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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 
   
 
 
FORM 8-K 
    
 
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
 
June 27, 2023
Date of report (Date of earliest event reported)
 
GENPREX, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
001-38244
90-0772347
(State or other jurisdiction of
incorporation or organization)
(Commission File Number)
(I.R.S. Employer
Identification Number)
     
3300 Bee Cave Road, #650-227, Austin, TX
 
78746
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (512) 537-7997
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.001 per share
 
GNPX
 
The Nasdaq Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).
Emerging growth company ☒
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
 
 


 
Item 5.07 Submission of Matters to a Vote of Security Holders.
 
On June 27, 2023, Genprex, Inc. (“we” or “our” or the “Company”) held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”). The final results for each of the matters submitted to a vote of stockholders at the Annual Meeting, as set forth in the Company’s Definitive Proxy Statement, filed with the Securities and Exchange Commission on April 28, 2023, are as follows:
 
Proposal 1. Election of Directors.
 
The Class III director nominees, Jose Antonio Moreno Toscano and J. Rodney Varner, were elected to serve until the 2026 annual meeting of stockholders or until their respective successors have been duly elected and qualified, or until such director’s earlier resignation, removal or death. The result of the votes to elect the Class III directors were as follows:
 
Name
 
Votes For
 
Votes Withheld
 
Broker Non-Votes
Jose Antonio Moreno Toscano
 
4,856,975
 
3,471,721
 
18,051,580
J. Rodney Varner   6,899,410   1,429,286   18,051,580
 
 
Proposal 2. Ratification of Appointment of Independent Registered Public Accounting Firm.
 
The proposal to ratify the appointment of CohnReznick LLP as the Company’s independent registered public accounting firm for the Company’s fiscal year ending December 31, 2023 was approved by the stockholders based upon the following votes: 
 
Votes For
 
Votes Against
 
Abstention
 
Broker Non-Votes
25,044,860
 
1,105,061
 
230,355
 
0
 
 
Item 8.01. Other Events.
 
Amended and Restated Outside Director Compensation Policy
 
On June 27, 2023, the Board of Directors of the Company (the “Board”) approved and adopted an Amended and Restated Outside Director Compensation Policy (the “Policy”), a copy of which is filed herewith as Exhibit 10.1 and incorporated by reference herein. The Policy was amended to include restricted stock units (“RSUs”) as a potential annual equity award available to be granted to the independent, non-employee members of the Board (the “Outside Directors”) pursuant to the Company’s 2018 Equity Incentive Plan.
 






 
Clinical Trial and REQORSA Manufacturing Updates
 
Acclaim-1
 
Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA® Immunogene Therapy (generic name: quaratusugene ozeplasmid), the Company’s lead oncology drug candidate, in combination with AstraZeneca’s Tagrisso® in patients with late-stage Non-Small Cell Lung Cancer (“NSCLC”) that has activating epidermal growth factor receptor (“EGFR”) mutations and progression after treatment with Tagrisso.  The Acclaim-1 study has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. On May 25, 2023, the Safety Review Committee (“SRC”) for the Acclaim-1 clinical trial approved advancement to the Phase 2 expansion portion of the trial following the completion of the Phase 1 portion of the trial. Based on full safety data, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® for the treatment of late-stage lung cancer. We are ready to begin the Phase 2 expansion portion of the trial. We expect we will dose the first patient in the third quarter of 2023 and are awaiting patient dosing due in part to additional time required in connection with our transition to a new lipid nanoparticle (“LNP”) third-party contract development and manufacturing organization (“LNP CDMO”) and manufacture of final drug product.
 
Acclaim-2
 
Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. The Acclaim-2 study has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. We currently are enrolling and treating patients in the Phase 1 dose escalation portion of Acclaim-2. We expect enrollment in the dose escalation portion of the study to be completed by the first quarter of 2024 due in part to slower than anticipated patient enrollment due to competition from other immunotherapy lung cancer studies, additional time required in connection with our transition to the new LNP CDMO and manufacture of final drug product as well as the addition of two more patients to the cohort. 
 
Acclaim-3
 
Acclaim-3 uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022, we filed with the FDA our protocol for our Phase 1/2 Acclaim-3 clinical trial. We expect to enroll the first patient in Acclaim-3 in the third quarter of 2023 due in part to additional time required in connection with our transition to the new LNP CDMO and manufacture of final drug product.  Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.
 
We currently estimate that we have enough REQORSA to treat all of our current patients in our ongoing trials through approximately September 2023. We plan to have produced another batch of REQORSA by this time, but if we do not, then our clinical trials would be delayed.
 
REQORSA 1.0 vs. REQORSA 2.0
 
The REQORSA product that we currently are utilizing in our clinical trials is referred to by us as REQORSA 1.0 because it is based on the original processes for the manufacture of REQORSA that were transferred from the Company’s academic collaboration partner to CDMOs starting over 10 years ago. As we move toward larger scale clinical trials and commercialization, we are making multiple process improvements primarily to better manage scalability, stability, shelf life and consistency and are in the process of transitioning to large scale, financially secure CDMOs with commercialization experience and deep expertise to implement these changes. We are also consolidating our CDMOs into two if not one to achieve greater efficiency. We refer to this next generation REQORSA as REQORSA 2.0. As technologies in the gene therapy space are rapidly evolving, we are continually evaluating them and strategizing as to their incorporation in our pipeline. 
 






 
Item 9.01: Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit
Number
 
 
Description
     
10.1
 
     
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document).
 
 
 


 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
GENPREX, INC.
 
       
Date: June 27, 2023
By:
/s/ Ryan Confer
 
   
Ryan Confer
 
   
Chief Financial Officer
(Principal Financial Officer)
 
 
 
 
EX-10.1 2 ex_538611.htm AMENDED AND RESTATED OUTSIDE DIRECTOR COMPENSATION POLICY HTML Editor

 

Exhibit 10.1

 

GENPREX, INC.

AMENDED AND RESTATED OUTSIDE DIRECTOR COMPENSATION POLICY

 

Genprex, Inc. (the “Company”) believes that the granting of equity and cash compensation to its members of the Board of Directors (the “Board,” and members of the Board, the “Directors”) represents an effective tool to attract, retain and reward Directors who are not employees of the Company (the “Outside Directors”). This Amended and Restated Outside Director Compensation Policy (the “Policy”) is intended to formalize the Company’s policy regarding cash compensation and grants of equity to its Outside Directors. Unless otherwise defined herein, capitalized terms used in this Policy will have the meaning given such term in the Company’s 2018 Equity Incentive Plan (the “Plan”). Each Outside Director will be solely responsible for any tax obligations incurred by such Outside Director as a result of the equity and cash payments such Outside Director receives under this Policy.

 

 

1.

CASH COMPENSATION

 

a.

Annual Cash Retainer. Each Outside Director will be paid an annual cash retainer of $40,000. There are no per-meeting attendance fees for attending Board meetings.

 

 

b.

Committee Chair and Membership Annual Cash Retainer. Each Outside Director who serves as chairman or a member of a committee of the Board will be paid additional annual fees as follows:

 

Chairman of Audit Committee:   $20,000

 

 

Member of Audit Committee (other than the Chairman of the Audit Committee):  $10,000

 

 

Chairman of Compensation Committee:  $10,000

 

 

Member of Compensation Committee (other than the Chairman of the Compensation Committee):  $5,000

 

 

Chairman of Nominating and Corporate Governance Committee:  $10,000

 

 

Member of Nominating and Corporate Governance Committee (other than the Chairman of the Nominating and Corporate Governance Committee):  $5,000

 

Each annual cash retainer and additional annual fee will be paid quarterly in arrears on a prorated basis.

 

The Board in its discretion may change and otherwise revise the terms of the cash compensation granted under this Policy, including, without limitation, the amount of cash compensation to be paid, on or after the date the Board determines to make any such change or revision.

 







 

 

2.

EQUITY COMPENSATION

 

Outside Directors will be entitled to receive all types of Awards (except Incentive Stock Options) under the Plan (or the applicable equity plan in place at the time of grant), including discretionary Awards not covered under this Policy. All grants of Awards to Outside Directors pursuant to Section 2 of this Policy will be automatic and nondiscretionary, except as otherwise provided herein, and will be made in accordance with the following provisions:

 

 

a.

Initial Award. Each individual who first becomes an Outside Director following the effective date of the registration statement in connection with the initial public offering of the Company’s securities (the “Registration Date”) and following the first annual meeting of the Company’s stockholders (an “Annual Meeting”) following the Registration Date will automatically be granted an Award (the “Initial Award”), which grant will be effective on the date on which such individual first becomes an Outside Director, whether through election by the stockholders of the Company or appointment by the Board to fill a vacancy. The Initial Award will have a Value (as defined below) of $80,000 multiplied by a fraction (1) the numerator of which is (x) 12 minus (y) the number of full months between the date of the last Annual Meeting and the date the Outside Director becomes a member of the Board and (2) the denominator of which is 12 (with the result rounded down to the nearest whole Share). For example, if nine months have lapsed between the last Annual Meeting and the Outside Director’s start date, his or her Initial Award will have a Value of $20,000. The Initial Award will be comprised solely of Nonstatutory Stock Options.

 

 

b.

Exceptions.  Notwithstanding the foregoing, a Director who is an Employee (an “Inside Director”) who ceases to be an Inside Director, but who remains a Director, will not receive an Initial Award.

 

 

c.

Annual Award. Each Outside Director will be granted an Award (an “Annual Award”) with a Value of $80,000 (rounded down to the nearest whole Share), which grant will be effective on the date of each Annual Meeting, beginning with the first Annual Meeting following December 31, 2018; provided that any Outside Director who is not continuing as a Director following the applicable Annual Meeting will not receive an Annual Award with respect to such Annual Meeting. The Annual Award will be comprised of Nonstatutory Stock Options and/or Restricted Stock Units (“RSUs”), subject to the annual determination and approval of the Board, based on recommendations and input from its independent compensation consultants (pursuant to Section 7 below).

 

 

d.

Exercise Price and Vesting. The Exercise Price of a Nonstatutory Stock Option Award may not be less than 100% of the Fair Market Value on the date of grant of the Award.  Subject to Sections 2.g and 5 below and Section 14 of the Plan, each Initial Award and Annual Award will vest as to 100% of the Shares subject thereto upon the earlier of the one (1) year anniversary of the grant date or the day prior to the Company’s next Annual Meeting occurring after the grant date, in each case, provided that the Outside Director continues to serve as a Service Provider through the applicable vesting date.

 

 

e.

Value. For purposes of this Policy, “Value” of an Award of a Nonstatutory Stock Option will equal the value of such Award, calculated in accordance with the Black Scholes Model in a manner consistent with the Company’s policies and practices for calculating the value of stock options for purposes of the Company’s financial statements. “Value” of an Annual Award of RSUs will be determined, as applicable, by a conversion factor of the calculated Nonstatutory Stock Option Award Value, as determined by the Board based on recommendations and input from its independent compensation consultants (pursuant to Section 7 below).

 

 

f.

No Discretion. No person will have any discretion to select which Outside Directors will be granted an Initial Award or Annual Awards under this Policy or to determine the number of Shares to be covered by such Initial Award or Annual Awards, as applicable (except as provided in Sections 2(e), 5 and 9 below).

 

 

g.

Change in Control. In the event of a Change in Control, each Outside Director will fully vest in his or her Initial Award or Annual Awards provided that the Outside Director continues to serve as a Director through such date.

 







 

 

3.

TRAVEL EXPENSES

 

Each Outside Director’s reasonable, customary and documented travel expenses to Board meetings will be reimbursed by the Company.

 

 

4.

ADDITIONAL PROVISIONS

 

All provisions of the Plan not inconsistent with this Policy will apply to Awards granted to Outside Directors.

 

 

5.

ADJUSTMENTS

 

In the event that any dividend or other distribution (whether in the form of cash, Shares, other securities or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase, or exchange of Shares or other securities of the Company or other change in the corporate structure of the Company affecting the Shares occurs, the Administrator, in order to prevent diminution or enlargement of the benefits or potential benefits intended to be made available under this Policy, will adjust the number of Shares issuable pursuant to Awards granted under this Policy.

 

 

6.

LIMITATIONS

 

No Outside Director may be issued, in any Fiscal Year, cash payments (including the fees under Section 1 above) with a value greater than $175,000, provided that such limit shall be $250,000 with respect to any Outside Director who serves in the capacity of Non-Executive Chairman of the Board, Lead Director and/or Audit Committee Chair at any time during the Fiscal Year. No Outside Director may be granted, in any Fiscal Year, Awards with a grant date Value greater than $600,000, increased to $900,000 in the Fiscal Year of his or her initial service as an Outside Director. Any Awards or other compensation granted to an individual for his or her services as an Employee, or for his or her services as a Consultant other than an Outside Director, will be excluded for purposes of the limitations under this Section 6.

 

 

7.

INDEPENDENT COMPENSATION CONSULTANTS

 

The Board shall have the authority to retain one or more independent compensation consultants to provide advice, analysis and recommendations to the Board in connection with compensation decisions under the Policy.

 







 

 

8.

SECTION 409A

 

In no event will cash compensation or expense reimbursement payments under this Policy be paid after the later of (a) the fifteenth (15th) day of the third (3rd) month following the end of the Company’s fiscal year in which the compensation is earned or expenses are incurred, as applicable, or (b) the fifteenth (15th) day of the third (3rd) month following the end of the calendar year in which the compensation is earned or expenses are incurred, as applicable, in compliance with the “short-term deferral” exception under Section 409A of the Internal Revenue Code of 1986, as amended, and the final regulations and guidance thereunder, as may be amended from time to time (together, “Section 409A”). It is the intent of this Policy that this Policy and all payments hereunder be exempt from or otherwise comply with the requirements of Section 409A so that none of the compensation to be provided hereunder will be subject to the additional tax imposed under Section 409A, and any ambiguities or ambiguous terms herein will be interpreted to be so exempt or comply. In no event will the Company reimburse an Outside Director for any taxes imposed or other costs incurred as a result of Section 409A.

 

 

9.

REVISIONS

 

The Board or any Committee designated by the Board may amend, alter, suspend or terminate this Policy at any time and for any reason. No amendment, alteration, suspension or termination of this Policy will materially impair the rights of an Outside Director with respect to compensation that already has been paid or awarded, unless otherwise mutually agreed between the Outside Director and the Company. Termination of this Policy will not affect the Board’s or the Compensation Committee’s ability to exercise the powers granted to it under the Plan with respect to Awards granted under the Plan pursuant to this Policy prior to the date of such termination.