STOCK TITAN

Instinct Bio named IN01 representative in Japan, China

IN01 has not received marketing approval, and development materials identify squamous non-small cell lung cancer as its lead indication.

(Neutral)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
6-K

Rhea-AI Filing Summary

BIOT was named by CelSiege Biosciences as its non-exclusive authorized introduction and business development representative in Japan and China for IN01, a clinical-stage cancer immunotherapy. Under a Letter of Authorisation signed September 18, 2026, BIOT may introduce the program to prospective partners and investors and facilitate preliminary discussions about potential investment, licensing, co-development, clinical development, manufacturing and commercialization. Any definitive transaction remains subject to separate negotiations, due diligence and definitive agreements.

CelSiege describes IN01 as an active immunotherapy, or therapeutic cancer vaccine, targeting epidermal growth factor. Development materials identify squamous non-small cell lung cancer as the lead indication. IN01 has not received marketing approval.

New lung cancer cases Approximately 2.5 million Worldwide in 2022, according to the International Agency for Research on Cancer
Lung cancer deaths Approximately 1.8 million Worldwide in 2022, according to the International Agency for Research on Cancer
NSCLC share of lung cancer cases Approximately 80% to 85% According to the American Cancer Society
Global NSCLC therapeutics market Approximately $38.49 billion Fortune Business Insights estimate for 2025; the estimate covers a broad therapeutic category, not IN01's addressable market
active immunotherapy medical
"IN01 is an active immunotherapy"
Active immunotherapy is a medical approach that trains a patient’s own immune system to recognize and attack disease, often by exposing it to a target that mimics the threat. Think of it like coaching the body's guard dogs to spot a specific intruder; for investors it matters because successful therapies can create durable, high-value treatments but also carry high clinical and regulatory risk and long development timelines.
therapeutic cancer vaccine medical
"or therapeutic cancer vaccine"
epidermal growth factor medical
"targeting epidermal growth factor"
sqNSCLC medical
""sqNSCLC" as the lead indication"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What can BIOT do as IN01's representative in Japan and China?

Under the non-exclusive appointment, BIOT may introduce IN01 to prospective strategic partners, investors, pharmaceutical and biotechnology companies, medical institutions, research organizations and investment funds in Japan and China. It may facilitate preliminary discussions about potential investment, licensing, co-development, clinical development, manufacturing and commercialization.

What is IN01, and is it approved?

IN01 is a clinical-stage active immunotherapy and has not received marketing approval. CelSiege describes it as a therapeutic cancer vaccine designed to stimulate the patient's immune system to produce antibodies against circulating epidermal growth factor. Development materials identify squamous non-small cell lung cancer as the lead indication, with potential expansion into colorectal, head-and-neck and other cancers.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Learn about SEC filing dates

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of October 2026

 

Commission File Number: 001-43415

 

INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC.

(Registrant’s Name)

 

3rd Floor West Side Gotanda bldg.

6-2-7 Nishi Gotanda, Shinagawa-ku,

Tokyo 1410031, Japan

(Address of Principal Executive Offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

x   Form 20-F            ¨   Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):    ¨

 

 

 

 

 

 

Information Contained in this Form 6-K Report

 

On September 30, 2026, Instinct Bio Technical Company Holdings Inc. (the “Company”) issued a press release (the “Press Release”) announcing that CelSiege Biosciences has named it as a non-exclusive authorized representative in Japan and China for IN01, a clinical-stage cancer immunotherapy, a copy of which is furnished as Exhibit 99.1 to this Report of Foreign Private Issuer on Form 6-K (this “Form 6-K”).

 

The information contained in this Form 6-K, including Exhibit 99.1 furnished herewith, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be incorporated by reference into 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.

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press Release dated September 30, 2026

  

 

 

 

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.

 

  INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC.
     
Date: October 1, 2026 By: /s/ Tomoki Nagano
    Name: Tomoki Nagano
    Title: Chief Executive Officer and Director

 

 

 

 

Exhibit 99.1

 

BIOT Named Authorized Representative for IN01 Cancer Immunotherapy

in Japan and China

 

Non-exclusive appointment by CelSiege Biosciences extends BIOT's business development activities into clinical-stage oncology

 

NEW YORK and TOKYO, September 30, 2026 — INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC. (Nasdaq: BIOT) ("BIOT" or the "Company") today announced that CelSiege Biosciences Inc. ("CelSiege") has appointed BIOT, on a non-exclusive basis, as its authorized introduction and business development representative in Japan and the People's Republic of China for IN01, a clinical-stage cancer immunotherapy program.

 

Under a Letter of Authorisation signed on September 18, 2026 by Johan Indot, Founder and Director of CelSiege, BIOT may introduce the IN01 Program to prospective strategic partners, investors, pharmaceutical and biotechnology companies, medical institutions, research organizations and investment funds in both countries. BIOT may also facilitate preliminary discussions on potential investment, licensing, co-development, clinical development, manufacturing and commercialization. Any definitive transaction remains subject to separate negotiations, due diligence and definitive agreements.

 

"We believe IN01 is a promising clinical-stage program in the field of active cancer immunotherapy, and we are fully committed to helping build a path for this science to reach the patients who need it," said Tomoki Nagano, Chief Executive Officer of BIOT. "Japan and China have the world's largest lung cancer patient populations alongside world-class clinical research capabilities, placing them at the center of unmet medical needs in oncology. We share with CelSiege a mission to bring this technology to patients. As CelSiege's authorized representative in these two markets, BIOT will work with a strong sense of ownership to identify partners and pursue collaborations that can advance the development and commercialization of IN01. Our enduring aspiration is to bring more smiles to patients and their families."

 

 

 

 

About IN01

 

According to information provided by CelSiege, IN01 is an active immunotherapy, or therapeutic cancer vaccine, targeting epidermal growth factor ("EGF"). It is designed to stimulate the patient's immune system to produce antibodies against circulating EGF, a growth factor involved in the proliferation of certain cancer cells. Development materials identify squamous non-small cell lung cancer ("sqNSCLC") as the lead indication, with potential expansion into colorectal, head-and-neck and other cancers. IN01 is a clinical-stage asset and has not received marketing approval.

 

The Medical Need

 

According to the International Agency for Research on Cancer, lung cancer was the world's most frequently diagnosed cancer in 2022, with approximately 2.5 million new cases, and the leading cause of cancer death, with approximately 1.8 million deaths. Non-small cell lung cancer accounts for approximately 80% to 85% of lung cancer cases, according to the American Cancer Society. Fortune Business Insights estimates the global NSCLC therapeutics market at approximately $38.49 billion in 2025. This third-party estimate relates to a broad therapeutic category and should not be read as an estimate of the addressable market, commercial potential or probability of success of IN01.

 

 

 

 

About CelSiege Biosciences

 

CelSiege Biosciences is a biotechnology company headquartered in Marseille, France, with operations in the United States, focused on the research and development of active immunotherapies. Its proprietary B-cell-mediated platform is designed to stimulate polyclonal antibody responses against disease-associated ligands, with applications in oncology and other therapeutic areas.

 

For more information, visit CelSiege’s corporate website.
CelSiege Biosciences

 

About INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC.

 

INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC. (Nasdaq: BIOT) is a diversified healthcare and biotechnology company focused on developing and expanding businesses across beauty, wellness, regenerative medicine and related healthcare sectors. Through its operations and strategic partnerships, BIOT seeks to build an integrated platform connecting innovative healthcare technologies, products and services with growth opportunities across Asia and other international markets. For more information, please visit https://instinct-biot.com/

 

 

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of applicable U.S. securities laws, including statements regarding BIOT's plans to identify and engage potential strategic partners for the IN01 Program in Japan and China; potential investment, licensing, co-development, clinical development, manufacturing, commercialization or other collaborations involving IN01; and the potential future development and regulatory approval of IN01. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that BIOT will identify suitable counterparties, that discussions will result in definitive agreements or transactions, or that IN01 will successfully complete clinical development, demonstrate safety or efficacy, or receive regulatory or marketing approval in Japan, China or any other jurisdiction. Third-party data cited in this press release has not been independently verified by BIOT. Readers are cautioned not to place undue reliance on forward-looking statements. BIOT undertakes no obligation to update or revise any forward-looking statements except as required by applicable law.

 

Contact

 

INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC.
Investor Relations
Email:
ir@instinct-bro.com
Website: https://instinct-biot.com/

 

 

 

Filing Exhibits & Attachments

1 document

Keep reading