PHAS PhaseBio Pharmaceuticals Inc.

4
+0.03  (+1%)
Previous Close 3.97
Open 3.97
52 Week Low 2.6
52 Week High 5.8299
Market Cap $191,929,720
Shares 48,042,483
Float 38,715,079
Enterprise Value $131,266,134
Volume 369,269
Av. Daily Volume 392,188
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Upcoming Catalysts

Drug Stage Catalyst Date
Bentracimab (PB2452) - (REVERSE-IT)
Reversal agent for ticagrelor
Phase 3
Phase 3
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Pemziviptadil (PB1046)
Pulmonary arterial hypertension (PAH)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Pemziviptadil (PB1046) - VANGARD
COVID-19 / acute respiratory distress syndrome (ARDS)
Phase 2
Phase 2
Development to be discontinued - October 23, 2020.

Latest News

  1. PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial), the pivotal Phase 3 trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require surgery or invasive procedure, has been accepted for presentation in a virtual Late Breaking Science session at the American Heart Association (AHA) Scientific Sessions 2021 on Monday, November 15, 2021.

    Presentation Information

    • Title: Effect of Bentracimab…

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial), the pivotal Phase 3 trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require surgery or invasive procedure, has been accepted for presentation in a virtual Late Breaking Science session at the American Heart Association (AHA) Scientific Sessions 2021 on Monday, November 15, 2021.

    Presentation Information

    • Title: Effect of Bentracimab on Platelet Inhibition and Hemostasis in Ticagrelor Patients with Uncontrolled Hemorrhage or Requiring Urgent Surgery in the REVERSE-IT Trial
    • Presenting Author: Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School
    • Session Title: New Drugs and New Drug Indications in Cardiovascular Disease
    • Session Number: LBS.07
    • Date: November 15, 2021
    • Session Time: 11:00 am – 12:00 pm ET
    • Presentation Time: 11:30 am – 11:38 am ET

    "We are pleased to have the opportunity to present the results from the pivotal REVERSE-IT Phase 3 trial as a late breaker at this year's American Heart Association Scientific Sessions," said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. "Presenting the results from this trial to a broad cross section of the cardiology community is an important milestone for PhaseBio and the REVERSE-IT trial. I'd like to thank the team at PhaseBio and our network of clinical investigators and advisors who have worked diligently to enroll the trial and rapidly analyze the data, enabling us to share the results at a high-profile medical congress like AHA.21."

    REVERSE-IT is a Phase 3, multi-center, open-label, prospective single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require surgery or invasive procedure. Approximately 200 patients are being targeted to be enrolled from major health centers worldwide. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal are eligible for enrollment. In August 2021, PhaseBio announced that it had enrolled the first 143 patients in the REVERSE-IT trial, 138 of whom required surgery or an invasive procedure and five of whom experienced uncontrolled major or life-threatening bleeding. The Company is commencing preparation of the BLA and targeting a BLA submission to the U.S. Food and Drug Administration (FDA) in mid-2022.

    Bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics.

    About Bentracimab (PB2452)

    Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and surgery situations. In a Phase 1 clinical trial, bentracimab demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor's antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019. In April 2019, bentracimab received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In both arms of the trial, bentracimab achieved immediate and sustained reversal of the antiplatelet effects of ticagrelor and was generally well-tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. PhaseBio initiated the REVERSE-IT trial, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a Biologics License Application for bentracimab in both major bleeding and surgery indications.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "potential," "projects," "target," "will," "would" and "future" or similar expressions are intended to identify forward-looking statements.

    Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the timing of availability or disclosure of data from those clinical trials and the timing of planned regulatory submissions, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

    Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

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  2. PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced the appointment of William D. Humphries to its board of directors. Additionally, Justin Klein, M.D., J.D., is stepping down from his role as director, effective immediately.

    "Bill's deep commercial expertise gained through his leadership roles at numerous specialty pharmaceutical companies will be an invaluable addition to our already robust board of directors," said Jonathan P. Mow, Chief Executive Officer of PhaseBio. "Bill joins us at an exciting and pivotal time in PhaseBio's growth, as we continue to advance our clinical programs and begin…

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced the appointment of William D. Humphries to its board of directors. Additionally, Justin Klein, M.D., J.D., is stepping down from his role as director, effective immediately.

    "Bill's deep commercial expertise gained through his leadership roles at numerous specialty pharmaceutical companies will be an invaluable addition to our already robust board of directors," said Jonathan P. Mow, Chief Executive Officer of PhaseBio. "Bill joins us at an exciting and pivotal time in PhaseBio's growth, as we continue to advance our clinical programs and begin to build a commercial organization to prepare to market bentracimab in the United States should it be approved."

    Mr. Mow added, "I would also like to thank Justin for his many contributions during his time as a director. He has proved himself to be a trusted advisor, who has been instrumental in helping PhaseBio get to where it is today, and continues to be one of the strongest champions of our mission."

    Mr. Humphries has more than 30 years of experience building and leading commercial-stage pharmaceutical organizations. He is currently the Chief Executive Officer of Isosceles Pharmaceuticals, a position he has held since May 2021. Prior to his role at Isosceles, Mr. Humphries served as President of Ortho Dermatologics, a Bausch Health Company. Before joining Ortho Dermatologics, he served as President and Chief Executive Officer of the North American business of Merz, an affiliate of Merz Pharma Group, where he oversaw strategic direction and collaboration among three North American companies: Merz Pharmaceuticals LLC, Merz Aesthetics Inc., and Merz Pharma Canada Ltd. Before joining Merz, he served in a number of leadership positions with Stiefel Laboratories, including as its Chief Commercial Officer and then as President, where he spearheaded two significant acquisitions and led the global integration of Stiefel into GlaxoSmithKline. Earlier in his career Mr. Humphries served in executive roles in sales and marketing, business development, and international marketing for Allergan, concluding as vice president of its U.S. skincare business.

    In addition to joining the PhaseBio board of directors, Mr. Humphries currently serves as the chairman of the board for Clearside Biomedical, chairman of the board for STRATA Skin Sciences, and as a director on the board of Aclaris Therapeutics. He received a B.A. from Bucknell University and an M.B.A. from Pepperdine University.

    "Having worked in commercially-focused roles in the pharmaceutical industry for much of my career, I am very passionate about bringing potentially life-changing medicines to the market and am thrilled to join the PhaseBio board at this critical juncture in the company's evolution," said Mr. Humphries. "I look forward to helping guide the building of the company's U.S. commercial organization and charting an exciting path forward for the company as we advance our mission of developing medicines to address key unmet needs for people with cardiopulmonary disease."

    In addition to joining the PhaseBio board, Mr. Humphries was also appointed as a member of its compensation committee.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "potential," "projects," "target," "will," "would" and "future" or similar expressions are intended to identify forward-looking statements.

    Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

    Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

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  3. VANCOUVER, Wash., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ:ABSI), the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins, today reported financial and operating results for the quarter ended June 30, 2021.

    "This has been a momentous year for Absci," said Sean McClain, founder and CEO. "We kicked off 2021 with our acquisition of Denovium, which formalized our identity as an AI-powered synthetic biology company focused on biopharmaceutical protein design and production technology. We've also grown the business substantially since January, more than doubling our team of 'unlimiters', signing partnership agreements, advancing programs…

    VANCOUVER, Wash., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ:ABSI), the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins, today reported financial and operating results for the quarter ended June 30, 2021.

    "This has been a momentous year for Absci," said Sean McClain, founder and CEO. "We kicked off 2021 with our acquisition of Denovium, which formalized our identity as an AI-powered synthetic biology company focused on biopharmaceutical protein design and production technology. We've also grown the business substantially since January, more than doubling our team of 'unlimiters', signing partnership agreements, advancing programs with current partners, enhancing our technology platform, building and moving into a new campus, and acquiring Totient."

    "Along the way, we've shared our progress and vision with investors, and with their support we completed two financing rounds since January, including our IPO in July. I could not be more proud of what we have accomplished, or more excited about what lies ahead as we pursue our vision of changing the world, one protein at a time."

    Second Quarter 2021 and Recent Highlights

    • Completed initial public offering raising net proceeds of approximately $210 million.
    • Announced acquisition of Totient, expanding the Integrated Drug Creation™ Platform to include antibody and target discovery technology.
    • Hired over 100 new employees since year-end 2020, and strengthened executive leadership team with additions of Nikhil Goel as Chief Business Officer and Sarah Korman, PhD, JD, as General Counsel.
    • Built out and relocated to new state-of-the-art 77,000 square foot campus in Vancouver, Washington.
    • Entered into a global technology development and license agreement with PhaseBio (NASDAQ:PHAS) to advance a successful ongoing Active Program for creation of a customized cell line to enable high-yield commercial production of a PhaseBio clinical candidate. The agreement entitles Absci to contingent milestone payments and royalties on sales upon PhaseBio's exercise of its option for an exclusive license to the producing cell line developed by Absci.
    • Signed a global technology development and license agreement with Alpha Cancer Technologies Inc. The agreement extends the existing technology development partnership and entitles Absci to contingent milestone payments and royalties on net sales of products comprising recombinant human alpha-fetoprotein manufactured using the producing cell line developed by Absci.

    Second Quarter 2021 Financial Results

    Revenue was $0.7 million for the three months ended June 30, 2021 compared to $0.6 million for the three months ended June 30, 2020

    Research and development expenses were $11.0 million for the second quarter of 2021, as compared to $2.3 million for the corresponding prior year period. This increase was primarily driven by additional investments in platform expansion, including data initiatives and AI capabilities.

    Selling, general, and administrative expenses were $5.2 million for the second quarter of 2021, as compared to $0.9 million for the corresponding prior period. This increase was due to personnel-related costs and professional services, including approximately $0.9 million of transaction related expenses related to the Totient acquisition.

    Net loss was $41.2 million for the second quarter of 2021, as compared to $3.0 million for the corresponding prior year period, which includes a non-cash charge of $28.1 million related to the revaluation of convertible notes and preferred stock warrants.

    Cash and cash equivalents were $99.5 million as of June 30, 2021. Subsequent to the end of the quarter, on July 26, 2021, Absci completed its initial public offering, raising approximately $210 million of net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses.

    About Absci

    Absci is the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins. We built our Integrated Drug Creation™ Platform to identify novel drug targets, discover optimal biotherapeutic candidates, and generate the cell lines to manufacture them in a single efficient process. Biotech and pharma innovators partner with us to create the next generation of protein-based drugs, including those that may be impossible to make with other technologies. Our goal is to enable the development of better medicines by Translating Ideas into Drugs™. For more information visit www.absci.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements containing the words "will," "pursues," "anticipates," "plans," "believes," "forecast," "estimates," "expects," and "intends," or similar expressions. We intend these forward-looking statements, including statements regarding operating plans, development and partnership efforts, and our ability to receive milestone payments and royalties, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we make this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved, and, furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control, including, without limitation, risks and uncertainties relating to our partners' ability to develop and commercialize product candidates generated using our platform and our ability to secure milestone payments and royalties; along with those risks set forth in our Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on September 7, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Investor Contact:

    investors@absci.com

    Media Contact:

    press@absci.com

    Absci Corporation

    Condensed Consolidated Statements of Operations (unaudited)

             
      For the Three Months Ended

    June 30,

      For the Six Months Ended

    June 30,

     
    (In thousands, except for share and per share data) 2021

      2020

      2021

      2020

     
    Revenues        
    Technology development revenue         $592  $517  $1,532  $1,042 
    Collaboration revenue         136  47  259  94 
    Total revenues         728  564  1,791  1,136 
    Operating expenses        
    Research and development         11,040  2,252  18,090  4,159 
    Selling, general and administrative         5,179  861  9,864  1,832 
    Depreciation and amortization         1,201  265  1,677  449 
    Total operating expenses         17,420  3,378  29,631  6,440 
    Operating loss         (16,692) (2,814) (27,840) (5,304)
    Other income (expense)        
    Interest expense         (2,009) (189) (2,464) (287)
    Other income (expense), net         (28,114) (5) (27,950) (75)
    Total other expense, net         (30,123) (194) (30,414) (362)
    Loss before income taxes         (46,815) (3,008) (58,254) (5,666)
    Income tax benefit         5,617    6,094   —  
    Net loss         (41,198) (3,008) (52,160) (5,666)
    Adjustment of redeemable preferred units and stock           (13,967)   (25,121)
    Cumulative undeclared preferred stock dividends         (1,047)   (2,042) —  
    Net loss applicable to common stockholders and unitholders         $(42,245) $(16,975) $(54,202) $(30,787)
             
    Net loss per share attributable to common stockholders and unitholders:

    Basic and diluted
     $(2.39) $(1.12) $(3.13) $(2.02)
                    
    Weighted-average common shares and units outstanding:

    Basic and diluted
     17,641,147  15,215,747  17,312,437  15,215,747 
             

    Absci Corporation

    Condensed Consolidated Balance Sheets (unaudited)

         
      June 30,

      December 31,

     
    (In thousands, except for share and per share data) 2021

      2020

     
    ASSETS    
    Current assets:    
    Cash and cash equivalents         $99,450  $69,867 
    Restricted cash         10,501   
    Receivables under development arrangements         545  1,594 
    Prepaid expenses and other current assets         1,895  1,773 
    Total current assets         112,391  73,234 
    Operating lease right-of-use assets         7,638  4,476 
    Property and equipment, net         37,802  8,909 
    Intangibles, net         56,677   
    Goodwill         22,893   
    Restricted cash         16,846  1,841 
    Other assets         2,823  109 
    TOTAL ASSETS         $257,070  $88,569 
    LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND OTHER STOCKHOLDERS' DEFICIT    
    Current liabilities:    
    Accounts payable         $9,004  $2,116 
    Accrued expenses         14,000  1,569 
    Loans payable           632 
    Long-term debt, current         1,577  903 
    Operating lease obligations, current         1,419  770 
    Financing lease obligations, current         1,984  1,475 
    Deferred revenue, current         1,775  2,630 
    Total current liabilities         29,759  10,095 
    Convertible promissory notes         150,107   
    Long-term debt - net of current portion         3,352  4,141 
    Operating lease obligations - net of current portion         8,978  3,813 
    Finance lease obligations - net of current portion         3,203  2,766 
    Deferred tax, net         5,228   
    Deferred revenue         839   
    Other long-term liabilities         18,489  749 
    TOTAL LIABILITIES         219,955  21,564 
    Commitments (See Note 7)    
    Redeemable convertible preferred stock, $0.0001 par value         161,377  156,433 
    OTHER STOCKHOLDERS' DEFICIT    
    Common stock, $0.0001 par value         2  2 
    Additional paid-in capital         17,972  635 
    Accumulated deficit         (142,225) (90,065)
    Accumulated other comprehensive income (loss)         (11)  
    TOTAL OTHER STOCKHOLDERS' DEFICIT         (124,262) (89,428)
    TOTAL LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND OTHER STOCKHOLDERS' DEFICIT         $257,070  $88,569 
         



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  4. PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that Chief Financial Officer John Sharp will provide a company overview at the 23rd Annual H.C. Wainwright Global Investment Conference. The presentation will be available on demand beginning at 7:00am ET on Monday, September 13, 2021.

    Interested parties can access the live and archived webcast of the event on the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals…

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that Chief Financial Officer John Sharp will provide a company overview at the 23rd Annual H.C. Wainwright Global Investment Conference. The presentation will be available on demand beginning at 7:00am ET on Monday, September 13, 2021.

    Interested parties can access the live and archived webcast of the event on the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

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  5. Entered exclusive licensing agreement with Alfasigma S.p.A with up to $245 million in milestone payments and tiered royalty payments for development and commercialization of bentracimab in European and other key markets

    Achieved interim enrollment milestone with first 143 bentracimab patients enrolled in the REVERSE-IT pivotal Phase 3 trial, with top-line results from interim analysis expected later this year

    Bentracimab Phase 2b trial enrollment completed; safety and efficacy data will supplement Phase 3 interim results, with combined data package planned to serve as the basis for a Biologics License Application (BLA) submission in mid-2022

    Cash and Equivalents of $64.5 million as of June 30, 2021

    PhaseBio Pharmaceuticals, Inc. (NASDAQ…

    Entered exclusive licensing agreement with Alfasigma S.p.A with up to $245 million in milestone payments and tiered royalty payments for development and commercialization of bentracimab in European and other key markets

    Achieved interim enrollment milestone with first 143 bentracimab patients enrolled in the REVERSE-IT pivotal Phase 3 trial, with top-line results from interim analysis expected later this year

    Bentracimab Phase 2b trial enrollment completed; safety and efficacy data will supplement Phase 3 interim results, with combined data package planned to serve as the basis for a Biologics License Application (BLA) submission in mid-2022

    Cash and Equivalents of $64.5 million as of June 30, 2021

    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 second-quarter 2021 financial results.

    "Since the end of the first quarter, the PhaseBio team has made excellent progress with our lead program, bentracimab, including completing enrollment of the first 143 patients in our pivotal Phase 3 REVERSE-IT trial, completing enrollment in the Phase 2b bentracimab trial and signing an exclusive licensing agreement with Alfasigma S.p.A for commercialization in nearly 50 countries across Europe and the Commonwealth of Independent States," said Jonathan P. Mow, Chief Executive Officer, PhaseBio Pharmaceuticals. "We believe these clinical and strategic milestones position PhaseBio to finish 2021 with significant momentum. The bentracimab program remains on track, and with Alfasigma taking the commercial lead across Europe and other key markets, we believe PhaseBio is well positioned to focus on the BLA submission for bentracimab and prepare for expected commercial launch in the United States."

    Program Highlights and Corporate Updates

    • Achieved Enrollment Milestones Supporting Interim Analysis of REVERSE-IT Global Phase 3 Trial of Bentracimab for Reversal of Antiplatelet Effects of Ticagrelor: In August 2021, PhaseBio announced that it had completed enrollment of the first 143 patients in its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab, 138 of whom required urgent surgery or an invasive procedure and five of whom experienced uncontrolled major or life-threatening bleeding. In total, the REVERSE-IT trial is expected to enroll approximately 200 major bleeding or urgent surgery patients at sites in the United States, Canada, European Union and China. Based on prior guidance following the End of Phase 1 Meeting with the U.S. Food and Drug Administration (FDA) to balance the two patient populations, the REVERSE-IT trial does not allow enrollment of more than approximately two thirds of either the uncontrolled major or life-threatening bleeding population or urgent surgery or invasive procedure population. Because the total number of patients enrolled to date includes 138 patients who required urgent surgery or an invasive procedure, the surgery cohort of the trial has been fully enrolled. With the successful completion of enrollment in this surgery cohort, REVERSE-IT trial sites have shifted focus to enrolling patients with uncontrolled major or life-threatening bleeding events. The Company is continuing to attempt 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 believes that a broader site footprint will increase the probability of enrolling these patients. The FDA also previously indicated that an interim analysis of the first approximately 100 patients enrolled in the REVERSE-IT trial would be sufficient to support the submission of a BLA for accelerated approval. The FDA recommended that the 100 patients comprising the interim analysis include approximately 50 patients from each of the uncontrolled major or life-threatening bleeding population and the urgent surgery or invasive procedure population, although the FDA noted that whether there are an adequate number of patients from either cohort would be a review issue and considered in the context of other data submitted with the BLA. The Company is commencing preparation of the BLA and targeting a BLA submission to the FDA in mid-2022.
    • Completed Enrollment in Bentracimab Phase 2b trial: In August 2021, PhaseBio announced the completion of enrollment in the randomized, double-blind, placebo-controlled Phase 2b trial of bentracimab. The Phase 2b trial enrolled 200 healthy older and elderly (ages 50 to 80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin; 150 subjects were randomized to receive bentracimab, with reversal of the antiplatelet effects of ticagrelor, as measured by the VerifyNow® PRUTest biomarker, serving as the primary endpoint for the trial. Top-line results from the Phase 2b trial are expected later this year. The Phase 2b trial was designed to supplement the safety and efficacy results that will be included in the BLA submission.
    • Announced Approval of Bentracimab IND in China: In August 2021, PhaseBio announced that the Investigational New Drug (IND) application for bentracimab submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in collaboration with development partner, SFJ Pharmaceuticals (SFJ), has been approved. PhaseBio and SFJ anticipate enrolling the first patients at sites in China later in 2021. Patients enrolled in China are expected to contribute to the completion of full enrollment of the trial, post interim analysis. In January 2020, PhaseBio announced a financing and co-development partnership with SFJ Pharmaceuticals, and since this time, SFJ has been leading clinical development efforts in China. PhaseBio retains commercial rights to bentracimab in China and is pursuing prospective commercial partners to license the marketing rights in China and other countries in the Asia-Pacific region.
    • Entered European Licensing Agreement with Alfasigma for Commercialization of Bentracimab: In June 2021, PhaseBio announced an exclusive licensing agreement with Alfasigma, a privately owned specialty pharmaceutical company focused on commercializing medicines in Europe and other key markets, for the commercialization of bentracimab. Under the terms of the license agreement, PhaseBio received a $20 million upfront payment and will be eligible to receive up to $35 million in pre-revenue regulatory milestones and up to $190 million in payments contingent upon the achievement of certain sales milestones. PhaseBio will also receive tiered royalties on net sales, with percentages starting in the low double digits and escalating up to the mid-twenties.
    • Presented Real-World Healthcare Cost and Bleeding Cost Data Featured at the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference: In May 2021, PhaseBio presented a poster analysis of the IBM® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. Among other things, results of the analyses demonstrated that, in the year prior to initiating therapy, total healthcare costs were higher among P2Y12 inhibitor patients compared to factor Xa and dabigatran patients. These conference proceedings present compelling evidence of an unmet medical and pharmacoeconomic need for an effective reversal agent for patients treated with P2Y12 inhibitors.
    • Presented Real-World Bleeding and Surgery Data Featured at The American College of Cardiology's 70th Annual Scientific Session: In May 2021, PhaseBio presented a poster summarizing an analysis of the IBM® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. The results of the analysis demonstrated that patients receiving P2Y12 inhibitors presented a significantly higher burden of baseline comorbid conditions than factor Xa and dabigatran patients. Additionally, the results indicate that bleeding complications and medical procedures are common in patients taking antithrombotic medications. PhaseBio and the authors believe this study demonstrates an unmet need for an effective reversal agent for patients prescribed P2Y12 inhibitors.
    • SFJ Financing and Co-Development Agreement Update: From execution of the co-development agreement through June 30, 2021, SFJ has funded or reimbursed $77.5 million of clinical trial costs and other expenses of the initial $90.0 million commitment under the agreement, leaving $12.5 million of funding remaining available to support the bentracimab Phase 3 program. PhaseBio is eligible to receive up to an additional $30 million of funding if specific, pre-defined clinical development milestones for bentracimab are met.

    Second-Quarter 2021 Financial Results

    • Cash and cash equivalents at June 30, 2021 were $64.5 million, compared to $28.1 million at December 31, 2020. The increase reflects proceeds from the March 2021 offering of common stock, partially offset by cash used in operating activities.
    • Sublicense revenue for the quarter was $10.3 million and reflects recognition of a portion of the upfront milestone payment received as part of the Alfasigma licensing agreement.
    • Net loss for the quarters ended June 30, 2021 and 2020 was $28.7 million.
    • Research and development expense increased to $27.4 million for the quarter ended June 30, 2021, as compared to $20.9 million for the same period in 2020, driven by an increase in manufacturing, clinical and nonclinical development activities related to bentracimab.
    • General and administrative expense increased to $4.0 million for the quarter ended June 30, 2021, compared to $3.2 million for the same period in 2020.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "potential," "projects," "target," "will," "would" and "future" or similar expressions are intended to identify forward-looking statements.

    Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the timing of availability or disclosure of data from those clinical trials and the timing of planned regulatory submissions, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, including through our partnerships with Alfasigma and SFJ. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

    Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

    PhaseBio Pharmaceuticals, Inc.

    Condensed Balance Sheets

    (in thousands)

    (unaudited)

     

    June 30,

     

    December 31,

     

    2021

     

    2020

    Assets:

       

    Cash and cash equivalents

     

    $

    64,456

     

     

    $

    28,122

     

    Receivable from sublicense

     

     

    18,400

     

     

     

     

    Prepaid expenses and other current assets

     

     

    5,644

     

     

     

    12,027

     

    Property and equipment, net

     

     

    10,379

     

     

     

    8,224

     

    Operating lease right-of-use assets

     

     

    1,701

     

     

     

    1,927

     

    Other non-current assets

     

     

    57

     

     

     

    57

     

    Total assets

     

    $

    100,637

     

     

    $

    50,357

     

         

    Liabilities and stockholders' deficit:

       

    Current portion of long-term debt

     

    $

    5,384

     

     

    $

    5,355

     

    Current portion of deferred sublicense revenue

     

     

    1,424

     

     

     

     

    Accounts payable, accrued expenses and other current liabilities

     

     

    9,366

     

     

     

    9,605

     

    Long-term debt, net

     

     

    4,073

     

     

     

    6,773

     

    Operating lease liabilities, net

     

     

    1,306

     

     

     

    1,548

     

    Deferred sublicense revenue, net

     

     

    8,238

     

     

     

     

    Development derivative liability

     

     

    89,329

     

     

     

    51,719

     

    Other long-term liabilities

     

     

    692

     

     

     

    559

     

    Stockholders' deficit

     

     

    (19,175

    )

     

     

    (25,202

    )

    Total liabilities and stockholders' deficit

     

    $

    100,637

     

     

    $

    50,357

     

    PhaseBio Pharmaceuticals, Inc.

    Condensed Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

    Three Months Ended June 30,

    Six Months Ended June 30,

    2021

    2020

    2021

    2020

     

    Revenue:

    Sublicense revenue

    $

    10,337

     

    $

     

    $

    10,337

     

    $

     

    Grant revenue

     

     

     

     

     

     

     

    320

     

    Total revenue

     

    10,337

     

     

     

     

    10,337

     

     

    320

     

    Operating expenses:

    Research and development

     

    27,366

     

     

    20,856

     

     

    49,686

     

     

    32,305

     

    General and administrative

     

    4,024

     

     

    3,242

     

     

    7,351

     

     

    6,401

     

    Total operating expenses

     

    31,390

     

     

    24,098

     

     

    57,037

     

     

    38,706

     

    Loss from operations

     

    (21,053

    )

     

    (24,098

    )

     

    (46,700

    )

     

    (38,386

    )

    Other (expense) income

     

    (6,026

    )

     

    (4,044

    )

     

    (7,737

    )

     

    (4,661

    )

    Net loss before income taxes

     

    (27,079

    )

     

    (28,142

    )

     

    (54,437

    )

     

    (43,047

    )

    Provision for income taxes

     

    1,600

     

     

     

     

    1,600

     

     

     

    Net loss

    $

    (28,679

    )

    $

    (28,142

    )

    $

    (56,037

    )

    $

    (43,047

    )

     

    Net loss per common share, basic and diluted

    $

    (0.60

    )

    $

    (0.98

    )

    $

    (1.41

    )

    $

    (1.50

    )

     

    Weighted average common shares outstanding, basic and diluted

     

    47,985,871

     

     

    28,805,238

     

     

    39,680,408

     

     

    28,789,256

     

     

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