Private company

SOLENO THERAPEUTICS INC

In its 2026 annual report the company says: “We are a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. We are incorporated in the State of Delaware and headquartered in Redwood City, California.”5

Last updated Oct 20, 2026.

Overview

  • IndustryPharmaceutical Preparations2
  • HeadquartersRedwood City, United States2
  • Incorporated inDE3
  • Business address100 Marine Parkway, Suite 400, Redwood City, Ca 940653
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI5493003LCY77N7FXK8442
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 30838822

See how the biggest companies compare on our leaderboards

We are a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. On March 26, 2025, we announced that our lead product candidate, VYKAT TM XR (diazoxide choline) extended-release tablets, formerly known as DCCR, had been approved by the U.S. Food and Drug Administration (FDA). VYKAT XR is indicated to treat hyperphagia in adults and pediatric patients four years of age and older with Prader-Willi syndrome (PWS). On April 14, 2025, we announced that prescriptions of VYKAT XR had been delivered to the first individuals living with PWS who had been prescribed the medication and began recognizing revenue from the sales of VYKAT XR during the three months ended June 30, 2025. We are incorporated in the State of Delaware and headquartered in Redwood City, California.5 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

4.9%Operating margin6
11.0%Net margin6
4.6%Return on equity6
0.11×Debt to equity6
$46.7MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$2.7M
  • Research and development21¢$40.6M
  • Selling, general and admin67¢$132.1M
  • Profit11¢$20.9M

Out of $190.4M in revenue.6

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$73.0K
  • Share buybacks100¢$100.1M

Out of $46.8M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.6

Financial statements

Operating income789106$9.4M in 2025
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: -$23.5M-$23.5M20192020: -$36.3M-$36.3M2020+55%2021: -$31.5M-$31.5M2021−13%2022: -$24.4M-$24.4M2022−23%2023: -$41.4M-$41.4M2023+70%2024: -$187.7M-$187.7M2024+353%2025: $9.4M$9.4M2025
Net income789106$20.9M in 2025
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: -$30.8M-$30.8M20192020: -$24.6M-$24.6M2020−20%2021: -$30.9M-$30.9M2021+25%2022: -$24.1M-$24.1M2022−22%2023: -$39.0M-$39.0M2023+62%2024: -$175.8M-$175.8M2024+351%2025: $20.9M$20.9M2025
Fiscal year2019202020212022202320242025
Revenue$190.4M6
Cost of revenue$2.7M6
Gross profit
Research and development$16.3M7$23.2M8$21.5M9$15.3M10$25.2M6$78.6M6$40.6M6
Selling, general and admin$13.5M6$105.9M6$132.1M6
Operating expenses$31.5M9$24.4M10$41.4M6$187.7M6$181.0M6
Operating income-$23.5M7-$36.3M8-$31.5M9-$24.4M10-$41.4M6-$187.7M6$9.4M6
Interest
Income before tax-$30.9M9-$24.1M10-$39.0M6-$175.8M6$20.9M6
Income tax$06$06$06
Net income-$30.8M7-$24.6M8-$30.9M9-$24.1M10-$39.0M6-$175.8M6$20.9M6
Earnings per share-$5.819-$2.8710-$2.366-$4.386$0.406
Earnings per share (diluted)-$5.819-$2.8710-$2.366-$4.386$0.396
Shares (weighted, basic)5.3M shares98.4M shares1016.5M shares640.2M shares650.8M shares6
Shares (weighted, diluted)5.3M shares98.4M shares1016.5M shares640.2M shares652.4M shares6

Compare SOLENO THERAPEUTICS INC with another company

Corporate structure

SOLENO THERAPEUTICS INC sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of SOLENO THERAPEUTICS INC

  • Wellington Management Company Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Aug 13, 2026 (3 filings since Feb 10, 2026)
  • Avoro Capital Advisors LLC Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest May 15, 2026 (4 filings since Nov 14, 2024)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest May 15, 2026 (3 filings since May 14, 2025)
  • State Street Corporation Filed SCHEDULE 13G on SOLENO THERAPEUTICS INC, latest May 12, 2026
  • FMR LLC Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest May 7, 2026 (4 filings since Aug 6, 2025)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest May 7, 2026 (10 filings since Oct 6, 2023)
  • BlackRock Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Apr 24, 2026 (3 filings since Oct 24, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Mar 27, 2026 (2 filings since Oct 31, 2025)
  • Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Nov 14, 2025 (8 filings since May 15, 2023)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Nov 13, 2025 (4 filings since Nov 12, 2024)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Aug 14, 2025 (7 filings since Feb 14, 2022)
  • ADAGE CAPITAL PARTNERS GP, L.L.C. Filed SCHEDULE 13G/A on SOLENO THERAPEUTICS INC, latest Feb 12, 2025 (3 filings since Oct 12, 2023)
  • SOLENO THERAPEUTICS INC Redwood City, California, United States
    • Essentialis, Inc. Subsidiary · Delaware, United States
    • Soleno Therapeutics Europe Ltd. Subsidiary · Ireland
    • Soleno Therapeutics U.K. Ltd. Subsidiary · United Kingdom

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 SOLENO 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, before depreciation$308.0K6 Dec 31, 2025$256.0K6 Dec 31, 2024+20.3%
Accumulated depreciation$123.0K6 Dec 31, 2025$70.0K6 Dec 31, 2024+75.7%
Property and equipment, net$185.0K6 Dec 31, 2025$186.0K6 Dec 31, 2024−0.5%
Operating-lease assets (leased space)$2.2M6 Dec 31, 2025$2.8M6 Dec 31, 2024−21.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$70.1M6 Dec 31, 2025$87.9M6 Dec 31, 2024−20.3%
Marketable securities, current$235.4M6 Dec 31, 2025$203.5M6 Dec 31, 2024+15.7%
Marketable securities, non-current$200.6M6 Dec 31, 2025$27.2M6 Dec 31, 2024+637.3%
Debt securities available for sale$436.0M6 Dec 31, 2025$230.7M10 Dec 31, 2024+89.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$4.9M6 Dec 31, 2025$6.8M6 Dec 31, 2024−28.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$15.0M6 Dec 31, 2025$014 Dec 31, 2018
Raw materials$6.4M6 Dec 31, 2025
Work in process$2.7M6 Dec 31, 2025$30.0K14 Dec 31, 2017+8933.3%
Finished goods$6.0M6 Dec 31, 2025$177.0K14 Dec 31, 2017+3302.3%

Properties, in its own words

Facilities

Our principal facilities primarily consist of one office space in Redwood City, California. We currently occupy 18,026 square feet of office space under a non-cancelable operating lease that expires in August 2029. On November 25, 2025, we executed an amendment to our operating lease which gives us access to another 17,779 square feet of office space, but we had not yet taken possession of such space as of December 31, 2025. We also lease a small office space in Dublin, Ireland that houses our European operations that expires in October 2026.

The rest of Item 2

We believe that the facilities that we currently lease are adequate for our needs for the immediate future and that, should it be needed, additional space can be leased on commercially reasonable terms to accommodate any future needs.

Item 2 of the 10-K filed Feb 25, 2026.5

Leadership

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

Chief executive

  1. Bhatnagar Anish2014–now

President

  1. Bhatnagar Anish2014–2019

Chief financial officer

  1. Jonathan Wolter2018–2019
  2. James H. Mackaness2019–2026
  3. Jennifer Fulk2026–now
201520202025
Board members and other officers (26)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorAnish Bhatnagar named Oct 4, 202344
  • DirectorWilliam Harris named Oct 4, 202344

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Essentialis, Inc. Delaware4
  • Soleno Therapeutics Europe Ltd. Ireland4
  • Soleno Therapeutics U.K. Ltd. United Kingdom4

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

Former names

  • Capnia, Inc.Feb 24, 2010 to May 11, 20173

Timeline

  1. May 18, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer45
  2. Apr 7, 20268-K Other events46
  3. Apr 6, 20268-K Entered a material agreement; Regulation FD disclosure47
  4. Mar 16, 20268-K Bylaws or fiscal year changed48
  5. Feb 26, 20268-K Executive or director change; Other events49
  6. Feb 25, 20268-K Results of operations50
  7. Jan 23, 20268-K Executive or director change51
  8. Jan 12, 20268-K Results of operations52
  9. Nov 12, 20258-K Entered a material agreement; New debt or obligation; Other events53
  10. Nov 4, 20258-K Results of operations54
  11. Oct 14, 20258-K Executive or director change; Other events55
  12. Sep 10, 20258-K Regulation FD disclosure56
  13. Nov 12, 2014New chief executive Bhatnagar Anish becomes CEO15
  14. Aug 25, 1999Founded SOLENO THERAPEUTICS INC is founded2

Calendar

When it reported results

  1. Feb 25, 2026Reported quarterly or annual results50
  2. Jan 12, 2026Reported quarterly or annual results52
  3. Nov 4, 2025Reported quarterly or annual results54
  4. Aug 6, 2025Reported quarterly or annual results57
  5. Jul 10, 2025Reported quarterly or annual results58
  6. May 7, 2025Reported quarterly or annual results59
  7. Mar 26, 2025Reported quarterly or annual results60
  8. Feb 27, 2025Reported quarterly or annual results61

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

Filings

446 filings to the SEC since October 2021: 6 annual reports, 14 quarterly reports, 67 major events, 196 insider forms, 72 large holders, 1 private raises, 90 other. The latest 20:

  1. Aug 13, 2026SCHEDULE 13G/A EDGAR
  2. May 28, 202615-12G EDGAR
  3. May 27, 2026EFFECT EDGAR
  4. May 21, 2026POS AM EDGAR
  5. May 21, 2026AW EDGAR
  6. May 18, 20264 EDGAR
  7. May 18, 20264 EDGAR
  8. May 18, 20264 EDGAR
  9. May 18, 20264 EDGAR
  10. May 18, 20264 EDGAR
  11. May 18, 20264 EDGAR
  12. May 18, 20264 EDGAR
  13. May 18, 20264 EDGAR
  14. May 18, 20264 EDGAR
  15. May 18, 20264 EDGAR
  16. May 18, 20264 EDGAR
  17. May 18, 20264 EDGAR
  18. May 18, 20264 EDGAR
  19. May 18, 2026S-8 POS EDGAR
  20. May 18, 2026S-8 POS EDGAR

The 446 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

150 open-market trades by officers, directors and large owners since October 2021: 21 buys and 129 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 27, 2026Huang Michael F.Sr. VP of Clinical DevelopmentSale6,582$30.44$200.4KForm 4
Mar 27, 2026Manning MeredithChief Commercial OfficerSale7,522$30.44$229.0KForm 4
Jul 1, 2025Hirano Patricia CSEE REMARKSSale3,830$82.76$317.0KForm 4
Jun 24, 2025Hirano Patricia CSEE REMARKSSale266$84.25$22.4KForm 4
Apr 1, 2025Hirano Patricia CSEE REMARKSSale3,782$70.11$265.2KForm 4
Mar 28, 2025Pauls MatthewDirectorSale5,937$71.55$424.8KForm 4
Mar 28, 2025Hirano Patricia CSEE REMARKSSale27,662$69.40$1.9MForm 4
Mar 28, 2025Vivo Opportunity Fund Holdings, L.P.10% ownerSale333,557$70.60$23.5MForm 4
Mar 27, 2025Yen KristenSEE REMARKSSale95,500$66.77$6.4MForm 4
Mar 27, 2025Manning MeredithChief Commercial OfficerSale45,249$67.28$3.0MForm 4
Mar 27, 2025Mackaness James HCHIEF FINANCIAL OFFICERSale90,622$69.45$6.3MForm 4
Mar 27, 2025Huang Michael F.Sr. VP of Clinical DevelopmentSale14,583$69.51$1.0MForm 4
Mar 27, 2025Hirano Patricia CSEE REMARKSSale128,653$68.32$8.8MForm 4
Mar 27, 2025Anish BhatnagarCHIEF EXECUTIVE OFFICERSale699,095$67.62$47.3MForm 4
Mar 27, 2025Vivo Opportunity Fund Holdings, L.P.10% ownerSale1,100,000$67.80$74.6MForm 4
Mar 26, 2025Vivo Opportunity Fund Holdings, L.P.10% ownerSale400,000$65.80$26.3MForm 4
Jan 3, 2025Yen KristenSEE REMARKSSale2,340$46.18$108.1KForm 4
Jan 3, 2025Mackaness James HCHIEF FINANCIAL OFFICERSale3,791$46.18$175.1KForm 4
Jan 3, 2025Hirano Patricia CSEE REMARKSSale1,459$46.18$67.4KForm 4
Jan 3, 2025Anish BhatnagarCHIEF EXECUTIVE OFFICERSale10,154$46.18$468.9KForm 4

All 150 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
2024Anish Bhatnagar57$640.0K$51.2M83
2024James Mackaness61$460.0K$8.8M83
2024Meredith ManningChief Commercial Officer53$415.2K$7.8M83
2024Patricia Hirano58$375.0K$6.1M83
2023CEO and Chairman of the Board$556.8K$4.1M83
2023Chief Financial Officer$400.0K$1.2M83
2023Senior Vice PresidentRegulatory Affairs$340.0K$1.0M83

Money raised

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

  1. Oct 2, 2023Raised $60 million in a private offering of equity Form D: 14 investors so far Form D

SEC filer profile

How SOLENO 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 EDGARSOLENO THERAPEUTICS INC1
  • CIK0001484565
  • Employer ID (EIN)77-05238915
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address100 Marine Parkway, Suite 400, Redwood City, CA 940651
  • Phone650-213-84441
  • Shares outstanding52,120,147 as of Apr 30, 202612
  • Public float$4.1M as of Jun 30, 20255
  • AuditorCBIZ CPAs P.C., San Francisco, CA PCAOB ID 199; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 24, 20101
  • Filings1,135 in all: 4 (436), 8-K (150), 424B3 (49), 3 (43), 10-Q (35), SC 13D/A (33), CORRESP (29), SCHEDULE 13G/A (29)1
    All 62 form types

    UPLOAD (28), SC 13G (24), 144 (22), S-1/A (22), SC 13G/A (20), EFFECT (17), 424B5 (16), S-8 (16), S-8 POS (16), DEF 14A (14), 10-K (12), D (10), S-1 (10), DEFA14A (9), SCHEDULE 13G (7), 4/A (6), 8-K/A (6), 10-Q/A (5), PRE 14A (5), SC 13D (5), SC TO-C (5), POS AM (4), SC TO-I/A (4), ARS (3), PRER14A (3), S-3 (3), SC TO-T/A (3), 10-K/A (2), 25-NSE (2), AW (2), CERTNAS (2), D/A (2), FWP (2), POSASR (2), S-4/A (2), SC 14D9/A (2), 15-12G (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-A12B/A (1), DEFM14A (1), DEFR14A (1), DEL AM (1), DRS (1), PREM14A (1), S-1MEF (1), S-3ASR (1), S-3MEF (1), S-4 (1), SC 14D9 (1), SC TO-I (1), SC TO-T (1), SC14D9C (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) May 7, 2026
    Proxy statement (DEF 14A) Apr 22, 2025
    Latest 8-K (8-K) May 18, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueSLNONASDAQ

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks SOLENO THERAPEUTICS INC names in Item 1A of its 10-K filed Feb 25, 2026: 62 risks under these headings, as written.5

  • Risks related to our financial condition and capital requirements
  • We have limited commercialization history as a company and, until recently, have incurred significant losses since our inception.
  • We have just begun to generate product revenue and are dependent upon the success of VYKAT XR.
  • 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 or below our guidance.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • We may not be able to enter into strategic transactions on a timely basis or on acceptable terms, which may impact our development and commercialization plans.
  • We may need additional funds to support our operations, and such funding may not be available to us on acceptable terms, or at all, which would force us to delay, reduce or suspend our research and development programs and other operations or commercialization efforts. Raising additional capital may subject us to unfavorable terms, cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our planned products and technologies.
  • We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future.
  • Risks related to the commercialization of VYKAT XR
  • VYKAT XR may fail to achieve the degree of market acceptance by physicians, patients, caregivers, healthcare payers and others in the medical community necessary for sustained commercial success.
  • If the market opportunity for VYKAT XR is smaller than we believe it is, then our revenues may be adversely affected, and our business may suffer.
  • If we are unable to execute our sales and marketing strategy for VYKAT XR or are unable to gain acceptance in the market, we may be unable to generate sufficient revenue to sustain our business.
The other 52 risks
  • If we are unable to build our sales, marketing, distribution, training and support functions or enter into agreements with third parties to perform these functions, we will not be able to effectively commercialize VYKAT XR and may not sustain profitability.
  • If physicians decide not to prescribe VYKAT XR, we may be unable to generate sufficient revenue to sustain our business.
  • We may attempt to form partnerships with respect to VYKAT XR, but we may not be able to do so, which may cause us to alter our development and commercialization plans and may cause us to terminate any such programs.
  • VYKAT XR may cause serious adverse events or side effects or have other properties that could limit the commercial desirability or result in significant negative consequences following commercialization.
  • We face competition, which may result in others discovering, developing or commercializing products more successfully than we do.
  • Even if we are able to engage partners in commercializing VYKAT XR, they may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.
  • If we fail to obtain regulatory approval for our products in the E.U. or other jurisdictions our business would be harmed.
  • International expansion of our business will expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the U.S.
  • Risks related to the operation of our business
  • We expect to continue to expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • The loss of key members of our executive management team could adversely affect our business.
  • There is a scarcity of experienced professionals in our industry. If we are not able to retain and recruit personnel with the requisite technical skills, we may be unable to successfully execute our business strategy.
  • Any future development or commercialization agreements we may enter into for our products may place the development or distribution of these products outside our control, may require us to relinquish important rights, or may otherwise be on terms unfavorable to us.
  • Because we intend to do business outside the U.S., we will be subject to additional risks.
  • We have incurred and will continue to incur significant increased costs as a result of operating as a public company, and our management has devoted and will be required to continue to devote substantial time to new compliance initiatives.
  • We are required by Section 404 to evaluate the effectiveness of our internal control over financial reporting. If we are unable to achieve and maintain effective internal controls, our operating results and financial condition could be harmed and the market price of our common stock may be negatively affected.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which would harm our business.
  • If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
  • In the future we may identify material weaknesses, fail to remediate our current material weakness or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our financial statements or cause us to fail to meet our periodic reporting obligations.
  • If we experience an interruption in supply from a material sole source supplier, our business may be harmed.
  • In the United States, we rely on one specialty pharmacy to dispense VYKAT XR, deliver customer support, and provide us with related services, and our business could be harmed and we could be subject to liabilities if these services are performed inadequately or in a manner that does not comply with applicable laws and regulations.
  • We rely on third parties to conduct certain components of our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies.
  • Risks related to intellectual property
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Our ability to successfully commercialize our products may be materially adversely affected if we are unable to obtain and maintain effective intellectual property rights for our planned products, or if the scope of the intellectual property protection is not sufficiently broad.
  • We may become involved in legal proceedings to protect or enforce our intellectual property rights, which could be expensive, time-consuming, or unsuccessful.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
  • We may not be able to protect or enforce our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Obtaining and maintaining 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 for non-compliance with these requirements.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • If we do not obtain a patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our planned products, our business may be materially harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Risks related to government regulation
  • The regulatory approval process is expensive, time consuming and uncertain, and we may not be successful in obtaining approvals for our planned products.
  • Any “topline”, interim, initial, or preliminary 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 that could result in material changes in the final data.
  • Even if we receive marketing approval for a planned product, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
  • Failure to obtain marketing approvals in foreign jurisdictions will prevent us from marketing our products internationally.
  • Healthcare reform measures could hinder or prevent our commercial success.
  • If we fail to comply with U.S. healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • Our relationships with healthcare providers, other customers, and third-party payers are subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, and diminished profits and future earnings.
  • We are subject to U.S. and foreign laws regarding privacy, data protection, and data security that could entail substantial compliance costs, while the failure to comply could subject us to significant liability.
  • Risks related to ownership of our securities
  • Our stock price may be volatile, and purchasers of our securities could incur substantial losses.
  • Future sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline, even if our business is doing well.
  • Our ability to use our net operating loss carry forwards and certain other tax attributes will be limited.
  • 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.
  • We recently have been and may be in the future become subject to short-selling campaigns, activist investors and securities litigation, which are expensive and could divert management attention.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our company policies may require us to pay severance benefits to our executive officers who are terminated in connection with a change in control of us, which could harm our financial condition or results.
  • We have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to the value of our stock.
  • General risks
  • Our information technology systems may fail or experience security breaches and incidents that could adversely impact our business and operations and subject us to liability.
  • Unfavorable U.S. or global economic conditions as a result of international conflict, or otherwise, could adversely affect our ability to raise capital and our business, results of operations and financial condition.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Environmental, social, and governance (ESG) matters are subject to increasing scrutiny and evolving expectations from customers, regulators, investors and other stakeholders and may expose us to reputational, cost and other risks.
  • If our facilities or our third-party manufacturers’ facilities become unavailable or inoperable, our research and development program and commercialization plan could be adversely impacted and manufacturing of our products could be interrupted.

Legal proceedings

We may, from time to time, be party to litigation and subject to claims that arise in the ordinary course of business. In addition, third parties may, from time to time, assert claims against us in the form of letters and other communications. We currently believe that these ordinary course matters will not have a material adverse effect on our business; however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.5

Sources

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

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
    SEC EDGAROther events
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83