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Neuphoria Therapeutics Inc.

In its 2026 annual report the company says: “Neuphoria Therapeutics Inc. is a Delaware corporation and a clinical-stage biotechnology company. We are currently conducting limited active internal research and development activities focused on our alpha7 nicotinic acetylcholine receptor negative allosteric modulator portfolio. Our lead product candidate, BNC210, is an oral, proprietary, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor.”4 It is headquartered in Burlington, Massachusetts.1

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Last updated Oct 21, 2026.

Overview

$1.2MRevenue, fiscal 20262
-$13.5MNet income, fiscal 20262

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  • TickerNEUP on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBurlington, Massachusetts1
  • Incorporated inAustralia3
  • Business address100 Summit Dr, Burlington, Ma 018033
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3

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Neuphoria Therapeutics Inc. is a Delaware corporation and a clinical-stage biotechnology company. Following the results of our Phase 3 AFFIRM-1 trial and the restructuring actions taken during fiscal 2026, our activities are focused on completing the proposed merger with Scancell Holdings plc ("Scancell"), preserving cash, maintaining our public-company and contractual obligations, and managing our intellectual property and economic interests in partnered programs. We are currently conducting limited active internal research and development activities focused on our alpha7 nicotinic acetylcholine receptor negative allosteric modulator portfolio.4 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 2026

-1401.1%Operating margin2
-1145.7%Net margin2
-92.5%Revenue growth, 20262
-54.7%Return on equity2

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Other costs88¢$1.0M
  • Income tax12¢$139.2K

Out of $1.2M in revenue.2 The company lost money this year.

Financial statements

Revenue5672$1.2M in 2026+2416% since 2020
0$5.0M$10.0M$15.0M$20.0M2020: $46.7K$46.7K20202022: $263.6K$263.6K2022+465%2023: $22.0K$22.0K2023−92%2025: $15.6M$15.6M2025+70882%2026: $1.2M$1.2M2026−92%
Operating income872-$16.5M in 2026−25% since 2023
-$30.0M-$20.0M-$10.0M02023: -$22.0M-$22.0M20232024: -$17.9M-$17.9M2024−19%2025: -$1.1M-$1.1M2025−94%2026: -$16.5M-$16.5M2026+1357%
Net income56872-$13.5M in 2026+89% since 2020
-$30.0M-$20.0M-$10.0M02020: -$7.1M-$7.1M20202021: -$8.7M-$8.7M2021+22%2022: -$21.8M-$21.8M2022+150%2023: -$21.4M-$21.4M2023−2%2024: -$15.5M-$15.5M2024−28%2025: -$369.6K-$369.6K2025−98%2026: -$13.5M-$13.5M2026+3539%

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

Period ending2026-06-302025-06-30
Total revenue$1.2M$15.6M
Research and development$3.5M$9.0M
General and administrative$7.4M$7.8M
Restructuring costs$1.3M
Goodwill impairment$5.4M
Total operating expenses$17.6M$16.8M
Loss from operations-$16.5M-$1.1M
Interest income, net$665.6K$166.5K
Loss on foreign currency transactions-$535.7K-$415.0K
Research and development incentive award$800.9K$299.9K
Gain on fair value adjustments$1.9M$239.7K
Total other income$2.9M$291.1K
Loss before income taxes-$13.6M-$838.0K
Income tax benefit$139.2K$468.4K
Net loss-$13.5M-$369.6K
Unrealized gain on foreign currency translation$781.9K$168.5K
Total other comprehensive income$781.9K$168.5K
Comprehensive loss-$12.7M-$201.1K
Net loss per share - basic-$3.06-$0.23
Net loss per share - diluted-$3.06-$0.23
Weighted-average common shares outstanding - basic4.4M shares1.6M shares
Weighted-average common shares outstanding - diluted4.4M shares1.6M shares

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Corporate structure

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

Major holders of Neuphoria Therapeutics Inc.

  • AdvisorShares Trust Filed SCHEDULE 13G on Neuphoria Therapeutics Inc., latest Oct 5, 2026
  • Coastlands Capital LP Filed SCHEDULE 13G/A on Neuphoria Therapeutics Inc., latest Jul 28, 2026 (2 filings since Nov 5, 2025)
  • Baselake Partners, LP Filed SCHEDULE 13G/A on Neuphoria Therapeutics Inc., latest Feb 6, 2026 (2 filings since Oct 31, 2025)
  • Lynx1 Capital Management LP Filed SCHEDULE 13D/A on Neuphoria Therapeutics Inc., latest Dec 29, 2025 (9 filings since Oct 30, 2023)
  • Shay Capital LLC Filed SCHEDULE 13G on Neuphoria Therapeutics Inc., latest Oct 31, 2025
  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Neuphoria Therapeutics Inc., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
  • Apeiron Investment Group Ltd. Filed SCHEDULE 13D/A on Neuphoria Therapeutics Inc., latest Jan 28, 2025 (3 filings since Dec 30, 2021)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Neuphoria Therapeutics Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2022)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Neuphoria Therapeutics Inc., latest Feb 14, 2024 (2 filings since Sep 29, 2023)
  • TANG CAPITAL PARTNERS LP Filed SC 13G/A on Neuphoria Therapeutics Inc., latest Feb 14, 2024 (2 filings since Oct 10, 2023)
  • Neuphoria Therapeutics Inc. Burlington, Massachusetts

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

What it owns

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$2.8K2 Jun 30, 2025$2.0K7 Jun 30, 2024+39.0%
Operating-lease assets (leased space)$102.6K2 Jun 30, 2025$217.0K7 Jun 30, 2024−52.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$19.9M2 Jun 30, 2026$14.2M2 Jun 30, 2025+39.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$3.5M2 Jun 30, 2026$8.6M2 Jun 30, 2025−59.5%
Intangible assets, net (excluding goodwill)$4.1M2 Jun 30, 2026$4.8M2 Jun 30, 2025−13.8%

Properties, in its own words

The lease for our offices located at 200 Greenhill Road, Eastwood, South Australia 5063, Australia, expired on May 31, 2026. We have no remaining leased properties at June 30, 2026.

Item 2 of the 10-K filed Sep 18, 2026.4

Leadership

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

Chief executive

  1. Spyridon Papapetropoulos2024–now

President

  1. Spyridon Papapetropoulos2025–now

Chief financial officer

  1. Timothy M. Cunningham2024
2025
Board members and other officers (5)

Former names

  • BIONOMICS LIMITED/FISep 11, 2002 to Dec 23, 20243

Timeline

  1. Jul 24, 20268-K Entered a material agreement; Change in control; Regulation FD disclosure18
  2. May 26, 20268-K Other events19
  3. Jan 8, 20268-K Entered a material agreement; Ended a material agreement20
  4. Dec 18, 20258-K Listing notice or transfer21
  5. Dec 17, 20258-K Shareholder vote22
  6. Oct 27, 20258-K Entered a material agreement; Change to shareholders' rights; Bylaws or fiscal year changed23
  7. Oct 20, 20258-K Other events24
  8. Sep 16, 20258-K Listing notice or transfer25
  9. Jul 18, 20258-K Listing notice or transfer26
  10. May 20, 20258-K Results of operations27
  11. Jan 14, 20258-K Other events28
  12. Dec 23, 20248-K Entered a material agreement; Listing notice or transfer; Unregistered sale of shares29
  13. Jul 8, 2024New chief executive Spyridon Papapetropoulos becomes CEO11

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($4.41) a share, on Nov 14, 2025.30

When it reported results

  1. May 20, 2025Reported quarterly or annual results27

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

Filings

216 filings to the SEC since October 2021: 6 annual reports, 6 quarterly reports, 19 major events, 20 insider forms, 26 large holders, 139 other. The latest 20:

  1. Oct 5, 2026SCHEDULE 13G EDGAR
  2. Sep 18, 202610-K EDGAR
  3. Sep 18, 2026DEFA14A EDGAR
  4. Sep 18, 2026DEFA14A EDGAR
  5. Sep 18, 2026DEF 14A EDGAR
  6. Jul 28, 2026SCHEDULE 13G/A EDGAR
  7. Jul 24, 2026DEFA14A CURRENT REPORT EDGAR
  8. Jul 24, 20268-K CURRENT REPORT EDGAR
  9. May 26, 20268-K CURRENT REPORT EDGAR
  10. May 15, 202610-Q EDGAR
  11. Feb 17, 202610-Q EDGAR
  12. Feb 6, 2026SCHEDULE 13G/A EDGAR
  13. Jan 21, 20264 EDGAR
  14. Jan 21, 20264 EDGAR
  15. Jan 21, 20264 EDGAR
  16. Jan 21, 20264 EDGAR
  17. Jan 8, 20268-K CURRENT REPORT EDGAR
  18. Dec 29, 2025SCHEDULE 13D/A EDGAR
  19. Dec 18, 20258-K CURRENT REPORT EDGAR
  20. Dec 17, 20258-K CURRENT REPORT EDGAR

The 216 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

1 open-market trades by officers, directors and large owners since October 2021: 1 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 21, 2025Lynx1 Capital Management LP10% ownerBuy639,110$5.14$3.3MForm 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
2026Spyros Papapetropoulos, MD.President and Chief Executive Officer$284.6K$1.7M41
2026Tim Cunningham Chief FinancialOfficer$325.9K41
2025Spyros Papapetropoulos, MD.President and Chief Executive Officer$550.0K$923.5K41
2025Tim CunninghamChief Financial Officer$254.4K41

Held by these funds

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

FundSharesValueShare of the fundChange
Lynx1 Capital Management LP875,328$3.8M0.4%No change
AdvisorShares Investments LLC252,909$1.1M0.1%+97,542
Vanguard Capital Management LLC173,488$758.1K0.0%+74,972
Shay Capital LLC155,822$680.9K0.1%+4,812
Balyasny Asset Management L.P.142,228$621.5K0.0%+45
Citadel Advisors LLC72,559$317.1K0.0%+53,228
Geode Capital Management, LLC49,516$216.4K0.0%−2,491
Ikarian Capital, LLC47,443$207.3K0.0%No change
Vanguard Fiduciary Trust Co33,806$147.7K0.0%+217
ADAR1 Capital Management, LLC30,000$131.1K0.0%No change
Renaissance Technologies LLC25,500$111.4K0.0%New
XTX Topco Ltd23,089$100.9K0.0%New
Jane Street Group, LLC14,903$65.1K0.0%New
Boothbay Fund Management, LLC14,000$61.2K0.0%No change
Commonwealth Equity Services, LLC11,222$49.0K0.0%No change
Northern Trust Corp10,610$46.4K0.0%New
Merck & Co., Inc.10,027$43.8K0.0%No change
UBS Group AG2,117$9.3K0.0%−199
Morgan Stanley58$2540.0%No change
Hrt Financial LP22,865$990.0%New
Caitong International Asset Management Co., Ltd3$130.0%New

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

SEC filer profile

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

  • Name on EDGARNeuphoria Therapeutics Inc.1
  • CIK0001191070
  • Employer ID (EIN)99-38454484
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsJune 301
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address100 Summit Dr, Burlington, MA 018031
  • Phone781-439-55511
  • Shares outstanding5,411,334 shares as of Sep 17, 20264
  • Public float$7.0M as of Dec 31, 20254
  • AuditorWolf & Company P.C., Boston, Massachusetts PCAOB ID 392; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 11, 20021
  • Filings418 in all: SUPPL (193), 6-K (48), 8-K (19), CORRESP (13), 4 (11), DEFA14A (11), UPLOAD (10), EFFECT (9)1
    All 50 form types

    3 (8), 424B5 (7), 10-Q (6), ARS (6), SCHEDULE 13D/A (6), DFAN14A (5), SC 13G (5), SC 13G/A (5), SCHEDULE 13G (4), 10-K (3), DEF 14A (3), F-1 (3), F-1/A (3), SCHEDULE 13G/A (3), 20-F (2), 424B4 (2), DEFC14A (2), DRS (2), POS AM (2), PREC14A (2), S-3 (2), S-3/A (2), S-8 (2), 12G3-2B (1), 15-12G (1), 20-F/A (1), 4/A (1), 424B3 (1), 8-A12B (1), CERT (1), D (1), DFRN14A (1), DRS/A (1), DRSLTR (1), F-1MEF (1), F-3 (1), F-6 (1), NT 10-Q (1), PRE 14A (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Sep 18, 2026
    Quarterly report (10-Q) May 15, 2026
    Proxy statement (DEF 14A) Sep 18, 2026
    Latest 8-K (8-K) Jul 24, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.00001 par value per shareNEUPThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Sep 18, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Neuphoria Therapeutics Inc. names in Item 1A of its 10-K filed Sep 18, 2026: 75 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Requirements
  • We are a clinical-stage biopharmaceutical company with no approved products. We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
  • Raising additional capital may cause dilution to our shareholders, including holders of our common stock, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • Sales of Common Stock issuable upon exercise of the Warrant and other derivative securities could cause the market price of our Common Stock to decline.
  • Sales of a substantial number of our shares of Common Stock by significant existing shareholders in the public market, or the perception that such sales may occur, could depress the trading price of our shares of Common Stock, and if there were a change of control transaction, the warrant holder may be entitled to significant cash payment in lieu of exercise thereunder.
  • The trading price of our shares of common stock has been volatile, and holders of our common stock may not be able to resell the shares of common stock at or above the price paid.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations and the price of our common stock.
  • If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our Common Stock.
  • An active, liquid trading market for our common stock may not be maintained.
  • We are not currently paying dividends and will likely continue not paying cash dividends on our common stock for the foreseeable future.
  • We are an “emerging growth company” (as defined in the JOBS Act) and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.
The other 64 risks
  • We incur significant costs as a result of operating as a U.S. listed public company and our management is required to devote substantial time and expense to various compliance issues.
  • If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our commons stock adversely, the trading price and volume of our Common Stock could decline.
  • As a U.S. public reporting company, we are required to maintain effective internal control over financial reporting suitable to prepare our publicly reported financial statements in a timely and accurate manner.
  • Our operating results and financial condition have been, and may continue to be, adversely affected by non-cash goodwill impairment charges.
  • We may become involved in securities class action litigation that could divert management’s attention and adversely affect our business and could subject us to significant liabilities.
  • Our financial statements in prior years had been prepared assuming that we will continue as a going concern.
  • Our operating results have fluctuated significantly in the past and may continue to do so in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • If we lose research and development incentives from the Australian government, then we could encounter difficulties in funding future research and development projects, which could harm our operating results.
  • Our ability to utilize our tax losses and certain other tax attributes may be limited.
  • Inflation could adversely affect our business and results of operations.
  • Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
  • Our preclinical and clinical programs may experience delays, unforeseen costs or may never advance, which could adversely affect our ability to obtain regulatory approvals or commercialize our product candidates on a timely basis or at all, which could have an adverse effect on our business and shareholder value.
  • If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • If we experience delays or difficulties in the initiation, enrollment and/or retention of patients in clinical trials, our regulatory submissions or receipt of necessary regulatory approvals could be delayed or prevented.
  • Interim, topline or preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If our clinical trials fail to replicate 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 our product candidates.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our current or future product candidates, we will not be able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.
  • Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
  • We may fail to obtain Breakthrough Therapy designation or Fast Track designation from the FDA for our current or future product candidates. Even if granted for any of our current or future product candidates, these programs may not lead to a faster development, regulatory review or approval process, and such designations do not increase the likelihood that any of our product candidates will receive marketing approval in the U.S.
  • If the market opportunities for our product candidates in PTSD or other indications we may pursue are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially.
  • Even if we receive marketing authorization for 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.
  • Even if we receive marketing approval for our current or future product candidates in the United States, we may never receive regulatory approval to market our current or future product candidates outside of the United States.
  • Changes in funding or disruptions at the FDA, the SEC, patent offices in the United States and abroad 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 or modified products from being developed, approved or commercialized in a timely
  • manner or at all, 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.
  • We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials, which may subject us to delays and expenses.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We have historically been highly dependent on the members of our senior management and scientific staff. We may in the future have difficulties in attracting and retaining key personnel, and if we fail to do so our business may suffer.
  • Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development programs and other critical business functions.
  • Risks associated with our international operations, including seeking and obtaining approval to commercialize our product candidates in foreign jurisdictions, could harm our business.
  • Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials are prolonged or delayed, we, or our collaborators, may be unable to commercialize our product candidates on a timely basis.
  • Risks Related to Our Reliance on Third Parties
  • If our collaboration partners fail to perform as expected, fail to advance our collaboration product candidates, are unable to obtain the required regulatory approvals for our collaboration product candidates, or if the arrangements are terminated, the potential for us to generate future revenue from such product candidates would be significantly reduced and our business would be significantly harmed.
  • We may explore future collaborations with third parties for the development and commercialization of our current product candidates that are not partnered. If we are unable to form such collaborations or they are not successful, we may not be able to complete the development of these product candidates.
  • We currently rely extensively, and expect to continue to rely, 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, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing authorizations for or commercialize our current and potential future product candidates and our business could be substantially harmed.
  • The third parties upon whom we rely for the supply drug product and starting materials used in our product candidates are limited in number, and the loss of any of these suppliers, or their noncompliance with regulatory requirements or our quality standards, could significantly harm our business.
  • We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development and supply of BNC210.
  • Our success is dependent on our executive management team’s ability to successfully pursue business development, strategic partnerships and investment opportunities as our company matures. We may also form or seek strategic alliances or acquisitions or enter into additional collaboration and licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances, acquisitions or licensing arrangements.
  • Manufacturing clinical trial ready product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide supply of our current or future product candidates for preclinical studies and future clinical trials or for commercial purposes could be delayed or stopped.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • The increasing use of social media platforms presents new risks and challenges.
  • Risks Related to Commercialization of our Product Candidates
  • Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.
  • If we are unable to establish sales, marketing, and distribution capabilities for any product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
  • Third-party payor coverage and reimbursement status of newly-approved drugs is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue.
  • We are exposed to potential product liability or similar claims, and insurance against these claims may not be available to us at a reasonable rate in the future or at all.
  • Risks Related to Regulation of Our Industry
  • The regulatory approval processes of the FDA, EMA and comparable authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.
  • Changes in methods of product candidate manufacturing, formulation and mixed clinical trial results calling for an altered clinical approach may result in additional costs or delay.
  • Even if we obtain and maintain approval for our product candidates from one jurisdiction, we may never obtain approval for our product candidates in other jurisdictions, which would limit our market opportunities and adversely affect our business.
  • We may be subject to healthcare laws, regulation and enforcement and our failure to comply with these laws could harm our results of operations and financial conditions.
  • Our employees, independent contractors, principal investigators, CROs, consultants, vendors and collaboration partners 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.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient patent and other intellectual property protection for our product candidates and technology, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any product candidates we may develop.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Changes in U.S. patent laws, or laws in other countries, could diminish the value of patents in general and may limit our ability to obtain, defend, and/or enforce our patents.
  • Some of our intellectual property is licensed to us by a third party. If we fail to comply with our obligations in the agreement under which we license intellectual property rights from that third party, or otherwise experience disruptions to our business relationships with our licensor, we could lose license rights that are important to our business.
  • Our intellectual property licensed from third parties may be subject to retained rights.
  • If we are unable to obtain intellectual property licenses from third parties on commercially reasonable terms or at all, our business could be harmed.
  • Any issued patents we may own covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO.
  • Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from developing or selling our products.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.

Legal proceedings

Our management is not aware of any current formal material claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows. From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. We intend to defend vigorously against any future claims and litigation.

The opening of Item 3, Legal Proceedings.4

Sources

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