Chiasma Reports Third Quarter 2017 Results
November 09 2017 - 4:05PM
Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical
company focused on improving the lives of patients with rare and
serious chronic diseases, today reported financial results for the
third quarter ended September 30, 2017.
“We are encouraged by the progress we are making toward
advancing octreotide capsules as a maintenance treatment for adult
acromegaly patients,” said Mark Fitzpatrick, president and CEO of
Chiasma. “During the quarter, Chiasma achieved three significant
milestones in the development of our octreotide capsules product
candidate, conditionally trade-named MYCAPSSA®. The Special
Protocol Assessment agreement with the FDA which we announced in
August provided sufficient regulatory clarity to proceed with our
new Phase 3 CHIASMA OPTIMAL clinical trial. In September, the first
patient was randomized in that trial, meeting our previous guidance
that enrollment in the study would begin during the second half of
2017. We also announced that we had surpassed 50% patients
randomized in our international Phase 3 clinical trial referred to
as MPOWEREDTM.
“We firmly believe in MYCAPSSA® as a potential new treatment
option for adult patients with acromegaly,” Fitzpatrick continued.
“We are dedicated to this important mission, and we are excited for
the journey ahead.
“Based on our current plans, we continue to expect to have a
cash and investment balance of at least $60 million at the end of
2017. We also expect that our existing cash and investments will be
sufficient to fund our operations through anticipated release of
top-line data from our CHIASMA OPTIMAL clinical trial by the end of
2019 and to support in parallel our European MPOWERED trial,”
Fitzpatrick concluded.
SPA Agreement
In August, Chiasma announced it had reached agreement with the
U.S. Food and Drug Administration (FDA) on the design of a new
Phase 3 clinical trial for its octreotide capsules product
candidate, conditionally trade-named MYCAPSSA®, for the maintenance
therapy of adult patients with acromegaly. The agreed-upon study is
designed to address the concerns previously raised in the FDA’s
Complete Response Letter (CRL) and was reached through Special
Protocol Assessment (SPA) with the FDA’s Division of Metabolism and
Endocrinology Products.
CHIASMA OPTIMAL Phase 3 Trial
In September 2017, Chiasma initiated its third Phase 3 clinical
trial per the SPA. CHIASMA OPTIMAL (Octreotide capsules vs.
Placebo Treatment In MultinationAL centers) is a randomized,
double-blind, placebo-controlled, nine-month clinical trial in 50
adult acromegaly patients (at least 20% of whom must be recruited
from the United States) whose disease is biochemically controlled,
based upon levels of IGF-1, a byproduct of increased growth hormone
(GH) levels caused by acromegaly, on injectable somatostatin
analogs at baseline (average IGF-1 ≤1.0 x upper limit of normal
(ULN)). The patients must also have confirmed active acromegaly
following their last surgical intervention based upon an elevated
IGF-1 at that time of ≥1.3×ULN. The trial will be randomized on a
1:1 basis to octreotide capsules or placebo. Patients will be dose
titrated from 40mg per day to up to a maximum of 80mg per day,
equaling two capsules in the morning and two capsules in the
evening. Patients meeting predefined withdrawal criteria during the
course of the trial will revert to their original treatment of
injections and will be monitored for the remainder of the
trial.
The primary endpoint of the study is the proportion of patients
who maintain their biochemical response compared to placebo at the
end of the nine-month, double-blind, placebo-controlled period as
measured using the average of the last two IGF-1 levels ≤ 1.0×ULN.
Hierarchical secondary endpoints that will be considered by the FDA
in evaluating the totality of evidence for octreotide capsules
treatment effect include: proportion of patients who maintain GH
response at week 36, compared to screening; time to loss of
response of IGF-1 > 1.0×ULN; time to loss of response of IGF-1
> 1.3×ULN; change in mean GH from screening to end of treatment;
and change in IGF-1 from baseline to end of treatment. Chiasma
anticipates the release of top-line data from this Phase 3 clinical
trial by the end of 2019.
MPOWERED™ Phase 3
Trial
Chiasma is conducting an international Phase 3 clinical trial
under a protocol accepted by the European Medicines Agency (EMA)
for the Company’s octreotide capsules product candidate for the
maintenance therapy of adult patients with acromegaly. The trial,
referred to as MPOWERED (Maintenance of Acromegaly Patients with
Octreotide Capsules Compared With Injections – Evaluation of
REsponse Durability), is a global, randomized, open-label and
active-controlled, 15-month trial. It is expected to enroll up to
150 adult acromegaly patients, of which it expects to randomize at
least 80 patients who are responders to octreotide capsules
following a six-month run-in to either octreotide capsules or
injectable somatostatin receptor ligands (octreotide or
lanreotide), and then followed for an additional nine months. The
trial was initiated in March 2016 and is designed to evaluate the
proportion of patients who maintain their biochemical response to
octreotide capsules and patient-reported outcomes in patients
treated with octreotide capsules, compared to patients treated with
standard of care injectable somatostatin receptor ligands. Chiasma
anticipates the release of top-line data from this Phase 3 clinical
trial in 2020.
Third Quarter 2017 Financial Results
- G&A Expenses: General and administrative
expenses were $2.3 million for the quarter ended September 30,
2017, compared with $3.9 million for the same period of 2016. The
decrease was primarily due to the reduction in pre-commercial
activity expenditures following the CRL, as well as the June and
August 2016 reductions in force of substantially all the Company’s
commercial personnel and certain administrative functions.
- R&D Expenses: Research and development
expenses were $4.7 million for the quarter ended September 30,
2017, compared with $4.5 million for the same period of 2016. The
increase was primarily due to costs related to the initiation of
the CHIASMA OPTIMAL clinical trial and was partially offset by
reduced compensation-related costs and other research and
development program efforts following the reductions of force in
June and August 2016.
- Restructuring Charges: There were no
restructuring charges for the quarter ended September 30, 2017,
compared with $1.0 million for the same period of 2016, which was
attributable to the restructuring plan announced in August
2016.
- Net Loss: For the quarter ended September 30,
2017, net loss was ($6.8) million, or ($0.28) per basic share. This
compares with a net loss of ($9.4) million, or ($0.38) per basic
share, for the same period of 2016.
- Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2017 were $73.2 million,
compared with $93.0 million as of December 31, 2016, primarily
reflecting the Company’s operating expenditures for the first nine
months of 2017. The Company expects its existing cash, cash
equivalents and marketable securities to fund operations through
the anticipated release of top-line CHIASMA OPTIMAL data by the end
of 2019 and to support in parallel the Company’s MPOWERED
trial.
About Chiasma
Chiasma is focused on improving the lives of patients who face
challenges associated with their existing treatments for rare and
serious chronic diseases. Employing its Transient Permeability
Enhancer (TPE®) technology platform, Chiasma seeks to develop oral
medications that are currently available only as injections. The
Company recently initiated a new Phase 3 clinical trial for its
octreotide capsules product candidate, conditionally trade-named
MYCAPSSA®, for the maintenance therapy of adult patients with
acromegaly following agreement with the FDA on the design of the
trial. Chiasma is headquartered in the United States with a wholly
owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are
registered trademarks of Chiasma. For more information, please
visit the Company’s website at www.chiasma.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the Company’s
commitment to develop new treatment options for patients with rare
and serious chronic diseases, specifically acromegaly, the
Company’s efforts to potentially obtain regulatory approval in the
United States by conducting the new Phase 3 CHIASMA OPTIMAL
clinical trial under a SPA, the Company’s efforts to potentially
obtain regulatory approval in Europe by conducting the ongoing
MPOWERED Phase 3 clinical trial, the Company’s ability to
successfully manufacture clinical trial material to enable the
enrollment of patients in both Phase 3 clinical trials, the timing
of receipt of top-line data and submission of regulatory filings,
including the Company’s ability to obtain top-line data from the
CHIASMA OPTIMAL trial by the end of 2019 and the Company’s ability
to obtain top-line data from the MPOWERED trial in 2020, and the
Company’s cash forecasts, including its expected cash and
investment balances as of the end of 2017 and the expectation that
it has sufficient existing cash and investments on hand to fund its
operations through its anticipated release of top-line data from
the new Phase 3 CHIASMA OPTIMAL clinical trial by the end of 2019
and to support the MPOWERED trial in parallel. Any forward-looking
statements in this press release are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. For a discussion of these and
other risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained
in the forward-looking statements, see the section entitled “Risk
Factors” in Chiasma’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2017 filed with the Securities
and Exchange Commission (SEC) on November 9, 2017, and in
subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the
date of the release, and Chiasma undertakes no duty to update this
information unless required by law.
|
Chiasma,
Inc. |
Condensed Consolidated Statements of
Operations |
(amounts in thousands except share and per
share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the three months ended |
|
For the nine months ended |
|
September 30, 2017 |
|
September 30, 2016 |
|
September 30, 2017 |
|
September 30, 2016 |
Operating
expenses: |
|
|
|
|
|
|
|
General
and administrative |
$ |
2,252 |
|
|
$ |
3,881 |
|
|
$ |
7,353 |
|
|
$ |
19,267 |
|
Research
and development |
|
4,691 |
|
|
|
4,521 |
|
|
|
13,625 |
|
|
|
26,526 |
|
Restructuring charges |
|
- |
|
|
|
1,037 |
|
|
|
- |
|
|
|
7,574 |
|
Total operating
expenses |
|
6,943 |
|
|
|
9,439 |
|
|
|
20,978 |
|
|
|
53,367 |
|
Loss from
operations |
|
(6,943 |
) |
|
|
(9,439 |
) |
|
|
(20,978 |
) |
|
|
(53,367 |
) |
Other
income, net |
|
(192 |
) |
|
|
(139 |
) |
|
|
(556 |
) |
|
|
(389 |
) |
Loss before provision
for income taxes |
|
(6,751 |
) |
|
|
(9,300 |
) |
|
|
(20,422 |
) |
|
|
(52,978 |
) |
Provision for income
taxes |
|
98 |
|
|
|
73 |
|
|
|
301 |
|
|
|
238 |
|
Net loss |
$ |
(6,849 |
) |
|
$ |
(9,373 |
) |
|
$ |
(20,723 |
) |
|
$ |
(53,216 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share of
common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.28 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.85 |
) |
|
$ |
(2.19 |
) |
Diluted |
$ |
(0.28 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.85 |
) |
|
$ |
(2.19 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
24,365,207 |
|
|
|
24,357,730 |
|
|
|
24,361,479 |
|
|
|
24,305,916 |
|
Diluted |
|
24,365,207 |
|
|
|
24,357,730 |
|
|
|
24,361,479 |
|
|
|
24,305,916 |
|
|
|
|
|
|
|
|
|
Chiasma,
Inc. |
Condensed Consolidated Balance Sheets
Information |
(amounts in
thousands) |
(unaudited) |
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
Cash and cash
equivalents |
$ |
12,133 |
|
$ |
37,013 |
Marketable
securities |
|
61,038 |
|
|
55,971 |
Prepaid expenses and
other current assets |
|
2,171 |
|
|
2,110 |
Property and equipment,
net |
|
584 |
|
|
683 |
Other assets |
|
927 |
|
|
979 |
Total assets |
$ |
76,853 |
|
$ |
96,756 |
|
|
|
|
|
|
Accounts payable |
$ |
1,982 |
|
$ |
1,166 |
Accrued expenses |
|
4,105 |
|
|
5,534 |
Other current
liabilities |
|
1,717 |
|
|
1,700 |
Long-term
liabilities |
|
1,083 |
|
|
2,631 |
Total liabilities |
|
8,887 |
|
|
11,031 |
Total stockholders'
equity |
|
67,966 |
|
|
85,725 |
Total liabilities and
stockholders' equity |
$ |
76,853 |
|
$ |
96,756 |
|
|
|
|
Contact: Andrew Blazier Sharon Merrill
Associates (617) 542-5300 chma@investorrelations.com
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