US Market News
3月前
Cerus Appoints Vivek Jayaraman as President and Chief Executive OfficerMarch 16, 2026 4:05 PM
Business Wire
William “Obi” Greenman to become Executive Chairman
Leadership changes to take effect July 1, 2026
Cerus Corporation (Nasdaq: CERS) today announced that Vivek Jayaraman, Cerus’ chief operating officer, will be promoted to president and chief executive officer, effective July 1, 2026. William “Obi” Greenman will become executive chairman of the board of directors. At the time of his appointment, Mr. Jayaraman will join the Board of Directors.
“Following a thorough succession planning process, this transition represents a natural step as we prepare for the next phase of growth at Cerus,” said Frank Witney, lead independent director on the Cerus Board of Directors. “The Board and I are deeply grateful to Obi for his tremendous contributions as CEO. Looking ahead, we are very confident that Vivek is the ideal leader for Cerus as the company enters its next chapter.”
Mr. Jayaraman joined Cerus in 2016, as Chief Commercial Officer and has served as Chief Operating Officer since 2020. During his tenure at Cerus, Mr. Jayaraman led the company’s growth from less than $40 million in annual product revenue to more than $200 million in 2025.
“I’m honored to lead Cerus, in partnership with our exceptional employees, during this exciting next chapter,” said Vivek Jayaraman. “We will broaden patient access to the INTERCEPT Blood System globally, expand our leadership in transfusion medicine, and improve patient outcomes. I am very grateful to Obi and the Cerus Board of Directors for entrusting me with this extraordinary opportunity to serve.”
Mr. Greenman joined Cerus in 1995 and has served as CEO for over 15 years. Under his leadership, Cerus transformed from a pre-clinical development company into a global commercial enterprise with product sales in over 40 countries.
“I am proud of the progress Cerus has made in advancing blood safety and availability,” said Obi Greenman. “Having worked with Vivek for nearly a decade, I am confident that he is the right person to lead Cerus towards the goal of making INTERCEPT the global standard of care.”
Added Greenman, “My goal has always been to establish Cerus as an enduring company. With four FDA product approvals in the past decade, a robust innovation pipeline, and a solid financial foundation, the company is well positioned to continue to lead the field of pathogen inactivation. As Executive Chair, I look forward to supporting Vivek as Cerus continues to deliver on its mission.”
About Vivek Jayaraman
Mr. Jayaraman was appointed as Cerus’ chief operating officer in March 2020. In this role, Mr. Jayaraman oversees commercial operations, supply chain, and customer service. Previously, Mr. Jayaraman served as chief commercial officer since August 2016. Prior to Cerus, Mr. Jayaraman led TriVascular’s commercial expansion as the company grew from a preclinical, venture-backed startup into a publicly traded, global medical device company. Prior to TriVascular, Mr. Jayaraman served in numerous executive roles at Medtronic in both the U.S. and Asia. Mr. Jayaraman received his M.B.A. from the Wharton School at the University of Pennsylvania and holds dual bachelor’s degrees from the University of Michigan.
About William “Obi” Greenman
Mr. Greenman was named president and chief executive officer in April 2011. He had served as Cerus’ chief business officer since April 2010. Previously, he was senior vice president, business development and marketing. From 2006 to 2008, he held the position of president, Cerus Europe, and prior to that, he served as vice president, business development. Prior to joining Cerus in 1995 as director of business development, he worked in various marketing and business development positions in Baxter’s Biotech Division from 1991 to 1995. Mr. Greenman previously served as a member of the Board of Directors of both Aduro Biotech and Chinook Therapeutics, as Audit and Compensation Committee Chairs, respectively, for a combined period of more than a decade. He received his B.A.S. in Economics and Biological Sciences from Stanford University.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
Cerus, INTERCEPT and the Cerus logo 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: the anticipated leadership transition effective July 1, 2026; Cerus’ expectations regarding its next phase of growth; Vivek Jayaraman’s expected leadership of the Company; William “Obi” Greenman’s expected service as Executive Chairman of the Board; Cerus’ expectations regarding the future growth, market position and adoption of its products, including INTERCEPT; and other statements that are not historical fact. Actual results may differ materially from these forward-looking statements as a result of a number of factors, including risks related to Cerus’ ability to execute successfully during the leadership transition; risks related to market acceptance and commercialization of Cerus’ products; risks related to Cerus’ ability to maintain and expand its commercial operations globally; risks related to product development and regulatory processes; risks related to Cerus’ ability to maintain an effective manufacturing and supply chain; risks associated with macroeconomic and market conditions; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260316126576/en/
Tim Lee – Head of Investor Relations
Cerus Corporation
ir@cerus.com
925-288-6128
Original: Cerus Appoints Vivek Jayaraman as President and Chief Executive Officer
US Market News
3月前
Cerus Corporation Announces Full-Year and Fourth Quarter 2025 Financial ResultsMarch 2, 2026 4:01 PM
Business Wire
2025 Total Revenue of $233.8 million, up 16% from 2024; 2025 Product Revenue of $206.1 million, up 14% from 2024
Strengthened Financial Foundation Through Strong Commercial Execution and Disciplined Operational Management
Cerus Corporation (Nasdaq: CERS) announced today financial results for its full year and fourth quarter ended December 31, 2025.
“Our strong 2025 results reflect our disciplined execution, as we continued to deliver on our mission of safeguarding the world’s blood supply. This past year, we achieved our highest annual kit shipments, enabling an estimated 600,000 patients worldwide to receive INTERCEPT-treated blood components,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “This translated into record product revenue of over $206 million, a narrowing of our GAAP net loss, and positive non-GAAP adjusted EBITDA for the second consecutive year. Looking ahead to 2026, we remain focused on improving global access to our INTERCEPT technologies, advancing our product development programs and building upon the solid financial foundation we have established.”
Additional highlights include:
Full-year 2025 and fourth-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended
Twelve Months Ended
December 31,
Change
December 31,
Change
2025
2024
$
%
2025
2024
$
%
Product Revenue
$
57.8
$
50.8
$
7.0
14%
$
206.1
$
180.3
$
25.8
14%
Government Contract Revenue
6.8
5.9
0.9
15%
27.7
21.1
6.6
31%
Total Revenue
$
64.6
$
56.8
$
7.8
14%
$
233.8
$
201.3
$
32.5
16%
Numbers may not sum due to rounding. Percentages calculated from unrounded figures.
INTERCEPT Fibrinogen Complex (IFC) demand increased during the fourth quarter, with fourth quarter volumes - including kits and finished therapeutic doses (measured in FC15* equivalent units) - up over 50% compared to the prior year period. Fourth quarter U.S. IFC sales totaled $4.2 million, up from $3.0 million in the prior year period. For full year 2025, IFC demand more than doubled compared to 2024, while revenue increased approximately 80% to $16.7 million.
Entered into a group purchasing agreement with Blood Centers of America (BCA) during the fourth quarter, covering the Company’s licensed product portfolio. BCA is the largest blood supply cooperative in the U.S., with its member centers collecting and distributing approximately 50% of the nation’s blood supply.
Recently announced the start of the INITIATE study by the German Red Cross Blood Donation Service Baden-Württemberg – Hessen. INITIATE is a Phase 4 study evaluating the routine clinical use in Germany of pathogen-inactivated platelets utilizing the INTERCEPT Blood System.
Not including government grant revenue, the Company expects full-year 2026 product revenue to grow 9% to 11% year over year.
Cash, cash equivalents, and short-term investments were $82.9 million at December 31, 2025.
Revenue
Product revenue for the fourth quarter of 2025 was $57.8 million, compared to $50.8 million for the prior year period, representing year-over-year growth of 14%. Fourth quarter growth was primarily driven by strength in EMEA across the platelets franchise and continued rollout of INT200, as well as increased U.S. IFC sales. Product revenue for the full year 2025 was $206.1 million, compared to $180.3 million for the prior year, representing 14% growth. Full-year growth was driven by continued expansion of the Company’s global platelet products, increased U.S. IFC sales, and the launch of INT200 in EMEA.
Government contract revenue for the fourth quarter of 2025 was $6.8 million, compared to $5.9 million during the prior year period. Full year 2025 government contract revenue was $27.7 million, compared to $21.1 million during the prior year period. The increase in fourth quarter and full year government contract revenue was largely driven by BARDA-related projects.
Product Gross Profit and Margin
Product gross profit for the fourth quarter of 2025 was $29.7 million, increasing by 9% over the prior year period. Product gross margin for the fourth quarter of 2025 was 51.5% compared to 53.9% in the same period last year. Full-year 2025 product gross profit was $112.3 million, representing 13% growth compared to 2024. Full-year product gross margin was 54.5%, compared to 55.2% in the prior year. Higher IFC therapeutic production costs, ongoing trade regulation and inflationary pressures, as well as foreign exchange rates contributed to the change in product gross margin percentage compared to the prior year for both periods.
Operating Expenses
Total operating expenses for the fourth quarter of 2025 were $37.2 million, compared to $34.8 million in the same period of the prior year, representing a 7% year-over-year increase. For the full year 2025, total operating expenses were $148.6 million, compared to $134.8 million in 2024.
Research and development (R&D) expenses for the fourth quarter of 2025 were $16.4 million, compared to $15.4 million in the prior year period. For the full year 2025, R&D expenses totaled $67.7 million, compared to $58.9 million in 2024. Higher government contract costs and workforce-related costs contributed to the increase in R&D expenses for the fourth quarter. For the full year, the increase was driven by the same factors as well as increased development costs associated with the Company’s red blood cell and INT200 programs.
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2025 were $20.8 million, compared to $19.3 million in the prior year period. For the full year 2025, SG&A expenses totaled $80.9 million, compared to $75.9 million for the full year 2024.
Net Loss Attributable to Cerus Corporation
Net loss attributable to Cerus Corporation narrowed for the fourth quarter of 2025 and was $2.2 million, or $0.01 per basic and diluted share, compared to $2.5 million, or $0.01 per basic and diluted share, for the fourth quarter of 2024.
For the full year 2025, net loss attributable to Cerus Corporation was $15.6 million, or $0.08 per basic and diluted share, compared to $20.9 million, or $0.11 per basic and diluted share, in 2024.
Non-GAAP Adjusted EBITDA
Non-GAAP adjusted EBITDA for the fourth quarter of 2025 was $3.4 million, compared to $3.3 million for the fourth quarter of 2024. Full-year 2025 non-GAAP adjusted EBITDA was $9.5 million, compared to $5.7 million in 2024. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.
Balance Sheet and Cash Flows
At December 31, 2025, the Company had $82.9 million in cash, cash equivalents and short-term investments, compared to $80.5 million at December 31, 2024.
As of December 31, 2025, the Company had $65.0 million outstanding on its term loan and $19.0 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $16.0 million as of December 31, 2025, which is dependent on eligible assets supporting the borrowing base.
For the fourth quarter of 2025, the Company generated $6.2 million in operating cash flow, compared to $4.9 million in the prior year period. The Company generated $8.1 million of operating cash flow in the second half of 2025 offsetting operating cash used during the first half of 2025. As a result, for the full year 2025, the Company generated $4.8 million in operating cash flow, compared to $11.4 million generated during 2024. These results were consistent with the Company’s previously communicated expectations which anticipated first-half cash use related to inventory investment, followed by stronger operating cash flow in the second half of 2025.
Reaffirming 2026 Product Revenue Guidance
The Company expects full-year 2026 product revenue to be in the range of $224 million to $228 million, representing year-over-year growth of 9% to 11% compared to 2025 product revenue. Included in the 2026 guidance range is expected full-year 2026 IFC revenue of $20 million to $22 million, representing year-over-year growth of approximately 20% to 30% from 2025.
Quarterly Conference Call
The Company will host a conference call at 4:30 P.M. ET 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, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
A replay will be available on Cerus’ website approximately three hours after the call through March 23, 2026.
*FC15 equivalent to a therapeutic dose of a cryoAHF pool.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
Cerus, INTERCEPT and the Cerus logo 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’ expectation that full-year 2026 product revenue will be in the range of $224 million to $228 million, including IFC revenue of between $20 million and $22 million; Cerus’ expectation that full-year 2026 product revenue will grow 9% to 11% year over year; Cerus continuing to have access to $16.0 million under its revolving line of credit; Cerus’ ability to continue to improve global access to its INTERCEPT technologies; Cerus’ ability to advance our product development programs; the continued commercialization and launch of INT200 and IFC; and other statements that are not historical fact. 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 and IFC; the risk that Cerus may not meet its 2026 annual product revenue guidance; the risk that Cerus may not effectively continue to launch and commercialize the INTERCEPT Blood System for Cryoprecipitation or INT200; the risk that Cerus may not grow sales globally, including in its U.S. and European markets, and/or realize expected revenue contributions resulting from its U.S. and European market agreements; risks related to the uncertain and time-consuming development and regulatory process, including the risk that Cerus may be unable to obtain requisite regulatory approvals to advance its pipeline programs and bring them to market in a timely manner or at all; risks associated with macroeconomic developments, including ongoing military conflict in Ukraine, new or increased tariffs and escalating trade tensions, inflation, rising interest rates and foreign exchange volatility and the resulting global economic and financial disruptions; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other healthcare constituencies that pathogen reduction and the INTERCEPT Blood System are safe, effective and economical; risks related to product safety; risks associated with Cerus’ ability to maintain an effective, secure manufacturing supply chain, including risks that (a) Cerus’ supply chain could be negatively impacted as a result of macroeconomic developments, (b) Cerus’ manufacturers could be unable to comply with extensive regulatory agency requirements, and (c) Cerus may be unable to maintain its supply agreements with its third-party suppliers; risks associated with Cerus’ ability to access additional funds under its credit facility and to meet its debt service obligations, and its need for additional funding; risks associated with 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; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net loss attributable to Cerus Corporation as reported on the consolidated statement of operations, as adjusted to exclude, as applicable for the reporting period(s) presented, (i) net loss attributable to noncontrolling interest, (ii) provision for income taxes, (iii) foreign exchange (loss)/gain, (iv) interest income (expense), (v) other income (expense), net, (vi) depreciation and amortization, (vii) share-based compensation, (viii) goodwill and asset impairments, (ix) costs associated with our noncontrolling interest in our joint venture in China and, (x) revenue and direct costs associated with our government contracts. We are presenting this non-GAAP financial measure to assist investors in assessing our operating results. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Cerus’ GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Cerus’ operating results as reported under GAAP. This non-GAAP financial measure should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. This non-GAAP financial measure is not necessarily comparable to similarly-titled measures presented by other companies.
Supplemental Tables
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2025 vs. 2024
2025 vs. 2024
Platelet Kit Growth
North America
-3%
4%
International
6%
4%
Worldwide
0%
4%
Change in Calculated Number of Treatable Platelet Doses
North America
-3%
4%
International
4%
2%
Worldwide
-1%
3%
Dose treatable calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits)
CERUS CORPORATION
REVENUE BY REGION
(in thousands, except percentages)
Three Months Ended
Twelve Months Ended
December 31,
Change
December 31,
Change
2025
2024
$
%
2025
2024
$
%
North America
$
34,960
$
33,270
$
1,690
5%
$
135,875
$
119,978
$
15,897
13%
Europe, Middle East and Africa
21,801
16,080
5,721
36%
67,370
56,327
11,043
20%
Other
990
1,459
(469
)
-32%
2,888
3,965
(1,077
)
-27%
Total product revenue
$
57,751
$
50,809
$
6,942
14%
$
206,133
$
180,270
$
25,863
14%
CERUS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Unaudited Three Months Ended
Twelve Months Ended
December 31,
December 31,
2025
2024
Unaudited
2025
Audited
2024
Product revenue
$
57,751
$
50,809
$
206,133
$
180,270
Cost of product revenue
28,002
23,424
93,845
80,748
Gross profit on product revenue
29,749
27,385
112,288
99,522
Government contract revenue
6,828
5,942
27,665
21,051
Operating expenses:
Research and development
16,390
15,443
67,720
58,907
Selling, general and administrative
20,828
19,333
80,914
75,891
Total operating expenses
37,218
34,776
148,634
134,798
Loss from operations
(641
)
(1,449
)
(8,681
)
(14,225
)
Total non-operating expense, net
(1,424
)
(1,002
)
(6,602
)
(6,531
)
Loss before income taxes
(2,065
)
(2,451
)
(15,283
)
(20,756
)
Provision for income taxes
119
111
354
205
Net loss
(2,184
)
(2,562
)
(15,637
)
(20,961
)
Net loss attributable to noncontrolling interest
-
(41
)
(10
)
(43
)
Net loss attributable to Cerus Corporation
$
(2,184
)
$
(2,521
)
$
(15,627
)
$
(20,918
)
Net loss per share attributable to Cerus Corporation:
Basic and diluted
$
(0.01
)
$
(0.01
)
$
(0.08
)
$
(0.11
)
Weighted average shares outstanding:
Basic and diluted
192,109
185,734
190,594
184,563
CERUS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31,
December 31,
2025
2024
(unaudited)
(audited)
ASSETS
Current assets:
Cash and cash equivalents
$
19,961
$
20,266
Short-term investments
62,918
60,186
Accounts receivable, net
30,374
29,777
Current inventories
56,101
38,150
Prepaid and other current assets
5,030
3,643
Total current assets
174,384
152,022
Non-current assets:
Property and equipment, net
9,204
7,154
Operating lease right-of-use assets
10,124
8,384
Goodwill
1,316
1,316
Non-current inventories
15,143
14,145
Other assets and restricted cash
11,688
17,896
Total assets
$
221,859
$
200,917
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
53,279
$
40,638
Debt – current
43,343
19,297
Operating lease liabilities – current
2,905
2,275
Deferred revenue – current
1,274
1,398
Total current liabilities
100,801
63,608
Non-current liabilities:
Debt – non-current
40,545
64,862
Operating lease liabilities – non-current
10,153
11,663
Other non-current liabilities
5,395
3,888
Total liabilities
156,894
144,021
Stockholders' equity:
64,224
56,145
Noncontrolling interest
741
751
Total liabilities and stockholders' equity
$
221,859
$
200,917
CERUS CORPORATION
UNAUDITED RECONCILIATION OF NON-GAAP ADJUSTED EBITDA
(in thousands)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2025
2024
2025
2024
Net loss attributable to Cerus Corporation
$
(2,184
)
$
(2,521
)
$
(15,627
)
$
(20,918
)
Adjustments to net loss attributable to Cerus Corporation:
Net loss attributable to noncontrolling interest
-
(41
)
(10
)
(43
)
Provision for income taxes
119
111
354
205
Total non-operating expense, net (i)
1,424
1,002
6,602
6,531
Loss from operations
(641
)
(1,449
)
(8,681
)
(14,225
)
Adjustments to loss from operations:
Operating depreciation and amortization
1,108
1,104
4,240
4,568
Government contract revenue (ii)
(6,828
)
(5,942
)
(27,665
)
(21,051
)
Direct expenses attributable to government contracts (iii)
4,797
3,975
18,705
13,488
Share-based compensation (iv)
4,927
5,504
22,867
22,867
Costs attributable to noncontrolling interest (v)
-
82
21
85
Non-GAAP adjusted EBITDA
$
3,363
$
3,274
$
9,487
$
5,732
i.
Includes interest income/expense and foreign exchange gains/losses.
ii.
Represents revenue related to the cost reimbursement provisions under our government contracts.
iii.
Represents the direct expenses attributable to work supporting government contracts, which are reimbursed and reflected under government contract revenue in the condensed consolidated statement of operations.
iv.
Represents non-cash stock-based compensation.
v.
Represents costs associated with the noncontrolling interest in Cerus Zhongbaokang (Shandong) Biomedical Co., LTD.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260302840774/en/
Tim Lee – Head of Investor Relations
Cerus Corporation
ir@cerus.com
925-288-6128
Original: Cerus Corporation Announces Full-Year and Fourth Quarter 2025 Financial Results
mick
2年前
selling for about 2-1/2 times book value.
Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - Cerus Corporation (Nasdaq:CERS) today announced updates on the INTERCEPT red blood cell (RBC) programs in the U.S. and in Europe:
•
U.S. – New $248 million BARDA contract supports program beyond U.S. Phase 3 studies through anticipated PMA licensure and into commercialization
•
Europe – CE Mark review has concluded without approval; assessing strategy for anticipated future filing
“We are pleased with the progress we have made with our U.S. RBC program, which will now receive additional support from BARDA through a new contract valued at up to $248 million, intended to fund activities including continued improvement in the design of the product candidate and a future scale-up of commercial manufacturing activities,” commented Obi Greenman, Cerus’ president and chief executive officer. “In Europe, our CE Mark review under the Medical Device Regulation (MDR) has concluded without an approval. We believe that we can address the issues which prevented our approval in the context of an anticipated new regulatory submission.”
US – BARDA award and program update
In the U.S., Cerus has entered into a new six-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to further advance the development of the INTERCEPT RBC system. Valued at up to $248 million, this additional funding is intended to support a planned U.S. Food and Drug Administration (FDA) modular premarket approval (PMA) application and potential post-approval studies, accelerate development of an improved version of the INTERCEPT RBC system, and scale up the chemistry, manufacturing and controls (CMC) activities to enable a broad product launch, if approved. BARDA has awarded $32.1 million for the initial base period, with additional funding contingent on meeting specific contractual milestones.
In March 2024, Cerus announced positive topline results for the BARDA-funded ReCePI study, a pivotal U.S. Phase 3 clinical trial demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs when transfused to complex cardiac surgery patients. The Company is currently enrolling patients in its ongoing, BARDA-funded RedeS clinical trial, the second pivotal U.S. Phase 3
clinical trial in patient populations requiring RBC transfusion for acute and chronic anemia. Results from both trials are expected to be part of a planned modular PMA submission to the FDA, with the planned final PMA module expected to be submitted upon the anticipated completion of the RedeS trial.
“ReCePI investigators will be presenting a number of abstracts with study data at the Annual AABB meeting next week in Houston, including a plenary presentation,” said Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer. “We have recently begun enrolling at two additional RedeS study sites, including the Turkey site, but we are still assessing the potential impact to the anticipated timing of study completion and modular PMA submission, since these new sites began enrollment later than previously anticipated.”
The new BARDA contract will be funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Europe – CE Mark review update
For Cerus’ MDR application in Europe, Cerus’ Notified Body, TÜV-SÜD, reviewed the modules for clinical, non-clinical, manufacturing and quality and found them to be satisfactory. However, the Competent Authority, CBG-MEB, reviewed the active pharmaceutical ingredient module and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating TÜV-SÜD’s closure of Cerus’ MDR application without an approval. The Company, in collaboration with TÜV-SÜD, is assessing strategies for a potential enhanced new regulatory submission and the associated timeline.
“We continue to believe strongly in the need for pathogen inactivated RBCs and the regulatory dossier we filed in Europe. In addition to how we address the new questions CBG has raised, we want to take this opportunity to be thoughtful about leveraging the additional data that we have accumulated since our original CE Mark submission,” said Carol Moore, Cerus’ senior vice president. “For example, we believe the positive results from our U.S. Phase 3 ReCePI trial substantially expand the data available to evaluate the clinical safety and efficacy of INTERCEPT RBCs. We will be assessing how these data could allow us to propose a broader clinical indication in a potential new CE Mark submission in consultation with TÜV.”
Webcast
The Company will host a webcast later today at 5:00 P.M. EDT, during which management will provide an update on the INTERCEPT red blood cell program. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
2
A replay will be available on Cerus’ website approximately three hours after the call through October 30, 2024.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage 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.
mick
2年前
#2 \\// $CERS --- Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - Cerus Corporation (Nasdaq:CERS) today announced updates on the INTERCEPT red blood cell (RBC) programs in the U.S. and in Europe:
•
U.S. – New $248 million BARDA contract supports program beyond U.S. Phase 3 studies through anticipated PMA licensure and into commercialization
•
Europe – CE Mark review has concluded without approval; assessing strategy for anticipated future filing
“We are pleased with the progress we have made with our U.S. RBC program, which will now receive additional support from BARDA through a new contract valued at up to $248 million, intended to fund activities including continued improvement in the design of the product candidate and a future scale-up of commercial manufacturing activities,” commented Obi Greenman, Cerus’ president and chief executive officer. “In Europe, our CE Mark review under the Medical Device Regulation (MDR) has concluded without an approval. We believe that we can address the issues which prevented our approval in the context of an anticipated new regulatory submission.”
US – BARDA award and program update
In the U.S., Cerus has entered into a new six-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to further advance the development of the INTERCEPT RBC system. Valued at up to $248 million, this additional funding is intended to support a planned U.S. Food and Drug Administration (FDA) modular premarket approval (PMA) application and potential post-approval studies, accelerate development of an improved version of the INTERCEPT RBC system, and scale up the chemistry, manufacturing and controls (CMC) activities to enable a broad product launch, if approved. BARDA has awarded $32.1 million for the initial base period, with additional funding contingent on meeting specific contractual milestones.
In March 2024, Cerus announced positive topline results for the BARDA-funded ReCePI study, a pivotal U.S. Phase 3 clinical trial demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs when transfused to complex cardiac surgery patients. The Company is currently enrolling patients in its ongoing, BARDA-funded RedeS clinical trial, the second pivotal U.S. Phase 3
clinical trial in patient populations requiring RBC transfusion for acute and chronic anemia. Results from both trials are expected to be part of a planned modular PMA submission to the FDA, with the planned final PMA module expected to be submitted upon the anticipated completion of the RedeS trial.
“ReCePI investigators will be presenting a number of abstracts with study data at the Annual AABB meeting next week in Houston, including a plenary presentation,” said Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer. “We have recently begun enrolling at two additional RedeS study sites, including the Turkey site, but we are still assessing the potential impact to the anticipated timing of study completion and modular PMA submission, since these new sites began enrollment later than previously anticipated.”
The new BARDA contract will be funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Europe – CE Mark review update
For Cerus’ MDR application in Europe, Cerus’ Notified Body, TÜV-SÜD, reviewed the modules for clinical, non-clinical, manufacturing and quality and found them to be satisfactory. However, the Competent Authority, CBG-MEB, reviewed the active pharmaceutical ingredient module and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating TÜV-SÜD’s closure of Cerus’ MDR application without an approval. The Company, in collaboration with TÜV-SÜD, is assessing strategies for a potential enhanced new regulatory submission and the associated timeline.
“We continue to believe strongly in the need for pathogen inactivated RBCs and the regulatory dossier we filed in Europe. In addition to how we address the new questions CBG has raised, we want to take this opportunity to be thoughtful about leveraging the additional data that we have accumulated since our original CE Mark submission,” said Carol Moore, Cerus’ senior vice president. “For example, we believe the positive results from our U.S. Phase 3 ReCePI trial substantially expand the data available to evaluate the clinical safety and efficacy of INTERCEPT RBCs. We will be assessing how these data could allow us to propose a broader clinical indication in a potential new CE Mark submission in consultation with TÜV.”
Webcast
The Company will host a webcast later today at 5:00 P.M. EDT, during which management will provide an update on the INTERCEPT red blood cell program. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
2
A replay will be available on Cerus’ website approximately three hours after the call through October 30, 2024.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage 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.
mick
2年前
Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - Cerus Corporation (Nasdaq:CERS) today announced updates on the INTERCEPT red blood cell (RBC) programs in the U.S. and in Europe:
•
U.S. – New $248 million BARDA contract supports program beyond U.S. Phase 3 studies through anticipated PMA licensure and into commercialization
•
Europe – CE Mark review has concluded without approval; assessing strategy for anticipated future filing
“We are pleased with the progress we have made with our U.S. RBC program, which will now receive additional support from BARDA through a new contract valued at up to $248 million, intended to fund activities including continued improvement in the design of the product candidate and a future scale-up of commercial manufacturing activities,” commented Obi Greenman, Cerus’ president and chief executive officer. “In Europe, our CE Mark review under the Medical Device Regulation (MDR) has concluded without an approval. We believe that we can address the issues which prevented our approval in the context of an anticipated new regulatory submission.”
US – BARDA award and program update
In the U.S., Cerus has entered into a new six-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to further advance the development of the INTERCEPT RBC system. Valued at up to $248 million, this additional funding is intended to support a planned U.S. Food and Drug Administration (FDA) modular premarket approval (PMA) application and potential post-approval studies, accelerate development of an improved version of the INTERCEPT RBC system, and scale up the chemistry, manufacturing and controls (CMC) activities to enable a broad product launch, if approved. BARDA has awarded $32.1 million for the initial base period, with additional funding contingent on meeting specific contractual milestones.
In March 2024, Cerus announced positive topline results for the BARDA-funded ReCePI study, a pivotal U.S. Phase 3 clinical trial demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs when transfused to complex cardiac surgery patients. The Company is currently enrolling patients in its ongoing, BARDA-funded RedeS clinical trial, the second pivotal U.S. Phase 3
clinical trial in patient populations requiring RBC transfusion for acute and chronic anemia. Results from both trials are expected to be part of a planned modular PMA submission to the FDA, with the planned final PMA module expected to be submitted upon the anticipated completion of the RedeS trial.
“ReCePI investigators will be presenting a number of abstracts with study data at the Annual AABB meeting next week in Houston, including a plenary presentation,” said Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer. “We have recently begun enrolling at two additional RedeS study sites, including the Turkey site, but we are still assessing the potential impact to the anticipated timing of study completion and modular PMA submission, since these new sites began enrollment later than previously anticipated.”
The new BARDA contract will be funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Europe – CE Mark review update
For Cerus’ MDR application in Europe, Cerus’ Notified Body, TÜV-SÜD, reviewed the modules for clinical, non-clinical, manufacturing and quality and found them to be satisfactory. However, the Competent Authority, CBG-MEB, reviewed the active pharmaceutical ingredient module and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating TÜV-SÜD’s closure of Cerus’ MDR application without an approval. The Company, in collaboration with TÜV-SÜD, is assessing strategies for a potential enhanced new regulatory submission and the associated timeline.
“We continue to believe strongly in the need for pathogen inactivated RBCs and the regulatory dossier we filed in Europe. In addition to how we address the new questions CBG has raised, we want to take this opportunity to be thoughtful about leveraging the additional data that we have accumulated since our original CE Mark submission,” said Carol Moore, Cerus’ senior vice president. “For example, we believe the positive results from our U.S. Phase 3 ReCePI trial substantially expand the data available to evaluate the clinical safety and efficacy of INTERCEPT RBCs. We will be assessing how these data could allow us to propose a broader clinical indication in a potential new CE Mark submission in consultation with TÜV.”
Webcast
The Company will host a webcast later today at 5:00 P.M. EDT, during which management will provide an update on the INTERCEPT red blood cell program. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
2
A replay will be available on Cerus’ website approximately three hours after the call through October 30, 2024.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage 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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