PhaseBio Reports Third Quarter 2019 Financial Results and Recent Corporate Progress
November 14 2019 - 8:00AM
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 third quarter ended
September 30, 2019 and provided a corporate update.
“Our recent achievement of several critical
milestones exemplifies our focus on execution as we continue the
rapid pace of development for our lead program, PB2452,” said
Jonathan P. Mow, Chief Executive Officer of PhaseBio. “The
advancement of this potentially life-saving therapy from Phase 1
development to registrational studies this year highlights the
benefits afforded by Breakthrough Therapy designation and the
Accelerated Approval pathway. We believe we remain well positioned
to initiate a Phase 3 trial in the first quarter of 2020 in major
bleeding and urgent surgical populations to support the submission
of a Biologics License Application (“BLA”) for potential
accelerated approval of PB2452. With global ticagrelor sales
growing 24% year over year in the third quarter of 2019, we
continue to see an increasing potential market for PB2452 and are
working aggressively to complete the pivotal studies and deliver
this therapy to patients in need.”
Third Quarter and Recent Corporate Progress
- 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 U.S. Food and Drug
Administration (“FDA”) that was held in July 2019. The EOP 1
meeting was focused on gaining alignment with the FDA regarding the
clinical and regulatory pathway for potential U.S. approval of
PB2452. Based on the FDA’s 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.
- 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. PB2452 was generally well tolerated, with only
minor adverse events reported. These results are consistent with
the results observed in healthy younger subjects treated with
ticagrelor in the previously published Phase 1 trial. Additionally,
based on guidance provided by the FDA during the PB2452 EOP 1
meeting, 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 and was
well tolerated, consistent with the earlier cohorts in the Phase 2a
and Phase 1 trials. Based on the preliminary 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.
- Initiated Phase 2b trial of PB2452: In October
2019, PhaseBio announced that the first patient had been dosed in a
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 Phase 2b
trial marks the beginning of FDA-aligned registrational trials to
support the submission of a BLA for potential accelerated approval
of PB2452. Approximately 200 older and elderly (ages 50-80)
subjects are expected to be enrolled, resembling the patient
population most likely to be treated with ticagrelor and
potentially benefit from PB2452, if approved. Subjects will be
randomized in a ratio of 3:1 and will receive either PB2452 or
placebo, with approximately 150 subjects receiving PB2452. The
primary endpoint of the trial is reversal of the antiplatelet
effects of ticagrelor with intravenous infusion of PB2452 or
placebo, as measured by the VerifyNow® PRUTest®
biomarker.
Upcoming Milestones
- Presentation and publication of full PB2452 Phase 2a results in
1H 2020
- Initiation of Phase 3 trial of PB2452 in 1Q 2020
- Reporting of PB1046 Phase 2b trial results in 2H 2020
Third
Quarter 2019 Financial Results
Cash Position
Cash and cash equivalents at September 30, 2019
were $81.8 million, compared to $61.0 million at December 31, 2018.
The increase primarily reflects the net proceeds from our
underwritten public offering of our common stock in April 2019,
partially offset by cash used in operating activities, including
the development of our clinical stage programs.
Results of Operations
Three Months Ended September 30, 2019
PhaseBio reported a net loss of $11.4 million
for the three months ended September 30, 2019, compared with a net
loss of $7.9 million for the same period in 2018. This resulted in
a net loss of $0.40 per share for the three months ended September
30, 2019, compared to a net loss of $10.45 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 September 30, 2019, as PhaseBio incurred allowable
costs qualifying for reimbursement under the government grants.
PhaseBio recorded $0.4 million of grant revenue for the same period
in 2018. Research and development expense
increased to $9.0 million for the three months ended September
30, 2019, as compared to $4.4 million for the three months
ended September 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
$2.8 million for the three months ended September 30, 2019,
compared to $1.1 million for the three months ended September 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 PB2452
PB2452 is a novel, recombinant, human monoclonal
antibody antigen-binding fragment designed to reverse the
antiplatelet activity of ticagrelor in major bleeding and urgent
surgery situations. In a Phase 1 clinical trial, PB2452
demonstrated the potential to bring life-saving therapeutic benefit
through immediate and sustained reversal of ticagrelor’s
antiplatelet activity, mitigating concerns regarding bleeding risks
associated with the use of antiplatelet drugs. The Phase 1 clinical
trial of PB2452 in healthy volunteers was published in the New
England Journal of Medicine in March 2019.1 In April 2019, PB2452
received Breakthrough Therapy designation from the FDA.
Breakthrough Therapy designation may be granted by FDA when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapy. PhaseBio
plans to initiate a single pivotal Phase 3 clinical trial of PB2452
in the first quarter of 2020 to support a BLA for PB2452 in both
major bleeding and urgent surgery indications. There are currently
no approved reversal agents for ticagrelor or any other
antiplatelet drugs.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company focused on the development
and commercialization of novel therapies to treat cardiopulmonary
diseases. 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 June 30,
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.
|
PhaseBio
Pharmaceuticals, Inc. |
Condensed
Balance Sheets |
(in
thousands) |
(unaudited) |
|
|
|
|
|
September 30, 2019 |
|
December 31,2018 |
Assets: |
|
|
|
Cash and cash equivalents |
$ |
81,771 |
|
$ |
61,031 |
Other
receivable, prepaid expenses and other current assets |
|
1,598 |
|
|
1,597 |
Property and
equipment, net |
|
1,022 |
|
|
355 |
Operating
lease right-of-use assets |
|
1,780 |
|
|
— |
Other
non-current assets |
|
32 |
|
|
43 |
Total
assets |
$ |
86,203 |
|
$ |
63,026 |
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
Current
portion of long-term debt |
$ |
1,990 |
|
$ |
— |
Accounts
payable, accrued expenses and other current liabilities |
|
3,972 |
|
|
4,577 |
Long-term
debt |
|
7,740 |
|
|
7,500 |
Operating
lease liabilities |
|
1,577 |
|
|
— |
Other
long-term liabilities |
|
120 |
|
|
— |
Deferred
rent |
|
— |
|
|
22 |
Stockholders’ equity |
|
70,804 |
|
|
50,927 |
Total
liabilities and stockholders' equity |
$ |
86,203 |
|
$ |
63,026 |
|
|
|
|
|
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, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
Grant revenue |
$ |
241 |
|
|
$ |
411 |
|
|
$ |
1,097 |
|
|
$ |
411 |
|
Revenue under collaborative agreement |
|
— |
|
|
|
— |
|
|
|
500 |
|
|
|
— |
|
Total
revenue |
|
241 |
|
|
|
411 |
|
|
|
1,597 |
|
|
|
411 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
9,028 |
|
|
|
4,354 |
|
|
|
22,530 |
|
|
|
9,779 |
|
General and administrative |
|
2,803 |
|
|
|
1,056 |
|
|
|
7,523 |
|
|
|
2,616 |
|
Total
operating expenses |
|
11,831 |
|
|
|
5,410 |
|
|
|
30,053 |
|
|
|
12,395 |
|
Loss from
operations |
|
(11,590 |
) |
|
|
(4,999 |
) |
|
|
(28,456 |
) |
|
|
(11,984 |
) |
Other income
(expense) |
|
199 |
|
|
|
(2,902 |
) |
|
|
540 |
|
|
|
(6,994 |
) |
Net
loss |
$ |
(11,391 |
) |
|
$ |
(7,901 |
) |
|
$ |
(27,916 |
) |
|
$ |
(18,978 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
$ |
(0.40 |
) |
|
$ |
(10.45 |
) |
|
$ |
(1.03 |
) |
|
$ |
(25.33 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
28,719,932 |
|
|
|
755,908 |
|
|
|
27,065,774 |
|
|
|
749,198 |
|
|
|
|
|
|
|
|
|
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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