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 second quarter ended June 30,
2019 and provided a corporate update.
“The second quarter of 2019 marked an important
period in the evolution of PhaseBio, punctuated by the successful
accomplishment of several critical milestones,” said Jonathan P.
Mow, Chief Executive Officer of PhaseBio. “We reported positive
preliminary results from our Phase 2a trial of PB2452 for the
reversal of the antiplatelet activity of ticagrelor in older and
elderly subjects also taking aspirin, which resembles the patient
population most likely to be treated with ticagrelor and
potentially benefit from PB2452, if approved. We also received
Breakthrough Therapy designation for PB2452 and completed an
upsized and oversubscribed underwritten public offering of our
common stock, which generated net proceeds of $46.3 million. Our
achievement in the second quarter of key regulatory and development
milestones, coupled with an infusion of capital has positioned us
well to continue advancing our lead program, PB2452, while building
the infrastructure necessary to execute a successful commercial
launch, if approved, and ensure broad availability of this
potentially life-saving therapy.”
Second Quarter and Recent Corporate
Progress
- Reported positive
preliminary PB2452 Phase 2a results: In June 2019,
PhaseBio announced positive preliminary results from the Phase 2a
trial of PB2452 for the reversal of the antiplatelet activity of
ticagrelor in older and elderly subjects. This is the first trial
of PB2452 to include older (ages 50-64) and elderly (ages 65-80)
subjects on dual antiplatelet therapy of ticagrelor and low-dose
aspirin. Subjects in the trial resemble the patient population most
likely to be treated with ticagrelor and potentially to benefit
from PB2452, if approved. In the trial, statistically significant
reversal of ticagrelor was achieved within 5 minutes of initiation
of PB2452 infusion and sustained for over 20 hours. Platelet
function was normalized by 15 minutes following initiation of
PB2452 infusion and remained in the normal range for over 20 hours.
In these subjects, PB2452 was generally well tolerated, with only
minor adverse events reported.
- 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 $46.3 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.
- 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. PhaseBio
received an upfront payment upon execution of the agreement and is
eligible to receive development milestone payments and mid-single
digit royalty payments on net sales of products, including sales by
sublicensees.
Upcoming Milestones
- Complete Phase 2a trial of PB2452
in the fourth quarter of 2019.
- Initiate Phase 2b trial of PB2452
in the fourth quarter of 2019.
- Initiate Phase 3 trial of PB2452 in
2020.
Second Quarter 2019 Financial Results
Cash Position
Cash and cash equivalents at June 30, 2019 were
$90.3 million, compared to $61.0 million at December 31, 2018. The
increase primarily reflects proceeds from the underwritten public
offering of common stock completed in April, partially offset by
cash used in operating activities.
Results of Operations
Three Months Ended June 30, 2019
PhaseBio reported a net loss of $9.2 million for
the three months ended June 30, 2019, compared with a net loss of
$6.7 million for the same period in 2018. This resulted in a net
loss of $0.33 per share for the three months ended June 30, 2019,
compared to a net loss of $8.95 per share for the corresponding
period in 2018, on both a basic and diluted basis.
Grant revenue was $0.2 million for the three
months ended June 30, 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 June
30, 2018.
Revenue under collaborative agreements was $0.5
million for the three months ended June 30, 2019 and related to the
agreement with ImmunoForge. PhaseBio did not record any revenue
under collaborative agreements for the three months ended June 30,
2018.
Research and development expense increased to
$7.8 million for the three months ended June 30, 2019, as
compared to $3.2 million for the three months ended June 30,
2018, reflecting increased costs associated with preclinical and
clinical development activities largely related to PB2452 and
increased personnel costs.
General and administrative expense increased to
$2.4 million for the three months ended June 30, 2019, compared to
$0.9 million for the three months ended June 30, 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 or timing of our clinical trials
and our research, development and regulatory plans for PB2452,
PB1046 and our ELP research programs. 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 thereof, 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. |
Condensed Balance Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
90,342 |
|
|
$ |
61,031 |
|
Other receivable, prepaid expenses and other current assets |
|
|
4,555 |
|
|
|
1,597 |
|
Property and equipment, net |
|
|
677 |
|
|
|
355 |
|
Operating lease right-of-use assets |
|
|
1,832 |
|
|
|
— |
|
Other non-current assets |
|
|
32 |
|
|
|
43 |
|
Total assets |
|
$ |
97,438 |
|
|
$ |
63,026 |
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
Current portion of long-term debt |
|
$ |
1,265 |
|
|
$ |
— |
|
Accounts payable, accrued expenses and other current
liabilities |
|
|
4,481 |
|
|
|
4,577 |
|
Long-term debt |
|
|
8,429 |
|
|
|
7,500 |
|
Operating lease liabilities |
|
|
1,598 |
|
|
|
— |
|
Other long-term liabilities |
|
|
56 |
|
|
|
— |
|
Deferred rent |
|
|
— |
|
|
|
22 |
|
Stockholders’ equity |
|
|
81,609 |
|
|
|
50,927 |
|
Total liabilities and stockholders' equity |
|
$ |
97,438 |
|
|
$ |
63,026 |
|
|
|
|
|
|
|
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PhaseBio Pharmaceuticals, Inc. |
Condensed Statements of Operations |
(in thousands, except share and per share
amounts) |
(unaudited) |
|
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|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
203 |
|
|
$ |
— |
|
|
$ |
856 |
|
|
$ |
— |
|
Revenue under collaborative agreement |
|
|
500 |
|
|
|
— |
|
|
|
500 |
|
|
|
— |
|
Total Revenue |
|
|
703 |
|
|
|
— |
|
|
|
1,356 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
7,781 |
|
|
|
3,190 |
|
|
|
13,502 |
|
|
|
5,425 |
|
General and administrative |
|
|
2,404 |
|
|
|
917 |
|
|
|
4,720 |
|
|
|
1,560 |
|
Total operating expenses |
|
|
10,185 |
|
|
|
4,107 |
|
|
|
18,222 |
|
|
|
6,985 |
|
Loss from operations |
|
|
(9,482 |
) |
|
|
(4,107 |
) |
|
|
(16,866 |
) |
|
|
(6,985 |
) |
Other income (expense) |
|
|
250 |
|
|
|
(2,567 |
) |
|
|
341 |
|
|
|
(4,092 |
) |
Net loss |
|
$ |
(9,232 |
) |
|
$ |
(6,674 |
) |
|
$ |
(16,525 |
) |
|
$ |
(11,077 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(8.95 |
) |
|
$ |
(0.63 |
) |
|
$ |
(14.85 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted |
|
|
27,932,610 |
|
|
|
745,812 |
|
|
|
26,224,986 |
|
|
|
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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