Received FDA authorization to proceed with
“VANGARD” clinical trial to assess the efficacy and safety of
PB1046 in hospitalized COVID-19 patients at high risk for rapid
clinical deterioration and acute respiratory distress syndrome
(ARDS) and commenced dosing of patients
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular and
cardiopulmonary diseases, today provided an update on corporate
activities and reported second-quarter 2020 financial results.
“Throughout the second quarter of 2020, PhaseBio made
substantial progress driving our clinical development programs
forward,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio
Pharmaceuticals. “We successfully launched and dosed patients in
our VANGARD study, a Phase 2 clinical trial evaluating PB1046 for
the prevention of development of ARDS in 210 patients hospitalized
with COVID-19. Enrollment in the trial is ongoing and we expect to
report results by the end of 2020.”
Mow continued, “Building on the momentum from the recent
initiation of our pivotal Phase 3 trial for PB2452, our lead
product candidate for the reversal of the antiplatelet effects of
ticagrelor, we continue to enroll patients despite the COVID-19
pandemic, highlighting the significant unmet medical need for a
reversal agent for P2Y12 antagonists such as ticagrelor. While the
pandemic has created new challenges, we remain focused on executing
on our strategic objectives, enrolling patients in our clinical
programs, and delivering impactful medicines to people with unmet
medical needs.”
Recent Pipeline and Business
Highlights
- Initiated VANGARD Phase 2 Clinical: In May 2020,
PhaseBio announced that it had received U.S. FDA authorization to
proceed with VANGARD. VANGARD (VIP
ANalogue, in hospitalized COVID-19
patients at hiGh risk for rapid
clinical deterioration and ARDS) is a
multi-center, randomized, double-blind, parallel group clinical
trial that will assess the efficacy and safety of once-weekly
subcutaneous injections of PB1046 in hospitalized COVID-19 patients
at high risk for rapid clinical deterioration and ARDS. Dosing of
patients in the trial commenced in July 2020. Approximately 210
patients will be targeted to be enrolled at approximately 20 sites
nationwide. The FDA has informed PhaseBio that positive, clearly
interpretable and clinically meaningful trial results would enable
the company to submit a BLA for PB1046 in this indication. More
information about the Phase 2 trial is available at
ClinicalTrials.gov.
- Resumed Limited Enrollment in PB1046 Phase 2b Trial for
Pulmonary Arterial Hypertension (PAH): In June 2020, PhaseBio
resumed limited patient enrollment in the company’s Phase 2b
clinical study for the treatment of PAH. Earlier this year,
PhaseBio temporarily paused enrollment of new patients in the trial
as a precaution to minimize potential exposure of this patient
population at high risk of serious illness from COVID-19. Certain
existing sites in the United States are resuming patient screening
on a limited basis, while enrollment at new sites remains on
hold.
- SFJ Financing and Co-Development Agreement Update: From
execution of the Co-Development Agreement through June 30, 2020,
SFJ Pharmaceuticals has funded a total of $18 million of the
initial $90 million commitment under the agreement towards the
development of PB2452, leaving approximately $72 million of funding
available to support the PB2452 Phase 3 program through the end of
2021. PhaseBio is eligible to receive an additional $30 million of
funding if specific, pre-defined clinical milestones for PB2452 are
met.
Second-Quarter 2020 Financial
Results
- Cash and cash equivalents at June 30, 2020 were $53.0 million,
compared to $74.0 million at December 31, 2019. The decrease
reflects cash used in operating activities.
- Net loss for the quarter was $28.1 million, compared to a net
loss of $9.2 million for prior-year period.
- Research and development expense increased to $20.9 million, as
compared to $7.8 million for the same period in 2019, driven by an
increase in manufacturing, clinical and preclinical development
activities related to PB2452 and PB1046.
- General and administrative expense increased to $3.2 million,
compared to $2.4 million for prior-year period, primarily due to
increases in professional services, personnel, and
insurance-related expenses.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular and
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 PAH and hospitalized COVID-19 patients
at high risk for rapid clinical deterioration and ARDS; 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 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, whether, if approved, these product candidates will be
successfully distributed and marketed and the success of our
collaboration with SFJ, including whether we will receive all of
the contemplated funding under the co-development agreement .
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 June 30,
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)
Three Months Ended June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Revenue:
Grant revenue
$
—
$
203
$
320
$
856
Revenue under collaborative agreement
—
500
—
500
Total revenue
—
703
320
1,356
Operating expenses:
Research and development
20,856
7,781
32,305
13,502
General and administrative
3,242
2,404
6,401
4,720
Total operating expenses
24,098
10,185
38,706
18,222
Loss from operations
(24,098
)
(9,482
)
(38,386
)
(16,866
)
Other (expense) income
(4,044
)
250
(4,661
)
341
Net loss
$
(28,142
)
$
(9,232
)
$
(43,047
)
$
(16,525
)
Net loss per common share, basic and
diluted
$
(0.98
)
$
(0.33
)
$
(1.50
)
$
(0.63
)
Weighted average common shares
outstanding, basic and diluted
28,805,238
27,932,610
28,789,256
26,224,986
PhaseBio Pharmaceuticals,
Inc.
Condensed Balance
Sheets
(in thousands)
(unaudited)
June 30, 2020
December 31, 2019
Assets:
Cash and cash equivalents
$
53,025
$
74,025
Other receivables, prepaid expenses and
other current assets
10,716
4,798
Property and equipment, net
4,876
1,924
Operating lease right-of-use assets
2,136
1,715
Other non-current assets
57
32
Total assets
$
70,810
$
82,494
Liabilities and stockholders'
equity:
Current portion of long-term debt
$
5,015
$
2,378
Accounts payable, accrued expenses and
other current liabilities
12,787
6,101
Long-term debt, net
9,768
12,326
Operating lease liabilities, net
1,773
1,508
Development derivative liability
14,686
—
Other long-term liabilities
388
203
Stockholders’ equity
26,393
59,978
Total liabilities and stockholders'
equity
$
70,810
$
82,494
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200811005796/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.
will@canalecomm.com 619-961-8848
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