BOSTON, Aug. 7, 2019 /PRNewswire/ -- Proteostasis
Therapeutics, Inc. (NASDAQ: PTI), a clinical stage
biopharmaceutical company dedicated to the discovery and
development of groundbreaking therapies to treat cystic fibrosis
(CF) and other diseases caused by dysfunctional protein processing,
today announced financial results for the second quarter ended
June 30, 2019 and provided a
corporate update.
"PTI continues to advance the clinical development of our
proprietary combination cystic fibrosis transmembrane conductance
regulator (CFTR) modulators. We recently initiated dosing in
the 28-day global Phase 2 study of our doublet (PTI-808 and
PTI-801) and triplet (PTI-808, PTI-801 and PTI-428)
combinations in F508del homozygous and heterozygous CF
subjects and we remain on track to report top line results
from this study in the first quarter of 2020. The CF community
continues to seek alternatives to today's standard of care
CFTR modulator therapy, validating PTI's mission to provide
additional disease-modifying treatment options for
patients with CF," said Meenu
Chhabra, President and Chief Executive Officer of
Proteostasis Therapeutics.
Recent Highlights and Upcoming Milestones
During the first quarter, PTI appointed Dr. Badrul Chowdhury, the former FDA Director of
Pulmonology, Allergy, and Rheumatology, to the Company's board of
directors. Dr. Chowdhury is Senior Vice President and Chief
Physician-Scientist, Respiratory Inflammation and Autoimmunity
(RIA) Late Stage, R&D Biopharmaceuticals, at AstraZeneca.
He was previously Director of the Division of Pulmonary,
Allergy, and Rheumatology Products at the U.S. Food and Drug
Administration's (FDA) Center for Drug Evaluation and
Research (CDER).
In May, the European Commission (EC) granted orphan
drug designation (ODD) to PTI-428 for the treatment of cystic
fibrosis. PTI-428 is the Company's proprietary CFTR amplifier that
is currently in clinical development. In addition to ODD from the
EC, PTI-428 has Orphan Drug Designation, Breakthrough
Therapy Designation and Fast Track Designation from
the U.S. Food and Drug Administration.
Data from the Company's CF clinical development programs were
presented during three panel presentations at the
42nd European Cystic Fibrosis Society (ECFS)
Conference in June. The panel presenters were
Damian Downey, M.D., Clinical Senior
Lecturer in Respiratory Medicine, Queen's University
Belfast, Belfast, UK; Manu
Jain, M.D., Professor of Medicine (Pulmonary and Critical
Care) and Pediatrics, Northwestern Medicine (Feinberg School of Medicine), Chicago, IL,
US; and Geoffrey Gilmartin of
PTI.
In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the
Company's Chief Medical Officer (CMO), and Andrey E.
Belous, M.D., Ph.D., as a Senior Medical Director. Dr.
Gilmartin most recently served as Chief Medical Affairs Officer of
the Company. Dr. Belous joined the Company from Galapagos
NV (NASDAQ:GLPG), where he most recently served as a Medical
Director for the company's Phase 3 program in Idiopathic Pulmonary
Fibrosis (IPF).
PTI announced in July that the first patient
was dosed in the Company's 28-day, Phase 2 study evaluating
its proprietary CFTR modulator combinations in CF
subjects. The global, multicenter, randomized,
placebo-controlled study is expected to enroll up to 30 F508del
homozygous patients and up to 30 F508del heterozygous patients.
Dose selection (600 mg of PTI-801 and 300 mg of PTI-808, with
or without 10 mg PTI-428) was based on the totality of dose range
finding data from approximately 250 CF subjects studied thus
far. Study endpoints include safety, changes in sweat chloride
concentration and changes in ppFEV1. Data from the
study are expected in the first quarter of 2020.
Second Quarter 2019 Financial Results
Proteostasis reported a net loss of approximately $20.0 million for the three months ended
June 30, 2019, as compared to a net
loss of $15.5 million for the same
period in the prior year.
There was no revenue for the three months ended June 30, 2019, as compared to $0.8 million for the same period in the prior
year. Revenue for the three months ended June 30, 2018 was related to the collaboration
agreement with Astellas, or the Astellas Agreement, which ended in
the fourth quarter of 2018.
Research and development expenses for the three months ended
June 30, 2019 were $16.9 million, as compared to $12.6 million for the same period in the prior
year. The increase in research and development expenses was
primarily due to an increase in clinical-related research
activities, as well as increases in employee-related expenses and
professional fees.
General and administrative expenses for the second quarter of
2019 were $3.7 million, as compared
to $4.0 million for the same period
in the prior year. The decrease in general and administrative
expenses was primarily due to a decrease in professional fees and
employee-related expenses.
Cash, cash equivalents and short-term investments totaled
$88.0 million as of June 30, 2019, compared to $105.3 million as of March
31, 2019. We believe that our existing cash, cash
equivalents and short-term investments are sufficient to fund our
operations into 2021, allowing us to complete our Phase 2 studies
and initiate key activities to support our Phase 3 program. As part
of its effort to deliver new treatment options to CF patients in
geographies around the world, the Company also announced today that
it is exploring partnership opportunities to maximize the value of
its assets.
About Proteostasis Therapeutics, Inc.
Proteostasis Therapeutics, Inc. is a clinical stage
biopharmaceutical company developing small molecule therapeutics to
treat cystic fibrosis and other diseases caused by dysfunctional
protein processing. Headquartered in Boston, MA, the Proteostasis Therapeutics team
focuses on identifying therapies that restore protein function. For
more information, visit www.proteostasis.com.
Safe Harbor
To the extent that statements in this release are not historical
facts, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Words such as "aim," "may," "will," "expect,"
"anticipate," "estimate," "intend," and similar expressions (as
well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. Examples of forward-looking
statements made in this release include, without limitation,
statements regarding the sufficiency of the cash and cash resources
to fund the Company's operating plans, expenses and capital
expenditure requirements, the further development of the Company's
programs, the potential of our proprietary combination therapies
for the treatment of CF, the potential benefit to patients of our
proprietary combination therapies, expected timing of patient
enrollment in, data from, the completion of, our clinical studies
and cohorts for our clinical programs, including our planned Phase
2 program and initiation of a pivotal study. Forward-looking
statements made in this release involve substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by the forward-looking statements,
and we, therefore cannot assure you that our plans, intentions,
expectations or strategies will be attained or achieved. Such
risks and uncertainties include, without limitation, our ability to
fund our operations and planned clinical trials, the possibility
final or future results from our drug candidate trials (including,
without limitation, longer duration studies) do not achieve
positive results or are materially and negatively different from or
not indicative of the preliminary results reported by the Company
(noting that these results are based on a small number of patients
and small data set), uncertainties inherent in the execution and
completion of clinical trials (including, without limitation, the
possibility that FDA or other regulatory agency comments
delay, change or do not permit trial commencement, or intended
label, or the FDA or other regulatory agency requires us
to run cohorts sequentially or conduct additional cohorts or
pre-clinical or clinical studies), in the enrollment of CF patients
in our clinical trials in a competitive clinical environment, in
the timing of availability of trial data, in the results of the
clinical trials, in possible adverse events from our trials, in the
actions of regulatory agencies, in the endorsement, if any, by
therapeutic development arms of CF patient advocacy groups (and the
maintenance thereof), and those set forth in our Annual Report on
Form 10-K for the year ended December 31, 2018, our Quarterly
Report on Form 10-Q for the quarter ended June 30,
2019 and our other SEC filings. We assume no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
PROTEOSTASIS
THERAPEUTICS, INC.
|
|
CONDENSED
STATEMENTS OF OPERATIONS
(In thousands,
except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenue
|
|
$
-
|
|
$
843
|
|
$
5,000
|
|
$
1,785
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
16,925
|
|
12,604
|
|
33,072
|
|
21,004
|
General and
administrative
|
|
3,682
|
|
3,957
|
|
7,626
|
|
7,780
|
Total operating
expenses
|
|
20,607
|
|
16,561
|
|
40,698
|
|
28,784
|
Loss from
operations
|
|
(20,607)
|
|
(15,718)
|
|
(35,698)
|
|
(26,999)
|
Interest
income
|
|
297
|
|
194
|
|
654
|
|
359
|
Other income,
net
|
|
292
|
|
46
|
|
608
|
|
136
|
Net loss
|
|
$
(20,018)
|
|
$
(15,478)
|
|
$
(34,436)
|
|
$
(26,504)
|
Net loss per
share—basic and diluted
|
|
$
(0.39)
|
|
$
(0.43)
|
|
$
(0.67)
|
|
$
(0.75)
|
Weighted average
common shares outstanding—basic
and diluted
|
|
51,097,456
|
|
36,009,109
|
|
51,037,514
|
|
35,245,796
|
PROTEOSTASIS
THERAPEUTICS, INC.
|
|
CONDENSED BALANCE
SHEET DATA
(In
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
June
30,
|
|
December 31,
|
|
|
2019
|
|
2018
|
Cash, cash
equivalents and short-term investments
|
|
$
88,021
|
|
$
118,379
|
Total
assets
|
|
105,749
|
|
136,142
|
Total
liabilities
|
|
23,764
|
|
21,800
|
Total stockholders'
equity
|
|
81,985
|
|
114,342
|
CONTACTS:
Investors:
David Pitts
/ Claudia Styslinger
Argot Partners
212.600.1902
david@argotpartners.com / claudia@argotpartners.com
Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com
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SOURCE Proteostasis Therapeutics, Inc.