CATB Catabasis Pharmaceuticals Inc.

2.09
+0.46  (+28%)
Previous Close 1.63
Open 1.84
52 Week Low 1.25
52 Week High 8.59
Market Cap $41,976,264
Shares 20,084,337
Float 17,010,235
Enterprise Value $-19,714,905
Volume 197,917,334
Av. Daily Volume 1,530,875
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Drug Pipeline

Drug Stage Notes
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - October 26, 2020.
CAT-2054
Hypercholesterolemia
Phase 2a
Phase 2a
Phase 2a did not meet primary endpoint - June 2016

Latest News

  1. -- Cash and Cash Equivalents Totaled $52.9 Million as of September 30, 2020 --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    As previously reported, the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet the primary endpoint, change from baseline in the North Star Ambulatory Assessment, over one year of treatment compared to placebo. The secondary endpoint timed function tests also did not show statistically significant improvements. Edasalonexent was observed to be generally safe and well-tolerated in this trial, consistent with the safety profile seen to date…

    -- Cash and Cash Equivalents Totaled $52.9 Million as of September 30, 2020 --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    As previously reported, the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet the primary endpoint, change from baseline in the North Star Ambulatory Assessment, over one year of treatment compared to placebo. The secondary endpoint timed function tests also did not show statistically significant improvements. Edasalonexent was observed to be generally safe and well-tolerated in this trial, consistent with the safety profile seen to date. As previously announced, Catabasis is stopping activities related to the development of edasalonexent, including the ongoing GalaxyDMD open-label extension trial.

    Catabasis has engaged Ladenburg Thalmann & Co. Inc. to act as its strategic financial advisor for the previously announced plan to explore and evaluate strategic options. Potential strategic options that may be evaluated include a merger, business combination, in-licensing, out-licensing or other strategic transaction. There can be no assurance that this process will result in any such transaction. We do not intend to discuss or disclose further developments during this process unless and until our Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

    Third Quarter 2020 Financial Results

    Cash Position: As of September 30, 2020, Catabasis had cash, cash equivalents and short-term investments of $52.9 million, compared to $53.9 million as of June 30, 2020. Based on the Company's current operating plan, Catabasis expects that it has sufficient cash to fund operations for at least the next 12 months. Net cash used in operating activities for the three months ended September 30, 2020 was $10.0 million, compared to $6.5 million for the three months ended September 30, 2019.

    R&D Expenses: Research and development expenses were $7.8 million for the three months ended September 30, 2020, compared to $4.7 million for the three months ended September 30, 2019.

    G&A Expenses: General and administrative expenses were $3.1 million for the three months ended September 30, 2020, compared to $2.0 million for the three months ended September 30, 2019.

    Operating Loss: Loss from operations was $10.9 million for the three months ended September 30, 2020, compared to $6.7 million for the three months ended September 30, 2019.

    Net Loss: Net loss was $10.9 million, or $0.56 per share, for the three months ended September 30, 2020, compared to a net loss of $6.5 million, or $0.56 per share, for the three months ended September 30, 2019.

    About Catabasis

    Catabasis Pharmaceuticals is a biopharmaceutical company. Our mission is to bring hope with life-changing therapies to patients and families.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about its exploration and evaluation of strategic options, the termination of activities related to the edasalonexent program, including the ongoing GalaxyDMD open-label extension trial, and cash to fund operations, and other statements containing the words "believes," "anticipates," "plans," "hopes," "expects," and similar expressions, constitute forward-looking statements within the meaning of applicable securities laws and regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: the impact of the COVID-19 pandemic and the effectiveness of the steps we have implemented to address the pandemic; the availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; unexpected costs or expenses, including any that arise during the termination of activities related to the edasalonexent program; risks inherent in the Company's exploration, evaluation and implementation of its review of strategic options; and general market and economic conditions; and other factors discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2020, 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.

    Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

    2020

     

    2019

     

    2020

     

    2019

     
    Operating expenses:
    Research and development

    $

    7,806

     

    $

    4,697

     

    $

    19,845

     

    $

    14,054

     

    General and administrative

     

    3,057

     

     

    1,985

     

     

    8,612

     

     

    6,287

     

    Total operating expenses

     

    10,863

     

     

    6,682

     

     

    28,457

     

     

    20,341

     

    Loss from operations

     

    (10,863

    )

     

    (6,682

    )

     

    (28,457

    )

     

    (20,341

    )

    Other income (expense):
    Interest and investment income

     

    4

     

     

    214

     

     

    231

     

     

    697

     

    Other expense, net

     

    (3

    )

     

    (46

    )

     

    (96

    )

     

    (39

    )

    Total other income, net

     

    1

     

     

    168

     

     

    135

     

     

    658

     

    Net loss

    $

    (10,862

    )

    $

    (6,514

    )

    $

    (28,322

    )

    $

    (19,683

    )

    Net loss per share - basic and diluted

    $

    (0.56

    )

    $

    (0.56

    )

    $

    (1.59

    )

    $

    (1.80

    )

    Weighted-average common shares outstanding used in net loss per share - basic and diluted

     

    19,424,866

     

     

    11,624,232

     

     

    17,769,738

     

     

    10,945,765

     

     

    Catabasis Pharmaceuticals, Inc.

    Selected Consolidated Balance Sheets Data

    (In thousands)

    (Unaudited)

     

    September 30,

     

    December 31,

    2020

     

    2019

    Assets
    Cash and cash equivalents

    $

    52,856

    $

    9,899

    Short-term investments

     

    -

     

     

    26,345

     

    Right-of-use asset

     

    1,178

     

     

    2,349

     

    Other current and long-term assets

     

    2,816

     

     

    3,187

     

    Total assets

     

    56,850

     

     

    41,780

     

    Liabilities and stockholders' equity
    Current portion of operating lease liabilities

     

    648

     

     

    1,225

     

    Long-term portion of operating lease liabilities

     

    559

     

     

    1,028

     

    Other current and long-term liabilities

     

    6,332

     

     

    3,807

     

    Total liabilities

     

    7,539

     

     

    6,060

     

    Total stockholders' equity

    $

    49,311

     

    $

    35,720

     

     

    Catabasis Pharmaceuticals, Inc.

    Selected Consolidated Statements of Cash Flows Data

    (In thousands)

    (Unaudited)

     

    Nine Months Ended September 30,

    2020

     

    2019

    Net cash used in operating activities

    $

    (24,424

    )

    $

    (18,799

    )

    Net cash provided by (used) in investing activities

     

    26,310

     

     

    (578

    )

    Net cash provided by financing activities

     

    40,829

     

     

    21,848

     

    Net increase in cash, cash equivalents and restricted cash

    $

    42,715

     

    $

    2,471

     

     

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  2. -- PolarisDMD Trial Did Not Achieve Primary or Secondary Endpoints --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of edasalonexent compared to placebo. The secondary endpoint timed function tests (time to stand, 10-meter walk/run and 4-stair climb) also did not show statistically significant improvements. Edasalonexent was observed to be generally safe and well-tolerated in this trial. Catabasis is stopping activities related to the development of edasalonexent including…

    -- PolarisDMD Trial Did Not Achieve Primary or Secondary Endpoints --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of edasalonexent compared to placebo. The secondary endpoint timed function tests (time to stand, 10-meter walk/run and 4-stair climb) also did not show statistically significant improvements. Edasalonexent was observed to be generally safe and well-tolerated in this trial. Catabasis is stopping activities related to the development of edasalonexent including the ongoing GalaxyDMD open-label extension trial. The Company plans to work with external advisors to explore and evaluate strategic options going forward.

    "We are deeply saddened and disappointed by the results of our Phase 3 PolarisDMD trial," said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. "I want to sincerely thank all of the boys, their families and caregivers, investigators and the trial sites that participated in and enabled this program. The entire Catabasis team has worked tirelessly to find a treatment for this progressive disease. We hope that our data and work to date can be used to benefit ongoing and future research in DMD."

    The Phase 3 trial was a one-year placebo-controlled trial designed to evaluate the safety and efficacy of edasalonexent in boys ages 4-7 (up to 8th birthday) with DMD. The global trial enrolled 131 boys across eight countries, with any mutation type, who were not on steroids. Edasalonexent was well-tolerated, consistent with the safety profile seen to date. The majority of adverse events were mild in nature and the most common treatment-related adverse events were diarrhea, vomiting, abdominal pain and rash. There were no treatment-related serious adverse events and no dose reductions. The global COVID-19 pandemic had no meaningful impact on the trial or its results. Data from the PolarisDMD trial will be further analyzed and are expected to be presented at an upcoming scientific conference and published.

    "These results are disheartening for the Duchenne community, and specifically for the boys who participated in this trial and their families. However, the results contribute to the natural history data of Duchenne and add to the knowledge base that will one day produce a foundational, long-term therapy for this disease," said Pat Furlong, Founding President and Chief Executive Officer of Parent Project Muscular Dystrophy (PPMD). "The continued advancement of research and the development of possible treatment options will remain of critical importance to our community. We appreciate Catabasis' efforts and commitment to every family that is or has ever been affected by Duchenne."

    The Company expects to report Q3 2020 financials in November of 2020. As of September 30, 2020, Catabasis had cash and cash equivalents of approximately $52.9 million.

    About Catabasis

    Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company. Our mission is to bring hope and life-changing therapies to patients and their families.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about its exploration and evaluation of strategic options, the termination of activities related to the edasalonexent program, including the ongoing GalaxyDMD open-label extension trial, and plans to publish data from the Phase 3 PolarisDMD trial, and other statements containing the words "believes," "anticipates," "plans," "hopes," "expects," and similar expressions, constitute forward-looking statements within the meaning of applicable securities laws and regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: the impact of the COVID-19 pandemic and the effectiveness of the steps we have implemented to address the pandemic; the availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; unexpected costs or expenses that arise during the termination of activities related to the edasalonexent program; risks inherent in the Company's exploration, evaluation and implementation of its review of strategic options; and general market and economic conditions; and other factors discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2020, 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.

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  3. -- New Preclinical Research Indicates that Edasalonexent Could Have Positive Effects on Cardiac Function and Preserve Bone Health --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today shared information on the edasalonexent program in Phase 3 development for Duchenne muscular dystrophy (DMD) in poster presentations at the Virtual 25th International Congress of the World Muscle Society. The posters include new preclinical research findings supporting potential positive effects on cardiac function and preservation of bone health with edasalonexent in mouse models of DMD. Information from clinical trials with edasalonexent was also presented with baseline assessments from the Phase 3 PolarisDMD trial…

    -- New Preclinical Research Indicates that Edasalonexent Could Have Positive Effects on Cardiac Function and Preserve Bone Health --

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today shared information on the edasalonexent program in Phase 3 development for Duchenne muscular dystrophy (DMD) in poster presentations at the Virtual 25th International Congress of the World Muscle Society. The posters include new preclinical research findings supporting potential positive effects on cardiac function and preservation of bone health with edasalonexent in mouse models of DMD. Information from clinical trials with edasalonexent was also presented with baseline assessments from the Phase 3 PolarisDMD trial and long-term safety results from the Phase 2 MoveDMD trial and open-label extension.

    "As we approach top-line Phase 3 PolarisDMD results, which we expect to report in the fourth quarter of this year, we are pleased to share new findings from preclinical studies with edasalonexent that could support its potential as a foundational therapy for those affected by Duchenne," said Andrew Nichols, Ph.D., Chief Scientific Officer of Catabasis. "Cardiac function and bone health are critical components of Duchenne care and we are excited to learn more about these key areas that are important to patients, their caregivers and physicians."

    Persistent activation of NF-kB in DMD can drive cardiac dysfunction, which is the leading cause of mortality in DMD. In a preclinical study performed in the laboratory of Pradeep Mammen, M.D., Medical Director of the Neuromuscular Cardiomyopathy Clinic and Director of Translational Research for the Advanced Heart Failure and Transplant Cardiology Program at UT Southwestern, edasalonexent prevented the development of DMD-associated cardiomyopathy in the mdx:Utrn+/- mouse model of DMD. Edasalonexent reduced the cardiac hypertrophy apparent in these mice, reduced myocardial fibrosis and prevented the development of DMD-associated cardiomyopathy.

    In DMD, NF-kB activation also drives inflammation and fibrosis, leading to loss of skeletal muscle function and disease progression. Reduced skeletal muscle function results in reduced bone strength. Steroids, which activate the glucocorticoid receptor (GR), can further negatively impact bone health. In a preclinical study led by Frank Rauch, M.D., of Shriners Hospitals for Children - Canada, edasalonexent was seen to maintain bone density and bone strength in mdx mice. Consistent with these results, edasalonexent treatment in cells inhibited NF-kB and as expected did not impact the GR, while the steroid prednisolone strongly activated the GR.

    Information from the edasalonexent clinical program was also presented at the Congress of the World Muscle Society. The primary endpoint of the Phase 3 PolarisDMD trial for edasalonexent is the North Star Ambulatory Assessment (NSAA), a validated measure of physical function designed for use in ambulatory boys affected by DMD. In an analysis of baseline characteristics of the patients enrolled in the Phase 3 trial (boys affected by DMD, ages 4 to 7, up to 8th birthday, not on steroids), Catabasis saw reliable and consistent NSAA scores between the two pre-treatment measures at screening and baseline, which indicate no significant learning effect between visits.

    An additional evaluation of data from patients at baseline (prior to any treatment) in the Phase 3 PolarisDMD trial was shared by Leanne Ward, M.D., FRCPC, Scientific Director of Ottawa Pediatric Bone Health Research Group. This analysis showed that lean body mass index (a marker for muscle mass) was reduced in young boys affected by DMD and correlated with reduced muscle function. An analysis of the same patients was presented earlier this month at the American Society for Bone and Mineral Research 2020 Annual Conference and showed that DMD has a negative impact on bone strength, including low bone density and mild vertebral fractures at an early stage of disease course prior to any treatment.

    As Catabasis has previously presented, the Phase 2 MoveDMD trial and open-label extension was also shared showing that edasalonexent was well-tolerated for up to 150 weeks and associated with favorable growth patterns. The most common related adverse effect was diarrhea, generally mild and transient.

    The posters are available to registered attendees during the conference and for three months afterwards. Select posters are available in the "Our Science" section of www.catabasis.com.

    About Edasalonexent (CAT-1004)

    Edasalonexent (CAT-1004) is an investigational oral small molecule designed to inhibit NF-kB that is being developed as a potential foundational therapy for all patients affected by DMD, regardless of their underlying mutation. In DMD the loss of dystrophin leads to chronic activation of NF-kB, which is a key driver of skeletal and cardiac muscle disease progression. The ongoing global Phase 3 PolarisDMD trial is evaluating the efficacy and safety of edasalonexent for registration purposes. Edasalonexent is also being evaluated in the GalaxyDMD open-label extension trial. In the MoveDMD Phase 2 trial and open-label extension, the Company observed that edasalonexent preserved muscle function and substantially slowed disease progression compared to rates of change in a control period, and significantly improved biomarkers of muscle health and inflammation. 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, please visit www.catabasis.com.

    About Catabasis

    At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our lead program is edasalonexent, an NF-kB inhibitor in Phase 3 development for the treatment of Duchenne muscular dystrophy. For more information on edasalonexent and our Phase 3 PolarisDMD trial, please visit www.catabasis.com.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the clinical program of edasalonexent, including the expected timing of release of Phase 3 data, edasalonexent potentially being a foundational therapy for DMD patients, and edasalonexent potentially having positive effects on cardiac function and preservation of bone health, along with other statements containing the words "believes," "anticipates," "plans," "expects," "may" and similar expressions, constitute forward-looking statements within the meaning of applicable securities regulations and laws. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties: inherent in the initiation and completion of clinical trials and clinical development; related to whether the results of pre-clinical studies will be predictive of results of clinical trials; related to whether the results of earlier stage clinical trials will be predictive of the results of later stage trials; related to the regulatory review and approval process; inherent in the commercialization of marketed products; related to competitive products, including those already approved and those in development; related to other matters that could affect the clinical development, regulatory status, availability or commercial potential of edasalonexent, as well as the risks and uncertainties discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2020, 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.

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  4. Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that it will present information on the edasalonexent program, in Phase 3 development for the treatment of Duchenne muscular dystrophy (DMD), during the 25th International Congress of the World Muscle Society which begins September 28, 2020.

    During the Virtual Poster Session on October 1, 2020 from 12:30 – 2:30pm ET, Catabasis and collaborators will present five posters entitled:

    • Inhibition of NF-kB Signaling Prevents the Development of DMD-Associated Cardiomyopathy in mdx:Utrn+/- Mice
    • Edasalonexent Maintains Bone Density and Bone Strength in the mdx Mouse Model of Duchenne Muscular Dystrophy
    • Edasalonexent Treatment in Young Boys

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that it will present information on the edasalonexent program, in Phase 3 development for the treatment of Duchenne muscular dystrophy (DMD), during the 25th International Congress of the World Muscle Society which begins September 28, 2020.

    During the Virtual Poster Session on October 1, 2020 from 12:30 – 2:30pm ET, Catabasis and collaborators will present five posters entitled:

    • Inhibition of NF-kB Signaling Prevents the Development of DMD-Associated Cardiomyopathy in mdx:Utrn+/- Mice
    • Edasalonexent Maintains Bone Density and Bone Strength in the mdx Mouse Model of Duchenne Muscular Dystrophy
    • Edasalonexent Treatment in Young Boys with Duchenne Muscular Dystrophy is Associated with Age-Normative Growth and Normal Adrenal Function
    • In the Global Phase 3 PolarisDMD Trial for Edasalonexent, Standardized Outcome Measure Training Produces Excellent Test-Retest Variability in the North Star Ambulatory Assessment
    • Lean Body Mass is Associated with Whole Body Mineral Density and Muscle Strength in Treatment-Naïve, Ambulatory Boys with Duchenne Muscular Dystrophy

    The poster session will be available to registered conference attendees during the conference and for 3 months afterwards. Select posters will be made available in the "Our Science" section of www.catabasis.com.

    About Edasalonexent (CAT-1004)

    Edasalonexent (CAT-1004) is an investigational oral small molecule designed to inhibit NF-kB that is being developed as a potential foundational therapy for all patients affected by DMD, regardless of their underlying mutation. In DMD the loss of dystrophin leads to chronic activation of NF-kB, which is a key driver of skeletal and cardiac muscle disease progression. The ongoing global Phase 3 PolarisDMD trial is evaluating the efficacy and safety of edasalonexent for registration purposes. Edasalonexent is also being evaluated in the GalaxyDMD open-label extension trial. In the MoveDMD Phase 2 trial and open-label extension, the Company observed that edasalonexent preserved muscle function and substantially slowed disease progression compared to rates of change in a control period, and significantly improved biomarkers of muscle health and inflammation. 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, please visit www.catabasis.com.

    About Catabasis

    At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our lead program is edasalonexent, an NF-kB inhibitor in Phase 3 development for the treatment of Duchenne muscular dystrophy. For more information on edasalonexent and our Phase 3 PolarisDMD trial, please visit www.catabasis.com.

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  5. Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, announced today that it has promoted Noah Clauser to Chief Financial Officer. Mr. Clauser brings close to 20 years of financial experience to this role and has been with Catabasis for 9 years, most recently as Vice President, Finance.

    "Noah has strategically built our financial and operations functions and has been a valuable team member through a critical stage for Catabasis," said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. "We are looking forward to his expanded role as we approach our potential future transition to a commercial organization."

    "I am excited for this new opportunity as we approach the next stage of our company, with…

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, announced today that it has promoted Noah Clauser to Chief Financial Officer. Mr. Clauser brings close to 20 years of financial experience to this role and has been with Catabasis for 9 years, most recently as Vice President, Finance.

    "Noah has strategically built our financial and operations functions and has been a valuable team member through a critical stage for Catabasis," said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. "We are looking forward to his expanded role as we approach our potential future transition to a commercial organization."

    "I am excited for this new opportunity as we approach the next stage of our company, with top-line results from the Phase 3 PolarisDMD trial for edasalonexent expected in the fourth quarter of this year," said Mr. Clauser. "I am looking forward to continuing our work to make an impact in the lives of patients and families affected by Duchenne muscular dystrophy."

    Mr. Clauser most recently served as Vice President, Finance at Catabasis, leading the Company's finance and operations functions since August 2017. Previously, he served as Senior Director, Finance and Controller of the Company from January 2016 to August 2017, and Controller from April 2011 to December 2015. Prior to joining Catabasis, Mr. Clauser worked at Impress Software, where he served as Accounting Manager. Mr. Clauser is a licensed CPA in Massachusetts and holds an M.S. in Accounting and a B.S. in Management from the University of Massachusetts at Boston.

    About Edasalonexent (CAT-1004)

    Edasalonexent (CAT-1004) is an investigational oral small molecule designed to inhibit NF-kB that is being developed as a potential foundational therapy for all patients affected by DMD, regardless of their underlying mutation. In DMD the loss of dystrophin leads to chronic activation of NF-kB, which is a key driver of skeletal and cardiac muscle disease progression. The ongoing global Phase 3 PolarisDMD trial is evaluating the efficacy and safety of edasalonexent for registration purposes. Edasalonexent is also being evaluated in the GalaxyDMD open-label extension trial. In the MoveDMD Phase 2 trial and open-label extension, the Company observed that edasalonexent preserved muscle function and substantially slowed disease progression compared to rates of change in a control period, and significantly improved biomarkers of muscle health and inflammation. 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, please visit www.catabasis.com.

    About Catabasis

    At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our lead program is edasalonexent, an NF-kB inhibitor in Phase 3 development for the treatment of Duchenne muscular dystrophy. For more information on edasalonexent and our Phase 3 PolarisDMD trial, please visit www.catabasis.com.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's global Phase 3 PolarisDMD trial in DMD, the anticipated timing for top-line results and the Company's planned transition to a commercial-stage organization and other statements containing the words "believes," "anticipates," "plans," "expects," "may" and similar expressions, constitute forward-looking statements within the meaning of applicable securities laws and regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks and uncertainties: related to the impact of the COVID-19 pandemic and the effectiveness of the steps we have implemented to address the pandemic, including the use of telehealth visits; inherent in the completion of clinical trials and clinical development; related to whether the results of earlier stage clinical trials will be predictive of the results of later stage trials; related to the regulatory review and approval process; inherent in the commercialization of marketed products; related to successfully managing the Company's potential transformation into a fully integrated company; related to competitive products, including those already approved and those in development; inherent in transitioning from a clinical to commercial supply chain, including the ability to enter into long-term agreements with key contract manufacturers, overseeing such manufacturers, and managing inventory, particularly where the Company expects to use sole source manufacturers for the foreseeable future; related to the availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; related to other matters that could affect the clinical development, regulatory status, availability or commercial potential of the Company's product candidates; and related to general market and economic conditions and other factors discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2020, 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.

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