RNTX on Nasdaq

Rein Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical stage biopharmaceutical company focused on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications with no approved or limited effective treatments. We currently have two product candidates in clinical development, LTI-03 and LTI-01, however, due to insufficient funding we have paused development of LTI‑01 for an undetermined period of time and are prioritizing LTI‑03.”3 It is headquartered in Austin, Texas.1 Its shares trade on Nasdaq under the symbol RNTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerRNTX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersAustin, Texas1
  • Business address12407 N. Mopac Expy., Suite 250 #390, Austin, Tx 787582
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

We are a clinical stage biopharmaceutical company focused on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications with no approved or limited effective treatments. We currently have two product candidates in clinical development, LTI-03 and LTI-01, however, due to insufficient funding we have paused development of LTI‑01 for an undetermined period of time and are prioritizing LTI‑03. Our pipeline includes:3 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

-294.8%Return on equity4

Financial statements

Revenue567894$0 in 2025
02019: $0$020192020: $0$020202021: $0$020212022: $0$020222023: $0$020232024: $0$020242025: $0$02025
Operating income567894-$50.6M in 2025+69% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$30.0M-$30.0M20192020: -$20.5M-$20.5M2020−32%2021: -$26.6M-$26.6M2021+30%2022: -$27.6M-$27.6M2022+4%2023: -$16.3M-$16.3M2023−41%2024: -$65.1M-$65.1M2024+300%2025: -$50.6M-$50.6M2025−22%
Net income57894-$49.9M in 2025+70% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$29.4M-$29.4M20192020: -$27.3M-$27.3M2020−7%2021: -$26.2M-$26.2M2021−4%2022: -$27.3M-$27.3M2022+4%2023: -$15.7M-$15.7M2023−42%2024: -$62.9M-$62.9M2024+300%2025: -$49.9M-$49.9M2025−21%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenue$0$0
Research and development$11.0M$14.2M
General and administrative$10.9M$13.9M
Impairment loss on intangible assets$28.7M$37.0M
Total operating expenses$50.6M$65.1M
Loss from operations-$50.6M-$65.1M
Other income, net$48.0K$685.0K
Income tax benefit$712.0K$1.5M
Net loss-$49.9M-$62.9M
Net loss per share - basic-$1.96-$3.51
Net loss per share - diluted-$1.96-$3.51
Weighted average common shares outstanding - basic25.4M shares17.9M shares
Weighted average common shares outstanding - diluted25.4M shares17.9M shares
Unrealized (loss) gain on investments, net of tax of $0-$15.0K$45.0K
Foreign currency translation adjustments-$29.0K$0
Total other comprehensive (loss) gain-$44.0K$45.0K
Total comprehensive loss-$49.9M-$62.8M
Unrealized gain on investments, tax$0$0

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Corporate structure

Rein 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 Rein Therapeutics, Inc.

  • ADAR1 Capital Management, LLC Filed SCHEDULE 13G on Rein Therapeutics, Inc., latest Aug 14, 2026
  • Lynwood Capital Management Inc. Filed SCHEDULE 13G/A on Rein Therapeutics, Inc., latest Aug 14, 2026 (2 filings since May 8, 2026)
  • Laurence W. Lytton Filed SCHEDULE 13G/A on Rein Therapeutics, Inc., latest Aug 13, 2026 (2 filings since May 6, 2026)
  • Voss Capital, LP Filed SCHEDULE 13G/A on Rein Therapeutics, Inc., latest Jul 14, 2026 (4 filings since May 14, 2025)
  • BIOS Fund I, LP Filed SCHEDULE 13G/A on Rein Therapeutics, Inc., latest May 8, 2026 (2 filings since Nov 13, 2023)
  • Funicular Funds, LP Filed SCHEDULE 13G on Rein Therapeutics, Inc., latest May 7, 2026
  • UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO Filed SCHEDULE 13G/A on Rein Therapeutics, Inc., latest Nov 5, 2024 (2 filings since Mar 5, 2024)
  • Muneer A. Satter Filed SC 13D/A on Rein Therapeutics, Inc., latest Apr 16, 2024 (3 filings since Nov 3, 2023)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Rein Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
  • Scott Kapnick Filed SC 13G/A on Rein Therapeutics, Inc., latest Feb 5, 2024 (3 filings since Feb 14, 2022)
  • Rein Therapeutics, Inc. Austin, Texas

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

What it owns

What Rein 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$04 Dec 31, 2025$1.0K4 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$3.2M4 Dec 31, 2025$12.9M4 Dec 31, 2024−75.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$6.3M4 Dec 31, 2025$6.3M4 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$13.5M4 Dec 31, 2025$42.2M4 Dec 31, 2024−68.0%
Indefinite-lived intangibles (excluding goodwill)$13.5M4 Dec 31, 2025$42.2M4 Dec 31, 2024−68.0%

Properties, in its own words

On August 16, 2021, Lung entered into an operating lease agreement to rent approximately 6,455 square feet of office space for its corporate headquarters in Austin, Texas, beginning on October 1, 2021. The lease expired March 31, 2024, and we did not renew the lease. Following expiration of the lease, we are operating virtually, and expect to do so for the foreseeable future. Our current address is used solely as a mailing address for the receipt of correspondence.

Item 2 of the 10-K filed Mar 26, 2026.3

Leadership

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

Board members and other officers (28)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerBrian L. Windsor, Ph.D. named Nov 16, 202343
  • Executive Officer, DirectorManuel Alves-Aivado, M.D., Ph.D. named Nov 16, 202343
  • DirectorJosef H. von Rickenbach named Nov 16, 202343
  • DirectorNolan H. Sigal, M.D., Ph.D. named Nov 16, 202343

Former names

  • Aileron Therapeutics, Inc.Apr 1, 2024 to Dec 9, 20242
  • AILERON THERAPEUTICS INCDec 3, 2007 to Mar 29, 20242

Timeline

  1. Sep 4, 20268-K Regulation FD disclosure44
  2. Aug 27, 20268-K Listing notice or transfer45
  3. Jul 21, 20268-K Shareholder vote46
  4. May 4, 20268-K Entered a material agreement; Other events47
  5. Mar 2, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares48
  6. Feb 19, 20268-K Executive or director change49
  7. Jan 16, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares50
  8. Dec 11, 20258-K Ended a material agreement51
  9. Nov 3, 20258-K Other events52
  10. Oct 24, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares53
  11. Oct 9, 20258-K Other events54
  12. Sep 22, 20258-K Other events55
  13. Dec 4, 2024New chief executive James Brian Windsor becomes CEO12
  14. Sep 7, 2018New chief executive Manuel Aivado becomes CEO14
  15. May 17, 2018New chief executive John P. Longenecker Phd. becomes CEO13

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.21) a share, on Nov 14, 2025.56

When it reported results

  1. May 15, 2025Reported quarterly or annual results57
  2. Nov 14, 2024Reported quarterly or annual results58
  3. Aug 14, 2024Reported quarterly or annual results59
  4. May 15, 2024Reported quarterly or annual results60
  5. May 1, 2024Reported quarterly or annual results61
  6. Apr 15, 2024Reported quarterly or annual results62

Drug trials and FDA: coming up

  1. Sep 30, 2027Phase 2 trial readout expected Phase 2 trial of LTI-03 in Idiopathic Pulmonary Fibrosis (IPF): primary completion expected Sep 30, 2027 (ClinicalTrials.gov NCT06968845).63

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

214 filings to the SEC since October 2021: 9 annual reports, 15 quarterly reports, 53 major events, 57 insider forms, 22 large holders, 1 private raises, 57 other. The latest 20:

  1. Sep 4, 20268-K EDGAR
  2. Aug 27, 20268-K EDGAR
  3. Aug 14, 202610-Q EDGAR
  4. Aug 14, 2026SCHEDULE 13G EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 13, 2026SCHEDULE 13G/A EDGAR
  7. Jul 21, 20268-K EDGAR
  8. Jul 14, 2026SCHEDULE 13G/A EDGAR
  9. Jun 8, 2026ARS EDGAR
  10. Jun 8, 2026DEFA14A EDGAR
  11. Jun 8, 2026DEF 14A EDGAR
  12. May 28, 20264 EDGAR
  13. May 28, 2026PRE 14A EDGAR
  14. May 15, 202610-Q EDGAR
  15. May 13, 20264 EDGAR
  16. May 8, 2026SCHEDULE 13G/A EDGAR
  17. May 8, 2026SCHEDULE 13G EDGAR
  18. May 7, 2026SCHEDULE 13G EDGAR
  19. May 6, 2026SCHEDULE 13G EDGAR
  20. May 4, 20268-K EDGAR

The 214 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

24 open-market trades by officers, directors and large owners since October 2021: 12 buys and 12 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 27, 2026VON RICKENBACH JOSEF HDirectorBuy4,500$1.07$4.8KForm 4
May 26, 2026VON RICKENBACH JOSEF HDirectorBuy23,190$1.06$24.6KForm 4
May 22, 2026VON RICKENBACH JOSEF HDirectorBuy15,950$1.05$16.7KForm 4
May 21, 2026VON RICKENBACH JOSEF HDirectorBuy3,420$1.04$3.6KForm 4
Apr 30, 2026WINDSOR JAMES BRIANSee RemarksBuy25,000$1.00$25.0KForm 4
Nov 14, 2025Voss Value Master Fund, LP10% ownerBuy104,183$1.22$127.1KForm 4
Oct 28, 2025Voss Value-Oriented Special Situations Fund, LP10% ownerBuy178,392$1.39$248.0KForm 4
Oct 27, 2025Voss Value-Oriented Special Situations Fund, LP10% ownerBuy97,482$1.37$133.6KForm 4
Oct 24, 2025Voss Value-Oriented Special Situations Fund, LP10% ownerBuy30,176$1.39$41.9KForm 4
Dec 5, 2024WINDSOR JAMES BRIANSee RemarksBuy400$2.24$898Form 4
Jun 17, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale4,707$3.25$15.3KForm 4
Jun 14, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale1,900$3.30$6.3KForm 4
Jun 12, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale9,342$3.25$30.4KForm 4
Jun 11, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale5,752$3.26$18.7KForm 4
Jun 10, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale9,577$3.30$31.6KForm 4
Jun 7, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale1,740$3.26$5.7KForm 4
Jun 6, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale4,284$3.29$14.1KForm 4
Jun 5, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale6,291$3.30$20.8KForm 4
May 1, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale20,315$4.21$85.5KForm 4
May 1, 2024UNIVERSITY OF TEXAS/TEXAS AM INVESTMENT MANAGEMENT CO10% ownerSale20,315$4.21$85.5KForm 4

All 24 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
2025Brian WindsorPh.D.$575.0K$882.7K74
2025Timothy M. Cunningham64$433.9K74
2024President and Chief Executive Officer$506.2K$1.8M74
2024Interim Chief Financial Officer$275.6K74

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$18.3M 2023–2023
Money received by yearMoney received by year, 2023–2023: $18.3M in all. Private raises (Form D) $18.3M.$0$5M$10M$15M$20M2023 · Private raises (Form D): $18.3M2023
Figures by year
YearPrivate raises (Form D)Total
2023$18.3M$18.3M

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 2, 2023Raised $18.3 million in a private offering of equity43 Form D: 15 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 59. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Voss Capital, LP5,261,921$5.5M0.3%+873,559
Cable Car Capital, LP5,195,000$5.4M0.1%+4,775,000
ADAR1 Capital Management, LLC4,500,000$4.7M0.2%New
Vanguard Capital Management LLC3,377,910$3.5M0.0%+2,379,389
BIOS Capital Management, LP2,982,375$3.1M7.4%+1,000,000
Ikarian Capital, LLC2,950,000$3.1M0.5%New
Great Point Partners LLC2,575,000$2.7M0.6%New
Citadel Advisors LLC2,438,711$2.5M0.0%New
Velan Capital Investment Management LP1,700,000$1.8M1.1%New
Senvest Management, LLC1,230,895$1.3M0.0%+1,000,000
Prosight Management, LP1,100,000$1.1M0.2%+688,400
Bleichroeder LP1,000,000$1.0M0.2%New
Boothbay Fund Management, LLC889,450$925.0K0.0%New
Geode Capital Management, LLC733,139$762.5K0.0%+388,449
University Of Texas/texas Am Investment Management Co511,610$532.1K0.1%No change
Vanguard Fiduciary Trust Co382,515$397.8K0.0%+228,003
State Street Corp379,604$394.8K0.0%+303,700
Empery Asset Management, LP370,834$385.7K0.4%New
Sigma Planning Corp353,677$367.8K0.0%+5,000
BlackRock, Inc.326,204$339.3K0.0%+257,676
Texas Capital Bank Wealth Management Services Inc300,758$312.8K0.0%+27,133
Sequoia Financial Advisors, LLC250,000$260.0K0.0%New
Gagnon Securities LLC229,070$238.2K0.0%−10,450
Stonepine Capital Management, LLC218,038$226.8K0.2%New
Palogic Value Management, L.P.180,000$187.2K0.1%No change

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

SEC filer profile

How Rein 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 EDGARRein Therapeutics, Inc.1
  • CIK0001420565
  • Employer ID (EIN)13-41960173
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address12407 N. Mopac Expy., Suite 250 #390, Austin, TX 787581
  • Phone73780219891
  • Shares outstanding86,267,032 as of Aug 12, 202611
  • Public float$32.3M as of Jun 30, 20253
  • AuditorCBIZ CPAs P.C., New York, NY PCAOB ID 199; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 3, 20071
  • Filings525 in all: 4 (156), 8-K (88), 3 (43), 10-Q (28), 424B5 (16), CORRESP (15), SC 13D/A (15), UPLOAD (13)1
    All 44 form types

    EFFECT (12), SC 13G/A (12), DEFA14A (11), 10-K (9), DEF 14A (9), 4/A (8), S-8 (8), SC 13G (8), SCHEDULE 13G/A (7), S-3 (6), 10-K/A (5), D (5), PRE 14A (5), S-1 (5), SC 13D (5), SCHEDULE 13G (5), ARS (4), DRS/A (4), CT ORDER (2), DRS (2), DRSLTR (2), NT 10-K (2), S-1/A (2), 144 (1), 3/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DEL AM (1), FWP (1), POS AM (1), REGDEX (1), REGDEX/A (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jun 8, 2026
    Latest 8-K (8-K) Sep 4, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueRNTXNasdaq

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Rein Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 68 risks under these headings, as written.3

  • Careful consideration should be given to the following risk factors, in addition to the other information set forth in this Annual Report on Form 10-K and in other documents that we file with the SEC, in evaluating our company and our business. Investing in our common stock involves a high degree of risk. If any of the following risks actually occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.
  • Risks Related to Our Financial Condition
  • We require substantial additional capital to finance our operations. Our cash and cash equivalents are not sufficient to enable us to sustain our operations beyond the second quarter of 2026 or complete the development and commercialization of LTI-03. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our clinical and research and development programs, future commercialization efforts or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to LTI-03, LTI-01 or other product candidates.
  • We have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our prospects and likelihood of success.
  • We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future and do not expect to achieve or maintain profitability; Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.
  • Global and macroeconomic developments can disrupt our supply chains and adversely affect our financial condition and results of operations.
  • We have identified material weaknesses in our internal control over financial reporting and may identify additional material weaknesses in the future or fail to maintain an effective system of internal control over financial reporting, which may result in material misstatements of our financial statements or cause us to fail to meet our periodic reporting obligations.
  • We hold a portion of our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts that could be adversely affected if the financial institutions holding such funds fail.
  • Risks Related to the Discovery, Development and Commercialization of Product Candidates
  • Our business is highly dependent on the success of our lead product candidate, LTI-03.
  • Our approach to drug research and development in the area of fibrotic diseases, with a focus on Cav1-related peptides, is unproven and may not result in marketable products.
The other 58 risks
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
  • We are conducting and may in the future choose to conduct clinical trials for current or future product candidates outside of the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of LTI-03.
  • Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies or earlier clinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.
  • Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome.
  • If we encounter difficulties enrolling and retaining patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • If approved, our product candidates that are regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Although we have received U.S. and EU Orphan Drug Designation for LTI-03 for IPF and U.S. and EU Orphan Drug Designation for LTI-01 for pleural empyema, we may be unable to obtain and maintain Orphan Drug Designation for our other product candidates and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
  • If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of our product candidates.
  • Risks Related to Marketing Approval
  • We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any product candidate.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us, or any future collaborators, from obtaining approvals for the commercialization of LTI-03, LTI-01 or any other product candidate that we may develop. As a result, we cannot predict when or if, and in which territories or for which indications, we, or any future collaborators, will obtain marketing approval to commercialize LTI-03, LTI-01 or any other product candidate that we may develop.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we are granted for LTI-03 or LTI-01 in the U.S. would not assure approval of our product candidates in foreign jurisdictions.
  • The design or execution of our ongoing and future clinical trials may not support marketing approval.
  • If the FDA or comparable foreign regulatory authorities approve generic or competitor versions of any of our drugs that receive marketing approval, or such authorities do not grant our drugs appropriate periods of data or market exclusivity before approving generic or competitor versions of our drugs, the sales of our drugs could be adversely affected.
  • Risks Related to Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
  • Even if we receive regulatory approval of any product candidates, we will be subject to 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, if approved.
  • We may seek to obtain certain regulatory designations for our product candidates. We may not receive such designations, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • Accelerated approval by the FDA, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Additional laws and regulations governing international operations could negatively impact or restrict our operations.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to conduct certain aspects of our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.
  • Because we rely on third-party manufacturing and supply vendors, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
  • We depend on sole-source third-party suppliers for materials that are necessary for the conduct of preclinical studies and manufacture of our product candidates for clinical trials, and the loss of these third-party suppliers and manufacturers or their inability to supply us with sufficient quantities of adequate materials, or to do so at acceptable quality levels and on a timely basis, could harm our business.
  • Risks Related to Our Intellectual Property
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We are currently party to license or other collaboration agreements that impose certain obligations on us, and we may enter into additional license or collaboration agreements in the future. If we fail to comply with our obligations under such present or future agreements with third parties, we could lose license rights that may be important to our business.
  • Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • 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 for non-compliance with these requirements.
  • Our collaborators may assert ownership or commercial rights to inventions they develop from research we support or that we develop from our use of samples or other materials, which they provide to us, or otherwise arising from the collaboration.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Third parties may assert that we are employing their proprietary technology without authorization, infringing, misappropriating, or otherwise violating their intellectual property rights. We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Any current or future patents, if issued, covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes in patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to Employee Matters and Managing Growth
  • Our internal computer systems, or those of our vendors or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Risks Related to Our Common Stock
  • If we fail to maintain compliance with the requirements for continued listing on the Nasdaq Capital Market, our common stock could be delisted from trading, which would adversely affect the liquidity of our common stock.
  • An active trading market for our common stock may not be sustained.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • The price of our stock may be volatile, and you could lose all or part of your investment.
  • We could be subject to securities class action litigation.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • A significant portion of our total outstanding shares may be sold into the market at any time, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • Assuming the conversion of all outstanding Series X Preferred Stock and the exercise of outstanding warrants, there is a concentration of ownership of our outstanding common stock by one group of affiliated stockholders. If this group chooses to act together, it could exert substantial influence over our business, and the interests of this group may conflict with those of other stockholders.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation designates the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers and employees.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse impact on us because of defense and settlement, costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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