Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) has released its audited results for the full year ended 31 December 2022, showing a strong balance sheet and cash in hand, and provided an overview of recent corporate developments as it progresses its clinical programs.
"I am extremely proud of the progress we made in 2022 for the bexmarilimab program and building our corporate infrastructure, both in the US and in Europe, to support the ambitious plans we have for 2023 and beyond," said Dr Markku Jalkanen, chief executive officer of Faron in the results statement.
"Last year we accelerated the development of bexmarilimab in hematological malignancies and reported exciting early data that lays a solid trajectory. We also demonstrated compelling antitumor activity in heavily pretreated patients across multiple solid tumor types, setting the stage for a combination with standard of care in first-line solid tumors. We accomplished all of this while also strengthening our balance sheet, adding highly experienced team members and expanding our global footprint with a growing presence in the US," he added.
During 2022, the clinical-stage biopharmaceutical group, which is focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, reported that for the Phase I/II BEXMAB study of bexmarilimab, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), that a partial responder achieved complete remission of blasts in blood and bone marrow followed by normalization of blood counts. A second patient showed reduced blast counts.
Bexmarilimab has been evaluated as a single agent in the Phase I/II MATINS in more than 200 patients and found to be well-tolerated. The MATINS study median overall survival was 14.9 months for patients who achieved stabilization of disease from bexmarilimab compared to 4.4 months for those who did not, representing a 3.4-fold increase.
Bexmarilimab ignites the immune system by inducing IFN-y production. A high baseline level of IFN-γ in the tumor indicates that the immune system is already set to attack cancer cells and seems required for PD-1 blockade to work. Thus, adding bexmarilimab to PD-1 blockade is anticipated to enhance efficacy.
The company plans to initiate the Phase II BEXCOMBO study investigating bexmarilimab in metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved SoC.
Post period-end in January 2023, Faron reported that three out of five patients achieved objective responses in the first doublet cohort of the Phase I/II BEXMAB study evaluating the combination of azacitidine and bexmarilimab. Two of the three responders were refractory to SoC azacitidine monotherapy. The addition of bexmarilimab to SoC was well-tolerated. Both the 1mg/kg and 3mg/kg doublet arms are fully enrolled, and the dose-escalation meeting is planned for Q1 2023.
Looking at its financials, in June 2022, Faron successfully raised a total of €5.0mln gross (€4.8mln net) from new and existing shareholders, through the issuance of a total of 3,318,421 new ordinary shares to itself without consideration and, in October 2022, the company successfully raised a total of €8.4mln gross (€8.2mln net) from new and existing shareholders, through issuance of a total of 3,229,930 new ordinary shares to itself. Those shares and the 1,311,800 existing treasury shares were conveyed to investors.
Proceeds from both raises will be used to accelerate clinical development of Faron's main drug candidate, continue the CMC process and US build-up and to strengthen the company's balance sheet.
Post period-end, in January 2023, Faron successfully raised a total of €12.0mln gross through the issuance of 3,692,308 ordinary shares to itself without consideration which were conveyed to investors. This fundraising round was supported by long-only institutional investors, family offices, existing shareholders, and the Leukemia & Lymphoma Society.
In February 2022, the company secured a debt funding agreement with IPF Partners for up to €30mln, of which €10mln was accessed upon signing of the agreement, with an additional €20mln available in the future though additional tranches of €5mln and €15mln, subject to certain conditions being met.
As of December 31, 2022, Faron held cash balances of €7.0mln (2021: €6.9mln) and its net assets on the same date were -€11.5mln (2021: €2.9mln).
The company's loss for the financial year ended December 31, 2022, was €28.7mln (2021: €21.2mln).
Faron said it will hold a virtual briefing and Q&A at 8.00am (EDT)/12.00pm (GMT)/2.00pm (EET) today, Friday, 3 March 2023. The full-year results release for 2022, presentation, webcast details, and Annual Report 2022 will be made available at www.faron.com/investors . A replay of the analyst briefing will be made available shortly afterwards.