BOSTON, Nov. 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 third quarter ended
September 30, 2019 and provided a
corporate update.
"With equally strong demand from both US and ex-US clinical
centers, we were able to complete enrollment in a little over
four months for our 28-day global Phase 2 study of our
doublet and triplet cystic fibrosis transmembrane conductance
regulator (CFTR) combinations, and we now expect to
report top line results later this quarter," said Meenu Chhabra, President and Chief Executive
Officer of Proteostasis Therapeutics. "CFTR modulator therapy
is on the threshold of transforming CF from a life limiting disease
into a chronic condition, increasing life span and quality of life.
Yet standard of care CFTR modulator treatment still leaves behind
many people with CF, as tolerability, efficacy, access and
eligibility remain disparate across patient populations. PTI is
committed to delivering additional CFTR modulator treatment options
to address these significant unmet needs."
Recent Highlights and Upcoming Milestones
Earlier this week, PTI announced the completion
of enrollment in the Company's 28-day, Phase 2 study
evaluating its proprietary doublet (PTI-808 and PTI-801) and
triplet (PTI-808, PTI-801 and PTI-428) CFTR modulator
combinations, at doses selected based on the totality of dose
range finding data from approximately 250 CF subjects studied thus
far. The study design targeted up to 30 F508del homozygous and
up to 30 F508del heterozygous subjects. Study endpoints
include safety, changes in sweat chloride concentration and changes
in percent predicted
FEV1 (ppFEV1). Due to rapid
enrollment from centers in the United
States, Canada,
Western Europe, and New Zealand, data from the study are now
expected in the fourth quarter of 2019 instead of the first quarter
of 2020.
Data from the Company's CF clinical development programs were
recently highlighted at the North American Cystic Fibrosis
Conference in presentations delivered by Patrick
Flume, M.D., Professor of Medicine and Pediatrics, Medical
University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S.,
Associate Professor of Medicine and Pediatrics, and Co-Director and
CF Therapeutics Development Network Director of the Adult CF
Program at National Jewish Health.
Last month, PTI hosted a cystic fibrosis patient summit on the
disparity in access to CFTR modulator treatments. The event
featured members of the CF community, including thought leaders,
people with CF and CF advocates, and panel discussions focused on
current unmet needs in CF.
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 served previously as the medical lead for the
Kalydeco label expansion program at Vertex Pharmaceuticals Inc. Dr.
Belous joined the Company from Galapagos NV, where he
most recently served as a Medical Director for the Company's Phase
3 program in Idiopathic Pulmonary Fibrosis (IPF).
Third Quarter 2019 Financial Results
Proteostasis reported a net loss of approximately $12.8 million for the three months ended
September 30, 2019, as compared to a
net loss of $18.4 million for the
same period in the prior year.
There was no revenue for the three months ended September 30, 2019, as compared to $1.1 million for the same period in the prior
year. The decrease of $1.1
million is due to the termination of the Company's
collaboration agreement with Astellas.
Research and development expenses for the three months ended
September 30, 2019 were $10.1 million, as compared to $15.6 million for the same period in the prior
year. The decrease was primarily due to a decrease in
clinical-related research activities.
General and administrative expenses for the third quarter of
2019 were $3.2 million, as compared
to $4.2 million for the same period
in the prior year. The decrease in general and administrative
expenses in these periods was due primarily to lower professional
fees and facility expenses.
Cash, cash equivalents and short-term investments
totaled $77.8 million as of September 30,
2019, compared to $88.0 million as of June 30,
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 study and fund activities
supporting our pathway to product registrations.
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 our operating plans, expenses and capital expenditure
requirements, the further development of the our programs, the
potential of our proprietary combination therapies for the
treatment of CF, the potential benefit to patients of our
proprietary combination therapies, the ongoing trials of our
product candidates, the expected timing for completion and
reporting of top line results of our Phase 2 clinical trial and our
expectations regarding expanding available therapeutic options for
CF patients. 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, the potential of our proprietary combination
therapies for the treatment of CF, the potential benefit of our
proprietary combination therapies to patients, expected completion
of our clinical studies and cohorts for our clinical programs,
including our planned Phase 2 program and initiation of a pivotal
or registrational study, 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),
in the commercialization and acceptance of new therapies, 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 September 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.
CONDENSED
STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenue
|
|
$
-
|
|
$
1,055
|
|
$
5,000
|
|
$
2,840
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
10,145
|
|
15,591
|
|
43,217
|
|
36,595
|
General and
administrative
|
|
3,154
|
|
4,150
|
|
10,781
|
|
11,931
|
Total operating
expenses
|
|
13,299
|
|
19,741
|
|
53,998
|
|
48,526
|
Loss from
operations
|
|
(13,299)
|
|
(18,686)
|
|
(48,998)
|
|
(45,686)
|
Interest
income
|
|
224
|
|
171
|
|
879
|
|
530
|
Other income,
net
|
|
242
|
|
87
|
|
850
|
|
224
|
Net loss
|
|
$
(12,833)
|
|
$
(18,428)
|
|
$
(47,269)
|
|
$
(44,932)
|
Net loss per
share—basic and diluted
|
|
$
(0.25)
|
|
$
(0.50)
|
|
$
(0.93)
|
|
$
(1.26)
|
Weighted average
common shares
outstanding—basic
and diluted
|
|
51,099,307
|
|
36,694,957
|
|
51,058,339
|
|
35,734,159
|
CONDENSED BALANCE
SHEET DATA (In
thousands) (Unaudited)
|
|
|
|
September
30,
|
|
December 31,
|
|
|
2019
|
|
2018
|
Cash, cash
equivalents and short-term investments
|
|
$
77,761
|
|
$
118,379
|
Total
assets
|
|
94,038
|
|
136,142
|
Total
liabilities
|
|
23,917
|
|
21,800
|
Total stockholders'
equity
|
|
70,121
|
|
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.