After setback, Polyphor opts for a merger

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02.09.2021
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Polyphor stopped the Phase III clinical trial of its lead molecule this summer and took several weeks to evaluate strategic options. Now, the company announced a merger with Enbiotix.

Polyphor and Enbiotix 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. Upon completion of the merger, former EnBiotix equity holders (including investors of a 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. 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. Boston-based EnBiotix Inc. is a privately held late clinical-stage rare disease company currently focused on products for rare, chronic respiratory diseases.

In July Polyphor announced that due to the lack of meaningful clinical benefit based on objective response rate (ORR) and clinical response rate (CBR) in the third-line or later population and following a thorough analysis, the company had decided to close its FORTRESS study evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2-negative, locally recurrent or metastatic breast cancer. 

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. The transaction has been unanimously approved by the board of directors of both companies.

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.
(Press release / SK)

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