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QTTB on Nasdaq

Q32 Bio Inc.

American pharmaceutical preparations company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with alopecia areata and other autoimmune and inflammatory diseases driven by pathological immune dysfunction. We have completed two Phase 2a clinical trials evaluating bempikibart, SIGNAL-AA Part A, for the treatment of AA, and SIGNAL-AD, for the treatment of atopic dermatitis.”3 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol QTTB.1

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Last updated Oct 21, 2026.

Overview

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  • TickerQTTB on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address830 Winter Street, Waltham, Ma 024512
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with alopecia areata (“AA”) and other autoimmune and inflammatory diseases driven by pathological immune dysfunction.3 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

31.5%Operating margin4
55.5%Net margin4
71.0%Return on equity4
-$33.5MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development36¢$19.2M
  • Other costs9¢$4.8M
  • Profit55¢$29.8M

Out of $53.7M in revenue.4

Financial statements

Revenue56784$53.7M in 2025+3126% since 2019
0$20.0M$40.0M$60.0M2019: $1.7M$1.7M20192020: $2.7M$2.7M2020+62%2021: $34.0M$34.0M2021+1157%2022: $3.2M$3.2M2022−91%2023: $1.2M$1.2M2023−64%2024: $0$020242025: $53.7M$53.7M2025
Operating income567894$16.9M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$109.9M-$109.9M20192020: -$130.3M-$130.3M2020+18%2021: -$95.9M-$95.9M2021−26%2022: -$133.3M-$133.3M2022+39%2023: -$48.3M-$48.3M2023−64%2024: -$66.1M-$66.1M2024+37%2025: $16.9M$16.9M2025
Net income567894$29.8M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$103.9M-$103.9M20192020: -$128.7M-$128.7M2020+24%2021: -$95.8M-$95.8M2021−26%2022: -$5.0M-$5.0M2022−95%2023: -$53.7M-$53.7M2023+974%2024: -$47.7M-$47.7M2024−11%2025: $29.8M$29.8M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Collaboration arrangement revenue$53.7M$0
Research and development$19.2M$48.1M
General and administrative$17.7M$18.0M
Total operating expenses$36.8M$66.1M
Income (loss) from operations$16.9M-$66.1M
Change in fair value of convertible notes$0$15.9M
Gain on sale of asset$11.7M$0
Other income (expense), net$1.2M$4.1M
Total other income (expense), net$12.9M$20.0M
Income (loss) before provision for income taxes and loss from equity method investment$29.8M-$46.1M
Provision for income taxes$0-$21.0K
Loss from equity method investment$0-$1.6M
Net income (loss)$29.8M-$47.7M
Net income (loss) per share- basic$2.42-$5.12
Net income (loss) per share- diluted$2.42-$6.58
Weighted-average common shares - basic12.3M shares9.3M shares
Weighted-average common shares - diluted12.3M shares9.7M shares

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Corporate structure

Q32 Bio Inc. 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 Q32 Bio Inc.

  • Q32 Bio Inc. Waltham, Massachusetts

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Q32 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$2.8M4 Dec 31, 2025$2.8M4 Dec 31, 20240%
Accumulated depreciation$1.8M4 Dec 31, 2025$1.5M4 Dec 31, 2024+26.9%
Property and equipment, net$979.0K4 Dec 31, 2025$1.4M4 Dec 31, 2024−28.5%
Operating-lease assets (leased space)$5.1M4 Dec 31, 2025$5.7M4 Dec 31, 2024−10.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$48.3M4 Dec 31, 2025$78.0M4 Dec 31, 2024−38.1%
Marketable securities, current$09 Dec 31, 2024$09 Dec 31, 2023

Properties, in its own words

Our principal office is located at 830 Winter Street, Waltham, Massachusetts 02451, where we lease approximately 15,771 square feet of office space. The lease term began in January 2022 and will end in December 2031. We believe that this facility will be adequate to meet our near-term needs. If required, we believe that suitable additional or substitute space will be available in the future on commercially reasonable terms to accommodate any such expansion of our operations.

Item 2 of the 10-K filed Mar 10, 2026.3

Leadership

Who has led Q32 Bio Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Arthur Tzianabos2018–2022
  2. Jodie Pope Morrison2024–now

President

  1. Arthur Tzianabos2018–2022
  2. Lee Kalowski2024–now

Chief financial officer

  1. Lee Kalowski2024–now

Chief operating officer

  1. Siyamak Rasty2018–2019
  2. Timothy P. Kelly2021–2022
20202025
Board members and other officers (26)

Former names

  • Homology Medicines, Inc.Jan 6, 2016 to Mar 22, 20242

Timeline

  1. Sep 30, 20268-K Regulation FD disclosure; Other events41
  2. Sep 14, 20268-K Regulation FD disclosure; Other events42
  3. Aug 5, 20268-K Results of operations43
  4. Jul 15, 20268-K Entered a material agreement44
  5. Jul 13, 20268-K Regulation FD disclosure; Other events45
  6. Jul 13, 20268-K Other events46
  7. Jun 16, 20268-K Shareholder vote47
  8. May 27, 20268-K Entered a material agreement; Unregistered sale of shares; Other events48
  9. May 5, 20268-K Results of operations49
  10. Apr 24, 20268-K Other events50
  11. Mar 27, 20268-K Entered a material agreement51
  12. Mar 10, 20268-K Results of operations52
  13. Mar 27, 2024New chief executive Jodie Pope Morrison becomes CEO12
  14. Mar 27, 2018New chief executive Arthur Tzianabos becomes CEO13

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.60) a share, on Nov 13, 2025.53

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results43
  2. May 5, 2026Reported quarterly or annual results49
  3. Mar 10, 2026Reported quarterly or annual results52
  4. Nov 13, 2025Reported quarterly or annual results54
  5. Aug 6, 2025Reported quarterly or annual results55
  6. May 8, 2025Reported quarterly or annual results56
  7. Mar 11, 2025Reported quarterly or annual results57
  8. Nov 7, 2024Reported quarterly or annual results58

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

Filings

339 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 52 major events, 153 insider forms, 34 large holders, 79 other. The latest 20:

  1. Oct 14, 20264 EDGAR
  2. Oct 14, 20264 EDGAR
  3. Oct 14, 20264 EDGAR
  4. Oct 9, 2026SCHEDULE 13G EDGAR
  5. Sep 30, 20268-K EDGAR
  6. Sep 14, 20268-K EDGAR
  7. Aug 27, 20264 EDGAR
  8. Aug 27, 20264 EDGAR
  9. Aug 27, 20264 EDGAR
  10. Aug 14, 2026SCHEDULE 13G/A EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 5, 202610-Q EDGAR
  13. Aug 5, 20268-K EDGAR
  14. Jul 31, 2026SCHEDULE 13G/A EDGAR
  15. Jul 28, 2026EFFECT EDGAR
  16. Jul 28, 2026424B3 EDGAR
  17. Jul 21, 20264/A EDGAR
  18. Jul 21, 20264/A EDGAR
  19. Jul 21, 20264/A EDGAR
  20. Jul 21, 20264/A EDGAR

The 339 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

33 open-market trades by officers, directors and large owners since October 2021: 2 buys and 31 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 25, 2026Kalowski LeeCFO and PresidentSale3,972$16.56$65.8KForm 4
Aug 25, 2026Morrison Jodie PopeCEOSale9,845$16.56$163.0KForm 4
Aug 25, 2026Violette Shelia M.Chief Scientific OfficerSale2,798$16.56$46.3KForm 4
May 28, 2026Xu DiyongDirectorBuy1,875,000$8.00$15.0MForm 4
May 28, 2026OrbiMed Capital GP VII LLCDirectorBuy1,875,000$8.00$15.0MForm 4
Feb 25, 2026Kalowski LeeCFO and PresidentSale3,995$4.51$18.0KForm 4
Feb 25, 2026Morrison Jodie PopeCEOSale9,896$4.51$44.6KForm 4
Feb 25, 2026Violette Shelia M.Chief Scientific OfficerSale2,815$4.51$12.7KForm 4
Dec 2, 2025Morrison Jodie PopeCEOSale22,506$3.46$77.9KForm 4
Dec 2, 2025Kalowski LeeCFO and PresidentSale9,072$3.46$31.4KForm 4
Aug 26, 2025Morrison Jodie PopeCEOSale10,494$1.80$18.9KForm 4
Aug 26, 2025Violette Shelia M.Chief Scientific OfficerSale2,990$1.80$5.4KForm 4
Aug 26, 2025Kalowski LeeCFO and PresidentSale4,240$1.80$7.6KForm 4
Mar 25, 2024TZIANABOS ARTHURDirectorSale265$24.20$6.4KForm 4
Mar 25, 2024Alloway PaulSee RemarksSale268$24.21$6.5KForm 4
Mar 25, 2024Michaud Charles JrSee RemarksSale75$24.20$1.8KForm 4
Jan 9, 2024TZIANABOS ARTHURDirectorSale13,037$0.57$7.4KForm 4
Jan 3, 2024Alloway PaulSee RemarksSale7,280$0.57$4.2KForm 4
Jan 3, 2024Michaud Charles JrSee RemarksSale1,708$0.57$974Form 4
Sep 6, 2023Seymour AlbertSee RemarksSale1,448$1.15$1.7KForm 4

All 33 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
2025Jodie Morrison50$645.6K$1.6M78
2025Lee Kalowski45$565.0K$987.1K78
2025Shelia ViolettePh.D.$455.0K$774.4K78
2024Chief Executive Officer and Director$627.1K$6.0M78
2024Chief Financial Officer and President$432.4K$2.9M78

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 71. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Orbimed Advisors LLC4,127,987$52.6M1.0%+1,875,000
Boxer Capital Management, LLC3,149,310$40.1M3.0%New
Atlas Venture Life Science Advisors, LLC2,717,106$34.6M3.9%+625,000
Bvf Inc/il2,350,000$29.9M0.8%New
Ra Capital Management, L.P.2,332,457$29.7M0.3%New
Point72 Asset Management, L.P.1,173,396$14.9M0.0%New
Opaleye Management Inc.931,000$11.9M1.1%−325,228
Logos Global Management LP800,000$10.2M0.4%New
SummitTX Capital, L.P.733,774$9.3M0.2%New
Vanguard Capital Management LLC518,803$6.6M0.0%+212,402
Ikarian Capital, LLC430,000$5.5M0.9%New
Woodline Partners LP286,212$3.6M0.0%New
American Century Companies Inc272,752$3.5M0.0%+253,982
Sanofi244,083$3.1M0.6%No change
Acorn Capital Advisors, LLC216,171$2.8M0.8%−98,881
Renaissance Technologies LLC179,600$2.3M0.0%−27,315
Jane Street Group, LLC162,747$2.1M0.0%+97,148
Monimus Capital Management, LP132,036$1.7M0.4%−2,274
Boothbay Fund Management, LLC130,427$1.7M0.0%New
Geode Capital Management, LLC122,690$1.6M0.0%+4,538
Citadel Advisors LLC120,663$1.5M0.0%+105,182
BlackRock, Inc.118,507$1.5M0.0%+32,360
Marshall Wace, Llp67,045$854.2K0.0%+14,605
Vanguard Fiduciary Trust Co66,217$843.6K0.0%+16,222
Carlyle Group Inc.60,363$769.0K0.0%−1,042,378

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

SEC filer profile

How Q32 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 EDGARQ32 Bio Inc.1
  • CIK0001661998
  • Employer ID (EIN)47-34681543
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address830 Winter Street, Waltham, MA 024511
  • Phone781-999-02321
  • Shares outstanding29,769,466 as of Aug 3, 202611
  • Public float$10.4M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Boston, Massachusetts, USA PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJan 6, 20161
  • Filings585 in all: 4 (238), 8-K (69), 3 (40), 10-Q (26), SC 13G/A (16), 4/A (15), SC 13G (13), 424B3 (12)1
    All 48 form types

    CORRESP (12), UPLOAD (11), EFFECT (10), SCHEDULE 13G (10), 424B5 (9), 425 (9), 10-K (8), SCHEDULE 13G/A (8), DEF 14A (7), DEFA14A (7), S-3 (5), S-8 (5), SCHEDULE 13D/A (5), SC 13D (4), SC 13D/A (4), SEC STAFF LETTER (4), ARS (3), S-1/A (3), S-4/A (3), 144 (2), 3/A (2), CT ORDER (2), D (2), DRS/A (2), DRSLTR (2), POS AM (2), S-1 (2), 10-K/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D/A (1), DRS (1), FWP (1), POS EX (1), POSASR (1), PRE 14A (1), S-3ASR (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareQTTBNASDAQ

From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Q32 Bio Inc. names in Item 1A of its 10-K filed Mar 10, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Business
  • Risks Related to Our Limited Operating History, Financial Position and Need for Capital
  • We have incurred significant losses since inception, 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.
  • 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 a limited operating history 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.
  • 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 bempikibart or other product candidates.
  • Bempikibart and the rest of our pipeline are in early 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, bempikibart, and our clinical trials of our lead 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 bempikibart or any other product candidates may be delayed.
  • 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.
The other 63 risks
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • If we encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Preliminary, “topline” 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 future collaborators may reveal significant adverse events or undesirable side effects not seen in our preclinical and/or early clinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of bempikibart or any other product candidates or result in potential product liability claims.
  • We may expend our limited resources to pursue a particular product candidate, such as bempikibart, 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 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 submit applications for regulatory authorizations 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 Intellectual Property
  • Our ability to protect our patents and other proprietary rights is uncertain, exposing it to the possible loss of competitive advantage.
  • Our rights to develop and commercialize our product candidates are, and in the future, may be subject to the terms and conditions of licenses granted to us by others. If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Our current or future license agreements may be subject to certain rights retained by third parties.
  • We cannot ensure that patent rights relating to inventions described and claimed in our current or future licensors pending patent applications will issue or that patents based on us or any of our current future licensors patent applications will not be challenged and rendered invalid and/or unenforceable.
  • We enjoy only limited geographical protection with respect to our patents and licensed patents and may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
  • Issued patents covering one or more of our product candidates could be found invalid or unenforceable.
  • Patent terms may be inadequate to protect our competitive position with respect to our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, if approved, our business may be materially harmed.
  • Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our intellectual property.
  • 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 product candidates, if approved.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • 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 be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • We may become involved in third-party claims of intellectual property infringement, misappropriation or violation, which may prevent or delay our product discovery and development efforts.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to damages resulting from claims that we or our employees or consultants have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors. These claims may be costly to defend and if we do not successfully do so, it may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
  • We may not be able to effectively secure first-tier technologies when competing against other companies or investors.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property 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.
  • Changes in funding for, or other disruptions to the operations of, the FDA, the SEC, the National Institute of Health (“NIH”), and other government agencies, including from government shutdowns could hinder our 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.
  • We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates.
  • We have and may in the future conduct clinical trials for our product candidates at sites outside the U.S., 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 bempikibart 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 bempikibart 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 U.S. tend to impose strict price controls, which may adversely affect our revenue, if any.
  • We may seek one or more designations or expedited programs for our product candidates, but may not receive such designations or be allowed to proceed on expedited program pathways, and even with the fast track designation (“FTD”) we received for bempikibart or may receive for another product candidate in the future, such designations or expedited programs may not lead to a faster development or regulatory review or approval process, and each designation does not increase the likelihood that any of our product candidates will receive regulatory approval in the U.S.
  • We may pursue orphan drug designation for certain of our product candidates, but may not be able to obtain such designation, or obtain or maintain the benefits of such designation including orphan drug exclusivity, and even if we do obtain orphan designation for our product candidates, any orphan drug exclusivity it receives may not prevent regulatory authorities from approving other competing products.
  • Risks Related to Our Third Party Relationships
  • We currently rely and expect to rely on third parties in the future to conduct our clinical trials and some aspects of our research, as well as some aspects of our delivery methods, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
  • We have collaborations and license agreements with third parties, including our existing license agreements with BMS and Colorado and expect to collaborate with third parties in the future. We may not be successful in finding strategic collaborators for continuing development of certain of our future product candidates or successfully commercializing or competing in the market for certain indications.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • We rely, and anticipate that we will rely, on third parties to assist in designing, conducting, supervising and monitoring our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • We rely on third parties in the supply and manufacture of our product candidates for our research, preclinical and clinical activities, and may do the same for commercial supplies of our product candidates.
  • Our relationships with healthcare providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and other healthcare laws and regulations, which could expose it to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
  • Risks Related to Our Business, Personnel and Operations
  • 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 computer systems, or those of any of our CROs, manufacturers, other contractors, third party service providers or consultants or potential future collaborators, may fail or suffer security incidents, data privacy breaches or other unauthorized or improper access to, use of, or destruction of our 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.
  • 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.
  • Our use of new and evolving technologies, such as artificial intelligence (“AI”), may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • 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.
  • If we are unable to attract and retain qualified key management and scientists, staff, consultants and advisors, our ability to implement our business plan may be adversely affected.
  • We expect to expand our research, development, delivery, manufacturing, commercialization, regulatory and future sales and marketing capabilities over time, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • 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, government shutdowns, geopolitical events, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.

Legal proceedings

From time to time, we may become involved in litigation relating to claims arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations or financial condition.

The opening of Item 3, Legal Proceedings.3

Sources

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