MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, has 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.
- Expanded REVERSE-IT Trial for Bentracimab into the European Union and Dosed First Patients: In January 2021, PhaseBio announced that, working with its financing and co-development partner SFJ Pharmaceuticals, the company had expanded the REVERSE-IT trial into the European Union, having opened trial sites for enrollment and begun dosing its first patients.
Pemziviptadil Highlights and Recent Updates
- Pemziviptadil Phase 2b results expected in first half 2022: PhaseBio announced recently that the ongoing VIP (Vasoactive Intestinal Peptide in adult patients with pulmonary arterial hypertension) Phase 2b trial of pemziviptadil in pulmonary arterial hypertension (PAH) is expected to read out in the first half of 2022, instead of the second half of 2021, due to supply chain delays and impacts of the COVID-19 pandemic, both of which affected projected patient enrollment. As of October 2020, approximately one third of the patients targeted for enrollment had completed the initial 16 week protocol, with approximately 90% of these patients electing to enroll in VIP EXTEND (Vasoactive Intestinal Peptide extension trial in adult patients with pulmonary arterial hypertension), the open label extension of the Phase 2b trial.
- Presented Data from Phase 1b/2a Trial of Pemziviptadil for the Treatment of PAH at the Pulmonary Vascular Research Institute (PVRI) Virtual World Congress: In January 2021, PhaseBio announced presentation of data from a Phase 1b/2a pilot study highlighting three patients who received pemziviptadil (PB1046), the company’s potentially first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue for the treatment of PAH. The data, which were presented virtually at the 15th PVRI World Congress on January 27, 2021, continue to highlight the favorable safety and tolerability profile of pemziviptadil, as well as clinically-meaningful, long-term improvement of six-minute walk test (6MWT) distance for one patient after 18 months of treatment. Additionally, the data demonstrated stability in functional status with no clinically-meaningful deterioration for two patients at two and six months after treatment. All three patients completed the study with no drug-related serious adverse events associated with study drug discontinuation and pemziviptadil appeared to be well tolerated.
- Completed Underwritten Public Offering of Common Stock: In March 2021, PhaseBio closed an underwritten public offering of 18.4 million shares of its common stock at a price to the public of $3.50 per share, including the full exercise of the underwriters’ option to purchase an additional 2.4 million shares. The net proceeds to PhaseBio from the offering, after deducting the underwriting discounts and commissions and other estimated offering expenses, were approximately $60.1 million.
- SFJ Financing and Co-Development Agreement Update: From execution of the co-development agreement through March 31, 2021, SFJ Pharmaceuticals has funded or reimbursed $62.3 million of clinical trial costs and other expenses of the initial $90 million commitment under the agreement, leaving $27.7 million of funding remaining available to support the bentracimab Phase 3 program through the end of 2021. PhaseBio is eligible to receive up to an additional $30 million of funding if specific, pre-defined clinical development milestones for bentracimab are met.
First-Quarter Financial Results
- Cash and cash equivalents at March 31, 2021 were $77.0 million, compared to $28.1 million at December 31, 2020. The increase reflects proceeds from the March 2021 offering of common stock, offset by cash used in operating activities.
- Net loss for the quarter was $27.4 million, compared to a net loss of $14.9 million for the quarter ended March 31, 2020.
- Research and development expense increased to $22.3 million, as compared to $11.4 million for the same period in 2020, driven by an increase in manufacturing, clinical and nonclinical development activities related to bentracimab and pemziviptadil.
- General and administrative expense increased to $3.3 million, compared to $3.2 million for the same period in 2020.
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