Document


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
___________________________________
FORM 8-K
___________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 30, 2020
___________________________________
PhaseBio Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
___________________________________

Delaware
001-38697
03-0375697
(State or Other Jurisdiction of
Incorporation)
(Commission
 File Number)
(IRS Employer
Identification No.)
1 Great Valley Parkway, Suite 30
Malvern, Pennsylvania
19355
(Address of Principal Executive Offices)
(Zip Code)

(610) 981-6500
(Registrant’s Telephone Number, Including Area Code)

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
___________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
 
☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act.
Title of each class
Trading Symbol(s)
Name of exchange on which registered
Common Stock
PHAS
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x
 





Item 2.02 Results of Operations and Financial Condition.
On March 30, 2020, PhaseBio Pharmaceuticals, Inc. (the “Company”) reported financial results for the fourth quarter and year ended December 31, 2019. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference.

The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 7.01 Regulation FD Disclosure.
On March 30, 2020, the Company updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

Item 9.01 Financial Statements and Exhibits.
 
(d)    Exhibits

 
 
 
Exhibit No.
 
Description
 
 
 
 
 
 
 








SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
PhaseBio Pharmaceuticals, Inc.
 
 
 
 
Dated: March 30, 2020
 
By:
/s/ John P. Sharp
 
 
John P. Sharp
 
 
 
 
Chief Financial Officer
 




Exhibit


Exhibit 99.1
https://cdn.kscope.io/1506ee26ce043b9cd212213f9acd5e0b-phasebiologo2a06.jpg

PhaseBio Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Recent Business Highlights

Recently Initiated PB2452 Phase 3 Trial for the Reversal of the Antiplatelet Effects of Ticagrelor
Received FDA Breakthrough Therapy Designation and EMA Prime Designation for PB2452
Secured PB2452 Financing and Co-Development Collaboration with SFJ Pharmaceuticals® 
Malvern, PA and San Diego, CA, March 30, 2020 - PhaseBio Pharmaceuticals, Inc. (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.

“Over 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,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio. “The 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.”

PB2452 Phase 3 Initiation Update: 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 ClinicalTrials.gov. 

PB1046 Clinical Trial Enrollment Update: 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.


PB2452 Recent Highlights





Granted PRIME Designation for PB2452 from European Medicines Agency: In February 2020, PhaseBio announced that PB2452 was granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for the reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or an invasive procedure. The EMA prioritizes PRIME designated drugs for special support, including enhanced interactions and dialogue with the EMA during development, as well as a pathway for accelerated evaluation and review for marketing authorization.

Received written scientific advice confirming the PB2452 clinical development plan: In February 2020, PhaseBio announced the receipt of written guidance from the Committee for Medicinal Products for Human Use (CHMP) of the EMA that generally agrees with PhaseBio’s proposed development plan for PB2452. After reviewing the Scientific Advice from CHMP, and based on prior interactions with the U.S. Food and Drug Administration (FDA), PhaseBio believes that the development plan for PB2452 has been designed to support regulatory filings in the United States and the European Union.

Entered into financing and co-development collaboration with SFJ Pharmaceuticals®: In January 2020, PhaseBio announced a financing and co-development collaboration with SFJ Pharmaceuticals (SFJ) to support the development of PB2452. Under the terms of the agreement, SFJ has agreed to fund up to $120 million to support the clinical development of PB2452 and to assume a central role in global clinical development and regulatory activities for PB2452 outside of the United States. SFJ will fund up to $90 million of development expenses through the end of 2021 and up to an additional $30 million based on PhaseBio meeting specific, pre-defined clinical milestones for PB2452.

Initiated Phase 2b trial: In October 2019, PhaseBio announced that the first patient had been dosed in its Phase 2b clinical trial of PB2452. The Phase 2b multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of PB2452 in reversing the antiplatelet effects of ticagrelor as part of a dual antiplatelet regimen including low-dose aspirin. Additionally, the start of the Phase 2b trial marked the beginning of FDA-aligned registrational trials to support the submission of a biologics license application (BLA) for potential accelerated approval of PB2452. The primary endpoint of the trial is reversal of the antiplatelet effects of ticagrelor with intravenous infusion of PB2452, as measured by the VerifyNow® PRUTest® biomarker.

Completed Phase 2a trial of PB2452: In September 2019, PhaseBio announced the completion of its Phase 2a trial of PB2452. In the trial, PB2452 achieved immediate and sustained reversal of ticagrelor in older and elderly subjects (ages 50-80) on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, based on guidance provided by the FDA, the Phase 2a trial also investigated a PB2452 regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In the supratherapeutic-dose cohort, PB2452 demonstrated immediate and sustained reversal of ticagrelor. Based on the results from this cohort, PhaseBio believes that it has identified an appropriate PB2452 regimen for use in patients who may have supratherapeutic blood levels of ticagrelor as a result of ticagrelor drug-drug interactions or overdosage. In both cohorts of the Phase 2a trial, PB2452 was generally well tolerated, with only minor adverse events reported.

End-of-Phase 1 meeting update: In August 2019, PhaseBio announced receipt of written minutes from the PB2452 End-of-Phase 1 (EOP 1) meeting with the FDA. Based on the minutes from the EOP 1 meeting, PhaseBio believes that it has reached general agreement with the FDA on the overall design of a single, non-randomized, open label Phase 3 trial of major bleeding and urgent surgical populations to support the submission of a BLA for potential accelerated approval of PB2452.

Received Breakthrough Therapy designation for PB2452: In April 2019, PhaseBio announced that the FDA granted Breakthrough Therapy designation for PB2452. The Breakthrough Therapy designation for PB2452 was supported by Phase 1 trial results in which PhaseBio observed that PB2452 achieved immediate and sustained reversal of the antiplatelet activity of ticagrelor. Breakthrough Therapy designation is designed to expedite the development and review of promising new drugs for serious or




life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Phase 1 Results Published in New England Journal of MedicineIn March 2019, full results from the Phase 1 clinical trial of PB2452 were published in the New England Journal of Medicine in a paper titled, “Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers” and simultaneously presented in a featured clinical research session at the American College of Cardiology’s 68th Annual Scientific Session. The results demonstrated that PB2452 provided immediate and sustained reversal of the antiplatelet activity of ticagrelor. 

PB1046 and Other Pipeline Highlights

Case Study of PB1046 presented at Pulmonary Vascular Research Institute World Congress: In February 2020, PhaseBio announced presentation of data from a patient who received more than 18 months of treatment with PB1046, the company’s first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue being evaluated for the treatment of patients with pulmonary arterial hypertension (PAH). The data demonstrated clinically meaningful improvements in all of the hemodynamic parameters assessed, which were sustained for up to three months after the last dose was administered. All three patients in the Phase 1b/2a pilot study completed the eight-week study with no drug-related serious adverse events, and PB1046 appeared to be well tolerated with only mild injection site erythema.

Bolstered pipeline with acquisition of novel oral aldosterone synthase inhibitor for treatment-resistant hypertension: In January 2020, PhaseBio announced it had signed an agreement with Viamet Pharmaceuticals Holdings, LLC and its wholly-owned subsidiary, Selenity Pharmaceuticals (Bermuda), Ltd., under which PhaseBio acquired all of the assets and intellectual property rights related to certain novel aldosterone synthase inhibitors, including the company’s lead development compound, now called PB6440, being developed for treatment-resistant hypertension. In preclinical studies completed to date, PB6440 was observed to be a highly potent and selective inhibitor of aldosterone synthase (CYP11B2) versus the closely-related steroid 11â-hydroxylase enzyme (CYP11B1). PB6440 demonstrated dose-dependent aldosterone reduction without a significant increase in 11-deoxycorticosterone or deoxycortisol in both rodent and primate models.

PB1023 licensing deal: In April 2019, PhaseBio announced that it had out-licensed the global rights for PB1023, a long-acting, recombinant GLP-1 analogue to ImmunoForge, Co. Ltd. (ImmunoForge) for the treatment of certain diseases, including conditions related to sarcopenia. PB1023 is a fusion protein utilizing PhaseBio’s proprietary elastin-like polypeptide (ELP) technology platform. PhaseBio received an upfront payment upon execution of the agreement and is eligible to receive development milestone payments and royalty payments on net sales of products, including sales from sublicense agreements.

Operational Updates

Appointed new members to the board of directors: In February 2020, Alex C. Sapir was appointed to the board of directors. In March 2019, Richard A. van den Broek was appointed to the board of directors.

Expanded executive management team: In October 2019, PhaseBio announced the appointment of Kris Hanson as Vice President, Head of Legal and Glen Burkhardt as Vice President of Human Resources. Mr. Hanson oversees and manages the company’s legal affairs, including support of clinical development efforts, strategic and licensing transactions, corporate governance, compliance and other key areas. Mr. Burkhardt oversees management of human resources at PhaseBio.

Completed underwritten public offering of common stock: In April 2019, PhaseBio closed an underwritten public offering of 4.1 million shares of its common stock at a price to the public of $12.00 per share, including shares sold pursuant to the full exercise of the underwriters’ option to purchase additional




shares. PhaseBio received $46.2 million in net proceeds, after deducting underwriting discounts and commissions and offering expenses.

Fourth Quarter and Full-Year 2019 Financial Results

Cash Position

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.

Results of Operations

Quarter Ended December 31, 2019
 
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.
 
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. 
 
Research and development expense increased to $8.4 million for the three months ended December 31, 2019, compared to $5.7 million for the three months ended December 31, 2018, reflecting an increase in manufacturing, clinical and preclinical development activities related to PB2452 and PB1046.
 
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.

Year Ended December 31, 2019

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.
 
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.
 
Research and development expenses increased to $30.9 million for the year ended December 31, 2019, compared to $15.5 million for the year ended December 31, 2018, reflecting an increase in manufacturing, clinical and preclinical development activities related to PB2452 and PB1046.
 
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.





About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases. The company’s pipeline includes: PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor; 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 (ELP) technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, 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.
 
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,” “projects,” 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 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 (“SEC”) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 14, 2019, and in our Annual Report on Form 10-K for the year ended December 31, 2019, which we intend to file shortly hereafter. 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)
 
 
 
 
 
 
 
December 31, 2019
 
December 31, 2019
Assets:
 
 
 
 
Cash and cash equivalents
 
$
74,025

 
$
61,031

Other receivables, prepaid expenses and other current assets
 
4,798

 
1,597

Property and equipment, net
 
1,924

 
355

Operating lease right-of-use assets
 
1,715

 

Other non-current assets
 
32

 
43

Total assets
 
$
82,494

 
$
63,026

 
 
 
 
 
Liabilities and stockholders' equity:
 
 
 
 
Current portion of long-term debt
 
$
2,378

 
$

Accounts payable, accrued expenses and other current liabilities
 
6,101

 
4,577

Long-term debt, net
 
12,326

 
7,500

Operating lease liabilities, net
 
1,508

 

Other long-term liabilities
 
203

 

Deferred rent
 

 
22

Stockholders' equity
 
59,978

 
50,927

Total liabilities and stockholders' equity
 
$
82,494

 
$
63,026







Statements of Operations
(in thousands, except share and per share amounts)
 
 
 
 
 
 
 
Quarter Ended December 31,
 
Year Ended December 31,
 
 
2019
 
2018
 
2019
 
2018
 
 
 
 
 
 
 
 
 
Revenue:
 
 
 
 
 
 
 
 
Grant revenue
 
$
689

 
$
257

 
$
1,786

 
$
668

Revenue under collaborative agreement
 
75

 

 
575

 

Total revenue
 
764

 
257

 
2,361

 
668

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
8,381

 
5,676

 
30,911

 
15,455

General and administrative
 
3,663

 
2,241

 
11,186

 
4,857

Total operating expenses
 
12,044

 
7,917

 
42,097

 
20,312

Loss from operations
 
(11,280
)
 
(7,660
)
 
(39,736
)
 
(19,644
)
Other (expense) income
 
(51
)
 
2,792

 
489

 
(4,202
)
Net loss
 
$
(11,331
)
 
$
(4,868
)
 
$
(39,247
)
 
$
(23,846
)
 
 
 
 
 
 
 
 
 
Net loss per common share, basic and diluted
 
$
(0.39
)
 
$
(0.26
)
 
$
(1.43
)
 
$
(4.49
)
 
 
 
 
 
 
 
 
 
Weighted average common shares outstanding, basic and diluted
 
28,762,962

 
18,824,091

 
27,493,558

 
5,305,062



###
Investor Contact:
John Sharp
PhaseBio Pharmaceuticals, Inc.
Chief Financial Officer
(610) 981-6506
john.sharp@phasebio.com

Media Contact:
Will Zasadny
Canale Communications
(619) 961-8848
will@canalecomm.com

phasebiocorporateoverc5e
Corporate Overview March 2020


 
Legal Disclaimer This presentation includes forward-looking statements. All statements contained in this presentation other than statements of historical facts, including statements regarding future results of operations and financial position of PhaseBio Pharmaceuticals, Inc. (“we,” “us” or “our”) our business strategy and plans, the preclinical and clinical development of our product candidates and our objectives for future operations, are forward-looking statements. The words “anticipate,” believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “will” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, clinical development, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-K for the year ended December 31, 2019. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of this presentation to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this presentation 2 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Company Overview Therapeutic Focus Clinical-stage biopharma company focused on the development and commercialization of novel therapies to treat cardiopulmonary indications PB2452 – Novel agent for immediate and sustained reversal of ticagrelor, the preferred antiplatelet therapy of the American College of Cardiology, the American Heart Association and European Society of Cardiology Product Candidates PB1046 – Once-weekly novel treatment for pulmonary arterial hypertension (PAH), based on elastin-like polypeptide (ELP) technology, that is vasodilatory, potentially disease-modifying and complementary to current standard-of-care therapies PB6440 – Oral aldosterone synthase inhibitor in early development for treatment-resistant hypertension ELP Technology Platform Technology • Extends circulating half-life of proteins and peptides, enhances solubility, stability and bioavailability while providing a sustained-release mechanism • Creates product candidates that are straightforward to manufacture and administer 2019  PB2452 Q1 2019 Publication of results of Phase 1 study in New England Journal of Medicine  PB2452 Q2 2019 Granted Breakthrough Therapy designation by United States Food and Drug Administration (FDA)  PB2452 Q3 2019 Completed Phase 2a trial in older/elderly subjects, and healthy subjects receiving supratherapeutic doses of ticagrelor  PB2452 Q4 2019 Initiated Phase 2b trial in older/elderly subjects to support Biologics License Application (BLA) safety database Milestones & Catalysts 2020  PB2452 Q1 2020 Executed PB2452 funding and co-development agreement with SFJ Pharmaceuticals  PB2452 Q1 2020 Granted PRIority MEdicines (PRIME) designation by European Medicines Agency (EMA)  PB2452 Q1 2020 Initiated Phase 3 trial based on plan to pursue accelerated approval pathway PB1046 2021 Reporting of Phase 2b data 3 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
A Clinical Stage, Cardiopulmonary Focused Biopharmaceutical Company Program Indication/Therapeutic Area Pre-Clinical Phase 1 Phase 2 Phase 3 WW Commercial Rights Milestones Q1 2020: • Initiated Phase 3 trial Reversal of Ticagrelor Phase 3 ongoing PB2452 based on plan to pursue Breakthrough Therapy designation granted in April 2019 Antiplatelet Activity accelerated regulatory pathway Pulmonary Arterial Phase 2b ongoing 2021: • Reporting of Phase 2b PB1046 (Enrollment paused due to COVID-19 risk to PAH patients) Hypertension (PAH) trial results IND-enabling 1H 2021: Resistant Hypertension • Plan to initiate first-in- PB6440 activities human clinical trial Partnering Opportunities GLP2-ELP Short Bowel Syndrome Late research CNP-ELP Achondroplasia Late research Early PROPRIETARY LONG ACTING INJECTABLE RECOMBINANT BIOPOLYMERS Programs (Elastin-like Polypeptides – ELPs) 4 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Corporate


 
Creating Value for Stakeholders in 2020 • Following a successful 2019, PhaseBio continues a rapid pace of development and execution in 2020  Announced innovative funding and co-development collaboration for PB2452 with SFJ Pharmaceuticals  Bolstered pipeline with acquisition of resistant hypertension asset, PB6440  Granted EMA PRIME designation for PB2452  Initiated pivotal Phase 3 trial for PB2452 in March 2020 • Experienced management team • Lead program (PB2452) funded through potential approvals in key global markets • Novel, first-in-class program for PAH (PB1046) being developed using ELP platform technology • Evolving focus on high-unmet need areas of cardiovascular disease with new pipeline asset (PB6440) 6 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Fourth-Quarter 2019 Financial Highlights • Operating expense: $12.0M − R&D: $8.4M − SG&A: $3.7M • Loss from Operations: ($11.3M) • Net Loss of ($11.3M) or ($0.39) per share − 28.8M shares used for computing Q4 2019 net loss per share • Cash and cash equivalents as of 12/31/2019: $74.0M All values in USD millions except share counts and net loss per share 7 Numbers may not sum to totals due to rounding Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Experienced Management Team JONATHAN MOW Amylin Pharmaceuticals, Corus Pharma, Chief Executive Officer PathoGenesis, BMS SUSAN ARNOLD, PhD Targeted Genetics, Viromed Biosafety Labs, VP of Preclinical & CMC BioRexis, NuPathe JIM BALLANCE, PhD Delta Biotechnology, Aventis Behring, BioRexis VP Research & Scientific Affairs GLEN BURKHARDT Hologic, Onyx Pharmaceuticals, Eli Lilly VP Human Resources KRIS HANSON Nalpropion, Orexigen, Morrison & Foerster LLP VP Legal JOHN LEE, MD, PhD, FACC Merck, BMS, Quintiles Chief Medical Officer JOHN SHARP Ligand Pharmaceuticals, HUYA Bioscience, Chief Financial Officer Sequenom, Diversa MICHAEL YORK Orexigen, Amylin Pharmaceuticals, Santarus, VP Corp Development & Commercial Strategy Amgen, AstraZeneca 8 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB2452 – Reversal Agent for Ticagrelor


 
PB2452 - Novel reversal agent for Brilinta (ticagrelor) • Within the P2Y12 antagonist class of oral antiplatelet therapies, ticagrelor has proven superiority vs. clopidogrel, and a unique reversible binding profile − Clopidogrel and prasugrel, the other members of the oral P2Y12 antagonist class, both permanently bind to the receptor and cannot be reversed • PB2452 is the only specific reversal agent in development for ticagrelor − PB2452 clinical data to date have demonstrated both immediate (<5 min) and sustained reversal (~24 hours) of ticagrelor antiplatelet effects • Approval would differentiate ticagrelor on safety vs. other oral antiplatelet agents − Expect further differentiation of ticagrelor vs. other P2Y12 agents to drive increased demand Significant unmet need for antiplatelet agent reversal Major Bleeding Urgent Surgery or Intervention • Intracranial Haemorrhage (ICH), GI, Trauma • Currently oral P2Y12 agents, including ticagrelor, require a 5 day washout prior to surgery1,2 • All oral antiplatelet agents have the potential to cause major bleeding, which can be severe or even fatal . Urgent surgery often cannot wait 5 days . Higher thrombotic risk during washout • PB2452 designed to immediately and sustainably reverse the antiplatelet effects of ticagrelor • In Phase 1 and Phase 2a studies, PB2452 observed to immediately and sustainably reverse ticagrelor inhibition of platelet activation . Enables immediate surgery 1. Plavix/clopidogrel Prescribing Information: https://packageinserts.bms.com/pi/pi_plavix.pdf, https://www.ema.europa.eu/en/documents/product-information/plavix-epar-product-information_en.pdf 10 2. Brilinta/Brilique/ticagrelor Prescribing Information: https://www.azpicentral.com/brilinta/brilinta.pdf#page=1, https://www.ema.europa.eu/en/documents/product-information/brilique-epar-product-information_en.pdf Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB2452: Well-Characterized Mechanism of Reversal of Ticagrelor Ticagrelor PB2452 ADP This is a reversible ADP ADP process with P2Y12 ticagrelor cycling Platelet Receptor on/off the P2Y12 receptors ADP binds to P2Y12 receptor Ticagrelor binds to P2Y12, inhibiting PB2452 binds to free ticagrelor 1. causing platelet aggregation 2. ADP-induced platelet aggregation 3. with very high affinity ADP ADP ADP Platelet 4. PB2452:ticagrelor binding is 5. As free ticagrelor is eliminated, 6. PB2452:ticagrelor is eliminated preferential to ticagrelor:P2Y12 ADP can again activate the P2Y12 from the bloodstream binding receptor, restoring platelet activity 11 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Clinical Studies PB2452: Development and Regulatory Timelines BLA enabling data 2019 2020 2021 2022 2023 NEJM Phase 2a Phase 2b: Older and elderly subjects N=200, 150 randomized to receive PB2452 Breakthrough FDA Therapy EOP1 Phase 3 Interim Analysis for Accelerated Approval Post-approval completion of Phase 3 EMA PRIME Designation N=100, ~50 major bleeding subjects, ~50 urgent surgery subjects N=100, ~50 major bleeding subjects, ~50 urgent surgery subjects Targeting BLA Submission for Accelerated Approval • Phase 2b initiated in October 2019 − N=200 total, evaluation of efficacy and overall safety of PB2452 in older and elderly subjects on DAPT • Phase 3 initiated in March 2020 − N=200 total, evaluation of efficacy in ticagrelor-treated subjects with major bleeding events or requiring urgent surgery − Interim analysis of first 100 patients recommended by FDA for BLA submission for Accelerated Approval NEJM= New England Journal of Medicine, EOP1=End-of-Phase 1 Meeting, DAPT=Dual antiplatelet therapy (ticagrelor + aspirin), BLA=Biologics License Application 12 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB2452 Phase 1 Proof-of-Concept Study in Healthy Subjects • Randomized, double-blind, placebo-controlled, single ascending dose (SAD), sequential group study (n=64) • Platelet function evaluated using three well established and commonly used assays: LTA, VerifyNow PRUTest® and VASP − Results from all three assays were highly correlated • Onset of reversal occurred within 5 minutes and was sustained for over 20 hours • Well tolerated with no drug-related serious adverse events Selected as late-breaking oral presentation during featured clinical research session at the • Importantly, no evidence of rebound in platelet activity American College of Cardiology’s Annual Scientific Session – March 17, 20191 after drug cessation Simultaneously published in the New England Journal of Medicine2 LTA = light transmittance aggregometry, VASP = vasodilator stimulated phosphoprotein phosphorylation immunoassay 1. https://www.acc.org/latest-in-cardiology/clinical-trials/2019/03/15/21/37/ticagrelor-reversal-agent 13 2. Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. https://www.nejm.org/doi/full/10.1056/NEJMoa1901778 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Normalized Platelet Function After Ticagrelor Reversal VerifyNow PRUTest Normal Platelet Inhibited Platelet Return to Normal Function: Pre- Function: Post- Platelet Function: Ticagrelor Dosing Ticagrelor Dosing Post-PB2452 Dosing Normal Platelet Function Inhibited Platelet Function PRU= Platelet Reactivity Units Cohorts 9 and 10 achieved study objectives and are the basis for dosing regimens for subsequent clinical trials  Dose-dependent response across all cohorts tested  Rapid resumption of ticagrelor dosing post infusion  Immediate reversal within 5 minutes of start of infusion  Well tolerated across all cohorts  Sustained duration of reversal extended to 20+ hours  No drug-related SAEs Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. https://www.nejm.org/doi/full/10.1056/NEJMoa1901778 Presented by Dr. Deepak L. Bhatt at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 17, 2019. Slides available at: https://www.acc.org/~/media/Clinical/PDF-Files/Approved-PDFs/2019/03/15/ACC19_Slides/Mar17_Sun/3pmET_Ticagrelor-Reversal-Agent- 14 acc-2019.pdf Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Positive Preliminary PB2452 Phase 2a Results • Positive preliminary results from the PB2452 Phase 2a trial were disclosed via press release1 − First trial of PB2452 to include older and elderly subjects (ages 50-80) on dual antiplatelet therapy (DAPT) of ticagrelor and low-dose aspirin − Subjects in the trial resembled the patient population most likely to be treated with ticagrelor and potentially benefit from PB2452, if approved • Per FDA request, the Phase 2a trial also explored reversal of supratherapeutic blood levels of ticagrelor that could result from ticagrelor overdosage or drug-drug interactions − PhaseBio believes an appropriate PB2452 regimen has been identified for these patients • Confirmed dosing regimen to be used in the Phase 2b and Phase 3 trials • Results to be presented at an upcoming medical congress Older & Elderly Subjects Supratherapeutic Dose PB2452 Phase 2a Trial on DAPT of Ticagrelor Immediate and sustained reversal of the antiplatelet effects of ticagrelor ✔ ✔ Efficacy demonstrated using same three assays used in Phase 1 trial2 ✔ ✔ Results highly correlated across assays ✔ ✔ Generally well tolerated with only minor adverse events reported ✔ ✔ 1. https://investors.phasebio.com/news-releases/news-release-details/phasebio-announces-completion-phase-2a-clinical-trial-pb2452 15 2. Bhatt, D. L. et al. Antibody-based ticagrelor reversal agent in healthy volunteers. N. Engl. J. Med. https://doi.org/10.1056/NEJMoa1901778 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB2452 Regulatory Updates Development plan for PB2452 designed with objective to broadly support global regulatory filings Separate written guidance from FDA and EMA indicates that a single, non-randomized, open-label Phase 3 trial of PB2452 in both surgical and major bleeding populations has the potential to support regulatory filings in the United States and the European Union EMA: • Received written Scientific Advice: February 2020 − Written guidance from the CHMP of the EMA generally agrees with PhaseBio’s proposed development plan for PB2452 • Granted PRIME designation: February 2020 − PRIME designation granted by the EMA to support medicines that demonstrate the potential to address substantial unmet medical need1 − Potentially expedites the review and approval process FDA: • Received meeting minutes from PB2452 End-of-Phase 1 meeting: August 2019 − FDA alignment on development plan and Accelerated Approval regulatory path • PB2452 granted Breakthrough Therapy designation: April 2019 − Breakthrough Therapy designation is designed to expedite the development and review of promising new drugs2 1. The European Medicines Agency. “PRIME: Priority Medicines” Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines#. Accessed February 2020 16 2. The U.S. Food and Drug Administration. “Expedited Programs for Serious Conditions – Drugs and Biologics.” Available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf. Accessed February 2020 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB2452 Pivotal Phase 3 Trial Overview • Phase 3 trial is a key element of development plan that has garnered FDA Breakthrough Therapy and EMA PRIME designations • Open-label, single-arm study of reversal of the antiplatelet effects of ticagrelor with PB2452 in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure • Total of 200 patients targeted for enrollment − 100 patients from major bleeding population, 100 patients from urgent surgery population − First ~50 patients from each of the respective target populations (total of ~100) will form the basis of accelerated BLA filing in US and MAA in EU • Accelerated BLA endpoint is of platelet function based on VerifyNow® PRUTest® platelet function assay − VerifyNow has been used in the Phase 1, Phase 2a and ongoing Phase 2b trials of PB2452 with consistent results across studies completed to date • Additional clinical endpoints related to hemostasis will also be captured as part of the primary outcome analysis • Trial posted online at https://www.ClinicalTrials.gov and initiated in March 2020 17 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
SFJ Pharmaceuticals Funding and Co-Development Collaboration • Innovative collaboration between SFJ and PhaseBio to support the global development of PB2452 • SFJ will fund up to $120 million to support the clinical development of PB2452 − SFJ has extensive experience in the global clinical development and regulatory approval of numerous pharmaceutical products across multiple indications and therapeutic areas • SFJ will assume a central role in global development and regulatory activities for PB2452 outside the United States − SFJ will lead development and regulatory activities in China and Japan − PhaseBio and SFJ and will work closely on clinical program in EU − PhaseBio is conducting Phase 3 trial in US • PhaseBio retains exclusive worldwide commercial rights to PB2452 18 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Expect Continued Long-Term Rx Growth of Ticagrelor PB2452 approval has the potential to drive continued positive momentum • Brilinta/Brilique sales in 2019 were $1.58B and growing (+20% Y/Y) − Patient growth drives Y/Y revenue growth in key regions: strong growth in the United States and Emerging Markets • In February 2019, Brilinta Phase 3 THEMIS1 trial met primary endpoint in patients with established coronary artery disease and type-2 diabetes • In January 2020, Brilinta Phase III THALES2 trial met primary endpoint in patients with acute ischemic stroke or patients with high-risk transient ischemic attack Ticagrelor Differentiation Now Post PB2452 Launch Post LOE of ticagrelor vs. clopidogrel Efficacy ✔ ✔ ✔ Safety ✔ ✔ (no reversal≈ agent) Price   ✔ (branded vs. generic) (branded vs. generic) 1. https://www.astrazeneca.com/media-centre/press-releases/2019/brilintas-phase-iii-themis-trial-met-primary-endpoint-in-patients-with-established-coronary-artery-disease-and-type-2-diabetes-25022019.html 19 2. https://www.astrazeneca.com/media-centre/press-releases/2020/brilinta-met-primary-endpoint-in-phase-iii-thales-trial-in-stroke-27012020.html Copyright © 20202019 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB1046 - Once Weekly Vasoactive Intestinal Peptide (VIP) Analog for Pulmonary Arterial Hypertension


 
High Unmet Need in an Orphan Disease Primary Pulmonary Arterial Hypertension (PAH, WHO Group 1 PH) McGlaughlin et al. (2015) J. Am. Coll. Cardiol., 65:18 • High unmet need for novel disease-modifying PAH therapies for greater efficacy − All 3 approved drug classes in PAH are vasodilators: prostacyclin, endothelin, and nitric oxide pathways − Patients inevitably continue to decline and die on current standard of care • VIP addresses PAH vasoconstriction, progressive vascular remodeling, and right heart failure 21 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB1046: Harnessing VIP to Create a Stable, Long-Acting Drug VIP as a THERAPEUTIC AGENT VPAC2 VPAC2 VPAC1 VPAC1 VIP Peptide PB1046 Half-Life ~ 1 minute in Humans Half-Life ~60 Hours in Humans PRECLINICAL STUDIES MECHANISM OF ACTION VIA VPAC2 RECEPTOR Support Clinical Development for: • Potent vasodilator • Pulmonary Arterial Hypertension • Anti-inflammatory and anti-fibrotic • DMD Cardiomyopathy • Cardiac support through increased • Heart Failure (Chemotherapy-Induced HF inotropy and lusitropy or HFpEF) • Cystic Fibrosis 22 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
Proprietary Elastin-Like Polypeptide (ELP) Technology Key to optimizing the profile of an injectable VIP product candidate PROLONGED CIRCULATING HALF-LIFE COACERVATION DELIVERS SLOW RELEASE “Biopolymer” Outside Body Inside Body Repeating ↑ Active Moiety Sequence of Temperature Human Elastin Peptides VPGXG Peptide/Protein n (VIP, GLP1, etc.) Highly Soluble ELP Non-Soluble ELP UP TO 200x INCREASE IN ½ LIFE WEEKLY OR MONTHLY DOSING IMPROVING • Pharmacokinetics • Slower rate of bioavailability • Ease of Administration • Patient Compliance 23 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB1046 Clinical Development Activities to Date Have Supported Advancement into a Phase 2b PAH Efficacy Study PHASE 1 Studies Completed PAH PHASE 2 Studies SAD study in HTN 4-week MAD study Open-Label Phase 2a Phase 2b PAH Efficacy patients washed in HFrEF patients CardioMEMS in PAH study: Safety 16-Wk Randomized, Controlled off meds on SOC and Hemodynamics Study CardioMEMS Open-Label PAH Study • Well tolerated for a week • Well tolerated across dose range; Phase 2b PAH 16 wk randomized, controlled over broad range of no drug-related SAEs • N = 3 patients, dosed weekly for 8 wks, exposure; no drug-related followed by extension study SAEs • Replicated PK/PD from SAD over 4 • No longer enrolling patients • N = ~60 NYHA class II/III PAH patients, weekly SC injections • Real-time PA pressure and other dosed weekly x 16 weeks • Prolonged PK/PD profile hemodynamic monitoring over 1 week • VIP activity reproduced in HFrEF • Individual dose titration to MTD patients on SOC • Initial data show improved hemodynamics • VIP activity confirmed • Efficacy endpoints PVR via RHC, 6MWD (Systolic and Diastolic BP • One drug-related SAE reported in Extension study to follow lowering) extension portion of open-label pilot study • COMPLETED COMPLETED Phase 2b enrollment temporarily COMPLETED paused due to COVID-19 risk 24 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB6440 – Aldosterone Synthase Inhibitor for Resistant Hypertension


 
PB6440 for Resistant Hypertension • Upwards of 10 million patients in the United States have resistant hypertension and are at risk for serious, costly medical consequences (stroke, heart attack, kidney failure, etc.)1 • Physicians currently prescribe numerous combinations of antihypertensives to lower blood pressure and diminish risk • Blocking aldosterone has been shown to be an effective mechanism for treating resistant hypertension − Currently available aldosterone blockers suffer from poor potency and pharmacokinetics (eplerenone) or poor tolerability (spironolactone) and thus are rarely used • Recent draft guidance from the FDA outlines a streamlined regulatory path for novel drugs to treat resistant hypertension without the need for large outcomes studies2 • Market research indicates that payors aware of high medical costs associated with resistant hypertension Large, growing patient population coupled with a high unmet need creates an attractive opportunity for a novel therapy to help patients and care providers better manage blood pressure 1. Carey RM, Sakhuja S, Calhoun DA, Whelton PK, Muntner P. Prevalence of apparent treatment‐resistant hypertension in the United States: comparison of the 2008 and 2018 American heart association scientific statements on resistant hypertension. Hypertension. 2019; 73: 424‐ 431. Available at: https://www.ahajournals.org/doi/full/10.1161/HYPERTENSIONAHA.118.12191?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed. Accessed February 2020 26 2. U. S. Food and Drug Administration. Center for Drug Evaluation and Research. (2018) Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension- conducting-studies-drugs-treat-patients-background-multiple-antihypertensive-drugs. Accessed February 2020 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved


 
PB6440 is Highly Selective for Aldosterone Synthase (CYP11B2) Selectivity and Potency Demonstrated in Primate Chronic Oral Dosing Model CYP11B Potency and Selectivity (IC50, µM) Human Monkey CYP11B2 CYP11B1# Selectivity CYP11B2 CYP11B1 Selectivity PB6440 PB6440 PB6440 0.024 4.859 202 0.016 5.802 363 LCI699* 0.0007 0.013 19 0.016 0.059 3.7 # Steroid 11β-hydroxylase *Discontinued Novartis compound; active in P2 studies, but blocked cortisol production, likely due to inadequate selectivity # 11-Deoxycorticosterone # # 11-Deoxycorticosterone In a primate model, oral PB6440 demonstrated a sustainable reduction in aldosterone without a significant increase in steroids upstream of CYP11B1, suggesting no significant inhibition of CYP11B1 in vivo 27 Copyright © 2020 PhaseBio Pharmaceuticals, Inc. All Rights Reserved