SBA Member, 07.09.2018
- IPO on SIX Swiss Exchange raising CHF 155 million
- Murepavadin entered Phase III
- Balixafortide gets Fast Track designation
- OMPTA platform - lead preclinical compound identified and supported by a strong partner
- Strong cash balance to finance pipeline to key value inflection points
Polyphor AG (SIX: POLN), a clinical stage biopharmaceutical company, focused on the discovery and development of antibiotics and other specialty pharma products for severe or life-threatening diseases announced its financial results for the first half of 2018.
IPO on SIX Swiss Exchange raising CHF 155 million
With the IPO on the SIX Swiss Exchange on May 15th, we raised CHF 155 million which allows us to advance the development of our products, aimed at helping patients affected by infections and hospital pneumonia, as well as women with metastatic breast cancer. Our IPO was the largest biotech IPO in Switzerland in over 10 years and one of the top three in Europe in the last three years in terms of proceeds raised by an issuer to finance the development of its pipeline. We are proud to have the support of so many new Swiss and international investors who see the value in our development programs and technology, we thank them for their trust and we remain committed to grow the value of their investment over time.
Murepavadin entered Phase III
In March we announced that the first patient has been enrolled for murepavadin (POL7080) in the PRISM-MDR (EMA study) Phase III clinical trial for the treatment of ventilator-associated bacterial pneumonia (VABP) due to Pseudomonas aeruginosa. The enrollment of the first patient is a significant step towards bringing forward this new treatment option. The PRISM-MDR study will compare murepavadin combined with one other anti‑pseudomonal antibiotic against two other anti-pseudomonal antibiotics and it is expected that it will take approximately two and a half years to complete. We are currently in the preparation to also start the PRISM-UDR (FDA study) Phase III clinical trial later this year, a pseudomonas monotherapy study designed to demonstrate non-inferiority of murepavadin compared to an anti-pseudomonal standard-of-care antibiotic in patients with nosocomial pneumonia.
Balixafortide gets Fast Track designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation in April for our immuno-oncology candidate balixafortide (POL6326), in combination with eribulin, for the treatment of patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regimens in the metastatic setting. The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This is another positive step for the development of balixafortide and a recognition of the need for better treatments for the women with this disease. We are making further progress with the preparation of the planned single pivotal study which we expect to start in the second quarter of 2019 to potentially support registration for balixafortide in the U.S.
OMPTA platform - lead preclinical compound identified and supported by a strong partner
After the successful completion of the collaboration with the Wellcome Trust for the development of novel Outer Membrane Protein Targeting Antibiotics against multi-drug resistant Gram-negative pathogens in April, we are very proud to have announced that the Novo REPAIR Impact Fund has chosen our lead OMPTA preclinical compounds as their first investment. Novo Holdings A/S committed to invest CHF 6.8 million in Polyphor through a capital increase and, in addition, it has committed to make a project based, royalty-bearing investment of CHF 4.7 million in cash at the achievements of predefined milestones of the OMPTA program and customary closing conditions. This represents a great endorsement of our efforts in finding new antibiotics to combat drug resistance. The Novo investment will support the development of our antibiotic OMPTA pipeline, which showed high activity at low doses against most resistant Gram-negative strains.
Strong cash balance to finance pipeline to key value inflection points
With the placement of 4 million newly issued registered shares at CHF 38 per share, we were able to raise a total of CHF 155 million in gross proceeds. This brings our total cash position to CHF 153 million (cash and cash equivalents as of June 30, 2018), which allows us to pursue our development efforts for murepavadin, balixafortide and our OMPTA program until the next inflection points.
Overall revenues increased by CHF 4.2 million to CHF 7.0 million in the first half of 2018 compared to the first half of 2017, mainly due to an initial payment, relating to a Licensing Agreement with Santhera Pharmaceuticals Ltd. ("Santhera") received in the form of Santhera shares. With our pipeline advancing to a next level, R&D cost increased by CHF 6.4 million to a total of CHF 21.7 million. The total loss for the period amounted to CHF 20.8 million and was impacted by a number of extraordinary items, such as the IPO costs, impairments of the technology platforms and leasehold improvements, as well as loss on the value of the Santhera shares.
With the initiation of the murepavadin PRISM-UDR Phase III study in the second half of 2018 and the planned initiation of the balixafortide pivotal study in the first half of 2019, we expect an increase in research and development cost. As a result, we expect the year end cash position to be substantially in line with the analyst consensus*, adjusted for the Novo investment. All our focus and efforts continue in progressing our pipeline and bringing first-in-class or best-in-class new medicines to patients.
* According to Bloomberg, net cash as at 31.12.2018 of CHF 126 million.
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