Chiasma Reports First Quarter 2018 Results
May 10 2018 - 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
first quarter ended March 31, 2018.
“We continue to execute on our plan to advance octreotide
capsules, conditionally trade-named MYCAPSSA®, as a maintenance
treatment for adult patients with acromegaly,” said Mark
Fitzpatrick, president and CEO of Chiasma. “Our two Phase 3
clinical trials remain on track as we drive toward potential
submissions for approval of MYCAPSSA in both the United States and
the European Union.”
The Company expects that its existing cash and investments will
be sufficient to fund its operations through the anticipated
release of top-line data from the CHIASMA OPTIMAL clinical trial by
the end of 2019 while supporting the MPOWERED trial in
parallel.
CHIASMA OPTIMAL Phase 3 Trial
Chiasma is conducting 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 × upper limit of normal (ULN)).
The patients also must have confirmed active acromegaly following
their last surgical intervention based upon an elevated IGF-1 at
that time of ≥1.3 × ULN. The trial is being randomized on a
1:1 basis to octreotide capsules or placebo. Patients are being
dose titrated from 40 mg per day to up to a maximum of 80 mg per
day, equaling two capsules in the morning and two capsules in the
evening. Patients meeting predefined biochemical failure criteria
in either treatment arm during the course of the trial will be
considered treatment failures and revert to their original
treatment of injections and will be monitored for the remainder of
the trial. The primary endpoint of the trial 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 from screening to end of treatment in mean
GH; and change in IGF-1 from baseline to end of treatment.
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
approximately 130 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.
First Quarter 2018 Financial Results
- G&A Expenses: General and administrative
expenses were $2.4 million for the first quarter ended March 31,
2018, compared with $2.5 million for the same period of 2017. The
decrease was primarily due to the reduction in costs following the
November 2017 termination of our office facility lease in Waltham,
MA and was partially offset by increased legal fees.
- R&D Expenses: Research and development
expenses were $4.9 million for the quarter ended March 31, 2018,
compared with $4.7 million for the same period of 2017. The
increase was primarily due to costs related to the CHIASMA OPTIMAL
clinical trial which was initiated in September 2017 and was
partially offset by reduced personnel costs associated with the
transition of the Company’s former Chief Development Officer from a
full-time employee to board of director member of both Chiasma and
its Israeli subsidiary.
- Net Loss: For the quarter ended March 31,
2018, net loss was ($7.0) million, or ($0.29) per basic share,
unchanged from the same period of 2017.
- Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2018 were $60.5 million,
compared with $66.9 million as of December 31, 2017, primarily
reflecting the Company’s operating expenditures for the first
quarter of 2018. The Company continues to expect to have a cash and
investment balance of at least $35.0 million at the end of 2018 and
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 while supporting its MPOWERED trial
in parallel.
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 CHIASMA OPTIMAL, its third Phase 3
clinical trial for its octreotide capsules product candidate,
conditionally trade-named MYCAPSSA®, for the maintenance therapy of
adult patients with acromegaly in whom prior treatment with
somatostatin analogs has been shown to be effective and tolerated
following agreement with the FDA on the design of the trial.
Chiasma is headquartered in Waltham, MA 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
development of octreotide capsules, conditionally named MYCAPSSA,
for the treatment of acromegaly, the Company’s efforts to
potentially obtain regulatory approval in the United States by
conducting the Phase 3 CHIASMA OPTIMAL clinical trial under a
Special Protocol Assessment, the Company’s efforts to potentially
obtain regulatory approval in the European Union by conducting the
ongoing MPOWERED Phase 3 clinical trial, the Company’s estimate
that 130 patients will be required for the MPOWERED trial, the
timing of receipt and announcement of top-line and other clinical
data and submission of regulatory filings, including the Company’s
ability to release top-line data from the CHIASMA OPTIMAL trial by
the end of 2019 and the Company’s ability to release 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 2018 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 Phase 3 CHIASMA
OPTIMAL clinical trial by the end of 2019 while supporting 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 March 31, 2018 filed with the Securities and Exchange
Commission (SEC) on May 10, 2018, 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.
Contact: Andrew BlazierSharon Merrill
Associates(617) 542-5300chma@investorrelations.com
Chiasma,
Inc. |
|
Condensed Consolidated Statements of
Operations |
|
(amounts in thousands except share and per
share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
For the three months ended |
|
|
|
March 31, 2018 |
|
March 31, 2017 |
|
|
Operating
expenses: |
|
|
|
|
|
General
and administrative |
$ |
2,434 |
|
|
$ |
2,460 |
|
|
|
Research
and development |
|
4,863 |
|
|
|
4,655 |
|
|
|
Total operating
expenses |
|
7,297 |
|
|
|
7,115 |
|
|
|
Loss from
operations |
|
(7,297 |
) |
|
|
(7,115 |
) |
|
|
Other
income, net |
|
(230 |
) |
|
|
(160 |
) |
|
|
Loss before income
taxes |
|
(7,067 |
) |
|
|
(6,955 |
) |
|
|
Provision (benefit) for
income taxes |
|
(24 |
) |
|
|
65 |
|
|
|
Net loss |
$ |
(7,043 |
) |
|
$ |
(7,020 |
) |
|
|
|
|
|
|
|
|
Earnings per share of
common stock: |
|
|
|
|
|
Basic |
$ |
(0.29 |
) |
|
$ |
(0.29 |
) |
|
|
Diluted |
$ |
(0.29 |
) |
|
$ |
(0.29 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
Basic |
|
24,381,924 |
|
|
|
24,359,584 |
|
|
|
Diluted |
|
24,381,924 |
|
|
|
24,359,584 |
|
|
|
|
|
|
|
|
|
Chiasma,
Inc. |
|
Condensed Consolidated Balance Sheets
Information |
|
(amounts in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
March 31, 2018 |
|
December 31, 2017 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
15,248 |
|
$ |
14,603 |
|
Marketable
securities |
|
45,250 |
|
|
52,336 |
|
Prepaid expenses and
other current assets |
|
1,688 |
|
|
1,768 |
|
Property and equipment,
net |
|
175 |
|
|
193 |
|
Other assets |
|
986 |
|
|
983 |
|
Total assets |
$ |
63,347 |
|
$ |
69,883 |
|
|
|
|
|
|
Accounts
payable |
$ |
2,295 |
|
$ |
1,017 |
|
Accrued expenses |
|
4,409 |
|
|
4,033 |
|
Other current
liabilities |
|
- |
|
|
1,695 |
|
Long-term
liabilities |
|
586 |
|
|
664 |
|
Total liabilities |
|
7,290 |
|
|
7,409 |
|
Total stockholders'
equity |
|
56,057 |
|
|
62,474 |
|
Total liabilities and
stockholders' equity |
$ |
63,347 |
|
$ |
69,883 |
|
|
|
|
|
|
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