CERS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-07-30

• In November 2020, we received FDA approval for the INTERCEPT Blood System for Cryoprecipitation. We sell kits to produce IFC to blood centers and in certain instances, procure finished IFC and sell to other blood centers for their hospital accounts. Similar to our

• blood centers may be forced to use alternate options allowed by the guidance document, which could permanently impact our ability to convert those blood centers to INTERCEPT users.

• The 2016 BARDA Agreement provides for the reimbursement of certain amounts incurred by us in connection with our satisfaction of certain contractual milestones. Under this agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs…

• In September 2024, we entered into the 2024 BARDA Agreement. The 2024 BARDA Agreement builds on the 2016 BARDA Agreement and aims to further advance the development of the red blood cell system. The 2024 BARDA Agreement includes access to funding that is intended to support a planned FDA modular pre…

• Government contract revenue decreased during the three and six months ended June 30, 2026, compared to the three and six months ended June 30, 2025, primarily due to the completion of our FDA agreement in September 2025, decreased activities under the 2024 BARDA Agreement relative to the same period…

Text removed vs the prior filing · source: 10-Q · 2026-04-30

• In November 2020, we received FDA approval for the INTERCEPT Blood System for Cryoprecipitation. We commercialize and sell finished IFC made by our manufacturing blood center partners and other blood centers directly to hospitals and indirectly through certain blood centers. Similar to our platelet …

• Final Guidance Document. Although the INTERCEPT Blood System is one of the options available to U.S. blood centers for compliance, we cannot predict if U.S. customers will continue to adopt INTERCEPT over other options or at what levels. Should we be unable to manufacture INTERCEPT in sufficient qua…

• submission to the FDA for the red blood cell system, and accelerating commercial scale up activities to facilitate potential adoption of the red blood cell system by U.S. blood centers.

• The 2016 BARDA Agreement provides for the reimbursement of certain amounts incurred by us in connection with our satisfaction of certain contractual milestones. Under this agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs…

• Government contract revenue increased during the three months ended March 31, 2026, compared to the three months ended March 31, 2025, primarily due to increased activities under the 2024 BARDA Agreement executed in the fourth quarter of 2024 and with the DoD relative to the same period in the prior…

Text added vs the prior filing · source: 10-Q · 2026-07-30

• We commercialize and sell disposable kits directly to blood centers for the manufacture of IFC for their own account or for hospitals with whom they already have contracts in place. In limited instances, we also sell the finished IFC made by other blood centers to certain blood centers. The American…

• In addition, while we believe that IFC has many advantages over competitors, traditional cryoprecipitate and fibrinogen concentrates are well established within hospital use. Even if we are able to generate compelling data regarding the use of IFC over other products or traditional cryoprecipitate, …

• cryoprecipitate poor plasma, we will continue to incur costs to discard the byproduct or be required to offset the economic impact to blood centers, which will continue to negatively impact our operating results.

• In some instances, we are relying on contract research organizations and other third parties to assist us in designing, managing, monitoring and otherwise carrying out our clinical trials and development activities for the red blood cell system. We do not control these third parties and, as a result…

• our red blood cell product’s reputation and may force us to suspend or terminate development activities related to the red blood cell system in the U.S.

Text removed vs the prior filing · source: 10-Q · 2026-04-30

• We have very limited experience selling directly to hospitals nor do we have prior experience or expertise complying with regulations governing finished biologics. Contracting with individual hospitals is time consuming and is often a protracted and bespoke process. Our blood center customers may vi…

• In addition, while we believe that IFC has many advantages over competitors, traditional cryoprecipitate and fibrinogen concentrates are well established within hospital use. Even if we are able to generate compelling data regarding the use of IFC over other products or traditional cryoprecipitate, …

• the competitors. Further, competitors may have more experience marketing and selling products directly to hospitals and may try to impede the marketability of our products. If additional BLAs are delayed or are never issued to blood centers producing IFC, there may not be production capacity to supp…

• In some instances, we are relying on contract research organizations and other third parties to assist us in designing, managing, monitoring and otherwise carrying out our clinical trials and development activities for the red blood cell system. We do not control these third parties and, as a result…

• Our products, both those sold commercially and those under development are subject to extensive and rigorous regulation by local, state and federal regulatory authorities in the U.S. and by foreign regulatory bodies and Notified Bodies. Our products must satisfy rigorous standards of safety and effi…