Results from Phase 1 clinical trial of PB2452
published in the New England Journal of Medicine and presented at
the American College of Cardiology’s Annual Scientific Session
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for orphan diseases, today
reported financial results for the fourth quarter and full-year
ended December 31, 2018, and provided an update on corporate
activities.
“For PhaseBio Pharmaceuticals, 2018 was a
transformative year during which we reported positive results from
our Phase 1 trial of PB2452, completed a successful initial public
offering and advanced our clinical program for PB1046,” said
Jonathan P. Mow, Chief Executive Officer of PhaseBio. “We are
pleased that the results from our Phase 1 clinical trial of PB2452
were presented at the American College of Cardiology’s Annual
Scientific Session and simultaneously published in the New England
Journal of Medicine. In the trial, PB2452 demonstrated an immediate
and sustained reversal of the antiplatelet effects of ticagrelor.
The totality of our recent accomplishments has positioned us well
to deliver on our goal of bringing important therapies to patients
with significant unmet medical need.”
Fourth Quarter and Recent Corporate
Progress
- Reported PB2452 Phase 1 results: In March
2019, full results from the Phase 1 clinical trial of PB2452 were
published online in the New England Journal of Medicine in a paper
titled, “An Antibody-Based Ticagrelor Reversal Agent in Normal
Volunteers” and simultaneously presented in a featured clinical
research session at the American College of Cardiology’s 68th
Annual Scientific Session. Results demonstrated PB2452 provided
immediate and sustained reversal of the antiplatelet activity of
ticagrelor.
- Secured up to $15.0 million term loan
facility: In March 2019, PhaseBio entered into a $15.0
million term loan facility with Silicon Valley Bank and WestRiver
Innovation Lending Fund. PhaseBio received an initial tranche of
$7.5 million upon execution of the loan agreement and will use the
funds to repay an existing term loan in full. A second tranche of
$2.5 million will be available through May 31, 2019. PhaseBio will
draw the remaining funding of $5.0 million upon the achievement of
certain clinical milestones related to the development of
PB2452.
- Appointed new members to the PhaseBio board of
directors: In March 2019, Richard A. van den Broek was
appointed to the board of directors. In December 2018, Edmund P.
Harrigan, M.D., was appointed to the board of directors. Caroline
M. Loewy was appointed to the board of directors in July 2018.
Nancy Hutson, Ph.D., and Linda Tufts were appointed to the board of
directors in March 2018.
- Dosed first patient in PB1046 Phase 2b trial:
In November 2018, PhaseBio dosed the first patient in a
multi-center, randomized, double-blind, parallel-group Phase 2b
trial to evaluate the safety, tolerability and efficacy of PB1046
for the treatment of pulmonary arterial hypertension
(“PAH”).
- Completed initial public offering and Series D
financing: In October 2018, PhaseBio closed an initial
public offering of 9,864,666 shares of common stock at a public
offering price of $5.00 per share, including shares sold pursuant
to the partial exercise of the underwriters’ option to purchase
additional shares. PhaseBio received $43.0 million in net proceeds,
after deducting underwriting discounts and commissions and offering
expenses. In September 2018, PhaseBio closed a Series D financing
that resulted in net proceeds of $17.7 million.
- Awarded $2.8 million NIH SBIR grant: In
February 2018, PhaseBio was awarded a $2.8 million Fast Track Small
Business Innovation Research (“SBIR”) grant from the National
Institutes of Health (“NIH”) to support the clinical development of
PB1046, a first-in-class, sustained-release vasoactive intestinal
peptide analogue, in patients with PAH.
Upcoming Milestones
- Initiate Phase 2a trial of PB2452 in the first half of
2019.
- Data readout from Phase 2a trial of PB2452 in the first half of
2019.
- Initiate Phase 2b trial of PB2452 in the second half of
2019.
Fourth Quarter and Full-Year 2018 Financial
Results
Cash Position
Cash and cash equivalents at December 31, 2018
were $61.0 million, compared to $13.4 million at December 31, 2017.
The increase reflects net proceeds from the initial public
offering, the issuance of Series D preferred stock and net proceeds
from term loan borrowings, partially offset by cash used in
operating activities.
Results of Operations
Three Months Ended December 31, 2018
PhaseBio reported a net loss of $4.9 million for
the three months ended December 31, 2018, which compared with a net
loss of $2.5 million for the same period in 2017. This resulted in
a net loss of $0.26 per share for the three months ended December
31, 2018, as compared to a net loss of $3.41 per share for the
corresponding period in 2017, on both a basic and diluted
basis.
Grant revenues were $0.3 million for the three
months ended December 31, 2018, as PhaseBio incurred allowable
costs qualifying for reimbursement under the government grants.
PhaseBio did not record any grant revenues for the three months
ended December 31, 2017.
Research and development expense increased
to $5.7 million for the three months ended December 31,
2018, as compared to $1.8 million for the three months
ended December 31, 2017, reflecting an increase in
manufacturing, clinical and preclinical development
activities related to PB2452 and PB1046.
General and administrative expense increased to
$2.2 million for the three months ended December 31, 2018, as
compared to $0.6 million for the three months ended December 31,
2017, primarily attributable to increases in professional services,
personnel, insurance and business travel-related expenses.
Year Ended December 31, 2018
PhaseBio reported a net loss of $23.8 million
for the year ended December 31, 2018, which compared with a net
loss of $10.2 million for 2017. This resulted in a net loss of
$4.49 per share for the year ended December 31, 2018, as compared
to a net loss of $13.78 per share for the corresponding period in
2017, on both a basic and diluted basis.
Grant revenues were $0.7 million for the year
ended December 31, 2018, as PhaseBio incurred allowable costs
qualifying for reimbursement under the government grants. PhaseBio
did not record any grant revenues for the year ended December 31,
2017.
Research and development expenses increased
to $15.5 million for the year ended December 31,
2018, as compared to $6.2 million for the year
ended December 31, 2017, reflecting an increase in clinical
and preclinical development activities related to PB2452
and PB1046.
General and administrative expenses were $4.9
million for the year ended December 31, 2018 compared to $2.3
million for the year ended December 31, 2017, 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 to treat orphan diseases,
with an initial focus on cardiopulmonary disorders. The company’s
lead development candidate is PB2452, a novel reversal agent for
the antiplatelet therapy ticagrelor. PhaseBio is also leveraging
its proprietary elastin-like polypeptide (“ELP”) technology
platform to develop therapies with the potential for less-frequent
dosing and improved pharmacokinetics. PhaseBio’s second product
candidate PB1046, which is based on ELP, is a once-weekly
vasoactive intestinal peptide receptor agonist for the treatment of
pulmonary arterial hypertension.
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,” “anticipates,” and “future” or
similar expressions are intended to identify forward-looking
statements.
Forward-looking statements include statements
concerning or implying the conduct of our clinical trials and the
timing of the release of the results of our clinical trials.
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 Annual Report on Form 10-K for the year ended December 31,
2018. 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.
Investor Contact:John SharpPhaseBio
Pharmaceuticals, Inc. Chief Financial Officer(610)
981-6506john.sharp@phasebio.com
Media Contact:Sarah Hall6 Degrees(215)
313-5638shall@6degreespr.com
|
|
PhaseBio Pharmaceuticals, Inc. |
Condensed Balance Sheets |
(in thousands) |
|
|
|
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
Assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
61,031 |
|
$ |
13,406 |
|
Other
receivable, prepaid expenses and other current assets |
|
|
1,597 |
|
|
360 |
|
Property
and equipment, net |
|
|
355 |
|
|
302 |
|
Other
non-current assets |
|
|
43 |
|
|
31 |
|
Total
assets |
|
$ |
63,026 |
|
$ |
14,099 |
|
|
|
|
|
|
|
|
|
Liabilities, redeemable convertible preferred stock
and stockholders' equity (deficit): |
|
|
|
|
|
|
|
Convertible promissory notes, net of discount |
|
$ |
— |
|
$ |
12,095 |
|
Derivative liability |
|
|
— |
|
|
3,028 |
|
Current
portion of long-term debt |
|
|
— |
|
|
761 |
|
Accounts
payable and accrued expenses |
|
|
4,577 |
|
|
1,711 |
|
Preferred stock warrant liability |
|
|
— |
|
|
1,656 |
|
Deferred
rent |
|
|
22 |
|
|
5 |
|
Long-term debt |
|
|
7,500 |
|
|
2,625 |
|
Redeemable convertible preferred stock |
|
|
— |
|
|
89,634 |
|
Stockholders’ equity (deficit) |
|
|
50,927 |
|
|
(97,416 |
) |
Total
liabilities, redeemable convertible preferred stock
and stockholders' equity (deficit) |
|
$ |
63,026 |
|
$ |
14,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PhaseBio Pharmaceuticals, Inc. |
Statements of Operations |
(in thousands, except share and per share
amounts) |
|
|
|
Quarter Ended December 31, |
|
Year Ended December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
revenues |
|
$ |
257 |
|
|
$ |
— |
|
|
$ |
668 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
5,676 |
|
|
|
1,823 |
|
|
|
15,455 |
|
|
|
6,210 |
|
General
and administrative |
|
|
2,241 |
|
|
|
628 |
|
|
|
4,857 |
|
|
|
2,328 |
|
Total
operating expenses |
|
|
7,917 |
|
|
|
2,451 |
|
|
|
20,312 |
|
|
|
8,538 |
|
Loss
from operations |
|
|
(7,660 |
) |
|
|
(2,451 |
) |
|
|
(19,644 |
) |
|
|
(8,538 |
) |
Other
income (expense) |
|
|
2,792 |
|
|
|
(84 |
) |
|
|
(4,202 |
) |
|
|
(1,709 |
) |
Net
loss |
|
$ |
(4,868 |
) |
|
$ |
(2,535 |
) |
|
$ |
(23,846 |
) |
|
$ |
(10,247 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(3.41 |
) |
|
$ |
(4.49 |
) |
|
$ |
(13.78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
|
18,824,091 |
|
|
|
744,155 |
|
|
|
5,305,062 |
|
|
|
743,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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