Chiasma, Inc. (NASDAQ: CHMA), a clinical stage biopharmaceutical
company focused on improving the lives of patients who face
challenges associated with their existing treatments for rare and
serious chronic diseases, today reported financial results for
the fourth quarter and year ended December 31, 2019 and provided a
business update.
“Our focus for 2020 is on obtaining U.S.
regulatory approval for MYCAPSSA® as a maintenance treatment for
adult patients with acromegaly and subsequently executing a
successful launch,” said Raj Kannan, Chief Executive Officer of
Chiasma. “With our NDA resubmission accepted for review by the FDA,
we are preparing for a commercial launch to establish the
foundation needed for long-term growth.”
Recent Business Highlights and
Anticipated 2020 Milestones
- MYCAPSSA NDA
Acceptance: Chiasma announced on January 13, 2020 that the
U.S. Food and Drug Administration (FDA) accepted
for review the New Drug Application (NDA)
resubmission for its oral octreotide capsules
investigational product candidate, conditionally trade named
MYCAPSSA, for the treatment of adults with acromegaly. The FDA
assigned a Prescription Drug User-Fee
Act (PDUFA) target action date of June 26, 2020,
which is a six-month review.
- The Management of
Acromegaly (MACRO) Registry: Chiasma began enrolling
patients in the first-ever industry sponsored U.S. disease state
registry for acromegaly. The MACRO registry is designed to enroll
patients from over 40 clinical sites in the U.S. and collect
real-world data on treatment burden and effectiveness of various
acromegaly treatments.
- Publication of CHIASMA
OPTIMAL Phase 3 Clinical Trial Results: Chiasma plans to
submit the positive results of the CHIASMA OPTIMAL trial to a
peer-reviewed journal for expected publication in mid-2020.
- MYCAPSSA Planned U.S.
Commercial Launch: Chiasma plans to launch MYCAPSSA in the
United States in the fourth quarter of 2020, pending the FDA’s
timely approval of the NDA and either of the planned prior approval
manufacturing supplements to the NDA.
- Top-line MPOWERED Phase 3
Clinical Trial Results: Chiasma expects to report top-line
results from the MPOWERED (Maintenance of
acromegaly Patients
with Octreotide capsules
compared With injections
– Evaluation
of REsponse Durability)
Phase 3 open-label clinical trial of octreotide capsules in the
fourth quarter of 2020.
- Pipeline Expansion
Leveraging Transient Permeability Enhancer (TPE®)
Technology: Chiasma plans to announce its pipeline
expansion plans to develop one or more oral therapies targeting
diseases with unmet needs following the anticipated approval of
MYCAPSSA for the maintenance treatment of adults with
acromegaly.
Fourth Quarter and Year Full Year 2019
Financial Results and Outlook
- G&A
Expenses: General and administrative expenses
were $5.9 million for the fourth quarter
ended December 31, 2019, compared with $2.7
million for the same period of 2018. The current period
results include increased pre-commercial activity and compensation
related expenses which were primarily offset by a reduction in
legal expenses. General and administrative expenses were $15.1
million for the year ended December 31, 2019, compared
with $10.0 million for the year ended December 31,
2018. The increase was primarily driven by the initiation of
pre-commercial activities and compensation related expenses which
were primarily offset by a reduction in legal expenses.
- R&D
Expenses: Research and development expenses
were $6.4 million for the fourth quarter
ended December 31, 2019, compared with $5.7
million for the same period of 2018. The increase was
primarily driven by increased regulatory and manufacturing costs
and offset by decreased clinical trials costs. Research and
development expenses were $22.5 million for the year
ended December 31, 2019, compared with $22.4
million for the year ended December 31, 2018. Though the
change was immaterial, we observed an increase in regulatory and
manufacturing costs offset by a decrease in clinical trials
costs.
- Net Loss: For
the quarter ended December 31, 2019, net loss was ($12.0)
million, or ($0.29) per basic share, compared
with ($8.1) million, or ($0.32) per basic share, for
the same period of 2018. For the year ended December 31, 2019, net
loss was ($36.3) million, or ($1.06) per basic share, compared with
($31.3) million, or ($1.28) per basic share, for the same period of
2018.
- Cash Position and
Outlook: Cash, cash equivalents and marketable securities
as of December 31, 2019, were $92.4 million, compared
with $41.7 million as of December 31, 2018. The
Company expects that its current cash, cash equivalents and
marketable securities balance is sufficient to fund its operations
as currently planned through at least 2020.
Conference Call and Webcast
Information
Chiasma management will host a conference call
and webcast to discuss the fourth quarter results in more detail
today, March 16, 2020, at 5:00 pm ET. The dial-in number in the
U.S. / Canada is 1-877-407-4018; for international
participants, the dial-in number is 1-201-689-8471. For all
callers, please refer to Conference ID 13699225. To access the live
webcast, please use the following link:
https://edge.media-server.com/mmc/p/b4e8rvsn
A live audio webcast of the call may also be
accessed under "Events & Presentations" on the News &
Investors section of the Company's
website, http://ir.chiasmapharma.com/events-presentations. An
archived replay of webcast will be available on the Company’s
website approximately two hours after the event. The archived
webcast will be available for one year.
CHIASMA OPTIMAL Global Phase 3
Trial
The CHIASMA OPTIMAL trial was a randomized,
double-blind, placebo-controlled, nine-month Phase 3 clinical trial
of octreotide capsules that was conducted under a SPA agreement
with the FDA. The trial enrolled 56 adult acromegaly patients whose
disease was biochemically controlled by injectable somatostatin
analogs based upon levels of IGF-1, a byproduct of increased growth
hormone, or GH, levels caused by acromegaly (average IGF-1 ≤ 1.0 ×
upper limit of normal (ULN)). The patients also had confirmed
active acromegaly following their last surgical intervention based
upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were
randomized on a 1:1 basis, to octreotide capsules or placebo.
Patients were dose titrated from 40 mg per day (equaling one
capsule in the morning and one capsule in the evening) to up to a
maximum of 80 mg per day (equaling two capsules in the morning and
two capsules in the evening). Patients who met the predefined
withdrawal criteria, or discontinued from oral treatment for any
reason, in either treatment arm during the course of the trial were
considered treatment failures, reverted to their original treatment
of injections and monitored for the remainder of the trial. The
primary endpoint of the trial was the proportion of patients who
maintained their biochemical response 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 (assessed at weeks
34 and 36). Hierarchical secondary endpoints that are expected to
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: IGF-1 of 2 consecutive visits is > 1.0
× ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥
1.3 × ULN; and proportion of patients requiring rescue
treatment.
MPOWERED™ Phase 3 Trial
Chiasma is also conducting an international
Phase 3 clinical trial under a protocol accepted by the EMA for the
company’s oral octreotide capsules for the maintenance treatment of
adult patients with acromegaly. The trial, referred to as MPOWERED,
is a randomized, open-label and active-controlled, 15-month trial
intended to support regulatory approval in the European Union.
Chiasma completed enrollment of 146 adult acromegaly patients into
the trial in June 2019. In January 2020, the randomization of
patients was completed. Of the 146 patients that entered the
six-month run-in phase of the trial, 92 of these patients (or 63%)
completed the run-in phase and were deemed to be responders to
octreotide capsules per protocol (IGF-1 <1.3 x ULN and GH<2.5
ng/mL). Responders to octreotide capsules were randomized
(2:3) per protocol to either go back to their original
long-acting injectable somatostatin analog or remain on octreotide
capsules at the dose identified during the run-in phase and then
followed for an additional nine months. The trial 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 expects to release top-line data from the
MPOWERED Phase 3 clinical trial during the fourth quarter of
2020.
About Acromegaly
Acromegaly typically develops when a benign
tumor of the pituitary gland produces too much growth hormone,
ultimately leading to significant health problems. Common features
of acromegaly are facial changes, intense headaches, joint pain,
impaired vision and enlargement of the hands, feet, tongue and
internal organs. Serious health conditions associated with the
progression of acromegaly include type 2 diabetes, hypertension,
respiratory disorders and cardiac and cerebrovascular disease. We
believe that approximately 8,000 adult acromegaly patients are
chronically treated with somatostatin analogs in the United
States.
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. In July 2019, the company reported positive topline
data from its CHIASMA OPTIMAL 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. Prior to trial
initiation, the company reached agreement with the FDA on the
design of the trial through a special protocol assessment. In
January 2020, the FDA accepted the company’s NDA resubmission
seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target
action date is June 26, 2020. Chiasma is headquartered in
Needham, 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,
statements regarding the timing of regulatory filings and reviews
and potential approvals, statements concerning the nature of the
FDA’s review of the NDA resubmission, statements concerning the
commercial or therapeutic potential of MYCAPSSA, if approved,
statements regarding the company’s plan to submit two manufacturing
supplements for an additional API manufacturer and an additional
API manufacturing site following a potential NDA approval and the
company’s expectations regarding the availability of product
supply, statements concerning the timing of potential commercial
launch of MYCAPSSA in the United States, statements regarding the
release of top-line results from the MPOWERED Phase 3 trial,
statements regarding the company’s cash forecasts and need for
capital, including that it has sufficient existing cash and
investments on hand to fund its operations through at least 2020,
and announcements of pipeline expansion plans. Such statements are
subject to numerous important factors, risks and uncertainties,
many of which are beyond the company’s control, that may cause
actual events or results to differ materially from the company’s
current expectations. Management’s expectations and,
therefore, any forward-looking statements in this press release
could be affected by risks and uncertainties relating to a number
of factors, including the following: the content and timing of
decisions made by the FDA, including with respect to the NDA and
any manufacturing supplements to the NDA the company may submit to
the FDA, the results of any inspections of the company’s
third-party manufacturers, the company’s reliance on third parties
to manufacture API and commercial octreotide capsules, the
company’s ability to obtain and retain requisite regulatory
approvals for the commercial launch of octreotide capsules in the
United States, and the timing and costs involved in establishing a
commercial organization. Furthermore, the company will require
additional capital to fund its planned operations beyond 2020,
which may not be available to it on attractive terms or at
all. If the company is unable to secure additional
capital, it may be forced to delay, limit, reduce or terminate its
development and planned commercialization of MYCAPSSA. For a
discussion of these and other risks and uncertainties, and other
important factors, any of which could cause the company’s actual
results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in Chiasma’s
Annual Report on Form 10-K for the year ended December 31, 2019.
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.
Corporate Contact:Dawn SchottlandtVice
President, Investor Relations and Corporate
Communications617-928-5208dawn.schottlandt@chiasmapharma.com
Media Relations:Patrick BurseyLifeSci
Communications646-876-4932pbursey@lifescicomms.com
| Chiasma,
Inc. |
|
| Condensed
Consolidated Statements of Operations |
|
| (amounts in
thousands except share and per share data) |
|
|
(unaudited) |
|
| |
|
|
|
|
|
|
|
|
| |
For the three months ended |
|
For the twelve months ended |
|
| |
December 31, 2019 |
|
December 31, 2018 |
|
December 31, 2019 |
|
December 31, 2018 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
|
General and administrative |
$ |
5,912 |
|
|
$ |
2,657 |
|
|
$ |
15,122 |
|
|
$ |
9,974 |
|
|
|
Research and development |
|
6,354 |
|
|
|
5,732 |
|
|
|
22,457 |
|
|
|
22,362 |
|
|
| Total
operating expenses |
|
12,266 |
|
|
|
8,389 |
|
|
|
37,579 |
|
|
|
32,336 |
|
|
| Loss from
operations |
|
(12,266 |
) |
|
|
(8,389 |
) |
|
|
(37,579 |
) |
|
|
(32,336 |
) |
|
| Other
income, net |
|
(469 |
) |
|
|
(259 |
) |
|
|
(1,543 |
) |
|
|
(1,044 |
) |
|
| Loss before
income taxes |
|
(11,797 |
) |
|
|
(8,130 |
) |
|
|
(36,036 |
) |
|
|
(31,292 |
) |
|
| Benefit from
Income Taxes |
|
250 |
|
|
|
(55 |
) |
|
|
284 |
|
|
|
(31 |
) |
|
| Net
loss |
$ |
(12,047 |
) |
|
$ |
(8,075 |
) |
|
$ |
(36,320 |
) |
|
$ |
(31,261 |
) |
|
| |
|
|
|
|
|
|
|
|
| Earnings per
share of common stock: |
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.29 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.28 |
) |
|
|
Diluted |
$ |
(0.29 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.28 |
) |
|
| |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
42,022,030 |
|
|
|
24,442,370 |
|
|
|
34,204,284 |
|
|
|
24,399,706 |
|
|
|
Diluted |
|
42,022,030 |
|
|
|
24,442,370 |
|
|
|
34,204,284 |
|
|
|
24,399,706 |
|
|
| |
|
|
|
|
|
|
|
|
| Chiasma,
Inc. |
|
| Condensed
Consolidated Balance Sheets Information |
|
| (amounts in
thousands) |
|
|
(unaudited) |
|
| |
|
|
|
|
| |
December 31, 2019 |
|
December 31, 2018 |
|
| |
|
|
|
|
|
Cash and cash equivalents |
$ |
27,855 |
|
$ |
13,060 |
|
| Marketable
securities |
|
64,520 |
|
|
28,602 |
|
| Insurance
recovery |
|
- |
|
|
18,288 |
|
| Prepaid
expenses and other current assets |
|
3,881 |
|
|
2,237 |
|
| Property and
equipment, net |
|
334 |
|
|
111 |
|
| Other
assets |
|
2,236 |
|
|
958 |
|
| Total
assets |
$ |
98,826 |
|
$ |
63,256 |
|
| |
|
|
|
|
| Accounts
payable |
$ |
3,253 |
|
$ |
2,029 |
|
| Estimated
settlement liability |
|
- |
|
|
18,750 |
|
| Accrued
expenses |
|
7,576 |
|
|
7,848 |
|
| Other
current liabilities |
|
546 |
|
|
- |
|
| Long-term
liabilities |
|
1,682 |
|
|
505 |
|
| Total
liabilities |
|
13,057 |
|
|
29,132 |
|
| Total
stockholders' equity |
|
85,769 |
|
|
34,124 |
|
| Total
liabilities and stockholders' equity |
$ |
98,826 |
|
$ |
63,256 |
|
| |
|
|
|
|
Chiasma (NASDAQ:CHMA)
Historical Stock Chart
From Apr 2024 to May 2024
Chiasma (NASDAQ:CHMA)
Historical Stock Chart
From May 2023 to May 2024
