On September 1, 2021 Polyphor and EnBiotix Inc., a privately held late clinical-stage rare disease company currently focused on products for rare, chronic respiratory diseases, reported that the companies have signed a merger agreement pursuant to which Polyphor acquires all of the outstanding capital stock of EnBiotix in exchange for shares of Polyphor common stock (Press release, Polyphor, SEP 1, 2021, View Source [SID1234639731]). The transaction is subject to a number of closing conditions, including approval by Polyphor and EnBiotix shareholders, satisfactory completion of due diligence and satisfactory assessment of tax consequences. Following closing, expected in Q4 2021, Polyphor will be renamed and is expected to trade under a new ticker symbol on the Swiss Stock Exchange.
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Assuming completion of the merger, the combined company’s initial pipeline will include:
– ColiFin(R) which EnBiotix has in-licensed from PARI Pharma GmbH, a global leader in nebulized therapies, for worldwide rights ex-Europe. Approved in Europe since 2010 as a front-line therapy for lung infections in cystic fibrosis (CF), ColiFin(R) has a proven safety, efficacy and commercial track record which the combined company will leverage towards the U.S. and global markets – and both within and outside the field of CF.
– Inhaled murepavadin, a novel class inhaled antibiotic specifically targeting P. aeruginosa, is being developed for the treatment of these infections in people with CF and is beginning Phase I development using eFlow(R) Technology nebulizer (PARI Pharma GmbH).
– EBX-002, a combination of amikacin (AMK) and a potentiator molecule for NTM infections which preclinical studies to date have shown potential for superior activity compared to ARYKACE(R).
– Polyphor’s new CXCR4 inhibitors focused on orphan, hematological malignancies.
The combined company plans to advance its pipeline through multiple clinical trials and strategic transactions to build a rare disease and oncology company, as follows:
– Initiation of a single Phase III trial of ColiFin(R) for the treatment of CF patients, upon completion of which the combined company plans to seek FDA approval in the US.
– Initiation of a Phase I trial of inhaled murepavadin for the treatment of CF patients.
– Additional oncology and non-oncology indications for balixafortide will be evaluated in collaboration with Fosun Pharma who owns China rights.
– Combined company aims to in-license or acquire other rare disease and oncology assets post-closing that will consolidate its position in these therapeutic areas.
"After an extensive and thorough review of a full range of strategic options for Polyphor, we are very pleased to announce the signing of a merger agreement with EnBiotix," said Kuno Sommer, chairman of the board of directors at Polyphor. "We believe the merged company’s strong pipeline and focus on rare diseases and oncology can provide substantial opportunities to benefit patients, in particular cystic fibrosis patients with two clinical stage programs."
"We are honored to merge with Polyphor to jointly expand our pipeline, shareholder base and management team in both the U.S. and Europe. As we continue to pursue a unique position as a rare disease and oncology company, this merger with Polyphor is truly strategic", said Jeffrey D. Wager, MD, Chairman & CEO of EnBiotix. "We believe the merged company will provide a powerful platform for pipeline and corporate development, and look forward to pursuing additional partnering opportunities as we seek to address the unmet needs of our target patient populations."
About the Proposed Merger
Pursuant to the merger agreement, Polyphor will offer to acquire all of the outstanding capital stock of EnBiotix in exchange for the issuance of newly issued shares of Polyphor common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including approval by Polyphor and EnBiotixs shareholders, satisfactory completion of due diligence and satisfactory assessment of tax consequences. Upon completion of the merger, former EnBiotix equity holders (including investors of the planned financing round) are expected to own approximately 74-77% of Polyphor’s common stock. Polyphor’s current shareholders are expected to own approximately 23-26 % of Polyphor’s issued common shares following the closing of the merger.
The transaction has been unanimously approved by the board of directors of both companies.
About Acquisition of Inhaled Murepavadin
Simultaneously, the companies have signed a definitive asset purchase agreement where EnBiotix acquires Polyphor’s inhaled murepavadin at an agreed valuation of USD 10 million in exchange for 2’599’655 of common shares of EnBiotix (15.4% fully diluted of EnBiotix). The closing of this agreement is expected in September 2021 and prior to the expected closing of the merger. In case Polyphor were to terminate the merger agreement following acceptance of a superior offer – a Polyphor option required under Swiss law -, EnBiotix has the option to reverse the sale.
Management and Organization
Upon completion of the merger, Jeffrey D. Wager, M.D., currently Chairman and CEO of EnBiotix, is expected to become Chairman of the Board of Directors and Chief Executive Officer of the combined company replacing the current CEO, Gökhan Batur, who will oversee the next steps until the closing of the merger. The board members and management team of the merged company will be announced at a later date.
Conference Call
Polyphor AG and EnBiotix Inc. Conference Call at 14.00 CET on September 3, 2021