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

Date of Report (Date of earliest event reported): December 18, 2023

enGene Holdings Inc.
(Exact name of registrant as specified in its charter)

British Columbia, Canada
 
001-41854
 
 N/A
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

4868 Rue Levy, Suite 220
Saint-Laurent, QC, Canada
 
H4R 2P1
(Address of principal executive offices)
 
(Zip code)

Registrant's telephone number, including area code (514) 332-4888


                                                       Not applicable                                                          
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ 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 Securities Exchange Act of 1934:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common shares ENGN The Nasdaq Stock Market LLC
Warrants, each exercisable for one Common share, at an exercise price of $11.50 per share
 ENGNW The Nasdaq Stock Market LLC

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 5.02.         Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On December 18, 2023, the Board of Directors (the “Board”) of enGene Holdings Inc. (the “Company”), increased its size from four members to five and, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed Lota Zoth to the Board as a Class I Director of the Board, with a term expiring at the Company’s first annual general meeting following her appointment, or until her successor is duly elected and appointed. Ms. Zoth will serve as Chair of the Company’s Audit Committee.

Ms. Zoth will participate in the standard compensation plan for the Company’s independent directors, including eligibility to receive equity grants pursuant to the enGene Holdings Inc. 2023 Incentive Equity Plan, included as Exhibit 10.20 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 31, 2023 (the “October 31, 2023  8-K”), and will also enter into the Company’s indemnification agreement with the Company substantially in the form of indemnification agreement included as Exhibit 10.25 to the October 31, 2023 8-K. There are no arrangements or understandings pursuant to which she was selected as a director and no transactions between the Company and Ms. Zoth that would be reportable under Item 404(a) of Regulation S-K.
 
Item 7.01.         Regulation FD Disclosure.
On December 19, 2023, the Company issued a news release with respect to the appointment of Ms. Zoth as a member of the Board of the Company, a copy of which is furnished with this Form 8-K as Exhibit 99.1 and incorporated into this Item 7.01 by reference. The information in this Item 7.01 of Form 8-K shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01.         Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description of Exhibit

*            Filed herewith.
SIGNATURE
 
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
ENGENE HOLDINGS INC.
   
December 20, 2023
By: 
/s/ Jason D. Hanson
   
Name: Jason D. Hanson
   
Title: Chief Executive Officer




Exhibit 99.1



enGene Appoints Lota S. Zoth, CPA, as Member of the Board of Directors

Boston, Mass. and Montreal, Canada, December 19, 2023 — enGene Holdings Inc. (“enGene,” Nasdaq: ENGN), a clinical-stage genetic medicines company whose lead program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced the appointment of Lota S. Zoth, CPA, as a member of the Board of Directors and Audit Committee Chair.

“The addition of Lota to our Board is another milestone in our progression as a public genetic medicines company, and we are fortunate to welcome her counsel and depth of experience as a leader,” said Jason D. Hanson, Chief Executive Officer of enGene. “Lota’s distinguished history of operational and financial leadership strengthens our Board of Directors, and we look forward to her perspective and insights as we advance our pivotal trial of EG-70 in NMIBC, as well as our mission to mainstream gene therapy for the benefit of underserved patients.”

Ms. Zoth has more than two decades of experience in senior financial and accounting roles, including as Senior Vice President and Chief Financial Officer of MedImmune, Inc. and Senior Vice President, Controller and Chief Accounting Officer of PSINet, Inc. She also spent nearly a decade with Ernst & Young leading auditing efforts for flagship clients. Ms. Zoth is an experienced Board of Directors member, having served in various roles at other companies, including Board Chair, Lead Independent Director, and Audit Committee Chair, as well as on Compensation, Transaction, Finance and Special Strategic Committees. She is currently serving on the Boards of the publicly traded companies Lumos Pharma, Inovio Pharmaceuticals, and 89 Bio. Her past Board experience includes Zymeworks, Spark Therapeutics, Aeras, Orexigen Therapeutics, Circassia Pharmaceuticals, Hyperion Therapeutics, and Ikaria.

“enGene is a truly differentiated company with a compelling vision, promising pipeline, and near-term potential to have a meaningful impact in the lives of patients living with BCG-unresponsive NMIBC,” said Ms. Zoth. “I am honored to join the Board of Directors and to serve as Audit Committee Chair to help build a successful future for enGene and patients in need.”

About enGene
enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is EG-70 for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), a disease posing a high clinical burden. EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com.

Forward-Looking Statements

Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”).  enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s expectations, hopes, beliefs, intentions, goals, strategies, forecasts and projections. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: enGene’s goal of mainstreaming gene therapy, enGene’s product pipeline and the near-term potential to have a meaningful impact in the lives of patients living with BCG-unresponsive NMIBC .


Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration for clinical trials and acquire technologies complimentary to, or necessary for, its programs; the Company’s ability to address diseases with high clinical needs; the Company’s ability to retain commercial rights to EG-70 in the United States and commercialize EG-70 independently, while selectively partnering outside of the United States; the Company’s plans and ability to secure regulatory approval, to execute product development, manufacturing process development, preclinical and clinical development efforts successfully and on anticipated timelines; enGene’s ability to design mainstream gene therapy and bring genetic medicines to community clinics across the globe; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Current Report on Form 8-K, filed with the SEC on October 31, 2023  (copies of which may be obtained at sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

Contact:

For further information: enGene, Inc. (media@engene.com).
For investor contact: investors@engene.com
For media contact: adam@scientPR.com