8-K

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): November 27, 2018

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))

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  ☒

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.  ☒

Item 2.02    Results of Operations and Financial Condition.

On November 29, 2018, PhaseBio Pharmaceuticals, Inc. (the “Company”) reported financial results for the quarter ended September 30, 2018. 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01    Other Events.

On November 27, 2018, the Company issued a press release to announce that the Company has dosed the first patient in its Phase 2b clinical trial of PB1046 in pulmonary arterial hypertension. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits

Exhibit No.	Description
99.1	Press Release, dated November 29, 2018, titled “PhaseBio Reports Third Quarter 2018 Financial and Business Results.”
99.2	Press Release, dated November 27, 2018, titled “PhaseBio Announces Dosing of First Patient in Phase 2b Clinical Trial of PB1046 in Pulmonary Arterial Hypertension.”

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: November 29, 2018	By:	/s/ John Sharp
		John Sharp
		Chief Financial Officer

EX-99.1

Exhibit 99.1

PhaseBio Reports Third Quarter 2018 Financial and Business Results

Closed initial public offering that raised $43.0 million in net proceeds

Demonstrated proof of concept for PB2452, supporting continued development for the reversal of antiplatelet activity of ticagrelor

Malvern, PA, and San Diego, CA, Nov. 29, 2018 — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, with an initial focus on cardiopulmonary disorders, today reported financial results for the third quarter ended September 30, 2018, and provided an update on corporate activities.

“The significant corporate and clinical progress PhaseBio has achieved thus far in 2018 reflects our commitment to advancing innovative therapies in areas of high unmet need,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio. “The proceeds from our initial public offering will support the advancement of our clinical programs, PB1046 and PB2452. In November, we dosed the first patient in the Phase 2b trial of PB1046, which leverages our proprietary elastin-like polypeptide technology for the treatment of pulmonary arterial hypertension. Additionally, preliminary data from our recently completed Phase 1 trial of PB2452 support its continued development as a reversal agent for the antiplatelet therapy ticagrelor, and we look forward to initiating a Phase 2a trial of PB2452 in the first half of 2019.”

Third Quarter 2018 and Recent Corporate Progress

• Dosed first patient in PB1046 Phase 2b trial: In November, PhaseBio dosed the first patient in a multi-center, randomized, double-blind, parallel-group Phase 2b trial to evaluate the safety, tolerability and efficacy of PB1046 for the treatment of pulmonary arterial hypertension (“PAH”).

• Completed initial public offering: In October, PhaseBio closed an initial public offering of 9,864,666 shares of common stock at a public offering price of $5.00 per share, including shares sold pursuant to the partial exercise of the underwriters’ option to purchase additional shares. PhaseBio received $43.0 million in net proceeds, after deducting underwriting discounts and commissions and offering expenses.

• Reported preliminary PB2452 Phase 1 data: In September 2018, PhaseBio announced positive preliminary results from its Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor. PhaseBio has locked the trial database and confirmed that PB2452 achieved rapid, complete and sustained reversal of ticagrelor’s antiplatelet activity, with no PB2452-related adverse events or serious adverse events reported, consistent with the preliminary results described in PhaseBio’s final prospectus for its IPO, filed with the Securities and Exchange Commission on October 19, 2018. PhaseBio expects to present the data from this trial at a medical meeting in 2019.

• Completed Series D financing: In August, PhaseBio raised $17.7 million in net proceeds from the sale of Series D preferred stock. Existing investors participated in the financing as well as new investors,including Cormorant Asset Management, Rock Springs Capital and Mountain Group Partners.

• Provided update on development of PB1046 for PAH: In July, PhaseBio reported the completion of a Phase 1b/2a multiple ascending dose trial of PB1046 in patients with heart failure with reduced ejection fraction, as well as preliminary data from a pilot study of PB1046 in PAH patients. Results from these studies support the continued evaluation of PB1046 as a once-weekly subcutaneous injection for the treatment of PAH.

• Appointed Caroline M. Loewy to board of directors: In July, Caroline M. Loewy joined PhaseBio’s board of directors and was appointed Chair of the Audit Committee. Ms. Loewy currently serves on the Board of Directors and Audit Committees of CymaBay Therapeutics and Aptose Biosciences.

Upcoming Milestones

• Initiate Phase 2a trial of PB2452 in healthy older adults in the first half of 2019.

• PhaseBio expects to present the final data from the completed Phase 1 trial of PB2452 at a medical meeting in 2019.

Third Quarter 2018 Financial Results

Cash Position

Cash and cash equivalents at September 30, 2018 were $24.3 million, compared to $13.4 million at December 31, 2017. The increase reflects net proceeds from the issuance of Series D preferred stock and net proceeds from term loan borrowings, partially offset by cash used in operating activities. This amount does not reflect the net proceeds from the IPO, which closed after September 30, 2018.

Results of Operations

Three Months Ended September 30, 2018

The Company reported a net loss of $7.9 million for the three months ended September 30, 2018, which compared with a net loss of $2.6 million for the same prior year period. This resulted in a net loss of $10.45 per share for the three months ended September 30, 2018, as compared to a net loss of $3.44 per share for the corresponding period in 2017, on both a basic and diluted basis.

Grant revenues were $0.4 million for the three months ended September 30, 2018. The Company did not record any grant revenues for the three months ended September 30, 2017.  

Research and development expenses increased to $4.4 million for the three months ended September 30, 2018, as compared to $1.3 million for the three months ended September 30, 2017 reflecting an increase in clinical development activities related to PB2452.

General and administrative expenses were $1.1 million for the three months ended September 30, 2018 as compared to $0.6 million for the three months ended September 30, 2017.

About PhaseBio

PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary disorders. The company’s lead development candidate is PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is also leveraging its proprietary elastin-like polypeptide (“ELP”) technology platform to develop therapies with the potential for less-frequent dosing and improved pharmacokinetics. PhaseBio’s second product candidate, PB1046, is based on ELP and is a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of PAH.

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,” “anticipates,” and “future” or similar expressions are intended to identify forward-looking statements.

Forward-looking statements include statements concerning or implying the conduct of our clinical trials, the timing of the release of the results of our clinical trials, and our cash use. 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 September 30, 2018. 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.

Investor Contact:

John Sharp

PhaseBio Pharmaceuticals, Inc.

Chief Financial Officer

(610) 981-6506

john.sharp@phasebio.com

Media Contact:

Sarah Hall

6 Degrees

(215) 313-5638

shall@6degreespr.com

PhaseBio Pharmaceuticals, Inc.

Condensed Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2018			2017			2018			2017
Grant revenues	$	411		$	—		$	411		$	—
Operating expenses:
Research and development		4,354			1,330			9,779			4,387
General and administrative		1,056			565			2,616			1,700
Total operating expenses		5,410			1,895			12,395			6,087
Loss from operations		(4,999	)		(1,895	)		(11,984	)		(6,087	)
Other expense		(2,902	)		(665	)		(6,994	)		(1,625	)
Net loss	$	(7,901	)	$	(2,560	)	$	(18,978	)	$	(7,712	)
Net loss per common share, basic and       diluted	$	(10.45	)	$	(3.44	)	$	(25.33	)	$	(10.38	)
Weighted average common shares       outstanding, basic and diluted		755,908			743,241			749,198			743,241

PhaseBio Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)

(unaudited)

	September 30,			December 31,
	2018			2017
Assets:
Cash and cash equivalents	$	24,341		$	13,406
Other receivable, prepaid expenses and other current assets		627			340
Property and equipment, net		251			302
Deferred offering costs		2,218			—
Other non-current assets		51			51
Total assets	$	27,488		$	14,099
Liabilities, redeemable convertible preferred stock and        stockholders' deficit:
Convertible promissory notes, net of discount	$	—		$	12,095
Derivative liability		—			3,028
Current portion of long-term debt		3,125			761
Accounts payable and accrued expenses		4,563			1,711
Preferred stock warrant liability		5,990			1,656
Deferred rent		—			5
Long-term debt		4,375			2,625
Redeemable convertible preferred stock		125,609			89,634
Stockholders’ deficit		(116,174	)		(97,416	)
Total liabilities, redeemable convertible preferred stock and        stockholders' deficit	$	27,488		$	14,099

EX-99.2

Exhibit 99.2

 

PhaseBio Announces Dosing of First Patient in Phase 2b Clinical Trial of PB1046 in Pulmonary Arterial Hypertension

MALVERN, Pa. and SAN DIEGO, Calif., Nov. 27, 2018 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, with an initial focus on cardiopulmonary disorders, today announced that the first patient in a Phase 2b clinical trial of PB1046 for the treatment of pulmonary arterial hypertension (PAH) has been dosed by Murali Chakinala, M.D., Professor of Medicine at the Washington University School of Medicine (WUSM) and Director of the WUSM and Barnes-Jewish Hospital Pulmonary Hypertension Care Center. PB1046 is a sustained-release analogue of human vasoactive intestinal peptide (VIP) fused to PhaseBio’s proprietary ELP half-life extension technology.

The randomized, double-blinded, parallel-group Phase 2b trial will assess the safety, tolerability and efficacy of PB1046 injected subcutaneously once weekly in approximately 60 PAH patients. The trial will evaluate the effects of PB1046 on pulmonary hemodynamics and exercise tolerance as measured by the six-minute walk test, an important clinical endpoint that the U.S. Food and Drug Administrationhas used as the basis for approval of other PAH drugs.

“PB1046 leverages our ELP technology to harness the positive therapeutic effects and extend the half-life of native human VIP, which has previously been limited in its application as a therapeutic by its rapid degradation and potential for gastrointestinal side effects,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “PB1046 has been generally safe and well tolerated in early clinical trials and we are excited to investigate its potential benefits in PAH, a rare disease with high unmet need for innovative therapies. We look forward to reporting results from the Phase 2b trial in the first half of 2020.”

The Phase 2b trial of PB1046 in PAH is supported in part by a Fast-Track Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL140690. The content of this press release is solely the responsibility of PhaseBio and does not necessarily represent the official views of the National Institutes of Health.

Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03556020.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a progressive and life-threatening orphan disease caused by abnormal constriction and adverse remodeling of the arteries in the lungs, leading to chronically elevated blood pressure in the pulmonary arteries. This increased pressure restricts blood circulation through the lungs, resulting in poor oxygenation, abnormal strain on the heart’s right ventricle and underfilling of the left ventricle. Over time, the remodeling worsens as inflammatory cells are recruited. This leads to tissue scarring and fibrosis, which results in severe restriction of blood flow, increasing the risk of developing life-threatening blood clots, heart failure and premature death. None of the approved treatment options is curative and long-term prognosis remains poor.

About PB1046

PB1046, a novel, subcutaneously-injected VIP analogue, is a recombinant fusion protein composed of VIP and PhaseBio’s proprietary ELP biopolymer.

Based on the pharmacokinetic profile of PB1046 observed in clinical trials, the fusion of VIP to ELP results in both a prolonged absorption profile and a longer circulating half-life, enabling once-weekly dosing. In addition to VIP-mediated vasodilation, PB1046 may suppress the adverse remodeling of blood vessels and increase cardiac contractility and relaxation. PB1046 has been administered to more than 60 patients with hypertension or a history of cardiac disease in three Phase 1/2 clinical trials conducted in the U.S., with no drug-related serious adverse events to date.

The U.S. Food and Drug Administration has granted PB1046 orphan drug designation for the treatment of PAH (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with dystrophinopathies.

About PhaseBio

PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary disorders. The company’s lead development candidate is PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is also leveraging its proprietary elastin-like polypeptide (ELP) technology platform to develop therapies with the potential for less-frequent dosing and improved pharmacokinetics. PhaseBio’s second product candidate PB1046, which is based on ELP, is a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension (PAH).

PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.

###

Investor Contact:

John Sharp

PhaseBio Pharmaceuticals, Inc.

Chief Financial Officer

(610) 981-6506

john.sharp@phasebio.com

Media Contact:

Sarah Hall

6 Degrees

(215) 313-5638

shall@6degreespr.com