THAR Tharimmune Inc

 

 

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 11, 2024

 

THARIMMUNE, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-41210		84-2642541
(State or other jurisdiction of incorporation)		(Commission File Number)		(I. R. S. Employer Identification No.)

 

1200 Route 22 East, Suite 2000

Bridgewater, NJ 08807

(Address of principal executive offices, including zip code)

 

(908) 955-3140

(Registrant’s telephone number, including area code)

 

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:

 

☐	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, $0.0001 par value		THAR		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 1.01 Entry into a Material Definitive Agreement.

 

On September 11, 2024, Tharimmune, Inc. (the “Company”) entered into a Patent License Agreement (the “Agreement”) with Intract Pharma Limited, a company incorporated in England and Wales (“Intract”). Pursuant to the Agreement, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Agreement, the Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program.

 

Intract received an upfront payment and is eligible to receive additional payments upon an equity financing of the Company and additional payments for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The Agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, the Company has the option to exercise the license to Intract’s platform for up to four additional targets.

 

The term of the Agreement expires upon the final payment obligation of the Company under the Agreement. In addition, the Agreement may be terminated by the Company at any time upon 90 days written notice to Intract. Either party may terminate the Agreement if the other party materially breaches any provision of the Agreement and fails to cure such breach within thirty (30) days after the breaching party receives written notice thereof. In addition, either party may terminate the Agreement on written notice in the event that either party declare: (a) becomes insolvent or admits inability to pay its debts generally as they become due; (b) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within sixty (60) days; (c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes a general assignment for the benefit of creditors; or (e) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.

 

A copy of the Agreement will be filed with the Company’s Form 10-Q for the three months ended September 30, 2024 to be filed in November 2024. A press release announcing the Agreement is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is hereby incorporated by reference.

 

Item 7.01 Regulation FD Disclosure.

 

The Company has made available a presentation about its business, a copy of which is filed as Exhibit 99.2 to Report and is hereby incorporated by reference.

 

The information contained in the presentation is summary information that should be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements the Company may make by press release or otherwise from time to time. The presentation speaks as of the date of this Report. While the Company may elect to update the presentation in the future to reflect events and circumstances occurring or existing after the date of this Report, the Company specifically disclaims any obligation to do so.

 

The presentation contains forward-looking statements, and as a result, investors should not place undue reliance on these forward-looking statements.

 

The information set forth in this Report, including, without limitation, the presentation, is not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such a filing. This Report (including the exhibits hereto) will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99,1		Press Release of Tharimmune, Inc.
99.2		Presentation Materials
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 hereunto duly authorized.

 

Date: September 16, 2024	Tharimmune, Inc.
	/s/ Randy Milby
	Randy Milby
	Chief Executive Officer

 

 

Exhibit 99.1

 

 

Tharimmune Acquires Global License and Partners with Intract Pharma to Develop an Oral Formulation of Infliximab

 

BRIDGEWATER, N.J. and LONDON / ACCESSWIRE / September 16, 2024 – Tharimmune, Inc. (NASDAQ: THAR) (“Tharimmune” or the “Company”), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announced today that it has entered into a definitive agreement with Intract Pharma to exclusively license INT-023/TH023, an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody infliximab. This strategic partnership aims to expand Tharimmune’s therapeutic pipeline and reinforce its commitment to pioneering novel treatments for autoimmune diseases.

 

Under the terms of the agreement, Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma’s Soteria^® and Phloral^® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Intract Pharma received an upfront payment and is eligible to receive additional payments upon an equity financing of the Company and is eligible for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, Tharimmune has the option to exercise the license to Intract’s platform for up to four additional targets.

 

Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-α. Tumor necrosis factor-alpha is a signaling protein involved in acute phase reactions and systemic inflammation. Infliximab is sold by Janssen Biotech under the Remicade^® brand for numerous indications including Crohn’s disease, ulcerative colitis, rheumatoid diseases and plaque psoriasis.

 

Traditionally administered through intravenous infusions, oral delivery of antibodies such as infliximab is challenging due to the complexity of navigating such large molecules through the gastrointestinal tract. This new partnership aims to overcome these challenges using Intract’s delivery platform, making it possible to administer infliximab in a pill form. An oral route of administration holds potential to improve patient compliance and quality of life, while also reducing the burden on the healthcare system associated with long-term intravenous therapy.

 

“The integration of Intract’s innovative technology, combined with the high-quality infliximab monoclonal antibody provided by their existing supply agreement, holds tremendous potential to accelerate and reinforce our commitment to immunology. This new collaboration not only broadens our therapeutic focus, but also aligns with our mission to improve patient outcomes by developing more convenient and accessible treatment options,” said Randy Milby, CEO of Tharimmune. “An oral form of infliximab represents a significant advancement in the treatment of chronic inflammatory diseases, and the opportunity for Tharimmune to compete in a multibillion-dollar global market.”

 

This partnership enables the targeted delivery of antibody therapeutics directly to the colon or small intestine. By leveraging Intract’s platform, Tharimmune aims to enhance the effectiveness of TNF-α inhibitors such as infliximab through precision delivery that maximizes proteolytic stabilization and tissue permeation. This novel approach offers significant potential for directly addressing inflammatory conditions within the gastrointestinal tract, including inflammatory bowel disease, as well as systemic inflammatory disorders where TNF-α plays a critical role in disease progression.

 

“Safer and orally available biological treatments for long term use in chronic inflammation and immune mediated diseases represents a major area of medical need for millions of patients” said Vipul Yadav, CEO of Intract. “We are delighted to be partnering with Tharimmune and bringing on board their clinical development expertise in immunology to further advance together our oral anti-TNFα antibody into the clinic”.

 

 

 

About Intract Pharma

 

Intract is a biopharmaceutical company developing disruptive oral antibody delivery solutions to significantly improve the efficacy and safety of emerging and established protein therapeutics, as well as improve patient experience and outcomes in inflammation and immunology indications. Its platform leverages the advantage of precision targeting of large proteins and antibodies to the colon, while also protecting the biologics from enzymatic breakdown, allowing tissue/systemic uptake to create next-generation oral antibody medicines. For more information, please visit www.intractpharma.com

 

About Tharimmune

 

Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company’s lead clinical-stage asset, TH104, is known to suppress chronic, debilitating pruritus or “uncontrollable itching” in PBC, a rare and orphan liver disease with no known cure. The Company’s early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform against these and other specified targets. For more information, please visit www.tharimmune.com.

 

Forward Looking Statements

 

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune’s future Phase 2 trial, Tharimmune’s strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “depends,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. Subsequent events and developments may cause the Company’s views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

 

Contacts:

 

Tharimmune, Inc.

ir@tharimmune.com

 

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

 

# # #

 

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v3.24.3

Cover	Sep. 11, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 11, 2024
Entity File Number	001-41210
Entity Registrant Name	THARIMMUNE, INC.
Entity Central Index Key	0001861657
Entity Tax Identification Number	84-2642541
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1200 Route 22 East
Entity Address, Address Line Two	Suite 2000
Entity Address, City or Town	Bridgewater
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08807
City Area Code	(908)
Local Phone Number	955-3140
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.0001 par value
Trading Symbol	THAR
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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