2019.

    Cash, Cash Equivalents and Investments

    At June 30, 2020, the Company had cash, cash equivalents and short-term investments of $136.5 million, compared to $85.7 million at December 31, 2019.

    At June 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to $39.4 million in outstanding term loan debt at December 31, 2019.

    2020 Product Revenue Guidance

    The Company expects 2020 product revenue to be in the range of $89 million to $93 million, unchanged from the guidance originally provided on January 13, 2020. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

    QUARTERLY CONFERENCE CALL

    The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company's financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, 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 6681405. The replay will be available approximately three hours after the call through August 18, 2020.

    ABOUT CERUS

    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 and follow us on LinkedIn.

    INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

    Forward Looking Statements

    Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus' products, prospects and expected results, including statements relating to Cerus' 2020 annual product revenue guidance; the potential approval of Cerus' PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex and the potential timing thereof; the potential for marketing approvals of the INTERCEPT red blood cell system; the potential to expand platelet label claims and development of the INTERCEPT red blood cell system; the total potential value of Cerus' agreement with BARDA; and other statements that are not historical facts. 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 (a) meet its 2020 annual product revenue guidance, (b) grow sales globally, including in its U.S. and European markets, and/or realize expected revenue contribution resulting from its U.S. and European market agreements, (c) realize meaningful and/or increasing revenue contributions from U.S. customers in the near term or at all, 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, and/or (d) realize any revenue contribution from its pipeline product candidates, whether due to Cerus' inability to obtain regulatory approval of its pipeline product candidates, or otherwise; risks associated with the ultimate duration and severity of the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus' business operations and financial results; 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 assure an uninterrupted supply of platelet additive solution (PAS); risks related to how any future PAS supply disruption could affect INTERCEPT's acceptance in the marketplace; risks related to how any future PAS supply disruption might affect current commercial contracts; 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; risks related to the uncertain and time-consuming development and regulatory process, including the risks (a) that the INTERCEPT Blood System does not have approved label claims for SARS-CoV-2 inactivation and may not successfully inactivate SARS-CoV-2; (b) that convalescent plasma therapies are unproven in treating, and may be ineffective in treating, patients with COVID-19, (c) that Cerus will continue to experience delays in successfully initiating, conducting or completing clinical trials as a result of the COVID-19 pandemic, (d) 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, (e) that Cerus may be unable to obtain U.S. marketing or CE Mark approvals, or any other regulatory approvals, of the INTERCEPT red blood cell system in a timely manner or at all, (f) related to Cerus' ability to expand the label claims and product configurations for the INTERCEPT platelet and plasma systems in the United States, including for pathogen-reduced cryoprecipitated fibrinogen complex, which will require additional regulatory approvals, (g) that Cerus' PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex may not be accepted or approved in a timely manner or at all, (h) that applicable regulatory authorities may disagree with Cerus‘ interpretations of the data from its clinical studies and/or may otherwise determine not to approve Cerus' regulatory submissions, including Cerus' PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex, in a timely manner or at all, and (i) that even if Cerus' regulatory submissions are approved, Cerus may not receive label claims for all requested indications or for indications with the highest unmet need or market acceptance; risks associated with Cerus' lack of experience in marketing products directly to hospitals and expertise complying with regulations governing finished biologics; risks associated with the uncertain nature of BARDA's funding over which Cerus has no control as well as actions of Congress and governmental agencies that may adversely affect the availability of funding under Cerus' BARDA agreement and/or BARDA's exercise of any potential subsequent option periods, including in connection with the general economic environment and uncertainty associated with the evolving effects of the COVID-19 pandemic, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted and that Cerus may not otherwise realize the total potential value under its agreement with BARDA; risks related to product safety, including the risk that the septic platelet transfusions may not be avoidable with the INTERCEPT Blood System; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or continued or more severe weakening in economic conditions resulting from the evolving effects of the COVID-19 pandemic or otherwise in the markets where Cerus currently sells and is anticipated to sell its products; Cerus' reliance on third parties to market, sell, distribute and maintain its products; Cerus' ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus' supply chain could be negative impacted as a result of the evolving effects of the COVID-19 pandemic, (b) Cerus' manufacturers could be unable to comply with extensive FDA and foreign regulatory agency requirements, and (c) Cerus may be unable to maintain its primary kit manufacturing agreement and its other supply agreements with its third party suppliers; Cerus' ability to identify and obtain additional partners to manufacture pathogen-reduced cryoprecipitate; risks associated with Cerus' ability to meet its debt service obligations and its need for additional funding; 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 Cerus' future capital requirements and its 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' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 5, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus' 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.

    CERUS CORPORATION

    REVENUE BY REGION

    (in thousands, except percentages)

     

     

    Three Months Ended

     

     

     

     

     

    Six Months Ended

     

     

     

     

     

    June 30,

     

    Change

     

    June 30,

     

    Change

     

    2020

     

    2019

     

    $

     

    %

     

    2020

     

    2019

     

    $

     

    %

    Europe, Middle East and Africa

    $

    14,462

     

    $

    12,748

     

    $

    1,714

     

    13

    %

     

    $

    26,682

     

    $

    25,400

     

    $

    1,282

     

    5

    %

    North America

     

    6,400

     

     

    5,158

     

     

    1,242

     

    24

    %

     

     

    12,477

     

     

    9,709

     

     

    2,768

     

    29

    %

    Other

     

    641

     

     

    303

     

     

    338

     

    112

    %

     

     

    955

     

     

    604

     

     

    351

     

    58

    %

    Total product revenue

    $

    21,503

     

    $

    18,209

     

    $

    3,294

     

    18

    %

     

    $

    40,114

     

    $

    35,713

     

    $

    4,401

     

    12

    %

     

    CERUS CORPORATION

    CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

    (in thousands, except per share information)

     

    Three Months Ended

    Six Months Ended

    June 30,

    June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Product revenue

    $

    21,503

     

    $

    18,209

     

    $

    40,114

     

    $

    35,713

     

    Cost of product revenue

     

    9,705

     

     

    8,111

     

     

    18,025

     

     

    16,543

     

    Gross profit on product revenue

     

    11,798

     

     

    10,098

     

     

    22,089

     

     

    19,170

     

    Government contract revenue

     

    5,324

     

     

    4,266

     

     

    11,354

     

     

    8,727

     

    Operating expenses:

    Research and development

     

    15,618

     

     

    14,417

     

     

    31,428

     

     

    27,857

     

    Selling, general and administrative

     

    16,112

     

     

    16,740

     

     

    32,025

     

     

    32,901

     

    Total operating expenses

     

    31,730

     

     

    31,157

     

     

    63,453

     

     

    60,758

     

    Loss from operations

     

    (14,608

    )

     

    (16,793

    )

     

    (30,010

    )

     

    (32,861

    )

    Total non-operating expense, net

     

    (196

    )

     

    (708

    )

     

    (1,203

    )

     

    (3,372

    )

    Loss before income taxes

     

    (14,804

    )

     

    (17,501

    )

     

    (31,213

    )

     

    (36,233

    )

    Provision for income taxes

     

    67

     

     

    61

     

     

    124

     

     

    121

     

    Net loss

    $

    (14,871

    )

    $

    (17,562

    )

    $

    (31,337

    )

    $

    (36,354

    )

     

    Net loss per share:

    Basic and diluted

    $

    (0.09

    )

    $

    (0.13

    )

    $

    (0.19

    )

    $

    (0.26

    )

    Weighted average shares used for calculating net loss per share:

    Basic and diluted

     

    164,383

     

     

    138,281

     

     

    160,894

     

     

    137,698

     

     

    CERUS CORPORATION

    CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

    (in thousands)

     

    June 30,

    December 31,

    2020

    2019

    ASSETS

    Current assets:

    Cash and cash equivalents

    $

    34,900

    $

    34,986

    Short-term investments

     

    101,570

     

    50,732

    Accounts receivable

     

    17,624

     

    16,882

    Inventories

     

    18,425

     

    19,490

    Prepaid and other current assets

     

    6,452

     

    6,018

    Total current assets

     

    178,971

     

    128,108

    Non-current assets:

    Property and equipment, net

     

    14,534

     

    14,898

    Goodwill and intangible assets, net

     

    1,347

     

    1,448

    Operating lease right-of-use assets

     

    13,768

     

    14,122

    Restricted cash and other assets

     

    6,874

     

    6,959

    Total assets

    $

    215,494

    $

    165,535

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Current liabilities:

    Accounts payable and accrued liabilities

    $

    35,696

    $

    43,136

    Debt – current

     

    4,950

     

    5,017

    Operating lease liabilities – current

     

    1,793

     

    1,613

    Deferred product revenue – current

     

    706

     

    570

    Total current liabilities

     

    43,145

     

    50,336

    Non-current liabilities:

    Debt – non-current

     

    39,500

     

    39,414

    Operating lease liabilities – non-current

     

    17,611

     

    18,406

    Other non-current liabilities

     

    713

     

    327

    Total liabilities

     

    100,969

     

    108,483

    Stockholders' equity:

     

    114,525

     

    57,052

    Total liabilities and stockholders' equity

    $

    215,494

    $

    165,535

     

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  3. Cerus Corporation (NASDAQ:CERS) today announced it has been awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services (BTS) for INTERCEPT Blood System for platelets. The Hong Kong Red Cross BTS is the only public institution providing blood to all hospitals, public and private, in Hong Kong.

    "Following a thorough selection process, we are pleased to be selected by the Hong Kong Red Cross BTS to supply INTERCEPT Blood System for platelets," said Pascal Maillard, Cerus' vice president of commercial operations for the Asia Pacific region. "INTERCEPT for platelets provides a robust, broad-spectrum inactivation, reducing the risks of transfusion-transmitted infections and thereby enhancing patient care."

    "This is an important…

    Cerus Corporation (NASDAQ:CERS) today announced it has been awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services (BTS) for INTERCEPT Blood System for platelets. The Hong Kong Red Cross BTS is the only public institution providing blood to all hospitals, public and private, in Hong Kong.

    "Following a thorough selection process, we are pleased to be selected by the Hong Kong Red Cross BTS to supply INTERCEPT Blood System for platelets," said Pascal Maillard, Cerus' vice president of commercial operations for the Asia Pacific region. "INTERCEPT for platelets provides a robust, broad-spectrum inactivation, reducing the risks of transfusion-transmitted infections and thereby enhancing patient care."

    "This is an important contract for Cerus," continued Maillard. "The Hong Kong Red Cross BTS is a member of the influential Asia Pacific Blood Network (APBN) and a key opinion leader globally. This tender award presents a unique opportunity to expand the use of INTERCEPT in Asia-Pacific, a region that represents a significant market growth opportunity for Cerus."

    The tender award builds upon the prior experience of the Hong Kong Red Cross BTS with the INTERCEPT Blood System for platelets. The Hong Kong Red Cross BTS, in collaboration with the Queen Mary Hospital, conducted a clinical study successfully transfusing INTERCEPT treated platelet components prepared without leukocyte reduction, without bacterial screening, and without gamma irradiation to allogeneic Hematopoietic Stem Cell Transplant (HSCT) patients (Sim, Tsoi et al. 2019).

    "This innovative study conducted by the Hong Kong Red Cross BTS and Queen Mary Hospital has the potential to change how patients are supported with platelet transfusions," said Dr. Laurence Corash, Cerus' chief scientific officer. "The study indicated that INTERCEPT treatment could potentially replace leukocyte filtration, a common practice to reduce the incidence of febrile transfusion reactions, alloimmunization, and cytomegalovirus (CMV) infection. The INTERCEPT platelet system has already demonstrated widespread replacement of bacterial screening, gamma irradiation, and CMV serology in the EU and U.S."

    The Hong Kong Red Cross BTS recently completed renovations and is a state-of-the-art facility that manufactures approximately 40,000 platelet doses per year, a portion of which will be treated with INTERCEPT.

    Sim, J., W. C. Tsoi, et al. (2019). "Transfusion of pathogen-reduced platelet components without leukoreduction." Transfusion 59(6): 1953-1961.

    ABOUT CERUS

    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 and follow us on LinkedIn.

    INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

    Forward Looking Statements

    Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus' belief that the INTERCEPT Blood System has the potential to change how patients are supported with platelet transfusions and to potentially replace leukocyte filtration, and other statements that are not historical facts. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: 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 risk that applicable regulatory authorities and healthcare practitioners may disagree with Cerus‘ interpretations of the data from its clinical studies; as well as 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, 2020, filed with the SEC on May 5, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus' 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.

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  4. Cerus Corporation (NASDAQ:CERS) announced today that its second quarter 2020 financial results will be released on Tuesday, August 4, 2020, after the close of the stock market. The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company's financial results and provide a general business overview and outlook.

    To listen to the live webcast and view the presentation slides, 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 Cerus' website, or by dialing (855) 859-2056 (U.S.) or (404…

    Cerus Corporation (NASDAQ:CERS) announced today that its second quarter 2020 financial results will be released on Tuesday, August 4, 2020, after the close of the stock market. The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company's financial results and provide a general business overview and outlook.

    To listen to the live webcast and view the presentation slides, 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 Cerus' website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6681405. The replay will be available approximately three hours after the call through August 18, 2020.

    ABOUT CERUS

    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 and follow us on LinkedIn.

    INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

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  5. Cerus Corporation (NASDAQ:CERS) announced today study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion. These data are consistent with prior INTERCEPT studies showing complete inactivation, to below the limit of detection, of other coronaviruses associated with severe pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-13 (2005).

    The in vitro study evaluated inactivation of SARS-CoV-2 in plasma components using both infection and molecular assays, as well as cell culture passaging experiments, allowing the confirmation of complete inactivation over time. Under the Principal Investigators Prof. Esam Ibraheem Azhar (Special Infectious…

    Cerus Corporation (NASDAQ:CERS) announced today study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion. These data are consistent with prior INTERCEPT studies showing complete inactivation, to below the limit of detection, of other coronaviruses associated with severe pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-13 (2005).

    The in vitro study evaluated inactivation of SARS-CoV-2 in plasma components using both infection and molecular assays, as well as cell culture passaging experiments, allowing the confirmation of complete inactivation over time. Under the Principal Investigators Prof. Esam Ibraheem Azhar (Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia) and Prof. Salwa Hindawi (Department of Hematology, Faculty of Medicine), the study was conducted at the Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia, with a local clinical SARS-CoV-2 isolate. This center is known for its expertise in coronavirus research. A manuscript for publication is currently in preparation. The investigators are currently conducting a subsequent study to assess the ability of the INTERCEPT Blood System to inactivate SARS-CoV-2 in platelet components. These studies are funded by the Saudi Arabia Ministry of Health and supported by Cerus.

    "Given the ongoing global COVID-19 pandemic, these study results are significant in showing efficacy against a highly pathogenic coronavirus," said Dr. Richard Benjamin, Cerus' chief medical officer. "While no transfusion transmitted SARS-CoV-2 infections have been reported to date, viral RNA has been observed in the plasma of some patients; and the inactivation data from this study indicate that the INTERCEPT Blood System could reduce the potential risk of SARS-CoV-2 transmission by transfusion of convalescent plasma from recovered COVID-19 patients."

    Separately, Cerus is conducting a set of in vitro studies in the United States to assess the INTERCEPT Blood System's ability to inactivate SARS-CoV-2 in red blood cells, as well as platelets and plasma. These studies are funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of Cerus' recent contract amendment and associated funding increase.

    BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been 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.

    The INTERCEPT Blood Systems for platelets, plasma, and red cells plasma are proactive interventions designed to inactivate a broad spectrum of viruses, bacteria, protozoa, and contaminating donor leukocytes in plasma components to reduce the risk of transfusion transmitted infections especially in pandemics of emerging pathogens before donor testing is available.

    1. Hindawi, S. I., A. M. Hashem, et al. (2018). "Inactivation of Middle East respiratory syndrome-coronavirus in human plasma using amotosalen and ultraviolet A light." Transfusion 58(1): 52-59.
    2. Hashem, A. M., A. M. Hassan, et al. (2019). "Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates." Transfusion Medicine 29 (6): 434-441.
    3. Pinna, D., A. Sampson-Johannes, et al. (2005). "Amotosalen photochemical inactivation of severe acute respiratory syndrome corona virus (SARS-CoV) in human platelet concentrates." Transfusion Medicine 15: 269-276.

    ABOUT SPECIAL INFECTIOUS AGENTS UNIT –BSL3

    The unit was established in late 2003 at King Fahd Medical Research Center, King Abdulaziz University with the aim of performing research projects and diagnostic assays for a wide range of infectious agents (Bacterial, Viral, Fungal, and Parasites). The unit is equipped with state-of-the-art technologies that allow to provide epidemic aid and conducts epidemiologic studies on the detection, prevention, and control of highly hazardous viral diseases. The unit provides primary isolation, identification, and characterization of highly hazardous disease agents that require biosafety level 3 laboratory conditions for their safe handling; develops, evaluates, and improves methods for treatment, prevention, and laboratory diagnosis of hazardous disease agents. The unit also conducts laboratory, clinical, and epidemiological investigations on the pathogenesis, pathophysiology, and prevention of viral infections caused by risk group 3 viruses; develops and evaluates education programs for educating health professionals about infection, prevention and laboratory diagnosis of infectious diseases.

    ABOUT CERUS

    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 and follow us on LinkedIn.

    INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

    Forward Looking Statements

    Except for the historical statements contained herein, this press release contains forward-looking statements concerning the potential reduction in the risk of transmission of SARS-CoV-2 as a result of the transfusion of convalescent plasma for COVID-19 patients, and other statements that are not historical facts. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risk that further studies may indicate that the INTERCEPT Blood System does not successfully inactivate SARS-CoV-2; that applicable regulatory authorities may disagree with Cerus‘ interpretations of the data from the in vitro studies; as well as 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, 2020, filed with the SEC on May 5, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus' 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.

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