CATB on NASDAQ
Catabasis Pharmaceuticals
In its 2025 annual report the company says: “We are a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for allergic and immunological diseases. Our focus is to develop first-choice therapies that improve the health and outcomes of patients with allergic and immunologic diseases.”5 It was founded in 2008.1 It is headquartered in Cambridge.1 Its shares trade on NASDAQ under the symbol CATB.1
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Last updated Oct 21, 2026.
Overview
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- TickerCATB on NASDAQ1
- IndustryPharmaceutical Preparations1
- HeadquartersCambridge1
- Websitewww.catabasis.com
- Incorporated inDE3
- Business address22 Boston Wharf Road, 10Th Floor, Boston, Ma 022103
- Filer categoryNon-accelerated filer, Smaller reporting company3
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We are a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for allergic and immunological diseases. Our focus is to develop first-choice therapies that improve the health and outcomes of patients with allergic and immunologic diseases. Our lead product candidate is navenibart, formerly known as STAR-0215, a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, or HAE, a rare, debilitating and potentially life-threatening disease. We believe that navenibart has the potential to be the market - leading and most patient-friendly chronic treatment option for HAE, based on proof-of-concept data in HAE patients and the existing HAE treatment landscape. Our second product candidate is STAR-0310, a monoclonal antibody OX40 antagonist that is in clinic…5 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2020
Financial statements
| Fiscal year | 2018 | 2019 | 2020 |
|---|---|---|---|
| Revenue | $08 | $09 | |
| Research and development | $17.0M10 | $18.3M9 | $25.6M9 |
| Operating expenses | |||
| Operating income | -$26.4M10 | -$27.1M9 | -$37.4M7 |
| Interest | $100.0K8 | ||
| Net income | -$25.9M10 | -$26.3M9 | -$37.3M7 |
| Earnings per share | -$12.207 | ||
| Earnings per share (diluted) | -$12.207 | ||
| Shares (weighted, basic) | |||
| Shares (weighted, diluted) |
| Fiscal year | 2018 | 2019 | 2020 |
|---|---|---|---|
| Cash | $15.3M10 | $9.9M9 | $24.9M7 |
| Current assets | $38.9M10 | $39.0M9 | $46.3M7 |
| Total assets | $39.2M10 | $41.8M9 | $47.5M7 |
| Accounts payable | |||
| Current liabilities | $4.2M10 | $5.0M9 | $6.4M7 |
| Long-term debt | |||
| Total liabilities | $4.2M10 | $6.1M9 | $6.8M7 |
| Retained earnings | |||
| Shareholders’ equity | $34.9M9 | $35.7M7 | $40.7M6 |
| Shares outstanding | 7.1M shares10 | 12.4M shares9 | 3.3M shares7 |
Corporate structure
Catabasis Pharmaceuticals sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Catabasis Pharmaceuticals
- Vestal Point Capital, LP Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Feb 17, 2026 (3 filings since Nov 14, 2024)
- GLAZER CAPITAL, LLC Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Feb 12, 2026 (2 filings since Dec 10, 2025)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13D/A on Catabasis Pharmaceuticals, latest Feb 9, 2026 (6 filings since Dec 21, 2022)
- Magnetar Financial LLC Filed SCHEDULE 13D/A on Catabasis Pharmaceuticals, latest Jan 28, 2026 (2 filings since Oct 24, 2025)
- ForGrowth III PA B.V. Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Nov 14, 2025 (3 filings since Jan 7, 2025)
- FMR LLC Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Nov 7, 2025 (9 filings since Jan 10, 2023)
- INTEGRATED CORE STRATEGIES (US) LLC Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Oct 20, 2025 (4 filings since Nov 1, 2024)
- Fairmount Funds Management LLC Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Oct 15, 2025 (6 filings since Feb 8, 2022)
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Aug 14, 2025 (5 filings since Feb 14, 2022)
- Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on Catabasis Pharmaceuticals, latest Feb 14, 2025 (3 filings since Jan 2, 2024)
- TCG Crossover GP II, LLC Filed SC 13G/A on Catabasis Pharmaceuticals, latest Nov 13, 2024 (2 filings since Jan 16, 2024)
- VANGUARD GROUP INC Filed SC 13G/A on Catabasis Pharmaceuticals, latest Nov 12, 2024 (5 filings since Feb 13, 2024)
- Catabasis Pharmaceuticals Cambridge
- Astria Securities Corporation Subsidiary · Delaware, United States
- Quellis Biosciences, LLC Subsidiary · Delaware, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Catabasis Pharmaceuticals reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Operating-lease assets (leased space) | $5.1M13 Dec 31, 2024 | $5.8M13 Jan 3, 2024 | −11.8% |
Real estate and locations
| Item | Latest | A year before | Change |
|---|---|---|---|
| Area of land | 30,110 sq ft13 Jan 3, 2024 |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $59.8M13 Dec 31, 2024 | $175.5M13 Dec 31, 2023 | −65.9% |
| Marketable securities, current | $268.3M13 Dec 31, 2024 | $71.0M13 Dec 31, 2023 | +277.9% |
Properties, in its own words
Our offices are located in Boston, Massachusetts and consist of approximately 30,110 square feet of subleased office space under a lease that is scheduled to end on November 30, 2028 or on such earlier date as the term may sooner cease or expire as set forth in the sublease agreement. We believe that our existing facilities are sufficient for our needs for the foreseeable future.
Item 2 of the 10-K filed Mar 11, 2025.5
Leadership
Who has led Catabasis Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerJill C. Milne Jun 24, 2015 to now14
- PresidentJill C. Milne Jun 24, 2015 to now14
- Chief financial officerNoah Clauser Sep 21, 2020 to now15
- Chief financial officerIan C. Sanderson Jun 24, 2015 to Feb 16, 201616
Board members and other officers (25)
- Chief Business OfficerAndrea Matthews Apr 19, 2023 to now17
- Chief Medical OfficerChristopher Morabito Jul 15, 2022 to now18
- Chief Commercial OfficerAndrew Komjathy Sep 19, 2019 to now19
- Vice President, FinanceNoah Clauser Dec 19, 2019 to Feb 14, 202020
- Chief Business OfficerEdward K. Hibben Feb 17, 2017 to Feb 9, 201821
- Chief Scientific OfficerAndrew John Nichols Oct 5, 2016 to Mar 3, 202222
- Chief Medical OfficerJoanne M. Donovan Jun 24, 2015 to Feb 14, 202023
- Chief Scientific OfficerMichael Jirousek Jun 24, 2015 to Jun 30, 201524
- Chief Business OfficerRick Modi Jun 24, 2015 to Sep 13, 201625
- Board memberSunil Agarwal Apr 9, 2024 to now26
- Board memberFred Callori Feb 1, 2021 to now27
- Board memberJonathan Violin Feb 1, 2021 to now28
- Board memberJoseph Edelman Feb 3, 2021 to Feb 5, 202429
- Board memberGregg Anthony Lapointe Jan 4, 2019 to now30
- Board memberJoanne T. Beck Feb 15, 2019 to now31
- Board memberHugh M. Cole Jul 30, 2019 to now32
- Board memberBurt A. Adelman Apr 7, 2016 to Jun 12, 202033
- Board memberMichael D. Kishbauch Apr 7, 2016 to now34
- Board memberJean George Jun 24, 2015 to Jun 7, 201835
- Board memberJill C. Milne Jun 24, 2015 to now14
- Board memberKenneth Bate Jun 24, 2015 to now36
- Board memberNicholas Galakatos Jun 24, 2015 to Aug 5, 201637
- Board memberRon Laufer Jun 24, 2015 to Jun 30, 201538
- General counselBenjamin Harshbarger Jun 12, 2020 to now39
- General counselDeirdre A. Cunnane Feb 16, 2016 to Feb 15, 201940
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- CATABASIS PHARMACEUTICALS INCJan 21, 2009 to Aug 20, 20213
Timeline
- Jan 23, 20268-K Entered a material agreement; Completed an acquisition or sale; New debt or obligation41
- Jan 21, 20268-K Shareholder vote; Other events42
- Dec 23, 20258-K Other events43
- Nov 12, 20258-K Results of operations44
- Oct 14, 20258-K Entered a material agreement; Results of operations; Other events45
- Aug 6, 20258-K Entered a material agreement; Regulation FD disclosure; Other events46
- Jun 12, 20258-K Executive or director change; Shareholder vote47
- Mar 11, 20258-K Results of operations48
- Jan 13, 20258-K Regulation FD disclosure49
- Dec 19, 20248-K Executive or director change50
- Jun 6, 20248-K Executive or director change; Shareholder vote51
- Apr 9, 20248-K Executive or director change52
- Jun 24, 2015New chief executive Jill C. Milne becomes CEO14
- 2008Founded Founded1
Calendar
When it reported results
- Nov 12, 2025Reported quarterly or annual results44
- Oct 14, 2025Reported quarterly or annual results45
- Mar 11, 2025Reported quarterly or annual results48
- Nov 13, 2023Reported quarterly or annual results53
- Mar 22, 2023Reported quarterly or annual results54
- Jan 5, 2023Reported quarterly or annual results55
- Nov 10, 2021Reported quarterly or annual results56
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
279 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 36 major events, 87 insider forms, 67 large holders, 72 other. The latest 20:
- Feb 17, 2026SCHEDULE 13G/A EDGAR
- Feb 12, 2026SCHEDULE 13G/A EDGAR
- Feb 9, 2026SCHEDULE 13D/A EDGAR
- Feb 2, 202615-12G EDGAR
- Jan 28, 2026SCHEDULE 13D/A EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 27, 2026EFFECT EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
- Jan 23, 2026S-8 POS EDGAR
The 279 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
8 open-market trades by officers, directors and large owners since October 2021: 5 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Apr 1, 2024 | Morabito ChristopherChief Medical Officer | Sale | 10,000 | $13.59 | $135.9K | Form 4 |
| Feb 1, 2024 | Perceptive Xontogeny Venture Fund, LPDirector | Buy | 2,481,350 | $12.09 | $30.0M | Form 4 |
| Jan 29, 2024 | Morabito ChristopherChief Medical Officer | Sale | 9,200 | $11.15 | $102.6K | Form 4 |
| Jan 26, 2024 | Morabito ChristopherChief Medical Officer | Sale | 800 | $11.02 | $8.8K | Form 4 |
| Dec 21, 2023 | PERCEPTIVE ADVISORS LLCDirector | Buy | 740,000 | $6.20 | $4.6M | Form 4 |
| Oct 16, 2023 | PERCEPTIVE LIFE SCIENCES MASTER FUND LTDDirector | Buy | 1,074,608 | $6.51 | $7.0M | Form 4 |
| Dec 19, 2022 | PERCEPTIVE LIFE SCIENCES MASTER FUND LTDDirector | Buy | 908,265 | $11.01 | $10.0M | Form 4 |
| Nov 19, 2021 | Komjathy AndrewChief Commercial Officer | Buy | 100 | $6.70 | $670 | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Vestal Point Capital, LPSCHEDULE 13G/A, 3 filings Nov 14, 2024 to Feb 17, 202657
- GLAZER CAPITAL, LLCSCHEDULE 13G/A, 2 filings Dec 10, 2025 to Feb 12, 202658
- PERCEPTIVE ADVISORS LLCSCHEDULE 13D/A, 6 filings Dec 21, 2022 to Feb 9, 202659
- Magnetar Financial LLCSCHEDULE 13D/A, 2 filings Oct 24, 2025 to Jan 28, 202660
- Pa B.v. Forgrowth Iii.SCHEDULE 13G/A, 3 filings Jan 7, 2025 to Nov 14, 202561
- FMR LLCSCHEDULE 13G/A, 9 filings Jan 10, 2023 to Nov 7, 202562
- INTEGRATED CORE STRATEGIES (US) LLCSCHEDULE 13G/A, 4 filings Nov 1, 2024 to Oct 20, 202563
- Fairmount Funds Management LLCSCHEDULE 13G/A, 6 filings Feb 8, 2022 to Oct 15, 202564
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 5 filings Feb 14, 2022 to Aug 14, 202565
- Venrock Healthcare Capital Partners III, L.P.SCHEDULE 13G/A, 3 filings Jan 2, 2024 to Feb 14, 202566
- TCG Crossover GP II, LLCSC 13G/A, 2 filings Jan 16, 2024 to Nov 13, 202467
- VANGUARD GROUP INCSC 13G/A, 5 filings Feb 13, 2024 to Nov 12, 202468
- BlackRockSC 13G, 5 filings Feb 24, 2022 to Nov 8, 202469
- Cormorant Asset Management, LPSC 13G/A, 3 filings Sep 2, 2022 to Feb 14, 202470
- Deep Track Capital, LPSC 13G/A, 3 filings Dec 22, 2022 to Feb 14, 202471
- Vivo Opportunity, LLCSC 13G/A, 3 filings Sep 8, 2022 to Feb 13, 202472
- Altium Capital Management LLCSC 13G/A, 2 filings Dec 21, 2022 to Feb 14, 202373
- Rosalind Advisors, Inc.SC 13G, 1 filing Jan 7, 202274
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Jill C. Milne, Ph.D.President and Chief Executive Officer | 57 | $637.9K | $6.6M75 |
| 2024 | Christopher Morabito, M.D.Chief Medical Officer | 55 | $485.9K | $2.5M75 |
| 2024 | Benjamin HarshbargerChief Legal Officer | 56 | $461.6K | $2.4M75 |
| 2023 | Jill C. Milne, Ph.D.President and Chief Executive Officer | 57 | $601.8K | $3.0M75 |
| 2023 | Christopher Morabito, M.D.Chief Medical Officer | 55 | $458.4K | $1.3M75 |
| 2023 | Benjamin HarshbargerChief Legal Officer | 56 | $439.6K | $1.3M75 |
SEC filer profile
How Catabasis Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAstria Therapeutics, Inc.2
- CIK0001454789
- Employer ID (EIN)26-36871685
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 312
- Industry code (SIC)2834 Pharmaceutical Preparations2
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
- Business address22 Boston Wharf Road, 10Th Floor, Boston, MA 022102
- Phone617-349-19712
- Shares outstanding57,084,838 as of Oct 31, 202511
- Public float$370.2M as of Jun 28, 20245
- AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceJan 21, 20092
- Filings628 in all: 4 (171), 8-K (83), SC 13G/A (45), 10-Q (32), 3 (31), SC 13G (30), 424B5 (21), EFFECT (15)2
All 50 form types
SCHEDULE 13G/A (15), CORRESP (13), 4/A (12), DEF 14A (12), S-8 (12), S-8 POS (12), DEFA14A (11), SC 13D/A (11), 10-K (10), 425 (8), POS AM (7), UPLOAD (7), 424B3 (6), D (6), S-3 (6), S-1/A (5), D/A (4), PRE 14A (4), S-3/A (4), SC 13D (4), ARS (3), SCHEDULE 13D/A (3), SCHEDULE 13G (3), 144 (2), 424B4 (2), S-1 (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 25-NSE/A (1), 5 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), REGDEX (1), S-1MEF (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Mar 11, 2025
Quarterly report (10-Q) Nov 12, 2025
Proxy statement (DEF 14A) Apr 28, 2025
Latest 8-K (8-K) Jan 23, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value per share | ATXS | Nasdaq |
From the cover page of the 10-K filed Mar 11, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Catabasis Pharmaceuticals names in Item 1A of its 10-K filed Mar 11, 2025: 71 risks under these headings, as written.5
- Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
- Our business is entirely dependent on the success of navenibart as a potential treatment for HAE and STAR-0310 as a potential treatment for AD.
- Interim topline, initial proof-of-concept and preliminary data from our clinical trials that we announce or publish from time to time may change as more study participant data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, and results of later stage clinical trials may not enable marketing approval.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome. If clinical trials of a product candidate fail to satisfactorily demonstrate safety and efficacy to the FDA and other comparable foreign regulators, we, or any future collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates.
- Adverse events or undesirable side effects caused by, or other unexpected properties of, a product candidate may be identified during development that could delay or prevent their marketing approval or limit their use.
- If we, or any future collaborators, experience any of a number of possible unforeseen events in connection with clinical trials of a product candidate, potential marketing approval or commercialization of such product candidate could be delayed or prevented.
- If we, or any future collaborators, experience delays or difficulties in the enrollment of patients in clinical trials, our or their receipt of necessary regulatory approvals could be delayed or prevented.
- We have conducted and intend to conduct certain of our clinical trials globally. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
- Changes in product candidate manufacturing or formulation may result in additional costs or delay.
- We face substantial competition from other pharmaceutical and biotechnology companies, and our operating results may suffer if we fail to compete effectively.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
The other 59 risks
- Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials and we may be unsuccessful in identifying any new product candidates.
- We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any future product candidate we may seek to develop.
- If navenibart, STAR-0310 or any other future product candidate receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.
- Even if navenibart, STAR-0310 or any other future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidate may be smaller than we estimate.
- If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing any future product candidates that we may develop if and when those product candidates are approved.
- Even if we, or any future collaborators, are able to commercialize any product candidate that we, or they, develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business.
- Navenibart, STAR-0310 and any other future biologic product candidates will be regulated as biological products, or biologics, and therefore they may be subject to competition from biologic products that are biosimilar to or interchangeable with an FDA-licensed reference biologic product.
- Business disruptions could delay completion of clinical trials, seriously harm our future revenue and financial condition and increase our costs and expenses.
- Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
- Risks Related to Our Financial Position and Need for Additional Capital
- We will need substantial additional funding. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
- We have incurred significant losses since inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- Risks Related to Our Dependence on Third Parties
- We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- If we enter into collaborations with third parties for the development and commercialization of a product candidate, our prospects with respect to such product candidate will depend in significant part on the success of those collaborations.
- We rely on third parties to conduct our preclinical studies and clinical trials. If they do not perform satisfactorily, our business could be significantly harmed.
- The manufacturing of pharmaceutical products and, in particular, biologics, is complex and we do not have our own manufacturing capabilities. We rely and intend to rely on third parties to produce preclinical, clinical and commercial supplies of our current and future product candidates as well as the device candidates that we intend to commercialize with our product candidates.
- Changes in U.S./China trade policies may adversely impact our business and operating results.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain sufficient patent protection for product candidates, or if the scope of the patent protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize such product candidates successfully may be adversely affected.
- If we do not obtain protection under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, and similar non-United States legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.
- We rely on in-licensed patent and other intellectual property rights for our STAR-0310 program and we may need to obtain licenses from third parties to other intellectual property rights for the development and commercialization of our STAR-0310 and navenibart programs; if we fail to comply with our existing or future obligations under these licenses, or if these licenses are terminated, we could lose license rights that are important to our business.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
- An intellectual property litigation could lead to unfavorable publicity that could harm our reputation and cause the market price of our common stock to decline.
- If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing current and future product candidates.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
- Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- We may obtain only limited geographical protection with respect to certain patent rights, which may diminish the value of our intellectual property rights in those jurisdictions and prevent us from enforcing our intellectual property rights throughout the world.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
- Risks Related to Marketing Approval and Other Legal Compliance Matters
- Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us or any future collaborators from obtaining approvals for the commercialization of navenibart, STAR-0310 or any other future product candidates. As a result, we cannot predict when or if, and in which territories, we, or any future collaborators, will obtain marketing approval to commercialize a product candidate.
- Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we may be granted for our product candidates in the United States would not assure approval of our product candidates in foreign jurisdictions and any of our product candidates that may be approved for marketing in a foreign jurisdiction will be subject to risks associated with foreign operations.
- We, or any future collaborators, may not be able to obtain or maintain orphan drug designation or orphan drug exclusivity for any future product candidates.
- Any product candidate for which we obtain marketing approval would remain subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved.
- We may seek certain designations for our product candidates, including Breakthrough Therapy, RMAT Therapy, Fast Track and Priority Review designations in the United States, and the PRIority MEdicines, or PRIME, designation in the European Union, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
- We may seek a Rare Pediatric Disease priority review voucher, or PRV, for our current and future product candidates. A BLA or NDA for our current and future product candidates will not, however, meet the eligibility criteria for a PRV, unless this program is reauthorized by Congress and we secure rare pediatric disease designation and approval of the BLA or NDA for the product candidate before any required dates established in such legislation.
- We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, competing priorities or other disruptions to these agencies’ operations, and regulatory reform efforts, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our product candidates that do receive marketing approval.
- The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed.
- The insurance coverage and reimbursement status of newly approved products is uncertain. Our product candidates, if approved, may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for any of our product candidates for which we obtain approval could limit our ability to market those products and decrease our ability to generate revenue.
- We may be subject to certain healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations, and diminished profits and future earnings.
- We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
- We are subject to United States and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business.
- Our employees, independent contractors, CROs, consultants, contract manufacturers, commercial partners, vendors and principal investigators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- Risks Related to Taxation
- Changes in tax law could adversely affect our business and financial condition.
- Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.
- Risks Related to Employee Matters, Managing Growth and Information Technology
- Our future success depends on our ability to retain our senior management and key employees.
- We may experience difficulty in locating, attracting and retaining experienced and qualified personnel, which could adversely affect our business.
- Security breaches and other disruptions to our information technology systems could compromise our information, disrupt our business and expose us to liability, which would cause our business and reputation to suffer.
- Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
- Risks Related to Our Common Stock
- Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- The price of our common stock has been and is likely to continue to be highly volatile, which could result in substantial losses for our stockholders.
- We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
- A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
- We do not anticipate paying any cash dividends on our capital stock in the foreseeable future, accordingly, stockholders must rely on capital appreciation, if any, for any return on their investment.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
- Risks Relating to our Certificate of Incorporation and Bylaws
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our certificate of incorporation designates the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors and officers.
Legal proceedings
From time to time we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of the date of this Annual Report on Form 10-K, we do not believe we are party to any claim or litigation, the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
The opening of Item 3, Legal Proceedings.5
Links
- Websitewww.catabasis.com1
- WikidataQ17143508
- SEC EDGARCIK 1454789
Sources
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- 25SEC EDGARRick Modi, Chief Business Officer
- 26SEC EDGARSunil Agarwal, Board member
- 27SEC EDGARFred Callori, Board member
- 28SEC EDGARJonathan Violin, Board member
- 29SEC EDGARJoseph Edelman, Board member
- 30SEC EDGARGregg Anthony Lapointe, Board member
- 31SEC EDGARJoanne T. Beck, Board member
- 32SEC EDGARHugh M. Cole, Board member
- 33SEC EDGARBurt A. Adelman, Board member
- 34SEC EDGARMichael D. Kishbauch, Board member
- 35SEC EDGARJean George, Board member
- 36SEC EDGARKenneth Bate, Board member
- 37SEC EDGARNicholas Galakatos, Board member
- 38SEC EDGARRon Laufer, Board member
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- 40SEC EDGARDeirdre A. Cunnane, General counsel
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- 42SEC EDGARShareholder vote; Other events
- 43SEC EDGAROther events
- 44SEC EDGARResults of operations
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- 48SEC EDGARResults of operations
- 49SEC EDGARRegulation FD disclosure
- 50SEC EDGARExecutive or director change
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- 52SEC EDGARExecutive or director change
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