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Polyphor announces financial results for the full-year 2018 Freitag, 15. März 2019 - 07:00
Polyphor AG / Key word(s): Annual Results
Polyphor announces financial results for the full-year 2018
15-March-2019 / 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, March 15, 2019
Polyphor announces financial results for the full-year 2018
- Successful listing on SIX Swiss Exchange raising CHF 155 million
- Murepavadin - Phase III PRISM-MDR trial started, Phase III PRISM-UDR trial
enrolling first centers
- Balixafortide - Phase III study agreed with the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) and receives
Fast Track designation
- OMPTA platform - lead compound identified and supported by Novo Holdings
A/S and CARB-X
- Strong cash balance to finance pipeline to key inflection points
Polyphor AG (SIX: POLN), a clinical stage, Swiss biopharmaceutical company
focused on the discovery and development of antibiotics and immuno-oncology
compounds today announced its financial results for the full-year of 2018.
Successful listing on SIX Swiss Exchange
The listing of Polyphor on SIX Swiss Exchange on May 15, 2018 was the
largest primary biotech IPO in Switzerland in over 10 years. With this
transaction we were able to raise CHF 155 million which gives us the
opportunity to advance the development of our pipeline, as well as to
broaden our investor base, gaining the support of many new Swiss and
international investors who see the value creation potential of our
development programs and technology. Besides the IPO, we have made
significant progress in the advancement of all of our key programs -
murepavadin, balixafortide and the OMPTA platform.
Murepavadin (POL7080)
In March 2018 the first patient was enrolled in the PRISM-MDR European Phase
III clinical trial for the treatment of ventilator-associated bacterial
pneumonia (VABP) due to Pseudomonas aeruginosa. The PRISM-MDR study will
compare murepavadin combined with one other anti-pseudomonal antibiotic
against two other anti-pseudomonal antibiotics, and is expected to take
approximately two and a half years to complete. In 2019, the independent
DSMB (Data Safety and Monitoring Board) made its first review and
recommended the study to proceed without modifications. For the second
pivotal Phase III study (PRISM-UDR) we have reached an agreement with the
U.S. Food and Drug Administration (FDA) on the protocol for the study and
have already started to enroll the first centers. The monotherapy study is
designed to demonstrate non-inferiority of murepavadin compared to an
anti-pseudomonal standard-of-care antibiotic in patients with
hospital-acquired pneumonia due to Pseudomonas aeruginosa.
Balixafortide (POL6326)
After the FDA granted Fast Track designation in the beginning of 2018 for
our immuno-oncology candidate balixafortide, we could announce towards the
end of the year positive results from the FDA Type B Guidance meeting on the
planned Phase III study. The FDA reviewed the design and the inclusion and
exclusion criteria of the international study, which will comprise a total
of 384 patients and evaluate the efficacy and safety of balixafortide and
eribulin versus eribulin monotherapy in patients with HER2-negative
metastatic breast cancer. We are making further progress with the
preparation of the planned single pivotal study, which started in the first
quarter of 2019. In addition, we are conducting preclinical work to
establish the potential of balixafortide in combination with other drugs and
other oncology combinations and/or indications.
OMPTA platform
We progressed with the development of our OMPTA (Outer Membrane Protein
Targeting Antibiotics) platform and identified the lead preclinical
candidate, POL7306. We are honored that the Novo REPAIR Impact Fund has
chosen our lead OMPTA compounds for their first investment. Novo Holdings
A/S committed to invest up to CHF 11.5 million in Polyphor to accelerate the
development of the novel OMPTA compound addressing the deadliest and most
resistant Gram-negative bacterial pathogens including those designated as a
critical concern by the World Health Organization (WHO). This represents a
great endorsement of our efforts in finding new antibiotics to combat drug
resistance. In addition, Polyphor was awarded a grant from CARB-X (Combating
Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) of up to USD
5.6 million to fund the preclinical development and Phase I clinical trial
of the recently selected novel OMPTA candidate POL7306. We are aiming to
start the clinical studies with POL7306 in the first part of 2020. Finally,
thanks to the work done on OMPTA, we are honored to have received the most
important technology prize in Switzerland for innovation and technology
transfer, from the Swiss Innovation Forum in the category "Innovation
Leader".
Strong cash balance
In 2018 Polyphor was able to raise a total of CHF 162.8 million in gross
proceeds, including CHF 155.0 from the IPO and CHF 6.8 million from the
first tranche of the Novo REPAIR Impact Fund. This strong financial position
allows us to maximize the potential of our lead candidates murepavadin and
balixafortide, giving us the opportunity to continue the development of the
pivotal trials and to pursue the development of our OMPTA program until the
next inflection point.
With the initiation of the murepavadin Phase III trials and preparation of
the pivotal trial of balixafortide, R&D costs increased by 37% compared to
last year to a total of CHF 44.8 million. Overall revenues increased on a
like-for like basis by CHF 6.3 million from the last reporting period to CHF
6.5 million, mainly associated with a licensing agreement with Santhera
Pharmaceuticals Ltd. This brings our total cash position to CHF 133.8
million (cash and cash equivalents) as of December 31, 2018.
Priorities in 2019
For 2019 we will focus on advancing our pipeline, with special attention to
the Phase III trials of our two lead candidates murepavadin and
balixafortide. Our aim is to progress the enrollment of patients in the
murepavadin PRISM-MDR study that was initiated last year, and start the
dosing of the first patient in the PRISM-UDR study in the first half of
2019. We are also looking forward to starting the dosing of the first
patient in the balixafortide Phase III study around mid-2019, which will be
a significant step in bringing forward this new treatment option for
metastatic breast cancer. With the commencement of the different clinical
studies, we expect an increase in our research and development costs. In
addition, we will continue to further develop our preclinical programs, such
as our novel OMPTA candidate POL7306 against multidrug-resistant
Gram-negative pathogens, and the inhaled formulation of murepavadin. In line
with our strategy, we are also evaluating new partnerships for
co-development or co-commercialization of balixafortide in particular
regions and indications.
Full-year 2018 results conference call at 14.00 CET on March 15, 2018
Giacomo Di Nepi (CEO) and Kalina Scott (CFO) will provide a corporate and
financial update, followed by a Q&A session.
Dial-in number:
(CH) +41 44 580 6522
(UK) +44 20 3009 2470
(USA) +1 87 7423 0830
Conference-ID: 24916773#
To follow the presentation, please use the below webcast link (no audio
signal):
https://webcasts.eqs.com/polyphor20190315/no-audio
Please use the following link for the audio webcast with replay function
(audio and slides):
https://webcasts.eqs.com/polyphor20190315
Financial Highlights
CHF million
Profit and Loss1 2018 20172
Revenue 6.5 0.3
Research and development expenses -44.8 -32.6
Net loss -50.9 -39.1
Average net cash burn3 3.5 2.5
Balance Sheet 2018 2017
Cash on hand 133.8 24.6
Total assets 144.1 40.3
Total equity 120.6 17.3
Equity ratio 84% 43%
1) based on the consolidated IFRS financial statements
2) 2017 figures have been restated to reflect the discontinued operations
3) represents the average monthly cash used in operating and investing
activities
The annual report 2018 is available for download on our website:
https://www.polyphor.com/investor-relations/reporting/
For further information please contact:
For Investors:
Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email: IR@polyphor.com
For Media:
Alexandre Müller
Dynamics Group AG
Tel: +41 43 268 32 31
Email: amu@dynamicsgroup.ch
About Polyphor
Polyphor is a clinical stage, Swiss biopharmaceutical company focused on the
discovery and development of antibiotics and immuno-oncology compounds. It
has discovered and is developing the OMPTA (Outer Membrane Protein Targeting
Antibiotics). The OMPTA are potentially the first new class of antibiotics
against Gram-negative bacteria to have reached phase III stage in the last
50 years. The company's lead OMPTA, murepavadin, (POL7080) is in Phase III
development against Pseudomonas aeruginosa - recognized as a critical
priority 1 pathogen by WHO; in addition, Polyphor is developing a pipeline
of further preclinical antibiotics based on its OMPTA platform. In addition,
Polyphor is developing an immuno-oncology candidate, balixafortide
(POL6326), which is starting a Phase III trial in combination with eribulin
in patients with advanced breast cancer, and exploring in parallel its
potential for further combinations and indications. 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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