Clementia Reports Third Quarter 2018 Operating Results and Pipeline Updates
07 Noviembre 2018 - 5:30AM
Recent FDA Meeting Identifies Path Towards NDA
Submission in the Second Half of 2019
Clementia Pharmaceuticals Inc. (NASDAQ: CMTA), a clinical-stage
biopharmaceutical company innovating treatments for people with
ultra-rare bone disorders and other diseases, today reported
financial results for the third quarter ended September 30, 2018
and provided an update on recent progress and upcoming milestones.
“This has been a transformational year for Clementia, with our
lead product candidate, palovarotene, advancing towards an NDA
submission in the second half of 2019, which if approved, could be
the first available treatment indicated for FOP,” said Clarissa
Desjardins, Ph.D., president and chief executive officer of
Clementia. “Over the next 12 months we also expect to complete
enrollment in our MO-Ped Trial, the first-ever clinical trial to
test a potential treatment for Multiple Osteochondromas (MO), to
reach the first two interim analyses from our MOVE Trial, and to
report the results of our Phase 1 study of our palovarotene eye
drop formulation for dry eye disease. With our recently completed
financing we now have the resources to bring palovarotene to market
upon approval, while advancing our other clinical programs to key
value inflection points.”
Recent Pipeline Progress and Upcoming
Milestones
- On October 23, 2018 Clementia announced that it plans to submit
a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) requesting marketing authorization of
palovarotene for the treatment of fibrodysplasia ossificans
progressiva (FOP), with an anticipated submission in the second
half of 2019. The FDA has agreed, and the meeting minutes confirm,
that available data from the completed Phase 2 clinical program
would support the filing of an NDA for palovarotene for the
prevention of heterotopic ossification (HO) associated with flare
up symptoms in patients with FOP.
- On October 2, 2018 the company announced the initiation of a
Phase 1 clinical trial evaluating an eye drop formulation of
palovarotene in healthy volunteers. Data from this trial are
expected in the first quarter of 2019 and will be utilized to
inform the design of a proof of concept trial evaluating
palovarotene in dry eye disease, which is expected to begin in
2019.
- In September 2018, Clementia reported updated 12-week flare-up
imaging data from the open label extension (“Part B”) of its
ongoing Phase 2 clinical trial of palovarotene in fibrodysplasia
ossificans progressiva (FOP) at ASBMR 2018. The data demonstrated a
greater than 70 percent reduction in new HO across three different
dosing regimens.
- On August 16, 2018 the company announced the early completion
of enrollment in the MOVE Trial, Clementia’s Phase 3 study
evaluating the safety and efficacy of a chronic 5 mg daily dose in
addition to the episodic 20/10 mg dosing regimen at the time of a
flare-up for the potential treatment of individuals with FOP. If
successful, this study would add a new dosing regimen for patients
with FOP. The company expects two interim analyses in 2019, with a
third interim and final results in 2020.
Recent Business Updates
- On October 30, 2018 the company filed a prospectus for a
follow-on offering of 5,300,000 common shares, and the underwriters
exercised their option to purchase an additional 795,000 common
shares, resulting in the issue of 6,095,000 shares for net proceeds
of $75 million, after underwriting discounts and commissions and
the estimated offering expenses payable by the company. The
proceeds of this financing, together with Clementia’s existing cash
and investments balance, results in approximately $180 million as
of the closing of the offering.
Third Quarter 2018 Financial Results (all amounts are
presented in U.S. dollars)
- Cash: As of September 30, 2018, Clementia had
cash and investments of $107.1 million.
- Research and development (R&D) expenses:
R&D expenses were $10.7 million and $29.1 million for the three
and nine months ended September 30, 2018, compared to $7.1 million
and $16.8 million for the same periods in 2017. Increases in
R&D expenses were primarily due to increases in: clinical
studies and CRO related activities as a result of patient
enrollment in the MOVE and MO-Ped Trials; manufacturing activities
to meet clinical supply requirements of the MOVE and MO-Ped
studies; pre-clinical research activities to support ocular studies
and other potential indications; and personnel related expenses in
support of increased development activities.
- General and administrative (G&A)
expenses: G&A expenses were $4.4 million and
$11.2 million for the three and nine months ended September 30,
2018, compared to $2.8 million and $6.9 million for the same
periods in 2017. Increases in G&A expenses were primarily due
to higher pre-commercial marketing activities, higher personnel and
related costs to support the continued growth of the company and
higher operating expenses.
- Net Loss: Clementia reported net losses for
the three and nine months ended September 30, 2018 of $14.8 million
($0.46 per share) and $38.8 million ($1.22 per share), compared to
$39.0 million ($1.83 per share) and $103.7 million ($11.81 per
share) for the same periods in 2017. The decreases in net losses
period over period were largely driven by non-cash financial
expenses primarily due to the re-measurement at fair value of the
preferred shares embedded derivative in 2017 as compared to 2018.
With the successful completion of the company’s IPO in August 2017,
all classes of preferred shares were converted into common shares
and as such, gains or losses on the re-measurement of embedded
derivatives at fair value and the accretion expenses ended in the
third quarter of 2017.
About Clementia Pharmaceuticals Inc.Clementia
is a clinical-stage company innovating treatments for people with
ultra-rare bone disorders and other diseases with high medical
need. The company is preparing for a 2019 NDA submission to the FDA
to seek approval of its lead product candidate, palovarotene, a
novel RARγ agonist, for the prevention of heterotopic ossification
(HO) associated with flare up symptoms in patients with
fibrodysplasia ossificans progressiva (FOP). The ongoing Phase 3
MOVE Trial is evaluating an additional dosing regimen of
palovarotene which includes a chronic 5 mg daily dose in addition
to the episodic 20/10 mg dosing regimen at the time of a flare-up.
Palovarotene is also in a Phase 2 trial, the MO-Ped Trial, for the
treatment of multiple osteochondromas (MO, also known as multiple
hereditary exostoses, or MHE). In addition, Clementia has commenced
a Phase 1 trial for an eye drop formulation of palovarotene for the
potential treatment of dry eye disease and is also investigating
other conditions that may benefit from RARγ therapy. For more
information, please visit www.clementiapharma.com and connect with
us on Twitter @ClementiaPharma.
Cautionary Note Regarding Forward-Looking
StatementsThis press release may include “forward-looking
statements” within the meaning of the applicable securities laws,
including with respect to the proposed timing of submission of the
NDA for palovarotene. Each forward-looking statement contained in
this press release is subject to known and unknown risks and
uncertainties and other unknown factors that could cause actual
results to differ materially from historical results and those
expressed or implied by such statement. In addition to statements
which explicitly describe such risks and uncertainties, readers are
urged to consider statements labeled with the terms “believes,”
“belief,” “expects,” “intends,” “anticipates,” “will,” or “plans”
to be uncertain and forward-looking. Applicable risks and
uncertainties include, among others, the company’s ability to
successfully complete in a timely manner the studies required to be
completed in order to submit the NDA; the company’s ability to
generate revenue and become profitable; the risks related to its
heavy reliance on palovarotene, its only current product candidate;
the risks associated with the development of palovarotene and any
future product candidate, including the demonstration of efficacy
and safety; its dependence on licensed intellectual property,
including the ability to source and maintain licenses from
third-party owners; as well as the risks identified under the
heading “Risk Factors” in the company’s Annual Report on Form 20-F
filed with the Securities and Exchange Commission (“SEC”), as well
as the other information it files with the SEC or on SEDAR.
Clementia cautions investors not to rely on the forward-looking
statements contained in this press release when making an
investment decision in its securities. Investors are encouraged to
read the company’s filings with the SEC or on SEDAR, available at
www.sec.gov or www.sedar.com, for a discussion of these and other
risks and uncertainties. The forward-looking statements in this
press release speak only as of the date of this press release, and
the company undertakes no obligation to update or revise any of
these statements, whether as a result of new information, future
events or otherwise, except as required by law.
Investor/Media Contact:Joseph WalewiczClementia
Pharmaceuticals Inc.+1-514-940-1080
Alicia DavisTHRUST Strategic Communications+1-910- 620-3302
Clementia Pharmaceuticals Inc. |
Interim Condensed Consolidated Statements of
Financial Position (unaudited) |
|
|
|
As at(in US dollars) |
September 30, 2018 |
|
December 31, 2017 |
Assets |
|
|
Current
assets |
|
|
Cash |
$12,056,908 |
|
$36,230,343 |
Short-term
investments |
70,000,000 |
|
30,000,000 |
Interest
receivable |
181,407 |
|
575,499 |
Sales tax and other
receivables |
168,459 |
|
94,497 |
Income tax and tax
credits receivable |
1,044,285 |
|
977,901 |
Prepaid
expenses |
4,609,489 |
|
3,023,125 |
Total current
assets |
88,060,548 |
|
70,901,365 |
Non-current
assets |
|
|
Long-term
investments |
25,000,000 |
|
75,000,000 |
Long-term prepaid
expenses |
733,058 |
|
775,757 |
Property and
equipment |
18,987 |
|
33,084 |
Intangible assets |
1,570,486 |
|
1,715,192 |
Total
non-current assets |
27,322,531 |
|
77,524,033 |
Total assets |
$115,383,079 |
|
$148,425,398 |
Liabilities |
|
|
Current
liabilities |
|
|
Accounts payable and
accrued liabilities |
$8,792,166 |
|
$6,718,666 |
Total liabilities |
8,792,166 |
|
6,718,666 |
Equity |
|
|
Common shares |
230,659,692 |
|
230,659,692 |
Contributed
surplus |
6,319,484 |
|
2,659,348 |
Deficit |
(130,388,263 |
) |
(91,612,308) |
Total equity |
106,590,913 |
|
141,706,732 |
|
|
|
Total equity and liabilities |
$115,383,079 |
|
$148,425,398 |
Clementia Pharmaceuticals Inc. |
Interim Condensed Consolidated Statements of
Net Loss and Comprehensive Loss
(unaudited) |
|
|
|
|
|
|
|
Three-month periods ended September
30, |
|
Nine-month periods ended September
30, |
|
(in US
dollars) |
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
|
Research and
development expenses |
$10,691,399 |
|
$7,073,872 |
|
$29,124,117 |
|
$16,813,902 |
|
Investment tax credits |
(363,232 |
) |
(91,484 |
) |
(718,187 |
) |
(211,524 |
) |
|
10,328,167 |
|
6,982,388 |
|
28,405,930 |
|
16,602,378 |
|
|
|
|
|
|
General and
administrative expenses |
4,447,953 |
|
2,816,980 |
|
11,204,722 |
|
6,878,786 |
|
|
|
|
|
|
Interest income |
(531,479 |
) |
(316,081 |
) |
(1,622,109 |
) |
(503,915 |
) |
Financial expenses |
3,776 |
|
29,415,957 |
|
71,541 |
|
80,440,739 |
|
|
|
|
|
|
Net loss before income taxes |
14,248,417 |
|
38,899,244 |
|
38,060,084 |
|
103,417,988 |
|
|
|
|
|
|
Income tax expense |
528,694 |
|
106,310 |
|
715,871 |
|
248,338 |
|
|
|
|
|
|
Net loss and comprehensive loss |
($ 14,777,111 |
) |
($39,005,554 |
) |
($ 38,775,955 |
) |
($103,666,326 |
) |
|
|
|
|
|
Basic and diluted loss
per share |
($0.46 |
) |
($1.83 |
) |
($1.22 |
) |
($11.81 |
) |
Weighted
average number of outstanding basic and diluted shares |
31,717,584 |
|
21,317,604 |
|
31,717,584 |
|
8,778,602 |
|
Clementia Pharmaceuticals Inc. |
Interim Condensed Consolidated Statements of
Cash Flows (unaudited) |
|
|
|
|
|
|
Three-month periods ended September
30, |
|
Nine-month periods ended September
30, |
|
(in US
dollars) |
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
Operating activities |
|
|
|
|
Net
loss |
($14,777,111 |
) |
($39,005,554 |
) |
($38,775,955 |
) |
($103,666,326 |
) |
Adjusting
items |
|
|
|
|
Interest income recognized in net loss |
(531,479 |
) |
(316,081 |
) |
(1,622,109 |
) |
(503,915 |
) |
Depreciation of property and equipment |
4,733 |
|
6,063 |
|
14,097 |
|
19,855 |
|
Amortization of intangible assets |
48,765 |
|
48,673 |
|
144,706 |
|
130,718 |
|
Transaction costs recognized in net loss |
- |
|
- |
|
- |
|
35,175 |
|
Embedded derivative loss recognized in net loss |
- |
|
29,007,078 |
|
- |
|
77,902,663 |
|
Accretion of preferred shares |
- |
|
393,425 |
|
- |
|
2,479,161 |
|
Share-based compensation |
1,656,408 |
|
795,806 |
|
3,660,136 |
|
1,478,082 |
|
Net foreign exchange gain |
(16,729 |
) |
(32,634 |
) |
37,884 |
|
(48,026 |
) |
Income tax expense recognized in net loss |
528,694 |
|
106,310 |
|
715,871 |
|
248,338 |
|
Income taxes paid |
(4,375 |
) |
(42,500 |
) |
(64,068 |
) |
(130,589 |
) |
Tax credits |
(248,641 |
) |
- |
|
(409,638 |
) |
- |
|
Net changes
in working capital |
|
|
|
|
Sales tax and other receivables |
(95,768 |
) |
(49,860 |
) |
(75,846 |
) |
(74,884 |
) |
Investment tax credits receivable |
(114,591 |
) |
(91,484 |
) |
(308,549 |
) |
(211,524 |
) |
Deferred financing costs |
(18,165 |
) |
275,784 |
|
(18,165 |
) |
- |
|
Prepaid expenses |
583,103 |
|
(3,727,642 |
) |
(1,525,500 |
) |
(3,807,706 |
) |
Accounts payable and accrued liabilities |
330,564 |
|
457,938 |
|
2,078,396 |
|
1,835,789 |
|
Net operating cash flows |
(12,654,592 |
) |
(12,174,678 |
) |
(36,148,740 |
) |
(24,313,189 |
) |
Investing activities |
|
|
|
|
Interest
income received |
1,752,656 |
|
184,040 |
|
2,016,201 |
|
551,412 |
|
Acquisition
of short and long-term investments |
(15,000,000 |
) |
(109,000,000 |
) |
(20,000,000 |
) |
(134,000,000 |
) |
Maturity of
short-term investments |
25,000,000 |
|
19,000,000 |
|
30,000,000 |
|
49,000,000 |
|
Acquisition
of property and equipment |
- |
|
(4,194 |
) |
- |
|
(17,022 |
) |
Acquisition
of intellectual property |
- |
|
- |
|
- |
|
(1,000,000 |
) |
Net investing cash flows |
11,752,656 |
|
(89,820,154 |
) |
12,016,201 |
|
(85,465,610 |
) |
Financing activities |
|
|
|
|
Issuance of
common shares |
- |
|
- |
|
- |
|
31,588 |
|
Issuance of
common shares upon public offering |
- |
|
137,865,000 |
|
- |
|
137,865,000 |
|
Share
issuance costs |
- |
|
(10,236,593 |
) |
- |
|
(10,236,593 |
) |
Issuance of
preferred shares |
- |
|
- |
|
- |
|
10,000,080 |
|
Issue costs
of preferred shares |
- |
|
- |
|
- |
|
(129,520 |
) |
Net financing cash flows |
- |
|
127,628,407 |
|
- |
|
137,530,555 |
|
Net
(decrease) increase in cash |
(901,936 |
) |
25,633,575 |
|
(24,132,539 |
) |
27,751,756 |
|
Cash at
beginning of period |
12,937,235 |
|
11,584,221 |
|
36,230,343 |
|
9,434,495 |
|
Effect of
exchange rate fluctuations on cash held |
21,609 |
|
20,400 |
|
(40,896 |
) |
51,945 |
|
Cash at end of period |
12,056,908 |
|
$37,238,196 |
|
12,056,908 |
|
$37,238,196 |
|
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