Chiasma Reports Second Quarter 2017 Results
11 August 2017 - 6:02AM
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
second quarter ended June 30, 2017.
“We are excited to move forward in our mission of advancing
octreotide capsules as a maintenance treatment for adult acromegaly
patients,” said Mark Fitzpatrick, president and CEO of Chiasma.
“The Special Protocol Assessment agreement with the FDA that we
announced today is a critical milestone in the continued
development of our octreotide capsules product candidate,
conditionally trade-named Mycapssa®. With this regulatory clarity,
we now plan to initiate enrollment of patients into our new Phase 3
OPTIMAL clinical trial during the second half of this year.
“Based on our current plans, we expect to have a cash and
investment balance of at least $60 million at the end of 2017, and
we expect that our existing cash and investments will be sufficient
to fund our operations through anticipated release of top-line data
from our new Phase 3 clinical trial by the end of 2019 and to
support in parallel our European MPOWERED trial,” Fitzpatrick
concluded.
SPA AgreementAs announced today, Chiasma has
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. The trial, referred to as
“OPTIMAL” (Octreotide capsules vs. Placebo Treatment In
MultinationAL centers), is a randomized, double-blind,
placebo-controlled, nine-month trial in 50 adult acromegaly
patients (at least 20% of whom must be recruited from the United
States). OPTIMAL utilizes levels of insulin-like growth factor,
IGF-1, a byproduct of increased growth hormone (GH) levels caused
by acromegaly, as the sole primary endpoint measure. The Company
believes the trial is adequately powered to assess maintenance of
biochemical control with octreotide capsules compared to placebo in
adult acromegaly patients who previously demonstrated biochemical
control on somatostatin receptor ligand injections.
MPOWERED™ Phase 3
Trial The Company continues to enroll patients in its
international Phase 3 MPOWERED clinical trial of octreotide
capsules for the maintenance treatment of adult patients with
acromegaly to potentially support regulatory approval in Europe.
However, in order to support enrollment rates for the OPTIMAL Phase
3 clinical trial, Chiasma has significantly reduced the number of
sites enrolling patients in the MPOWERED trial. Chiasma has
preserved more than two-thirds of the clinical sites previously
designated as MPOWERED investigative sites for exclusive enrollment
in the OPTIMAL trial. Chiasma now expects to have top-line data
from the MPOWERED Phase 3 clinical trial in 2020.
Second Quarter 2017 Financial Results
- G&A Expenses: General and administrative
expenses were $2.6 million for the quarter ended June 30, 2017,
compared with $5.4 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 $4.3 million for the quarter ended June 30, 2017,
compared with $14.8 million for the same period of 2016. The
decrease was primarily due to approximately $7.4 million of API
purchases and pre-commercial manufacturing validation activities in
2016 that did not reoccur in the quarter ended June 30, 2017, as
well as reduced compensation-related costs and other research and
development program efforts following the reductions of force in
June and August 2016. In addition, clinical trial costs decreased
by $0.8 million during the three months ended June 30, 2017
compared with the same period of 2016.
- Restructuring Charges: There were no
restructuring charges for the quarter ended June 30, 2017, compared
with $6.5 million for the same period of 2016 consisting of
one-time employee severance benefits and related costs of $1.5
million, one-time non-cash restructuring charges related to
previously capitalized commercial software of $0.4 million and
one-time manufacturing commitment-related suspension fees of $4.7
million.
- Net Loss: For the quarter ended June 30, 2017,
net loss was ($6.9) million, or ($0.28) per basic share. This
compares with a net loss of ($26.7) million, or ($1.10) per basic
share, for the same period of 2016.
- Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2017 were $80.1 million,
compared with $93.0 million as of December 31, 2016, primarily
reflecting the Company’s first half operating expenditures. The
Company expects its existing cash, cash equivalents and marketable
securities to fund operations through the anticipated release of
top-line 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 has reached
agreement under Special Protocol Assessment (SPA) 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. Chiasma is headquartered in the
United States with a wholly owned subsidiary in Israel. Mycapssa
and TPE 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 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 the OPTIMAL trial
in the second half of 2017, 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 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 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. These
risks and uncertainties include, but are not limited to, risks
associated with the regulatory review and approval process
generally; risks associated with Chiasma’s Phase 3 clinical trial
to support regulatory approval of octreotide capsules in the E.U.;
risks associated with Chiasma conducting an additional randomized,
double-blind and controlled Phase 3 clinical trial to support
regulatory approval of octreotide capsules in the United
States, including risks related to the enrollment, timing and
associated expenses; risks associated with Special Protocol
Assessment agreements, including the risk that SPA agreements are
not a guarantee of approval and the FDA may not approve octreotide
capsules even if the Phase 3 trial is successful; risks associated
with the ability of the Company’s suppliers to pass future
regulatory inspections; risks associated with obtaining,
maintaining and protecting intellectual property; risks associated
with Chiasma’s ability to enforce its patents against infringers
and defend its patent portfolio against challenges from third
parties; the risk that octreotide capsules, if approved, will not
be successfully commercialized; the risk of competition from
currently approved therapies and from other companies developing
products for similar uses; risks associated with Chiasma’s
financial position, including its ability to manage operating
expenses and/or obtain additional funding to support its business
activities; risks associated with Chiasma’s dependence on third
parties; and risks associated with defending any litigation,
including the risk that we incur more costs than we expect and
uncertainty involving the outcome. 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 June 30, 2017 filed with
the Securities and Exchange Commission (SEC)
on August 10, 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 six months ended |
|
June 30, 2017 |
|
June 30, 2016 |
|
June 30, 2017 |
|
June 30, 2016 |
Operating
expenses: |
|
|
|
|
|
|
|
General
and administrative |
$ |
2,641 |
|
|
$ |
5,392 |
|
|
$ |
5,101 |
|
|
$ |
15,386 |
|
Research
and development |
|
4,279 |
|
|
|
14,779 |
|
|
|
8,934 |
|
|
|
22,005 |
|
Restructuring charges |
|
- |
|
|
|
6,537 |
|
|
|
- |
|
|
|
6,537 |
|
Total operating
expenses |
|
6,920 |
|
|
|
26,708 |
|
|
|
14,035 |
|
|
|
43,928 |
|
Loss from
operations |
|
(6,920 |
) |
|
|
(26,708 |
) |
|
|
(14,035 |
) |
|
|
(43,928 |
) |
Other
income, net |
|
(204 |
) |
|
|
(121 |
) |
|
|
(364 |
) |
|
|
(250 |
) |
Loss before provision
for income taxes |
|
(6,716 |
) |
|
|
(26,587 |
) |
|
|
(13,671 |
) |
|
|
(43,678 |
) |
Provision for income
taxes |
|
138 |
|
|
|
76 |
|
|
|
203 |
|
|
|
165 |
|
Net loss |
$ |
(6,854 |
) |
|
$ |
(26,663 |
) |
|
$ |
(13,874 |
) |
|
$ |
(43,843 |
) |
|
|
|
|
|
|
|
|
Earnings per share of
common stock: |
|
|
|
|
|
|
|
Basic |
$ |
(0.28 |
) |
|
$ |
(1.10 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.81 |
) |
Diluted |
$ |
(0.28 |
) |
|
$ |
(1.10 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.81 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
24,359,584 |
|
|
|
24,321,069 |
|
|
|
24,359,584 |
|
|
|
24,279,580 |
|
Diluted |
|
24,359,584 |
|
|
|
24,321,069 |
|
|
|
24,359,584 |
|
|
|
24,279,580 |
|
|
|
|
|
|
|
|
|
Chiasma,
Inc. |
|
Condensed Consolidated Balance Sheets
Information |
|
(amounts in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
18,369 |
|
$ |
37,013 |
|
Marketable
securities |
|
61,739 |
|
|
55,971 |
|
Prepaid expenses and
other current assets |
|
1,407 |
|
|
2,110 |
|
Property and equipment,
net |
|
607 |
|
|
683 |
|
Other assets |
|
926 |
|
|
979 |
|
Total assets |
$ |
83,048 |
|
$ |
96,756 |
|
|
|
|
|
|
Accounts payable |
$ |
2,015 |
|
$ |
1,166 |
|
Accrued expenses |
|
4,145 |
|
|
5,534 |
|
Other current
liabilities |
|
1,685 |
|
|
1,700 |
|
Long-term
liabilities |
|
1,102 |
|
|
2,631 |
|
Total liabilities |
|
8,947 |
|
|
11,031 |
|
Total stockholders'
equity |
|
74,101 |
|
|
85,725 |
|
Total liabilities and
stockholders' equity |
$ |
83,048 |
|
$ |
96,756 |
|
|
|
|
|
|
Contact:
Andrew Blazier
Sharon Merrill Associates
(617) 542-5300
chma@investorrelations.com
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