Initiated PB2452 Phase 3 Trial for the Reversal
of the Antiplatelet Effects of Ticagrelor
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 from the first quarter ending
March 31, 2020 and provided an update on corporate activities.
“The first quarter of 2020 marked an important period of
progress for PhaseBio, including the advancement of our lead
program PB2452 into a Phase 3 registrational trial,” said Jonathan
P. Mow, Chief Executive Officer of PhaseBio. “We are continuing to
work to open additional clinical sites in the United States and to
identify potential clinical sites in both Europe and Asia with our
partner SFJ Pharmaceuticals. Although the COVID-19 pandemic is
temporarily impacting the pace of site initiation and patient
enrollment, we are encouraged that investigators continue to view
PB2452 as an important potential option to help treat ticagrelor
patients who require emergency surgery or who experience a major
bleeding event. During these unprecedented times, we will continue
to work to advance our strategic objectives, which are focused on
delivering impactful medicines to patients with significant unmet
medical needs.”
PB2452 Recent Highlights
- Initiated Phase 3 Clinical Trial for PB2452: In March
2020, PhaseBio commenced the pivotal Phase 3 trial of PB2452, which
will evaluate reversal of the antiplatelet effects of ticagrelor in
patients with uncontrolled major or life-threatening bleeding or
requiring urgent surgery or an invasive procedure. Timing of
initiation of new trial sites and patient enrollment is dependent
on the 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.
- 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 agreed to fund $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. To date, SFJ has made
an initial payment to PhaseBio of $10 million, which was received
in the first quarter of 2020, and has reimbursed PhaseBio for other
clinical trial costs.
Other Pipeline and Operational
Highlights:
- PB1046 Clinical Trial Enrollment Update: PhaseBio
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 also informed investigators that they could
continue dosing drug and performing assessments for current trial
participants if they deemed it appropriate and such activities were
permitted by their respective institutions. The company has
recently begun working with trial sites to help design plans to
enable them to resume new patient enrollment, once appropriate and
permitted, and certain sites have resumed screening patients on a
limited basis. Additionally, the company continues to identify new
trial sites for future initiation. 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.
- 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.
- Acquired novel oral aldosterone synthase inhibitor for
development in 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 11β-hydroxylase enzyme
(CYP11B1). PB6440 demonstrated dose-dependent aldosterone reduction
without a significant increase in 11-deoxycorticosterone or
deoxycortisol in both rodent and primate models.
First Quarter 2020 Financial
Results
Cash Position
Cash and cash equivalents at March 31, 2020 were $59.4 million,
compared to $74.0 million at December 31, 2019. The decrease
reflects cash used in operating activities, partially offset by
receipt of the initial $10.0 million payment from SFJ as part of
the PB2452 financing and co-development agreement.
Results of Operations
Three Months Ended March 31, 2020
PhaseBio reported a net loss of $14.9 million for the three
months ended March 31, 2020, which compared with a net loss of $7.3
million for the same period in 2019. This resulted in a net loss of
$0.52 per share for the three months ended March 31, 2020, compared
to a net loss of $0.30 per share for the corresponding period in
2019, on both a basic and diluted basis.
Grant revenues were $0.3 million for the three months ended
March 31, 2020, as PhaseBio incurred allowable costs qualifying for
reimbursement under the government grants. Grant revenues for the
same period in 2019 were $0.7 million.
Research and development expense increased to $11.4 million for
the three months ended March 31, 2020, compared to $5.7 million for
the three months ended March 31, 2019, reflecting an increase in
manufacturing and clinical activities related to PB2452 and PB1046
as well as other preclinical development activities.
General and administrative expense increased to $3.2 million for
the three months ended March 31, 2020, compared to $2.3 million for
the three months ended March 31, 2019, 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 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 success of our collaboration with SFJ, including
whether we will receive all of the contemplated funding under the
co-development agreement, 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 March 31,
2020, 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 Statements of
Operations
(in thousands, except share
and per share amounts)
(unaudited)
Quarter Ended March
31,
2020
2019
Grant revenue
$
320
$
653
Operating expenses:
Research and development
11,449
5,721
General and administrative
3,159
2,316
Total operating expenses
14,608
8,037
Loss from operations
(14,288
)
(7,384
)
Other (expense) income
(617
)
91
Net loss
$
(14,905
)
$
(7,293
)
Net loss per common share, basic and
diluted
$
(0.52
)
$
(0.30
)
Weighted average common shares
outstanding, basic and diluted
28,773,274
24,498,388
PhaseBio Pharmaceuticals,
Inc.
Condensed Balance
Sheets
(in thousands)
(unaudited)
March 31, 2020
December 31, 2019
Assets:
Cash and cash equivalents
$
59,441
$
74,025
Other receivables, prepaid expenses and
other current assets
13,100
4,798
Property and equipment, net
2,637
1,924
Operating lease right-of-use assets
1,648
1,715
Other non-current assets
32
32
Total assets
$
76,858
$
82,494
Liabilities and stockholders'
equity:
Current portion of long-term debt
$
3,686
$
2,378
Accounts payable, accrued expenses and
other current liabilities
3,809
6,101
Long-term debt, net
11,058
12,326
Operating lease liabilities, net
1,438
1,508
Development derivative liability
3,086
—
Other long-term liabilities
295
203
Stockholders’ equity
53,486
59,978
Total liabilities and stockholders'
equity
$
76,858
$
82,494
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200512005835/en/
Investor Contact: John Sharp PhaseBio Pharmaceuticals,
Inc. Chief Financial Officer (610) 981-6506
john.sharp@phasebio.com
Media Contact: Will Zasadny Canale Communications, Inc.
(619) 961-8848 will@canalecomm.com
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