{"id":8519,"date":"2020-03-30T14:40:58","date_gmt":"2020-03-30T22:40:58","guid":{"rendered":"https:\/\/sfj-pharma.com\/?p=8519"},"modified":"2021-06-28T12:53:25","modified_gmt":"2021-06-28T20:53:25","slug":"phasebio-reports-fourth-quarter-and-full-year-2019-financial-results-and-provides-recent-business-highlights","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/phasebio-reports-fourth-quarter-and-full-year-2019-financial-results-and-provides-recent-business-highlights\/","title":{"rendered":"PhaseBio Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Recent Business Highlights"},"content":{"rendered":"
Recently Initiated PB2452 Phase 3 Trial for the Reversal of the Antiplatelet Effects of Ticagrelor<\/em><\/p>\n Received FDA Breakthrough Therapy Designation and EMA PRIME Designation for PB2452<\/em><\/p>\n Secured PB2452 Financing and Co-Development Collaboration with SFJ Pharmaceuticals\u00ae<\/em><\/p>\n MALVERN, Pa. and SAN DIEGO, March 30, 2020 (GLOBE NEWSWIRE) \u2014\u00a0PhaseBio Pharmaceuticals, Inc.<\/u><\/a>\u00a0(Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2019, and provided an update on corporate activities.<\/p>\n \u201cOver the past year, PhaseBio has made tremendous progress building the organization for its next phase of growth and strengthening its pipeline, notably with the advancement of PB2452 into a Phase 3 registrational trial,\u201d said Jonathan P. Mow, Chief Executive Officer of PhaseBio. \u201cThe New England Journal of Medicine publication featuring results from the Phase 1 trial of PB2452 generated significant interest in the program and, having subsequently received FDA Breakthrough Therapy designation and EMA PRIME designation, the program heads into the pivotal Phase 3 trial with momentum. Looking ahead, the remainder of 2020 will be an important period for PhaseBio as we continue to engage investigators, activate more clinical trial sites in the U.S. and abroad and work to maintain the positive trajectory we have established for our lead program and for the company.\u201d<\/p>\n PB2452 Phase 3 Initiation Update:\u00a0<\/strong>PhaseBio recently commenced its PB2452 Phase 3 trial. The pivotal Phase 3 trial of PB2452 will evaluate the reversal of the antiplatelet activity of ticagrelor in patients experiencing major, uncontrolled bleeding events or in patients requiring urgent or emergency surgery. Actual timing of patient enrollment is dependent on the trial sites as they weigh the potential impact of the COVID-19 pandemic on emergency medicine and critical care resources. More information about the Phase 3 trial is available at\u00a0ClinicalTrials.gov<\/u><\/a>.<\/p>\n PB1046 Clinical Trial Enrollment Update:\u00a0<\/strong>PB1046, a first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue is being evaluated for the treatment of patients with pulmonary arterial hypertension (PAH). The company has temporarily paused enrollment of new patients in its Phase 2b study of PB1046 as a precaution to minimize potential exposure of this patient population at high risk of serious illness from COVID-19. However, the company has also informed investigators that they may continue dosing drug and performing assessments for current trial participants if they deem it appropriate and such activities are permitted by their respective institutions. Additionally, the company continues to identify new trial sites for future initiation. Although PhaseBio has been targeting to report results from this trial in the fourth quarter of 2020, the company believes that COVID-19 will temporarily prevent it from being able to initiate new trial sites and enroll new patients, likely pushing the expected readout of the trial into 2021. With patient safety being the top priority, the company will continue to actively monitor the situation, consult with necessary regulatory agencies and provide updates as they become available.<\/p>\n PB2452 Recent Highlights<\/u><\/strong><\/p>\n PB1046 and Other Pipeline Highlights<\/u><\/strong><\/p>\n Operational Updates<\/u><\/strong><\/p>\n Fourth Quarter and Full-Year 2019 Financial Results<\/u><\/strong><\/p>\n Cash Position<\/strong><\/p>\n Cash and cash equivalents at December 31, 2019 were $74.0 million, compared to $61.0 million at December 31, 2018. The increase reflects net proceeds from the April 2019 offering of common stock, partially offset by cash used in operating activities.<\/p>\n Results of Operations<\/strong><\/p>\n Quarter Ended December 31, 2019<\/em><\/p>\n PhaseBio reported a net loss of $11.3 million for the three months ended December 31, 2019, which compared with a net loss of $4.9 million for the same period in 2018. This resulted in a net loss of $0.39 per share for the three months ended December 31, 2019, compared to a net loss of $0.26 per share for the corresponding period in 2018, on both a basic and diluted basis.<\/p>\n Grant revenues were $0.7 million for the three months ended December 31, 2019, as PhaseBio incurred allowable costs qualifying for reimbursement under the government grants. Grant revenues for the same period in 2018 were $0.3 million. Revenue under collaborative agreement was $0.1 million for the three months ended December 31, 2019, which was related to revenue from the ImmunoForge agreement entered into in April 2019.<\/p>\n Research and development expense\u00a0increased to $8.4\u00a0million for the three months ended December\u00a031, 2019,\u00a0compared to $5.7\u00a0million for the three months ended\u00a0December 31, 2018,\u00a0reflecting an increase in manufacturing, clinical and preclinical development activities\u00a0related to\u00a0PB2452 and PB1046.<\/p>\n General and administrative expense increased to $3.7 million for the three months ended December 31, 2019, compared to $2.2 million for the three months ended December 31, 2018, primarily attributable to increases in professional services, personnel, insurance and business travel-related expenses.<\/p>\n Year Ended December 31, 2019<\/em><\/p>\n PhaseBio reported a net loss of $39.2 million for the year ended December 31, 2019, which compared with a net loss of $23.8 million for 2018. This resulted in a net loss of $1.43 per share for the year ended December 31, 2019, compared to a net loss of $4.49 per share for the corresponding period in 2018, on both a basic and diluted basis.<\/p>\n Grant revenues were $1.8 million for the year ended December 31, 2019, as PhaseBio incurred allowable costs qualifying for reimbursement under the government grants. Grant revenues in 2018 were $0.7 million. Revenue under collaborative agreement was $0.6 million for the year ended December 31, 2019, which was related to revenue from the ImmunoForge agreement entered into in April 2019.<\/p>\n Research and development expenses\u00a0increased to $30.9\u00a0million for the year ended December\u00a031, 2019, compared to $15.5\u00a0million for the year ended\u00a0December 31, 2018, reflecting an increase in manufacturing, clinical and preclinical development activities\u00a0related to\u00a0PB2452 and PB1046.<\/p>\n General and administrative expenses were $11.2 million for the year ended December 31, 2019, compared to $4.9 million for the year ended December 31, 2018, primarily attributable to increases in professional services, personnel, insurance and business travel-related expenses.<\/p>\n\n
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