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-Barre Syndrome, and Multiple Sclerosis related Optic Neuritis
Complements Bioasis’ differentiated xB3TM platform for delivering therapeutics across the blood-brain barrier
NEW HAVEN, Conn., U.S.A., June 16, 2022 (GLOBE NEWSWIRE) — BIOASIS TECHNOLOGIES INC. (TSXV:BTI.V; OTCQB:BIOAF), (the “Company” or “Bioasis”) a biopharmaceutical company developing its proprietary xB3TM platform technology 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 of Oslo, Norway.
“This transaction is transformational for Bioasis, bringing Phase 2 ready assets aligned with our focus in rare disease and orphan drug indications. EGF1-48 comes with a full IND package and clinical experience indicating that it is safe and well tolerated in humans. The molecule has a unique dual mechanism of action, stimulating myelination and downregulating neuroinflammation, thus offering neuroprotective properties that support development in Guillain-Barre Syndrome, Chronic Inflammatory Degenerative Polyneuropathy and certain clinical manifestations related to onset and/or progression of multiple sclerosis including optic neuritis and relapses of the disease,” said Dr. Deborah Rathjen, Executive Chair of Bioasis.
“This transaction follows a number of recent partnering deals, with a growing list of pharmaceutical and biotechnology collaborations already established for our xB3TM technology,” Dr Rathjen added.
“The transfer of these assets to Bioasis will speed up the development of EGF therapeutics for the treatment of certain rare neurodegenerative disorders,” Professor Francois Curtin, co-founder and Vice-Chairman of the Cresence Board observed.
“We are thrilled by this agreement with Bioasis as it will progress the development of new therapeutic solutions based on EGF peptides for the treatment of rare neurodegenerative disorders where there is still significant unmet medical need. In addition, the combination of Bioasis xB3TM platform with our EGF technology is anticipated to improve the brain delivery of our neurotherapeutic molecules,” he added.
Professor Ferdinando Nicoletti, Cresence CSO and co-founder, added, “We believe that adding our EGF technology to the Bioasis platform will create new synergies allowing rapid development of innovative drugs in neurology. We expect these synergies will ultimately lead to tailored delivery of our molecules to the central nervous system and possibly broaden the therapeutic areas of their application within immunoinflammatory and degenerative diseases of the central nervous system.”
Members of the Cresence team have entered into consultancy agreements with Bioasis and will be involved in preparations for the Phase 2 clinical trials of EGF1-48.
Under the terms of the agreement, the Company 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 such EGF assets could be key in treatment of Guillain-Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy, among other indications.
The addition of this key intellectual property provides Bioasis a Phase 2 clinical stage ready molecule that is synergistic with Bioasis’ existing technology and therapeutic areas of interest. It is also providing the Company with a chance to complete rapid 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 achievement of additional milestones as follows: 3.0 million shares are issuable to the Sellers upon the Company’s initiation of a pivotal clinical trial in the U.S. for the first product and 3.0 million shares are issuable to the Sellers upon the U.S. FDA approval of any Bioasis application for the first product. Milestone payments of US$1.0 million each will be made upon attaining the second and third FDA approved indication in neurology for a product. A running royalty of 1% of net sales is payable for any product until the expiration of a specified royalty period.
The Sellers have agreed that they will not 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 remains subject to TSX Venture Exchange approval.
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On behalf of the Board of Directors of Bioasis Technologies Inc.
Deborah Rathjen, Ph.D., Chair & Chief Executive Officer
Bioasis Technologies Inc. is a biopharmaceutical company developing the xB3TM platform, a proprietary technology for the delivery of therapeutics across the BBB and the treatment of CNS disorders in areas of high unmet medical need. The delivery of therapeutics across the BBB represents the final frontier in treating neurological disorders. Bioasis’ internal pipeline programs are focused on treatments for certain brain cancers and rare diseases, including Gaucher’s Disease Type II, neurodegenerative diseases including Parkinson’s disease and Lewy Body Dementia and neuroinflammatory conditions including 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 disorders 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 legislation that may not be based on historical fact along with other statements containing the words “believe,” “may,” “plan,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” 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 that 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 express or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: products that we develop may not succeed in preclinical or clinical trials, or future products in our targeted corporate objectives; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and the costs of launching our products may be greater than anticipated; we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Canadian securities regulatory authorities 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 Chair & Chief Executive Officer
+1 203 533 7082
Francois Curtin, MD, Vice-Chairman & acting Chief Executive Officer
+41 78 936 50 85
Bioasis Investor Contact:
Colwell Capital Corp.
+1 403 561 8989