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
“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
Recent Corporate Highlights
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.
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.
- 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 millionand $27.4 million, respectively, for the fourth quarter and year ended December 31, 2017, compared to $5.3 millionand $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 millionand $9.3 million, respectively, for the fourth quarter and year ended December 31, 2017, compared to $0.8 millionand $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, 2017of $11.8 million( $0.37per share) and $115.5 million( $7.93per share), respectively, compared to $48.4 million( $20.57per share) and $57.5 million( $24.46per 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.
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
THRUST Investor Relations
|Clementia Pharmaceuticals Inc.|
|Consolidated Statements of Financial Position (unaudited)|
(in US dollars)
|Sales tax and other receivables||94,497||90,966|
|Income tax and tax credits receivable||977,901||139,223|
|Total current assets||71,677,122||40,624,421|
|Property and equipment||33,084||38,163|
|Total non-current assets||76,748,276||932,747|
|Accounts payable and accrued liabilities||$6,718,666||$4,521,537|
|Income taxes payable||-||2,176|
|Total current liabilities||6,718,666||4,523,713|
|Total non-current liabilities||-||185,705,563|
|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|
|Research and development expenses||$27,405,648||$16,851,974||$14,396,563|
|General and administrative expenses||9,287,036||3,405,615||5,478,833|
|Net loss before income taxes||114,811,428||57,365,525||75,740,723|
|Income tax expense||643,765||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 shares||14,560,482||2,351,347||2,295,402|
|Clementia Pharmaceuticals Inc.|
|Consolidated Statements of Cash Flows (unaudited)|
(in US dollars)
|Interest income recognized in net loss||(1,082,030||)||(398,559||)||(109,670||)|
|Depreciation of property and equipment||25,297||35,055||14,506|
|Amortization of intangible assets||179,392||137,526||134,258|
|Transaction costs recognized in net loss||35,175||-||819,271|
|Embedded derivative loss recognized in net loss||77,902,663||33,982,042||52,563,759|
|Accretion of preferred shares||2,479,162||3,742,178||2,378,992|
|Net foreign exchange (gain) loss||(40,913||)||(82,589||)||382,982|
|Income tax expense recognized in net loss||643,765||146,454||156,220|
|Income taxes paid||(392,620||)||(98,218||)||(296,630||)|
|Net changes in working capital|
|Sales tax and other receivables||3,641||(48,207||)||24,435|
|Income tax and tax credits receivable||(761,999||)||238,690||(85,360||)|
|Accounts payable and accrued liabilities||2,193,009||504,976||2,060,688|
|Net operating cash flows||(35,566,460||)||(18,828,083||)||(17,623,279||)|
|Interest income received||814,110||95,526||105,124|
|Acquisition of short-term investments||(134,000,000||)||(40,000,000||)||(40,000,000||)|
|Maturity of short-term investments||59,000,000||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||)|
|Issuance of common shares||31,588||-||50,256|
|Proceeds of IPO||137,865,000||-||-|
|Issuance costs – IPO||(10,236,593||)||-||-|
|Issuance of Preferred Shares||10,000,080||-||73,182,730|
|Issuance costs – Preferred Shares||(129,520||)||-||(2,561,518||)|
|Net financing cash flows||137,530,555||-||70,671,468|
|Net (decrease) increase in cash||26,757,987||(48,760,475||)||52,988,182|
|Cash, beginning of year||9,434,495||58,106,885||5,503,938|
|Effect of exchange rate fluctuations on cash held||37,861||88,085||(385,235||)|
|Cash, end of year||$36,230,343||$9,434,495||$58,106,885|
Source: Clementia Pharmaceuticals Inc.