CABA on Nasdaq

Cabaletta Bio, Inc.

American biological products company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a late clinical-stage biotechnology company focused on the discovery and development of innovative engineered T cell therapies that have the potential to provide deep and durable, perhaps curative, responses with one-time administration for patients with autoimmune diseases. Our proprietary CABA ®, or Cabaletta Approach to B cell Ablation platform, focuses on the CARTA approach.”5 It is headquartered in Philadelphia, Pennsylvania.1

$1.55 down 0.07 (4.32%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerCABA on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersPhiladelphia, Pennsylvania1
  • Incorporated inDE3
  • Business address2929 Arch Street, Suite 600, Philadelphia, Pa 191043
  • Filer categoryNon-accelerated filer, Smaller reporting company3

We are a late clinical-stage biotechnology company focused on the discovery and development of innovative engineered T cell therapies that have the potential to provide deep and durable, perhaps curative, responses with one-time administration for patients with autoimmune diseases. Our proprietary CABA ® , or Cabaletta Approach to B cell Ablation platform, focuses on the CARTA approach. CARTA refers to Chimeric Antigen Receptor T cells for Autoimmunity and is designed to potentially reset the immune system. Based on clinical data reported to date, we believe our CABA ® platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases and that it has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income67891011-$172.2M in 2025+822% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$18.7M-$18.7M20192020: -$33.8M-$33.8M2020+81%2021: -$46.3M-$46.3M2021+37%2022: -$54.1M-$54.1M2022+17%2023: -$74.7M-$74.7M2023+38%2024: -$125.1M-$125.1M2024+68%2025: -$172.2M-$172.2M2025+38%
Net income67891011-$167.9M in 2025+891% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$16.9M-$16.9M20192020: -$33.3M-$33.3M2020+97%2021: -$46.3M-$46.3M2021+39%2022: -$53.0M-$53.0M2022+14%2023: -$67.7M-$67.7M2023+28%2024: -$115.9M-$115.9M2024+71%2025: -$167.9M-$167.9M2025+45%

Every line of the income statement as filed: the last 2 fiscal years, latest first.11

Period ending2025-12-312024-12-31
Research and development$142.7M$97.2M
General and administrative$29.6M$27.9M
Total operating expenses$172.2M$125.1M
Loss from operations-$172.2M-$125.1M
Interest income$6.0M$10.0M
Interest expense-$2.0M-$748.0K
Other income, net$358.0K$0
Net loss-$167.9M-$115.9M
Net unrealized gain (loss) on available-for-sale investments, net of tax$25.0K-$39.0K
Net comprehensive loss-$167.8M-$115.9M
Net loss per share of voting and non-voting common stock, basic-$2.10-$2.34
Net loss per share of voting and non-voting common stock, diluted-$2.10-$2.34

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Corporate structure

Cabaletta Bio, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Cabaletta Bio, Inc.

  • Cabaletta Bio, Inc. Philadelphia, Pennsylvania
    • Cabaletta Bio (Germany) GmbH Subsidiary · Germany

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 Cabaletta Bio, Inc. 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$9.1M11 Dec 31, 2025$8.2M11 Dec 31, 2024+10.0%
Accumulated depreciation$7.2M11 Dec 31, 2025$5.5M11 Dec 31, 2024+29.9%
Property and equipment, net$1.9M11 Dec 31, 2025$2.7M11 Dec 31, 2024−29.9%
Finance-lease assets$15.7M11 Dec 31, 2025$7.0M11 Dec 31, 2024+123.6%
Operating-lease assets (leased space)$3.4M11 Dec 31, 2025$6.3M11 Dec 31, 2024−45.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$83.0M11 Dec 31, 2025$164.0M11 Dec 31, 2024−49.4%
Marketable securities, current$50.6M11 Dec 31, 2025$011 Dec 31, 2024
Debt securities available for sale$133.6M11 Dec 31, 2025$241.2M10 Dec 31, 2023−44.6%

Properties, in its own words

Our corporate headquarters are located in Philadelphia, PA, where we lease 7,672 square feet of office space subject to a lease agreement that is in effect through June 30, 2026. We also have a lease consisting of approximately 13,179 square feet of laboratory space in Philadelphia, PA subject to a lease agreement that is in effect through November 15, 2026. We believe our facilities are currently adequate for us to conduct our business.

Item 2 of the 10-K filed Mar 23, 2026.5

Leadership

Who has led Cabaletta Bio, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (12)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Cabaletta Bio (Germany) GmbH Germany4
  • Cabaletta Bio GmbH Switzerland4
  • Cabaletta Bio, Inc. Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 14, 20268-K Other events28
  2. Aug 13, 20268-K Results of operations29
  3. Jun 11, 20268-K Bylaws or fiscal year changed; Shareholder vote30
  4. Jun 3, 20268-K Regulation FD disclosure; Other events31
  5. May 14, 20268-K Regulation FD disclosure; Other events32
  6. May 14, 20268-K Results of operations33
  7. May 4, 20268-K Other events34
  8. May 4, 20268-K Entered a material agreement; Results of operations; Other events35
  9. Apr 20, 20268-K Other events36
  10. Mar 23, 20268-K Results of operations; Regulation FD disclosure37
  11. Jan 12, 20268-K Regulation FD disclosure; Other events38
  12. Nov 10, 20258-K Results of operations39
  13. Oct 24, 2019New chief executive Steven Nichtberger becomes CEO14

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.44) a share, on Nov 10, 2025.40

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results29
  2. May 14, 2026Reported quarterly or annual results33
  3. May 4, 2026Reported quarterly or annual results35
  4. Mar 23, 2026Reported quarterly or annual results37
  5. Nov 10, 2025Reported quarterly or annual results39
  6. Aug 7, 2025Reported quarterly or annual results41
  7. May 15, 2025Reported quarterly or annual results42
  8. Mar 31, 2025Reported quarterly or annual results43

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

322 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 75 major events, 94 insider forms, 84 large holders, 49 other. The latest 20:

  1. Sep 14, 20268-K EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 13, 202610-Q EDGAR
  6. Aug 13, 20268-K EDGAR
  7. Aug 12, 2026SCHEDULE 13G EDGAR
  8. Aug 12, 2026SCHEDULE 13G/A EDGAR
  9. Jul 31, 2026SCHEDULE 13G EDGAR
  10. Jul 27, 2026SCHEDULE 13G EDGAR
  11. Jul 23, 2026SCHEDULE 13G/A EDGAR
  12. Jun 11, 20268-K EDGAR
  13. Jun 10, 20264 EDGAR
  14. Jun 10, 20264 EDGAR
  15. Jun 10, 20264 EDGAR
  16. Jun 10, 20264 EDGAR
  17. Jun 10, 20264 EDGAR
  18. Jun 5, 2026SCHEDULE 13G/A EDGAR
  19. Jun 4, 2026SCHEDULE 13G/A EDGAR
  20. Jun 3, 20268-K EDGAR

The 322 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

24 open-market trades by officers, directors and large owners since October 2021: 14 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 21, 2026Chang David J.Chief Medical OfficerBuy8,800$2.26$19.9KForm 4
Jan 21, 2026Binder GwendolynPresident, Science & Tech.Buy11,312$2.19$24.8KForm 4
Jan 21, 2026Tomasello ShawnDirectorBuy22,725$2.21$50.2KForm 4
Jan 21, 2026Gavel SteveChief Commercial OfficerBuy22,170$2.27$50.3KForm 4
Jan 21, 2026Bollard CatherineDirectorBuy4,405$2.27$10.0KForm 4
Jan 21, 2026Nichtberger StevenPresident & CEOBuy45,000$2.24$100.8KForm 4
Jan 21, 2026Simon MarkDirectorBuy11,061$2.28$25.2KForm 4
Jan 21, 2026Gerard MichaelGeneral CounselBuy6,600$2.27$15.0KForm 4
Jan 19, 2024Binder GwendolynPresident, Science & Tech.Sale11,000$19.59$215.5KForm 4
Dec 19, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$21.89$240.8KForm 4
Nov 20, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$17.82$196.0KForm 4
Oct 19, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$13.36$146.9KForm 4
Sep 19, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$17.56$193.2KForm 4
Aug 21, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$13.42$147.6KForm 4
Jul 19, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$13.82$152.0KForm 4
Jun 20, 2023Binder GwendolynPresident, Science & Tech.Sale11,000$12.99$142.9KForm 4
May 19, 2023Binder GwendolynPresident, Science & Tech.Sale22,000$11.81$259.8KForm 4
Oct 19, 2022Nichtberger StevenPresident & CEOBuy8,127$1.25$10.2KForm 4
Oct 18, 2022Bollard CatherineDirectorBuy1,000$0.99$990Form 4
Oct 18, 2022Marda AnupChief Financial OfficerBuy50,000$0.99$49.5KForm 4

All 24 trades can be filtered by person here when JavaScript is on.

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.

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.

YearExecutiveAgeSalaryTotal pay
2025Steven NichtbergerM.D.64$659.5K$2.0M70
2025Gwendolyn K. BinderPh.D.$516.7K$1.0M70
2025David J. ChangM.D., M.P.H.63$516.7K$959.7K70
2024President and Chief Executive Officer$646.3K$8.1M70
2024Chief Medical Officer$496.8K$3.3M70
2024PresidentScience and Technology$496.9K$3.3M70

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Jennison Associates LLC20,033,730$62.3M0.0%+11,063,152
Bain Capital Life Sciences Investors, LLC17,241,445$53.6M3.2%+7,564,320
BlackRock, Inc.10,754,701$33.4M0.0%+8,381,698
Adage Capital Partners Gp, L.l.c.9,174,758$28.5M0.0%+345,000
State Street Corp7,839,305$24.4M0.0%+7,369,327
Vanguard Capital Management LLC7,227,018$22.5M0.0%+3,198,027
Cormorant Asset Management, LP5,000,000$15.6M0.8%−500,000
Woodline Partners LP4,200,142$13.1M0.0%+2,949,900
Norges Bank4,112,401$12.8M0.0%New
Opaleye Management Inc.3,863,800$12.0M1.1%+2,483,800
Citadel Advisors LLC3,522,112$11.0M0.0%New
Geode Capital Management, LLC3,459,464$10.8M0.0%+2,326,219
Franklin Resources Inc2,413,937$7.5M0.0%New
Goldman Sachs Group Inc2,211,825$6.9M0.0%+1,428,605
Millennium Management LLC2,068,491$6.4M0.0%−3,834,790
Cantor Fitzgerald, L. P.1,600,002$5.0M0.0%+835,002
Marshall Wace, Llp1,565,939$4.9M0.0%−613,879
Renaissance Technologies LLC1,535,300$4.8M0.0%−501,363
UBS Group AG1,471,895$4.6M0.0%+865,231
Qube Research & Technologies Ltd1,426,840$4.4M0.0%−508,150
Vanguard Portfolio Management LLC1,418,108$4.4M0.0%New
Two Sigma Investments, LP1,410,931$4.4M0.0%−1,086,986
Morgan Stanley1,345,526$4.2M0.0%−62,626
Sphera Funds Management Ltd.1,329,012$4.1M0.6%New
Superstring Capital Management LP1,278,652$3.5M2.2%+212,413

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Cabaletta Bio, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCabaletta Bio, Inc.1
  • CIK0001759138
  • Employer ID (EIN)82-16857685
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2929 Arch Street, Suite 600, Philadelphia, PA 191041
  • Phone(267) 759-31001
  • Shares outstanding169,545,445 as of Aug 7, 202613
  • Public float$137.0M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceDec 10, 20181
  • Filings444 in all: 4 (120), 8-K (92), SC 13G/A (39), SCHEDULE 13G/A (26), SC 13G (22), 10-Q (21), 3 (17), S-8 (9)1
    All 40 form types

    144 (8), CORRESP (8), 10-K (7), 424B5 (7), DEF 14A (7), SCHEDULE 13G (7), DEFA14A (6), EFFECT (5), SC 13D/A (5), UPLOAD (5), ARS (4), S-3 (3), 8-K/A (2), D (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SEC STAFF LETTER (2), 4/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), DRS (1), FWP (1), POS AM (1), POSASR (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.00001 per shareCABAThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Cabaletta Bio, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 73 risks under these headings, as written.5

  • Risks Related to Our Business, Technology and Industry
  • We are early in our development efforts. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Cellular therapies, including our engineered chimeric antigen receptor T cell, or CAR T, chimeric autoantibody receptor T cell, or CAAR T, product candidates, represent a novel approach to the treatment of autoimmune diseases, which creates significant challenges for us. Negative perception or increased regulatory scrutiny of any product candidates that we develop could adversely affect our ability to conduct our business or obtain regulatory approvals for such product candidates.
  • Patients receiving T cell-based immunotherapies, such as our product candidates, have in the past and may in the future experience serious adverse events, including ICANS, CRS and killing of cells other than the intended B cells that express the autoantibodies. If our product candidates are revealed to have high and unacceptable severity and/or prevalence of side effects or unexpected characteristics, their clinical development, regulatory approval, and commercial potential will be negatively impacted, which will significantly harm our business, financial condition and prospects.
  • Preconditioning regimens, as currently implemented in several of our clinical trials, may increase the risk of adverse side effects and impact our ability to accurately assess the efficacy of our product candidates.
  • Our business is highly dependent on the success of our initial product candidates targeting autoimmune diseases where B cells may play a role in initiating or maintaining disease. All of our product candidates will require significant additional preclinical and/or clinical development before we can seek regulatory approval for and launch a product commercially.
  • We have never successfully completed any clinical trials, and we may be unable to do so for any product candidates we develop.
  • Our registrational trials may rely on a single-arm design and an external control; if regulatory authorities determine that the external control is unsuitable, we may be unable to obtain approval on our anticipated timelines, or at all.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Our preclinical studies and clinical trials may fail to demonstrate the safety, potency and purity of any of our product candidates, which would prevent or delay regulatory approval and commercialization.
  • Interim, topline or preliminary data from any preclinical studies or clinical trials that we conduct may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
The other 62 risks
  • The increasing use of social media platforms presents new risks and challenges.
  • We may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect or at all.
  • Monitoring safety of patients receiving our product candidates will be challenging, which could adversely affect our ability to obtain regulatory approval and commercialize our product candidates.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain the market acceptance among physicians, patients, hospitals, treatment centers and others in the medical community necessary for commercial success.
  • We may not be successful in our efforts to identify additional product candidates. Due to our limited resources and access to capital, we must prioritize development of certain product candidates, which may prove to be wrong and may adversely affect our business.
  • If we fail to develop additional product candidates, our commercial opportunity will be limited.
  • We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We expect to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Business disruptions, including due to natural disasters, global conflicts or political unrest, could seriously impact our operations, research and trials and harm our future revenue and financial condition.
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have incurred net losses in every period since our inception and anticipate that we will incur substantial net losses over the next several years, and may never achieve or maintain profitability.
  • We have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability, and we may face significant challenges and expense as we test our product candidates and build our capabilities.
  • We have not generated any revenue from our product candidates and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of areas.
  • We will require substantial additional financing to develop and commercialize our product candidates and implement our operating plans. We have also identified conditions that raise substantial doubt about our ability to continue as a going concern. If we fail to obtain additional financing or cannot obtain financing at the levels we require, we may be forced to delay, reduce or discontinue our plans and operations or unable to complete the development and commercialization of our product candidates.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Our outstanding common stock warrants may not be exercised, and we may not receive any additional funds upon the exercise of such warrants.
  • We will not receive any meaningful amount of additional funds upon the exercise of the pre-funded warrants; however, any exercise would increase the number of shares of our common stock eligible for future resale in the public market and result in dilution to our stockholders.
  • Risks Related to Our Intellectual Property
  • We rely heavily on certain in-licensed patent and other intellectual property rights in connection with our development of our product candidate and, if we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • If our efforts to protect the proprietary nature of the intellectual property related to our current and any future product candidates are not adequate, we may not be able to compete effectively in our market.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We or our licensors may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property that we own or license.
  • Some intellectual property which we have in-licensed was discovered through government funded programs and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We may become involved in lawsuits to protect or enforce our patent rights or other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we are unable to protect the confidentiality of trade secrets, our business and competitive position would be harmed.
  • Patent term may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • We may become subject to claims that we are infringing certain third-party patents or other third-party intellectual property rights, any of which may prevent or delay our development and commercialization efforts and have a material adverse effect on our business.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Our Reliance on Third Parties
  • We currently, and will likely continue to, rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We intend to rely on third parties to manufacture our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if licensed.
  • We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • We may not realize the benefits of acquired assets or other strategic transactions, including any transactions whereby we acquire or license manufacturing and other advanced technologies.
  • Risks Related to Manufacturing and Supply
  • We are reliant on Minaris and Lonza for our current manufacturing activities and termination would disrupt normal business operations, and we intend to continue to rely on other third parties for our future manufacturing needs prior to establishing our own manufacturing facility.
  • Changes in manufacturers or manufacturing processes for rese‑cel, including process optimization and scale‑up for commercial production, present significant risks. If we cannot establish comparability, validate our processes and methods (including for critical materials such as lentiviral vector), and/or if our CMO(s) fails pre-approval inspection, the initiation or completion of pivotal studies, regulatory approval and commercialization could be delayed or prevented.
  • Our product candidates are uniquely manufactured. If we or any of our third-party manufacturers encounter difficulties in manufacturing our product candidates, our ability to provide supply of our product candidates for clinical trials or, if licensed, for commercial sale, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • The manufacturing process for any products that we may develop is subject to the FDA approval process, and we will need to contract with manufacturers who can meet all applicable FDA requirements on an ongoing basis.
  • The manufacture of viral vectors is complex and variable, and there are a limited number of manufacturers able to supply us with viral vectors.
  • If we are to operate our own manufacturing facility, significant resources will be required and we may fail to successfully operate our facility, which could adversely affect our clinical trials and the commercial viability of our product candidates.
  • The manufacture of biopharmaceutical products is complex and requires significant expertise, and can be impacted by resource constraints, labor disputes and workforce limitations.
  • We are dependent upon the availability of specialty raw materials and the production capabilities of small manufacturers to source the components of our product candidates.
  • We may encounter difficulties in production, particularly with respect to process development or scaling up of our manufacturing capabilities. If we encounter such difficulties, our ability to provide supply of our CAR T cells for clinical trials or for commercial purposes could be delayed or stopped.
  • If we or our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay, which could adversely affect our business, results of operations and financial condition.
  • Risks Related to Government Regulation
  • The regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
  • We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition.
  • The regulatory landscape that will govern our product candidates is uncertain; regulations relating to more established cell therapies and other therapies for autoimmune diseases where B cells may play a role in initiating or maintaining disease are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of our product candidates or unexpected costs in obtaining regulatory approval.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • Even though we may apply for orphan drug designation for our product candidates, we may not be able to obtain orphan drug marketing exclusivity.
  • The FDA has granted rare pediatric disease designation to rese-cel for the treatment of juvenile dermatomyositis. However, a marketing application for rese-cel or any other product candidate, if approved, may not meet the eligibility criteria for a priority review voucher.
  • A fast track designation by the FDA, even if granted, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our current product candidate and any future product candidates will receive marketing approval.
  • Although we may pursue expedited regulatory approval pathways for a product candidate, it may not qualify for expedited development or, if it does qualify for expedited development, it may not actually lead to a faster development or regulatory review or approval process.
  • Disruptions at the FDA, the USPTO, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, 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.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • 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 have a material adverse effect on the success of our business.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if licensed, profitably.
  • Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • Our relationships with customers, healthcare providers, physicians, and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
  • Risks Related to Data Privacy and Security

Legal proceedings

From time to time, we may be involved in lawsuits, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters which arise in the ordinary course of business. While the outcome of any such proceedings cannot be predicted with certainty, as of December 31, 2025, we were not party to any legal proceedings that we would expect to have a material adverse impact on our financial position, results of operations or cash flow.

The opening of Item 3, Legal Proceedings.5

Sources

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  1. 1
  2. 2
    Yahoo FinanceCABA quote
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  28. 28
    SEC EDGAROther events
  29. 29
  30. 30
  31. 31
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    SEC EDGAROther events
  35. 35
  36. 36
    SEC EDGAROther events
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
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  44. 44
  45. 45
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  65. 65
  66. 66
  67. 67
  68. 68
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  70. 70