Genprex Inc
For the period ended Dec 31, 2024. Filed Apr 1, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Apr 1, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Financial Statements
Note1 – Description of Business and Basis of Presentation
Genprex, Inc. (“Genprex” or the “Company”), incorporated in Delaware in* April 2008,is a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. The Company’s oncology platform utilizes its systemic, non-viral ONCOPREX® Delivery System which uses lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor gene-expressing plasmids to cancer cells. The product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s diabetes technology is designed to work in Type1* diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but* maybe distinct enough from beta cells to evade the body’s immune system. In Type2* diabetes, the Company’s technology is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin.
Genprex’s lead oncology drug candidate, REQORSA® gene therapy (generic name:quaratusugene ozeplasmid), previously referred to as GPX-001, is initially being developed in combination with prominent, approved cancer drugs to treat Non-Small Cell Lung Cancer (“NSCLC”) and Small Cell Lung Cancer (“SCLC”). REQORSA has multimodal effects on cancer cells. It harms the metabolism of cancer cells, which leads to reduced cancer cell growth. It has a mechanism of action whereby it decreases tumor glucose metabolism, interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and increases the immune response against cancer cells. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company’s strategy is to develop REQORSA in combination with currently approved therapies and the Company believes REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
TheTUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, isone of a series of genes on the short arm of Chromosome3 whose therapeutic use is covered by the Company’s exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center (“MD Anderson”). The Company believes that its ONCOPREX Delivery System allows for the delivery of a number of cancer-fighting tumor suppressor genes, alone or in combination with other cancer therapies, to combat multiple types of cancer and the Company is in early stages of discovery programs to identify other cancer candidates. In* August 2022,the Company entered into athree*-year sponsored research agreement with MD Anderson to support further preclinical studies ofTUSC2 and other tumor suppressor genes. Additionally, the Company is collaborating with MD Anderson to discover, develop and utilize biomarkers to select the patient population most likely to respond to REQORSA and enable decisions on progression of its drug candidates to the next phase of development. MD Anderson is currently analyzing biomarkers that would indicate lack of response in lung cancer that could enrich the Company’s population of responders in its clinical trials and enhance patient screening and enrollment in order to increase the likelihood of potential success of the Acclaim studies for the Company.
Acclaim –1: The Company currently is enrolling and treating patients in the Phase2a expansion portion of its Phase1/2 Acclaim-1 clinical trial. The Acclaim-1 trial uses a combination of REQORSA and AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Following the* May 2023completion of the Phase1* dose escalation portion of the study, the Acclaim-1 Safety Review Committee (“Acclaim-1 SRC”) approved advancement from the Phase1 dose escalation portion to the Phase2a expansion portion of the study. Based on a review of safety data which showedno dose limiting toxicities (“DLTs”), the Acclaim-1 SRC determined the recommended Phase2 dose (“RP2D”) of REQORSA to be0.12 mg/kg. This was the highest dose level delivered in the Phase1 portion of the study and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® (erlotinib) for the treatment of late-stage lung cancer. There werethree patients originally enrolled in the Phase1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after thesecond course of REQORSA and Tagrisso and has maintained this response through47 courses of treatment (approximately35 months) and continues to receive REQORSA and Tagrisso treatment to date. Asecond patient had stable disease without disease progression through32 courses of treatment (approximately24 months) but recently had disease progression and isno longer receiving treatment. Genprex opened the Phase2a expansion portion of the study and enrolled and dosed thefirst patient in* January 2024.The initial trial design of the Phase2a* expansion portion of the study includedtwo cohorts with half being patients who received only prior Tagrisso treatment and the other half being patients who received prior Tagrisso treatment and chemotherapy. However, as previously announced in* August 2024,based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, the Company decided to limit its enrollment efforts moving forward to patients who received only prior Tagrisso treatment and cease enrollment of thesecond* cohort (patients who received prior Tagrisso treatment and chemotherapy). However, noting that both of the patients with prolonged PFS in the Phase1 portion of the study had previously received both chemotherapy and Tagrisso, in* February 2025,the Company amended the protocol to allow entry of patients progressing on Tagrisso or Tagrisso-containing regimens. The Phase2a* expansion portion of the trial, is now expected to enroll approximately33 patients; all of whom have progressed on Tagrisso or Tagrisso-containing regimens. The Phase2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, will remain unchanged. There will be an interim analysis following the treatment of19 patients in the Phase2a portion of the Acclaim-1 study. The Company expects to complete the enrollment of thefirst 19 patients for interim analysis in the Phase2a expansion portion of the study by the end of2025 and expects the interim analysis in thefirst half of2026.
The Food and Drug Administration (“FDA”) has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed on Tagrisso treatment.
The Phase2a expansion portion of the Acclaim-1 study provides the Company the advantage of early insight into drug effectiveness in defined and distinct patient populations at the maximum tolerated dose (the “MTD”) orRP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase2 trial which will follow the expansion portion of the study.
Acclaim –2: The Acclaim-2 trial involved a combination of REQORSA and Merck & Co.’s Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. As previously announced in* August 2024,based on a number of factors, including enrollment challenges and delays due to competition for investigators and eligible patients with numerous other trials involving the same patient population, the Company decided to cease enrollment of new patients in the Acclaim-2 trial to prioritize its resources and focus on the othertwo* Acclaim trials in SCLC and NSCLC, respectively. There areno longer any patients receiving study treatment in the Acclaim-2 trial. Although the Acclaim-2 study in patients progressing on Keytruda containing regimens has been closed due to, among other factors, slow enrollment, the Company continues to believe that this combination could be beneficial.
Acclaim –3: The Company is currently enrolling and treating patients in the Phase2 expansion portion of its Phase1/2 Acclaim-3 clinical trial. The Acclaim-3 clinical trial uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who developed tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. On* December 16, 2024,the Company announced that it had completed the Phase1* dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showedno DLTs, the Acclaim-3 Safety Review Committee (“Acclaim-3 SRC”) determined that theRP2D of REQORSA will be0.12 mg/kg, which was the highest dose level delivered in the Phase1 portion of the trial, and approved the opening of the Phase2 expansion portion of the trial. The Company anticipates that the Phase2 expansion portion will enroll approximately50 patients at approximately10 to15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase2 portion is to determine the18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase2 futility analysis will be performed after the25th patient enrolled and treated reaches18 weeks of follow up. The Company expects to complete enrollment of thefirst 25 patients for interim analysis in the Phase2 expansion portion of the study in thesecond half of2025.
The Acclaim-3 clinical trial has received FDA Fast Track Designation for this patient population and Acclaim-3 has also received an FDA Orphan Drug Designation.
In diabetes, Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh” or “UP”) multiple technologies relating to the development of a gene therapy product for each of Type1 and Type2 diabetes. The same general novel approach is used in each of Type1 and Type2 diabetes whereby an adeno-associated virus (“AAV”) vector containing thePdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. The Company’s diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh. GPX-002 is being developed using the same construct for the treatment of both Type1 diabetes and Type2 diabetes. GPX-002 for Type1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but* maybe distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type2* diabetes (formerly known as GPX-003), where autoimmunity isnot at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. The Company finalized the components of the diabetes construct to take forward for nonclinical studies and in* December 2023,the Company submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug (“IND”) application and initiatefirst*-in-human studies. As a result of the FDA’s response, Genprex decided to continue with its planned additional nonclinical studies before requesting regulatory guidance for the IND-enabling studies. The Company is currently working with the University of Pittsburgh on species analyses for the animal models as well as on other regulatory and clinical strategic planning, including the planned initiation of research in Type2 diabetes animal models, following which the Company believes it would be poised to seek further regulatory guidance from the FDA on IND-enabling studies in thesecond half of2025. In* October 2023,the Company entered into aone*-year extension to its* August 2022sponsored research agreement with UP for the use of GPX-002 in a non-human primate (“NHP”) model in Type2* diabetes. The extension includes a revised research plan to encompass the Company’s most recent technologies to which Genprex originally acquired exclusive rights from UP in* July 2023as amended and restated in the comprehensive New UP License Agreement in February 2025 (as defined and described below). These include a MafB promoter to drive expression of thePdx1* and MafA transcription factors that can potentially be used for both Type1 and Type2 diabetes. See also “Note7 – Commitments and Contingencies” to the Company’s financial statements included in this Annual Report on Form10-K. In* February 2023,the Company’s research collaborators at UP presented preclinical data in a NHP model of Type1* diabetes highlighting the therapeutic potential of GPX-002 at the16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD2023) in Berlin, Germany. The statistically significant study results showed the treated animals had decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance compared to baseline. In* April 2023,the Company hosted a Key Opinion Leader virtual event entitled “Novel Gene Therapy to Treat Type1* Diabetes,” which discussed preclinical data reported at ATTD2023 supporting gene therapy to treat Type1 diabetes. The Company has also initiated research on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments.
F-8
Capital Requirements, Liquidity and Going Concern Considerations
The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles (“US GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying financial statements, the Company has sustained substantial losses from operations since inception and hasno current source of revenue. In addition, the Company has used, rather than provided, cash in its operations. Genprex expects to continue to incur significant expenditures to further clinical trials for the commercial development of its patents.
The Company recognizes that it must obtain additional capital resources to successfully commercialize its product candidates. To date, Genprex has received funding in the form of equity and debt, and the Company plans to seek additional funding in the future. However,no assurances can be given that it will be successful in raising additional capital. If the Company isnot able to timely and successfully raise additional capital, the timing of its clinical trials, financial condition and results of operations* maybe materially and adversely affected. These financial statements donot* include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.
Genprex believes that its current cash and cash equivalents will be sufficient to fund expenditure requirements for its necessary operations and expected clinical trial activities into thesecond quarter of2025. Genprex has based these estimates, however, on assumptions that* mayprove to be wrong, and could spend available financial resources much faster than it currently expects. The Company will need to raise additional funds to continue funding its development and operations. The Company plans to secure such additional funding, although there areno* guarantees or commitments for additional funding.
As a result of its recurring losses from operations and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern. These financial statements donot include any adjustments that might be necessary if Genprex is unable to continue as a going concern.
Note2 – Summary of Significant Accounting Policies
Genprex’s financial statements have been prepared in accordance with US GAAP. Accordingly, they donot include all the information and footnotes required by generally accepted accounting principles for complete financial statements. In the Company’s opinion the financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the financial statementsnot misleading. The results of operations for any interim periods arenot necessarily indicative of results to be expected for the full year. A summary of the Company’s significant accounting policies consistently applied in the preparation of the accompanying financial statements follows.
Reverse Stock Split
On* February 2, 2024,Genprex completed a1*-for-40 reverse stock split (“Reverse Split”) of its issued and outstanding shares of common stock. The Reverse Split didnot change the number of authorized shares of common stock or par value. All references in these financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, as applicable, on a retroactive basis, to reflect the Reverse Split (See Note4 – Equity – Reverse Stock Split).
Use of Estimates
The preparation of Genprex’s financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
Genprex considers all highly liquid short-term investments with an initial maturity ofthree months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed Federal Deposit Insurance Corporation (“FDIC”) insured limits expose the Company to cash concentration risk. Genprex has cash in a money market account and had $1,351,625 and $6,490,117 in excess of FDIC insured limits of*$250,000* at* December 31, 2024and2023*, respectively. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.
F-9
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock, which includes common stock equivalents consisting of (i)632,323 unexercised options granted by the Company’s board of directors and warrants to purchase shares of common stock, and (ii)51,862 unvested restricted stock units to purchase shares of common stock granted by the Company’s board of directors as of* December 31, 2024*.
Segments
Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company’s CODM is its Chief Executive Officer and the Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is focused on pioneering the discovery and development of gene therapies for use in patient populations with unmet medical needs. See “Note8 – Segment Reporting” for additional disclosures related to segment reporting.
Fair Value of Financial Instruments
The carrying amounts reported in the balance sheets for cash, money-market savings account, accounts receivable, and accounts payables approximate fair value because of the immediate or short-term maturity of these financial instruments.
Property and Equipment
Furniture and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three tofive years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
Research and Development Materials Costs
Research and development expenditures consist of costs incurred to conduct research, develop engineering materials for further study, and develop clinical strategies for current and future programs associated with the Company’s preclinical and Phase1/2 clinical trials. These expenditures are expensed in the period incurred and include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities, and overhead costs.
Materials acquired to be used in clinical research, that have an alternative future use, are capitalized when the materials are acquired, and included in research and development supplies. These supplies are recognized as expense as they are consumed through use for testing or clinical activities, or have spoiled. The costs of materials that were acquired for a particular research and development activity and haveno alternative future use are expensed in the period acquired.
Research and development supplies purchased and capitalized for future use were $2,046,858 and $2,347,488 at* December 31, 2024and2023*, respectively.
F-10
Intellectual Property
Intellectual property consists of legal and related costs associated with patents, trademarks, and other proprietary technology and rights developed, acquired, or licensed by Genprex. Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These patent-related legal costs are reported as a component of general and administrative expenses.
Accounting for Stock-Based Compensation
Genprex uses the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. The Company measures options granted at fair value determined as of the grant date and recognizes the expense over the periods in which the options vest or are expected to vest and related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.
Long-Lived Assets
Genprex reviews long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset* may**not* be recoverable. In evaluating the fair value and future benefits of its intangible assets, the Company performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. The Company recognizes an impairment loss if the carrying value of the asset exceeds the discounted expected future cash flows. During the years ended* December 31, 2024and2023*, there wereno deemed impairments of the Company’s long-lived assets.
Modification of Equity Classified Warrants
A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.
Recent Accounting Developments
Accounting pronouncements issued butnot effective until after* December 31, 2024* arenot expected to have a significant effect on the Company’s financial condition, results of operations, or cash flows.
In* November 2023,the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)2023-07, “Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures,” which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The purpose of the amendment is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. The guidance is effective for fiscal years beginning after* December 15, 2023,and interim periods within fiscal years beginning after December 15, 2024,with early adoption permitted. The Company adopted this as of December 31, 2024and the adoption hadno* material impact to the Company’s financial position, results of operation, or cash flows. See “Note8 – Segment Reporting” for additional disclosures related to segment reporting.
In* December 2023,the FASB issued ASU2023*-09, “Income Taxes (Topic740): Improvements to Income Tax Disclosures,” which modifies the rules on income tax disclosures to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The guidance is effective for annual periods beginning after* December 15, 2024,with early adoption permitted. The Company is currently evaluating the effect the amendments in ASU2023*-09 will have on its tax disclosures.
F-11
Note3 – Intellectual Property
As of* December 31, 2024,*Genprex owned or had exclusive license agreements on 13 granted patents and 30 pending patent applications worldwide for technologies developed in-house or by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, the University of Michigan, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.
University of Pittsburgh
On* February 11, 2020,Genprex entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type1* and Type2 diabetes. This license wasfirst amended on* August 17, 2022,to extend the milestone related to the filing of a new investigational drug (“IND”) application. This license was amended again on November 3, 2022,to include a new licensed glucagon promoter technology related to Type1* diabetes and set FDA and clinical milestones related to the glucagon technology.
On* November 22, 2022,Genprex entered into an exclusive license agreement with the University of Pittsburgh relating to the transformation of macrophages enabling them to reduce autoimmunity activity in Type1* diabetes.
On* December 29, 2022,Genprex entered into an exclusive license agreement with the University of Pittsburgh relating to the use of an insulin promoter in combination with the Company’s existing gene therapy, including thePdx1* and MafA transcription factors, as a potential treatment for Type2 diabetes.
On* July 14, 2023,Genprex entered into an exclusive license agreement with the University of Pittsburgh related to a gene therapy for both Type1* and Type2 diabetes using a MafB promoter to drive expression of thePdx1 and MafA transcription factors.
See “Note10 – Subsequent Events – Amended and Restated Exclusive License Agreement” for a description of the Company’s* February 17, 2025*exclusive license with the University of Pittsburgh involving all of the aforementioned UP licensed rights and technologies.
The University of Texas MD Anderson Cancer Center
On* May 4, 2020,Genprex entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating to a portfolio of patent applications and related technology for the treatment of cancer using the Company’s lead drug candidate and immunotherapies. See “Note7* - Commitments and Contingencies - Commitments - MD Anderson” for information on additional agreements involving MD Anderson licensed rights and technologies.
University of Michigan
On* November 11, 2024,*Genprex and the Regents of the University of Michigan (“UM” or the “University of Michigan”) entered into a Patent License Agreement (“UM License Agreement”), which granted Genprex a worldwide, exclusive license to the University of Michigan’s patent rights in a co-owned patent application relating to the use of REQORSA in combination with ALK-inhibitors for the treatment of ALK-EML4 positive translocated lung cancer.
Note4 – Equity
Reverse Stock Split
At Genprex’s special meeting of stockholders held on* December 14, 2023,the Company’s stockholders granted the Company’s board of directors the discretion to effect a reverse stock split of the Company’s issued and outstanding common stock through an amendment (the “Certificate of Amendment”) to the Company’s Amended and Restated Certificate of Incorporation, as amended and restated to date, at a ratio ofnot* less than1-for-10 andnot more than1-for-50, such ratio to be determined by the Company’s board of directors. On* January 19, 2024,the Company’s board of directors approved a1*-for-40 reverse stock split and authorized the filing of the Certificate of Amendment for the Reverse Split with the Secretary of State of the State of Delaware. The Reverse Split became effective in accordance with the terms of the Certificate of Amendment on* February 2, 2024.The Certificate of Amendment didnot* change the number of authorized shares of common stock or the par value. All references in these financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Split.
Registered Direct Offerings
On* March 1, 2023,Genprex completed a registered direct offering, in which the Company sold to an accredited healthcare-focused institutional investor an aggregate of 95,239 shares of its common stock and warrants to purchase up to 95,239 shares of its common stock, at a combined offering price of $42.00 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $44.00 per share. The Company received net proceeds of approximately $3.6 million after $400,000 of commissions and expenses, excluding any proceeds that may*be received in the future from any exercise of the warrants.
On* July 21, 2023,Genprex completed a registered direct offering priced at the market under Nasdaq rules, in which the Company sold to accredited healthcare-focused institutional investors an aggregate of (i)185,644 shares of its common stock, and (ii) warrants to purchase up to 185,644 shares of its common stock, at a combined offering price of $40.40 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $35.40 per share. Also, the Company agreed to issue to H.C. Wainwright & Co., LLC or its designees (the “Placement Agent”) warrants to purchase up to an aggregate of 11,140 shares of the Company’s common stock. The warrants issued to the Placement Agent have substantially the same terms as the warrants issued to the investors except that the Placement Agent warrants have an exercise price of $50.50 per share and expire on July 18, 2028.Genprex received net proceeds of approximately $6.7 million after approximately $800,000 of commissions and expenses, excluding any proceeds that may*be received in the future from any exercise of the warrants.
On* March 21, 2024,the Company completed a registered direct offering priced at the market under Nasdaq rules, in which the Company sold to an institutional investor an aggregate of (i)165,000 shares of common stock, (ii) pre-funded warrants (the “March 2024Pre-Funded Warrants”) exercisable for up to an aggregate of 1,377,112 shares of common stock, and (iii) warrants (the “March 2024Common Warrants”) exercisable for up to an aggregate of 1,542,112 shares of common stock. The offering price for each share of common stock and accompanying March 2024Common Warrant was $4.215, and the offering price for each March 2024Pre-Funded Warrant and accompanying March 2024Common Warrant was $4.2149. The March 2024Pre-Funded Warrants were exercisable immediately upon issuance at an exercise price of $0.0001 per share and expired when exercised in full. The March 2024Common Warrants are exercisable immediately upon issuance at an exercise price of $4.09 per share and will expire infive years from the date of issuance. The Company received net proceeds of approximately $5.8 million after commissions and expenses, excluding any proceeds received from any exercise of the March 2024Common Warrants. In connection with the offering, the Company also amended certain existing warrants to purchase up to an aggregate of 194,248 shares of common stock that were previously issued to investors in March 2023and July 2023,with exercise prices of $44.00 and $35.40 per share and expiration dates of March 1, 2028and July 21, 2028for $0.125 per amended warrant, such that the amended warrants have a reduced exercise price of $4.09 per share and an expiration date offive years from the closing of the March 2024offering. As of December 31, 2024*, all of the 1,377,112 * March 2024*Pre-Funded Warrants had been exercised for shares of common stock.
At-The Market Offering
On* November 18, 2022,Genprex entered into an Equity Distribution Agreement with JMP Securities LLC (“JMP Securities”) pursuant to which the Company could sell from time to time, at its option, shares of its common stock through JMP Securities, as sales agent (the“2022* ATM Facility”), up to an aggregate offering price of $50 million. Sales of the shares were made under the Company’s previously filed Registration Statement on Form S-3 (Reg.No. 333-239134), by means of ordinary brokers’ transactions on the NASDAQ Global Market or otherwise. Additionally, under the terms of the Equity Distribution Agreement, the shares could be sold at market prices, at negotiated prices or at prices related to the prevailing market price. Genprex agreed to pay JMP Securities a commission of 3.0% of the gross proceeds from the sale of the shares. During the year ended* December 31, 2023*, the Company sold 1,342 shares of common stock for aggregate net proceeds of $78,355 under the2022 ATM Facility. On* December 12, 2023,the Company provided notice to JMP Securities of its termination of the2022* ATM Facility. The termination of the Equity Distribution Agreement with JMP Securities was effective as of* December 13, 2023.*
On* December 13, 2023,Genprex entered into an At The Market (“ATM”) Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program (the“2023* ATM Facility”) under which the Company* mayoffer and sell through the Agent, from time to time at its sole discretion, up to such number or dollar amount of shares of its common stock (the “Shares”) as registered on the prospectus supplement covering the2023* ATM Facility offering, as* maybe amended or supplemented from time to time. Any Shares offered and sold pursuant to this Agreement will be issued pursuant to the Company’s currently effective shelf Registration Statement on Form S-3 (FileNo.* 333-271386) filed with the SEC on* April 21, 2023,which was declared effective on June 9, 2023.The Company has agreed to pay the Agent a commission equal tothree* percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Agreement, and also have provided the Agent with customary indemnification and contribution rights. During the year ended* December 31, 2024*, the Company sold 7,684,953 shares of common stock for aggregate net proceeds of approximately $6.1 million under the2023 ATM Facility.
See “Note10 – Subsequent Events –2023 ATM Facility” for a description of the Company’s usage of the2023 ATM Facility after* December 31, 2024* resulting in net proceeds of approximately $6,028,104.
Stock Issuances
During the year ended* December 31, 2024*, Genprex issued (i)15,125 shares of common stock for services provided to the Company valued at $27,435 to the Chairman of its Scientific Advisory Board, (ii)36,250 shares of common stock to service providers of the Company valued at $179,550, (iii)31,623 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $96,460 to Company executives and employees, non-employee directors, and former Company executives (Mr. Varner and Ms. Vaczy) pursuant to the terms of employment and/or separation agreements, (iv)64,690 shares of common stock due to adjustments related to the Company's Reverse Split, (v)165,000 shares of common stock sold for aggregate net proceeds of approximately $5.8 million associated with the Company's* March 2024offering, as described above, (vi)7,684,953 shares of common stock sold for aggregate net proceeds of $6,100,562 under the Company's2023* ATM Facility, as described above, and (vii)1,377,112 shares of common stock upon the exercise of pre-funded warrants at a nominal price associated with the Company's* March 2024*offering.
During the year ended* December 31, 2023*, Genprex issued (i)500 shares of common stock for services provided to the Company valued at $19,020 to the Chairman of its Scientific Advisory Board, (ii)1,342 shares of common stock for aggregate net proceeds of $78,355 under the2022 ATM Facility, (iii)280,883 shares of common stock sold for aggregate net proceeds of approximately $10.5 million associated with the Company's* March 2023and July 2023*offerings, as described above, and (iv)500 shares of common stock upon the exercise of options by a former board member of the Company.
F-12
Preferred Stock
Genprex is authorized to issue 10,000,000 shares of preferred stock at a par value of $0.001 per share, none of which are outstanding as of* December 31, 2024*.
Common Stock
Genprex is authorized to issue 200,000,000 shares of common stock at a par value of $0.001 per share, all of which is voting common stock. There were 10,860,655 shares of common stock outstanding at* December 31, 2024*.
Common Stock Purchase Warrants
Common stock purchase warrant activity for the years ended* December 31, 2024and2023* respectively are as follows:
| 2024 | 2023 | |||
|---|---|---|---|---|
| Number of | Weighted Average | Number of | Weighted Average | |
| Warrants | Exercise Price | Warrants | Exercise Price | |
| Outstanding at January 1, | 346,440 | $37.99 | 53,695 | $172.81 |
| Warrants issued | 3,011,751 | 2.26 | 296,273 | 15.46 |
| Warrants exercised | 1,377,112 | 0.00 | — | — |
| Warrants cancelled or expired | — | — | 3,528 | 209.77 |
| Outstanding at December 31, | 1,981,079 | $10.05 | 346,440 | $37.99 |
| Exercisable at December 31, | 1,976,079 | $9.85 | 340,585 | $37.10 |
During the year ended* December 31, 2024* and in connection with the registered direct offering, with an institutional investor, completed on* March**21,* 2024, Genprex (i) issued pre-funded warrants to purchase up to an aggregate of 1,377,112 shares of common stock at a nominal exercise price of $0.0001 per share, the remaining balance of the purchase price of each share of common stock associated with each pre-funded warrant net of the portion of the subscription price therefor paid at closing, (ii) issued warrants to purchase up to 1,542,112 shares of common stock, at an exercise price of $4.09 per share, (iii) issued warrants to purchase up to 92,527 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”), at an exercise price of $5.2688 per share, (iv) amended existing warrants to purchase up to an aggregate of 194,248 shares of common stock that were previously issued to the same institutional investor in* March 2023and July 2023,such that the amended warrants have a reduced exercise price of $4.09 per share and an expiration date offive years from the closing of the March 2024offering, and (v) issued 1,377,112 shares of common stock associated with the exercise of March 2024Pre-Funded Warrants. During the year ended December 31, 2024*, the Company recorded share-based compensation of $18,039 associated with the vesting and issuance of warrants.
During the year ended* December 31, 2023*, Genprex issued (i) warrants to purchase up to an aggregate of 4,250 shares of common stock to service providers at exercise prices ranging from $26.00 to $66.00 per share, the fair market value of a share of common stock on the date of issuance, (ii) warrants to purchase up to 95,239 shares of common stock to accredited healthcare-focused institutional investors in connection with the registered direct offering completed on* March 1, 2023,at an exercise price of $44.00 per share, (iii) warrants to purchase up to 185,644 shares of common stock to accredited healthcare-focused institutional investors in connection with the registered direct offering completed on July 21, 2023,at an exercise price of $35.40 per share, and (iv) warrants to purchase up to 11,140 shares of common stock to the Placement Agent in connection with the registered direct offering completed on July 21, 2023,at an exercise price of $50.50 per share. During the year ended December 31, 2023*, the Company was deemed to cancel (i) warrants to purchase up to an aggregate of 960 shares of common stock upon termination of warrants previously issued to placement agents associated with the Company’s Initial Public Offering (“IPO”) in* March 2018,and (ii) warrants to purchase up to an aggregate of 2,568 shares of common stock upon termination of warrants to a service provider. During the year ended December 31, 2023*, the Company recorded share-based compensation of $133,558 associated with the vesting and issuance of warrants.
As of* December 31, 2024*, Genprex had outstanding warrants to purchase 1,981,079 shares of common stock at a weighted average exercise price of $10.05 that have been issued to various consultants, investors, and placement agents of the Company. These warrants vest immediately or over periods ranging up to12 months, are exercisable for a period of up tofive years, enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $4.09 to $288.80 per share and have per-share fair values ranging from $1.40 to $185.00, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for the years ended* December 31, 2024and2023*, respectively.
| Twelve Months Ended December 31, 2024 | Twelve Months Ended December 31, 2023 | |
|---|---|---|
| Expected term (in years): | 2.5 | 2.5 - 3.0 |
| Risk-free rate: | 4.52% | 4.99% - 5.52% |
| Volatility: | 87.49% | 83.14% - 83.42% |
| Dividend yield: | 0% | 0% |
Warrant Modifications
On* March 21, 2024the Company amendedtwo* warrants whereby, for both warrants, the exercise price was reduced to $4.09 per share and the maturity dates were extended to a term offive years. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.
| Post-modification | Pre-modification | |
|---|---|---|
| Exercise Price | $4.09 | 35.400 -44.0000 |
| Expected term (in years): | 5.0 | 4.00 - 4.50 |
| Risk-free rate: | 4.52% | 4.99% - 5.35% |
| Volatility: | 87.49% | 83.42% |
| Dividend yield: | 0% | 0% |
The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $277,119, which was treated as a deemed dividend and is reflected as “Deemed dividend related to warrant modifications” in the accompanying statement of operations and comprehensive loss.
F-13
2018 Equity Incentive Plan
The Company’s board of directors and stockholders have approved and adopted the Genprex2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of the Company’s IPO on* April 3, 2018.The2018* Plan provides for the grant of incentive stock options that are intended to qualify under Section422 of the Internal Revenue Code of1986, as amended (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, RSU awards, performance-based stock awards and performance-based cash awards. ISOs* maybe granted only to employees. All other awards may*be granted to employees, including officers, and to the Company’s non-employee directors and consultants.
A total of 104,000 shares of common stock were initially available under the2018 Plan, plus a number of shares of common stock (not to exceed 65,719 shares) subject to outstanding awards under the Company’s2009 Equity Incentive Plan (the*“2009* Plan”) as of the IPO that expire, are forfeited or otherwise terminate or that are used to cover the exercise price or applicable tax withholdings.No further grants will be made under the2009 Plan.
In addition, the number of shares of common stock reserved for issuance under the2018 Plan automatically increases on* January 1of each year, since January 1, 2019,by 5% of the total number of shares of the Company’s common stock outstanding on December 31of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors or a committee of the board of directors appointed to administer the2018* Plan.
On* January 1, 2023and2024,* the number of shares of common stock reserved for issuance under the2018 Plan was increased by an aggregate of 60,132 and 74,294 shares, respectively. As of* December 31, 2024*, a total of 1,085 shares of common stock remain available for issuance for future awards under the2018 Plan. Subsequent to the year ended* December 31, 2024*, an additional 543,032 shares of common stock became available for issuance for future awards under the2018 Plan pursuant to the evergreen provision thereof.
2018 Employee Stock Purchase Plan
The Company’s board of directors and stockholders approved and adopted the Genprex2018 Employee Stock Purchase Plan (“ESPP”), which became effective on* April 3, 2018.The ESPP hasnot* yet been utilized as a benefit available to the Company’s employees. The ESPP authorizes the issuance of 5,202 shares of common stock pursuant to purchase rights that* maybe granted to eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1of each calendar year, beginning on January 1, 2019,by 2% of the total number of shares of common stock outstanding on December 31of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP determinednot* to increase the number of shares reserved for issuance under the ESPP on* January 1, 2024.*
F-14
Stock Options
As of* December 31, 2024*, Genprex had outstanding stock options to purchase 283,636 shares of common stock that have been granted to various executives, employees, directors, and independent contractors of the Company, including outstanding stock options to purchase 25,417 shares of common stock issued as inducement grants, outside of the2018 Plan, associated with the hiring of new executives in2021 and2023. These options vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up toten years, and enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $18.00 to $140.00 per share. The per-share fair values of these options range from $12.62 to $98.84, based on Black-Scholes-Merton pricing models with the following assumptions:
| Twelve Months Ended December 31, 2024 | Twelve Months Ended December 31, 2023 | |
|---|---|---|
| Expected term (in years): | — | 6.0 |
| Risk-free rate: | — | 4.60% – 5.37% |
| Volatility: | — | 83.14% - 83.42% |
| Dividend yield: | — | 0% |
The Company didnot issue stock options during the year ended* December 31, 2024*. During the year ended* December 31, 2024*, the Company cancelled stock options to purchase 2,247 shares of common stock with exercise prices ranging from $32.40 to $88.00 per share in connection with the termination of employees.
During the year ended* December 31, 2023*, Genprex (i) granted stock options to purchase an aggregate of 8,251 shares of the Company’s common stock with exercise prices ranging from $18.00 to $60.40 per share to employees, (ii) cancelled options to purchase 6,245 shares of common stock at an exercise prices ranging from $50.80 to $142.00 per share in connection with the termination of certain employees, and (iii) issued 500 shares of the Company’s common stock upon the exercise of options held by a former board member with an exercise price of $11.92 per share.
The weighted average remaining contractual term for the outstanding options at* December 31, 2024and2023* is 5.11 and 6.13 years, respectively.
Stock option activity for the years ended* December 31, 2024and2023*, respectively, is as follows:
| 2024 | 2023 | |||
|---|---|---|---|---|
| Number of | Weighted Average | Number of | Weighted Average | |
| Options | Exercise Price | Options | Exercise Price | |
| Outstanding at January 1, | 285,883 | $121.11 | 284,377 | $123.19 |
| Options granted | — | — | 8,251 | 30.14 |
| Options exercised | — | — | 500 | 11.92 |
| Options expired or cancelled | 2,247 | 50.86 | 6,245 | 104.42 |
| Outstanding at December 31, | 283,636 | $121.67 | 285,883 | $121.11 |
| Exercisable at December 31, | 275,566 | $123.41 | 237,859 | $124.73 |
F-15
Restricted Stock Units
During the year ended* December 31, 2024*, the Company (i) issued 81,700 RSUs to executives, employees, and non-employee directors, (ii) cancelled 410 RSUs associated with the termination of employees, (iii) withheld 9,830 RSUs to cover taxes associated with the vesting of employee issued RSUs, and (iv) issued 31,623 shares of common stock associated with the vesting of RSUs to executives, employees, and non-employee directors.
During the year ended* December 31, 2023*, the Company (i) issued 57,119 RSUs to executives, employees, and non-employee directors, and (ii) cancelled 5,257 RSUs associated with the termination of employees.
A summary of the RSU activity under the2018 Plan during the years ended* December 31, 2024and2023*, respectively, is presented below. These amounts include RSUs granted to executives, other employees, and board members.
| 2024 | 2023 | |||
|---|---|---|---|---|
| Number of | Weighted Average | Number of | Weighted Average | |
| Units | Grant Date Fair Value | Units | Grant Date Fair Value | |
| Outstanding at January 1, | 51,862 | $59.48 | — | $— |
| Restricted stock units granted | 95,950 | 1.08 | 57,119 | 60.08 |
| Restricted stock units vested | 31,623 | 55.31 | — | — |
| Restricted stock units forfeited or cancelled | 10,240 | 66.00 | 5,257 | 66.00 |
| Outstanding at December 31, | 105,949 | $66.00 | 51,862 | $59.48 |
Share-Based Compensation
In the year ended* December 31, 2024*, Genprex’s total share-based compensation was approximately $3.3 million, consisting of $2.7 million and $0.6 million associated with G&A expense and R&D expense, respectively, which represents the vesting of options and warrants issued to service providers, executives, employees, and board members of the Company. As of* December 31, 2024*, the Company’s total compensation cost related to non-vested time-based stock option awards, RSUs, and warrants granted to executives, employees, board members, and service providers andnot yet recognized was approximately $0.4 million, consisting of $0.2 million and $0.2 million associated with G&A expense and R&D expense, respectively. Genprex expects to record this stock-based compensation expense over the next three years using a graded vesting method. As of* December 31, 2024*, the weighted average term over which these expenses are expected to be recognized is 0.91 years.
As of* December 31, 2024*, there areno performance-based stock option awards outstanding andone performance-based warrant outstanding issued to a service provider of the Company. Genprex’s total compensation cost related to the non-vested performance-based warrantnot yet recognized was approximately $300,000. The entirety of this warrant* may*be recognized and recorded upon the achievement of certain milestones.
In the year ended* December 31, 2023*, the Company’s total share-based compensation was approximately $5.4 million, consisting of $4.4 million and $1.0 million associated with G&A expense and R&D expense, respectively, which represents the vesting of options and warrants issued to service providers, executives, employees, and board members of the Company.
Note5 -401(k) Savings****Transactions
In2022, Genprex established a defined-contribution savings plan under Section401(k) of the Internal Revenue Code (“401(k) Plan”) and established an employer matching program for participants in the401(k) Plan. The401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. Genprex incurred $125,731 and $141,564 of expense for matching contributions to the401(k) Plan for the years ended* December 31, 2024and2023*, respectively.
Note6 - Related Party Transactions
Introgen Research Institute
Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, who prior to his passing in* May 2024,was the Company’s President, Chief Executive Officer and Chairman of the Board and who was IRI’s sole officer. IRI is owned by trusts of which Mr. Varner's descendants are the sole beneficiaries. In April 2009,prior to Mr. Varner becoming an officer and director of Genprex in August 2012,the Company entered into an Assignment and Collaboration Agreement with IRI, providing Genprex with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in2011* to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson (see Note7 – Commitments and Contingences – Commitments – MD Anderson Cancer Center). There wereno amounts incurred or due under this agreement at the years ended* December 31, 2024and2023*, respectively.
F-16
Note7 - Commitments and Contingencies
Commitments
MD Anderson
In* July 2018,Genprex entered into atwo*-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy with a projected total cost of approximately $2 million. This agreement was extended beyond the original expiration date, expiring in* May 2022after giving effect to such extension. In August 2022,the Company entered into athree*-year sponsored research agreement with MD Anderson (* “August 2022SRA”) to sponsor preclinical studies focused on REQORSA andNPRL2* in oncology to resensitize NSCLC and SCLC to targeted therapies and immunotherapies with an initial projected total cost of approximately $2.9 million. On* June 7, 2024,the Company amended the August 2022SRA with MD Anderson to (i) extend the sponsored research program an additionalsix* months, (ii) amend the quarterly budget from approximately $240,000 to $165,000 per quarter, and (iii) amend the total commitment from $2.9 million to approximately $2.75 million. The Company incurred approximately $811,540 of expense from this agreement during the year ended* December 31, 2024*. As of* December 31, 2024*, the Company has paid approximately $1.44 million toward this $2.76 million commitment.
In2011, the Company agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under the1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). The Company also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. The Company assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.
On* March 3, 2021,the Company entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020,with MD Anderson. The MD License Amendment grants Genprex a worldwide, exclusive, sublicensable license to an additional portfolio ofsix* patents andone patent application and related technology for methods for treating cancer by administration of aTUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive toTUSC2 therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the midfive figures to the lowsix figures, (ii) total milestone payments of $6,150,000, (iii) aone-time fee in the midfive figures and (iv) certain patent related expenses. As of* December 31, 2024*, Genprex has paid approximately $370,000 toward this commitment.
National Institutes of Health
Genprex has a royalty obligation to the National Institutes of Health (“NIH”) to be paid upon the Company’s receipt of FDA approval using NIH technology. The $240,000 contingent obligation which increases annually by $20,000 and is $380,000 and $360,000 for the years ended* December 31, 2024and2023*, respectively, will be recognized when the Company obtains regulatory approval (the event that triggers the payment obligation).
University of Michigan
On* November 11, 2024,the Company and the University of Michigan entered into the UM License Agreement, which granted Genprex a worldwide, exclusive license to the University of Michigan’s patent rights in a co-owned patent application relating to the use of REQORSA in combination with ALK-inhibitors for the treatment of ALK-EML4 positive translocated lung cancer. Genprex agreed to pay: (i) an initial license issue fee of $30,000, (ii) running low single digit percentage royalties ranging from 1% to 3% of net sales, (iii) minimum annual royalties in a fixed cash amount of $15,000 for2025* and2026, and $30,000 for2027 and each year thereafter during the term of the UM License Agreement, (iv) a tiered double digit percentage share of non-royalty sublicense income ranging from 10% to 40%, and (v) certain potential clinical milestone payments through FDA regulatory approval up to an aggregate of approximately $350,000 in addition to certain potential commercial sales milestones. As of* December 31, 2024,*Genprex has paid approximately $15,000 toward this commitment.
F-17
University of Pittsburgh
Pursuant to an exclusive license agreement dated* February 11, 2020by and between Genprex and the University of Pittsburgh, amended on August 17, 2022,and amended again on November 3, 2022,Genprex agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a glucagon promoter and gene therapy technologies to potentially treat Type1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. As of* December 31, 2024*, Genprex has paid approximately $150,000 toward this commitment.
Pursuant to an exclusive license agreement dated* November 22, 2022by and between Genprex and the University of Pittsburgh, Genprex agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a macrophage technology and gene therapy technologies to potentially treat Type1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. As of* December 31, 2024*, Genprex has paid approximately $50,000 toward this commitment.
Pursuant to an exclusive license agreement dated* December 29, 2022by and between Genprex and the University of Pittsburgh, Genprex agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of an insulin promoter and gene therapy technologies to potentially treat Type2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. As of* December 31, 2024*, Genprex has paid approximately $50,000 toward this commitment.
Pursuant to an exclusive license agreement dated* July 14, 2023,by and between Genprex and the University of Pittsburgh, Genprex agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for thefirst* year, $50,000 for thesecond andthird years, and $100,000 for thefourth year and each subsequent year following thefourth anniversary of the agreement thereafter until the anniversary prior to the year of thefirst commercial sale, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $4,225,000 in milestone payments related to the usage of an MafB promoter and gene therapy technologies to potentially treat Type1 and Type2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. As of* December 31, 2024*, Genprex has paid approximately $50,000 toward this commitment.
See “Note10 – Subsequent Events – Amended and Restated Exclusive License Agreement” for a description of the Company’s exclusive license dated* February 17, 2025*by and between the University of Pittsburgh involving all of the aforementioned UP licensed rights and technologies.
Contract Development and Manufacturing Organization
Genprex entered into athree-year development services agreement in* July 2022,amended in each of January 2023and March 2023,with a contract development and manufacturing organization (“CDMO”) to manufacture good manufacturing practices (“GMP”) grade materials for use in the Company’s clinical trials with a projected total cost at inception of approximately $4.5 million. On April 2, 2024,the Company was informed by the CDMO that the CDMO was ceasing certain manufacturing operations subject to the development services agreement. On June 30, 2024,the development services agreement was terminated by mutual agreement and the CDMO agreed to return $1.3 million to the Company andno* additional commitments are obligated or owed by the Company. The Company incurred $0 and $2.6 million of expense from this agreement during the years ended* December 31, 2024and2023*, respectively.
Contingencies
From time to time, the Company* maybecome subject to threatened and/or asserted claims arising in the ordinary course of its business. The Company isnot* aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on its financial condition, results of operations or liquidity.
F-18
Note8 – Segment Reporting
Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company manages its operations as a single segment (the “Segment”) for the purposes of assessing performance and making operating decisions. The CODM of the Segment is the Company’s Chief Executive Officer. The Segment is focused on pioneering the discovery and development of gene therapies for use in patient populations with unmet medical needs. The accounting policies for the Segment are the same as those described in Note2, Summary of Significant Accounting Policies. The CODM assesses the performance of the Segment and decides how to allocate resources based on net loss that is reported on the statements of operations and comprehensive loss. Further, the following represents information about segment loss and significant segment expenses:
| Year Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Revenues | $— | $— |
| Less: | ||
| Clinical and regulatory | 7,809,750 | 6,149,359 |
| Manufacturing | 1,658,373 | 9,133,564 |
| Research | 483,927 | 1,286,023 |
| General and administrative support | 7,877,622 | 9,064,207 |
| Non-cash expenses(1) | 3,344,495 | 5,423,741 |
| Other income | 0 | — |
| Interest income | 63,574 | 215,109 |
| Plus: | ||
| Realized loss | 570 | 18,676 |
| Segment and net loss | $21,111,163 | $30,860,461 |
(1) Inclusive of $3.3 million and $5.4 million of stock-based compensation expense for the years ended* December 31, 2024and2023,* respectively, and $6,693 and $15,004 of depreciation and amortization expense for the years ended* December 31, 2024and2023,* respectively.
F-19
Note9 – Income Taxes
Components of income tax benefit for the year ended* December 31, 2024and2023*, respectively, are as follows:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Current Tax Expense (Benefit): | ||
| Federal | $— | $— |
| State | 2,650 | — |
| Total | 2,650 | — |
| Deferred Tax Expense (Benefit): | ||
| Federal | — | — |
| State | — | — |
| Total | — | — |
| Total Provision for Income Taxes | $2,650 | $— |
Temporary differences between financial statement carrying amount and tax basis of assets and liabilities that give rise to significant portions of the deferred tax assets and liabilities at* December 31, 2024and2023*, respectively, are as follows:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Deferred tax assets: | ||
| Intangible Assets - R&D Expenses | $5,298,509 | $4,710,079 |
| Accrued Expenses | 529,638 | 684,700 |
| Tax Credits | 728,701 | 1,434,851 |
| Stock Compensation Expense | 1,302,638 | 306,906 |
| Net Operating Losses | 20,215,112 | 16,915,002 |
| Other | 87,089 | — |
| Total Deferred Income Tax Assets | 28,161,687 | 24,051,538 |
| Deferred Income Tax Liabilities: | ||
| Fixed Assets | — | (1,650) |
| Prepaid Expenses | (537,405) | (629,136) |
| Lease - Right of Use | — | — |
| Total Deferred Income Tax Liabilities | (537,405) | (630,786) |
| Less Valuation Allowance | (27,624,282) | (23,420,752) |
| Net Deferred Income Tax Asset | $— | $— |
At* December 31, 2024and2023*, the Company had federal net operating losses of $96.2 million and $80.5 million, respectively. Net deferred tax assets are mainly comprised of temporary differences between financial statement carrying amount and tax basis of assets and liabilities.
In assessing the ability to realize the deferred tax assets, management considers whether it is more likely thannot that some portion or all of the deferred tax assets willnot be realized. The ultimate realization of deferred tax assets is dependent on the generation of future taxable income during the period in which these temporary differences become deductible. Management considers the projected future taxable income and prudent and feasible tax planning strategies in making this assessment. As of* December 31, 2024and2023*, valuation allowances of $27.6 million and $23.4 million have been recorded, respectively.
The Company has federal research and development (“R&D”) credit carryforwards of $0.7 million which will begin to expire in2037.
Effective* January 1, 2009the Company adopted ASC740*-10, the provision formerly FASB InterpretationNo. 48, "Accounting for Uncertainty in Income Taxes," (“FIN48”) and began evaluating tax positions utilizing atwo-step process. Thefirst step is to determine whether it is more-likely-than-not that a tax position will be sustained upon examination based on the technical merits of the position. Thesecond step is to measure the benefit to be recorded from tax positions that meet the more-likely-than-not recognition threshold by determining the largest amount of tax benefit that is greater than50 percent likely of being realized upon ultimate settlement and recognizing that amount in the financial statements.
The following table reflects changes in the gross unrecognized tax benefits (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Unrecognized tax benefits at beginning of period | $(159,428) | $(80,967) |
| Gross increases – tax positions in current period | — | (78,461) |
| Gross decreases – tax positions in prior period | 78,461 | — |
| Settlements | — | — |
| Lapse of Statute of Limitations | — | — |
| Unrecognized tax benefits at end of period | $(80,967) | $(159,428) |
We classify uncertain tax positions as non-current unrecognized tax liabilities unless expected to be paid withinone year or otherwise directly related to an existing deferred tax asset, in which case the uncertain tax position is recorded as an offset to the asset on the consolidated balance sheet. As of* December 31, 2024,*$80,867 of our gross unrecognized tax benefits were recorded as a reduction of the related deferred tax assets.
F-20
Note10 – Subsequent Events
The Company has evaluated subsequent events through the filing of this Annual Report on Form10-K and determined that there have beenno recognized subsequent events that have occurred that would require adjustments to the Company’s disclosures in the financial statements. The following are nonrecognized subsequent events through the filing of this Annual Report on Form10-K.
Reserves of2018 Equity Incentive Plan and2018* Employee Stock Purchase Plan***
On* January 1, 2025,the total shares of common stock reserved under the2018* Plan increased by 543,032 shares pursuant to the “evergreen” provision of the2018 Plan. On* January 7, 2025,the Company’s board of directors determined thatno* additional shares would be reserved during the2024 fiscal year for the ESPP given thatno shares have yet been issued under the ESPP.
Share Issuances
On* January 2, 2025,*Genprex issued (i)5,000 shares of common stock to the Chairman of the Company’s Scientific Advisory Board in consideration for services, and (ii)8,527 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $3,496 to Company executives and employees.
2023 ATM Facility
From* January 1, 2025through the date of filing of this Annual Report on Form10*-K, Genprex has sold 13,278,666 shares of its common stock for aggregate net proceeds to the Company totaling $6,028,104 under the2023 ATM Facility.
Amended and Restated Exclusive License Agreement
On* February 17, 2025,Genprex and the University of Pittsburgh (“Pitt”) entered into an amended and restated Exclusive License Agreement (the “New Pitt License Agreement”) to update and consolidate, into a single agreement, prior license agreements and licensed technologies covered by the prior Pitt agreements related to a gene therapy for both Type1* diabetes and Type2 diabetes using the genes of thePdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters. As of* February 17, 2025,the New Pitt License Agreement effectuates the termination of, and amends, restates, replaces and supersedes in their entirety, the prior license agreements between Genprex and Pitt which were effective as of February 10, 2020 (as amended August 17, 2022and November 3, 2022),** December 29, 2022and July 14, 2023.Genprex also terminated, effective February 17, 2025,a prior agreement with Pitt related to a license for macrophage technology dated November 22, 2022.*
Formation of Wholly Owned Subsidiary
On* February 18, 2025,*Genprex announced the formation of a wholly-owned subsidiary, Convergen Biotech, Inc. (“Convergen”). The Company intends to transfer the diabetes program into Convergen in an effort to focus development and commercialization efforts separately from the Company's oncology program.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.