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UPB on Nasdaq

Upstream Bio, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. We are developing verekitug, the only known antagonist currently in clinical development that targets the receptor for Thymic Stromal Lymphopoietin, a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases.”3 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol UPB.1

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Last updated Oct 21, 2026.

Overview

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  • TickerUPB on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address890 Winter Street, Suite 200, Waltham, Ma 024512
  • Filer category, Emerging growth company2

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We are a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. We are developing verekitug, the only known antagonist currently in clinical development that targets the receptor for Thymic Stromal Lymphopoietin (“TSLP”), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Preclinical and clinical data to date demonstrate verekitug’s highly potent inhibition of the TSLP receptor, which we believe will translate to a differentiated product profile, including improved clinical outcomes, substantially extended dosing intervals and the potential to treat a broad spectrum of patients. We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment…3 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-5618.8%Operating margin4
-5026.0%Net margin4
20.4%Revenue growth, 20254
-42.2%Return on equity4
-$133.4MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$136.8M

Out of $2.9M in revenue.4 The company lost money this year.

Financial statements

Revenue54$2.9M in 2025+20% since 2023
0$1.0M$2.0M$3.0M2023: $2.4M$2.4M20232024: $2.4M$2.4M2024−0%2025: $2.9M$2.9M2025+20%
Operating income54-$160.4M in 2025+300% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$40.1M-$40.1M20232024: -$77.8M-$77.8M2024+94%2025: -$160.4M-$160.4M2025+106%
Net income54-$143.4M in 2025+598% since 2023
-$150.0M-$100.0M-$50.0M02023: -$20.5M-$20.5M20232024: -$62.8M-$62.8M2024+206%2025: -$143.4M-$143.4M2025+128%

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

Period ending2025-12-312024-12-31
Collaboration revenue$2.9M$2.4M
Research and development$136.8M$63.0M
General and administrative$26.4M$17.2M
Total operating expenses$163.2M$80.1M
Loss from operations-$160.4M-$77.8M
Change in fair value of preferred stock tranche right liability$0$2.9M
Interest income$16.9M$12.1M
Other expense, net-$15.0K-$24.0K
Total other income, net$16.9M$15.0M
Redeemable convertible preferred stock cumulative dividends$0-$13.6M
Net loss attributable to common stockholders-$143.4M-$76.4M
Net loss per share attributable to common stockholders, basic-$2.66-$5.58
Net loss per share attributable to common stockholders, diluted-$2.66-$5.58
Weighted-average common shares outstanding, basic53.9M shares13.7M shares
Weighted-average common shares outstanding, diluted53.9M shares13.7M shares
Net loss-$143.4M-$62.8M
Unrealized gain (loss) on investments, net of tax$555.0K-$46.0K
Total other comprehensive income (loss)$555.0K-$46.0K
Comprehensive loss-$142.9M-$62.9M

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Corporate structure

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

Major holders of Upstream Bio, Inc.

  • Upstream Bio, Inc. Waltham, Massachusetts

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

What it owns

What Upstream Bio, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$903.0K4 Dec 31, 2025$738.0K4 Dec 31, 2024+22.4%
Accumulated depreciation$344.0K4 Dec 31, 2025$156.0K4 Dec 31, 2024+120.5%
Property and equipment, net$559.0K4 Dec 31, 2025$582.0K4 Dec 31, 2024−4.0%
Operating-lease assets (leased space)$1.2M4 Dec 31, 2025$1.8M4 Dec 31, 2024−31.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$101.6M4 Dec 31, 2025$325.9M4 Dec 31, 2024−68.8%
Marketable securities, current$239.9M4 Dec 31, 2025$144.6M4 Dec 31, 2024+66.0%
Debt securities available for sale$239.9M4 Dec 31, 2025$144.6M4 Dec 31, 2024+66.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$05 Dec 31, 2024

Properties, in its own words

Our corporate headquarters is presently located in Waltham, Massachusetts, where we lease and occupy 16,801 square feet of office space. The initial term of the lease expires on November 1, 2027, with an option to extend the lease for an additional three years thereafter.

We believe that our leased premises will be sufficient for our needs for the foreseeable future. To meet the future needs of our business, we may lease additional or alternate space, and we believe suitable additional or alternative space will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 26, 2026.3

Leadership

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

Chief executive

  1. Everett Rand Sutherland2024–now
2025
Board members and other officers (10)

Timeline

  1. Sep 1, 20268-K Regulation FD disclosure; Other events18
  2. Aug 11, 20268-K Results of operations19
  3. Jun 10, 20268-K Shareholder vote20
  4. May 13, 20268-K Results of operations21
  5. Mar 26, 20268-K Results of operations22
  6. Mar 26, 20268-K Entered a material agreement23
  7. Feb 11, 20268-K Regulation FD disclosure; Other events24
  8. Feb 11, 20268-K Results of operations; Regulation FD disclosure25
  9. Nov 5, 20258-K Results of operations26
  10. Sep 2, 20258-K Regulation FD disclosure; Other events27
  11. Aug 6, 20258-K Results of operations28
  12. Jun 12, 20258-K Shareholder vote29
  13. Oct 10, 2024New chief executive Everett Rand Sutherland becomes CEO8

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.63) a share, on Nov 5, 2025.30

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results19
  2. May 13, 2026Reported quarterly or annual results21
  3. Mar 26, 2026Reported quarterly or annual results22
  4. Feb 11, 2026Reported quarterly or annual results25
  5. Nov 5, 2025Reported quarterly or annual results26
  6. Aug 6, 2025Reported quarterly or annual results28
  7. May 6, 2025Reported quarterly or annual results31
  8. Mar 12, 2025Reported quarterly or annual results32

Drug trials and FDA: coming up

  1. Sep 2027Phase 2 trial readout expected Phase 2 trial of Verekitug in Severe Asthma: primary completion expected Sep 2027 (ClinicalTrials.gov NCT06966479).33
  2. Oct 2027Phase 2 trial readout expected Phase 2 trial of Verekitug in Chronic Obstructive Pulmonary Disease: primary completion expected Oct 2027 (ClinicalTrials.gov NCT06981078).34

Drug trials and FDA: recently

  1. Dec 16, 2025Phase 2 trial completed Phase 2 trial of Verekitug (UPB-101) in Severe Asthma: primary completion Dec 16, 2025, no results posted yet (ClinicalTrials.gov NCT06196879).35
  2. Jul 7, 2025Phase 2 trial completed Phase 2 trial of Verekitug (UPB-101) in Chronic Rhinosinusitis With Nasal Polyps: primary completion Jul 7, 2025, results posted Sep 18, 2026 (ClinicalTrials.gov NCT06164704).36

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

133 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 16 major events, 62 insider forms, 15 large holders, 32 other. The latest 20:

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

The 133 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

18 open-market trades by officers, directors and large owners since October 2021: 3 buys and 15 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Deykin AaronChief Medical OfficerSale895$5.49$4.9KForm 4
Sep 16, 2026Sutherland Everett RandChief Executive OfficerSale2,095$5.49$11.5KForm 4
Sep 16, 2026Houghton AdamChief Business OfficerSale700$5.49$3.8KForm 4
Sep 16, 2026GRAY MICHAELCFO and COOSale853$5.49$4.7KForm 4
Sep 16, 2026Ambrose AllisonGeneral CounselSale485$5.49$2.7KForm 4
Jun 16, 2026GRAY MICHAELCFO and COOSale853$6.10$5.2KForm 4
Jun 16, 2026Sutherland Everett RandChief Executive OfficerSale2,095$6.10$12.8KForm 4
Jun 16, 2026Houghton AdamChief Business OfficerSale700$6.10$4.3KForm 4
Jun 16, 2026Deykin AaronChief Medical OfficerSale895$6.10$5.5KForm 4
Jun 16, 2026Ambrose AllisonGeneral CounselSale477$6.10$2.9KForm 4
Mar 16, 2026GRAY MICHAELCFO and COOSale852$9.29$7.9KForm 4
Mar 16, 2026Deykin AaronChief Medical OfficerSale894$9.29$8.3KForm 4
Mar 16, 2026Sutherland Everett RandChief Executive OfficerSale2,093$9.29$19.4KForm 4
Mar 16, 2026Ambrose AllisonGeneral CounselSale475$9.29$4.4KForm 4
Mar 16, 2026Houghton AdamChief Business OfficerSale699$9.29$6.5KForm 4
Oct 15, 2024Access Industries Holdings LLC10% ownerBuy1,175,000$17.00$20.0MForm 4
Oct 15, 2024Chimovits ErezDirectorBuy825,000$17.00$14.0MForm 4
Oct 15, 2024ORBIMED ADVISORS LLCDirectorBuy825,000$17.00$14.0MForm 4

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
2025E. Rand SutherlandM.D.56$650.0K$4.3M46
2025Michael Paul GrayM.B.A.55$490.0K$2.0M46
2025Aaron Deykin, M.D.Chief Medical Officer and Head of Research and Development60$515.0K$1.8M46
2024Chief Executive Officer$408.0K$9.1M46
2024Chief Financial Officer and ChiefOperating Officer$352.7K$2.9M46

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC8,162,897$56.5M0.0%+61,334
Orbimed Advisors LLC5,693,589$39.4M0.7%No change
Norges Bank3,768,619$26.1M0.0%New
BlackRock, Inc.3,753,358$26.0M0.0%+382,669
Decheng Capital LLC2,724,868$18.9M2.6%No change
Enavate Sciences Gp, LLC2,459,703$17.0M4.9%No change
Vanguard Capital Management LLC1,876,734$13.0M0.0%+3,160
Millennium Management LLC1,143,775$7.9M0.0%+206,452
D. E. Shaw & Co., Inc.1,036,044$7.2M0.0%+215,564
Jpmorgan Chase & Co1,012,044$7.0M0.0%+549,043
Qube Research & Technologies Ltd978,500$6.8M0.0%+359,179
Parkman Healthcare Partners LLC935,247$6.5M0.7%+148,464
Geode Capital Management, LLC931,261$6.4M0.0%−19,356
SEB Asset Management AB878,473$6.1M0.0%No change
Woodline Partners LP831,481$5.8M0.0%No change
State Street Corp766,323$5.3M0.0%+60,973
Vanguard Portfolio Management LLC712,667$4.9M0.0%−15,044
Y-Intercept (Hong Kong) Ltd693,555$4.8M0.1%−307,076
Bain Capital Life Sciences Investors, LLC600,949$4.2M0.2%−266,262
Aqr Capital Management LLC544,869$3.8M0.0%+472,698
Morgan Stanley524,632$3.6M0.0%−27,977
Bnp Paribas Financial Markets511,546$3.5M0.0%+385,546
Walleye Capital LLC498,490$3.4M0.0%New
Trexquant Investment LP466,430$3.2M0.0%+289,773
Point72 Asset Management, L.P.453,011$3.1M0.0%+274,843

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

SEC filer profile

How Upstream 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 EDGARUpstream Bio, Inc.1
  • CIK0002022626
  • Employer ID (EIN)38-41876943
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address890 Winter Street, Suite 200, Waltham, MA 024511
  • Phone781-208-24661
  • Shares outstanding54,771,041 as of Aug 4, 20267
  • Public float$467.9M as of Jun 30, 20253
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJun 12, 20241
  • Filings133 in all: 4 (48), 8-K (16), 3 (14), 10-Q (6), SCHEDULE 13G/A (6), SCHEDULE 13G (5), CORRESP (4), S-8 (3)1
    All 28 form types

    UPLOAD (3), 10-K (2), ARS (2), DEF 14A (2), DEFA14A (2), DRS/A (2), DRSLTR (2), SC 13D (2), SC 13G (2), SEC STAFF LETTER (2), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), DRS (1), EFFECT (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Sep 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareUPBThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Upstream Bio, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 73 risks under these headings, as written.3

  • Risks related to our limited operating history, financial condition and need for additional capital
  • We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future.
  • We will require additional funding in order to finance operations. If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to verekitug or any other potential future product candidates.
  • Risks related to our business
  • Verekitug is our only product candidate, and we are dependent on a third party having accurately generated, collected and reported data from certain preclinical studies that were previously conducted for verekitug.
  • If we are unable to advance verekitug in clinical development for one or more of the indications that we are pursuing, obtain regulatory approval and ultimately commercialize verekitug, or experience significant delays in doing so, our business will be materially harmed.
  • We are currently conducting, and may in the future conduct, clinical trials for verekitug or any other potential future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • The successful development of pharmaceutical products involves a lengthy and expensive process and is highly uncertain.
  • Certain estimates of market opportunity and forecasts may prove to be smaller than we believe.
  • Due to the significant resources required for drug development and depending on our ability to access capital, we must prioritize the development of verekitug. Moreover, we may fail to expend our limited resources on the development of verekitug for the treatment of additional indications or for the development of other potential future product candidates that may have been more profitable or for which there is a greater likelihood of success.
  • If we successfully commercialize verekitug, our results of operations will be affected by the level of royalty payments that we are required to pay to Regeneron.
The other 62 risks
  • We may 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 other strategic alliances. 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.
  • We, our collaborators, and our service providers are subject to a variety of stringent and evolving privacy and data security laws, regulations, and rules, contractual obligations, industry standards, policies, and other obligations related to privacy and data security. Any actual or perceived failure to comply with such obligations could expose us to significant fines or other penalties and otherwise harm our business and operations.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • Risks related to the discovery and development of verekitug or any other potential future product candidates
  • The regulatory approval processes of the FDA, the EMA, and the European Commission and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for verekitug or any other potential future product candidates, our business will be substantially harmed.
  • Verekitug represents a novel approach to the treatment of inflammatory diseases, which makes it difficult to predict its likelihood of success and the timing and cost of development and obtaining regulatory approval.
  • If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize verekitug or any other potential future product candidates.
  • Interim, initial, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Verekitug or any other potential future product candidates may cause undesirable side effects or have other properties that could delay or prevent regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained.
  • If we fail to expand our development of verekitug into additional indications, or discover or acquire, and subsequently develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.
  • Risks related to the commercialization of verekitug or any other potential future product candidates
  • Even if verekitug or any other potential future product candidates receive regulatory approval, such product candidate may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
  • Competitive products may reduce or eliminate the commercial opportunity for verekitug or any other potential future product candidates, if approved. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective or safer than ours, our ability to develop and successfully commercialize verekitug or any other potential future product candidates may be adversely affected.
  • If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing verekitug or any other potential future product candidates.
  • The increasing use of social media platforms presents new risks and challenges.
  • Risks related to employee matters and managing growth
  • We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our ability to develop verekitug or any other potential future product candidates and our future growth depends on attracting, hiring and retaining our key personnel and recruiting additional qualified personnel.
  • Risks related to our dependence on third parties
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize verekitug or any other potential future product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
  • Our information technology systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches, which could adversely affect our business.
  • We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • Our existing research and development arrangement as well as any future collaborations with third parties for the development and commercialization of verekitug or any other potential future product candidates may not be successful, which could adversely affect our ability to advance verekitug or any other potential future product candidates.
  • Our use of third parties to manufacture verekitug or any other potential future product candidates may increase the risk that we will not have sufficient quantities of verekitug or any other potential future product candidates, raw materials, active pharmaceutical ingredients (“APIs”) or drug products when needed or at an acceptable cost.
  • If any third-party manufacturer of verekitug or any other potential future product candidates is unable to increase the scale of its production or the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Risks related to government regulation
  • Obtaining and maintaining regulatory approval of verekitug or any other potential future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.
  • Even if we receive regulatory approval of verekitug or any other potential future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with verekitug or any other potential future product candidates.
  • Verekitug or any other potential future product candidates for which we intend to seek approval as biological products may face competition sooner than anticipated.
  • While we may in the future seek designations for verekitug or any other potential future product candidates with the FDA and comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or regulatory exclusivity, there can be no assurance that we will successfully obtain such designations. In addition, even if verekitug or any other potential future product candidates are granted such designations, we may not be able to maintain such designations or realize the intended benefits of such designations.
  • 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.
  • Changes in funding for, or disruptions to the staffing and operations of, the FDA, the SEC, and other U.S. government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our relationships with healthcare professionals and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for verekitug or any other potential future product candidates, if approved, which could make it difficult for us to sell them profitably.
  • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
  • Our employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Off-label use or misuse of verekitug or any other potential future product candidates may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.
  • EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States.
  • We are subject to export and import controls, economic sanctions, and anti-corruption laws and regulations of the United States and other jurisdictions. We can face criminal liability and other serious consequences for violations of these laws and regulations, which can harm our business.
  • If we or any third-party manufacturer we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could have a material adverse effect on our business.
  • Risks related to our intellectual property
  • Our success is largely based upon our intellectual property and proprietary technologies, and we may be unable to protect and/or enforce our intellectual property.
  • We may be forced to litigate to enforce or defend our intellectual property rights.
  • If we or our partners are sued for infringing or misappropriating the intellectual property rights of third parties, it could be costly and time consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on our business.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position on verekitug or any other potential future product candidates for an adequate amount of time.
  • If we do not obtain sufficient patent term protections for verekitug or any other potential future product candidates, our business may be materially harmed.
  • Changes in patent law in the United States and in non U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technologies and verekitug or any other potential future product candidates.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
  • Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks related to ownership of our common stock
  • An active trading market for our common stock may not be sustained.
  • The price of our common stock may be volatile, which could result in substantial losses for our stockholders.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • If securities or industry analysts do not continue to publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Our executive officers, directors, principal stockholders and their respective affiliates own a significant percentage of our common stock and have the ability to exert significant control over matters subject to stockholder approval.
  • Sales of a substantial number of shares of our common stock in the public market could cause our common stock price to fall.
  • Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
  • We do not currently intend to pay dividends on our common stock and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation of the value of our common stock.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • Our second amended and restated bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
  • We may not be able to continue to satisfy the listing requirements of Nasdaq.
  • Other general risks
  • Unfavorable global economic and market volatility resulting from geopolitical conditions, including those affecting the financial services industry, could adversely affect our business, financial condition, stock price, and results of operations.

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 and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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