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JBIO on Nasdaq

Jade Biosciences, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company developing novel biologic therapies for patients living with autoimmune diseases. Our approach is to discover and efficiently develop biologics that address emerging targets supported by third-party clinical data and that overcome shortcomings of existing product candidates in development, such as potency, bioavailability, formulation, and pharmacokinetic properties.”4 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol JBIO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerJBIO on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address221 Crescent St., Building 23, Suite 105, Waltham, Ma 024532
  • Filer category, Emerging growth company2

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We are a clinical-stage biopharmaceutical company developing novel biologic therapies for patients living with autoimmune diseases. Our goal is to improve meaningfully upon the existing treatment paradigm through the delivery of improved dosing and convenience, a comparable safety profile, and potentially increased clinical activity. Our approach is to discover and efficiently develop biologics that address emerging targets supported by third-party clinical data and that overcome shortcomings of existing product candidates in development, such as potency, bioavailability, formulation, and pharmacokinetic properties.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-$113.5M in 2025+1177% since 2020
-$150.0M-$100.0M-$50.0M02020: -$8.9M-$8.9M20202021: -$23.0M-$23.0M2021+159%2022: -$53.2M-$53.2M2022+131%2023: -$81.4M-$81.4M2023+53%2024: -$74.6M-$74.6M2024−8%2025: -$113.5M-$113.5M2025+52%
Net income56789-$127.4M in 2025+1226% since 2020
-$150.0M-$100.0M-$50.0M02020: -$9.6M-$9.6M20202021: -$23.0M-$23.0M2021+139%2022: -$51.5M-$51.5M2022+124%2023: -$75.5M-$75.5M2023+47%2024: -$69.6M-$69.6M2024−8%2025: -$127.4M-$127.4M2025+83%

Every line of the income statement as filed: the last 1 fiscal year, latest first.9

Period ending2025-12-31
General and administrative$20.4M
Total operating expenses$113.5M
Total operating expenses-$113.5M
Interest income$7.8M
Other expense-$8.0K
Total other expense, net-$13.8M
Net loss before income tax expense-$127.4M
Income tax expense-$58.0K
Net loss-$127.4M
Currency translation adjustment-$28.0K
Unrealized gain on investments$157.0K
Comprehensive loss-$127.3M
Net loss per share attributable to common stockholders, basic-$3.19
Net loss per share attributable to common stockholders, diluted-$3.19
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic31.4M shares
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted31.4M shares
Research and development$93.1M
Change in fair value of Convertible Notes payable$21.6M

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Corporate structure

Jade Biosciences, Inc. sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Jade Biosciences, Inc.

  • Jade Biosciences, Inc. Waltham, Massachusetts
    • Jade Biosciences Canada ULC Subsidiary · British Columbia, Canada
    • Jade Biosciences MA Security Corporation Subsidiary · Massachusetts, United States

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 Jade Biosciences, 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$170.0K9 Dec 31, 2025$6.0K8 Dec 31, 2024+2733.3%
Operating-lease assets (leased space)$726.0K9 Dec 31, 2025$209.0K8 Dec 31, 2024+247.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$88.4M9 Dec 31, 2025$69.4M9 Dec 31, 2024+27.5%
Marketable securities, current$247.7M9 Dec 31, 2025$09 Dec 31, 2024
Debt securities available for sale$247.7M9 Dec 31, 2025$44.9M8 Dec 31, 2024+452.1%

Properties, in its own words

We are a primarily remote company and do not maintain a physical headquarters. We believe this arrangement supports our current and near-term future anticipated needs. For administrative purposes, we lease office space in Vancouver, Canada and maintain a mailing address at 221 Crescent St., Building 23, Suite 105, Waltham, MA. As we expand, we believe that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Mar 6, 2026.4

Leadership

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

Chief executive

  1. Timothy P. Noyes2021–2024
  2. Tom Frohlich2025–now

Chief financial officer

  1. Bradford D. Dahms2025–now
2025
Board members and other officers (28)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Jade Biosciences Canada ULC British Columbia3
  • Jade Biosciences MA Security Corporation Massachusetts3

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

Former names

  • Aerovate Therapeutics, Inc.Jan 8, 2020 to Apr 30, 20252

Timeline

  1. Sep 30, 20268-K Other events39
  2. Aug 10, 20268-K Results of operations40
  3. Jul 1, 20268-K Entered a material agreement41
  4. Jun 26, 20268-K Executive or director change; Regulation FD disclosure42
  5. Jun 11, 20268-K Bylaws or fiscal year changed; Shareholder vote43
  6. Jun 4, 20268-K Other events44
  7. Jun 1, 20268-K Regulation FD disclosure; Other events45
  8. May 7, 20268-K Results of operations46
  9. Apr 22, 20268-K Executive or director change47
  10. Apr 2, 20268-K Executive or director change48
  11. Mar 6, 20268-K Results of operations49
  12. Jan 5, 20268-K Results of operations; Regulation FD disclosure50
  13. May 1, 2025New chief executive Tom Frohlich becomes CEO12
  14. Jun 29, 2021New chief executive Timothy P. Noyes becomes CEO13

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.48) a share, on Nov 13, 2025.51

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results40
  2. May 7, 2026Reported quarterly or annual results46
  3. Mar 6, 2026Reported quarterly or annual results49
  4. Jan 5, 2026Reported quarterly or annual results50
  5. Nov 14, 2025Reported quarterly or annual results52
  6. Aug 13, 2025Reported quarterly or annual results53
  7. May 14, 2025Reported quarterly or annual results54
  8. May 1, 2025Reported quarterly or annual results55

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

Filings

449 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 56 major events, 184 insider forms, 49 large holders, 140 other. The latest 20:

  1. Sep 30, 20268-K EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 10, 202610-Q EDGAR
  5. Aug 10, 20268-K EDGAR
  6. Jul 17, 2026SCHEDULE 13G EDGAR
  7. Jul 8, 2026SCHEDULE 13G/A EDGAR
  8. Jul 1, 20268-K EDGAR
  9. Jun 26, 20264 EDGAR
  10. Jun 26, 20263 EDGAR
  11. Jun 26, 20268-K EDGAR
  12. Jun 11, 20264 EDGAR
  13. Jun 11, 20264 EDGAR
  14. Jun 11, 20264 EDGAR
  15. Jun 11, 20264 EDGAR
  16. Jun 11, 20264 EDGAR
  17. Jun 11, 20268-K EDGAR
  18. Jun 9, 2026SCHEDULE 13D/A EDGAR
  19. Jun 5, 2026DEFA14A EDGAR
  20. Jun 4, 20268-K EDGAR

The 449 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

119 open-market trades by officers, directors and large owners since October 2021: 2 buys and 117 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 16, 2025Frohlich TomChief Executive OfficerBuy6,000$7.40$44.4KForm 4
Jun 17, 2024Shah Rajeev M.10% ownerBuy928,110$1.67$1.5MForm 4
Jun 14, 2024Eldridge George ASEE REMARKSSale15,000$25.03$375.4KForm 4
Jun 14, 2024Verwijs MarinusCHIEF TECHNICAL OFFICERSale10,600$25.00$265.0KForm 4
Jun 13, 2024Gillies HunterCHIEF MEDICAL OFFICERSale6,000$24.50$147.0KForm 4
May 17, 2024Gillies HunterCHIEF MEDICAL OFFICERSale4,000$21.09$84.3KForm 4
May 16, 2024NOYES TIMOTHY PCHIEF EXECUTIVE OFFICERSale10,000$21.57$215.7KForm 4
May 2, 2024Verwijs MarinusCHIEF TECHNICAL OFFICERSale1,981$21.02$41.6KForm 4
May 1, 2024NOYES TIMOTHY PCHIEF EXECUTIVE OFFICERSale11,357$20.33$230.9KForm 4
Apr 17, 2024Dake Benjamin TSEE REMARKSSale6,853$22.38$153.4KForm 4
Apr 17, 2024Gillies HunterCHIEF MEDICAL OFFICERSale4,000$22.38$89.5KForm 4
Apr 16, 2024NOYES TIMOTHY PCHIEF EXECUTIVE OFFICERSale10,000$24.70$247.0KForm 4
Apr 10, 2024Eldridge George ASEE REMARKSSale7,500$26.85$201.4KForm 4
Apr 9, 2024GRAYZEL DAVID S.DirectorSale11,882$28.15$334.5KForm 4
Apr 1, 2024Verwijs MarinusCHIEF TECHNICAL OFFICERSale5,300$29.19$154.7KForm 4
Apr 1, 2024NOYES TIMOTHY PCHIEF EXECUTIVE OFFICERSale10,000$30.00$300.0KForm 4
Apr 1, 2024Dake Benjamin TSEE REMARKSSale3,325$31.97$106.3KForm 4
Apr 1, 2024Eldridge George ASEE REMARKSSale12,495$31.23$390.2KForm 4
Mar 28, 2024Gillies HunterCHIEF MEDICAL OFFICERSale9,000$29.50$265.5KForm 4
Mar 27, 2024Dake Benjamin TSEE REMARKSSale11,068$27.97$309.6KForm 4

All 119 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
2025Tom FrohlichChief Executive Officer, President and Director50$622.0K$9.8M74
2025Andrew King, Ph.D.President, Research and Development47$507.3K$4.5M74
2025Bradford DahmsChief Financial Officer38$233.0K$4.1M74
2025Timothy P. NoyesFormer Chief Executive Officer$213.8K$1.8M74
2024Timothy P. NoyesFormer Chief Executive Officer$641.0K$3.4M74
2024Tom FrohlichChief Executive Officer, President and Director50$146.9K$1.4M74
2024Andrew King, Ph.D.President, Research and Development47$313.6K$751.6K74

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 LLC9,126,877$202.8M0.0%+2,041,454
Jupiter Topco LLC6,273,262$139.4M0.1%New
Fairmount Funds Management LLC4,553,494$101.2M6.7%No change
Ra Capital Management, L.P.3,671,083$81.6M0.7%No change
Venrock Adviser, LLC3,220,364$71.6M2.2%No change
Bellevue Group AG3,057,996$67.9M1.4%−443,506
Paradigm Biocapital Advisors LP2,857,405$63.5M1.2%New
BlackRock, Inc.2,801,451$62.2M0.0%+487,502
Franklin Resources Inc2,792,080$62.0M0.0%New
State Street Corp2,335,285$51.9M0.0%+1,679,595
Vanguard Capital Management LLC2,244,773$49.9M0.0%+448,121
Adage Capital Partners Gp, L.l.c.1,910,812$42.5M0.1%New
Polar Capital Holdings Plc1,846,982$41.0M0.1%New
Avidity Partners Management LP1,700,708$37.8M6.1%−1,100,708
Remedium Capital Partners, LLC1,577,750$35.1M7.8%No change
Soleus Capital Management, L.P.1,550,690$34.5M1.2%+753,946
Jpmorgan Chase & Co1,475,079$32.6M0.0%+1,459,216
Baker Bros. Advisors LP1,230,426$27.3M0.1%−410,711
Logos Global Management LP1,125,000$25.0M1.1%+725,000
Versant Venture Management, LLC991,783$22.0M13.6%−534,037
Acorn Capital Advisors, LLC986,760$21.9M6.0%+200,000
Geode Capital Management, LLC985,178$21.9M0.0%+162,658
Citadel Advisors LLC929,407$20.7M0.0%+792,185
Foresite Capital Management VI LLC886,667$19.7M3.1%+566,667
Balyasny Asset Management L.P.878,726$19.5M0.0%+476,237

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

SEC filer profile

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

  • Name on EDGARJade Biosciences, Inc.1
  • CIK0001798749
  • Employer ID (EIN)83-13778884
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inNevada4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address221 Crescent St., Building 23, Suite 105, Waltham, MA 024531
  • Phone(781) 312-30131
  • Shares outstanding63,597,387 as of Aug 3, 202611
  • Public float$289.4M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJan 8, 20201
  • Filings507 in all: 4 (184), 8-K (59), 144 (52), 3 (30), 425 (17), 10-Q (16), CORRESP (14), SCHEDULE 13G/A (13)1
    All 41 form types

    SCHEDULE 13G (10), SC 13G/A (9), UPLOAD (9), 424B3 (8), SC 13D/A (8), EFFECT (7), S-8 (7), 10-K (5), DEFA14A (5), SCHEDULE 13D/A (5), ARS (4), DEF 14A (4), S-3 (4), S-4/A (4), SC 13G (4), 424B5 (3), S-1 (3), S-1/A (3), SC 13D (3), D (2), POS EX (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), CERT (1), DRS (1), PRE 14A (1), RW (1), S-1MEF (1), S-4 (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 6, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareJBIONasdaq

From the cover page of the 10-K filed Mar 6, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Jade Biosciences, Inc. names in Item 1A of its 10-K filed Mar 6, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We are a clinical stage biotechnology company with a limited operating history on which to assess our business; we have not completed any clinical trials, and we have no products approved for commercial sale, which may make it difficult to evaluate our current business and likelihood of success and viability.
  • We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.
  • We expect to continue to incur losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have no products approved for sale, have not generated any revenue from our product candidates and may never generate revenue or become profitable.
  • Risks Related to Our Discovery, Development and Commercialization
  • We face competition from entities that have developed or may develop products for the diseases addressed by our product candidates.
  • Our programs are in the clinical and preclinical stages of development and may fail in development or suffer delays that materially and adversely affect our viability. If we or our current or future collaborators are unable to complete development of or commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We are substantially dependent on the success of JADE101, and our current and anticipated future clinical trials of such product candidate may not be successful.
  • If we do not achieve our projected development objectives in the time frames we announce and expect, the commercialization of our product candidates may be delayed which may harm our reputation and prospects, increase our expenses and cause our stock price to decline.
  • The target patient population for the treatment of IgAN is small and has not been definitively determined, and if our estimates of the number of treatable patients is lower than expected, our potential revenues from sales of our product candidates, if approved, and our ability to achieve profitability would be compromised.
  • Our approach to the discovery and development of our product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value.
  • Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
The other 62 risks
  • We may find it difficult to enroll participants in our clinical trials, particularly given the relatively small patient population and significant competition for patients who have the diseases for which JADE101 is being developed. If we encounter difficulties enrolling participants in our current clinical trial of JADE101 or future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Preliminary, “topline” or interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures.
  • Our current and future clinical trials or those of our current or future collaborators may reveal significant adverse events or undesirable side effects not seen in our preclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of our product candidates.
  • We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.
  • Any approved products resulting from our current programs or any future program may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such products.
  • Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.
  • We plan to conduct clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
  • Risks Related to Our Reliance on Third Parties
  • We rely on collaborations and licensing arrangements with third parties, including Paragon. If we are unable to maintain these collaborations or licensing arrangements, or if these collaborations or licensing arrangements are not successful, our business could be negatively impacted.
  • Risks associated with the in-licensing or acquisition of product candidates could cause substantial delays in the preclinical and clinical development of our product candidates.
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical 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.
  • Our reliance on foreign CROs and CMOs may increase the risks associated with our development programs.
  • We rely on the use of third-party CMOs to manufacture our product candidates, and we expect to continue to rely on third-party CMOs to produce our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.
  • Risks Related to Our Business and Operations
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our internal information technology systems, or those of any of our CROs, manufacturers, other contractors or consultants, third party service providers, or existing or future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
  • Our business may be affected by the evolving regulatory framework for AI Technologies.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • We may acquire businesses, product candidates or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions or alliances.
  • We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
  • Risks Related to Our Intellectual Property
  • We do not currently own any issued patents or pending patent applications and we in-license rights to JADE101 and JADE201 and hold an exclusive option to in-license rights to JADE301. Therefore, our ability to obtain and protect our patent rights, and protect other proprietary rights, is uncertain, exposing us to the possible loss of competitive advantage.
  • If we are unable to obtain or maintain necessary rights to our programs through acquisitions and in-licenses, our business may be materially harmed.
  • We may be subject to intellectual property lawsuits or may need to file lawsuits to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.
  • Our success will depend in part on our and our current and future licensors’ ability to obtain, maintain and enforce patent protection for our licensed intellectual property.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • 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 products.
  • We may become subject to claims challenging the inventorship or ownership of our patents, if issued, and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position of our product candidates for an adequate amount of time.
  • Our technology licensed from various third parties may be subject to retained rights.
  • Risks Related to Government Regulation
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates.
  • Our product candidates for which we intend to seek approval as biologics may face competition from biosimilars sooner than anticipated.
  • Even if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Disruptions at the FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages, staffing limitations or policy changes 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.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • We may face difficulties from healthcare and regulatory legislative reform measures.
  • Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Even if we are able to commercialize any product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such product candidates at competitive prices, which would seriously harm our business.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • If we seek and are unable to obtain accelerated approval, the amount, size and duration of our clinical trials could be greater than planned, which could increase the expense, reduce the likelihood, and/or delay the timing of obtaining necessary regulatory approvals. Even if we receive accelerated approval, if confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-approval requirements, such authorities may withdraw accelerated approval.
  • General Risk Factors
  • We may become exposed to costly and damaging liability claims, when testing a product candidate in the clinical stage or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Litigation costs and the outcome of litigation could have a material adverse effect on our business.
  • Our business could be adversely affected by economic downturns, inflation, fluctuating interest rates, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
  • Risks Related to the Ownership of Our Common Stock
  • The market price of our common stock has been and is expected to continue to be volatile.
  • We are governed by Nevada law and our articles of incorporation and bylaws, provisions of which have anti-takeover implications.
  • Because our articles of incorporation and bylaws limit the court in which you may bring an action against us, you may have difficulty obtaining a more favorable judicial forum or you may incur more expense enforcing any rights which you may claim as compared to another forum.
  • We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
  • Once we are no longer a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results and cash flows.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • Conflicts of interest may arise between us and Paragon or us and Fairmount.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, then our stock price and trading volume could decline.
  • Our ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of our recent merger.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to or aware of any legal proceedings that, in the opinion of management, would have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm, and other factors.

The opening of Item 3, Legal Proceedings.4

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