PhaseBio Reports First-Quarter 2021 Financial Results and Recent Business Highlights

Rhea-AI Summary

PhaseBio Pharmaceuticals (Nasdaq: PHAS) reported advancements in its clinical and corporate strategies during Q1 2021. The company is progressing with its pivotal Phase 3 clinical trial for bentracimab, with 60 of an estimated 100 patients enrolled, aiming for a Biologics License Application (BLA) submission in mid-2022. Additionally, PhaseBio has signed a commercial scale manufacturing agreement with BioVectra to support bentracimab's production. The successful execution of these plans could pave the way for the first ticagrelor reversal agent.

Positive

• Enrollment of 60 patients in REVERSE-IT trial, nearing 100 patient target.
• Commercial scale manufacturing agreement with BioVectra for bentracimab.
• Targeting BLA submission for bentracimab in mid-2022.

Negative

• Enrollment timelines may be affected by the COVID-19 pandemic.

PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today provided an update on corporate activities and reported first-quarter 2021 financial results.

“Throughout the first quarter of 2021, we made meaningful progress in executing on our strategic business and clinical objectives. Our headway was anchored by continued enrollment of our pivotal Phase 3 clinical trial for our lead product candidate bentracimab, including expansion of the trial into the European Union, and was furthered with the signing of a commercial scale manufacturing agreement with BioVectra to support bentracimab scale up,” said Jonathan P. Mow, Chief Executive Officer, PhaseBio Pharmaceuticals. “I am tremendously pleased with the expansion of our REVERSE-IT clinical trial into Europe, as well as continued patient enrollment at our Canadian sites, which together help bring us closer to potentially commercializing the first ticagrelor reversal agent for patients with critical unmet need. The program is continuing to progress towards a BLA submission as we approach the first 100 patients enrolled, a key milestone that remains on track for mid-2021.”

Bentracimab Highlights and Recent Updates

• Enrollment Progress in Ongoing REVERSE-IT Phase 3 Clinical Trial for Bentracimab: In March 2021, PhaseBio announced that the REVERSE-IT Phase 3 clinical trial for lead product candidate bentracimab had enrolled 60 of the first approximately 100 patients needed to support a Biologics License Application (BLA), nearly all of whom to date have required urgent surgery or an invasive procedure. PhaseBio is attempting to accelerate enrollment of patients with uncontrolled major or life-threatening bleeding, including by working to increase the number of enrolling clinical trial sites in the United States, Canada, and the European Union as it is believed that a broader site footprint will increase the probability of enrolling these patients. All of the first approximately 100 patients enrolled in the REVERSE-IT trial will be measured against the same VerifyNow® PRUTest biomarker that is the primary endpoint for all patients enrolled in the REVERSE-IT trial. PhaseBio continues to expect to complete enrollment of the first 100 patients in mid-2021 and is targeting to submit a BLA for bentracimab in mid-2022, although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor).

• Announced Supply Agreement with BioVectra for Bentracimab to Support Development and Commercialization: In March 2021, PhaseBio announced a commercial scale supply agreement with BioVectra, an innovative global contract development and manufacturing organization (CDMO), for the production of bentracimab. Under the terms of the agreement, BioVectra will provide its integrated CDMO services for the manufacturing of the active pharmaceutical ingredient (API) of bentracimab for use in PhaseBio’s ongoing Phase 2b and Phase 3 clinical trials and for global commercial use if bentracimab receives regulatory approval.

• <

FAQ

What are the latest updates from PhaseBio Pharmaceuticals on bentracimab?

PhaseBio announced that 60 patients have been enrolled in the Phase 3 REVERSE-IT clinical trial for bentracimab, with a target of 100 patients for BLA submission.

When is PhaseBio Pharmaceuticals planning to submit the BLA for bentracimab?

PhaseBio aims to submit the Biologics License Application for bentracimab in mid-2022.

What manufacturing agreement did PhaseBio Pharmaceuticals sign?

PhaseBio signed a commercial scale manufacturing agreement with BioVectra for the production of bentracimab's active pharmaceutical ingredient.

How many patients does PhaseBio Pharmaceuticals need for the bentracimab trial?

PhaseBio aims to enroll approximately 100 patients in the REVERSE-IT trial for bentracimab.

What impact does the COVID-19 pandemic have on PhaseBio Pharmaceuticals' timelines?

The enrollment timelines for the bentracimab trial may be impacted by the continued scope and duration of the COVID-19 pandemic.