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XLO on Nasdaq

Xilio Therapeutics, Inc.

American pharmaceutical preparations company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company discovering and developing masked immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer. Our integrated biology and protein engineering approach enables us to design and develop highly potent, masked biologics that are activated, or unmasked, by tumor-specific proteases within the tumor microenvironment.”11 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol XLO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerXLO on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address828 Winter Street, Waltham, Ma 024512
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2

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Financials

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

Key numbers, fiscal 2025

-95.9%Operating margin3
-80.1%Net margin3
589.9%Revenue growth, 20253
-99.3%Return on equity3
-$5.5MFree cash flow3

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$56.0M

Out of $43.8M in revenue.3 The company lost money this year.

Financial statements

Revenue3$43.8M in 2025+590% since 2024
0$20.0M$40.0M$60.0M2024: $6.3M$6.3M20242025: $43.8M$43.8M2025+590%
Operating income45673-$42.0M in 2025−23% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$54.6M-$54.6M20202021: -$75.0M-$75.0M2021+38%2022: -$89.1M-$89.1M2022+19%2023: -$79.1M-$79.1M2023−11%2024: -$60.6M-$60.6M2024−23%2025: -$42.0M-$42.0M2025−31%
Net income45673-$35.0M in 2025−37% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$55.2M-$55.2M20202021: -$75.8M-$75.8M2021+37%2022: -$88.2M-$88.2M2022+16%2023: -$76.4M-$76.4M2023−13%2024: -$58.2M-$58.2M2024−24%2025: -$35.0M-$35.0M2025−40%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2025-12-312024-12-31
Total Revenue$43.8M$6.3M
Research and development$56.0M$41.2M
General and administrative$29.7M$24.8M
Restructuring$937.0K
Total operating expenses$85.7M$66.9M
Loss from operations-$42.0M-$60.6M
Change in fair value of common stock warrant liabilities$5.8M
Other income, net$1.1M$2.3M
Total other income, net$6.9M$2.3M
Net loss and comprehensive loss-$35.0M-$58.2M
Net loss per share, basic (in dollars per share)-$4.19-$15.24
Net loss per share, diluted (in dollars per share)-$4.19-$15.24
Weighted average common shares outstanding, basic (in shares)8.4M shares3.8M shares
Weighted average common shares outstanding, diluted (in shares)8.4M shares3.8M shares

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Corporate structure

Xilio Therapeutics, 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 Xilio Therapeutics, Inc.

  • Xilio Therapeutics, 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 Xilio Therapeutics, 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$12.6M3 Dec 31, 2025$11.9M3 Dec 31, 2024+6.3%
Accumulated depreciation$8.8M3 Dec 31, 2025$7.4M3 Dec 31, 2024+17.9%
Property and equipment, net$3.9M3 Dec 31, 2025$4.5M3 Dec 31, 2024−13.0%
Operating-lease assets (leased space)$4.0M3 Dec 31, 2025$4.6M3 Dec 31, 2024−13.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$137.5M3 Dec 31, 2025$55.3M3 Dec 31, 2024+148.7%

Properties, in its own words

We occupy approximately 28,000 square feet of office and laboratory space in Waltham, Massachusetts under a lease that expires in March 2030 with an option to renew for an additional five years. We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Mar 23, 2026.11

Leadership

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

Chief executive

  1. Rene Russo2021–now

President

  1. Martin H. Huber Jr.2021–2023
  2. Rene Russo2021–now

Chief financial officer

  1. Salvatore Giovine2021–2022
  2. Christopher James Frankenfield2025–now

Chief operating officer

  1. Christopher James Frankenfield2023–2024
2025
Board members and other officers (13)

Timeline

  1. Aug 12, 20268-K Results of operations29
  2. Jun 12, 20268-K Executive or director change; Shareholder vote30
  3. May 12, 20268-K Results of operations31
  4. Apr 16, 20268-K Executive or director change32
  5. Mar 23, 20268-K Results of operations33
  6. Mar 12, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed34
  7. Mar 9, 20268-K Regulation FD disclosure35
  8. Feb 24, 20268-K Shareholder vote36
  9. Feb 12, 20268-K Entered a material agreement; Regulation FD disclosure37
  10. Jan 8, 20268-K Results of operations; Executive or director change38
  11. Jan 5, 20268-K Regulation FD disclosure39
  12. Nov 25, 20258-K Executive or director change; Shareholder vote40
  13. Oct 21, 2021New chief executive Rene Russo becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/202641

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results29
  2. May 12, 2026Reported quarterly or annual results31
  3. Mar 23, 2026Reported quarterly or annual results33
  4. Jan 8, 2026Reported quarterly or annual results38
  5. Nov 13, 2025Reported quarterly or annual results42
  6. Aug 14, 2025Reported quarterly or annual results43
  7. May 8, 2025Reported quarterly or annual results44
  8. Mar 11, 2025Reported quarterly or annual results45

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

Filings

349 filings to the SEC since October 2021: 6 annual reports, 17 quarterly reports, 65 major events, 150 insider forms, 47 large holders, 64 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20263 EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 12, 2026S-8 EDGAR
  5. Aug 12, 202610-Q EDGAR
  6. Aug 12, 20268-K EDGAR
  7. Jun 12, 20264 EDGAR
  8. Jun 12, 20264 EDGAR
  9. Jun 12, 20264 EDGAR
  10. Jun 12, 20264 EDGAR
  11. Jun 12, 20264 EDGAR
  12. Jun 12, 20264 EDGAR
  13. Jun 12, 20264 EDGAR
  14. Jun 12, 20268-K EDGAR
  15. May 29, 2026EFFECT EDGAR
  16. May 27, 2026CORRESP EDGAR
  17. May 27, 2026S-3/A EDGAR
  18. May 18, 2026UPLOAD EDGAR
  19. May 15, 2026SCHEDULE 13G/A EDGAR
  20. May 15, 2026SCHEDULE 13G EDGAR

The 349 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

22 open-market trades by officers, directors and large owners since October 2021: 15 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 26, 2026Shannon James SamuelDirectorBuy5,000$8.79$44.0KForm 4
Jan 2, 2026Brennan Kevin M.SVP, FINANCE AND ACCOUNTINGSale1,826$0.64$1.2KForm 4
Jan 2, 2026Frankenfield Christopher JamesChief Financial OfficerSale7,030$0.64$4.5KForm 4
Jun 17, 2025Shannon James SamuelDirectorBuy25,000$0.69$17.2KForm 4
Jun 16, 2025Shannon James SamuelDirectorBuy45,000$0.69$31.1KForm 4
Jun 16, 2025Russo RenePRESIDENT AND CEOBuy36,289$0.68$24.7KForm 4
Jan 2, 2025Frankenfield Christopher JamesChief Financial OfficerSale6,954$0.98$6.8KForm 4
Jan 2, 2025Brennan Kevin M.SVP, FINANCE AND ACCOUNTINGSale1,803$0.98$1.8KForm 4
Dec 18, 2024GILEAD SCIENCES, INC.10% ownerBuy1,759,978$1.04$1.8MForm 4
Apr 2, 2024GILEAD SCIENCES, INC.10% ownerBuy485,250$0.76$368.8KForm 4
Feb 8, 2024Atlas Venture Fund XI, L.P.10% ownerSale1,000$0.64$640Form 4
Jan 12, 2024Atlas Venture Associates Opportunity I, L.P.10% ownerSale2,100$0.83$1.7KForm 4
Jan 11, 2024Atlas Venture Associates Opportunity I, L.P.10% ownerSale2,135$0.87$1.9KForm 4
Dec 10, 2021BCIP Life Sciences Associates, LP10% ownerBuy25,000$9.65$241.2KForm 4
Dec 9, 2021BCIP Life Sciences Associates, LP10% ownerBuy4,011$9.84$39.5KForm 4
Dec 8, 2021BCIP Life Sciences Associates, LP10% ownerBuy13,458$9.62$129.5KForm 4
Oct 26, 2021Deerfield Mgmt L.P.Buy775,000$16.00$12.4MForm 4
Oct 26, 2021Rock Springs Capital Master Fund LP10% ownerBuy500,000$16.00$8.0MForm 4
Oct 26, 2021BAY CITY CAPITAL LLC10% ownerBuy312,500$16.00$5.0MForm 4
Oct 26, 2021Atlas Venture Opportunity Fund I, L.P.10% ownerBuy187,500$16.00$3.0MForm 4

All 22 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
2025René RussoPharm.D.$643.7K$6.5M66
2025Christopher Frankenfield44$533.1K$3.2M66
2025Katarina LuptakovaM.D.50$481.3K$2.2M66
2024President and Chief Executive Officer$613.9K$1.5M66
2024Chief Financial and Operating Officer$506.1K$1.0M66
2024Chief Medical Officer$465.0K$746.9K66

Held by these funds

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

FundSharesValueShare of the fundChange
Bain Capital Life Sciences Investors, LLC664,021$6.4M0.4%No change
Orbimed Advisors LLC592,300$5.7M0.1%New
Frazier Life Sciences Management, L.P.422,505$4.0M0.1%No change
Stonepine Capital Management, LLC225,994$2.2M1.6%+161,832
Vanguard Capital Management LLC178,517$1.7M0.0%+54,857
Sio Capital Management, LLC152,464$1.5M0.3%No change
Adage Capital Partners Gp, L.l.c.111,541$1.1M0.0%New
Merck & Co., Inc.105,982$1.0M0.2%No change
Renaissance Technologies LLC64,153$614.6K0.0%+14,587
Morgan Stanley56,954$545.6K0.0%−539
Geode Capital Management, LLC39,055$374.2K0.0%+1,858
Citadel Advisors LLC25,950$248.6K0.0%New
Vanguard Fiduciary Trust Co22,594$216.5K0.0%−5,881
Bridgeway Capital Management, LLC17,544$168.1K0.0%New
Two Sigma Investments, LP14,544$139.3K0.0%New
Velan Capital Investment Management LP14,285$136.8K0.1%No change
State Street Corp13,311$127.5K0.0%No change
Prelude Capital Management, LLC11,600$111.1K0.0%New
BlackRock, Inc.8,757$83.9K0.0%New
Steward Partners Investment Advisory, LLC714$6.8K0.0%New
Barclays PLC115$1.1K0.0%New
Key Financial Inc59$5650.0%No change
Jones Financial Companies Lllp29$2620.0%New
UBS Group AG14$1340.0%−4,024
Gsa Capital Partners Llp13,590$1300.0%−3,356

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

SEC filer profile

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

  • Name on EDGARXilio Therapeutics, Inc.1
  • CIK0001840233
  • Employer ID (EIN)85-162339711
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company11
  • Incorporated inDelaware11
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address828 Winter Street, Waltham, MA 024511
  • Phone617-833-10271
  • Shares outstanding5,782,511 shares as of Mar 18, 202611
  • Public float$34.9M as of Jun 30, 202511
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting11
  • On EDGAR sinceJan 21, 20211
  • Filings357 in all: 4 (106), 8-K (65), 3 (40), 10-Q (15), SC 13G/A (15), SCHEDULE 13G/A (12), SC 13G (11), CORRESP (8)1
    All 34 form types

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

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareXLONasdaq

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).11

Risk factors and legal proceedings

The risks Xilio Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 80 risks under these headings, as written.11

  • We will need to obtain substantial additional capital in the future to finance our operations and complete the development of any current or future product candidates.
  • If we fail to regain and maintain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
  • The recently implemented reverse stock split of our common stock may not achieve the intended benefits and could have a materially adverse effect on the market price of our common stock.
  • We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
  • Raising additional capital in the future may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology. In addition, the issuance of shares of common stock upon the exercise of our outstanding prefunded warrants or common stock warrants will result in immediate and substantial dilution to our existing stockholders.
  • We have no products approved for commercial sale and have not generated any revenue from product sales. We may never generate any revenue from product sales or become profitable and, if we achieve profitability, we may not be able to sustain it.
  • Our limited operating history may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Our business is highly dependent on the success of our current product candidates, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and commercially launch a product.
  • Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
  • Preclinical studies and clinical trials are expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials.
  • We may encounter substantial delays in the commencement or completion, or termination or suspension, of our clinical trials, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
The other 68 risks
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Our product candidates may cause undesirable or unexpectedly severe side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We expect to develop certain of our product candidates in combination with third-party drugs and we will have limited or no control over the safety, supply, regulatory status or regulatory approval of such third-party drugs.
  • We may not be successful in our efforts to use our platform technology to enable the development of a pipeline of masked I-O product candidates.
  • We may not be successful in our efforts to identify or discover additional product candidates.
  • Our approach to the discovery and development of product candidates based on our technological approaches is unproven, and we do not know whether we will be able to develop any products of commercial value.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or following commercial sale, and any product liability insurance we may obtain may not cover all damages from such claims.
  • Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our development or commercialization programs.
  • If we or any CDMO with which we contract for manufacturing and supply fails to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, a clinical hold, refusal to approve a pending application for a new drug product or biologic product, revocation of a pre-existing approval, or an import alert. As a result, our business, financial condition and results of operations may be materially harmed.
  • Certain of our research and development and manufacturing activities take place in China through WuXi Biologics. A significant disruption in our ability to rely on WuXi Biologics could materially adversely affect our business, financial condition and results of operations.
  • If we or any CDMOs and suppliers we engage 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 expect to rely on third parties to conduct, supervise and monitor IND-enabling studies and clinical trials, and to perform other functions for us, and if these third parties perform in an unsatisfactory manner, it may harm our business, reputation and results of operations.
  • We have entered into, and may in the future seek to enter into, licenses, collaborations or similar arrangements with third parties for the research, development and commercialization of certain of our current or future product candidates. If any such arrangements are not successful, we may not be able to capitalize on the market potential of those product candidates.
  • If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize any products that receive regulatory approval, either on our own or together with collaborators.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of any of our product candidates may be delayed, and our business could be harmed.
  • If approved, our product candidates that are licensed and regulated as biological products, or biologics, may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • The sizes of the potential markets for our product candidates are difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
  • The successful commercialization of our product candidates will depend in part on the extent to which we obtain and maintain favorable insurance coverage, adequate reimbursement levels and cost-effective pricing policies with third-party payors.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community necessary for commercial success.
  • If we are unable to obtain and maintain patent protection for any product candidates we develop or for other proprietary technologies we may develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates and technology similar or identical to our product candidates and technology, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
  • 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 for non-compliance with these requirements.
  • Issued patents covering our product candidates or technology could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes to patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • We rely on in-license agreements for patent rights with respect to our product candidates and may in the future acquire or in-license additional third-party intellectual property rights on which we may similarly rely. We face risks with respect to such reliance, including the risk that we could lose these rights that are important to our business if we fail to comply with our obligations under these licenses or that we may be unable to acquire or in-license third-party intellectual property that may be necessary or important to our business operations.
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies and product candidates are not adequate, we may not be able to compete effectively in our market.
  • Our proprietary position depends upon patents that are manufacturing, formulation or method-of-use patents, which may not prevent a competitor or other third party from designing around or using the same product candidate for another use.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement or violations may prevent or delay our discovery and development efforts.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • In the future, we may in-license intellectual property that may have been discovered through government funded programs and thus may be subject to federal regulations and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • If we do not obtain patent term extension for any of our current or future product candidates, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we will obtain marketing approval to commercialize a product candidate.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program, progress development efficiently, and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we may be granted for our product candidates in the U.S. would not assure approval of our product candidates in foreign jurisdictions and any of our product candidates that may be approved for marketing in a foreign jurisdiction will be subject to risks associated with foreign operations.
  • We may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing products.
  • Any product candidate for which we obtain marketing approval is subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved.
  • Any regulatory approval to market any of our products candidates for which we obtain approval will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of any of our product candidates for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations in the U.S. and PRIME Designation in the EU, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • Accelerated approval by the FDA, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions.
  • Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing, and that could materially impact our ability to generate revenues.
  • We may be subject to certain healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations, and diminished future profits and earnings, if any.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • We are subject to U.S. and certain foreign export control, import, sanctions, anti-corruption, and anti-money laundering laws and regulations with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
  • Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results.
  • 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 harm our business.
  • Our employees, independent contractors, CROs, consultants, commercial partners, vendors and principal investigators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • We depend on our information technology systems and those of our third-party service providers, and any failure of these systems could harm our business. Security breaches, loss of data, inability to access systems, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability or competitive or reputational harm, which could adversely affect our business, results of operations and financial condition.
  • A variety of risks associated with marketing our product candidates internationally, if approved, could materially adversely affect our business.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a catastrophic event, such as a terrorist attack, war or other armed conflict, geopolitical tensions or trade wars, pandemic or natural disaster.
  • Our common stock may be subject to a low trading volume and volatile market price related or unrelated to our operations and purchasers of our common stock could have difficulty selling their shares or could suffer a decline in value.
  • If securities or industry analysts do not publish research or reports about our company, or if they issue unfavorable or inaccurate research regarding our business, or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline.
  • Unstable global economic and political conditions, including economic uncertainty tied to interest rates and heightened inflation, credit and financial market instability, and uncertainty related to ongoing geopolitical conflicts, could adversely affect our business, financial condition, stock price and ability to raise capital.
  • Our principal stockholders and management own a significant percentage of our common stock and exert significant control over matters subject to stockholder approval.
  • We have broad discretion regarding use of our cash and cash equivalents, and we may not use them effectively.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are currently not a party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.11

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