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RLYB on Nasdaq

Rallybio

Logo: rallybio.com4

American biotechnology company based in New Haven1

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company comprised of experienced biopharma industry leaders with extensive research, development, and rare disease expertise with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Our lead program, RLYB116, is a differentiated complement component 5 inhibitor with the potential to treat diseases of complement dysregulation.”6

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Last updated Oct 21, 2026.

Overview

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  • TickerRLYB on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersNew Haven1
  • Websiterallybio.com
  • Incorporated inDE5
  • Business address234 Church Street, Suite 1020, New Haven, Ct 065105
  • Filer category, Emerging growth company5
  • Legal formCorporation3
  • LEI254900OR8EZO4FXWJY123
  • StatusActive3
  • LEI statusIssued and current3
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 79655103

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Rallybio image from its website
Image: rallybio.com4

We are a clinical-stage biotechnology company comprised of experienced biopharma industry leaders with extensive research, development, and rare disease expertise with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Our lead program, RLYB116, is a differentiated complement component 5 (“C5”) inhibitor with the potential to treat diseases of complement dysregulation. In addition, RLYB332, a long-acting matriptase-2 ("MTP-2") antibody for the treatment of diseases of iron overload, is currently in preclinical development.6 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

-3853.6%Operating margin7
-1046.4%Net margin7
34.9%Revenue growth, 20257
-15.5%Return on equity7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Collaboration And License Revenue brought in 52% of the revenue Rallybio broke down this way in fiscal 2025.

  1. Collaboration And License Revenue$858.0K752%up 35% from 2024
  2. License$800.0K748%up 33% from 2024
Products and services by year
Products and services20242025
Collaboration And License Revenue$636.0K$858.0K
License$600.0K$800.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$19.6M

Out of $858.0K in revenue.7 The company lost money this year.

Financial statements

Revenue7$858.0K in 2025+35% since 2024
0$250.0K$500.0K$750.0K$1.0M2024: $636.0K$636.0K20242025: $858.0K$858.0K2025+35%
Operating income8910117-$33.1M in 2025+31% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$25.3M-$25.3M20202021: -$45.6M-$45.6M2021+80%2022: -$67.9M-$67.9M2022+49%2023: -$78.9M-$78.9M2023+16%2024: -$60.5M-$60.5M2024−23%2025: -$33.1M-$33.1M2025−45%
Net income8910117-$9.0M in 2025−66% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$26.4M-$26.4M20202021: -$47.0M-$47.0M2021+78%2022: -$66.7M-$66.7M2022+42%2023: -$74.6M-$74.6M2023+12%2024: -$57.8M-$57.8M2024−23%2025: -$9.0M-$9.0M2025−84%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Total revenue$858.0K$636.0K
Research and development$19.6M$41.5M
General and administrative$14.3M$19.6M
Total operating expenses$33.9M$61.1M
Loss from operations-$33.1M-$60.5M
Interest income$2.2M$4.2M
Gain on sale of joint venture and other income$22.8M$744.0K
Total other income, net$25.0M$5.0M
Loss before equity in losses of joint venture-$8.1M-$55.5M
Loss on investment in joint venture$874.0K$2.2M
Net loss-$9.0M-$57.8M
Net loss per common share, basic (in dollars per share)-$1.59-$10.61
Net loss per common share, diluted (in dollars per share)-$1.59-$10.61
Weighted-average common shares outstanding, basic (in shares)5.6M shares5.4M shares
Weighted-average common shares outstanding, diluted (in shares)5.6M shares5.4M shares
Net unrealized (loss) gain on marketable securities-$50.0K$53.0K
Other comprehensive (loss) gain-$50.0K$53.0K
Comprehensive loss-$9.0M-$57.7M

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Corporate structure

Rallybio 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 Rallybio

  • Rallybio Wilmington, Delaware, United States

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

What it owns

What Rallybio 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$503.0K7 Dec 31, 2025$769.0K7 Dec 31, 2024−34.6%
Accumulated depreciation$480.0K7 Dec 31, 2025$654.0K7 Dec 31, 2024−26.6%
Property and equipment, net$23.0K7 Dec 31, 2025$115.0K7 Dec 31, 2024−80.0%
Operating-lease assets (leased space)$175.0K7 Dec 31, 2025$152.0K7 Dec 31, 2024+15.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$31.4M7 Dec 31, 2025$13.9M7 Dec 31, 2024+125.7%
Marketable securities, current$23.4M7 Dec 31, 2025$51.6M7 Dec 31, 2024−54.7%
Debt securities available for sale$30.6M7 Dec 31, 2025$60.3M7 Dec 31, 2024−49.3%

Properties, in its own words

Our corporate headquarters is located at 234 Church Street, New Haven, CT 06510, where we lease and occupy 4,500 square feet of office space. The current term of our lease in New Haven expires September 30,

2027. We believe that this office space is sufficient to meet our current needs. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 16, 2026.6

Leadership

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

Chief executive

  1. Martin Mackay2021–2023
  2. Stephen Uden2024–2025

Chair

  1. Martin Mackay2024

Chief financial officer

  1. Jeffrey M. Fryer2022
  2. Jonathan I. Lieber2024–now
2025
Board members and other officers (14)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorHUI M. LIU named Apr 22, 202431
  • DirectorRONALD M. HUNT named Apr 22, 202431

Former names

  • Rallybio Holdings, LLCMay 7, 2018 to Jun 7, 20215

Timeline

  1. Sep 9, 20268-K Executive or director change32
  2. Jun 1, 20268-K Entered a material agreement; Unregistered sale of shares; Change in control33
  3. May 4, 20268-K Ended a material agreement34
  4. Mar 31, 20268-K Executive or director change35
  5. Mar 2, 20268-K Entered a material agreement; Unregistered sale of shares; Change in control36
  6. Jan 29, 20268-K Bylaws or fiscal year changed; Shareholder vote37
  7. Nov 6, 20258-K Results of operations38
  8. Aug 29, 20258-K Listing notice or transfer39
  9. Aug 7, 20258-K Results of operations40
  10. Jul 8, 20258-K Entered a material agreement; Completed an acquisition or sale; Other events41
  11. Jun 27, 20258-K Executive or director change42
  12. May 16, 20258-K Shareholder vote43
  13. Feb 16, 2024New chief executive Stephen Uden becomes CEO14
  14. Jul 29, 2021New chief executive Martin Mackay becomes CEO15
  15. May 11, 2020Founded Rallybio is founded3

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/202644

When it reported results

  1. Nov 6, 2025Reported quarterly or annual results38
  2. Aug 7, 2025Reported quarterly or annual results40
  3. May 8, 2025Reported quarterly or annual results45
  4. Mar 13, 2025Reported quarterly or annual results46
  5. Nov 7, 2024Reported quarterly or annual results47
  6. Aug 8, 2024Reported quarterly or annual results48
  7. May 9, 2024Reported quarterly or annual results49
  8. Mar 12, 2024Reported quarterly or annual results50

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

Filings

242 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 47 major events, 99 insider forms, 37 large holders, 1 private raises, 38 other. The latest 20:

  1. Oct 15, 2026424B3 EDGAR
  2. Oct 14, 2026S-4/A S-4/A NO. 4 EDGAR
  3. Oct 14, 20264 EDGAR
  4. Oct 13, 20264 EDGAR
  5. Oct 8, 20264 EDGAR
  6. Oct 5, 2026S-4/A S-4/A NO. 3 EDGAR
  7. Oct 1, 20264 EDGAR
  8. Sep 28, 20264 EDGAR
  9. Sep 18, 20264 EDGAR
  10. Sep 16, 2026S-4/A S-4/A NO. 2 EDGAR
  11. Sep 9, 20268-K EDGAR
  12. Aug 26, 2026S-4/A EDGAR
  13. Aug 14, 2026SCHEDULE 13G/A EDGAR
  14. Aug 14, 2026SCHEDULE 13G/A EDGAR
  15. Aug 14, 2026SCHEDULE 13G/A EDGAR
  16. Aug 6, 202610-Q EDGAR
  17. Aug 6, 2026SCHEDULE 13G/A EDGAR
  18. Aug 4, 2026SCHEDULE 13G/A EDGAR
  19. Jul 15, 2026S-4 EDGAR
  20. Jul 10, 20264 EDGAR

The 242 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

25 open-market trades by officers, directors and large owners since October 2021: 16 buys and 9 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 19, 2026ADAR1 Capital Management, LLC10% ownerBuy10,200$13.98$142.6KForm 4
May 18, 2026ADAR1 Capital Management, LLC10% ownerBuy6,009$13.98$84.0KForm 4
May 15, 2026Schneeberger Daniel10% ownerBuy300$13.90$4.2KForm 4
May 13, 2026Schneeberger Daniel10% ownerBuy79,259$13.99$1.1MForm 4
May 12, 2026ADAR1 Capital Management, LLC10% ownerBuy800$13.83$11.1KForm 4
May 11, 2026ADAR1 Capital Management, LLC10% ownerBuy50,000$14.00$700.0KForm 4
May 5, 2026Schneeberger Daniel10% ownerBuy35,101$14.00$491.4KForm 4
May 4, 2026Schneeberger Daniel10% ownerBuy120,804$13.97$1.7MForm 4
Feb 23, 2026Lieber Jonathan IChief Financial OfficerSale789$5.06$4.0KForm 4
Mar 14, 2023Lieber Jonathan IChief Financial OfficerBuy5,000$5.21$26.1KForm 4
Mar 7, 2023PARMAR KUSHDirectorSale100,000$8.20$820.0KForm 4
Mar 7, 2023Schwab Andrew J.10% ownerSale100,000$8.20$820.0KForm 4
Jun 3, 2022PARMAR KUSHDirectorSale150,000$12.50$1.9MForm 4
Jun 3, 20225AM Partners V, LLC10% ownerSale150,000$12.50$1.9MForm 4
May 23, 2022PARMAR KUSHDirectorSale100,000$13.00$1.3MForm 4
May 23, 20225AM Partners V, LLC10% ownerSale100,000$13.00$1.3MForm 4
Mar 21, 2022Fryer Jeffrey MSee RemarksBuy3,000$8.04$24.1KForm 4
Feb 8, 20225AM Ventures V, L.P.10% ownerSale210,000$13.05$2.7MForm 4
Feb 8, 2022PARMAR KUSHDirectorSale210,000$13.05$2.7MForm 4
Jan 19, 2022Fryer Jeffrey MSee RemarksBuy1,400$8.70$12.2KForm 4

All 25 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.

Money raised

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

  1. Apr 10, 2024Raised $6.6 million in a private offering of equity Form D: 1 investor 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 37. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
ADAR1 Capital Management, LLC926,352$14.8M0.7%+905,817
Citadel Advisors LLC7,705,787$12.7M0.0%+7,685,901
Fmr LLC794,720$12.7M0.0%+1,269
Viking Global Investors LP524,347$8.4M0.0%No change
Tpg Gp A, LLC378,551$6.1M0.1%No change
Nantahala Capital Management, LLC376,844$6.0M0.2%+76,209
Pivotal bioVenture Partners Investment Advisor LLC300,579$4.8M1.6%No change
Renaissance Technologies LLC199,907$3.2M0.0%+43,380
Vanguard Capital Management LLC172,497$2.8M0.0%+60,457
Almitas Capital LLC120,682$1.9M0.5%−70,524
Rangeley Capital, LLC104,850$1.7M1.6%+74,720
Mariner, LLC50,566$809.1K0.0%No change
Jane Street Group, LLC47,423$758.8K0.0%New
Geode Capital Management, LLC32,047$512.9K0.0%−3,378
BlackRock, Inc.30,332$485.3K0.0%+12,846
XTX Topco Ltd21,497$344.0K0.0%+10,271
Vanguard Fiduciary Trust Co16,820$269.1K0.0%+3,273
Two Sigma Investments, LP16,619$265.9K0.0%New
State Street Corp12,996$207.9K0.0%New
Quadrature Capital Ltd12,995$207.9K0.0%New
Dimensional Fund Advisors LP11,280$180.5K0.0%No change
Vanguard Global Advisers, LLC1,442$23.1K0.0%No change
Hartford Financial Management Inc.812$13.0K0.0%No change
SBI Securities Co., Ltd.506$8.1K0.0%−18
Caitong International Asset Management Co., Ltd434$6.9K0.0%New

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

SEC filer profile

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

  • Name on EDGARRallybio Corp2
  • CIK0001739410
  • Employer ID (EIN)85-10837896
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address234 Church Street, Suite 1020, New Haven, CT 065102
  • Phone203- 859-38202
  • Shares outstanding5,310,499 as of Jul 30, 202613
  • Public float$10.6M as of Jun 30, 20256
  • AuditorDeloitte & Touche LLP, Hartford, Connecticut PCAOB ID 34; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceMay 7, 20182
  • Filings292 in all: 4 (100), 8-K (49), 3 (20), 10-Q (16), SC 13G/A (10), SCHEDULE 13G/A (10), SC 13G (7), CORRESP (6)2
    All 38 form types

    SCHEDULE 13G (6), 10-K (5), DEF 14A (5), S-4/A (5), S-8 (5), 424B5 (4), EFFECT (4), UPLOAD (4), D (3), S-3 (3), SC 13D (3), SC 13D/A (3), SCHEDULE 13D/A (3), 424B3 (2), 425 (2), S-4 (2), SEC STAFF LETTER (2), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), DRS/A (1), DRSLTR (1), PRE 14A (1), RW (1), S-1 (1), S-1/A (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Jan 2, 2026
    Latest 8-K (8-K) Sep 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareRLYBNASDAQ

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Rallybio names in Item 1A of its 10-K filed Mar 16, 2026: 73 risks under these headings, as written.6

  • Risks Related to the Merger
  • Failure to complete, or delays in completing, the proposed Merger with Candid could materially and adversely affect our results of operations, business, financial results and/or stock price.
  • We are substantially dependent on our remaining employees to facilitate the consummation of the Merger.
  • The Exchange Ratio will not be adjusted based on the market price of our common stock, so the consideration at the closing of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed.
  • The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes and/or other causes.
  • Some of our executive officers and directors have interests in the Merger that are different from our stockholders and that may influence them to support or approve the Merger without regard to the interests of our stockholders.
  • Our stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.
  • Our equityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.
  • Lawsuits may be filed against us and the members of our board of directors arising out of the proposed Merger, which may delay or prevent the proposed Merger.
  • During the pendency of the Merger Agreement, we may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.
  • Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.
  • If the Merger does not qualify as a reorganization under the Code, U.S. holders of our Common Stock may be taxed on the full amount of the consideration received in the Merger.
The other 62 risks
  • We or Candid may waive one or more of the conditions to the Merger without recirculation of the related proxy statement/prospectus or resoliciting stockholder approval.
  • Our winddown of our historical operations, the sale of assets, the suspension of development activities and the proposed Merger, resulting in the conversion of Candid into a public company, will make us subject to the SEC requirements applicable to reporting shell company business combinations. As a result, the combined company will be subject to more stringent reporting requirements, offering limitations and resale restrictions.
  • Our stockholders may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.
  • The tax treatment of the CVRs is uncertain.
  • If the Merger is not completed, our stock price may decline significantly.
  • If we do not complete the Merger, we may face substantial competition for attractive counterparties for any proposed strategic transactions.
  • If we do not successfully consummate the Merger or another strategic transaction, our board of directors may decide to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, as to which we can give you no assurance.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception and anticipate that, if we continue to progress the development of our product candidates, we will continue to incur losses in the foreseeable future. We have not commercialized any products and have never generated revenue from the commercialization of any product. We are not currently profitable, and we may never achieve or sustain profitability.
  • If we continue to progress the development of our product candidates, we will require significant additional capital to fund our operations. If we continue to progress the development of our product candidates and fail to obtain necessary financing, we may not be able to complete the development or commercialization of RLYB116 or any other product candidate. Given our limited resources and access to capital, we may decide to prioritize development of certain product candidates, the choice of which may prove to be wrong and adversely affect our business.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our intellectual property or product candidates.
  • We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.
  • Our quarterly and annual financial results may fluctuate, which makes our results difficult to predict and may cause our results to fall short of expectations.
  • Our ability to use our net operating loss and income tax credit carryforwards to offset future income tax liabilities may be subject to certain limitations.
  • Risks Related to Discovery, Development, Clinical Testing, Manufacturing, Marketing Approval and Commercialization
  • We are heavily dependent on the success of RLYB116, which is in early-stage clinical development. If we continue to progress the development of our product candidates, and we are not able to develop,
  • obtain marketing approval for, or successfully commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
  • Preclinical studies and clinical trials are expensive, time consuming and difficult to design and implement, and involve uncertain outcomes. If we continue to progress the development of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
  • If we continue to progress the development of our product candidates, results of preclinical studies, clinical trials or analyses that we may announce or publish from time to time, may not be indicative of results obtained in later trials, and any interim results we may publish could be different than final results.
  • Enrollment and retention of patients in rare disease clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • If we continue to progress the development of our product candidates, any product candidates that we develop or the administration thereof, may cause serious adverse events or undesirable side effects, which may halt their clinical development, delay or prevent marketing approval, or, if approved, require them to be taken off the market, include safety warnings, or otherwise limit their sales.
  • The marketing approval processes of the FDA, EMA and comparable foreign regulatory authorities, including the MHRA, are lengthy, time- consuming and inherently unpredictable, and if we continue to progress the development of our product candidates, and are ultimately unable to obtain marketing approval for RLYB116 or any of our other product candidates, our business will be substantially harmed.
  • Our product candidates target rare diseases and conditions, and if we continue to progress the development of our product candidates, the market opportunities for RLYB116 or any of our other product candidates, if approved, may be smaller than we anticipate. We must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • We face significant competition from biotechnology and pharmaceutical companies, and if we continue to progress the development of our product candidates, our operating results will suffer if we fail to compete effectively.
  • Disruptions in the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which, if we continue to progress the development of our product candidates, could negatively impact our business.
  • Even if we obtain marketing approval for a product candidate in the United States, we or our current or future collaborators may never obtain approval for or commercialize the product candidate in any other jurisdiction, which would limit our ability to realize its full market potential.
  • Even if we obtain marketing approval for any of our product candidates, we will still face extensive and ongoing regulatory requirements and obligations and continued regulatory review, which may result in significant additional expense. We may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any product candidates.
  • If we continue to progress the development of our product candidates, we may seek Fast Track designation, Breakthrough Therapy designation, or PRIME designation for our product candidates, but we might not receive any such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval process.
  • If we continue to progress the development of our product candidates, we may be unsuccessful in obtaining or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity. If our competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as RLYB116 or any of our other product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
  • If we continue to progress the development of our product candidates, we may seek accelerated approval by the FDA for one or more of our product candidates. Accelerated approval by the FDA, even if granted for any of 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.
  • If we continue to progress the development of our product candidates, the successful commercialization of any product candidate we develop will depend in part on the extent to which regulatory authorities and private health insurers establish coverage and reimbursement. Failure to obtain or maintain coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our or our ability to generate revenue.
  • If we continue to progress the development of our product candidates, even if a product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • If approved, our product candidates that are regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • If we continue to progress the development of our product candidates, and are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing any product candidates we develop, if approved.
  • Under the current presidential administration, we face uncertainty regarding potential regulatory developments that may adversely affect our business if we continue to progress the development of our product candidates.
  • Risks Related to Our Dependence on Third Parties
  • Our reliance on a central team consisting of a limited number of employees and third parties who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.
  • Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • If we continue to progress the development of our product candidates, we will continue to rely on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If we fail to effectively oversee and manage these third parties, if they do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business.
  • Risks Related to Healthcare Laws and Other Legal Compliance Matters
  • If we continue to progress the development of our product candidates, enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.
  • If we continue to progress the development of our product candidates, our business operations and current and future relationships with contractors, investigators, healthcare professionals, consultants, third-party payors, patient organizations, customers, and others will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Our business operations may subject us to data protection laws, including the GDPR, the UK GDPR, the CCPA and other similar laws.
  • We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize similar or identical technology and products, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.
  • Obtaining and maintaining patent protection depends on compliance with various procedural requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of our patents, thereby impairing our ability to protect our products.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms, our business could be harmed.
  • If we fail to comply with our obligations in our intellectual property licenses with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • Patent terms may not protect our competitive position for an adequate amount of time.
  • If we do not obtain a patent term extension for any product candidates we might develop, our business might be materially harmed.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, 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.
  • Third parties may allege that we are violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
  • We may be subject to claims by third parties asserting that our employees, consultants or contractors have wrongfully used or disclosed confidential information or trade secrets of such third parties, that we have misappropriated their intellectual property, or that they own what we regard as our own intellectual property.
  • Intellectual property litigation or other legal proceedings relating to intellectual property could cost substantial resources.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Our Employees, Managing Our Growth and Our Operations
  • Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
  • Our business and operations would suffer in the event of system failures.
  • Our proprietary or confidential information may be lost, or we may suffer security breaches.
  • Risks Related to Our Common Stock
  • An active trading market for our common stock may not be sustained.
  • Our failure to meet the listing standards of the Nasdaq could result in the delisting of our common stock. Delisting could adversely affect the liquidity of our common stock and the market price of our common stock could decrease, and our ability to obtain sufficient additional capital to fund our operations and to continue to operate as a going concern would be substantially impaired.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources, negative publicity and reputational harm and other factors.

The opening of Item 3, Legal Proceedings.6

Sources

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