AYTU on Nasdaq

AYTU BIOPHARMA, INC

AYTU BIOPHARMA, INC is an American pharmaceutical preparations company, incorporated in Delaware.1 It is headquartered in Denver, Colorado.1

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Last updated Oct 21, 2026.

Overview

$57.6MRevenue, fiscal 20262
-$14.3MNet income, fiscal 20262

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  • TickerAYTU on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersDenver, Colorado1
  • Incorporated inDE3
  • Business address7900 E. Union Avenue, Suite 920, Denver, Co 802373
  • Filer categoryNon-accelerated filer, Smaller reporting company3

Aytu BioPharma, Inc. (“Aytu,” the “Company,” “we,” “us,” or “our”) is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. We were originally incorporated as Rosewind Corporation on August 9, 2002, in the state of Colorado and re-incorporated as Aytu BioScience, Inc. in the state of Delaware on June 8, 2015. In March 2021, we changed our name to Aytu BioPharma, Inc. Our common stock trades on the Nasdaq Capital Market LLC (the “Nasdaq”) under the ticker symbol “AYTU.” Our principal office is located at 7900 East Union Avenue, Suite 920, Denver, Colorado 80237, and our telephone number is (720) 437-6580.4 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

64.0%Gross margin2
-14.4%Operating margin2
-24.8%Net margin2
-13.3%Revenue growth, 20262
-40.4%Return on equity2
0.26×Debt to equity2
$3.3MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Cost of revenue36¢$20.8M
  • Other costs64¢$36.8M
  • Income tax0¢$21.0K

Out of $57.6M in revenue.2 The company lost money this year.

Where each dollar of operating cash went, fiscal 2026

  • Capital spending1¢$29.0K
  • Kept or used elsewhere99¢$3.3M

Out of $3.3M of cash from operations.2

Financial statements

Revenue56789102$57.6M in 2026+686% since 2019
0$50.0M$100.0M$150.0M2019: $7.3M$7.3M20192020: $27.6M$27.6M2020+277%2021: $65.6M$65.6M2021+138%2022: $96.7M$96.7M2022+47%2023: $107.4M$107.4M2023+11%2024: $65.2M$65.2M2024−39%2025: $66.4M$66.4M2025+2%2026: $57.6M$57.6M2026−13%
Gross profit6789102$36.8M in 2026+90% since 2020
0$20.0M$40.0M$60.0M$80.0M2020: $19.4M$19.4M20202021: $29.2M$29.2M2021+51%2022: $52.3M$52.3M2022+79%2023: $66.6M$66.6M2023+27%2024: $49.1M$49.1M2024−26%2025: $45.8M$45.8M2025−7%2026: $36.8M$36.8M2026−20%
Operating income56789102-$8.3M in 2026−51% since 2019
-$150.0M-$100.0M-$50.0M02019: -$16.8M-$16.8M20192020: -$21.1M-$21.1M2020+25%2021: -$58.9M-$58.9M2021+179%2022: -$109.9M-$109.9M2022+87%2023: -$17.1M-$17.1M2023−84%2024: -$1.6M-$1.6M2024−91%2025: -$7.8M-$7.8M2025+392%2026: -$8.3M-$8.3M2026+6%
Net income56789102-$14.3M in 2026−47% since 2019
-$150.0M-$100.0M-$50.0M02019: -$27.1M-$27.1M20192020: -$13.6M-$13.6M2020−50%2021: -$58.3M-$58.3M2021+328%2022: -$108.8M-$108.8M2022+87%2023: -$17.1M-$17.1M2023−84%2024: -$15.8M-$15.8M2024−7%2025: -$13.6M-$13.6M2025−14%2026: -$14.3M-$14.3M2026+5%

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

Period ending2026-06-302025-06-30
Net revenue$57.6M$66.4M
Cost of goods sold$20.8M$20.6M
Gross profit$36.8M$45.8M
Selling and marketing$23.4M$20.9M
General and administrative$19.3M$17.4M
Research and development$0$1.3M
Amortization of intangible assets$2.5M$3.7M
Restructuring costs$0$2.1M
Impairment expense$0$8.3M
Total operating expenses$45.1M$53.7M
Loss from operations-$8.3M-$7.8M
Other income (expense), net$713.0K-$512.0K
Interest expense-$1.9M-$3.7M
Derivative warrant liabilities loss-$4.7M-$1.7M
Loss from continuing operations before income tax expense-$14.2M-$13.7M
Income tax expense-$21.0K-$437.0K
Net loss from continuing operations-$14.3M-$14.2M
Net income from discontinued operations, net of tax$0$620.0K
Net loss-$14.3M-$13.6M
Basic and diluted weighted-average common shares outstanding (in shares)12.3M shares6.3M shares
Basic and diluted - continuing operations (in dollars per share)-$1-$2
Basic and diluted - discontinued operations, net of tax (in dollars per share)$0$0
Basic and diluted - net loss (in dollars per share)-$1.16-$2.16

Compare AYTU BIOPHARMA, INC with another company

Corporate structure

AYTU BIOPHARMA, 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 AYTU BIOPHARMA, INC

  • Laurence W. Lytton Filed SCHEDULE 13G/A on AYTU BIOPHARMA, INC, latest Aug 14, 2026 (4 filings since Jun 13, 2025)
  • AWM Investment Company, Inc. Filed SCHEDULE 13G/A on AYTU BIOPHARMA, INC, latest Feb 13, 2026 (2 filings since Aug 14, 2025)
  • Philotimo Fund, LP Filed SCHEDULE 13G/A on AYTU BIOPHARMA, INC, latest Nov 12, 2025 (5 filings since Jun 26, 2025)
  • Stonepine Capital Management, LLC Filed SCHEDULE 13G/A on AYTU BIOPHARMA, INC, latest Aug 13, 2025 (5 filings since Feb 11, 2022)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13D/A on AYTU BIOPHARMA, INC, latest Jun 9, 2025 (4 filings since May 26, 2023)
  • CVI Investments, Inc. Filed SC 13G/A on AYTU BIOPHARMA, INC, latest Feb 14, 2023 (2 filings since Aug 15, 2022)
  • AYTU BIOPHARMA, INC Denver, Colorado

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

What it owns

What AYTU BIOPHARMA, 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$1.2M2 Jun 30, 2026$1.2M2 Jun 30, 2025−4.2%
Accumulated depreciation$809.0K2 Jun 30, 2026$714.0K2 Jun 30, 2025+13.3%
Property and equipment, net$385.0K2 Jun 30, 2026$532.0K2 Jun 30, 2025−27.6%
Operating-lease assets (leased space)$857.0K2 Jun 30, 2026$1.1M2 Jun 30, 2025−19.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$26.3M2 Jun 30, 2026$31.0M2 Jun 30, 2025−15.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$41.4M2 Jun 30, 2026$42.2M2 Jun 30, 2025−1.9%
Finite-lived intangibles, gross$58.4M2 Jun 30, 2026$55.4M2 Jun 30, 2025+5.4%
Accumulated amortization$17.0M2 Jun 30, 2026$13.2M2 Jun 30, 2025+28.8%
Finite-lived intangibles, net$41.4M2 Jun 30, 2026$42.2M2 Jun 30, 2025−1.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$6.9M2 Jun 30, 2026$11.4M2 Jun 30, 2025−40.0%
Raw materials$1.1M2 Jun 30, 2026$1.1M2 Jun 30, 2025+1.8%
Work in process$2.3M2 Jun 30, 2026$1.4M2 Jun 30, 2025+68.6%
Finished goods$3.4M2 Jun 30, 2026$8.9M2 Jun 30, 2025−62.0%

Properties, in its own words

We lease various office buildings within the United States, which we continuously review and evaluate as a part of our strategy to optimize our business operations. The following table sets forth a list of our properties as of June 30, 2026:

Location · Leased/Owned · Purpose

The rest of Item 2

Denver, CO · Leased · Corporate headquarters

Berwyn, PA · Leased · Office

Item 2 of the 10-K filed Sep 22, 2026.4

Leadership

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

Board members and other officers (15)

Former names

  • AYTU BIOSCIENCE, INCJun 9, 2015 to Mar 22, 20213
  • Rosewind CORPJan 11, 2007 to Jun 8, 20153

Timeline

  1. Sep 22, 20268-K Results of operations36
  2. Jun 25, 20268-K Ended a material agreement37
  3. May 13, 20268-K Results of operations38
  4. Apr 2, 20268-K Entered a material agreement; Results of operations; Unregistered sale of shares39
  5. Feb 3, 20268-K Results of operations40
  6. Jan 20, 20268-K Regulation FD disclosure41
  7. Dec 10, 20258-K Shareholder vote42
  8. Nov 13, 20258-K Results of operations43
  9. Sep 23, 20258-K Results of operations44
  10. Aug 7, 20258-K Ended a material agreement45
  11. Jun 23, 20258-K Entered a material agreement; New debt or obligation; Regulation FD disclosure46
  12. Jun 17, 20258-K Regulation FD disclosure47
  13. Apr 27, 2015New chief executive Joshua R. Disbrow becomes CEO13

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.08) a share, on Nov 13, 2025.48

When it reported results

  1. Sep 22, 2026Reported quarterly or annual results36
  2. May 13, 2026Reported quarterly or annual results38
  3. Apr 2, 2026Reported quarterly or annual results39
  4. Feb 3, 2026Reported quarterly or annual results40
  5. Nov 13, 2025Reported quarterly or annual results43
  6. Sep 23, 2025Reported quarterly or annual results44
  7. May 14, 2025Reported quarterly or annual results49
  8. Feb 12, 2025Reported quarterly or annual results50

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

Filings

266 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 85 major events, 74 insider forms, 22 large holders, 63 other. The latest 20:

  1. Sep 22, 202610-K EDGAR
  2. Sep 22, 20268-K EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Jul 30, 20264 EDGAR
  5. Jul 30, 20264 EDGAR
  6. Jul 30, 20264 EDGAR
  7. Jul 30, 20264 EDGAR
  8. Jul 30, 20264 EDGAR
  9. Jul 30, 20264 EDGAR
  10. Jul 30, 20264 EDGAR
  11. Jul 30, 20264 EDGAR
  12. Jun 25, 20268-K EDGAR
  13. May 13, 202610-Q EDGAR
  14. May 13, 20268-K EDGAR
  15. Apr 2, 20268-K EDGAR
  16. Feb 17, 2026SCHEDULE 13G/A EDGAR
  17. Feb 13, 2026SCHEDULE 13G/A EDGAR
  18. Feb 3, 202610-Q EDGAR
  19. Feb 3, 20268-K EDGAR
  20. Jan 20, 20268-K EDGAR

The 266 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

9 open-market trades by officers, directors and large owners since October 2021: 9 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 9, 2025Disbrow JarrettChief Business OfficerBuy16,666$1.50$25.0KForm 4
Jun 9, 2025Disbrow Joshua R.Chief Executive OfficerBuy66,666$1.50$100.0KForm 4
Feb 28, 2025Disbrow Joshua R.Chief Executive OfficerBuy15,000$1.30$19.5KForm 4
Jun 16, 2023PYSZCZYMUKA GREGChief Commercial OfficerBuy12,000$1.87$22.4KForm 4
Jun 14, 2023Disbrow Joshua R.Chief Executive OfficerBuy14,000$1.86$26.0KForm 4
Dec 19, 2022Disbrow Joshua R.Chief Executive OfficerBuy112,371$0.22$24.7KForm 4
Dec 19, 2022PYSZCZYMUKA GREGChief Commercial OfficerBuy100,000$0.24$24.0KForm 4
Nov 18, 2022Disbrow Joshua R.Chief Executive OfficerBuy222,000$0.24$53.3KForm 4
Nov 18, 2022Oki Mark KChief Financial OfficerBuy90,000$0.23$20.7KForm 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
2025Chief Executive Officer since April 2015$590.0K$883.9K57
2025Chief Business Officer since November 2022$386.2K$549.2K57
2025Chief Financial OfficerCorporate Secretary and Treasurer since November 2024$379.8K$538.6K57
2025Chief Commercial Officer since January 2022$401.4K$522.1K57
2025Former Chief Financial OfficerCorporate Secretary and Treasurer$238.4K57
2024Chief Executive Officer since April 2015$590.0K$928.2K57
2024Former Chief Financial OfficerCorporate Secretary and Treasurer$427.4K$584.7K57
2024Chief Business Officer since November 2022$386.2K$542.1K57
2024Chief Commercial Officer since January 2022$389.4K$516.3K57

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 36. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Nantahala Capital Management, LLC2,173,624$4.7M0.1%+1,086,812
Stonepine Capital Management, LLC912,921$2.0M1.5%+120,632
AWM Investment Company, Inc.619,574$1.3M0.1%No change
Vanguard Capital Management LLC261,146$561.5K0.0%No change
Crown Advisors Management, Inc.200,000$430.0K0.2%+55,000
Diadema Partners LP148,546$319.4K0.1%−204,531
Two Sigma Investments, LP105,326$226.5K0.0%−16,647
Renaissance Technologies LLC104,823$225.4K0.0%+11,100
Geode Capital Management, LLC93,647$201.4K0.0%+1,011
Citadel Advisors LLC49,414$106.2K0.0%+12,573
Vanguard Fiduciary Trust Co47,048$101.2K0.0%No change
Dimensional Fund Advisors LP45,326$97.5K0.0%+1,741
Persistent Asset Partners Ltd37,984$81.7K0.0%−54,913
Northern Trust Corp27,925$60.0K0.0%+8,756
Bellevue Asset Management, LLC25,013$53.8K0.0%No change
BlackRock, Inc.22,793$49.0K0.0%No change
XTX Topco Ltd21,416$46.0K0.0%−166
Daytona Street Capital LLC10,000$22.4K0.0%No change
UBS Group AG2,377$5.1K0.0%+714
Tower Research Capital LLC (TRC)2,232$4.8K0.0%+668
Royal Bank Of Canada378$1.0K0.0%+342
Osaic Holdings, Inc.462$9910.0%No change
Jpmorgan Chase & Co154$3370.0%No change
Wells Fargo & Company/mn127$2730.0%No change
Morgan Stanley125$2690.0%No change

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

SEC filer profile

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

  • Name on EDGARAYTU BIOPHARMA, INC1
  • CIK0001385818
  • Employer ID (EIN)47-08831444
  • Filer statusNon-accelerated filer not 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 address7900 E. Union Avenue, Suite 920, Denver, CO 802371
  • Phone(720) 437-65801
  • Shares outstanding10,866,708 shares as of Sep 15, 20264
  • Public float$24.0M as of Dec 31, 20254
  • AuditorGRANT THORNTON LLP, Denver, Colorado PCAOB ID 248; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJan 11, 20071
  • Filings905 in all: 8-K (224), 4 (154), 10-Q (54), 424B3 (45), CORRESP (42), UPLOAD (32), EFFECT (27), 3 (24)1
    All 61 form types

    SC 13G/A (22), 425 (21), SC 13G (20), 10-K (19), S-1/A (18), DEF 14A (15), DEFA14A (15), 424B5 (12), S-1 (12), SC 13D/A (12), 8-K/A (9), PRE 14A (9), SCHEDULE 13G/A (8), 4/A (7), D (7), FWP (7), S-3 (7), 424B4 (6), POS AM (6), S-8 (5), 10QSB (4), SC 13D (4), SCHEDULE 13G (4), 10-K/A (3), ARS (3), CT ORDER (3), DEF 14C (3), S-1MEF (3), S-3/A (3), S-4 (3), SB-2/A (3), 10-Q/A (2), 10QSB/A (2), NT 10-K (2), NT 10-Q (2), PRE 14C (2), PRER14A (2), S-4/A (2), SC TO-I/A (2), 10KSB (1), 3/A (1), 424B2 (1), 5 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), D/A (1), DEL AM (1), DRS (1), REGDEX (1), SB-2 (1), SC TO-I (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Sep 22, 2026
    Quarterly report (10-Q) May 13, 2026
    Proxy statement (DEF 14A) Oct 24, 2025
    Latest 8-K (8-K) Sep 22, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareAYTUNasdaq

From the cover page of the 10-K filed Sep 22, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks AYTU BIOPHARMA, INC names in Item 1A of its 10-K filed Sep 22, 2026: 47 risks under these headings, as written.4

  • Risks Related to Our Business and Financial Position
  • We have incurred losses to date and can give no assurance of profitability.
  • We may need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain necessary capital when needed may force us to delay, limit or terminate our growth efforts or other operations. Further, future sales and issuances of our common stock or rights to purchase common stock will result in dilution of the percentage ownership of our existing stockholders and could cause our stock price to fall.
  • We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
  • The terms of our loan agreement place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We have been and, in the future, may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.
  • Risks Related to Commercialization
  • We are heavily dependent on the commercial success of our commercial products. To date, we have not generated sufficient net revenue from the sales of these products to achieve company-wide profitability and we may never achieve or maintain profitability.
  • If we are unable to differentiate our products from branded drugs or existing generic therapies for similar treatments, or if the FDA or other applicable regulatory authorities approve additional generic products that compete with any of our products, our ability to successfully commercialize such products would be adversely affected.
  • Our pharmaceutical products may prove to be difficult to effectively commercialize as planned or on the timeframes we announce and expect.
  • We rely on limited sources of supply for our products, and any disruption in the chain of supply may impact production and sales of our products, and cause delays in developing and commercializing our currently manufactured and commercialized products.
The other 37 risks
  • We rely on third parties to manufacture certain products, and third-party manufacturing risks and inefficiencies may result in costs and delays that prevent us from successfully commercializing products and adversely affect our ability to produce our products.
  • We face substantial competition, including the introduction of generics, from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us.
  • Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate net revenue.
  • Our financial results will depend on the acceptance among clinicians, third-party payors and the medical community of our products.
  • If third-party payors do not reimburse our customers for the products we sell or if reimbursement levels are set too low for us to sell one or more of our products at a profit, our ability to sell those products and our results of operations will be harmed.
  • Reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to comply with those obligations could subject us to penalties and sanctions.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • We are subject to United States and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
  • We are subject to various health care fraud and abuse and reimbursement laws pertaining to the marketing of our approved products.
  • Adzenys and Cotempla contain controlled substances, and their manufacture, use, sale, importation, exportation, prescribing and distribution are subject to regulation by the DEA.
  • The design, development, manufacture, supply and distribution of our products are technically complex and require regulatory compliance.
  • There is a risk we may be unable to sell and distribute certain of our products if we cannot continue to comply with the serialization requirements of the Drug Quality and Security Act within the necessary time frames.
  • Failure to comply with health and data protection laws and regulations could lead to United States federal and state government enforcement actions, including civil or criminal penalties, private litigation, and adverse publicity and could negatively affect our operating results and business.
  • We may use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time-consuming and costly.
  • Risks Related to Our Intellectual Property
  • A dispute concerning the infringement or misappropriation of our proprietary rights, or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
  • We are dependent on our relationships and license agreements, and we rely on the intellectual property rights granted to us pursuant to the license agreements.
  • The expiration or loss of patent protection may adversely affect our future net revenue and operating results.
  • Our ability to compete may decline if we do not adequately protect or enforce our intellectual property rights.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • Risks Related to Our Organization, Structure and Operation
  • Our efforts to expand and transform our businesses may require significant investments; if our strategies are unsuccessful, our business, results of operations and/or financial condition may be materially adversely affected.
  • We may have difficulties integrating acquired businesses or assets and such acquisitions may not result in the anticipated benefits, as a result, our business, results of operations and/or financial condition may be materially adversely affected.
  • In fiscal 2026, the great majority of our gross revenue and gross accounts receivable were due to five significant customers, the loss of which could materially and adversely affect our results of operations.
  • Our accounts receivable subjects us to credit risk.
  • Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Public concern over the abuse of medications that are controlled substances, including increased legislative, legal and regulatory action, could negatively affect our business.
  • Certain of our stockholders own a large percentage of our stock and their interests may conflict with yours.
  • Risk Related to Securities Markets and Investment in Our Securities
  • Our failure to maintain compliance with Nasdaq's continued listing requirements could result in the delisting of our common stock, which could adversely affect the liquidity and market price of our common stock and our ability to raise capital.
  • Effecting a reverse stock split, if determined by the Board in its discretion, may not achieve one or more of our objectives.
  • Our share price is volatile and may be influenced by numerous factors, some of which are beyond our control.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and any trading volume could decline.
  • Some provisions of our charter documents and applicable Delaware law may discourage an acquisition of us by others, even if the acquisition may be beneficial to some of our stockholders.
  • We are and may continue to be subject to short-selling strategies.
  • General Risk Factors
  • We are and may become involved in litigation or other proceedings from time to time relating to the enforcement or defense of patent and other intellectual property rights, which could cause us to divert our resources and could put our intellectual property at risk.
  • Our business and operations would suffer in the event of system failures, cybersecurity attacks, data leakages or other security breaches.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

Legal proceedings

From time to time, we become involved in or are threatened with legal disputes arising out of our business and operations in the normal course of business. Most of these disputes are not likely to have a material effect on our business, financial condition, or operations. Except as described below, as of the filing of this Annual Report, no legal proceedings are pending against us that we believe individually or collectively are likely to have a materially adverse effect upon our financial condition, results of operations, or cash flows.

Granules Paragraph IV. On October 31, 2024, the Company received the Notice Letter from Granules, stating that it intends to market a generic version of Adzenys before the expiration of all patents currently listed in the Orange Book. The Notice Letter states that Granules’ NDA for the generic version of Adzenys contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic version of Adzenys. On December 11, 2024, the Company filed a patent infringement lawsuit against Granules which triggered a stay precluding the FDA from approving Granules’ NDA for a generic version of Adzenys for up to 30 months or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. On January 7, 2025, Granules submitted an answer to the complaint. This litigation is ongoing, with trial originally scheduled to begin on December 7, 2026, now rescheduled to January 12, 2027. The Company plans to vigorously enforce its intellectual property rights related to Adzenys.

The opening of Item 3, Legal Proceedings.4

Sources

The numbers on this page point here. Each one links to the record it came from.

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