Faron 2023 Half-Year Financial Results-FARON PHARMACEUTICALS OY

Faron 2023 Half-Year Financial Results-FARON PHARMACEUTICALS OY

Faron Reports Half-Year Financial Results, January 1 - June 30, 2023

Company Announcement, August 29, 2023

Summary Highlights (including post-period events)  

·      The US Food and Drug Administration (FDA) granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).

·      The latest data from the Phase I/II BEXMAB study reinforces bexmarilimab's potential to improve the therapeutic benefit for patients with aggressive hematological malignancies who do not respond to the current standard of care (SoC).   

·      Compelling data with objective responses were observed in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort.  

·      Eight of fifteen objective responses were observed across all three doublet dosing cohorts, with one patient still on treatment after 13 months. 

·      Continued efficacy signals with the prolonged duration of responses thus far support advancement to Phase II in Q4 2023 in relapsed/refractory AML and myelodysplastic syndromes (MDS) patients failing hypomethylating agents (HMAs). 

·      New biomarker data presented at the EHA2023 Congress indicates that bexmarilimab's mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow. This mechanism results in notable increases in T and NK cells, along with enhanced antigen presentation. 

·      The Phase II BEXCOMBO protocol has been approved by the FDA.

·      The Board was strengthened with the addition of Tuomo Pätsi, and the Leadership team was enhanced with the appointment of James O'Brien, CPA, MBA, as Chief Financial Officer. 

·      Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron. 

·      Cash position was strengthened through two private placements directed to institutional and other investors, successfully raising EUR 18.6 million.

·      Virtual briefing and Q&A to be held today at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST).

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period").

 

"I am extremely proud of the progress we made in the first half of 2023," said Dr. Markku Jalkanen, Chief Executive Officer of Faron. "We continued to execute on advancing our clinical Phase I/II BEXMAB study of bexmarilimab, our wholly-owned immunotherapy asset, in hematological malignancies. To date, we achieved strong objective responses across all three cohorts in relapsed/refractory to SoC patients, including objective responses in three of five patients receiving the high dose. Based on this compelling data, we are advancing into the Phase II portion of the study and actively preparing for regulatory submission in the first half of 2025. The recent  FDA Orphan Drug Designation for bexmarilimab in AML further reaffirms our program by offering important clinical development and commercialization benefits. We also strengthened our cash position and welcomed a former Board member as a transactional advisor. I am excited for what the future holds."

 

Pipeline Highlights

 

Bexmarilimab - Faron's wholly-owned, novel precision cancer immunotherapy candidate, in Phase I/II development for relapsed/refractory AML and MDS.

 

·      The FDA has granted ODD for bexmarilimab for the treatment of AML.

·      Updated data from the Phase I/II BEXMAB study showed objective responses (OR) with complete remission of blasts in the bone marrow (mCR) in three of five patients in the 6 mg/kg bexmarilimab + azacitidine cohort. In addition, one of the three patients achieved complete recovery of blood counts i.e., complete remission (CR). 

·      Eight of fifteen ORs were observed across all three doublet dosing cohorts. 

·      Four of the eight patients across the three doublet dosing cohorts (1, 3, and 6 mg/kg) had failed prior SoC hypomethylating agents (HMAs). 

·      All three patients with MDS and prior HMA failure demonstrated ORs (partial response (PR), mCR, and CR) across the dosing cohorts. 

·      Four patients out of six in the triplet dosing cohort treated with azacitidine, venetoclax, and bexmarilimab have shown objective responses. 

·      The updated BEXMAB data supports advancement to Phase II in Q4 2023 in SoC relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA). 

·      Biomarker data presented at the European Hematology Association 2023 Hybrid Congress showed bexmarilimab's mode of action in AML/MDS is supported with durable Clever-1 target engagement in the bone marrow, with increases observed in T and NK cells, and antigen presentation. 

·      The Company presented two posters at the American Association for Cancer Research Annual Meeting 2023 on its Phase I/II MATINS study of bexmarilimab in solid tumors and published a manuscript via medRxiv. The findings from MATINS, which have established strong foundations for Faron's ongoing development program, indicate that bexmarilimab monotherapy facilitates macrophage conversion, and induces changes in the tumor microenvironment resulting in disease control and prolonged survival in late-stage cancer. Furthermore,  targeting Clever-1 with bexmarilimab is well-tolerated. A positive Phase I/II meeting with the FDA supported bexmarilimab's development in solid tumors. 

·      Preparations are ongoing for the initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade, aimed at improving the clinical benefits from standard-of-care PD-1 blockade.  The first, proof-of-concept cohort under the investigation will be in head and neck cancer, followed by bladder and non-small cell lung cancers. Patient cohorts will comprise between 15 and 40 subjects, with the opportunity for subgroup enrichment.  

 

Corporate Highlights

·      The cash position has been strengthened through two private placements directed to institutional and other investors to raise EUR 18.6 million in January 2023 (EUR 12.0 million) and in June 2023 (EUR 6.6 million), which settled in early July 2023.

·      James O'Brien, CPA, MBA, joined as Chief Financial Officer. Mr. O'Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. His appointment highlights Faron's progression towards becoming a global biopharmaceutical company.

·      Mr. Tuomo Pätsi joined the Board as a Non-Executive Director of the Company. Dr. Gregory B. Brown stepped down from his position as a Non-Executive Director. Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development, and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was until recently the Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.

·      Mr. Leopoldo Zambeletti, who joined Faron's Board as a Non-Executive Director in September 2015, stepped down to take on a business development consulting role within Faron. He is a highly respected figure within the life sciences and investment banking industries and, since 2013, has been an independent strategic advisor to life science companies on mergers and acquisitions, out-licensing deals, and financing strategy.

 

Half-Year Financial Results

·      Cash balances of EUR 6.3 million on June 30, 2023 (2022: EUR 9.9 million). The Company raised EUR 6.6 million at the end of June which had not been settled until July 2023. The Company entered the third quarter with EUR 12.8 million and has funds sufficient to support operations into Q4 2023.

·      Operating loss of EUR 12.8 million for the six months ended June 30, 2023 (2022: EUR 13.4 million).

·      Net assets of EUR -9.5 million on June 30, 2023 (2022: EUR -5.2 million).

·      The cash position has been strengthened by two private placements directed to institutional and other investors to raise EUR 18.6 million.

·      On June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. On June 30, 2023, and August 28, 2023, the Company was in compliance with all covenants while holding cash balances of EUR 6.3 million and EUR 9.1 million, respectively. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the year end of 2023.



 

Consolidated key figures, IFRS

 EUR'000

Unaudited

Unaudited     

Audited

 

1-6/2023

1-6/2022

1-12/2022

Revenue

0

0

0

Other operating income

0

485

803

Research and Development expenses

(8 518)

(10 047)

(20 730)

General and Administrative expenses

(4 294)

(3 801)

(7 498)

Loss for the period

(13 730)

(13 121)

(28 730)

Unaudited

Unaudited

Audited

1-6/2023

1-6/2022

1-12/2022

Loss per share, EUR

(0.22)

(0.25)

(0.52)

Number of shares at end of period

66 161 373

56 575 453*

59 805 383

Average number of shares

62 985 028

53 235 643

55 229 835

 EUR'000

Unaudited

Unaudited

Audited

Cash and cash equivalents

6 315

9 936

6 990

Equity

(9 483)

(5 194)

(11 476)

Balance sheet total

12 836

16 729

11 271

 

* of which 1,311,800 were held in treasury

August 29, 2023

Faron Pharmaceuticals

Board of Directors

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").

Conference call information

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and James O'Brien, Chief Financial Officer, today, August 29, 2023, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST) on the day of results.

Webcast registration link: https://faron.videosync.fi/h1-2023

 

The half-year report, presentation, and a replay of the webcast will be available on the Company's website at https://www.faron.com/investors.

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