PhaseBio Reports First Quarter 2019 Financial Results and Recent Corporate Progress
May 09 2019 - 4:01PM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for orphan diseases, today
reported financial results for the first quarter ended March 31,
2019 and provided a corporate update.
“Our priorities for 2019 include advancing our
clinical stage development programs, creating value by partnering
our early-stage programs and building on our strong financial
position,” said Jonathan P. Mow, Chief Executive Officer of
PhaseBio. “We have recently made significant progress on all three
fronts: presenting positive Phase 1 results and receiving
Breakthrough Therapy designation for our lead program, PB2452;
signing a licensing agreement with ImmunoForge for PB1023; and
completing an upsized and oversubscribed underwritten public
offering of our common stock, which generated net proceeds of $46.2
million. With our first quarter performance and recent developments
providing a strong tailwind, we are in an excellent position to
execute on our strategic objectives, which are focused on
delivering important medicines to patients with significant unmet
medical needs.”
First Quarter and Recent Corporate Progress
- 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.
- Received Breakthrough Therapy designation for
PB2452: In April 2019, PhaseBio announced that the U.S.
Food and Drug Administration (“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.
- Reported and published PB2452 Phase 1 results:
In 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, “An 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.
- Secured up to $15.0 million term loan
facility: In March 2019, PhaseBio entered into a $15.0
million term loan facility with Silicon Valley Bank (“SVB”) and
WestRiver Innovation Lending Fund. PhaseBio received an initial
tranche of $7.5 million upon execution of the loan agreement and
used the funds to repay its existing term loan with SVB in full. A
second tranche of $2.5 million will be available through May 31,
2019. PhaseBio will draw the remaining funding of $5.0 million upon
the achievement of certain clinical milestones related to the
development of PB2452.
- PB1023 licensing deal: In April 2019, PhaseBio
announced it licensed to ImmunoForge, Co. Ltd. (“ImmunoForge”) the
global rights for PB1023, a long-acting, ELP-based GLP-1 agonist.
Under the terms of the agreement, PhaseBio granted ImmunoForge an
exclusive, worldwide license, with rights to sublicense, to PB1023
for the development and commercialization of treatments for all
diseases except diabetes, obesity and non-alcoholic steatohepatitis
(“NASH”). 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.
Upcoming
Milestones
- Dose the first patient in the Phase 2a trial of PB2452 in the
second quarter of 2019.
- Report preliminary data from the Phase 2a trial of PB2452 in
the second quarter of 2019.
- Initiate Phase 2b trial of PB2452 in the second half of
2019.
First
Quarter 2019 Financial Results
Cash Position
Cash and cash equivalents at March 31, 2019 were
$51.9 million, compared to $61.0 million at December 31, 2018. The
decrease primarily reflects cash used in operating activities.
Results of Operations
Three Months Ended March 31, 2019
PhaseBio reported a net loss of $7.3 million for
the three months ended March 31, 2019, compared with a net loss of
$4.4 million for the same period in 2018. This resulted in a net
loss of $0.30 per share for the three months ended March 31, 2019,
compared to a net loss of $5.90 per share for the corresponding
period in 2018, on both a basic and diluted basis.
Grant revenue was $0.7 million for the three
months ended March 31, 2019, as PhaseBio incurred allowable costs
qualifying for reimbursement under the government grants. PhaseBio
did not record any grant revenue for the three months ended March
31, 2018.
Research and development expense increased to
$5.7 million for the three months ended March 31, 2019,
as compared to $2.2 million for the three months ended March
31, 2018, reflecting an increase in manufacturing, clinical and
preclinical development activities primarily related to PB2452.
General and administrative expense increased to
$2.3 million for the three months ended March 31, 2019, compared to
$0.6 million for the three months ended March 31, 2018, primarily
attributable to increases in professional services including legal,
marketing and other consulting services, personnel expense due to
additional headcount and expenses associated with being a public
company.
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.
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 of our clinical trials and the
timing of the release of the results of our clinical trials.
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 March
31, 2019. 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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PhaseBio Pharmaceuticals, Inc. |
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Condensed Balance Sheets |
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(in thousands) |
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(unaudited) |
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March 31, 2019 |
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December 31, 2018 |
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Assets: |
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Cash and cash equivalents |
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$ |
51,894 |
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$ |
61,031 |
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Other receivable, prepaid expenses and other current assets |
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2,181 |
|
|
1,597 |
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Property and equipment, net |
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|
380 |
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355 |
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Operating lease right-of-use assets |
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1,899 |
|
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— |
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Other non-current assets |
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32 |
|
|
43 |
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Total assets |
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$ |
56,386 |
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$ |
63,026 |
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Liabilities and stockholders' equity: |
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Current portion of long-term debt |
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$ |
423 |
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$ |
— |
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Accounts payable, accrued expenses and other current
liabilities |
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3,374 |
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4,577 |
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Long-term debt |
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6,841 |
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|
7,500 |
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Operating lease liabilities |
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1,666 |
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— |
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Deferred rent |
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— |
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|
22 |
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Stockholders’ equity |
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44,082 |
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50,927 |
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Total liabilities and stockholders' equity |
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$ |
56,386 |
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$ |
63,026 |
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PhaseBio Pharmaceuticals, Inc. |
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Condensed Statements of Operations |
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(in thousands, except share and per share
amounts) |
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(unaudited) |
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Three Months Ended March 31, |
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2019 |
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2018 |
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Grant revenue |
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$ |
653 |
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$ |
— |
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Operating expenses: |
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Research and development |
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5,721 |
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2,235 |
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General and administrative |
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2,316 |
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643 |
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Total operating expenses |
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8,037 |
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2,878 |
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Loss from operations |
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(7,384 |
) |
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(2,878 |
) |
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Other income (expense) |
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91 |
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(1,525 |
) |
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Net loss |
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$ |
(7,293 |
) |
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$ |
(4,403 |
) |
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Net loss per common share, basic and diluted |
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$ |
(0.30 |
) |
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$ |
(5.90 |
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Weighted average common shares outstanding, basic and
diluted |
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24,498,388 |
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745,812 |
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Investor Contact:John SharpPhaseBio
Pharmaceuticals, Inc.Chief Financial Officer(610)
981-6506john.sharp@phasebio.com
Media Contact:Gina Cestari6 Degrees(917)
797-7904gcestari@6degreespr.com
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