Faron's public offering has ended
A warm thank you to everyone who participated in the offering
The objective of the offering is to strengthen the company’s cash position so that the company would have sufficient funding to reach its key milestones for the year 2024, i.e. a significant commercial partnering deal and to finance its product development costs until the latter half of March 2025.
The product development costs mainly include the production and research costs in respect of the Company’s lead program bexmarilimab, i.e. costs related to the completion of enrolment of the patients for the BEXMAB Phase II trial, treatment of patients and publication of readouts as well as obtaining regulatory feedback from the FDA regarding measures required to obtain regulatory approval in the U.S.
By the end of 2024, the company is also aiming to conclude a global partnership deal to fund Phase III clinical research and to commercialise bexmarilimab, and it believes that the better the company is financed the better its position is to conclude a partnership.
If the company succeeds in completing the offering of approximately EUR 30.7 million, the company believes it would have sufficient resources to execute its core business and deliver its key milestones of the year 2024 under the current business plan and in compliance with the financial covenants of the IPF Facilities Agreement until the latter half of March 2025.1
1 Part of the proceeds sought by the Company in the Offering may be raised through the separate UK Offering arranged at the same time as the Offering.
Key strengths
Strong preliminary Phase I and II data with novel investigational treatment
The BEXMAB Phase 1 results have already indicated a high overall response rate (ORR) of 87.5% (7 patients out of 8) amongst HMA-failed MDS patients treated with a combination of bexmarilimab and azacitidine, as announced by the Company on 18 March 2024. There are now a total of 14 HMA-failed MDS patients treated in both Phase 1 & 2 with this novel combination. On 20 May 2024, the Company reported an ORR of 79% (11 patients out of 14) in this population. The treatment has been well tolerated, without any dose-limiting toxicity. The current true remission rate is 64% (9 patients out of 14). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. The median estimated overall survival in phase I patients of BEXMAB has also increased to 13.4 months, compared to a historical reference of 5-6 months.1 This median may still change as the study progresses.
Large addressable market of cancers that are difficult to treat, with focus on MDS unresponsive to treatment
The MDS market represents a large and growing indication with projected sales of USD 4.5 billion in 2028.2 Among the different blood cancer types, MDS is one of the earliest fatal cancers,3 for which there is no approved treatment4,5: 50% of patients will not respond to HMA treatment and of the 50% who respond, 80%6 will relapse within 1-2 years.7 If drug development is successful, the Company expects bexmarilimab to take a large share of the addressable market, as a new potentially effective treatment. Bexmarilimab has also been preliminarily tested in the MATINS study, which focused on solid, non-operable tumours, which showed that the drug candidate is safe and well tolerated, with promising efficacy results. The Company is advancing plans to study the use of bexmarilimab in combination with anti-PD-1 therapy in selected advanced solid tumors.
The Company aims to reach key milestones by the end of Q1 2025
If the Company succeeds in raising the funds sought through the Capital Raise, the Company is aiming to complete the BEXMAB Phase II trial patient recruitment, announce interim and final results and to obtain regulatory feedback from the FDA regarding required actions for regulatory approval in the U.S in order to be ready to move to Phase III8.
Potential for future value creation with strong patent protection and committed management
More than 250 patients have already been treated with bexmarilimab without any safety challenges. The Company is aiming to enter into a global partnership agreement by the end of 2024 to commercialise bexmarilimab and fund Phase III of the clinical trial. The Company’s business is based on a foundation of nearly 20 years of pioneering academic research and drug development at Faron with highly experienced scientists, clinical experts and a management team. Bexmarilimab also has extensive and long-term patent protection to support its development, where, for example, patents protecting the drug candidate are valid until 2037.
1Prébet, et al. 2011, Outcome of high-risk myelodysplastic syndrome after azacitidine treatment failure.
2Evaluate Pharma 2024, Sales by indication.
3Surveillance, Epidemiology and End Results (SEER) 2022.
4Bewersdorf, Carraway & Prebet 2020.
5Santini et al. 2019.
6Awada et al. 2023, What’s Next after Hypomethylating Agents Failure in Myeloid Neoplasms? A Rational Approach.
7Fenaux et al. 2021.
8Part of the proceedings sought by the Company in the Offering may be raised through the separate UK Offering arranged at the same time as the Offering.
Find out more about the public offering from the Marketing Brochure
Download the Marketing Brochure (in Finnish)
The information presented in this Marketing Brochure is based on a prospectus prepared by Faron, which prospective investors should consult before making an investment decision in order to understand the potential risks and rewards associated with their investment decision. This is not a prospectus approved by the Finnish Financial Supervisory Authority. The prospectus approved by the Finnish Financial Supervisory Authority is available here
Make a share subscription
The place of subscription in the Public Offering is Nordnet Bank AB. More information about the subscription at www.nordnet.fi/faron
Webinar
Watch the recordings of the English and Finnish webinars, held on 6 June 2024, here.
Neuvottelija podcast
A link to the Neuvottelija podcast (in Finnish)
Important dates
5 June 2024 at 10:00 a.m. (Finnish time)
The subscription period for the offering commences
18 June 2024 at 4:00 p.m. (Finnish time)
The subscription period for the public offering ends
20 June 2024 (estimate)
Announcement of the results of the offering
20 June 2024 (estimate)
The offer shares are registered in the Trade Register
24 June 2024 (estimate)
The offer shares subscribed for in the offering are recorded in the book-entry accounts of investors
24 June 2024 (estimate)
Trading in the offer shares commences on the First North Growth Market
Questions and Answers
The objective of the offering is to strengthen the company’s cash position so that the company would have sufficient funding to reach its key milestones for the year 2024, i.e. a significant commercial partnering deal and to finance its product development costs until the latter half of March 2025.
Private persons and legal entities can participate the offering in Finland. You do not need to be a shareholder of Faron to participate in the offering.
Subscriptions are binding and may not be modified or cancelled other than in cases described in the terms and conditions of the offering.
The offering circular and further information on the share issue are available on this Faron's website. You can also contact your account operator for more information.
Materials
Offering Circular
Marketing Brochure (in Finnish)
Releases
2024-06-20 09:00
Faron publishes the final result of the fully subscribed EUR 30.7 million share offering
2024-06-04 09:00
Faron commences a share offering
Further information
Juho Jalkanen
CEO
[email protected]
Yrjö Wichmann
CFO (interim)
[email protected]
Paavo Koivisto
IR & Funding Director
[email protected]
+358 400 845 559