PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular diseases,
today reported financial results for the second quarter ended June
30, 2022, and provided an update on corporate activities.
“The second quarter of 2022 marked a period of continued
progress for PhaseBio,” said Jonathan Mow, Chief Executive Officer
of PhaseBio Pharmaceuticals. “Following a successful meeting with
the U.S. Food and Drug Administration (FDA) during our
pre-biologics license application (pre-BLA) meeting earlier this
year and as previously disclosed, we have been focused on clinical
development and regulatory efforts to support a planned BLA
submission for our lead program, bentracimab, in the fourth quarter
of this year. Additionally, we continue to make progress towards
completing initial new drug application (IND) enabling studies for
PB6440, our aldosterone synthase inhibitor in development for
resistant hypertension. We expect to file our IND for PB6440 in the
first half of 2023 and to initiate first-in-human trials in
mid-2023.”
Program Highlights
- SFJ Financing and Co-Development Agreement Update: In
January 2020, PhaseBio entered into an agreement with SFJ
Pharmaceuticals (SFJ Agreement), pursuant to which SFJ provides the
company funding to support the global development of bentracimab.
Under the agreement, SFJ agreed to pay the company up to $120.0
million to support the clinical development of bentracimab. In
addition to $90.0 million of initial funding, the company has
elected to receive an additional $30.0 million of funding having
met specific, pre-defined clinical development milestones for
bentracimab. From the inception of the SFJ Agreement through June
30, 2022, SFJ has provided funding and paid for amounts on the
company’s behalf in the aggregate amount of $99.0 million. PhaseBio
expects that SFJ will fund or reimburse an additional $21.0 million
of clinical trial costs and other expenses.
- PB6440 IND enabling studies continue to advance: In the
second quarter of 2022, PhaseBio completed the development and
optimization of a robust manufacturing process to support
anticipated upcoming proof-of-concept trials, positioning the
program for initial GMP manufacturing runs in the fourth quarter of
2022. PB6440 is a highly selective aldosterone synthase inhibitor
in development to target treatment resistant hypertension and other
indications where elevated aldosterone is known to contribute to
disease process, such as uncontrolled hypertension, chronic kidney
disease, and heart failure. The drug appears to modulate the
renin-angiotensin-aldosterone system, which exhibits a critical
role in regulation of systemic blood pressure. According to the
American Heart Association, 20% of hypertensive Americans, which
potentially represents more than 10 million patients, have not
achieved normotensive status despite taking three or more blood
pressure drugs; we believe this represents a significant unmet need
with a large market potential. PB6440 is undergoing IND-enabling
studies, with first human trials targeted for mid-2023.
Quarter Ending June 30,
2022
- Cash and cash equivalents on June 30, 2022, were $7.8 million,
compared to $41.8 million at December 31, 2021. The decrease
primarily reflects cash used in operating activities.
- Net loss for the quarter was $16.7 million, compared to a net
loss of $28.7 million for the prior-year period.
- Research and development expense for the quarter decreased to
$20.9 million, as compared to $27.4 million for the same period in
2021. The decrease was primarily attributable to drug manufacturing
activity in 2021, study site startup costs for the Phase 2b trial
related to bentracimab in 2021, and the voluntary ending of the
Phase 2b trial of pemziviptadil in the fourth quarter of 2021,
partially offset by an increase in costs related to development of
PB6440, and personnel costs and other costs associated with our
general research and development efforts.
- General and administrative expense for the quarter increased to
$4.6 million, compared to $4.0 million for the prior-year period.
The increase was primarily attributable to increases in consulting
costs and personnel expenses due to additional headcount.
About Bentracimab (PB2452)
Bentracimab is a novel, recombinant, human monoclonal antibody
antigen-binding fragment designed to reverse the antiplatelet
activity of ticagrelor in patients who present with uncontrolled
bleeding or require surgery. In a Phase 1 clinical trial,
bentracimab 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 this antiplatelet drug.
Data from the Phase 1 clinical trial of bentracimab in healthy
volunteers was published in the New England Journal of Medicine in
March 2019. In April 2019, bentracimab received Breakthrough
Therapy Designation from the FDA. In September 2019, PhaseBio
completed a Phase 2a trial in which bentracimab was investigated in
healthy, older subjects on dual antiplatelet therapy of ticagrelor
and low-dose aspirin. Additionally, the Phase 2a trial investigated
a bentracimab regimen for the reversal of supratherapeutic doses of
ticagrelor in healthy younger subjects. In November 2021, PhaseBio
completed a Phase 2b trial in which bentracimab was investigated in
older subjects on dual antiplatelet therapy of ticagrelor and
low-dose aspirin, with complete results announced and presented in
April 2022. In all active treatment arms in both the Phase 2a and
Phase 2b trials, bentracimab achieved immediate and sustained
reversal of the antiplatelet effects of ticagrelor and 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. PhaseBio initiated REVERSE-IT, a pivotal
Phase 3 clinical trial of bentracimab, in March 2020 to support a
potential Biologics License Application for bentracimab to treat
patients with uncontrolled bleeding or requiring surgery. Interim
results from the Phase 3 REVERSE-IT trial were presented in
November 2021 and subsequently published in NEJM Evidence in
December 2021.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular diseases.
The Company’s pipeline includes: bentracimab (PB2452), a novel
reversal agent for the antiplatelet therapy ticagrelor; 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, 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, and follow us on
Twitter @PhaseBio and LinkedIn.
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,” “potential,” “projects,” “target,” “will,” “would” 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, including
enrollment, and our research, development and regulatory plans for
our product candidates, the timing of availability or disclosure of
data from those clinical trials and the timing of planned
regulatory submissions, the potential for these product candidates
to receive regulatory approval from the FDA, EMA or equivalent
foreign regulatory agencies, and whether, if approved, these
product candidates will be successfully distributed, marketed and
commercialized, including having sufficient product supply at
launch, and our ability to complete post-approval requirements.
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, 2022.
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 Balance
Sheets
(in thousands)
(unaudited)
June 30, 2022
December 31, 2021
Assets:
Cash and cash equivalents
$
7,804
$
41,800
Prepaid expenses and other assets
3,760
6,984
Property and equipment, net
9,322
10,230
Operating lease right-of-use assets
1,222
1,469
Other assets
58
57
Total assets
$
22,166
$
60,540
Liabilities and stockholders'
deficit:
Current portion of long-term debt
$
4,073
$
5,413
Current portion of deferred sublicense
revenue
1,400
1,547
Accounts payable, accrued expenses and
other current liabilities
19,206
20,923
Long-term debt, net
—
1,359
Operating lease liabilities, net
869
1,073
Long term portion of deferred sublicense
revenue, net
7,443
7,622
Development derivative liability
106,573
114,843
Other long-term liabilities
—
794
Total stockholders’ deficit
(117,398
)
(93,034
)
Total liabilities and stockholders'
deficit
$
22,166
$
60,540
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,
2022
2021
2022
2021
Revenue:
Sublicense revenue
$
208
$
10,338
$
325
$
10,338
Total revenue
208
10,338
325
10,338
Operating expenses:
Research and development
20,939
27,366
35,275
49,686
General and administrative
4,581
4,025
8,590
7,352
Total operating expenses
25,520
31,391
43,865
57,038
Loss from operations
(25,312
)
(21,053
)
(43,540
)
(46,700
)
Other income (expense)
8,647
(6,026
)
15,734
(7,737
)
Net loss before income taxes
(16,665
)
(27,079
)
(27,806
)
(54,437
)
Provision for income taxes
—
1,600
—
1,600
Net loss
$
(16,665
)
$
(28,679
)
$
(27,806
)
$
(56,037
)
Net loss per common share, basic and
diluted
$
(0.34
)
$
(0.60
)
$
(0.57
)
$
(1.41
)
Weighted average common shares
outstanding, basic and diluted
49,182,813
47,985,871
48,910,437
39,680,408
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version on businesswire.com: https://www.businesswire.com/news/home/20220812005048/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.zasadny@canalecomm.com
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