Genprex Inc
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
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Sep 30, 2024 · Filed Nov 13, 2024
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Notes to Unaudited Condensed Financial Statements
GENPREX, INC.
SEPTEMBER 30, 2024
Note1 - Description of Business and Basis of Presentation
Unless the context requires otherwise, references to “Genprex,” the “Company,” “we,” “us” or “our” in this Quarterly Report on Form10-Q refer to Genprex, Inc. Genprex, incorporated in Delaware in* April 2009,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.
Oncology Platform
Genprex’s lead oncology drug candidate, Reqorsa® (quaratusugene ozeplasmid), previously referred to as GPX-001, is a gene therapy 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 also 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 current 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”). Genprex 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,Genprex 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 the Company’s 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-3: The Company is currently enrolling and treating patients in the Phase1 dose escalation 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 in patients with extensive stage small cell lung cancer (“ES-SCLC”) who didnot develop 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. In* January 2024,the Company opened the Phase1* portion of the Acclaim-3 study for enrollment and enrolled and dosed thefirst patient in* May**2024.* In* October 2024,the Company announced the completion of the0.09* mg/kg dose group of the Phase1 portion and that there wereno dose limiting toxicities in this dose group. The Acclaim-3 Safety Review Committee therefore approved escalation to the highest dose group of0.12 mg/kg, which will now be enrolled. The Company continues to anticipate completion of enrollment in the Phase1 dose escalation portion of the study and to start the Phase2 expansion portion of the study in thesecond half of2024, dependent on the number of patients needed to be enrolled in the0.12 mg/kg dose group. Thefirst patient treated in the Phase1 dose escalation portion of the Acclaim-3 trial experienced an initial positive response after enrollment and dosing commenced in* May.The patient had a partial remission (“PR”), which is defined as at least athirty* percent (30%) decrease in tumor size, from the time the patient had a baseline CT scan after induction therapy and prior to the start of maintenance therapy to the time of the CT scan performed aftertwo cycles of maintenance therapy. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already receivedfour cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, the Company believes this suggests that REQORSA* maybe providing clinical benefit. A follow-up CT scan, performed afterfour* cycles of maintenance therapy (three months), confirmed that the patient still had a30% decrease in tumor size in measurable lesions; however,one lesionnot previously measurable had grown in size, thus leading to a conclusion of disease progression atthree months. In* June 2023,the United States Food and Drug Administration (“FDA”) granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who didnot* develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. In* August 2023,*the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC.
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. Theone patient continuing to receive REQORSA treatment in the Phase1 dose escalation portion of the study will continue to be treated until disease progression.
Acclaim-1: The Company is currently 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 after treatment with Tagrisso. 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, the Acclaim-1 SRC determined the recommended Phase2 dose 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 are stilltwo patients originally enrolled in the Phase1 dose escalation portion of the study who have had prolonged progression-free survival and continue to receive treatment with REQORSA and Tagrisso,one who attained a PR after thesecond course of REQORSA and Tagrisso and has maintained this response through41 courses of treatment (approximately30 months), andone with stable disease without disease progression through26 courses of treatment (approximately19 months) who is also continuing to receive REQORSA and Tagrisso 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). The Phase2a expansion portion of the trial withone cohort is now expected to enroll approximately33 patients. 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 in the Phase2a expansion portion of the study and conduct an interim analysis in thefirst half of2025. The FDA has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.
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Diabetes Gene Therapy
In diabetes, the Company has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) 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. Genprex 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, the Company will 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 and anticipates requesting further regulatory guidance from the FDA in thefirst half of2025. In* October 2023,Genprex entered into aone*-year extension to its* August 2022sponsored research agreement with the University of Pittsburgh 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 it acquired exclusive rights from the University of Pittsburgh in* July 2023.These include using a MafB promoter to drive expression of thePdx1* and MafA transcription factors that can potentially be used for both Type1 and Type2 diabetes. Additionally, in* September 2024,Genprex announced that it is considering various strategic alternatives and opportunities to enhance stockholder value, including evaluating ways to optimize its clinical and research programs and operational strategies, such as its intention to potentially transfer the Company’s diabetes clinical development program and its diabetes gene therapy assets into a new, initially wholly-owned subsidiary (“NewCo”). NewCo would focus on developing and commercializing GPX-002. The spin-out, if completed as presently contemplated, would result in NewCo focusing on developing GPX-002, while Genprex would retain its oncology clinical development programs and other oncology pipeline assets. The potential formation and transfer of the clinical development program into the wholly-owned subsidiary is currently anticipated to occur by the end of2024,* subject to adequate financing, the satisfaction of customary conditions and final approval from the Genprex management and board of directors.
Capital Requirements, Liquidity and Going Concern Considerations
The Company's unaudited condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, 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 unaudited condensed 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* December**2024.* The Company 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. The unaudited condensed financial statements donot include any adjustments that might be necessary if the Company is unable to continue as a going concern.
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Note2 - Summary of Significant Accounting Policies
Genprex’s unaudited condensed financial statements have been prepared in accordance with US GAAP and the requirements of the United States Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that is normally required by US GAAP can be condensed or omitted. Accordingly, they donot include all of the information and footnotes normally included in financial statements prepared in conformity with US GAAP. The* December 31, 2023condensed balance sheet was derived from the December 31, 2023audited financial statements. Genprex’s unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s2023* Annual Report on Form10-K, filed with the SEC on* April 1, 2024 (the “Form10*-K”).
The accompanying condensed financial statements are unaudited and include all adjustments (consisting of normal recurring adjustments) that management considers necessary for a fair presentation of Genprex’s condensed financial position and results of operations for the interim periods presented. The results of operations for the interim periods arenot necessarily indicative of the results that* may*be expected for any other interim period or for the entire year.
A summary of Genprex’s significant accounting policies consistently applied in the preparation of the accompanying unaudited condensed financial statements follows.
Change in Accounting Principle
During thenine months ended* September 30, 2024*, the Company changed an accounting principle related to accounting treatment of intellectual property expenditures. Previously, the Company capitalized certain intellectual property costs associated with the filing or maintenance of specific patents, including application costs, filing fees, and patent prosecution, in accordance with ASC350-30. The Company voluntarily changed this accounting principle to expense, rather than capitalize, these intellectual property costs on the basis that the new treatment is favorable.
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 unaudited condensed 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 (see Note4 – Equity – Reverse Stock Split).
Use of Estimates
The preparation of Genprex’s unaudited condensed 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 unaudited condensed 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. The Company has cash in a money market account and had $1,238,246 and $6,490,117 in excess of FDIC insured limits of*$250,000* at* September 30, 2024* and* December 31, 2023*, 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.
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)2,264,871 unexercised options granted by the Company’s board of directors and unexercised warrants to purchase shares of common stock, and (ii)10,143 unvested restricted stock units granted by the Company’s board of directors representing the right upon vesting to receive shares of common stock as of* September 30, 2024*.
Fair Value of Financial Instruments
The carrying amounts reported in the condensed balance sheets for cash, money-market savings account, accounts receivable, and accounts payable approximate fair value because of the immediate or short-term maturity of these condensed financial instruments.
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Property and Equipment
Property 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 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, valued at cost, and capitalized for future use were $1,989,299 and $2,347,488 at* September 30, 2024* and* December 31, 2023*, respectively.
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 thethree andnine months ended* September 30, 2024* and2023, there wereno deemed impairments of the Company’s long-lived assets.
Recent Accounting Developments
Accounting pronouncements issued butnot effective until after* September 30, 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 is currently evaluating the effect the amendments in ASU2023*-07 will have on its segment disclosures.
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.
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Note3 - Intellectual Property
As of* September 30, 2024*, Genprex owned or had exclusive license agreements on 22 granted patents and 26 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, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims and costs are expensed as incurred.
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 (see Note7 – Commitments and Contingences – Commitments – University of Pittsburgh).
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.
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.
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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 unaudited condensed 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 five 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 September 30, 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* 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 thethree months ended* September 30, 2024*, the Company sold 2,149,417 shares of common stock for aggregate net proceeds of $1,215,105 under the2023 ATM Facility. During thenine months ended* September 30, 2024*, the Company sold 2,318,450 shares of common stock for aggregate net proceeds of $2,117,752 under the2023 ATM Facility (inclusive of the shares issued during thethree months ended* September 30, 2024*, as described in the immediately preceding sentence).
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. The Company didnot use the2022 ATM Facility during thethree months ended* September 30, 2023*. During thenine months ended* September 30, 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.*
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Stock Issuances
During thethree months ended* September 30, 2024*, Genprex issued (i)5,000 shares of common stock for services provided to the Company valued at $9,650 to the Chairman of its Scientific Advisory Board, (ii)779,000 shares of common stock upon the exercise of pre-funded warrants at a nominal price associated with the Company's* March 2024offering, and (iii)2,149,417 shares of common stock sold for aggregate net proceeds of $1,215,105 under the Company’s2023* ATM Facility.
During thenine months ended* September 30, 2024*, Genprex issued (i)10,125 shares of common stock for services provided to the Company valued at $25,670 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)2,318,450 shares of common stock sold for aggregate net proceeds of $2,117,752 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 2024offering (inclusive of the shares issued during thethree* months ended* September 30, 2024*, as described in the immediately preceding sentence).
During thethree months ended* September 30, 2023*, the Company issued (i)125 shares of common stock for services provided to the Company valued at $4,800 to the Chairman of our Scientific Advisory Board, (ii)185,644 shares of common stock sold for aggregate net proceeds of approximately $6.7 million associated with the Company’s* July 2023offering, as described above and (iii)500 shares of common stock upon the exercise of options by a former board member. During thenine* months ended* September 30, 2023*, the Company issued (i)375 shares of common stock for services provided to the Company valued at $17,150 to the Chairman of the Company's Scientific Advisory Board (inclusive of the 125 shares issued during thethree months ended* September 30, 2023*, as described in the immediately preceding sentence), (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 2023offerings, as described above, and (iv)500 shares of common stock upon the exercise of options by a former board member (inclusive of the shares issued during thethree* months ended* September 30, 2023*, as described in the immediately preceding sentence).
Preferred Stock
Genprex is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding as of* September 30, 2024* and* December 31, 2023*.
Common Stock
Genprex is authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share, all of which are voting common stock. There were 5,489,152 and 1,485,902 shares of its common stock outstanding as of* September 30, 2024* and* December 31, 2023*, respectively.
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Common Stock Purchase Warrants
Common stock purchase warrant activity for thethree andnine months ended* September 30, 2024* and2023, respectively, is as follows:
| 2024 | 2023 | |||
|---|---|---|---|---|
| Number of | Weighted Average | Number of | Weighted Average | |
| Warrants | Exercise Price | Warrants | Exercise Price | |
| Outstanding at January 1, | 346,440 | $57.79 | 53,695 | $172.81 |
| Warrants issued | 3,011,751 | 2.26 | 95,989 | 44.17 |
| Warrants cancelled or expired | — | — | 960 | 250.00 |
| Outstanding at March 31, | 3,358,191 | $5.93 | 148,724 | $64.01 |
| Warrants exercised | 598,112 | 0.00 | — | — |
| Outstanding at June 30, | 2,760,079 | $7.22 | 148,724 | $64.01 |
| Warrants issued | — | — | 200,284 | 20.68 |
| Warrants exercised | 779,000 | 0.00 | — | — |
| Outstanding at September 30, | 1,981,079 | $10.05 | 349,008 | $39.14 |
The Company (i) didnot issue any warrants, and (ii) issued 779,000 shares of common stock associated with the partial exercise of* March 2024Pre-Funded Warrants, during thethree* months ended* September 30, 2024*. During thenine months ended* September 30, 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 598,112 shares of common stock associated with the partial exercise of March 2024Pre-Funded Warrants (inclusive of the shares issued during thethree* months ended* September 30, 2024*, as described in the immediately preceding sentence). During thethree andnine months ended* September 30, 2024*, Genprex recorded share-based compensation of $2,281 and $18,039, respectively, associated with the vesting and issuance of warrants. The Company doesnot expect to record any additional share-based compensation for time-based vesting through the end of the fiscal year2024 and $300,000 of share-based compensation based on performance-based vesting in the future with respect to its warrants outstanding as of* September 30, 2024*.
The Company issued (i) warrants to purchase up to an aggregate of 3,500 shares of common stock to service providers at exercise prices ranging from $26.00 to $37.94 per share, the fair market value of a share of common stock on the date of issuance, (ii) 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 (iii) warrants to purchase up to 11,140 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”) in connection with the registered direct offering completed on July 21, 2023,at an exercise price of $50.50 per share, during thethree* months ended* September 30, 2023*. During thenine months ended* September 30, 2023*, the Company (i) issued 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) issued warrants to purchase up to an aggregate of 292,023 shares of common stock at exercise prices ranging from $29.20 to $66.00 per share to service providers, institutional investors, and the Placement Agent, and (iii) was deemed to cancel warrants to purchase 960 shares of common stock upon termination of warrants previously issued to placement agents associated with our Initial Public Offering in* March 2018 (inclusive of the warrants issued during thethree*-month period ended* September 30, 2023,as described in the immediately preceding sentence). During thethree* andnine months ended* September 30, 2023,*the Company recorded share-based compensation of $50,853 and $128,164, respectively, associated with the vesting and issuance of warrants.
As of* September 30, 2024*, the Company 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. The warrants are fully vested, 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 $1.21 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 thethree andnine months ended* September 30, 2024* and2023:
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2023 | |
|---|---|---|---|---|
| Expected term (in years): | — | 2.5 | 2.5 - 3.0 | 2.5 - 3.0 |
| Risk-free rate: | — | 4.52% | 5.33% - 5.52% | 4.99% - 5.52% |
| Volatility: | — | 87.49% | 83.42% | 83.14% - 83.42% |
| Dividend yield: | — | 0% | 0% | 0% |
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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* September 30, 2024*, a total of 96,617 shares of common stock remain available for issuance under the2018 Plan.
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 ofshares reserved for issuance under the ESPP on* January 1, 2024*.
Stock Options
As of* September 30, 2024*, Genprex had outstanding stock options to purchase 283,792 shares of common stock that have been granted to various executives, employees, non-employee 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 $392.00 per share. The per-share fair values of these options range from $12.62 to $317.20. There wereno options issued for thethree andnine months ended* September 30, 2024*. Assumptions of the Black-Scholes-Merton pricing model for options issued for thethree andnine months ended* September 30, 2024*, and2023, respectively, is as follows:
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2023 | |
|---|---|---|---|---|
| Expected term (in years): | — | — | 6.0 | 6.0 |
| Risk-free rate: | — | — | 5.37% | 4.60% - 5.37% |
| Volatility: | — | — | 83.42% | 83.14% - 83.42% |
| Dividend yield: | — | — | 0% | 0% |
15
The Company didnot issue stock options for thethree ornine months ended* September 30, 2024*. During thethree months ended* September 30, 2024*, the Company cancelled stock options to purchase 460 shares of common stock with exercise prices ranging from $54.80 to $59.60 per share in connection with the termination of employees. During thenine months ended* September 30, 2024*, the Company cancelled stock options to purchase 2,091 shares of common stock with exercise prices ranging from $32.40 to $80.00 per share in connection with the termination of employees (inclusive of the options cancelled during thethree months ended* September 30, 2024* described in the immediately preceding sentence).
During thethree months ended* September 30, 2023*, the Company (i) granted stock options to purchase an aggregate of 5,000 shares of common stock with an exercise price of $18.00 per share to an employee, (ii) cancelled options to purchase 308 shares of common stock at exercise prices ranging from $88.00 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 $12.00 per share. During thenine months ended* September 30, 2023*, the Company (i) granted stock options to purchase an aggregate of 8,251 shares of common stock with exercise prices ranging from $18.00 to $60.40 per share to employees, (ii) cancelled options to purchase 308 shares of common stock at exercise prices ranging from $88.00 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 $12.00 per share (inclusive of the options granted or cancelled, and shares issued, during thethree months ended* September 30, 2023*, as described in the immediately preceding sentence).
The weighted average remaining contractual term for the outstanding options at* September 30, 2024* and* December 31, 2023* is 5.36 and 6.13 years, respectively.
Stock option activity for thethree andnine months ended* September 30, 2024* and2023, 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 | — | — | 2,063 | 57.23 |
| Options expired or cancelled | 438 | 32.40 | — | — |
| Outstanding at March 31, | 285,445 | $121.25 | 286,440 | $122.72 |
| Options granted | — | — | 1,188 | 34.17 |
| Options expired or cancelled | 1,193 | 14.75 | — | — |
| Outstanding at June 30, | 284,252 | $121.52 | 287,628 | $122.35 |
| Options granted | — | — | 5,000 | 18.00 |
| Options exercised | — | — | 500 | 11.92 |
| Options expired or cancelled | 460 | 55.25 | 308 | 124.64 |
| Outstanding at September 30, | 283,792 | $121.63 | 291,820 | $120.75 |
Restricted Stock Units
During thethree months ended* September 30, 2024*, the Company (i) didnot issue RSUs, and (ii) cancelled nine RSUs associated with the termination of employees. During thenine months ended* September 30, 2024*, the Company (i) withheld 9,830 RSUs to cover taxes associated with the vesting of employee issued RSUs, (ii) cancelled 275 RSUs associated with the termination of employees, and (iii) issued 31,623 shares of common stock associated with the vesting of RSUs to executives, employees, and non-employee directors (inclusive of the RSUs described in the immediately preceding sentence during thethree months ended* September 30, 2024*).
During thethree months ended* September 30, 2023*, the Company (i) didnot issue RSUs, and (ii) cancelled 257 RSUs associated with the termination of employees. During thenine months ended* September 30, 2023*, the Company issued 57,119 RSUs to executives, employees, and non-employee directors.
A summary of the RSU activity under the2018 Plan during thethree andnine months ended* September 30, 2024* and2023, 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 | — | — | 47,834 | 66.00 |
| Restricted stock units vested | 12,145 | 66.00 | — | — |
| Restricted stock units forfeited or cancelled | 6,086 | 66.00 | — | — |
| Outstanding at March 31, | 33,631 | $55.95 | 47,834 | $66.00 |
| Restricted stock units granted | — | — | 9,285 | 29.60 |
| Restricted stock units vested | 19,478 | 48.65 | — | — |
| Restricted stock units forfeited or cancelled | 4,010 | 66.00 | — | — |
| Outstanding at June 30, | 10,143 | $66.00 | 57,119 | $60.08 |
| Restricted stock units forfeited or cancelled | 9 | 66.00 | 257 | 66.00 |
| Outstanding at September 30, | 10,134 | $66.00 | 56,862 | $60.06 |
16
Share-Based Compensation
For thethree andnine months ended* September 30, 2024*, the Company’s total share-based compensation was approximately $0.4 million, including $0.2 million of R&D expense and $0.2 million of G&A expense, and $2.7 million, including $0.5 million of R&D expense and $2.2 million of G&A expense, respectively, which represents the expected vesting of options or RSUs issued to executives, other employees, board members, and service providers, as well as the issuance of shares to service providers. As of* September 30, 2024*, the Company’s total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, other employees, board members, and service providers andnot yet recognized was approximately $0.6 million. The Company expects to record this stock-based compensation expense over the nextthree years using a graded vesting method. As of* September 30, 2024*, the weighted average term over which these expenses are expected to be recognized is 0.58 years.
For thethree andnine months ended* September 30, 2023*, the Company’s total share-based compensation was approximately $1.5 million, including $0.3 million of R&D expense and $1.2 million of G&A expense, and $4.4 million, including $1.0 million of R&D expense and $3.4 million of G&A expense, respectively, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers and RSUs issued to executives, other employees, and board members. As of* September 30, 2023*, the Company’s total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, other employees, board members, and service providers andnot yet recognized was approximately $5.9 million. The Company expects to record this stock-based compensation expense over the nextthree years using a graded vesting method. As of* September 30, 2023*, the weighted average term over which these expenses are expected to be recognized is 1.37 years.
As of* September 30, 2024*, there areno performance-based stock option awards outstanding andone performance-based warrant outstanding issued to a service provider. The Company’s total compensation cost related to the non-vested performance-based warrantnot yet recognized was approximately $0.3 million. The entirety of this warrant* may*be recognized and recorded upon the achievement of certain clinical milestones.
Note5 -401(k) Savings Plan
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. The Company incurred $31,930 and $105,848 of expense for matching contributions to the401(k) Plan during thethree andnine months ended* September 30, 2024*, respectively. We incurred $29,817 and $120,623 of expense for matching contributions to the401(k) Plan during thethree andnine months ended* September 30, 2023*, respectively.
Note6 - Related Party Transactions
Introgen Research Institute
Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, the Company’s former President, Chief Executive Officer and Chairman of the Board, who served in such capacity until his death on* May 7, 2024,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* September 30, 2024* and* December 31, 2023*.
17
Note7 - Commitments and Contingencies
Commitments
MD Anderson Cancer Center
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 $165,701 of expense from this agreement during thethree months ended* September 30, 2024*. The Company incurred approximately $645,839 of expense from this agreement during thenine months ended* September 30, 2024* inclusive of the amount stated in the preceding sentence. As of* September 30, 2024*, the Company has paid approximately $1.2 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 ("NIH").
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. The Company incurredno expense for thethree months ended* September 30, 2024* and2023, respectively. The Company incurred $50,000 and $45,000 of expense from this agreement during thenine months ended* September 30, 2024* and2023, respectively. As of* September 30, 2024*, the Company has paid approximately $370,000 toward the above-described commitment under this agreement.
National Institutes of Health
Genprex has a royalty obligation to the National Institutes of Health 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 as of* September 30, 2024* and* December 31, 2023,*respectively, will be recognized if and when it is probable the Company will obtain regulatory approval (the event that triggers the payment obligation).
18
University of Pittsburgh
Pursuant to an exclusive license agreement dated* February 11, 2020,by and between Genprex and the University of Pittsburgh, amended on August 17, 2022,and amended again on November 3, 2022,the Company 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. The Company incurredno expense from this agreement for thethree months ended* September 30, 2024*, and2023, respectively. The Company incurred $40,000 and $25,000 of expense from this agreement during thenine months ended* September 30, 2024*, and2023, respectively. As of* September 30, 2024*, the Company has incurred and paid approximately $150,000 toward this commitment.
Pursuant to an exclusive license agreement dated* November 22, 2022,by and between Genprex and the University of Pittsburgh, the Company 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. The Company incurredno expense from this agreement during thethree andnine months ended* September 30, 2024*. The Company incurred $0 and $25,000 of expense from this agreement during thethree andnine months ended* September 30, 2023*. As of* September 30, 2024*, the Company has incurred and paid approximately $50,000 toward this commitment.
Pursuant to an exclusive license agreement dated* December 29, 2022,by and between Genprex and the University of Pittsburgh, the Company 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. The Company incurredno expense from this agreement during thethree andnine months ended* September 30, 2024*. The Company incurred $0 and $25,000 of expense from this agreement during thethree andnine months ended* September 30, 2023*. As of* September 30, 2024*, the Company has incurred and 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, the Company 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. The Company incurredno expense from this agreement during thethree months ended* September 30, 2024* and2023, respectively. The Company incurred $25,000 of expense from this agreement during each of thenine months ended* September 30, 2024* and2023, respectively. As of* September 30, 2024*, the Company has incurred and paid approximately $50,000 toward this commitment.
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 $2.2 million of expense from this agreement during thenine months ended* September 30, 2024* and2023, respectively.
Contingencies
From time to time, the Company* maybecome subject to threatened and/or asserted claims arising in the ordinary course of its business. Management isnot* aware of any pending matters, either individually or in the aggregate, that are reasonably likely to have a material impact on the Company’s financial condition, results of operations or liquidity.
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*** SEPTEMBER30,* 2024
Note8 - Subsequent Events
The Company has evaluated subsequent events through the filing of this Quarterly Report on Form10-Q and determined that there have beenno recognized subsequent events that have occurred that would require adjustments to the Company's disclosures in the condensed financial statements. The following are nonrecognized subsequent events through the filing of this Quarterly Report on Form10-Q.
Share Issuances
On* October 1,2024, Genprex issued 5,000 shares of its common stock to the Chairman of its Scientific Advisory Board in consideration for services. Subsequent to September 30, 2024,the Company has sold 3,013,916 shares of its common stock for aggregate net proceeds to the Company totaling $1,286,014 under the2023* ATM Facility.
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