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YARW on Nasdaq

Yarrow Bioscience, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need. We have exclusive worldwide rights to research, develop and commercialize products containing small molecule bromodomain and extra-terminal domain inhibitors for the treatment of any disease, disorder or condition in humans, which we licensed from Tay Therapeutics Ltd., formerly known as In4Derm Ltd.”4 It is headquartered in New Haven, Connecticut.1 Its shares trade on Nasdaq under the symbol YARW.1

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Last updated Oct 21, 2026.

Overview

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  • TickerYARW on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew Haven, Connecticut1
  • Incorporated inDE2
  • Business address470 James Street, Suite 007, New Haven, Ct 065132
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need.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 2025

-5219.1%Operating margin5
-4646.1%Net margin5
13.8%Revenue growth, 20255
-95.4%Return on equity5
0.00×Debt to equity5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$19.2M
  • Income tax0¢$4.0K

Out of $570.0K in revenue.5 The company lost money this year.

Financial statements

Revenue6789105$570.0K in 2025+29% since 2019
0$10.0M$20.0M$30.0M2019: $443.0K$443.0K20192020: $21.0M$21.0M2020+4639%2021: $931.0K$931.0K2021−96%2022: $477.0K$477.0K2022−49%2023: $424.0K$424.0K2023−11%2024: $501.0K$501.0K2024+18%2025: $570.0K$570.0K2025+14%
Operating income6789105-$29.7M in 2025−69% since 2019
-$300.0M-$200.0M-$100.0M02019: -$95.9M-$95.9M20192020: -$252.5M-$252.5M2020+163%2021: -$38.9M-$38.9M2021−85%2022: -$34.3M-$34.3M2022−12%2023: -$29.3M-$29.3M2023−15%2024: -$43.6M-$43.6M2024+49%2025: -$29.7M-$29.7M2025−32%
Net income6789105-$26.5M in 2025−72% since 2019
-$300.0M-$200.0M-$100.0M02019: -$95.2M-$95.2M20192020: -$255.6M-$255.6M2020+169%2021: -$73.3M-$73.3M2021−71%2022: -$23.2M-$23.2M2022−68%2023: -$28.5M-$28.5M2023+23%2024: -$39.8M-$39.8M2024+40%2025: -$26.5M-$26.5M2025−34%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenues$570.0K$501.0K
Research and development$19.2M$30.9M
General and administrative$11.1M$13.2M
Total operating expenses$30.3M$44.1M
Operating loss-$29.7M-$43.6M
Other income, net$3.0M$3.8M
Loss from continuing operations before income taxes-$26.7M-$39.8M
Income tax expense$4.0K$4.0K
Loss from continuing operations-$26.7M-$39.8M
Income (loss) from discontinued operations, net of income taxes$253.0K-$27.0K
Net loss-$26.5M-$39.8M
Loss per share from continuing operations, basic (in dollars per share)-$1-$1
Loss per share from continuing operations, diluted (in dollars per share)-$1-$1
(Loss) income per share from discontinuing operations, basic (in dollars per share)$0$0
(Loss) income per share from discontinuing operations, diluted (in dollars per share)$0$0
Loss per share basic (in dollars per share)-$0.62-$0.93
Loss per share diluted (in dollars per share)-$0.62-$0.93
Weighted average shares outstanding - basic (in shares)42.8M shares42.6M shares
Weighted average shares outstanding - diluted (in shares)42.8M shares42.6M shares
Unrealized losses on marketable securities, net of tax of $0-$18.0K-$6.0K
Total other comprehensive loss-$18.0K-$6.0K
Comprehensive loss-$26.5M-$39.8M
Unrealized income on marketable securities, tax$0$0

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Corporate structure

Yarrow Bioscience, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Yarrow Bioscience, Inc.

  • Yarrow Bioscience, Inc. New Haven, Connecticut
    • VYNE Pharmaceuticals Inc. Subsidiary · Delaware, United States
    • Yellow Merger Sub Corp. Subsidiary · Delaware, 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 Yarrow Bioscience, 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$117.0K5 Dec 31, 2025$117.0K5 Dec 31, 20240%
Accumulated depreciation$27.0K5 Dec 31, 2025$4.0K5 Dec 31, 2024+575.0%
Property and equipment, net$90.0K5 Dec 31, 2025$113.0K5 Dec 31, 2024−20.4%
Operating-lease assets (leased space)$05 Dec 31, 2025$93.0K5 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$24.0M5 Dec 31, 2025$19.9M5 Dec 31, 2024+20.6%
Marketable securities, current$5.0M5 Dec 31, 2025$41.6M5 Dec 31, 2024−88.0%
Debt securities available for sale$5.0M5 Dec 31, 2025$41.6M5 Dec 31, 2024−88.0%

Properties, in its own words

Our previous executive offices in the United States were located in Bridgewater, New Jersey. We leased approximately 5,755 square feet of office space under lease agreements, which expired on October 31, 2025. Starting November 1, 2025, the Company began operating on a fully remote model.

Item 2 of the 10-K filed Feb 27, 2026.4

Leadership

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

Chief executive

  1. Steven L. Basta2018–2019
  2. David Domzalski2020–2026
  3. Rebecca Frey2026–now

President

  1. David Domzalski2020–now

Chief financial officer

  1. Kristine M. Ball2018
  2. Ilan Hadar2020
  3. Andrew Saik2020–2021
  4. Tyler Zeronda2021–now

Chief operating officer

  1. Rachael Alford2026–now
20202025
Board members and other officers (33)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • VYNE Pharmaceuticals Inc. Delaware3
  • Yellow Merger Sub Corp. Delaware3

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

Former names

  • VYNE Therapeutics Inc.Sep 8, 2020 to Jul 24, 20262
  • Menlo Therapeutics Inc.Nov 28, 2017 to Sep 2, 20202
  • Menlo Therapeutics, Inc.Jul 28, 2017 to Jan 31, 20182
  • Tigercat Pharma, Inc.Jan 7, 2013 to Jan 7, 20132

Timeline

  1. Sep 14, 20268-K Entered a material agreement51
  2. Sep 10, 20268-K Other events52
  3. Aug 13, 20268-K Results of operations; Regulation FD disclosure53
  4. Jul 30, 20268-K Other events54
  5. Jul 29, 2026New chief executive Rebecca Frey becomes CEO13
  6. Jul 28, 20268-K Entered a material agreement; Completed an acquisition or sale; Results of operations55
  7. Jul 21, 20268-K Regulation FD disclosure; Other events56
  8. Jul 20, 20268-K Shareholder vote57
  9. Jul 14, 20268-K Regulation FD disclosure58
  10. Jul 10, 20268-K Regulation FD disclosure; Other events59
  11. May 21, 20268-K Regulation FD disclosure60
  12. Mar 11, 20268-K Listing notice or transfer61
  13. Jan 30, 20268-K Entered a material agreement62
  14. Mar 11, 2020New chief executive David Domzalski becomes CEO14
  15. Jan 24, 2018New chief executive Steven L. Basta becomes CEO15

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($8.50) a share, on Nov 6, 2025.63

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results53
  2. Jul 28, 2026Reported quarterly or annual results55
  3. Nov 6, 2025Reported quarterly or annual results64
  4. Aug 14, 2025Reported quarterly or annual results65
  5. Jul 30, 2025Reported quarterly or annual results66
  6. May 8, 2025Reported quarterly or annual results67
  7. Mar 6, 2025Reported quarterly or annual results68
  8. Nov 7, 2024Reported quarterly or annual results69

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

Filings

318 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 157 insider forms, 33 large holders, 2 private raises, 43 other. The latest 20:

  1. Oct 7, 2026SCHEDULE 13G EDGAR
  2. Sep 17, 2026SCHEDULE 13G EDGAR
  3. Sep 14, 20268-K EDGAR
  4. Sep 11, 2026424B5 EDGAR
  5. Sep 11, 2026424B5 EDGAR
  6. Sep 10, 20268-K EDGAR
  7. Aug 19, 2026EFFECT EDGAR
  8. Aug 14, 2026SCHEDULE 13G EDGAR
  9. Aug 14, 2026POS AM EDGAR
  10. Aug 14, 2026SCHEDULE 13G EDGAR
  11. Aug 13, 2026SCHEDULE 13G/A EDGAR
  12. Aug 13, 202610-Q EDGAR
  13. Aug 13, 20268-K/A EDGAR
  14. Aug 7, 2026SCHEDULE 13G EDGAR
  15. Aug 7, 2026SCHEDULE 13G/A EDGAR
  16. Aug 5, 2026SCHEDULE 13D EDGAR
  17. Aug 4, 2026SCHEDULE 13G EDGAR
  18. Aug 3, 2026SCHEDULE 13G EDGAR
  19. Jul 30, 2026SCHEDULE 13G EDGAR
  20. Jul 30, 20264 OWNERSHIP DOCUMENT EDGAR

The 318 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

5 open-market trades by officers, directors and large owners since October 2021: 5 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 15, 2025LEPORE PATRICK GDirectorBuy15,000$2.92$43.8KForm 4
Nov 15, 2023LEPORE PATRICK GDirectorBuy13,000$3.91$50.8KForm 4
Mar 20, 2023LEPORE PATRICK GDirectorBuy20,000$2.48$49.6KForm 4
Mar 20, 2023Harsch MutyaCHIEF LEGAL OFFICER AND GCBuy10,000$2.50$25.0KForm 4
Nov 30, 2021LEPORE PATRICK GDirectorBuy12,500$1.02$12.8KForm 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
2024David DomzalskiPresident and Chief Executive Officer59$637.6K$2.0M86
2024Iain StuartChief Scientific Officer52$455.6K$908.4K86
2024Mutya HarschChief Legal Officer, General Counsel and Secretary51$443.3K$891.5K86
2023David DomzalskiPresident and Chief Executive Officer59$637.6K$2.7M86
2023Iain StuartChief Scientific Officer52$421.8K$1.2M86
2023Mutya HarschChief Legal Officer, General Counsel and Secretary51$382.6K$1.1M86

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$88.5M 2022–2023
Money received by yearMoney received by year, 2022–2023: $88.5M in all. Private raises (Form D) $88.5M.$0$25M$50M$75M$100M2022 · Private raises (Form D): $300.0K20222023 · Private raises (Form D): $88.2M2023
Figures by year
YearPrivate raises (Form D)Total
2023$88.2M$88.2M
2022$300.0K$300.0K

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Nov 1, 2023Raised $88.2 million in a private offering of equity87 Form D: 19 investors so far Form D
  2. Nov 14, 2022Raised $300,000 in a private offering of equity88 Form D: 1 investor so far Form D

SEC filer profile

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

  • Name on EDGARYarrow Bioscience, Inc.1
  • CIK0001566044
  • Employer ID (EIN)45-37577894
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address470 James Street, Suite 007, New Haven, CT 065131
  • Phone(203) 433-75771
  • Shares outstanding2,669,746 as of Aug 10, 202612
  • Public float$32.0M as of Jun 30, 20254
  • AuditorBaker Tilly US, LLP, Tewksbury, Massachusetts PCAOB ID 23; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJan 7, 20131
  • Filings677 in all: 4 (268), 8-K (130), 3 (45), 10-Q (26), SC 13G/A (20), 425 (18), CORRESP (16), SC 13G (15)1
    All 43 form types

    4/A (12), SCHEDULE 13G/A (12), SCHEDULE 13G (10), 10-K (9), DEF 14A (8), DEFA14A (8), EFFECT (8), S-8 (8), UPLOAD (8), 424B5 (7), ARS (4), D (4), PRE 14A (4), S-3 (4), 424B3 (3), 8-K/A (3), S-1/A (3), S-4/A (3), DRS (2), DRSLTR (2), S-4 (2), SC 13D (2), 10-K/A (1), 424B2 (1), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), DRS/A (1), POS AM (1), S-1 (1), S-1MEF (1), SC 13D/A (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Nov 12, 2025
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001VYNEThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Yarrow Bioscience, Inc. names in Item 1A of its 10-K filed Feb 27, 2026: 73 risks under these headings, as written.4

  • Risks Related to the Proposed Merger
  • Failure to complete, or delays in completing, the potential Merger with Yarrow could materially and adversely affect VYNE's results of operations, business, financial results and/or common stock price.
  • VYNE and Yarrow may mutually agree to waive the condition to the Merger requiring approval for listing on Nasdaq Stock Market ("Nasdaq"), and if such condition is waived, the Combined Company’s stock may not be listed on Nasdaq following completion of the Merger.
  • The Exchange Ratio for the Merger will not change or otherwise be adjusted based on the market price of VYNE common stock.
  • The issuance of VYNE common stock, including the shares of our Common Stock issued in exchange for shares of Yarrow common stock issued in the Yarrow Pre-Closing Financing, to Yarrow stockholders pursuant to the Merger Agreement and the resulting change in control from the Merger must be approved by our stockholders, and the Merger Agreement and transactions contemplated thereby must be approved by the Yarrow stockholders.
  • The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.
  • If the Merger is not completed, VYNE's stock price may decline significantly.
  • If we complete the Merger, the Combined Company will need to raise additional capital, including by potentially issuing equity securities or incurring debt, which may cause significant dilution to the Combined Company’s stockholders or restrict the Combined Company’s operations.
  • Additional financing may not be available to the Combined Company, when we need it or may not be available on favorable terms.
  • Some of Yarrow’s and VYNE's directors and executive officers have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.
  • The VYNE stockholders and the stockholders of Yarrow may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger, including the conversion of Yarrow common stock issued in the Yarrow Pre-Closing Financing.
  • VYNE securityholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, the Combined Company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.
The other 62 risks
  • Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.
  • Because the lack of a public market for Yarrow common stock makes it difficult to evaluate the fair market value of its capital stock, the value of VYNE common stock to be issued to Yarrow stockholders may be more or less than the fair market value of Yarrow common stock.
  • Lawsuits may be filed against us, Yarrow, or any of the members of our or Yarrow's boards of directors arising out of the Merger, which may delay or prevent the Merger.
  • VYNE has never paid and, other than in connection with the Merger with Yarrow, does not intend to pay any cash dividends in the foreseeable future.
  • If VYNE does not successfully consummate the Merger or another strategic transaction, VYNE's board of directors may decide to pursue a dissolution and liquidation of VYNE. In such an event, the amount of cash available for distribution to VYNE stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, as to which VYNE can give you no assurance.
  • VYNE will not have any right to make damage claims against Yarrow for the breach of any representation, warranty or covenant made by Yarrow in the Merger Agreement.
  • Risks Related to the Proposed Reverse Stock Split
  • The reverse stock split may not increase the Combined Company’s stock price over the long-term.
  • The reverse stock split may decrease the liquidity of the Combined Company common stock.
  • The reverse stock split may lead to a decrease in the Combined Company’s overall market capitalization.
  • Risks Related to Development of Our Current Product Candidates
  • Our current business has been and, if the Merger is not consummated, is expected to be substantially dependent upon the successful development and regulatory approval of our biopharmaceutical product candidates. If we are unable to successfully develop or obtain regulatory approval for any such candidate, our business may be materially harmed.
  • Our product candidates may fail in development or suffer delays that materially and adversely affect their viability. If the Merger is not consummated and we 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 may encounter delays in enrolling patients and successfully completing clinical trials for our product candidates and may be delayed in, or prevented from, commencing or completing such trials due to factors that are largely beyond our control.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Drug development is very expensive, time-consuming and uncertain. Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates, or serious adverse side effects could be identified. Any of these outcomes could prevent or delay regulatory approval and commercialization or, if the Merger is not consummated, harm our ability to pursue other strategic alternatives for our product candidates.
  • New chemical entities may require more time and resources for development, testing and regulatory approval.
  • Results obtained in preclinical studies and completed clinical trials may not predict success in later clinical trials.
  • Top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as additional data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We have a limited history as a clinical-stage biopharmaceutical company developing product candidates for immuno-inflammatory conditions, which may make it difficult to assess our future viability.
  • We may spend 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 face competition from entities that have developed or may develop product candidates for the diseases addressed by our product candidates, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.
  • We have not obtained regulatory approvals to market our product candidates, and we may be delayed in obtaining or fail to obtain such regulatory approvals and to commercialize these product candidates.
  • Even if our product candidates receive marketing approval, we may continue to face future developmental and regulatory difficulties. In addition, we are subject to government regulations and we may experience delays in obtaining required regulatory approvals to market our proposed product candidates.
  • We have historically relied on third parties to conduct, supervise and monitor our clinical trials, and if these third parties perform in an unsatisfactory manner, it may harm our business.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.
  • Risks Related to Our Financial Position and Need for Capital
  • We will need substantial additional funding to pursue our business objectives if the Merger is not completed. If we are unable to raise capital when needed, we could be forced to curtail our planned operations.
  • We have incurred significant losses since our inception and we anticipate that we will continue to incur significant losses for the foreseeable future, which could harm our future business prospects.
  • SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.
  • Other Risks Related to Our Business and Financial Operations
  • Collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • We are subject to various risks and uncertainties arising out of the completed divestiture of our commercial business, any of which could materially and adversely affect our business and operations, and our stock price.
  • Our failure to successfully in-license, acquire, develop and market additional product candidates or approved products could impair our ability to grow our business.
  • If the Merger is not consummated, we may engage in strategic transactions, which could impact our liquidity, increase our expenses and present significant distractions to our management.
  • We may decide not to continue developing any of our product candidates at any time during development or of any of our products after approval, which would reduce or eliminate our potential return on investment for those product candidates or products.
  • Supply interruptions may disrupt the availability of our product candidates and cause delays in conducting preclinical or clinical activities.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
  • The Israeli Tax Authority may disagree with our conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
  • If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully execute our strategy.
  • We may become subject to lawsuits or investigations that could have a material adverse impact on our business, results of operations and financial condition.
  • If our information technology systems or those of third parties upon which we rely or our data are, or were, compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse consequence.
  • Our employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our business.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • Risks Related to Government Regulation
  • We and third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
  • Healthcare reforms by governmental authorities and related reductions in pharmaceutical pricing, reimbursement and coverage by third party payors may adversely affect our business.
  • Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates and to produce, market, and distribute our products after clearance or approval is obtained.
  • We and any of our contract manufacturers on which we rely or may rely in the future, are subject to significant regulation with respect to manufacturing of our product candidates. The manufacturing facilities on which we rely, or may rely in the future, may not continue to meet regulatory requirements and have limited capacity.
  • Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
  • We are subject to various U.S. and foreign anti-bribery and anti-corruption laws, and any violations by us of such laws could result in substantial penalties.
  • Our business involves the use of hazardous materials and we and our third party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Sanctions and other trade control laws create the potential for significant liabilities, penalties and reputational harm.
  • Risks Related to Our Intellectual Property
  • If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to any of our product candidates are not adequate, we may not be able to compete effectively and we otherwise may be harmed.
  • We have in-licensed intellectual property necessary to develop our BET inhibitor product candidates, and if we fail to comply with our obligations under any of these arrangements, we could lose such intellectual property rights.
  • Since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we or our licensor were the first to (i) file any patent application related to our product candidates or (ii) conceive and invent any of the inventions claimed in our patents or patent applications or in our licensed in patents or patent applications.
  • Changes in U.S. or foreign patent law and practice could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we infringe or are alleged to infringe or otherwise violate intellectual property rights of third parties, our business could be harmed.
  • Obtaining and maintaining our intellectual property protection, such as patent protection, depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, such as patent agencies, and our intellectual property protection, such as patent protection, could be reduced or eliminated for non-compliance with these requirements.
  • If we are unable to secure trademark registrations, secure appropriate domain names and protect our trademarks or trade dress from infringement, our business prospects may be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.
  • An adverse determination of any litigation or other proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.
  • We may not obtain intellectual property rights or otherwise be able to protect our intellectual property rights throughout the world.
  • We may not be able to enforce covenants not to compete under applicable employment laws.
  • Risks Related to the Ownership of Our Common Stock
  • The trading price of the shares of our common stock is volatile, and stockholders could incur substantial losses.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings relating to claims that we consider to be arising from the ordinary course of our business. There are currently no claims or actions pending against us that, in the opinion of our management, are likely to have a material adverse effect on our business.

The opening of Item 3, Legal Proceedings.4

Sources

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