Catabasis Pharmaceuticals Reports First Quarter 2018 Financial Results and Reviews Business Progress
-- 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 --
“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
Recent and Upcoming Corporate Highlights
-
Edasalonexent significantly slowed Duchenne muscular dystrophy (DMD)
disease progression as measured by MRI through one year of treatment,
as reported at the
American Academy of Neurology 70th Annual Meeting inApril 2018 . Statistically significant improvements in MRI T2 rate of change through 48 weeks of oral 100 mg/kg of edasalonexent treatment compared to control were observed in the MoveDMD trial. The rate of fat fraction accumulation slowed in both the soleus and vastus lateralis through 48 weeks of edasalonexent treatment compared to the off-treatment control period. There was a greater reduction in the rate of fat fraction accumulation in boys on edasalonexent treatment than in a population of boys in a separate ImagingDMD natural history study who were largely on steroids. Edasalonexent continued to be well tolerated with no safety signals observed throughout the trial. -
Height and weight through 60 weeks of edasalonexent treatment was on
track with standard growth curves for unaffected boys, as presented at
the 2018
Muscular Dystrophy Association (MDA) Clinical Conference inMarch 2018 . This profile is favorably differentiated from the typical profile associated with the corticosteroid standard of care in DMD, which includes weight gain and curtailed growth. -
Heart rate data from boys treated with edasalonexent decreased toward
age-normative values through 48 weeks of treatment, as reported at the
MDA Clinical Conference inMarch 2018 . In the 4-7 year old age range, boys typically have resting tachycardia, a heart rate that exceeds the normal resting rate, which is the first cardiac manifestation in DMD. Cardiac failure is a leading cause of mortality in DMD. -
Observations from an ImagingDMD natural history study, as presented at
the
MDA Clinical Conference inMarch 2018 , were generally consistent with the absolute functional abilities as well as declines in abilities experienced by boys in the off-treatment control period of the Catabasis MoveDMD trial. We believe that these data provide important corroboration that the MoveDMD off-treatment control period observations are characteristic of the expected natural history and provide added confidence in the slowing of disease progression treatment effects observed with edasalonexent. -
Preservation of muscle function and substantially slowed DMD disease
progression through more than a year of edasalonexent treatment, as
reported at the
XVI International Conference on Duchenne and Becker Muscular Dystrophy inFebruary 2018 . Consistent improvements in all assessments of muscle function (North Star Ambulatory Assessment, time to stand, 4-stair climb and 10-meter walk/run) were observed following 48 and 60 weeks of edasalonexent treatment compared to the rates of change in the off-treatment control period. Statistically significant improvements in multiple non-effort based biomarkers of muscle health and inflammation (muscle enzymes and C-reactive protein) were observed compared to baseline. - Company resources have been aligned to focus on its lead program edasalonexent for the treatment of DMD. Catabasis is preparing for a global Phase 3 trial to evaluate the safety and efficacy of edasalonexent for registration purposes.
First Quarter 2018 Financial Results
Cash Position: As of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses remained
consistent at
Operating Loss: Loss from operations was
Net Loss: Net loss was
Conference Call and Webcast
Catabasis 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: | 2192025 |
Please 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
About Catabasis
At
Forward Looking Statements
Any 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
Catabasis Pharmaceuticals, Inc. |
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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 | 19,093,273 | |||||
Catabasis Pharmaceuticals, Inc. |
||||||||
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 | $ | 11,792 | ||||
Catabasis Pharmaceuticals, Inc. |
||||||
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 |
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Source:
Investor and Media Contact
Catabasis
Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com