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Share Name | Share Symbol | Market | Type |
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Catabasis Pharmaceuticals Inc | NASDAQ:CATB | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 8.54 | 8.45 | 8.63 | 0 | 01:00:00 |
-- MoveDMD® Trial Data Through One Year of Treatment Reinforce Edasalonexent Potential as Disease-Modifying Therapy for Duchenne Muscular Dystrophy --
-- 2018 Priorities Focused on Advancing Edasalonexent and Improving the Lives of Boys Affected by Duchenne Muscular Dystrophy --
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2018, and reviewed recent business progress.
“We are pleased to see additional positive clinical data from our MoveDMD trial early in 2018 that continue to demonstrate the potential of edasalonexent as a disease-modifying therapy for all patients affected by Duchenne, regardless of mutation. As evidenced by sustained improvements in all assessments of physical function and in biomarkers of muscle health and inflammation, edasalonexent has slowed the progression of Duchenne in the MoveDMD trial,” said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. “We believe that these effects ultimately will translate to boys with Duchenne maintaining functional abilities longer.”
Recent and Upcoming Corporate Highlights
First Quarter 2018 Financial Results
Cash Position: As of March 31, 2018, Catabasis had cash and cash equivalents of $17.0 million, compared to $16.4 million as of December 31, 2017. Based on the Company’s current operating plan, Catabasis believes that it has sufficient cash to fund operations through December 2018. To advance edasalonexent in the Phase 3 trial, Catabasis expects to seek additional funds through equity or debt financings and/or through partnering or licensing transactions. Net cash used in operating activities for the three months ended March 31, 2018 was $6.8 million, compared to $8.1 million for the three months ended March 31, 2017.
R&D Expenses: Research and development expenses were $5.2 million for the three months ended March 31, 2018, compared to $5.4 million for the three months ended March 31, 2017.
G&A Expenses: General and administrative expenses remained consistent at $2.4 million for the three months ended March 31, 2018 and for the three months ended March 31, 2017.
Operating Loss: Loss from operations was $7.6 million for the three months ended March 31, 2018, compared to $7.8 million for the three months ended March 31, 2017.
Net Loss: Net loss was $7.7 million, or $0.29 per share, for the three months ended March 31, 2018, compared to a net loss of $7.9 million, or $0.41 per share, for the three months ended March 31, 2017.
Conference Call and WebcastCatabasis will host a conference call and webcast at 8:30am ET today to provide an update on corporate developments and to discuss first quarter 2018 financial results.
Participant Toll-Free Dial-In Number: (877) 388-2733 Participant International Dial-In Number: (541) 797-2984 Pass Code: 2192025Please specify to the operator that you would like to join the “Catabasis First Quarter 2018 Results Call.”
Interested parties may access a live audio webcast of the conference call via the investor section of the Catabasis website, www.catabasis.com. Please connect to the Catabasis website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. The webcast will be archived for 90 days.
About Edasalonexent (CAT-1004)Edasalonexent (CAT-1004) is an investigational oral small molecule that is being developed as a potential disease-modifying therapy for all patients affected by DMD, regardless of their underlying mutation. Edasalonexent inhibits NF-kB, a protein that is activated in DMD and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration. Edasalonexent continues to be dosed in the open-label extension of the MoveDMD Phase 2 clinical trial and Catabasis is preparing for a single global Phase 3 trial to evaluate the efficacy and safety of edasalonexent for registration purposes, dependent on raising capital. The FDA has granted orphan drug, fast track and rare pediatric disease designations and the European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. For a summary of clinical results reported to date, please visit www.catabasis.com.
About CatabasisAt Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our SMART (Safely Metabolized And Rationally Targeted) Linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. Our lead program in development is edasalonexent for the treatment of Duchenne muscular dystrophy. For more information on edasalonexent and our pipeline of drug candidates, please visit www.catabasis.com.
Forward Looking StatementsAny statements in this press release about future expectations, plans and prospects for the Company, including statements about future clinical trial plans including, among other things, statements about the Company’s plans to commence a single global Phase 3 trial in DMD to evaluate the efficacy and safety of edasalonexent for registration purposes, and the Company’s expectation that based on its current operating plan it has sufficient cash to fund operations through December 2018, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products; the Company’s ability to obtain financing on acceptable terms and in a timely manner to fund the Company’s planned Phase 3 trial of edasalonexent in DMD for registration purposes; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s product candidates; and general economic and market conditions and other factors discussed in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.
Catabasis Pharmaceuticals, Inc.Condensed Consolidated Statements of Operations(In thousands, except share and per share data)(Unaudited)
Three Months Ended March 31, 2018 2017 Operating expenses: Research and development 5,247 5,398 General and administrative 2,392 2,363 Total operating expenses 7,639 7,761 Loss from operations (7,639) (7,761) Other (expense) income: Interest expense (57) (149) Interest and investment income 32 39 Other income (expense), net 12 (5) Total other expense, net (13) (115) Net loss $ (7,652) $ (7,876) Net loss per share - basic and diluted $ (0.29) $ (0.41) Weighted-average common shares outstanding used in net loss per share - basic and diluted 26,555,840 19,093,273Catabasis Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(In thousands)(Unaudited)
March 31, December 31, 2018 2017 Assets Cash and cash equivalents $ 17,030 $ 16,369 Total assets 18,290 17,897 Liabilities and stockholders’ equity Current portion of notes payable, net of discount 1,657 2,479 Total liabilities 5,359 6,105 Total stockholders’ equity $ 12,931 $ 11,792Catabasis Pharmaceuticals, Inc.Condensed Consolidated Statements of Cash Flows(In thousands)(Unaudited)
Three Months Ended March 31, 2018 2017 Net cash used in operating activities $ (6,819) $ (8,105) Net cash provided by investing activities - 14,901 Net cash provided by financing activities 7,480 1,403 Net increase in cash and cash equivalents $ 661 $ 8,199
View source version on businesswire.com: https://www.businesswire.com/news/home/20180510005248/en/
Investor and Media ContactCatabasis Pharmaceuticals, Inc.Andrea Matthews, 617-349-1971amatthews@catabasis.com
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