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iBio Announces Sale of Preclinical PD-1 Agonist Antibody Program to Otsuka

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iBio, Inc. (IBIO) announces a strategic asset purchase agreement with Otsuka Pharmaceutical Co., Ltd., involving an upfront payment of $1 million and potential future milestone payments of up to $52.5 million. The deal focuses on iBio's early-stage PD-1 agonist program, enhancing its immuno-oncology pipeline. PD-1 agonists play a crucial role in immune system modulation, offering promising therapeutic potential for autoimmune diseases. The transaction aims to provide iBio with significant non-dilutive capital, validate its technology stack, and enable a focused approach on immuno-oncology and AI-based drug discovery.
Positive
  • Strategic asset purchase agreement with Otsuka Pharmaceutical Co., Ltd.
  • Upfront payment of $1 million and potential milestone payments up to $52.5 million
  • Focus on iBio's early-stage PD-1 agonist program for immuno-oncology
  • PD-1 agonists crucial for immune system modulation and autoimmune disease treatment
  • Transaction to provide non-dilutive capital, validate technology stack, and enhance focus on immuno-oncology and AI-based drug discovery
Negative
  • None.

The transaction between iBio and Otsuka Pharmaceutical involving the PD-1 agonist program represents a strategic divestiture for iBio, potentially bolstering its financial position with $1 million upfront cash and up to $52.5 million in milestone payments. This deal could enhance shareholder value by providing non-dilutive funding, which is preferable to equity financing as it does not dilute existing shareholders' stakes. The successful development and commercialization of the PD-1 agonist by Otsuka may lead to substantial future cash inflows for iBio, which can be reinvested into their core immuno-oncology pipeline or to accelerate their AI-based drug discovery platform.

It is also worth noting that milestone payments are contingent on the achievement of specific goals, which introduces an element of uncertainty. Investors should monitor Otsuka's progress with the program to gauge the likelihood of these payments materializing. Furthermore, the deal size relative to iBio's market capitalization and cash reserves could indicate the importance of the deal to the company's financial health.

The focus on immuno-oncology and the divestiture of the PD-1 agonist program reflects iBio's strategic prioritization of its resources. PD-1 is a crucial immune checkpoint and while antagonists in this area have been successful in cancer therapy, PD-1 agonists are rare and represent a novel approach to treating autoimmune diseases. The scientific novelty and potential therapeutic impact of PD-1 agonists could signify a significant advancement in autoimmune disease treatment options.

For stakeholders, the success of this program under Otsuka's stewardship would validate iBio's capabilities in antibody development, potentially enhancing the company's reputation and enabling future partnerships. However, the early-stage nature of the program suggests a long development timeline with inherent risks, including clinical trial failures, regulatory hurdles and market competition. These factors must be weighed when considering the long-term implications of the agreement.

The immunotherapy market is highly competitive, with numerous players seeking to develop innovative treatments. iBio's decision to sell its PD-1 agonist program and focus on its proprietary immuno-oncology candidates could be a strategic move to concentrate on areas where it has a competitive edge or sees greater market potential. The use of AI in drug discovery is an emerging trend that could give iBio a technological advantage, potentially leading to a more efficient drug development process and shorter time-to-market for its candidates.

Understanding the competitive landscape, including the number of existing PD-1 agonists and the demand for new autoimmune therapies, is crucial. If the PD-1 agonist program develops into a successful product, it could disrupt the current market dynamics, depending on its efficacy and safety profile compared to existing treatments. This transaction allows iBio to potentially benefit from Otsuka's success with the program while reallocating resources to areas where it can differentiate itself and capture market share.

– Deal includes $1 million upfront and potential future milestone payments

– iBio’s proprietary therapeutic pipeline will now be comprised entirely of promising immuno-oncology candidates

BRYAN, Texas and SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), an AI-driven innovator of precision antibody immunotherapies, announces today that it has entered into an asset purchase agreement (“Agreement”) with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), pursuant to which Otsuka acquired iBio’s assets related to its early-stage programmed cell death protein 1 (“PD-1” ) agonist program. The transaction closed on February 25, 2024.

Under the terms of the Agreement, iBio will receive an upfront payment of $1.0 million in cash at closing. iBio will also be eligible to receive additional contingent cash payments totaling up to $52.5 million upon the achievement of certain pre-specified clinical development and commercial milestones.

PD-1 is a pivotal checkpoint in the immune system, acting as a type of "off switch" that helps keep the cells from attacking other cells in the body. By agonizing or enhancing the signaling of PD-1, it is possible to temper the immune response, making it particularly valuable in the treatment of autoimmune diseases. In conditions where the immune system mistakenly wages war on the body's own cells, such as in autoimmune diabetes or lupus, therapies that target PD-1 can potentially reduce the severity of these autoimmune reactions. However, unlike PD-1 antagonists used in immuno-oncology, PD-1 agonists, like the one iBio is selling to Otsuka, are difficult to find.

“We believe this is an important transaction for iBio, and a win-win for both companies,” said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D. “The deal provides iBio with a potential significant new source of non-dilutive capital if all of the milestones are satisfied; further validates the ability of our precision-driven and deeply integrated technology stack to efficiently deliver antibody candidates against challenging targets, including the development of complex antibody modalities such as agonistic antibodies; and allows us to focus our resources squarely on the continued development of our proprietary immuno-oncology pipeline and AI-based drug discovery platform. At the same time, it provides a path forward for the PD-1 agonist program via further development by Otsuka.”

About Otsuka Pharmaceutical Co., Ltd.

Otsuka is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed approximately 48,000 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and X at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/.

About iBio, Inc.

iBio develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases. iBio’s mission is to decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets. For more information, visit www.ibioinc.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the expected closing date of the transaction and the potential milestone payments to the Company, the Company’s new source of non-dilutive capital; its ability to further validate our precision-driven and deeply integrated technology stack to deliver antibody candidates against challenging targets, including the development of complex antibody modalities such as agonistic antibodies; its ability to continue to develop of our proprietary immuno-oncology pipeline and the patented AI-powered tech stack, the ability of the PD-1 agonist program to be developed. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate non-dilutive capital; Otsuka’s ability to generate results from the acquisition of the PD-1 agonist program; Otsuka’s ability to obtain regulatory approvals for commercialization of the PD-1 agonist program to generate commercial sales, or to comply with ongoing regulatory requirements; or the Company’s ability to maintain its NYSE American listing; and the other factors discussed in the Company’s filings with the SEC including the Company’s Annual Report on Form 10-K for the year ended June 30, 2023 and the Company’s subsequent filings with the SEC on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and the Company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contacts:

Stephen Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
skilmer@ibioinc.com

Susan Thomas
iBio, Inc.
Media Relations
(619) 540-9195
susan.thomas@ibioinc.com


The asset purchase agreement involves iBio selling its assets related to the early-stage PD-1 agonist program to Otsuka.

iBio received an upfront payment of $1 million in cash at closing.

iBio is eligible to receive additional contingent cash payments totaling up to $52.5 million upon achieving certain pre-specified clinical development and commercial milestones.

PD-1 agonists act as a crucial checkpoint in the immune system, helping to regulate immune responses and potentially treating autoimmune diseases.

The transaction aims to provide iBio with significant non-dilutive capital, validate its technology stack, and enable a focused approach on immuno-oncology and AI-based drug discovery.
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About IBIO

ibio is a contract development and manufacturing organization equipped to take clients from the early stages of product selection through regulatory approval and commercial product launch. ibio’s technology platform and facility capabilities are applicable to the development of biotherapeutics, vaccines, diagnostic products, and certain types of medical devices – and often provide significant time and value advantages over traditional approaches. ibio’s lab to launch capabilities assure the most rapid manufacturing support to reach the clinic. ibio’s team is comprised of knowledgeable protein scientists, microbiologists and manufacturing and regulatory experts, all of whom add significant expertise and value throughout the entire process. the same team and facility that produces preclinical and clinical material will be the same team producing your product for market launch; contributing to the seamless scale-up process the ibio technology platform creates.