Announced topline data from Phase 2b clinical
trial of bentracimab, which was conducted in healthy, older
volunteers 50-80 years old
Reached interim enrollment milestone for the
REVERSE-IT Phase 3 trial of bentracimab
Prespecified interim analysis of pivotal
REVERSE-IT Phase 3 trial to be presented during late-breaking
science session on November 15 at the American Heart Association’s
Scientific Sessions 2021
PhaseBio to host analyst and investor event on
November 15 at 12:30 pm ET to review interim analysis of the
REVERSE-IT trial
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today provided an update on corporate activities and reported
third-quarter 2021 financial results.
“During the third quarter of 2021, we made important progress
advancing our lead product candidate bentracimab closer to
potential commercialization for patients in critical need of an
antiplatelet reversal agent,” said Jonathan P. Mow, Chief Executive
Officer, PhaseBio Pharmaceuticals. “In August, we were pleased to
achieve our interim enrollment milestone for the pivotal REVERSE-IT
Phase 3 trial, and we look forward to presenting data from the
prespecified interim analysis at the American Heart Association’s
Scientific Sessions on November 15. Looking ahead, we remain
focused on targeting a Biologics License Application (BLA)
submission in mid-2022 and are excited about the future prospects
of potentially commercializing the first ticagrelor reversal agent
for patients who need urgent surgery or suffer from spontaneous
bleeding events.”
Program Highlights and Corporate
Updates
- Prespecified Interim Analysis from Pivotal REVERSE-IT Phase
3 Trial to be Presented at the American Heart Association’s
Scientific Sessions 2021: On November 15, 2021, at a
late-breaking science session at the American Heart Association’s
Scientific Sessions 2021, PhaseBio will present a prespecified
interim analysis from REVERSE-IT, the pivotal Phase 3 trial
designed to study reversal of the antiplatelet effects of
ticagrelor with bentracimab in patients who present with
uncontrolled major or life-threatening bleeding or who require
surgery or invasive procedure. Details about the upcoming
presentation were set forth in PhaseBio’s press release on October
6, 2021.
Presentation Information
- Title: Effect of Bentracimab on Platelet Inhibition and
Hemostasis in Ticagrelor Patients with Uncontrolled Hemorrhage or
Requiring Urgent Surgery in the REVERSE-IT Trial
- Presenting Author: Deepak L. Bhatt, MD, MPH, Executive
Director of Interventional Cardiovascular Programs, Brigham and
Women's Hospital Heart & Vascular Center and Professor of
Medicine at Harvard Medical School
- Session Title: New Drugs and New Drug Indications in
Cardiovascular Disease
- Session Number: LBS.07
- Date: November 15, 2021
- Session Time: 11:00 am – 12:00 pm ET
- Presentation Time: 11:30 am – 11:38 am ET
- Announced Topline Results from Completed Bentracimab Phase
2b Trial: In November 2021, PhaseBio announced topline data
from its Phase 2b clinical trial of bentracimab, which was
conducted in healthy, older volunteers 50-80 years old. The Phase
2b trial is a multi-center, randomized, double-blind,
placebo-controlled study with 150 subjects receiving bentracimab
and 50 subjects receiving placebo, all after pretreatment with dual
antiplatelet therapy composed of ticagrelor and low-dose aspirin.
The Phase 2b pivotal trial was conducted concurrently with
REVERSE-IT, as agreed upon with the U.S. Food and Drug
Administration (FDA) following an End-of-Phase 1 meeting in July
2019. The Phase 2b trial achieved its primary endpoint. The primary
efficacy endpoint was reversal of ticagrelor’s inhibition of
platelet function in actively treated subjects versus placebo as
measured using the point-of-care VerifyNow® PRUTest® platelet
function assay (VerifyNow). VerifyNow is also the primary
measurement used to evaluate efficacy in the ongoing REVERSE-IT
Phase 3 trial. Treatment with bentracimab in the Phase 2b trial had
a safety profile consistent with the Phase 1 and 2a trials
previously completed by the company, with no drug-related serious
adverse events or thrombotic events reported in the trial. The most
common adverse events were injection site bruising and headache,
with similar rates seen in both the placebo and active-treatment
arms. These new data are consistent with results from PhaseBio’s
previously completed Phase 1 trial, conducted in healthy younger
volunteers treated with ticagrelor alone and not aspirin, and Phase
2a trial, also conducted in healthy, older (ages 50-80) subjects on
dual antiplatelet therapy of ticagrelor and low-dose aspirin. More
than 300 subjects have been treated with bentracimab across the
Phase 1, 2, and 3 clinical trials that comprise the bentracimab
development program. Additional information on the Phase 2b trial
can be found on www.ClinicalTrials.gov using the identifier
NCT04122170.
- Achieved Enrollment Milestones Supporting Interim Analysis
of REVERSE-IT: In August 2021, PhaseBio announced that it had
enrolled the first 143 patients in REVERSE-IT, 138 of whom required
urgent surgery or an invasive procedure and five of whom
experienced uncontrolled major or life-threatening bleeding. The
REVERSE-IT trial is expected to enroll approximately 200 major
bleeding or urgent surgery patients at sites in the United States,
Canada, the European Union and China. Based on prior guidance from
the FDA, to balance the two patient populations, the REVERSE-IT
trial does not allow enrollment of more than approximately
two-thirds of either the uncontrolled major or life-threatening
bleeding population or urgent surgery or invasive procedure
population. Because the total number of patients enrolled included
138 patients who required urgent surgery or an invasive procedure,
the surgery cohort of the trial has been fully enrolled. With the
successful completion of enrollment in this surgery cohort,
REVERSE-IT trial sites have shifted focus to enrolling patients
with uncontrolled major or life-threatening bleeding events.
PhaseBio is seeking to accelerate enrollment of patients with
uncontrolled major or life-threatening bleeding, including by
working to increase the number of enrolling clinical trial sites as
it believes that a broader site footprint will increase the
probability of enrolling these patients. The FDA also previously
indicated that an interim analysis of the first approximately 100
patients enrolled in the REVERSE-IT trial would be sufficient to
support the submission of a BLA for accelerated approval of
bentracimab. The FDA recommended that the 100 patients comprising
the interim analysis include approximately 50 patients from each of
the major or life-threatening bleeding population and urgent
surgery or invasive procedure population, although the FDA noted
that whether there are an adequate number of patients from either
cohort would be a review issue and considered in the context of
other data submitted with the BLA. PhaseBio is commencing
preparation of the BLA and, subject to favorable results being
observed, is targeting a BLA submission to the FDA in
mid-2022.
- Announced Approval of Bentracimab IND in China: In
August 2021, PhaseBio announced that the Investigational New Drug
(IND) application for bentracimab submitted to the Center for Drug
Evaluation of the China National Medical Products Administration,
in collaboration with development partner, SFJ Pharmaceuticals
(SFJ), has been approved. PhaseBio and SFJ anticipate enrolling the
first patients at sites in China in early 2022. Patients enrolled
in China will contribute to the completion of full enrollment of
the REVERSE-IT trial, post interim analysis. In January 2020,
PhaseBio announced a financing and co-development partnership with
SFJ, and since this time, SFJ has been leading clinical development
efforts in China. PhaseBio retains commercial rights to bentracimab
in China and is pursuing prospective commercial partners to license
the marketing rights in China and other countries in the
Asia-Pacific region.
Operational Updates
- Appointed New Member to the Board of Directors: In
September 2021, William D. Humphries, Chief Executive Officer of
Isosceles Pharmaceuticals, was appointed to PhaseBio’s board of
directors.
- SFJ Financing and Co-Development Agreement Update: From
execution of the co-development agreement through September 30,
2021, SFJ has funded or reimbursed $79.1 million of clinical trial
costs and other expenses of the initial $90.0 million commitment
under the agreement, leaving $10.9 million of funding remaining
available to support the bentracimab Phase 3 program. PhaseBio is
eligible to receive up to an additional $30 million of funding if
specific, pre-defined clinical development milestones for
bentracimab are met.
Third-Quarter Financial
Results
- Cash and cash equivalents at September 30, 2021 were $56.4
million, compared to $28.1 million at December 31, 2020. The
increase reflects proceeds from the March 2021 public offering of
common stock and the $20.0 million upfront milestone payment
received in July 2021 as part of the Alfasigma licensing agreement,
partially offset by cash used in operating activities.
- Sublicense revenue for the quarter was $0.3 million and
reflects recognition of a portion of the upfront milestone payment
received as part of the Alfasigma licensing agreement.
- Net loss for the quarter ended September 30, 2021 was $31.9
million, compared to a net loss of $25.1 million for the same
period in 2020.
- Research and development expense increased to $25.1 million for
the quarter ended September 30, 2021, as compared to $17.4 million
for the same period in 2020, driven by an increase in
manufacturing, clinical and nonclinical development activities
related to bentracimab.
- General and administrative expense increased to $3.8 million
for the quarter ended September 30, 2021, compared to $3.1 million
for the same period in 2020.
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. PhaseBio’s pipeline includes: bentracimab
(PB2452), a novel reversal agent for the antiplatelet therapy
ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive
intestinal peptide (VIP) 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 pemziviptadil, 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,” “future,”
“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 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 or equivalent foreign regulatory
agencies, and whether, if approved, these product candidates will
be successfully distributed, marketed and commercialized, including
through our partnership with SFJ. 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 September 30,
2021. 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)
September 30, 2021
December 31, 2020
Assets:
Cash and cash equivalents
$
56,357
$
28,122
Prepaid expenses and other current
assets
8,884
12,027
Property and equipment, net
10,841
8,224
Operating lease right-of-use assets
1,586
1,927
Other non-current assets
57
57
Total assets
$
77,725
$
50,357
Liabilities and stockholders'
deficit:
Current portion of long-term debt
$
5,399
$
5,355
Current portion of deferred sublicense
revenue
1,414
—
Accounts payable, accrued expenses and
other current liabilities
14,644
9,605
Long-term debt, net
2,718
6,773
Operating lease liabilities, net
1,182
1,548
Deferred sublicense revenue, net
7,913
—
Development derivative liability
94,037
51,719
Other long-term liabilities
747
559
Stockholders’ deficit
(50,329
)
(25,202
)
Total liabilities and stockholders'
deficit
$
77,725
$
50,357
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,
2021
2020
2021
2020
Revenue:
Sublicense revenue
$
335
$
—
$
10,673
$
—
Grant revenue
—
—
—
320
Total revenue
335
—
10,673
320
Operating expenses:
Research and development
25,066
17,416
74,752
49,721
General and administrative
3,845
3,076
11,197
9,477
Total operating expenses
28,911
20,492
85,949
59,198
Loss from operations
(28,576
)
(20,492
)
(75,276
)
(58,878
)
Other (expense) income
(3,348
)
(4,651
)
(11,085
)
(9,312
)
Net loss before income taxes
(31,924
)
(25,143
)
(86,361
)
(68,190
)
Provision for income taxes
—
—
1,600
—
Net loss
$
(31,924
)
$
(25,143
)
$
(87,961
)
$
(68,190
)
Net loss per common share, basic and
diluted
$
(0.66
)
$
(0.86
)
$
(2.07
)
$
(2.36
)
Weighted average common shares
outstanding, basic and diluted
48,046,307
29,243,181
42,499,685
28,941,669
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211110006244/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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