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CLYM on Nasdaq

Climb Bio, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company committed to developing potential best-in-class therapeutics that address significant unmet need for patients living with immune-mediated diseases. We are developing our product candidates for multiple immune-mediated diseases, as summarized in the pipeline figure below. We have worldwide rights to develop and commercialize budoprutug for all indications, except for oncology.”4 It is headquartered in Wellesley Hills, Massachusetts.1 Its shares trade on Nasdaq under the symbol CLYM.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCLYM on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWellesley Hills, Massachusetts1
  • Incorporated inDE2
  • Business address20 William Street, Suite G50, Wellesley Hills, Ma2
  • Filer category, Emerging growth company2
  • Legal formCorporation

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We are a clinical-stage biotechnology company committed to developing potential best-in-class therapeutics that address significant unmet need for patients living with immune-mediated diseases. We have built our pipeline by strategically acquiring or in-licensing product candidates that we believe have clear biological rationale, well-defined development pathways, and the potential to address multiple indications.4 From its latest annual report

Financials

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

Financial statements

Operating income56789-$67.9M in 2025+224% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$20.9M-$20.9M20202021: -$35.7M-$35.7M2021+70%2022: -$45.1M-$45.1M2022+27%2023: -$40.3M-$40.3M2023−11%2024: -$82.0M-$82.0M2024+104%2025: -$67.9M-$67.9M2025−17%
Net income56789-$59.9M in 2025+190% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$20.7M-$20.7M20202021: -$47.5M-$47.5M2021+130%2022: -$45.2M-$45.2M2022−5%2023: -$35.1M-$35.1M2023−22%2024: -$73.9M-$73.9M2024+110%2025: -$59.9M-$59.9M2025−19%

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
Acquired in-process research and development, related party$0$51.7M
Research and development expense$46.7M$14.3M
General and administrative$21.2M$16.0M
Total operating expenses$67.9M$82.0M
Total loss from operations-$67.9M-$82.0M
Foreign currency loss-$291.0K-$9.0K
Interest income$8.3M$8.1M
Total other income (expense)$8.0M$8.1M
Net loss per share, diluted-$0.88-$1.53
Net loss per share, basic-$0.88-$1.53
Weighted-average number of shares used to compute net loss per share, diluted67.8M shares48.2M shares
Weighted-average number of shares used to compute net loss per share, basic67.8M shares48.2M shares
Net Income (Loss)-$59.9M-$73.9M
Unrealized gain on marketable securities$412.0K$25.0K
Comprehensive loss-$59.4M-$73.9M
Income tax$0$0

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Corporate structure

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

Major holders of Climb Bio, Inc.

  • Climb Bio, Inc. Wellesley Hills, Massachusetts
    • Eliem Therapeutics (UK) Ltd. Subsidiary · United Kingdom

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Climb 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, net$288.0K9 Dec 31, 2025$199.0K9 Dec 31, 2024+44.7%
Operating-lease assets (leased space)$505.0K9 Dec 31, 2025$490.0K9 Dec 31, 2024+3.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.7M9 Dec 31, 2025$87.2M9 Dec 31, 2024−59.1%
Marketable securities, current$65.4M9 Dec 31, 2025$63.7M9 Dec 31, 2024+2.7%
Marketable securities, non-current$59.6M9 Dec 31, 2025$61.6M9 Dec 31, 2024−3.3%

Properties, in its own words

We lease approximately 5,728 square feet of office space for our company headquarters in Wellesley Hills, Massachusetts under a non-cancelable operating lease, as amended, that expires in December 2026, with an option to extend for an additional 12 months. We believe that our facility arrangement is sufficient for our current needs.

Item 2 of the 10-K filed Mar 5, 2026.4

Leadership

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

Chief executive

  1. Robert Azelby2021–2022
  2. Aoife Brennan2024–now

Chair

  1. Andrew David Levin2023–2024

President

  1. Robert Azelby2022
  2. Aoife Brennan2024–now

Chief financial officer

  1. Erin Lavelle2021–2022
  2. Susan Altschuller2025–now

Chief operating officer

  1. Erin Lavelle2021–2022
  2. Brett Kaplan2024–2025
2025
Board members and other officers (19)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorAlexander (Bo) Combo named May 4, 202635
  • DirectorJudith Dunn named Jul 2, 2024 to May 4, 202635

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Eliem Therapeutics (UK) Ltd. England and Wales3

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

Former names

  • Eliem Therapeutics, Inc.Feb 19, 2019 to Sep 20, 20242

Timeline

  1. Sep 3, 20268-K Regulation FD disclosure36
  2. Aug 14, 20268-K Other events37
  3. Aug 6, 20268-K Results of operations38
  4. Jul 1, 20268-K Executive or director change39
  5. Jun 12, 20268-K Entered a material agreement; Other events40
  6. Jun 11, 20268-K Other events41
  7. Jun 8, 20268-K Executive or director change; Shareholder vote42
  8. Jun 5, 20268-K Other events43
  9. May 7, 20268-K Results of operations44
  10. May 5, 20268-K Regulation FD disclosure45
  11. Apr 28, 20268-K Entered a material agreement; Unregistered sale of shares; Other events46
  12. Apr 3, 20268-K Executive or director change47
  13. Jun 27, 2024New chief executive Aoife Brennan becomes CEO12
  14. Aug 9, 2021New chief executive Robert Azelby becomes CEO13

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.19) a share, on Nov 6, 2025.48

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 7, 2026Reported quarterly or annual results44
  3. Mar 5, 2026Reported quarterly or annual results49
  4. Nov 6, 2025Reported quarterly or annual results50
  5. Aug 12, 2025Reported quarterly or annual results51
  6. May 14, 2025Reported quarterly or annual results52
  7. Mar 25, 2025Reported quarterly or annual results53
  8. Jan 10, 2025Reported quarterly or annual results54

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

Filings

260 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 60 major events, 100 insider forms, 32 large holders, 3 private raises, 44 other. The latest 20:

  1. Sep 30, 20264 EDGAR
  2. Sep 17, 20264 EDGAR
  3. Sep 15, 2026144 EDGAR
  4. Sep 3, 20268-K EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 20268-K EDGAR
  7. Aug 6, 202610-Q EDGAR
  8. Aug 6, 20268-K EDGAR
  9. Jul 8, 2026SCHEDULE 13G EDGAR
  10. Jul 7, 2026SCHEDULE 13D/A EDGAR
  11. Jul 1, 20264 EDGAR
  12. Jul 1, 20264 EDGAR
  13. Jul 1, 20263 EDGAR
  14. Jul 1, 20268-K EDGAR
  15. Jun 30, 20264 EDGAR
  16. Jun 30, 2026144 EDGAR
  17. Jun 12, 20268-K EDGAR
  18. Jun 12, 2026424B5 EDGAR
  19. Jun 11, 20268-K EDGAR
  20. Jun 9, 2026EFFECT EDGAR

The 260 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

28 open-market trades by officers, directors and large owners since October 2021: 4 buys and 24 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026Thomas Stephen BasilDirectorSale100,000$13.67$1.4MForm 4
Jun 29, 2026Brennan AoifePresident and CEOSale30,902$13.17$407.0KForm 4
Feb 26, 2026Thomas Stephen BasilDirectorSale16,313$7.01$114.4KForm 4
Feb 25, 2026Thomas Stephen BasilDirectorSale33,687$7.00$235.8KForm 4
Feb 13, 2026Thomas Stephen BasilDirectorSale10,000$5.81$58.1KForm 4
Feb 12, 2026Thomas Stephen BasilDirectorSale90,000$5.23$470.7KForm 4
Jan 5, 2026RA Capital Healthcare Fund LPDirectorBuy7,111$3.50$24.9KForm 4
Dec 12, 2025Kolchinsky PeterDirectorBuy101,462$2.86$290.2KForm 4
Dec 11, 2025Kolchinsky PeterDirectorBuy213,099$2.18$464.6KForm 4
Jun 30, 2025Brennan AoifePresident and CEOSale20,618$1.22$25.2KForm 4
Jun 20, 2025Pimblett EmilySVP, Finance & CAOSale1,242$1.24$1.5KForm 4
Mar 20, 2025Pimblett EmilySVP, Finance & CAOSale1,199$1.31$1.6KForm 4
Dec 19, 2024Pimblett EmilySVP, Finance & CAOSale1,235$2.02$2.5KForm 4
Sep 20, 2024Pimblett EmilySVP, Finance & CAOSale1,191$8.18$9.7KForm 4
Jul 22, 2024Morisset ValerieEVP, R&D AND CSOSale69,005$8.03$554.2KForm 4
Jul 19, 2024Morisset ValerieEVP, R&D AND CSOSale60,201$7.21$434.3KForm 4
Jul 18, 2024Morisset ValerieEVP, R&D AND CSOSale38,576$6.93$267.3KForm 4
Jul 17, 2024Morisset ValerieEVP, R&D AND CSOSale3,207$6.91$22.2KForm 4
Jul 16, 2024Morisset ValerieEVP, R&D AND CSOSale50,000$7.13$356.5KForm 4
Jul 15, 2024Morisset ValerieEVP, R&D AND CSOSale42,377$7.01$297.1KForm 4

All 28 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
2025Aoife BrennanM.B., Ch B.$669.5K$2.9M66
2025Chief BusinessOfficer$406.9K$1.5M66
2025Brett KaplanM.D.$223.6K$1.2M66
2025Chief FinancialOfficer$127.5K$1.2M66
2024President and Chief Executive Officer$330.0K$6.0M66
2024Former ChiefOperating Officer$176.3K$3.0M66

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Apr 29, 2026Raised $110.1 million in a private offering of equity Form D: 22 investors so far Form D
  2. Jun 27, 2024Raised $41.9 million in a private offering of equity Form D: 6 investors so far Form D
  3. Jun 27, 2024Raised $120 million in a private offering of equity Form D: 8 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
Ra Capital Management, L.P.11,300,939$147.4M1.3%No change
Fmr LLC6,790,364$88.5M0.0%+6,783,967
UBS Group AG3,404,866$44.4M0.0%+3,318,921
Braidwell LP2,797,375$36.5M1.4%+1,267,700
Adage Capital Partners Gp, L.l.c.2,506,000$32.7M0.0%New
BlackRock, Inc.2,354,872$30.7M0.0%+1,953,223
Cormorant Asset Management, LP2,106,000$27.5M1.4%New
Frontier Capital Management Co LLC1,939,019$25.3M0.2%New
Vanguard Capital Management LLC1,698,654$22.2M0.0%+519,995
Woodline Partners LP1,582,291$20.6M0.1%New
Citadel Advisors LLC1,297,972$16.9M0.0%+952,309
Redmile Group, LLC1,226,330$16.0M1.1%New
Great Point Partners LLC1,000,000$13.0M3.1%−334,130
Affinity Asset Advisors, LLC972,000$12.7M0.6%+272,000
Millennium Management LLC908,198$11.8M0.0%−368,062
ADAR1 Capital Management, LLC822,649$10.7M0.5%+224,987
Driehaus Capital Management LLC790,000$10.3M0.1%+189,054
Geode Capital Management, LLC782,199$10.2M0.0%+469,200
Stempoint Capital LP742,745$9.7M1.7%New
State Street Corp686,772$9.0M0.0%+554,772
Ameriprise Financial Inc657,971$8.6M0.0%New
Parkman Healthcare Partners LLC563,484$7.3M0.8%New
Superstring Capital Management LP521,082$6.8M4.3%+321,873
Sphera Funds Management Ltd.483,747$6.3M0.9%+64,500
Invesco Ltd.373,445$4.9M0.0%New

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

SEC filer profile

How Climb 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 EDGARClimb Bio, Inc.1
  • CIK0001768446
  • Employer ID (EIN)83-22737414
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address20 William Street, Suite G50, Wellesley Hills, MA1
  • Phone1-866-857-25961
  • Shares outstanding57,436,255 as of Jul 31, 202611
  • Public float$44.8M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Seattle, Washington PCAOB ID 238; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 19, 20191
  • Filings317 in all: 4 (96), 8-K (62), 3 (23), 10-Q (16), CORRESP (10), SC 13D/A (10), DEFA14A (8), D (7)1
    All 40 form types

    SC 13G/A (7), S-8 (6), UPLOAD (6), 10-K (5), SC 13G (5), SCHEDULE 13D/A (5), 144 (4), ARS (4), DEF 14A (4), EFFECT (4), S-1/A (4), S-3 (3), SCHEDULE 13G (3), 424B3 (2), 424B5 (2), DRS/A (2), DRSLTR (2), SC 13D (2), SCHEDULE 13G/A (2), 10-K/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D/A (1), DEFM14A (1), DRS (1), FWP (1), PRE 14A (1), PREM14A (1), S-1 (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Sep 3, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareCLYMThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Climb Bio, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 70 risks under these headings, as written.4

  • Risks Related to our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception, expect to continue to incur substantial losses for the foreseeable future and may never achieve or sustain profitability.
  • If we are unable to access capital when needed, it could force us to delay, reduce or terminate our product candidate development programs, commercialization efforts, or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or our product candidates.
  • We currently have no source of product revenue and may never become profitable.
  • We may be required to make significant payments in connection with our license agreements, which could strain our capital resources.
  • Risks Related to our Business and the Development of our Product Candidates
  • Our future success is dependent on the regulatory approval and commercialization of our product candidates, and if we are unable to successfully develop and commercialize our product candidates, or experience any delay in doing so, our business could be materially harmed.
  • Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
  • Preliminary, initial, or interim results from clinical trials that we announce, present, or publish from time to time may change as more data and information become available (or are updated based upon audit, validation and verification procedures of the data/information commonly performed for clinical trials) that could result in material changes in the final trial results.
  • Nonclinical and clinical development involves a lengthy, complex and expensive process with an uncertain outcome. The outcome of nonclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities. Further, clinical development in immunology and autoimmune diseases presents inherent challenges, which may delay or impair our ability to demonstrate clinical benefit and obtain regulatory approval for our product candidates.
  • Our product candidates may cause adverse events or undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
The other 60 risks
  • If we encounter difficulties enrolling or retaining patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • We could be subject to product liability lawsuits based on the use of our product candidates in clinical testing or, if obtained, following any such product’s marketing approval and commercialization. Product liability lawsuits brought against us or any of our future collaborators could divert our resources and attention, require us to cease clinical testing, cause us to incur substantial liabilities or limit commercialization of our product candidates.
  • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, less expensive or more advanced or effective than us, which may harm our financial condition and our ability to successfully market or commercialize our product candidates.
  • Drug development is highly uncertain, and if we are unable to successfully develop and commercialize our product candidates, or experience significant delays in doing so, our business may be harmed.
  • Our estimates of market opportunity and forecasts of market growth for our product candidates 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 have no experience in sales, marketing and distribution and may have to enter into agreements with third parties to perform these functions, which could prevent us from successfully commercializing our product candidates.
  • 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 and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Risks Related to Legal and Regulatory Compliance
  • Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialize our product candidates, if and when approved, and may affect the prices we may charge for such product candidates, if and when approved.
  • Our business operations and current and future relationships with investigators, health care professionals, consultants, third-party payors and customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation, including class claims, and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations in the U.S., and PRIority MEdicines (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 our 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.
  • We have received orphan drug designation for budoprutug for the treatment of pMN, but we may be unable to realize the benefits associated with orphan drug designation, including market exclusivity.
  • If approved, our product candidates regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • We conduct clinical trials at sites outside the U.S. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the U.S. could subject us to additional delays and expense.
  • Our failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our product candidates outside the U.S.
  • Risks Related to our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our nonclinical 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 contract with third parties, including single-source manufacturers, for the manufacture of materials and expect to continue to do so for the development and, if approved, commercialization of our product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities of such materials or that such supply will not be available to us at an acceptable cost or timelines, which could delay, prevent, or impair our development or commercialization efforts.
  • If we or any contract manufacturers 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 may not have access to the raw materials and other components necessary for the manufacturing of our product candidates.
  • If we are not able to establish future collaborations, we may have to alter some of our future development and commercialization plans.
  • Changes in and uncertainty surrounding U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • Risks Related to Intellectual Property
  • We rely heavily on certain in-licensed patents and other intellectual property rights in connection with our development of our product candidates and may be required to acquire or license additional patents or other intellectual property rights to continue to develop and commercialize our product candidates.
  • The patent protection we obtain for budoprutug, CLYM116 or any other product candidates and technologies may be challenged and rendered invalid or unenforceable.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents covering our technology and product candidates could be found invalid or unenforceable if challenged.
  • We may not be able to protect our intellectual property rights throughout the world.
  • 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 we fail to comply with our obligations in the agreements under which we license intellectual property rights from our licensors, otherwise experience disruption to our business relationships with our licensors, or we are unable to obtain licenses from other third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, we could lose license rights that our important to our business and our business could be harmed.
  • Patent terms may be inadequate to protect our competitive position on budoprutug, CLYM116 or any other product candidates for an adequate amount of time.
  • Changes in patent law could diminish the value of our patents, thereby impairing our ability to protect our intellectual property for budoprutug, CLYM116 or any other product candidates.
  • Obtaining and maintaining 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.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.
  • We may be subject to claims by third parties asserting that we or our employees have infringed upon, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to our Business Operations and Employee Matters
  • If our information technology systems or data, or those of third parties upon which we rely, such as CROs, are or were compromised or interrupted, we could experience adverse consequences resulting from such compromise or interruption, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the U.S.
  • We may not be able to utilize a significant portion of our net operating loss carryforwards.
  • We have and may continue to seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the licensing of products or technologies from third parties or through other strategic alliances, and the failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business, could have a material adverse effect on our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • Risks Related to our Common Stock
  • The trading price of our common stock has been and may continue to be volatile, and purchasers of our common stock could incur substantial losses.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.
  • We have broad discretion in the use of our cash, cash equivalents and marketable securities and may not use them effectively.
  • A significant portion of our common stock may be sold into the market, which could cause the market price of our common stock to drop significantly.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders, including affiliates of RA Capital Management L.P., may limit or prevent new investors from influencing significant corporate decisions and also reduces the public float for our common stock, which could make our common stock less attractive to some investors or otherwise harm our stock price.
  • We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business.
  • 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 amended and restated certificate of incorporation designates the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America as the exclusive forums for substantially all disputes between us and our stockholders, which restricts our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or employees.
  • General Risk Factors
  • We are, have been, and may in the future become, involved in litigation that could result in significant costs, divert the attention of management and harm our business.
  • If equity research analysts publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • Unfavorable global economic conditions could adversely affect our business, financial condition, stock price, and results of operations.
  • We are an “emerging growth company” and a “smaller reporting company,” and as a result of the reduced reporting requirements applicable to “emerging growth companies” and “smaller reporting companies,” our common stock may be less attractive to investors.
  • We may be unable to maintain adequate insurance coverage.
  • Changes in tax laws or regulations that are applied adversely to us may seriously harm our business.

Legal proceedings

Information with respect to legal proceedings is included in Note 8 of the Notes to Consolidated Financial Statements contained in Part II, Item 8 of this Annual Report on Form 10-K, which is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.4

Sources

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