2020

20.02.2020 – Polyphor AG

Polyphor announces progress of the Phase III immuno-oncology program with balixafortide. Renewed strategy in advancing antibiotics and oncology research and pipeline

Polyphor AG / Key word(s): Miscellaneous
Polyphor announces progress of the Phase III immuno-oncology program with
balixafortide. Renewed strategy in advancing antibiotics and oncology
research and pipeline

20-Feb-2020 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.

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Allschwil, Switzerland, February 20, 2020


Polyphor announces progress of the Phase III immuno-oncology program with
balixafortide. Renewed strategy in advancing antibiotics and oncology
research and pipeline


Polyphor AG (SIX: POLN), a research based clinical stage biopharmaceutical
company, announces today progress of the Phase III immuno-oncology program
with balixafortide and a renewed strategy in advancing antibiotics and
oncology research and pipeline.

- Polyphor to prioritize and continue executing the near term priority,
Balixafortide Phase III program - enrollment is progressing ahead of plan as
a result of strong execution (192 patients, 50% total) and reaffirming
timelines for achieving its first co-primary end point, ORR (Overall
Response Rate).

- Polyphor to set strategic priorities and the plan for its portfolio
evolution beyond its major inflection point, ORR results for balixafortide:

- Given strong Phase III trial progress, complete the package for
balixafortide potential MA (Marketing Authorization) filing and expanding
its future opportunity.

- Renewed strategy for developing innovative antibiotics with focus to
formulation and peptide design optimization applying lessons learned from
the murepavadin IV program, which the company has decided to terminate.

- Advancing inhaled murepavadin for cystic fibrosis to Phase Ia in Q4 2020
after completion of the preclinical program suggesting broader (at least
5-10 times vs IV) safety margins.

- Switch to a new formulation / new peptide design for POL7306 and not
submit a CTA (Clinical Trial Application). Initiated a new target program
within OMPTA class, thanatin derivatives.

- A planned restructuring by up to 17 positions is expected to create
operational efficiencies and help become a leaner and high-performance
organization in delivering priorities.


Balixafortide Phase III Program:

- Polyphor's FORTRESS study, a pivotal Phase III study evaluating
balixafortide (POL6326) in combination with eribulin for the treatment of
patients with HER2 negative, locally recurrent or metastatic breast cancer
(MBC), has randomized 192 (50%) patients to-date and enrollment is
progressing ahead of plan.

- Completion of patient recruitment of 384 patients is expected for end of
Q3 2020 and Polyphor reconfirms the data-cut for its first co-primary end
point, ORR, by end of Q1 2021. ORR results could lead to an accelerated
approval in the US after a potential breakthrough designation submission.

- Co-primary endpoint PFS (Progression Free Survival) is expected in Q4 2021
and will be the basis for a regular MA submission in the US and EU.

- If successful, balixafortide will be the first in class CXCR4 antagonist
approved for a solid tumor indication widening the opportunities in the
field of immuno-oncology.


Balixafortide Development Strategy:

- Polyphor plans to expand balixafortide into additional clinical studies to
complete its package for a potential MA filing to capitalize on potential
positive Phase III outcome, investigate additional dosing and scheduling
options.

- Polyphor plans additional studies to enhance its characterization in CXCR4
driven immune pathway and pursue additional combinations in MBC.

- These studies are planned to be initiated starting from second half 2020
through 2021.


Oncology Research Expansion:

- Polyphor plans to expand research activities to further profile
balixafortide activity in other combinations and tumors.

- Plans to identify additional novel development candidates in the field of
immuno-oncology will be a strategic consideration moving forward.

- The company will actively pursue broadening academic and industry
collaboration in the mid-term.


Antibiotics Research and Programs:

- Based on the thorough analysis of the learning from our research and
development efforts, Polyphor will reprioritize remaining antibiotics
programs with strong focus on formulation and peptide design optimization
applying lessons learned from the murepavadin IV program, which the company
has decided to terminate.

- Following the successful completion of the preclinical program suggesting
at least 5-10 times higher safety margins versus IV formulation, Polyphor
plans to submit CTA for inhaled murepavadin and start Phase Ia program in Q4
2020 for a future cystic fibrosis indication.

- Despite the promising efficacy package after completion of its preclinical
program, the company will not submit a CTA for POL7306 program in 2020 due
to estimated therapeutic margins. Polyphor plans to focus on a new
formulation for POL7306 and peptide design optimization of its OMPTA BamA
program to achieve broader therapeutic margins before moving into clinical
trials.

- Polyphor initiated a new target program within OMPTA class, thanatin
derivatives targeting specifically Enterobacteriaceae including multidrug
resistant strains, one of the most common and resistant pathogens.

- Polyphor will continue research and development for the antibiotics
pipeline with the support of existing and future non-dilutive and/or
external financing.

Organization:

- In line with the renewed strategy, organization and resources will be
focused on greatest opportunities innovation and value creation.

- A planned restructuring by up to 17 positions is expected to create
operational efficiencies and help become a leaner and high-performance
organization in progressing breakthrough science and innovation;
consultation process with employees is initiated.

- New organization will be equipped to deliver balixafortide and inhaled
murepavadin clinical studies while maintaining the core in research in
antibiotics and oncology.

- Polyphor's Executive team consists of Gokhan Batur (CEO), Daniel Obrecht
(CSO), Frank Weber (CMDO), Hernan Levett (CFO) and Franziska Muller (Head of
HR) to lead the strategic transformation.


Financials:

- The company reconfirms its guidance that with existing cash, operations
are financed until the end of Q1 2021.

- Under the current plan, the cash position will allow Polyphor to develop
the balixafortide program towards the next value inflection point (ORR,
around end of Q1 2021).

- Early stage antibiotics programs partly financed through non-dilutive
funding and external financing. On-going discussions with key institutions
in order to further support the antibiotics pipeline.

- Polyphor plans to release its FY 2019 financial results on April 28th
2020.


Business update conference call at 15.00 CET on 20 February 2020

Gökhan Batur (CEO), Hernan Levett (CFO), Daniel Obrecht (CSO) and Frank
Weber (CMDO) will provide a business update, followed by a Q&A session.


Dial-in number:
(CH) +41 44 580 65 22
(UK) +44 20 3009 2470
(USA) +1 87 7423 0830
Conference-ID: 41267291#


To follow the presentation, please use the below webcast link (no audio
signal):
https://webcasts.eqs.com/polyphor20200220/no-audio

For further information please contact:

For Investors:
Hernan Levett
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 24
Email: IR@polyphor.com

For Media:
Stephan Feldhaus
Feldhaus & Partner GmbH
Tel: +41 79 865 92 56
Email: feldhaus@feldhaus-partner.ch


About Polyphor
Polyphor is a research based clinical stage, Swiss biopharmaceutical company
focused on the discovery and development of immuno-oncology compounds and a
new class of antibiotics. Polyphor is advancing balixafortide (POL6326) in a
Phase III trial in combination with eribulin in patients with advanced
breast cancer, and exploring its potential in other cancer indications. In
addition, it has discovered and is developing the Outer Membrane Protein
Targeting Antibiotics (OMPTA). OMPTA are po-tentially the first new class of
antibiotics in clinical development in the last 50 years against
Gram-negative bacteria. The company's lead OMPTA program is an inhaled
formulation of murepavadin for the treatment of Pseudomonas aeruginosa
infections in patients with cystic fibrosis. Polyphor is based in Allschwil
near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more
information, please visit www.polyphor.com.

Disclaimer
This press release contains forward-looking statements which are based on
current assumptions and forecasts of the Polyphor management. Known and
unknown risks, uncertainties, and other factors could lead to material
differences between the forward-looking statements made here and the actual
development, in particular Polyphor's results, financial situation, and
performance. Readers are cautioned not to put undue reliance on
forward-looking statements, which speak only of the date of this
communication. Polyphor disclaims any intention or obligation to update and
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.


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