MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) recently reported financial results for the second quarter ended June 30, 2022, and provided an update on corporate activities.
“The second quarter of 2022 marked a period of continued progress for PhaseBio,” said Jonathan Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. “Following a successful meeting with the U.S. Food and Drug Administration (FDA) during our pre-biologics license application (pre-BLA) meeting earlier this year and as previously disclosed, we have been focused on clinical development and regulatory efforts to support a planned BLA submission for our lead program, bentracimab, in the fourth quarter of this year. Additionally, we continue to make progress towards completing initial new drug application (IND) enabling studies for PB6440, our aldosterone synthase inhibitor in development for resistant hypertension. We expect to file our IND for PB6440 in the first half of 2023 and to initiate first-in-human trials in mid-2023.”
- SFJ Financing and Co-Development Agreement Update: In January 2020, PhaseBio entered into an agreement with SFJ Pharmaceuticals (SFJ Agreement), pursuant to which SFJ provides the company funding to support the global development of bentracimab. Under the agreement, SFJ agreed to pay the company up to $120.0 million to support the clinical development of bentracimab. In addition to $90.0 million of initial funding, the company has elected to receive an additional $30.0 million of funding having met specific, pre-defined clinical development milestones for bentracimab. From the inception of the SFJ Agreement through June 30, 2022, SFJ has provided funding and paid for amounts on the company’s behalf in the aggregate amount of $99.0 million. PhaseBio expects that SFJ will fund or reimburse an additional $21.0 million of clinical trial costs and other expenses.
- PB6440 IND enabling studies continue to advance: In the second quarter of 2022, PhaseBio completed the development and optimization of a robust manufacturing process to support anticipated upcoming proof-of-concept trials, positioning the program for initial GMP manufacturing runs in the fourth quarter of 2022. PB6440 is a highly selective aldosterone synthase inhibitor in development to target treatment resistant hypertension and other indications where elevated aldosterone is known to contribute to disease process, such as uncontrolled hypertension, chronic kidney disease, and heart failure. The drug appears to modulate the renin-angiotensin-aldosterone system, which exhibits a critical role in regulation of systemic blood pressure. According to the American Heart Association, 20% of hypertensive Americans, which potentially represents more than 10 million patients, have not achieved normotensive status despite taking three or more blood pressure drugs; the Company reportedly believes this represents a significant unmet need with a large market potential. PB6440 is undergoing IND-enabling studies, with first human trials targeted for mid-2023.
Quarter Ending June 30, 2022
- Cash and cash equivalents on June 30, 2022, were $7.8 million, compared to $41.8 million at December 31, 2021. The decrease primarily reflects cash used in operating activities.
- Net loss for the quarter was $16.7 million, compared to a net loss of $28.7 million for the prior-year period.
- Research and development expense for the quarter decreased to $20.9 million, as compared to $27.4 million for the same period in 2021. The decrease was primarily attributable to drug manufacturing activity in 2021, study site startup costs for the Phase 2b trial related to bentracimab in 2021, and the voluntary ending of the Phase 2b trial of pemziviptadil in the fourth quarter of 2021, partially offset by an increase in costs related to development of PB6440, and personnel costs and other costs associated with the Company’s general research and development efforts.
- General and administrative expense for the quarter increased to $4.6 million, compared to $4.0 million for the prior-year period. The increase was primarily attributable to increases in consulting costs and personnel expenses due to additional headcount.
For more information, visit www.phasebio.com.
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