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Clementia Reports 2017 Operating Results and Business Highlights

Enrollment Underway in Palovarotene Phase 3 MOVE Trial for Fibrodysplasia Ossificans Progressiva (FOP)

On-track to Enroll First Patient in Palovarotene Phase 2 MO-Ped Trial for Multiple Osteochondromas (MO) this Quarter

MONTREAL, Feb. 28, 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 fourth quarter and full-year ended December 31, 2017 and provided an update on recent corporate and clinical developments.

“Since our transition into a publicly traded company last August, we made significant progress with our palovarotene clinical programs, which have the opportunity to be the first treatments in two rare and severely disabling bone disorders,” commented Clarissa Desjardins, Ph.D., chief executive officer of Clementia. “The initiation of the Phase 3 MOVE Trial marks the first-ever registration study for the treatment of individuals with FOP, and we are on-track to initiate enrollment in the first-ever clinical trial in individuals with MO in the first quarter. These studies represent critical steps forward for Clementia and our transformation into a late-stage company that plans to bring our products to market ourselves. Palovarotene has the potential to change the way individuals with these debilitating bone disorders are treated, and we will continue working closely with patients and investigators around the world to advance these important studies.”

Recent Corporate Highlights

  • In December 2017, Clementia enrolled the first patient in its Phase 3 MOVE Trial, which is evaluating palovarotene, a retinoic acid receptor gamma agonist (RARγ), for the treatment of patients with FOP. The MOVE Trial is an international, multi-center, single-treatment arm study designed to support the registration of palovarotene in this indication.
  • In January 2018, Clementia announced the appointment of industry veteran Pierre Legault, MBA, CA, CPA, to its board of directors. Mr. Legault is an accomplished leader in the biopharmaceutical industry with a proven track record serving as chief executive officer or chief financial officer, leading corporate and business development and creating significant value for a premier set of international biopharmaceutical companies. In addition to Mr. Legault’s appointment, Clementia today announced that David Mott, who has served on the company’s board of directors since 2015, has stepped down from the board effective February 27, 2018.

Upcoming Milestones

  • Clementia remains on track to enroll the first patient in its global Phase 2 MO-Ped Trial of palovarotene for the treatment of patients with MO in the first quarter of 2018. 
  • The company anticipates reporting preliminary results from the Part B open-label extension portion of its ongoing Phase 2 study of palovarotene in FOP in the second quarter of 2018.

Fourth Quarter and Year End 2017 Financial Results (all amounts are presented in U.S. dollars)

  • Cash: As of December 31, 2017, Clementia had cash and investments of $141.2 million.
  • Research and development (R&D) expenses: R&D expenses were $10.6 million and $27.4 million, respectively, for the fourth quarter and year ended December 31, 2017, compared to $5.3 million and $16.9 million, respectively, for the same periods in 2016. Increases in R&D expenses were primarily due to clinical costs associated with palovarotene for FOP, including initiation of the MOVE Trial and related milestone payments to licensors; costs associated with palovarotene for MO, including preparatory activities for the MO-Ped Trial; pre-clinical research activities to support future ocular studies; and increased personnel and related expenses to support the company’s clinical development strategy.
  • General and administrative (G&A) expenses: G&A expenses were $2.4 million and $9.3 million, respectively, for the fourth quarter and year ended December 31, 2017, compared to $0.8 million and $3.4 million, respectively for the same periods in 2016. Increases in G&A expenses were primarily due to costs associated with its initial public offering, pre-commercial activities and personnel-related expenses due to the increase in headcount to support the growth of the company.
  • Net Loss: Clementia reported net losses for the fourth quarter and year ended December 31, 2017 of $11.8 million ($0.37 per share) and $115.5 million ($7.93 per share), respectively, compared to $48.4 million ($20.57 per share) and $57.5 million ($24.46 per share), respectively, for the same periods in 2016. The decrease in net loss quarter over quarter and the increase in net loss year over year 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 2016. With the successful completion of the company’s IPO in August 2017, all classes of preferred shares have been converted into common shares and as such, gains or losses on the re-measurement of embedded derivatives at fair value and the accretion expense has ended in the third quarter of 2017.

About Clementia Pharmaceuticals Inc.

Clementia is a clinical-stage biopharmaceutical company innovating new treatments for people with ultra-rare bone disorders and other diseases with high medical need. The company’s lead candidate, palovarotene, a novel RARγ agonist, is currently being evaluated in the Phase 3 MOVE Trial to treat fibrodysplasia ossificans progressiva (FOP), with additional clinical studies planned in multiple osteochondromas (MO, also known as hereditary multiple exostoses) and other diseases. For more information, please visit www.clementiapharma.com.

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, our ability to generate revenue and become profitable; the risks related to our heavy reliance on palovarotene, our only current product candidate; the risks associated with the development of palovarotene and any future product candidate, including the demonstration of efficacy and safety; our heavy dependence on licensed intellectual property, including our ability to source and maintain licenses from third-party owners; as well as the risks identified under the heading “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”), as well as the other information we file with the SEC or on SEDAR.  We caution investors not to rely on the forward-looking statements contained in this press release when making an investment decision in our securities.  You are encouraged to read our 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 we undertake 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

Chelcie Lister
THRUST Investor Relations
+1-910-777-3049

 
Clementia Pharmaceuticals Inc.
Consolidated Statements of Financial Position (unaudited)
As at
(in US dollars)
December 31,
2017
 December 31,
2016
 
Assets  
Current assets  
Cash   $36,230,343 $9,434,495 
Short-term investments30,000,000 30,000,000 
Interest receivable575,499 307,579 
Sales tax and other receivables94,497 90,966 
Income tax and tax credits receivable977,901 139,223 
Prepaid expenses3,798,882 652,158 
Total current assets71,677,122 40,624,421 
   
Non-current assets  
Long-term investments75,000,000 - 
Property and equipment33,084 38,163 
Intangible assets1,715,192 894,584 
Total non-current assets76,748,276 932,747 
   
Total assets$148,425,398 $41,557,168 
   
Liabilities  
Current liabilities  
Accounts payable and accrued liabilities$6,718,666 $4,521,537 
Income taxes payable- 2,176 
Total current liabilities6,718,666 4,523,713 
Long  
Non-current liabilities  
Preferred shares- 67,880,952 
Embedded derivatives- 117,824,611 
Total non-current liabilities- 185,705,563 
   
Total liabilities$6,718,666 190,229,276 
   
Equity  
Common shares230,659,692 272,391 
Contributed surplus2,659,348 498,471 
Deficit(91,612,308)(149,442,970)
Total equity141,706,732 (148,672,108)
Total equity and liabilities$148,425,398 $41,557,168 


 
Clementia Pharmaceuticals Inc.
Consolidated Statements of Net Loss and Comprehensive Loss (unaudited)
 Year ended Year ended Year ended 
 December 31, December 31, December 31, 
(in US dollars)2017 2016 2015 
    
Expenses   
    
Research and development expenses$27,405,648 $16,851,974 $14,396,563 
Tax credits(1,237,028)(139,212)(165,124)
 26,168,620 16,712,762 14,231,439 
    
General and administrative expenses9,287,036 3,405,615 5,478,833 
    
Interest income(1,082,030)(398,559)(109,670)
Financial expenses 80,437,802 37,645,707 56,140,121 
    
Net loss before income taxes114,811,428 57,365,525 75,740,723 
    
Income tax expense643,765 146,454 156,220 
    
Net loss and comprehensive loss($115,455,193)($57,511,979)($75,896,943)
    
Basic and diluted loss per share($7.93)($24.46)($33.06)
    
Weighted average number of outstanding basic and diluted shares14,560,482 2,351,347 2,295,402 


 
Clementia Pharmaceuticals Inc.
Consolidated Statements of Cash Flows (unaudited)
 

(in US dollars)
Year ended
December 31,
2017
 Year ended
December 31,
2016
 Year ended
December 31,
2015
 
Operating activities   
Net loss($115,455,193)($57,511,979)($75,896,943)
Adjusting items   
Interest income recognized in net loss(1,082,030)(398,559)(109,670)
Depreciation of property and equipment25,297 35,055 14,506 
Amortization of intangible assets179,392 137,526 134,258 
Transaction costs recognized in net loss35,175 - 819,271 
Embedded derivative loss recognized in net loss77,902,663   33,982,042 52,563,759 
Accretion of preferred shares2,479,162 3,742,178 2,378,992 
Share-based compensation2,180,915 174,419 164,456 
Net foreign exchange (gain) loss (40,913)(82,589)382,982 
Income tax expense recognized in net loss643,765 146,454 156,220 
Income taxes paid(392,620)(98,218)(296,630)
Tax credit(330,000)- - 
Net changes in working capital   
Sales tax and other receivables3,641 (48,207)24,435 
Income tax and tax credits receivable(761,999)238,690 (85,360)
Prepaid expenses(3,146,724)350,129 65,757 
Accounts payable and accrued liabilities2,193,009 504,976 2,060,688 
Net operating cash flows(35,566,460)(18,828,083)(17,623,279)
Investing activities   
Interest income received814,110 95,526 105,124 
Acquisition of short-term investments(134,000,000)(40,000,000)(40,000,000)
Maturity of short-term investments59,000,000 10,000,000 40,000,000 
Acquisition of property and equipment(20,218)(27,918)(48,855)
Acquisition of intangible assets(1,000,000)- (116,276)
Net investing cash flows(75,206,108)(29,932,392)(60,007)
Financing activities   
Issuance of common shares31,588 - 50,256 
Proceeds of IPO137,865,000 - - 
Issuance costs – IPO(10,236,593)- - 
Issuance of Preferred Shares10,000,080 - 73,182,730 
Issuance costs – Preferred Shares(129,520)- (2,561,518)
Net financing cash flows137,530,555 - 70,671,468 
Net (decrease) increase in cash26,757,987 (48,760,475)52,988,182 
Cash, beginning of year9,434,495 58,106,885 5,503,938 
Effect of exchange rate fluctuations on cash held37,861 88,085 (385,235)
Cash, end of year$36,230,343 $9,434,495 $58,106,885 
Wednesday, February 28, 2018 - 16:05