UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2018
Commission File Number: 333-219066
Clementia Pharmaceuticals Inc.
(Translation of registrant's name into English)
4150 St Catherine Street West, Suite 550
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On August 9, 2018, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated August 9, 2018
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Clementia Pharmaceuticals Inc. | ||
(Registrant) | ||
Date: August 9, 2018 | /s/ MICHAEL SINGER | |
Michael Singer | ||
Chief Financial Officer | ||
EXHIBIT 99.1
Clementia Reports Second Quarter 2018 Operating Results and Pipeline Updates
Patient Enrollment in Phase 3 MOVE Trial of Palovarotene for FOP On Track; Two Interim Data Analyses Expected in 2019
MONTREAL, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (NASDAQ: CMTA), a clinical-stage biopharmaceutical company innovating new treatments for people with ultra-rare bone disorders and other diseases, today reported financial results for the second quarter ended June 30, 2018 and provided an update on recent progress and upcoming milestones.
“The MOVE Trial is progressing very well and we continue to expect completion of enrollment in 2018, which we believe demonstrates the substantial need for treatments for people with FOP and the enthusiasm for palovarotene among the physician and patient community,” said Clarissa Desjardins, Ph.D., president and chief executive officer of Clementia. “Additionally, enrollment in our MO-Ped Trial, which to our knowledge is the first-ever clinical trial for multiple osteochondromas, a debilitating and life-altering bone disorder, is progressing well and we are on track to initiate a Phase 1 study of palovarotene for dry eye disease in the fourth quarter of this year. This is an incredibly exciting time for Clementia as we continue our work to bring important potential treatments to patients in need.”
Recent Pipeline Progress and Upcoming Milestones
Recent Business Updates
Second Quarter 2018 Financial Results (all amounts are presented in U.S. dollars)
About Clementia Pharmaceuticals Inc.
Clementia is a clinical-stage company innovating new treatments for people with ultra-rare bone disorders and other diseases with high medical need. The company’s lead product candidate, palovarotene, a novel RARγ agonist, is currently being evaluated in the Phase 3 MOVE Trial to treat fibrodysplasia ossificans progressiva (FOP) and in the Phase 2 MO-Ped Trial to treat multiple osteochondromas (MO, also known as multiple hereditary exostoses/MHE). Clementia is also investigating palovarotene for the potential treatment of 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 Statements
This press release may include “forward-looking statements” within the meaning of the applicable securities laws. 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 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 its file 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 Walewicz
Clementia Pharmaceuticals Inc.
+1-514-940-1080
Alicia Davis
THRUST Strategic Communications
+1-910- 620-3302
Clementia Pharmaceuticals Inc. | ||
Interim Condensed Consolidated Statements of Financial Position (unaudited) | ||
As at | June 30, | December 31, |
(in US dollars) | 2018 | 2017 |
Assets | ||
Current assets | ||
Cash | $12,937,235 | $36,230,343 |
Short-term investments | 55,000,000 | 30,000,000 |
Interest receivable | 1,402,584 | 575,499 |
Sales tax and other receivables | 71,105 | 94,497 |
Income tax and tax credits receivable | 1,205,372 | 977,901 |
Prepaid expenses | 5,907,485 | 3,798,882 |
Total current assets | 76,523,781 | 71,677,122 |
Non-current assets | ||
Long-term investments | 50,000,000 | 75,000,000 |
Property and equipment | 23,720 | 33,084 |
Intangible assets | 1,619,251 | 1,715,192 |
Total non-current assets | 51,642,971 | 76,748,276 |
Total assets | $128,166,752 | $148,425,398 |
Liabilities | ||
Current liabilities | ||
Accounts payable and accrued liabilities | $8,455,136 | $6,718,666 |
Total liabilities | 8,455,136 | 6,718,666 |
Equity | ||
Common shares | 230,659,692 | 230,659,692 |
Contributed surplus | 4,663,076 | 2,659,348 |
Deficit | (115,611,152) | (91,612,308) |
Total equity | 119,711,616 | 141,706,732 |
Total equity and liabilities | $128,166,752 | $148,425,398 |
Clementia Pharmaceuticals Inc. | |||||||||||||||||
Interim Condensed Consolidated Statements of Net Loss and Comprehensive Loss (unaudited) | |||||||||||||||||
Three-month periods ended | Six-month periods ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
(in US dollars) | 2018 | 2017 | 2018 | 2017 | |||||||||||||
Expenses | |||||||||||||||||
Research and development expenses | $7,437,155 | $6,332,519 | $18,432,718 | $9,740,030 | |||||||||||||
Investment tax credits | (203,917) | (70,414) | (354,955) | (120,040) | |||||||||||||
7,233,238 | 6,262,105 | 18,077,763 | 9,619,990 | ||||||||||||||
General and administrative expenses | 3,899,531 | 2,393,514 | 6,756,769 | 4,061,806 | |||||||||||||
Interest income | (538,872) | (106,837) | (1,090,630) | (187,834) | |||||||||||||
Financial expenses | 27,499 | 14,677,698 | 67,765 | 51,024,782 | |||||||||||||
Net loss before income taxes | 10,621,396 | 23,226,480 | 23,811,667 | 64,518,744 | |||||||||||||
Income tax expense | 146,211 | 97,665 | 187,177 | 142,028 | |||||||||||||
Net loss and comprehensive loss | ($10,767,607) | ($23,324,145) | ($23,998,844) | ($64,660,772) | |||||||||||||
Basic and diluted loss per share | ($0.34) | ($9.54) | ($0.76) | ($26.88) | |||||||||||||
Weighted average number of outstanding basic and diluted shares | 31,717,584 | 2,445,729 | 31,717,584 | 2,405,187 |
Clementia Pharmaceuticals Inc. | ||||||||
Interim Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||||
Three-month periods ended | Six-month periods ended | |||||||
June 30, | June 30, | |||||||
(in US dollars) | 2018 | 2017 | 2018 | 2017 | ||||
Operating activities | ||||||||
Net loss | ($10,767,607) | ($23,324,145) | ($23,998,844) | ($64,660,772) | ||||
Adjusting items | ||||||||
Interest income recognized in net loss | (538,872) | (106,837) | (1,090,630) | (187,834) | ||||
Depreciation of property and equipment | 4,682 | 6,314 | 9,364 | 13,792 | ||||
Amortization of intangible assets | 48,236 | 48,227 | 95,941 | 82,045 | ||||
Transaction costs recognized in net loss | - | - | - | 35,175 | ||||
Embedded derivative loss recognized in net loss | - | 13,578,536 | - | 48,895,585 | ||||
Accretion of preferred shares | - | 1,097,699 | - | 2,085,737 | ||||
Share-based compensation | 1,271,935 | 598,535 | 2,003,728 | 682,276 | ||||
Net foreign exchange gain | 37,429 | (8,353) | 54,613 | (15,393) | ||||
Income tax expense recognized in net loss | 146,211 | 97,665 | 187,177 | 142,028 | ||||
Income taxes paid | (54,447) | (42,500) | (59,693) | (88,089) | ||||
Tax credit | (126,337) | - | (160,997) | - | ||||
Net changes in working capital | ||||||||
Sales tax and other receivables | 40,984 | (64,316) | 19,922 | (25,024) | ||||
Investment tax credits receivable | (77,580) | (70,414) | (193,958) | (120,040) | ||||
Deferred financing costs | - | (182,240) | - | (275,784) | ||||
Prepaid expenses | (3,541,020) | (75,603) | (2,108,603) | (80,064) | ||||
Accounts payable and accrued liabilities | (195,284) | 2,246,567 | 1,747,832 | 1,377,851 | ||||
Net operating cash flows | (13,751,670) | (6,200,865) | (23,494,148) | (12,138,511) | ||||
Investing activities | ||||||||
Interest income received | 97,826 | 36,329 | 263,545 | 367,372 | ||||
Acquisition of short and long-term investments | - | (5,000,000) | (5,000,000) | (25,000,000) | ||||
Maturity of short-term investments | - | - | 5,000,000 | 30,000,000 | ||||
Acquisition of property and equipment | - | (5,302) | - | (12,828) | ||||
Acquisition of intellectual property | - | (1,000,000) | - | (1,000,000) | ||||
Net investing cash flows | 97,826 | (5,968,973) | 263,545 | 4,354,544 | ||||
Financing activities | ||||||||
Issuance of common shares | - | 5,859 | - | 31,588 | ||||
Issuance of preferred shares | - | - | - | 10,000,080 | ||||
Issue costs of preferred shares | - | - | - | (129,520) | ||||
Net financing cash flows | - | 5,859 | - | 9,902,148 | ||||
Net (decrease) increase in cash | (13,653,844) | (12,163,979) | (23,230,603) | 2,118,181 | ||||
Cash at beginning of period | 26,638,487 | 23,722,034 | 36,230,343 | 9,434,495 | ||||
Effect of exchange rate fluctuations on cash held | (47,408) | 26,166 | (62,505) | 31,545 | ||||
Cash at end of period | $12,937,235 | $11,584,221 | $12,937,235 | $11,584,221 |