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 fourth quarter and
full-year ended December 31, 2019, and provided an update on
corporate activities. “Over the past year, PhaseBio has made
tremendous progress building the organization for its next phase of
growth and strengthening its pipeline, notably with the advancement
of PB2452 into a Phase 3 registrational trial,” said Jonathan P.
Mow, Chief Executive Officer of PhaseBio. “The New England Journal
of Medicine publication featuring results from the Phase 1 trial of
PB2452 generated significant interest in the program and, having
subsequently received FDA Breakthrough Therapy designation and EMA
PRIME designation, the program heads into the pivotal Phase 3 trial
with momentum. Looking ahead, the remainder of 2020 will be an
important period for PhaseBio as we continue to engage
investigators, activate more clinical trial sites in the U.S. and
abroad and work to maintain the positive trajectory we have
established for our lead program and for the company.”
PB2452 Phase 3 Initiation
Update: PhaseBio recently commenced its PB2452 Phase 3
trial. The pivotal Phase 3 trial of PB2452 will evaluate the
reversal of the antiplatelet activity of ticagrelor in patients
experiencing major, uncontrolled bleeding events or in patients
requiring urgent or emergency surgery. Actual timing of patient
enrollment is dependent on the trial 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.
PB1046 Clinical Trial Enrollment
Update: PB1046, a first-in-class, sustained-release
vasoactive intestinal peptide (VIP) analogue is being evaluated for
the treatment of patients with pulmonary arterial hypertension
(PAH). The company has 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 has also
informed investigators that they may continue dosing drug and
performing assessments for current trial participants if they deem
it appropriate and such activities are permitted by their
respective institutions. Additionally, the company continues to
identify new trial sites for future initiation. Although PhaseBio
has been targeting to report results from this trial in the fourth
quarter of 2020, the company believes that COVID-19 will
temporarily prevent it from being able to initiate new trial sites
and enroll new patients, likely pushing the expected readout of the
trial into 2021. 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.
PB2452 Recent Highlights
- 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 will fund up to $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.
- Initiated Phase 2b trial: In October
2019, PhaseBio announced that the first patient had been dosed in
its 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 start of the
Phase 2b trial marked the beginning of FDA-aligned registrational
trials to support the submission of a biologics license application
(BLA) for potential accelerated approval of PB2452. The primary
endpoint of the trial is reversal of the antiplatelet effects of
ticagrelor with intravenous infusion of PB2452, as measured by the
VerifyNow® PRUTest® biomarker.
- 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. Additionally, based on
guidance provided by the FDA, 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. Based on the 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. In both cohorts of the Phase 2a trial,
PB2452 was generally well tolerated, with only minor adverse events
reported.
- 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 FDA. Based on the 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.
- Received Breakthrough Therapy designation for
PB2452: In April 2019, PhaseBio announced that
the FDA granted Breakthrough Therapy designation for PB2452.
The Breakthrough Therapy designation for PB2452 was supported by
Phase 1 trial results in which PhaseBio observed that PB2452
achieved immediate and sustained reversal of the antiplatelet
activity of ticagrelor. Breakthrough Therapy designation is
designed to expedite the development and review of promising new
drugs for serious or life-threatening conditions when preliminary
clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints.
- Phase 1 Results Published in New England Journal of
Medicine: In March 2019, full results from the
Phase 1 clinical trial of PB2452 were published in the New
England Journal of Medicine in a paper titled, “Antibody-Based
Ticagrelor Reversal Agent in Healthy Volunteers” and simultaneously
presented in a featured clinical research session at
the American College of Cardiology’s 68th Annual
Scientific Session. The results demonstrated that PB2452 provided
immediate and sustained reversal of the antiplatelet activity of
ticagrelor.
PB1046 and Other Pipeline
Highlights
- 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.
- Bolstered pipeline with acquisition of novel oral
aldosterone synthase inhibitor for 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.
- PB1023 licensing deal: In April
2019, PhaseBio announced that it had out-licensed the global rights
for PB1023, a long-acting, recombinant GLP-1 analogue
to ImmunoForge, Co. Ltd. (ImmunoForge) for the treatment
of certain diseases, including conditions related to sarcopenia.
PB1023 is a fusion protein utilizing PhaseBio’s proprietary
elastin-like polypeptide (ELP) technology platform. PhaseBio
received an upfront payment upon execution of the agreement and is
eligible to receive development milestone payments and royalty
payments on net sales of products, including sales from sublicense
agreements.
Operational Updates
- Appointed new members to the board of
directors: In February 2020, Alex C. Sapir was
appointed to the board of directors. In March
2019, Richard A. van den Broek was appointed to the board
of directors.
- Expanded executive management team: In October
2019, PhaseBio announced the appointment of Kris Hanson as Vice
President, Head of Legal and Glen Burkhardt as Vice President of
Human Resources. Mr. Hanson oversees and manages the company’s
legal affairs, including support of clinical development efforts,
strategic and licensing transactions, corporate governance,
compliance and other key areas. Mr. Burkhardt oversees management
of human resources at PhaseBio.
- Completed underwritten public offering of common
stock: In April 2019, PhaseBio closed an
underwritten public offering of 4.1 million shares of its common
stock at a price to the public of $12.00 per share,
including shares sold pursuant to the full exercise of the
underwriters’ option to purchase additional shares. PhaseBio
received $46.2 million in net proceeds, after deducting
underwriting discounts and commissions and offering expenses.
Fourth Quarter and Full-Year 2019
Financial Results
Cash Position
Cash and cash equivalents at December 31, 2019
were $74.0 million, compared to $61.0 million at December 31, 2018.
The increase reflects net proceeds from the April 2019 offering of
common stock, partially offset by cash used in operating
activities.
Results of Operations
Quarter Ended December 31, 2019
PhaseBio reported a net loss of $11.3 million
for the three months ended December 31, 2019, which compared with a
net loss of $4.9 million for the same period in 2018. This resulted
in a net loss of $0.39 per share for the three months ended
December 31, 2019, compared to a net loss of $0.26 per share for
the corresponding period in 2018, on both a basic and diluted
basis.
Grant revenues were $0.7 million for the three
months ended December 31, 2019, as PhaseBio incurred allowable
costs qualifying for reimbursement under the government grants.
Grant revenues for the same period in 2018 were $0.3 million.
Revenue under collaborative agreement was $0.1 million for the
three months ended December 31, 2019, which was related to revenue
from the ImmunoForge agreement entered into in April
2019.
Research and development expense increased
to $8.4 million for the three months ended December 31,
2019, compared to $5.7 million for the three months
ended December 31, 2018, reflecting an increase in
manufacturing, clinical and preclinical development
activities related to PB2452 and PB1046.
General and administrative expense increased to
$3.7 million for the three months ended December 31, 2019, compared
to $2.2 million for the three months ended December 31, 2018,
primarily attributable to increases in professional services,
personnel, insurance and business travel-related expenses.
Year Ended December 31, 2019
PhaseBio reported a net loss of $39.2 million
for the year ended December 31, 2019, which compared with a net
loss of $23.8 million for 2018. This resulted in a net loss of
$1.43 per share for the year ended December 31, 2019, compared to a
net loss of $4.49 per share for the corresponding period in 2018,
on both a basic and diluted basis.
Grant revenues were $1.8 million for the year
ended December 31, 2019, as PhaseBio incurred allowable costs
qualifying for reimbursement under the government grants. Grant
revenues in 2018 were $0.7 million. Revenue under collaborative
agreement was $0.6 million for the year ended December 31, 2019,
which was related to revenue from the ImmunoForge agreement entered
into in April 2019.
Research and development expenses increased
to $30.9 million for the year ended December 31, 2019,
compared to $15.5 million for the year ended December 31,
2018, reflecting an increase in manufacturing, clinical and
preclinical development activities related to PB2452 and
PB1046.
General and administrative expenses were $11.2
million for the year ended December 31, 2019, compared to $4.9
million for the year ended December 31, 2018, 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 (ELP) 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, 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 September 30, 2019, filed with the SEC on November 14, 2019,
and in our Annual Report on Form 10-K for the year ended December
31, 2019, 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 Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2019 |
|
2018 |
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
74,025 |
|
$ |
61,031 |
Other receivables, prepaid
expenses and other current assets |
|
|
4,798 |
|
|
1,597 |
Property and equipment, net |
|
|
1,924 |
|
|
355 |
Operating lease right-of-use
assets |
|
|
1,715 |
|
|
— |
Other non-current assets |
|
|
32 |
|
|
43 |
Total assets |
|
$ |
82,494 |
|
$ |
63,026 |
|
|
|
|
|
Liabilities and
stockholders' equity: |
|
|
|
|
Current portion of long-term
debt |
|
$ |
2,378 |
|
$ |
— |
Accounts payable, accrued
expenses and other current liabilities |
|
|
6,101 |
|
|
4,577 |
Long-term debt, net |
|
|
12,326 |
|
|
7,500 |
Operating lease liabilities,
net |
|
|
1,508 |
|
|
— |
Other long-term liabilities |
|
|
203 |
|
|
— |
Deferred rent |
|
|
— |
|
|
22 |
Stockholders’ equity |
|
|
59,978 |
|
|
50,927 |
Total liabilities and
stockholders' equity |
|
$ |
82,494 |
|
$ |
63,026 |
PhaseBio Pharmaceuticals, Inc. |
Statements of Operations |
(in thousands, except share and per share
amounts) |
|
|
|
|
Quarter Ended December 31, |
|
Year Ended December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
689 |
|
|
$ |
257 |
|
|
$ |
1,786 |
|
|
$ |
668 |
|
Revenue under collaborative agreement |
|
|
75 |
|
|
|
— |
|
|
|
575 |
|
|
|
— |
|
Total revenue |
|
|
764 |
|
|
|
257 |
|
|
|
2,361 |
|
|
|
668 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
8,381 |
|
|
|
5,676 |
|
|
|
30,911 |
|
|
|
15,455 |
|
General and administrative |
|
|
3,663 |
|
|
|
2,241 |
|
|
|
11,186 |
|
|
|
4,857 |
|
Total operating expenses |
|
|
12,044 |
|
|
|
7,917 |
|
|
|
42,097 |
|
|
|
20,312 |
|
Loss from operations |
|
|
(11,280 |
) |
|
|
(7,660 |
) |
|
|
(39,736 |
) |
|
|
(19,644 |
) |
Other (expense) income |
|
|
(51 |
) |
|
|
2,792 |
|
|
|
489 |
|
|
|
(4,202 |
) |
Net loss |
|
$ |
(11,331 |
) |
|
$ |
(4,868 |
) |
|
$ |
(39,247 |
) |
|
$ |
(23,846 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share, basic
and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.43 |
) |
|
$ |
(4.49 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
28,762,962 |
|
|
|
18,824,091 |
|
|
|
27,493,558 |
|
|
|
5,305,062 |
|
Investor Contact:
John Sharp
PhaseBio Pharmaceuticals, Inc.
Chief Financial Officer
(610) 981-6506
john.sharp@phasebio.com
Media Contact:
Chris Waite
Canale Communications, Inc.
chris@canalecomm.com
(619) 849-6005
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