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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

 

Date of Report (Date of earliest event reported): September 13, 2023

 

HOOKIPA PHARMA INC.

(Exact name of Registrant as Specified in Its Charter)

 

Delaware   001-38869   81-5395687

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer

Identification No.)

 

350 Fifth Avenue, 72nd Floor,

Suite 7240

 
New York, New York   10118
(Address of principal executive offices)   (zip code)

 

Registrant’s telephone number, including area code: +43 1 890 63 60

  

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 Instructions 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 Act:

 

Title of each class Trading Symbol(s) Name of exchange on which
registered
Common stock, $0.0001 HOOK The Nasdaq Global Select 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  x

 

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.  x

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure

 

On September 12, 2023, the Board of Directors (the “Board”) of HOOKIPA Pharma Inc. (the “Company”) accepted the resignation of Dr. Schlienger as Chief Medical Officer (“CMO”) of the Company, effective September 30, 2023.

 

In connection with the resignation of Dr. Schlienger, on September 13, 2023, the Company announced that a current member of its Board, Dr. Malte Peters, will lead HOOKIPA’s clinical activities ad interim as Senior Clinical Advisor until a CMO search is complete. Dr. Peters will remain a member of the Company’s Board.

 

On September 13, 2023, the Company issued a press release announcing the resignation of Dr. Schlienger as Chief Medical Officer and appointment of Dr. Peters as Senior Clinical Advisor. A copy of this press release is furnished as Exhibit 99.1 to this report on Form 8-K.

 

The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number
  Description
99.1   Press release issued by HOOKIPA Pharma Inc. on September 13, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: September 13, 2023 HOOKIPA Pharma  Inc.
   
  By: /s/ Joern Aldag
    Joern Aldag
    Chief Executive Officer
(Principal Executive Officer)

 

 

 

 

Exhibit 99.1

 

 

 

HOOKIPA announces executive leadership change

 

NEW YORK and VIENNA, September 13, 2023 - HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that Katia Schlienger, M.D., Ph.D., is stepping down from her position as Chief Medical Officer (CMO) to pursue new opportunities, effective September 30. Malte Peters, M.D., a current member of the Board of Directors of HOOKIPA, will lead HOOKIPA’s clinical activities ad interim as Senior Clinical Advisor until a CMO search is complete. During this time, Dr. Peters will remain a member of the HOOKIPA Board of Directors.

 

Dr. Peters is a seasoned executive with deep experience in bringing new therapies to patients. He retired from his role as Chief Research and Development Officer at MorphoSys in 2022. Prior, Dr. Peters was Global Head of Clinical Development of the biopharmaceuticals business unit of Sandoz in Germany and spent 12 years in leadership positions at Novartis Oncology. He was responsible for multiple development programs and clinical trials at Novartis, contributing to the approval of 28 cancer therapies. He is board certified in internal medicine and earned his medical degree from Freie Universität in Berlin, with a postdoctoral fellowship in Toronto. 

 

“We welcome Malte to HOOKIPA as we remain laser focused on executing against our clinical priorities: to prepare for the randomized trial of HB-200 in combination with pembrolizumab, to progress our HB-300 prostate cancer program, and to advance our partnered programs in our collaborations with Roche and Gilead,” said Joern Aldag, Chief Executive Officer. “I would like to thank Katia for her many contributions to HOOKIPA, especially guiding our clinical programs and bringing our lead HB-200 program to a successful proof-of concept in Phase 2. We wish her the very best in her future endeavors.”

 

About HOOKIPA

 

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.

 

Find out more about HOOKIPA online at www.hookipapharma.com.

 

 

 

 

Forward Looking Statements

 

Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from public health crises, the impact of public health crises on the enrollment of patients and timing of clinical results, and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended June 30, 2023, which is available on the SEC’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.

 

Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.

 

For further information, please contact:

 

Media Investors
Instinctif Partners Reinhard Kandera, Chief Financial Officer
hookipa@instinctif.com IR@hookipapharma.com
+44 (0) 7457 2020