SBA Member, 15.03.2019
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.
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.
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.
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.