Bioasis acquires rare orphan EGF assets ready for phase 2
Phase 2-ready assets transform Bioasis into a clinical-stage company with a multi-asset pipeline focused on rare and orphan drug indications
Unique approach to neurodegeneration targeting remyelination
Initial indications Chronic inflammatory degenerative polyneuropathy, Guillain-Barré syndrome and multiple sclerosis-related optic neuritis
Complements Bioasis differentiated xB3MT platform for delivering therapeutics across the blood-brain barrier
NEW HAVEN, Connecticut, U.S., June 16, 2022 (GLOBE NEWSWIRE) — BIOASIS TECHNOLOGIES INC. (TSXV: BTI.V; OTCQB: BIOAF), (the “Company” or “Bioasis”) a biopharmaceutical company developing its proprietary product xB3TM technology platform for the delivery of therapeutics across the blood-brain barrier (the “BBB”) announced today that it has entered into an asset purchase agreement with the owners (the “Sellers”) of Cresence AS from Oslo, Norway.
“This transaction is a transformation for Bioasis, bringing Phase 2 ready assets aligned with our focus in rare diseases and orphan drug indications. EGF1-48 comes with a full IND package and clinical experience indicating it is safe and well tolerated in humans. The molecule has a unique dual mechanism of action, stimulating myelination and downregulating neuroinflammation, thereby providing neuroprotective properties that support the development of Guillain-Barré syndrome, chronic inflammatory degenerative polyneuropathy and certain related clinical manifestations to the onset and/or progression of multiple sclerosis, including optic neuritis and disease relapses,” said Dr. Deborah Rathjen, Executive Chairman of Bioasis.
“This transaction follows a number of recent partnership agreements, with a growing list of pharmaceutical and biotechnology collaborations already established for our xB3MT technology,” Dr. Rathjen added.
“The transfer of these assets to Bioasis will accelerate the development of EGF therapeutics for the treatment of certain rare neurodegenerative diseases”, observed Professor François Curtin, co-founder and vice-chairman of the board of directors of Cresence.
“We are delighted with this agreement with Bioasis as it will advance the development of novel therapeutic solutions based on EGF peptides for the treatment of rare neurodegenerative diseases where there are still significant unmet medical needs. Furthermore, the combination of Bioasis xB3TM platform with our EGF technology should improve cerebral delivery of our neurotherapeutic molecules,” he added.
Professor Ferdinando Nicoletti, CSO and co-founder of Cresence, added: “We believe that the addition of our EGF technology to the Bioasis platform will create new synergies enabling the rapid development of innovative drugs in neurology. We anticipate that these synergies will ultimately lead to tailored delivery of our molecules to the central nervous system and eventually expand the therapeutic areas of their application in immuno-inflammatory and degenerative diseases of the central nervous system.
Members of the Cresence team have entered into consulting agreements with Bioasis and will be involved in the preparations for phase 2 clinical trials of EGF1-48.
Under the terms of the agreement, the Company has purchased all right, title and interest in the intellectual property owned by the Sellers related to their epidermal growth factor (EGF) platform. The Company believes that these EGF actives could be essential in the treatment of Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, among other indications.
The addition of this key intellectual property provides Bioasis with a Phase 2 clinical-stage-ready molecule that is synergistic with Bioasis’ existing technology and therapeutic areas of interest. It also offers the Company the possibility of rapidly carrying out proof-of-concept clinical trials in multiple rare and orphan indications.
In exchange for this intellectual property, Bioasis has agreed to issue 6.5 million common shares to the sellers upon completion of the transaction as well as up to an additional 6.0 million common shares subject to the completion of additional steps as follows: 3.0 million shares are to be issued to the sellers upon the company’s initiation of a pivotal clinical trial in the United States for the first product and 3.0 million shares can be issued to the sellers upon US FDA approval of any Bioasis application for the first product. Milestone payments of US$1.0 million each will be made upon reaching the second and third FDA-approved indication in neurology for a product. A current royalty of 1% of net sales is payable for any product until the expiration of a specified royalty period.
The sellers have agreed not to sell any of the common shares issued to them for a period of two years from the closing of the transaction. Thereafter, sales will be subject to certain volume limitations.
The transaction and the issuance and listing of the shares issuable to the sellers remain subject to the approval of the TSX Venture Exchange.
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On behalf of the Board of Directors of Bioasis Technologies Inc.
Deborah Rathjen, Ph.D., President and CEO
Bioasis Technologies Inc. is a biopharmaceutical company developing the xB3MT platform, a proprietary technology for delivering therapies through the BBB and treating CNS disorders in areas of high unmet medical need. The delivery of therapeutics through the BBB represents the final frontier in the treatment of neurological disorders. Bioasis’ internal pipeline programs are focused on treatments for certain brain cancers and rare diseases, including Gaucher disease type II, neurodegenerative diseases such as Parkinson’s disease and Lewy body dementia, and neuroinflammatory conditions. such as pain, epilepsy and multiple sclerosis. Bioasis trades on the TSX Venture Exchange under the symbol “BTI.V” and on the OTCQB under the symbol “BIOAF”. For more information about the company, please visit www.bioasis.us.
Cresence AS, Oslo, Norway, is a private company dedicated to the discovery and development of neuropeptides, in particular EGF derivatives, which have the potential to treat rare neurodegenerative diseases where there is a high unmet medical need.
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities laws that may not be based on historical facts. , as well as other statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect to” and similar expressions. Such forward-looking statements or information include statements regarding the Company’s proposed acquisition of EGF-related intellectual property and the potential benefits the Company expects to receive from its ownership of such assets and involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. These factors include, but are not limited to, our stage of development, lack of product revenue, additional capital requirements, risk associated with conducting clinical trials and obtaining regulatory approval to commercialize our products. , the ability to protect our intellectual property, reliance on partner collaborations, and the prospects for negotiating additional corporate collaborations or licensing agreements and their timing. Specifically, certain risks and uncertainties that could cause actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future event or results expressed or implied by such statements and information include, but are not limited to, without limitation, the risks and uncertainties that: the products we develop may not succeed in preclinical or clinical trials, or future products in our targeted business objectives; our future operating results are uncertain and subject to fluctuation; we may not be able to raise additional capital; we may not be successful in establishing additional business collaborations or license agreements; we may not be able to establish a market and the costs of launching our products may be higher than expected; we have no commercial manufacturing experience; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors described in detail in our filings with Canadian securities regulators at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law. .
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Deborah Rathjen, Ph.D., Executive Chairman and CEO
+1 203 533 7082
François Curtin, MD, Vice Chairman and Interim Chief Executive Officer
+41 78 936 50 85
Bioasis Investor Contact:
Colwell Capital Corp.
+1 403 561 8989