Bioniz - Spotlight

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Bioniz Therapeutics enters into an option agreement for acquisition by Almirall of its lead clinical candidate BNZ-1 in development for immuno-dermatologic and onco-dermatologic diseases

Irvine, CA, January, 2020 – Bioniz Therapeutics, Inc., a privately held clinical stage biopharmaceutical company developing first-in-class multi-cytokine peptide therapeutics for the treatment of immuno-inflammatory diseases and cancer, announced today the execution of an option agreement for acquisition by Almirall (ticker: ALM) including its lead candidate, BNZ-1. Almirall is a publicly traded company on the Spanish Stock Exchange based in Barcelona, Spain, and a global pharmaceutical leader specializing in the development of medicines for debilitating dermatological conditions.

Under the terms of the agreement, Bioniz will receive an initial payment of $15MM in exchange for the Almirall option to acquire all Bioniz outstanding shares.  Almirall will be able to elect to exercise its option following the availability of BNZ-1 phase 1/2 results in Cutaneous T-cell Lymphoma (CTCL) and other defined deliverables related to this trial.  If Almirall exercises its option, Bioniz will receive an option exercise fee of $47MM, plus additional milestone payments and royalties.

The closing of the option agreement by Almirall will result in the generation of a SpinCo (Bioniz NewCo), which will retain Bioniz’ proprietary multi-cytokine inhibitor platform technology, as well as the current BNZ-2, and BNZ-3 assets.  At the closing of the option agreement, the Bioniz NewCo will enter into a Research and Collaboration Agreement with Almirall for discovery of additional novel multi-cytokine inhibitors for treatment of dermatological diseases. From this collaboration, Bioniz NewCo is eligible to receive additional payments upon IND submission and further development and regulatory milestones.

The acquisition and research collaboration agreement with Almirall solidifies the effectiveness of Bioniz’s novel multi-cytokine technology platform to design first-in-class therapeutics for immuno-inflammatory and immuno-oncology conditions.  Bioniz has leveraged its technology platform to develop BNZ-1, a product in development for an immuno-dermatology franchise in CTCL, alopecia areata and vitiligo.  Similarly, two additional candidates in the Bioniz pipeline, BNZ-2, and its orally stable analog BNZ-3, are currently in development for Celiac disease and other immuno-inflammatory diseases of the GI tract such as ulcerative colitis and Crohn’s disease which share similar cytokine-driven pathology as Celiac disease.       

Bhushan Hardas, MD, MBA, Almirall’s Chief Scientific Officer, commented that “this agreement is a big step forward for us in our objective of becoming a leader in Onco-dermatology and Immuno-dermatology. With Bioniz Therapeutics Inc. combined with our long experience and understanding in the area of dermatology, we will be able to identify new avenues with the potential to develop the right therapies for patients with high unmet needs”.

Nazli Azimi, PharmD, PhD, Founder and Chief Executive Officer of Bioniz Therapeutics, Inc. stated “we are delighted to enter into this agreement with Almirall, a global leader in medical dermatology who shares our vision of building an Immuno-dermatology franchise for BNZ-1. This partnership highlights Company’s core capability in the discovery and early development of first-in-class multi-cytokine inhibitor peptides that each have the potential to impact multiple pathologies. We are committed to the further discovery of novel agents for the treatment of immuno-inflammatory diseases and cancer.”

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying science to provide medical solutions to patients and future generations. Our efforts are focused on fighting skin health diseases and helping people feel better. We support healthcare professionals in their continuous improvements, providing our innovative solutions where they are needed.

The company was founded almost 75 years ago and has its headquarters in Barcelona. It is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key source of value creation for society thanks to its commitment to its principal shareholders and its decision to help others by understanding their challenges and using science to provide solutions for real life. Total revenues in 2018 were 811 million euros. Almirall has around 1,800 employees of which 270 are dedicated to research and development (14% of Almirall staff).

For more information see www.almirall.es

About Bioniz Therapeutics

Bioniz Therapeutics is a clinical-stage biopharmaceutical company leading the discovery and development of first-in-class multi-cytokine inhibitory peptide therapeutics to address immuno-inflammatory diseases and cancer. Bioniz leverages its world-class expertise in cytokine biology, originated in research conducted at the National Institutes of Health (NIH), to develop a novel approach to selectively inhibit functionally redundant cytokines while leaving the rest of the cytokine network intact. Bioniz’ innovative platform has resulted in multiple peer-reviewed publications in notable scientific journals. Bioniz’ lead product candidate, BNZ-1, has completed Phase 1 SAD and MAD clinical trials in healthy volunteers and is currently in Phase1/2a clinical development in CTCL.