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DNTH on Nasdaq

Magenta Therapeutics

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company dedicated to developing potentially best-in-class therapies for patients living with severe autoimmune diseases. Our lead clinical-stage candidate, claseprubart, is a monoclonal antibody that is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein – enabling less frequent and more convenient self-administered subcutaneous injections suitable for a pre-filled pen.”5 It is headquartered in Cambridge, United States.1 Its shares trade on Nasdaq under the symbol DNTH.1

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Last updated Oct 21, 2026.

Overview

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  • TickerDNTH on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersCambridge, United States1
  • Websitewww.magentatx.com
  • Legal formDelaware corporation1
  • Incorporated inDE4
  • Business address7 Times Square, 43Rd Floor, New York, Ny 100364
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • LEI549300Z3N6ODPCOFC8903
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 57688703

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We are a clinical-stage biotechnology company dedicated to developing potentially best-in-class therapies for patients living with severe autoimmune diseases. Our lead clinical-stage candidate, claseprubart, is a monoclonal antibody that is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein (“C1s”) – enabling less frequent and more convenient self-administered subcutaneous (“S.C.”) injections suitable for a pre-filled pen. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. We believe claseprubart has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in …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 2025

-8739.3%Operating margin6
-7973.3%Net margin6
-67.3%Revenue growth, 20256
-32.9%Return on equity6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$145.6M

Out of $2.0M in revenue.6 The company lost money this year.

Financial statements

Revenue786$2.0M in 2025
0$2.0M$4.0M$6.0M$8.0M2019: $0$020192023: $2.8M$2.8M20232024: $6.2M$6.2M2024+121%2025: $2.0M$2.0M2025−67%
Operating income910111286-$177.9M in 2025+114% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$83.0M-$83.0M20192020: -$78.7M-$78.7M2020−5%2021: -$74.7M-$74.7M2021−5%2022: -$29.7M-$29.7M2022−60%2023: -$48.2M-$48.2M2023+62%2024: -$101.9M-$101.9M2024+111%2025: -$177.9M-$177.9M2025+75%
Net income910111286-$162.3M in 2025+111% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$76.8M-$76.8M20192020: -$74.9M-$74.9M2020−2%2021: -$71.1M-$71.1M2021−5%2022: -$28.5M-$28.5M2022−60%2023: -$43.6M-$43.6M2023+53%2024: -$85.0M-$85.0M2024+95%2025: -$162.3M-$162.3M2025+91%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Total revenues$2.0M$6.2M
Research and development$145.6M$83.1M
General and administrative$34.3M$25.0M
Total operating expenses$180.0M$108.1M
Loss from operations-$177.9M-$101.9M
Interest and investment income$16.1M$17.4M
Gain on investment in former related party$508.0K$148.0K
Loss on currency exchange, net-$57.0K-$64.0K
Other expense-$974.0K-$554.0K
Total other income$15.6M$16.9M
Net loss-$162.3M-$85.0M
Net loss per share attributable to common stockholders, basic-$4.20-$2.55
Net loss per share attributable to common stockholders, diluted-$4.20-$2.55
Weighted-average number of shares of common stock outstanding including shares issuable under equity-classified pre-funded warrants, used in computing net loss per share of common stock, basic38.6M shares33.3M shares
Weighted-average number of shares of common stock outstanding including shares issuable under equity-classified pre-funded warrants, used in computing net loss per share of common stock, diluted38.6M shares33.3M shares
Unrealized gain on marketable securities$383.0K$59.0K
Total other comprehensive income$383.0K$59.0K
Total comprehensive loss-$162.0M-$84.9M

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Corporate structure

Magenta Therapeutics sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Magenta Therapeutics

  • Magenta Therapeutics Cambridge, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Magenta Therapeutics 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$600.0K6 Dec 31, 2025$387.0K6 Dec 31, 2024+55.0%
Accumulated depreciation$304.0K6 Dec 31, 2025$193.0K6 Dec 31, 2024+57.5%
Property and equipment, net$296.0K6 Dec 31, 2025$194.0K6 Dec 31, 2024+52.6%
Operating-lease assets (leased space)$1.3M6 Dec 31, 2025$1.6M6 Dec 31, 2024−13.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$51.1M6 Dec 31, 2025$22.8M6 Dec 31, 2024+124.1%
Marketable securities, current$353.2M6 Dec 31, 2025$252.4M6 Dec 31, 2024+39.9%
Debt securities available for sale$463.3M6 Dec 31, 2025$334.2M6 Dec 31, 2024+38.7%
Long-term investments$110.1M6 Dec 31, 2025$81.7M6 Dec 31, 2024+34.8%

Properties, in its own words

We are currently a remote-based company, and a majority of our employees work remotely. We currently lease space for administrative offices in Waltham, Massachusetts and New York, New York. Our space in Waltham is approximately 2,750 square feet under a lease that expires in January 2027 and our space in New York is approximately 3,367 square feet under a lease that expires in February 2031. Our New York office is our corporate headquarters. As the company expands, we believe suitable additional, or substitute space will be available as and when needed.

Item 2 of the 10-K filed Mar 9, 2026.5

Leadership

Who has led Magenta Therapeutics, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Marino Garcia2023–now

President

  1. Marino Garcia2023–now

Chief financial officer

  1. Ryan Savitz2023–now
20202025
Board members and other officers (37)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerKenneth Evan Thompson named Apr 21, 202252

Former names

  • Magenta Therapeutics, Inc.Nov 23, 2016 to Sep 8, 20234

Timeline

  1. Aug 4, 20268-K Results of operations53
  2. Jun 12, 20268-K Other events54
  3. May 22, 20268-K Shareholder vote55
  4. May 5, 20268-K Results of operations56
  5. Mar 26, 20268-K Other events57
  6. Mar 12, 20268-K Entered a material agreement58
  7. Mar 9, 20268-K Results of operations; Regulation FD disclosure; Other events59
  8. Jan 12, 20268-K Results of operations; Regulation FD disclosure60
  9. Nov 5, 20258-K Results of operations61
  10. Nov 3, 20258-K Other events62
  11. Oct 16, 20258-K Entered a material agreement; Results of operations; Other events63
  12. Sep 11, 20258-K Entered a material agreement64
  13. Sep 13, 2023New chief executive Marino Garcia becomes CEO15
  14. Jun 17, 2015Founded Magenta Therapeutics is founded3

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.97) a share, on Nov 5, 2025.65

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results53
  2. May 5, 2026Reported quarterly or annual results56
  3. Mar 9, 2026Reported quarterly or annual results59
  4. Jan 12, 2026Reported quarterly or annual results60
  5. Nov 5, 2025Reported quarterly or annual results61
  6. Oct 16, 2025Reported quarterly or annual results63
  7. Aug 7, 2025Reported quarterly or annual results66
  8. May 12, 2025Reported quarterly or annual results67

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

Filings

386 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 53 major events, 141 insider forms, 77 large holders, 1 private raises, 93 other. The latest 20:

  1. Sep 18, 20264 EDGAR
  2. Sep 18, 2026S-3ASR EDGAR
  3. Sep 17, 2026144 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Sep 1, 2026144 EDGAR
  6. Aug 19, 20264 EDGAR
  7. Aug 14, 20264 EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 13, 2026SCHEDULE 13G EDGAR
  10. Aug 11, 20264 EDGAR
  11. Aug 11, 20264 EDGAR
  12. Aug 11, 20264 EDGAR
  13. Aug 10, 2026144 EDGAR
  14. Aug 10, 2026144 EDGAR
  15. Aug 10, 2026144 EDGAR
  16. Aug 7, 2026144 EDGAR
  17. Aug 7, 2026144 EDGAR
  18. Aug 7, 2026144 EDGAR
  19. Aug 7, 2026SCHEDULE 13G/A EDGAR
  20. Aug 7, 2026SCHEDULE 13G EDGAR

The 386 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

32 open-market trades by officers, directors and large owners since October 2021: 7 buys and 25 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 17, 2026CARR EDWARDCHIEF ACCOUNTING OFFICERSale20,000$101.38$2.0MForm 4
Sep 1, 2026Randhawa SimratEVP, Head of R&DSale23,124$106.41$2.5MForm 4
Aug 19, 2026Read SimonDirectorSale2,778$117.55$326.6KForm 4
Aug 10, 2026McGeorge AnneDirectorSale7,750$109.01$844.8KForm 4
Aug 10, 2026Veness Adam MSVP, General Counsel and Sec.Sale16,167$110.38$1.8MForm 4
Aug 10, 2026Read SimonDirectorSale2,777$109.55$304.2KForm 4
Aug 7, 2026Veness Adam MSVP, General Counsel and Sec.Sale3,833$110.70$424.3KForm 4
Aug 7, 2026Garcia MarinoCEO AND PRESIDENTSale166,000$108.11$17.9MForm 4
Jul 9, 2026Savitz RyanEVP, CFO & CBOSale31,249$101.03$3.2MForm 4
Jun 17, 2026Veness Adam MSVP, General Counsel and Sec.Sale30,000$80.80$2.4MForm 4
Jun 1, 2026Randhawa SimratEVP, Head of R&DSale26,530$90.62$2.4MForm 4
May 8, 2026Soteropoulos PaulaDirectorSale599$85.47$51.2KForm 4
Apr 9, 2026Savitz RyanEVP, CFO & CBOSale8,224$89.84$738.8KForm 4
Mar 31, 2026Savitz RyanEVP, CFO & CBOSale114,367$83.00$9.5MForm 4
Mar 31, 2026Soteropoulos PaulaDirectorSale599$80.11$48.0KForm 4
Mar 24, 2026Soteropoulos PaulaDirectorSale27,594$78.05$2.2MForm 4
Mar 12, 2026Randhawa SimratEVP, Head of R&DSale33,830$81.48$2.8MForm 4
Mar 12, 2026Garcia MarinoCEO AND PRESIDENTSale122,918$81.49$10.0MForm 4
Mar 12, 2026CARR EDWARDCHIEF ACCOUNTING OFFICERSale43,682$81.49$3.6MForm 4
Dec 4, 2025Savitz RyanEVP, CFO & CBOSale20,000$45.18$903.6KForm 4

All 32 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
2025Marino Garcia59$630.0K$10.6M93
2025Simrat RandhawaM.D.56$530.6K$5.2M93
2025Ryan Savitz37$482.6K$5.1M93
2024President and Chief Executive Officer$600.0K$8.8M93
2024Executive Vice PresidentChief Financial Officer, Chief Business Officer and Treasurer$464.0K$4.0M93

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$100.0M 2022–2022
Money received by yearMoney received by year, 2022–2022: $100.0M in all. Private raises (Form D) $100.0M.$0$25M$50M$75M$100M2022 · Private raises (Form D): $100.0M2022
Figures by year
YearPrivate raises (Form D)Total
2022$100.0M$100.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Apr 6, 2022Raised $100 million in a private offering of equity52 Form D: 22 investors so far Form D

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
Fmr LLC8,199,893$799.3M0.0%+432,207
BlackRock, Inc.4,123,822$402.0M0.0%+948,119
Wellington Management Group Llp3,229,882$314.8M0.1%+634,099
Fairmount Funds Management LLC2,537,191$247.3M16.3%No change
State Street Corp2,357,440$229.8M0.0%+958,527
Vanguard Capital Management LLC2,159,568$210.5M0.0%+128,319
Avidity Partners Management LP2,104,184$205.1M32.8%−2,104,184
Octagon Capital Advisors LP1,841,667$179.5M16.5%−105,000
TCG Crossover Management, LLC1,676,624$163.4M3.9%No change
Fred Alger Management, LLC1,302,493$127.0M0.4%+140,570
Geode Capital Management, LLC1,258,502$122.7M0.0%+342,291
Venrock Adviser, LLC1,180,000$115.0M3.5%No change
UBS Group AG1,140,260$111.2M0.0%+358,978
Deerfield Management Company, L.P.1,125,313$109.7M1.4%+105,500
Jennison Associates LLC1,021,763$99.6M0.1%+536,627
Polar Capital Holdings Plc1,018,726$99.3M0.3%−57,283
Citadel Advisors LLC974,911$95.0M0.1%−635,572
Franklin Resources Inc968,983$94.5M0.0%+801
Baker Bros. Advisors LP852,164$83.1M0.4%No change
Logos Global Management LP800,000$78.0M3.4%+400,000
Cormorant Asset Management, LP750,000$73.1M3.7%−200,000
Alliancebernstein L.P.834,150$70.0M0.0%−91,921
Braidwell LP594,562$58.0M2.2%−304,802
Vanguard Portfolio Management LLC570,115$55.6M0.0%+220,734
Assenagon Asset Management S.A.561,298$54.7M0.0%New

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

SEC filer profile

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

  • Name on EDGARDianthus Therapeutics, Inc. /DE/2
  • CIK0001690585
  • Employer ID (EIN)81-07241635
  • 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 address7 Times Square, 43Rd Floor, New York, NY 100362
  • Phone929-999-40552
  • Shares outstanding55,934,378 as of Aug 3, 202614
  • Public float$599.4M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, Morristown, New Jersey PCAOB ID 34; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceNov 23, 20162
  • Filings655 in all: 4 (242), 8-K (87), 3 (43), SCHEDULE 13G/A (26), 10-Q (25), SC 13G/A (23), 144 (21), SC 13G (21)2
    All 45 form types

    CORRESP (18), UPLOAD (14), S-8 (11), EFFECT (10), 424B5 (9), SCHEDULE 13G (9), 10-K (8), 424B3 (7), DEF 14A (7), DEFA14A (7), S-3 (7), SC 13D/A (7), S-1/A (6), CT ORDER (4), SC 13D (4), SCHEDULE 13D/A (4), 425 (3), 8-A12B (3), ARS (3), D (3), S-4/A (3), 4/A (2), 424B4 (2), DRS (2), S-1 (2), 10-K/A (1), 3/A (1), 5 (1), 8-K/A (1), CERT (1), DRS/A (1), DRSLTR (1), FWP (1), RW (1), S-3ASR (1), S-3MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 9, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common StockDNTHNasdaq

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Magenta Therapeutics names in Item 1A of its 10-K filed Mar 9, 2026: 73 risks under these headings, as written.5

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We have a limited operating history, have not completed any late-stage clinical trials and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and viability.
  • We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate clinical trials, product development programs or future commercialization efforts.
  • We have incurred significant losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have no products for sale, have not generated any product revenue and may never generate product revenue or become profitable.
  • Risks Related to Discovery, Development and Commercialization
  • We face competition from entities that have developed or may develop programs for the diseases we plan to address with claseprubart, DNTH212 or other product candidates.
  • Claseprubart, DNTH212 and our other programs are in varying stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If we or our current or future collaborators are unable to complete development of, or commercialize, our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We are substantially dependent on the success of our most advanced product candidate, claseprubart, and our anticipated clinical trials of such candidate may not be successful.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of claseprubart, DNTH212 or any other product candidates may be delayed and our expenses may increase and, as a result, our stock price may decline.
  • Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value.
  • Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
The other 62 risks
  • If we encounter difficulties enrolling patients in our current and future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Preliminary, “top-line” or interim data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures.
  • Our current or future clinical trials or those of our current or future collaborators may reveal significant adverse events or undesirable side effects not seen in our preclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of claseprubart, DNTH212 or any of our other product candidates or result in potential product liability claims.
  • We may expend our limited resources to pursue a particular product candidate, such as claseprubart, and fail to capitalize on candidates that may be more profitable or for which there is a greater likelihood of success.
  • Even if regulatory approval is obtained, any approved products resulting from claseprubart, DNTH212 or any other product candidate may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such products.
  • We have never commercialized a product candidate and may lack the necessary expertise, personnel and resources to successfully commercialize a product candidate on our own or together with suitable collaborators.
  • We have never completed any late-stage clinical trials and we may not be able to file an IND, a CTA or other applications for regulatory approval to commence additional clinical trials on the timelines we expect, and, even if we are able to, the FDA, EMA or comparable foreign regulatory authorities may not permit us to proceed and could also suspend/terminate the trial after it has been initiated.
  • Risks Related to Our Reliance on Third Parties
  • We currently rely and expect to rely in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture claseprubart, DNTH212 and any other product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.
  • If our CDMO, WuXi Biologics, is unable to obtain sufficient raw and intermediate materials on a timely basis or if our CDMO experiences other supply difficulties, our business may be materially and adversely affected.
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and 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 have collaborations with third parties, including our existing license and development collaboration with Tenacia for claseprubart and Leads for DNTH212. If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • Risks Related to Our Business and Operations
  • In order to successfully implement our plans and strategies, we will need to increase the size of our organization and we may experience difficulties in managing this growth.
  • We are highly dependent on our key personnel, and we anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CDMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our internal information technology systems, or those of any of our CROs, CDMOs, other contractors, third party service providers or consultants or potential future collaborators, may fail or experience cybersecurity incidents or data privacy breaches or other unauthorized or improper access to, use of, or destruction of proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • 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.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and 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 have a material adverse effect on the success of our business.
  • We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
  • We maintain our cash at financial institutions, at times in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
  • Risks Related to Intellectual Property
  • Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
  • We may not be successful in obtaining or maintaining necessary rights to product candidates through acquisitions and in-licenses.
  • We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing potential products.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining 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 non-compliance with these requirements.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Our technology licensed from various third parties may be subject to retained rights.
  • Risks Related to Government Regulation
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. 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, such product candidates, and our ability to generate revenue will be materially impaired.
  • Disruptions at the FDA and other government agencies could negatively affect the review of our regulatory submissions, which could negatively impact our business.
  • We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates.
  • We intend to deliver our product candidates via a drug delivery device that will have its own regulatory, development, supply and other risks.
  • We have and may in the future conduct clinical trials for our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
  • Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated.
  • Even if we receive regulatory approval of claseprubart, DNTH212 or other product candidates, we will be subject to extensive 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.
  • We may face difficulties from healthcare legislative reform measures.
  • Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Even if we are able to commercialize claseprubart, DNTH212 or other product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such products at competitive prices which would seriously harm our business.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • If we decide to pursue a Fast Track Designation or Orphan Drug Designation by the FDA, it may not lead to a faster development or regulatory review or approval process.
  • General Risk Factors
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • We may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinical or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Litigation costs and the outcome of litigation could have a material adverse effect on our business.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the conflict between Russia and Ukraine, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations, cash flows, and financial condition.
  • The market price of our common stock may be volatile, and the market price of our common stock may drop.
  • We will continue to incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If we no longer qualify as a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results and cash flows.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • Our certificate of incorporation and bylaws and provisions under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • Our bylaws provide that, unless we consent in writing to the selection of an alternative forum, certain designated courts will be the sole and exclusive forum for certain legal actions between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • We do not anticipate paying any cash dividends in the foreseeable future.
  • An active trading market for our common stock may not be sustained and our stockholders may not be able to sell their shares of common stock for a profit, if at all.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • Our executive officers, directors and principal stockholders will have the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • We have broad discretion in the use of our cash, cash equivalents and investments and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes is expected to be limited.

Legal proceedings

From time to time, we may be involved in litigation and other legal proceedings arising in the ordinary course of our business. We are not currently a party to or aware of any legal proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition, results of operations or cash flows. The outcome of any claims or litigation, regardless of the merits, is inherently uncertain. Regardless of the outcome, litigation and other legal proceedings can have a material adverse impact on us, our business, financial condition, results of operations or cash flows because of defense and settlement costs, diversion of management resources, in the case of intellectual property claims, requirements to change our product candidates, change our business practices, pay monetary damages or enter into short- or long-term royalty or licensing agreements, and other factors.

The opening of Item 3, Legal Proceedings.5

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