MBRX on Nasdaq

Moleculin Biotech, Inc.

American pharmaceutical preparations company based in Houston2

In its 2026 annual report the company says: “We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name “naxtarubicin”, which we believe is a “next-generation” anthracycline and, with it, are conducting a pivotal Phase 3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML).”4 Its shares trade on Nasdaq under the symbol MBRX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerMBRX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersHouston, United States2
  • Incorporated inDE3
  • Business address5300 Memorial Drive, Suite 950, Houston, Tx 770073
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300IB1TLJZCHEO3532
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 57932652

We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name “naxtarubicin”, which we believe is a “next-generation” anthracycline and, with it, are conducting a pivotal Phase 3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). We call this the “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). A blinded preliminary data readout has been released for the MIRACLE trial, and we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, thereby concluding Part A of the two-part trial. We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the concl…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

-223.6%Return on equity5
-$22.7MFree cash flow5

Financial statements

Revenue6789105$0 in 2025
02019: $0$020192020: $0$020202021: $0$020212022: $0$020222023: $0$020232024: $0$020242025: $0$02025
Operating income6789105-$25.1M in 2025+43% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$17.5M-$17.5M20192020: -$19.7M-$19.7M2020+13%2021: -$23.0M-$23.0M2021+16%2022: -$30.6M-$30.6M2022+33%2023: -$29.6M-$29.6M2023−3%2024: -$26.6M-$26.6M2024−10%2025: -$25.1M-$25.1M2025−6%
Net income6789105-$33.6M in 2025+154% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$13.2M-$13.2M20192020: -$17.4M-$17.4M2020+31%2021: -$15.9M-$15.9M2021−8%2022: -$29.0M-$29.0M2022+83%2023: -$29.8M-$29.8M2023+3%2024: -$26.0M-$26.0M2024−12%2025: -$33.6M-$33.6M2025+29%

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

Period ending2025-12-312024-12-31
Revenue$0$0
Research and development$15.9M$17.7M
General and administrative$9.1M$8.8M
Depreciation and amortization$90.0K$126.0K
Total operating expenses$25.1M$26.6M
Loss from operations-$25.1M-$26.6M
Gain from change in fair value of warrant liabilities$24.4M$0
Loss on issuance of warrant liabilities-$31.0M$0
Transaction costs allocated to warrant liabilities-$1.4M$0
Loss on extinguishment of warrant liabilities-$614.0K$0
Other (expense) income, net-$20.0K$43.0K
Interest income, net$105.0K$550.0K
Net loss-$33.6M-$26.0M
Warrant deemed dividend-$104.0K$0
Net loss available to common stockholders-$33.7M-$26.0M
Net loss per common share - basic and diluted (in dollars per share)-$28.42-$189.14
Weighted average common shares outstanding, basic and diluted (in shares)1.2M shares137.7K shares
Foreign currency translation$51.0K-$32.0K
Comprehensive loss-$33.5M-$26.1M

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Corporate structure

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

Major holders of Moleculin Biotech, Inc.

  • Moleculin Biotech, Inc. Houston, Texas, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Moleculin Biotech, 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
Accumulated depreciation$1.1M5 Dec 31, 2025$1.0M5 Dec 31, 2024+10.0%
Property and equipment, net$78.0K5 Dec 31, 2025$159.0K5 Dec 31, 2024−50.9%
Operating-lease assets (leased space)$314.0K5 Dec 31, 2025$424.0K5 Dec 31, 2024−25.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$8.9M5 Dec 31, 2025$4.3M5 Dec 31, 2024+107.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$11.1M5 Dec 31, 2025$11.1M5 Dec 31, 20240%

Properties, in its own words

Our corporate executive offices, laboratory and other spaces are located in leased facilities in Houston, Texas. In March 2018, we entered into a Lease Agreement (the “Lease”) which we use for corporate office space and headquarters. The term of the Lease began in August 2018 and had an initial term of 66 months, which had a renewal option for an additional 5 years. In September 2023, the Company executed an amendment to extend the corporate office lease until August 31, 2029, with an option to renew. The Company is required to remit base monthly rent of approximately $4,700 which will increase at an average approximate rate of 2% each year. The Company is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the building.

In June 2022, we entered into a Second Amendment to our Lab Lease Agreement. The term of the Lease will continue through September 30, 2027, with no further right or option to renew. We are required to remit base monthly rent which will increase at an average approximate rate of 3% each year. In August 2019, we entered into a sublease (which was extended in 2022 in connection with the lease extension) with Houston Pharmaceuticals, Inc. (HPI), which is affiliated with Dr. Priebe. We granted HPI access to all of the Lab Lease space and HPI has agreed to pay us 50% of the rent payable under the Lab Lease less 50% of any benefits from any sublease or other lab service agreement we may receive from the Lab Lease. Although HPI has access to the space, it is the intent of the parties that they equally share the Lab Lease space for research purposes. We believe our facilities, as expanded, will be sufficient to meet our current needs and that suitable space will be available as and when needed. We do not own any real property.

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

Leadership

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

Board members and other officers (8)

Timeline

  1. Oct 9, 20268-K Executive or director change; Shareholder vote26
  2. Oct 5, 20268-K Regulation FD disclosure27
  3. Sep 29, 20268-K Regulation FD disclosure28
  4. Sep 28, 20268-K Regulation FD disclosure29
  5. Sep 25, 20268-K Regulation FD disclosure30
  6. Sep 23, 20268-K Regulation FD disclosure; Other events31
  7. Sep 18, 20268-K Listing notice or transfer32
  8. Sep 14, 20268-K Regulation FD disclosure33
  9. Aug 31, 20268-K Regulation FD disclosure34
  10. Aug 14, 20268-K Results of operations35
  11. Aug 3, 20268-K Entered a material agreement36
  12. Jul 31, 20268-K Regulation FD disclosure37
  13. Jun 7, 2016New chief executive Walter Klemp V. becomes CEO13
  14. Jul 28, 2015Founded Moleculin Biotech, Inc. is founded2

Calendar

Coming up

  1. Oct 20, 2026Split Reverse split 1:20.38
  2. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.25) a share, on Nov 13, 2025.39

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results35
  2. May 15, 2026Reported quarterly or annual results40
  3. Mar 19, 2026Reported quarterly or annual results41
  4. Aug 13, 2025Reported quarterly or annual results42
  5. May 14, 2025Reported quarterly or annual results43
  6. Mar 24, 2025Reported quarterly or annual results44
  7. Nov 12, 2024Reported quarterly or annual results45
  8. Aug 14, 2024Reported quarterly or annual results46

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

Filings

451 filings to the SEC since October 2021: 9 annual reports, 15 quarterly reports, 235 major events, 77 insider forms, 9 large holders, 106 other. The latest 20:

  1. Oct 15, 2026S-8 EDGAR
  2. Oct 9, 20268-K EDGAR
  3. Oct 5, 20268-K EDGAR
  4. Sep 29, 20268-K EDGAR
  5. Sep 28, 20268-K EDGAR
  6. Sep 25, 20268-K EDGAR
  7. Sep 23, 20268-K EDGAR
  8. Sep 18, 20268-K EDGAR
  9. Sep 14, 20268-K EDGAR
  10. Aug 31, 20268-K EDGAR
  11. Aug 25, 2026SCHEDULE 13D EDGAR
  12. Aug 25, 2026SCHEDULE 13D EDGAR
  13. Aug 24, 2026DEFA14A EDGAR
  14. Aug 24, 2026DEF 14A EDGAR
  15. Aug 21, 2026424B5 EDGAR
  16. Aug 14, 2026PRE 14A EDGAR
  17. Aug 14, 20268-K EDGAR
  18. Aug 13, 202610-Q EDGAR
  19. Aug 10, 2026SCHEDULE 13G EDGAR
  20. Aug 6, 2026SCHEDULE 13G EDGAR

The 451 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

12 open-market trades by officers, directors and large owners since October 2021: 12 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 3, 2026Foster Jonathan P.Chief Financial OfficerBuy293,333Form 4
Aug 3, 2026KLEMP WALTER VCEO and PresidentBuy533,333Form 4
Aug 3, 2026PICKER DONALD HChief Science OfficerBuy173,333Form 4
Jun 23, 2025Foster Jonathan P.Chief Financial OfficerBuy270,270$0.37$100.0KForm 4
Jun 23, 2025KLEMP WALTER VCEO and PresidentBuy675,675$0.37$250.0KForm 4
Dec 26, 2023Foster Jonathan P.Chief Financial OfficerBuy28,986$0.69$20.0KForm 4
Dec 26, 2023George Robert E.DirectorBuy14,493$0.69$10.0KForm 4
Dec 26, 2023KLEMP WALTER VCEO and PresidentBuy188,404$0.69$130.0KForm 4
Nov 25, 2022KLEMP WALTER VCEO and PresidentBuy45,000$1.28$57.6KForm 4
Nov 21, 2022KLEMP WALTER VCEO and PresidentBuy22,500$1.15$25.9KForm 4
Nov 17, 2022KLEMP WALTER VCEO and PresidentBuy24,742$1.02$25.2KForm 4
Nov 16, 2022KLEMP WALTER VCEO and PresidentBuy85,213$0.97$82.7KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Walter V. KlempChairman, President -67$565.0K$1.3M52
2025Jonathan P. FosterExecutive Vice62$405.0K$907.3K52
2025Donald PickerChief Scientific Officer81$340.0K$622.9K52
2024Chief Executive Officer$565.0K$1.5M52
2024President and Chief Financial Officer$405.0K$989.6K52
2024Donald PickerChief Scientific Officer81$340.0K$694.1K52

Held by these funds

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

FundSharesValueShare of the fundChange
Geode Capital Management, LLC47,252$131.8K0.0%+14,923
Vanguard Capital Management LLC42,215$117.8K0.0%+28,346
Vanguard Fiduciary Trust Co29,883$83.4K0.0%+23,811
XTX Topco Ltd22,942$64.0K0.0%New
Morgan Stanley20,036$55.9K0.0%+20,000
Rockefeller Capital Management L.P.15,000$41.9K0.0%+10,579
Tower Research Capital LLC (TRC)3,514$9.8K0.0%+1,679
Citigroup Inc2,674$7.5K0.0%New
Barclays PLC621$1.7K0.0%New
BlackRock, Inc.491$1.4K0.0%No change
EFG International AG434$1.2K0.0%No change
Jones Financial Companies Lllp360$1.2K0.0%New
Wells Fargo & Company/mn200$5580.0%New
NFSG Corp114$3180.0%No change
SBI Securities Co., Ltd.44$1230.0%+1
Danske Bank A/s2$60.0%No change
CVA Family Office, LLC1$30.0%No change
Osaic Holdings, Inc.1$20.0%No change

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

SEC filer profile

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

  • Name on EDGARMoleculin Biotech, Inc.1
  • CIK0001659617
  • Employer ID (EIN)47-46719974
  • 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 address5300 Memorial Drive, Suite 950, Houston, TX 770071
  • Phone713-300-51601
  • Shares outstanding19,477,380 as of Aug 6, 202612
  • Public float$8.8M as of Jun 30, 20254
  • AuditorGRANT THORNTON LLP, Fort Lauderdale, Florida PCAOB ID 248; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 4, 20151
  • Filings831 in all: 8-K (393), 4 (122), CORRESP (33), 10-Q (32), 424B5 (23), S-1/A (20), EFFECT (19), UPLOAD (18)1
    All 42 form types

    DEF 14A (16), PRE 14A (16), 3 (11), DEFA14A (11), S-1 (11), SC 13G (11), 10-K (10), S-3 (8), S-8 (8), SC 13G/A (8), 424B3 (7), 8-K/A (7), 10-K/A (4), 4/A (4), 424B4 (4), FWP (4), DRS (3), S-3/A (3), SCHEDULE 13G/A (3), NT 10-Q (2), POS AM (2), PRER14A (2), RW (2), S-1MEF (2), SCHEDULE 13D (2), SCHEDULE 13G (2), 10-Q/A (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), D (1), NT 10-K (1), S-3MEF (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Aug 24, 2026
    Latest 8-K (8-K) Oct 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareMBRXNasdaq

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

Risk factors and legal proceedings

The risks Moleculin Biotech, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 74 risks under these headings, as written.4

  • Risks Related to Regulatory Approval and the Development and Commercialization of our Drug Candidates
  • Risks Related to Our Intellectual Property
  • Risks Relating to Our Business and Financial Condition
  • Risks Relating to Our Common Stock
  • We are developing our drug candidates to treat patients who are extremely or terminally ill, and severe adverse outcomes, including patient deaths, that occur in our clinical trials could negatively impact our business even if such outcomes are not shown to be related to our drugs.
  • We are conducting important clinical trials in the US and Europe, and additional countries in which to perform preclinical studies and clinical trials, and the risks associated with conducting research and clinical trials abroad could materially adversely affect our business.
  • There are limited suppliers for active pharmaceutical ingredients (API) used in our drug candidates and/or in manufacturing the final drug product. We utilize a single source for such API and/or final drug product for certain of our drug candidates.
  • We are required to order the API used in our drug candidates from our manufacturers significantly in advance of our delivery needs, and problems with our forecasts related to the manufacturer of the API used in our drug candidates may delay our clinical trials.
  • We cannot guarantee how long it will take regulatory agencies to review our applications for product candidates, and we may fail to obtain the necessary regulatory approvals to market our product candidates. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.
  • Changes in funding for the FDA and other government agencies and the implementation of tariffs could prevent new products and services from being developed or commercialized in a timely manner or at all, which could negatively impact our business.
  • Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for any of our product candidates.
  • As an organization, we have never before conducted pivotal clinical trials, and we may be unable to do so for any product candidates we may develop.
The other 65 risks
  • We may expend significant resources to pursue certain product candidates for specific indications and fail to capitalize on the potential of such product candidates for the potential treatment of other indications that may be more profitable or for which there is a greater likelihood of success.
  • We have commenced clinical trials and have never submitted an NDA, and any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
  • We may find it difficult to enroll subjects in our clinical trials, which could delay or prevent clinical trials of our product candidates.
  • A portion of our clinical development plan relies on physician-sponsored trials, which we do not control, and which may encounter delays for reasons outside of our control.
  • If any of our drug product candidates are found to be unsafe or lack sufficient efficacy, we will not be able to obtain regulatory approval for it and our business would be harmed.
  • Our product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
  • Even if our product candidates otherwise qualify for approval from the FDA, if the FDA does not find the manufacturing facilities of our future contract manufacturers acceptable for commercial production, we may not be able to commercialize our product candidates.
  • We received ODD for Annamycin, WP1066, and WP1122, but even if either product candidate is approved and receives ODE, ODE may not effectively prevent approval of a competing product.
  • We received four rare pediatric disease designations for WP1066, but may not be able to obtain a rare pediatric disease priority review voucher if WP1066 is approved or obtain future rare pediatric disease designations for our product candidates, which could adversely affect our potential profitability.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.
  • We have received Fast Track designation for two of our product candidates and may seek the same designation for one of more of our other product candidates. Such designation may not actually lead to a faster development or regulatory review or approval process. Fast Track designation may also be rescinded if the FDA believes the designation is no longer supported by data from our clinical development program.
  • Interim or preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may not be able to conduct, or contract others to conduct, animal testing in the future, which could harm our research and development activities.
  • We, or our third-party manufacturers, may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any.
  • Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize Annamycin and any future product candidates and may affect the prices we may set.
  • Risks Related to our Intellectual Property
  • We rely on patents and other intellectual property rights to protect our product candidates, the attainment, enforcement, defense and maintenance of which may be challenging and costly. Failure to enforce or protect these rights adequately could harm our ability to compete and impair our business.
  • We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world.
  • The intellectual property rights we have licensed from MD Anderson are subject to the rights of the US government.
  • Our patents and other proprietary rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage.
  • We may become subject to third parties’ claims alleging infringement of third-party patents and proprietary rights, or we may be involved in lawsuits to protect or enforce our patents and other proprietary rights, which could be costly and time consuming, delay or prevent the development and commercialization of our product candidates, or put our patents and other proprietary rights at risk.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop, manufacture and market our product candidates.
  • If we breach any of the agreements under which we license patent rights or if we fail to meet certain development deadlines, pay certain fees including extension fees or exercise certain rights to technology, we could lose or fail to obtain license rights that are important to our business.
  • We may not be successful in maintaining necessary rights to our product candidates or obtaining patent or other intellectual property rights important to our business through acquisitions and in-licenses.
  • 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.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering our product candidates, our ability to compete effectively could be impaired.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated third-party intellectual property, or claiming ownership of what we regard as our own intellectual property. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and lose valuable intellectual property rights or personnel.
  • Our business and operations may suffer, and proprietary information may be lost, in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
  • Risks Relating to Our Business and Our Financial Condition
  • We will require additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
  • Because successful development of our product candidates is uncertain, we are unable to estimate the actual amount of funding we will require to complete research and development and commercialize our products under development.
  • We have commenced clinical trials, have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance.
  • We have in the past completed related party transactions that were not conducted on an arm’s length basis.
  • We have never been profitable, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability.
  • Our financial condition would be adversely impacted if our intangible assets become impaired.
  • We have no sales, marketing or distribution experience and we will have to invest significant resources to develop those capabilities or enter into acceptable third-party sales and marketing arrangements.
  • We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop certain of our product candidates and our financial condition and operating results.
  • We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
  • We will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.
  • We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants.
  • We do not expect that our insurance policies will cover all of our business exposures thus leaving us exposed to significant uninsured liabilities.
  • We may incur penalties if we fail to comply with healthcare regulations.
  • We may not be able to recover from any catastrophic event affecting our suppliers.
  • Our business and operations would suffer in the event of third-party computer system failures, cyber-attacks on third-party systems or deficiency in our cyber security.
  • Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
  • We depend on our information technology and infrastructure so compromises could materially harm our ability to conduct business or delay our financial reporting.
  • We may be required to make significant payments under our license agreements with MD Anderson.
  • New tax laws or regulations that are enacted or existing tax laws and regulations that are interpreted, modified or applied adversely to us or our customers may have a material adverse effect on our business and financial condition.
  • We must comply with indirect tax laws in multiple jurisdictions, as well as complex customs duty regimes worldwide. Audits of our compliance with these rules may result in additional liabilities for taxes, duties, interest and penalties related to our international operations which would reduce our profitability.
  • Errors in our assumptions, estimates and judgments related to tax matters, including those resulting from regulatory reviews, could adversely affect our financial results.
  • We will require significant additional funding to complete the MIRACLE trial, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
  • Our stock price has been and may continue to be volatile, which could result in substantial losses for investors.
  • Shares issuable upon the exercise of outstanding options or warrants may substantially increase the number of shares available for sale in the public market and depress the price of our common stock.
  • As a biotechnology company, we are at increased risk of securities class action litigation.
  • If we are unable to maintain compliance with the listing requirements of The Nasdaq Capital Market, our common stock may be delisted from The Nasdaq Capital Market which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.
  • Failure to maintain our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • We cannot predict the effect that our reverse stock split will have on the market price for shares of our common stock.
  • There are provisions in certain of our outstanding warrants that could discourage an acquisition of us by a third party.
  • If our estimates or judgments relating to our critical accounting policies prove to be incorrect, or if financial reporting standards or interpretations change, our results of operations could be adversely affected.
  • General Risks
  • Your ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.
  • Negative research about our business published by analysts or journalists could cause our stock price to decline. A lack of regularly published research about our business could cause trading volume or our stock price to decline.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Legal proceedings

From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We are not able to estimate an aggregate amount or range of reasonably possible losses for those legal matters for which losses are not probable and estimable, primarily for the following reasons: (i) many of the relevant legal proceedings are in preliminary stages, and until such proceedings develop further, there is often uncertainty regarding the relevant facts and circumstances at issue and potential liability; and (ii) many of these proceedings involve matters of which the outcomes are inherently difficult to predict. We have insurance policies covering potential losses where such coverage is cost effective.

We are not at this time involved in any legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.

The opening of Item 3, Legal Proceedings.4

Sources

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