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Clementia Reports Second Quarter 2018 Operating Results and Pipeline Updates

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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

  • Patient enrollment in the MOVE Trial, Clementia's Phase 3 registration study evaluating the safety and efficacy of palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva (FOP), is on track to be completed by the end of 2018. Based on the current enrollment rate the company expects two interim analyses in 2019, with final results in 2020.
  • In May 2018, Clementia reported positive data from the Part B portion of the company's ongoing Phase 2 clinical trial evaluating palovarotene for the treatment of patients with FOP. Palovarotene was generally well-tolerated by patients treated, consistent with the experience across palovarotene clinical studies. Data from our Phase 2 trial will be presented in a poster at the ASBMR 2018 Annual Meeting in Montréal, Québec, Canada, September 28 - October 1.
  • In April 2018, Clementia announced enrollment of the first patient in our Phase 2 MO-Ped Trial. Enrollment is ongoing, with final results expected in 2021 and an interim data analysis expected in 2020. In May 2018 the European Medicines Agency granted Orphan Drug Designation for palovarotene for the treatment of multiple osteochondromas.

Recent Business Updates

  • In July 2018, Clementia announced the appointment of experienced finance executive, Steve Forte, as chief financial officer. Clementia's former CFO, Michael Singer, will remain with the company through year-end as a consultant to assist with the transition.
  • Also in July 2018, Clementia appointed accomplished industry executive, Shawn Tomasello, to the company's board of directors.

Second Quarter 2018 Financial Results (all amounts are presented in U.S. dollars)

  • Cash: As of June 30, 2018, Clementia had cash and investments of $117.9 million.
  • Research and development (R&D) expenses: R&D expenses were $7.4 million and $18.4 million for the three and six months ended June 30, 2018, compared to $6.3 million and $9.7 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 and related expenses in support of increased development activities.
  • General and administrative (G&A) expenses: G&A expenses were $3.9 million and $6.8 million for the three and six months ended June 30, 2018, compared to $2.4 million and $4.1 million for the same periods in 2017. Increases in G&A expenses were primarily due to higher personnel and related costs to support the continued growth of the Company, higher public company related costs and an increase in pre-commercial marketing activities.
  • Net Loss: Clementia reported net losses for the three and six months ended June 30, 2018 of $10.8 million ($0.34 per share) and $24.0 million ($0.76 per share), compared to $23.3 million ($9.54 per share) and $64.7 million ($26.88 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 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

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