Financial Statement January 1 to December 31 2022

Faron Pharmaceuticals Oy

 

Faron’s Financial Statement Release January 1 to December 31, 2022

 

Financial statement release March 3, 2023 at 09:00 AM (EET) / 07:00 AM (GMT) / 03:00 AM (EDT)  

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Oy (“Company”, AIM: FARN, First North: FARON) together with its subsidiaries (“Faron”), a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announced audited full-year financial results for January 1 to December 31, 2022 (the “period”) and H2 2022 and provided an overview of recent corporate developments.

 

2022 Highlights

      Faron 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.

      In MATINS, 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. 

      The Company conducted two successful fundraising rounds in 2022. Combined, they raised EUR 13.4 million gross and both rounds included new and existing investors. The Company also obtained up to EUR 30.0 million debt funding from IPF Partners, drew EUR 10.0 million upon signing in February 2022, further tranches possible under certain conditions

      Virtual briefing and Q&A to be held today at 8:00 AM (EDT) / 12:00 PM (GMT) / 2:00 PM (EET)

 

Major Events After the 2022 Financial Year

      Post period 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 standard of care (SoC) azacitidine monotherapy. The addition of bexmarilimab to standard of care 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.

      The Company successfully raised a total of EUR 12.0 million gross. This fundraising round was supported by long-only institutional investors, family offices, existing shareholders, and the Leukemia & Lymphoma Society® (LLS).

      Faron will support activities in preparation of a potential clinical trial with the Fred Hutchinson Cancer Center in Seattle, Washington, to investigate intravenous (IV) interferon beta in the prevention of cytokine release syndrome (CRS) and other CAR-T therapy side effects, such as neurotoxicity.

 

“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. “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.”

 

HIGHLIGHTS (including post period):

 

Pipeline Highlights

Bexmarilimab Faron’s wholly owned, novel precision cancer immunotherapy candidate, in Phase I/II development for difficult-to-treat cancers.

Hematological cancers

      Faron reported objective responses for three out of five patients enrolled in the first doublet cohort of the Phase I/II BEXMAB study investigating bexmarilimab and azacitidine in patients with hematological cancers. Notably, 2 of the 3 responders had been refractory to prior azicitidine therapy. No additional adverse events have been observed adding bexmarilimab to standard of care.

      BEXMAB’s 1mg/kg and 3mg/kg bexmarilimab doublet cohorts have fully enrolled. Faron anticipates sites in the US to be opened during Q1 2023 to speed up recruitment even further.

Advanced solid tumors

      Bexmarilimab has been evaluated as a single agent in the Phase I/II MATINS in more than 250 patients and found to be well-tolerated.

      Up to 36% of heavily pretreated patients achieved disease control in certain indications.

      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 treatment in MATINS induced significant systemic interferon gamma (IFN-γ) increase, again showing the therapy’s capacity to activate immune response in cancer patients, especially in patients with immunologically “cold” tumors. As presented at ASCO2022 in Chicago, the higher baseline CLEVER-1 levels in the tumors were associated with clinical benefit and could become an essential component as a diagnostic tool for patient selection.

      An FDA meeting will take place in Q1 2023 for feedback on the recommended dosing regimen and study design for further development of single agent bexmarilimab.

 

Traumakine® – Faron’s investigational intravenous (IV) interferon beta-1a therapy, in development for the prevention of complications from cytokine release syndrome, and hyperinflammatory conditions.

 

      Faron has refocused its therapeutic strategy of Traumakine and closed its Phase II/III HIBISCUS trial investigating Traumakine in the treatment of hospitalized COVID-19 patients compared to corticosteroid treatment with dexamethasone.

      Data from the preclinical Salvage, Preservation, and Advanced Resuscitation through Endothelial Stabilization (SPARES) study was presented at the Military Health System Research Symposium (MHSRS) held in Orlando, Florida. The results further highlight the promise of IV interferon beta-1a (IFN beta-1a) therapy as a potential therapeutic for emergency and trauma patients, especially when given early on.

      The Company filed a patent to the US Patent Office and Trademark Office regarding a patient selection method in terms of steroid treatment with an identified gene mutation in the interferon beta receptor. It received positive feedback in 2022.  

      Scientific Reports published data from INFORAAA study showing Traumakine induced up-regulation of CD73 was associated with 100% survival in surgically operated ruptured abdominal aorta aneurysm (RAAA) patients. These patients are at high risk of ischemia-reperfusion injury, with expected mortality between 30-40%.

      Another patent has been filed on sequencing interferon beta and steroid treatments, so that steroids can be used once adequate levels of CD73 are reached using IV IFN beta-1a.

 

Haematokine® – An investigative AOC3 (amine oxidase copper containing 3) protein inhibitor targeting Vascular Adhesion Protein-1 (VAP-1) for the use in regenerative medicine for the expansion of hematopoietic stem cells and to treat supressed bone marrow and the production of new blood cells.

 

Corporate Highlights

      Balance sheet was strengthened by raising EUR 13.4 million gross through fundraising rounds. This included two private placements, which encompassed existing and new investors, including The Leukemia & Lymphoma Society® (LLS). In February 2022, Faron also announced a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future through additional tranches of EUR 5 million and EUR 15 million, subject to certain conditions being met. Post period in January 2023, Faron raised EUR 12.0 million gross from new and existing shareholders, including The Leukemia & Lymphoma Society® (LLS).

      Marie-Louise Fjällskog, M.D., Ph.D., joined Faron’s Global Management Team as Chief Medical Officer, bringing with her over 30 years of experience in clinical oncology, translational research, and drug development. Dr. Fjällskog joined Faron from Sensei Biotherapeutics (NASDAQ: SNSE). As Chief Medical Officer at Sensei, she was responsible for leading clinical and development strategy and operations. Previously, she served as Vice President, Clinical Development at Merus (NASDAQ: MRUS) and Infinity Pharmaceuticals (NASDAQ: INFI) where she led development of multiple small molecule and immuno-oncology clinical programs. She was also formerly Global Clinical Program Leader at the Novartis Institute for Biomedical Research.

      Maija Hollmén, Ph.D, joined Faron’s Global Management Team as Chief Scientific Officer. In her role, Dr. Hollmén oversees preclinical and support clinical development for Faron. Her priority will be the further development of bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate. Dr. Hollmén is the world-leading expert on CLEVER-1 biology and CLEVER-1-expressing tumor-associated macrophages. She is an Adjunct Professor of Tumor Immunology on the Faculty of Medicine at the University of Turku in Finland, as well as a Principal Investigator.

      Juho Jalkanen, M.D., Ph.D., joined Faron’s Global Management Team as as Chief Operating Officer. In his role, Dr. Jalkanen will lead business strategy and daily operations for Faron. This includes oversight of academic and industry partnerships, resource prioritization and allocation, chemistry, manufacturing and controls, supply chain and driving performance measures. Dr. Jalkanen joined Faron in 2018 as the Faron’s Chief Development Officer. He also served as Faron’s interim Chief Medical Officer in 2021 prior to the appointment of Dr. Marie-Louise Fjällskog.

      Vesa Karvonen, LL.M.  General Counsel and Juuso Vakkuri, MA, MSc, EMBA, Chief Human Resources Officer joined Faron’s Global Management Team.

      Faron appointed Erik Ostrowski as a Non-Executive Director of the Company. Mr. Ostrowski is an experienced biotech and financial executive who is currently the Chief Financial Officer of AVROBIO, Inc. (NASDAQ: AVRO). 
 

 Financial Highlights

      On December 31, 2022, Faron held cash balances of EUR 7.0 million (2021: EUR 6.9 million).

      Loss for the period for the financial year ended December 31, 2022 was EUR 28.7 million (2021: EUR 21.2 million).

      Net assets on December 31, 2022 were EUR -11.5 million (2021: EUR 2.9 million).  

      In June 2022, the Company successfully raised a total of EUR 5.0 million gross (EUR 4.8 million net) from new and existing shareholders, through issuance of a total of 3,318,421 new ordinary shares to itself without consideration. 2,006,621 of those shares were conveyed to investors. In October 2022, the Company successfully raised a total of EUR 8.4 million gross (EUR 8.2 million 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.             

      In February 2022, the Company secured a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future though additional tranches of EUR 5 million and EUR 15 million, subject to certain conditions being met.

      Post period, in January 2023 the Company successfully raised a total of EUR 12.0 million gross through the issuance of 3,692,308 ordinary shares to itself without consideration which were conveyed to investors.

 

 

Consolidated key figures, IFRS

EUR ’000

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Other operating income

318

4,927

803

6,137

Research and Development expenses

(10,683)

(8,361)

(20,730)

(17,369)

General and Administrative expenses

(3,697)

(7,250)

(7,498)

(9,876)

Loss for the period

(15,609)

(10,649)

(28,730)

(21,194)

 

 

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Loss per share EUR

(0.27)

(0.21)

(0.52)

(0.42)

Number of shares at end of period

59,805,383

53,232,032

59,805,383

53,232,032

Average number of shares

57,230,625

51,836,953

55,229,835

50,723,964

 

EUR ’000

Unaudited

30 June 2022

Unaudited

30 June 2021

31 December 2022

31 December 2021

Cash and cash equivalents

9,936

6,967

6,990

6,853

Equity

(5,194)

2,813

(11,476)

2,919

Balance Sheet total

16,729

11,865

11,271

13,182

 

Board of Directors’ Proposal on the Dividend

The Company’s comprehensive loss for the period was EUR 28,924,250.82 (2021: EUR 21,270,235.71) . The Board of Directors proposes to the Annual General Meeting 2023 not to pay dividend.

March 2, 2023

Faron Pharmaceuticals Oy

Board of Directors

Webcast for investors, analysts and media

A live webcast and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer of Faron, and Toni Hänninen, Chief Financial Officer of Faron, at 2:00 pm EET / 12:00 pm GMT / 8:00 am EDT today. 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.

 

Webcast link: https://faron.videosync.fi/2022-financial-statement

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

Publication of financial information during year 2023

Faron’s financial statements for full year 2022 will be published today, March 3, 2023 and will also be available on Faron’s website at https://www.faron.com/investors/results. The half-year financial report for the period January 1 to June 30, 2023 is scheduled to be published on August 29, 2023. The Annual General Meeting is planned for March 24, 2023. A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanised antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced CLEVER-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional preclinical studies have proven that CLEVER-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that CLEVER-1 has the capacity to control T cell activation directly, suggesting that the inactivation of CLEVER-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules.

About Faron

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Forward-Looking Statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward- looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding  Faron’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of Faron. Other factors which could cause actual results to differ materially include the ability of the Faron to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Faron does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

CEO Statement

The past year 2022 has been an incredible year of transformation for Faron, in terms of development of our key asset bexmarilimab, building up a new Global Management Team with five new C-level members and the initiation of a clinical/regulatory team for US-based activities. We are excited to go into 2023 with strong clinical data behind us and clear plans to move forward.

The year 2022 started with premium recruitment when Dr. Marie-Louise Fjällskog (M.D., PhD) came on board as Chief Medical Officer, bringing over 30 years of experience in clinical oncology, translational research, and drug development. She joined Dr. Juho Jalkanen (M.D., PhD), Chief Operating Officer, as well as our new General Counsel, Vesa Karvonen. We also welcomed Juuso Vakkuri as our Chief Human Resources Officer, and most recently, Dr. Maija Hollmén, PhD, as our Chief Scientific Officer. She will spearhead further inventions around bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate.

Our first, large Phase I/II MATINS study has provided us a proper dosing regimen for bexmarilimab and demonstrated a good safety profile. Initial efficacy data on advanced solid tumors allows us to identify biomarkers predicting extended survival of these hard-to-treat cancer patients. Our teams have worked hard to build a solid data package for the FDA on the next steps forward. This feedback will significantly impact our activities in 2023.

Importantly, we have found bexamarilimab is effective for patients who are refractory to PD-1 blockade. These patients have silent immune reaction as observed in low interferon gamma (IFN-gamma) levels. This is opposite to PD-1 blockers that are usually are active in cancer patients with high IFN-gamma levels. This is understandable as their mode of action is based on activating the existing T-cells, not to generate new T-cell populations. Thus, the combination of PD-1 blockade with bexmarilimab provides a unique opportunity to stimulate immune ignition and effective T-cells.

Bexmarilimab is being evaluated for safety and efficacy in the Phase I/II BEXMAB clinical trial, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is very exciting as now we have cancer cells which express the therapy target molecule CLEVER-1 on their surfaces. This means that wherever they travel in cancer patients, they carry this immunosuppressive element with them. In December, we reported in BEXMAB a partial responder achieving complete remission of blasts in blood and bone marrow followed by normalization of blood counts. A second patient showed reduced blast counts. This is particularly noteworthy considering the population targeted in BEXMAB, such as those having AML, have high mortality rates. Post period, we reported even more positive news: 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 standard of care (SoC) azacitidine monotherapy.

We are thrilled with the progress and are pushing ahead in opening sites at US hematological centers.

We have also been successful in obtaining continued, long-term patent protection for bexmarilimab. During 2021 the United States Patent and Trademark Office and equivalent Japanese patent office approved protection, at least through 2037, for our humanized anti-CLEVER-1 antibody (bexmarilimab) sequence. During 2022 we obtained similarly patent coverage in Europe and other territories providing Faron excellent commercial opportunity in more than 90% of pharmaceutical markets. This fact has been recognised also by our partner candidates.

We have continued background work to advance both Traumakine® and Haematokine® programs to open clinical studies for both in 2023. We decided to close the HIBISCUS study using Traumakine due to lack of steroid-free patients. Our focus now is on opportunities where steroids cannot be used, and where ischemic conditions with vascular damage is the main reason for patient death. For the latter, we will continue to collaborate with the US Department of Defense (DoD). We also understand today the molecular basis of steroid interruption of IFN-beta signalling pathway and what role some genetic alterations may cause.

The third program in our pipeline, Haematokine, an investigational Vascular Adhesion Protein 1 (VAP-1) inhibitor, has preclinical studies continuing. We believe Haematokine could have broad applicability, not just in hematological malignancies, but across the field of regenerative medicine.

Our future looks bright, with the focus for 2023 to accelerate bexmarilimab’s clinical development, especially in BEXMAB. We also aim 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 standard of care. This combination regimen has the potential to change the future of cancer care. Future interactions with the FDA will guide our path forward.

I would like to thank our shareholders for their continued support of Faron and the management team. I would also like to express my profound gratitude to every Faron team member who come to work each day committed to disrupting the current treatment landscape and fundamentally improving patient outcomes.

Markku Jalkanen

Chief Executive Officer

March 2, 2023

 

Chairman Statement

During 2022, Faron has continued to focus on bexmarilimab, our novel, wholly owned novel precision cancer immunotherapy candidate, with exciting clinical data milestones anticipated for 2023. We have also grown the Company in the US and in Finland, bringing world-class expertise into Faron to advance bexmarilimab.

We have the ongoing Phase I/II MATINS clinical trial in pretreated, late-stage cancer, and as a result have delivered on our goals to understand monotherapy bexmarilimab efficacy and safety across multiple tumor types, as well as identify a dose and potential dosing regimens. We have also undertaken substantial work on biomarkers to develop enrichment strategies to identify patients who will best respond in future trials.

Faron has published data on bexmarilimab that consistently supports earlier positive results and continues to underscore that the mechanism of action demonstrates an effect on mortality in responders. The company will be presenting a data package to the US Food and Drug Administration in the first quarter of 2023.

Faron recognises the future of cancer treatment will be in combination therapies, and as such we have reported exciting data from the Phase I/II BEXMAB study in hematological malignancies. We also plan to initiate BEXCOMBO, a Phase II study of the combination therapy bexmarilimab plus PD-1 blockade in patients that have metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved standard of care.  

We continue to see bexmarilimab as the major value driver for Faron, and our goal is to deliver worldwide approvals to allow bexmarilimab to be used by cancer physicians to treat patients.

Despite Faron’s focus on bexmarilimab, we have used partnerships to develop Traumakine®, Faron’s investigational intravenous (IV) interferon (IFN) beta-1a therapy, to prevent multiorgan dysfunction.

We recognise the funding environment for European companies has been extremely challenging and despite that, we have continued to raise capital to finance Faron’s activities. In 2022, we announced Faron had entered into a secured debt agreement with IPF Partners to advance and accelerate its pipeline programs. We had two equity financing rounds and are pleased we continue to have supportive shareholders in Finland and the rest of Scandinavia. In January 2023 we completed a further financing round of EUR 12 million to support the continued development of bexmarilimab. We are delighted that The Leukemia & Lymphoma Society participated in the previous round and in the January fundraise.

In terms of building the company, Dr. Juho Jalkanen was promoted to COO and we welcomed CMO Marie-Louise Fjällskog, based in Boston, as well as a Vesa Karvonen, our new general counsel based in Turku and Juuso Vakkuri as Chief Human Resources Officer. We have developed the US team in Boston, investing in clinical and regulatory personnel. Erik Ostrowski joined the Board of Directors. He brings substantial finance experience including as the CFO of a NASDAQ-listed company. We anticipate continuing to add employees in 2023.

I’d like to thank the staff of Faron, our partner organizations, study steering and advisory committee members investigators and patients that have participated in our clinical trials. I am indebted to CEO Dr. Markku Jalkanen, CFO Toni Hänninen, COO Juho Jalkanen, CMO Marie-Louise Fjällskog, General Counsel Vesa Karvonen and CHRO Juuso Vakkuri for their contributions to Faron in 2022. We look forward to great success in 2023.

Dr Frank Armstrong

Chairman

March 2, 2023

 

Financial Review

Despite continuing challenging market conditions, the Company was able to conduct two successful fundraising rounds in 2022. Combined, they raised EUR 13.4 million gross and both rounds included new and existing investors. In our fundraising round in June we were able to attract The Leukemia & Lymphoma Society® (LLS) to support our newest bexmarilimab trial, BEXMAB. Faron became part of LLS’ Therapy Acceleration Program® (TAP). In our October fundraise we were further able to attract reputable Finnish pension funds.

Additionally, in February 2022, the Company secured a debt funding agreement with IPF Partners, one of the leading alternative financing providers focused on the healthcare sector, for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future, subject to certain conditions being met. This funding agreement strengthened our financial position and gives us the flexibility to access supplemental and inexpensive capital as we continue to accelerate the development of our pipeline assets.

As a result of these fundraising efforts, the net cash from financing activities of EUR 23.5 million exceeded the net cash used in operating activities of EU 23.0 million in 2022. We were able to accomplish this while also increasing R&D and reducing G&A expenditures, as per our plan, to focus on accelerating our pipeline.

Post period in January 2023, the Company successfully raised a total of EUR 12.0 million gross. This fundraising round was supported by long-only institutional investors, family offices, existing shareholders and the Leukemia & Lymphoma Society® (LLS).

 

Revenue and Other Operating Income

Faron’s revenue was nil for the year ended December 31, 2022 (2021: EUR nil). Faron recorded other income of EUR 0.8 million that consisted of grants from the European Union and Business Finland.

 

Research and Development Costs

R&D costs increased by EUR 3.4 million from EUR 17.4 million in 2021 to EUR 20.7 million in 2022. In total, almost 90% of the R&D costs are directly attributable to advancing our clinical programs, and Faron expects this to continue as we accelerate patient recruitment. The costs of outsourced clinical trial services were increased by EUR 1.6 million from EUR 3.5 to EUR 5.1 million. The cost of employee benefits increased by EUR 1.9 million from EUR 3.3 to EUR 5.2 million, mainly driven by additional headcount in the US.

 

General and Administration Costs

Administrative expenses decreased by EUR 2.4 million from EUR 9.9 million in 2021 to EUR 7.5 million in 2022. The decrease was mainly due to the EUR 3.5 million decrease of legal expenses, that consisted in 2021 of the arbitration with Rentschler Biopharma SE, resulting in Faron’s favor. Employee benefits increased by EUR 1.1 million from EUR 3.5 million to EUR 4.5 million due to additional headcount.

 

Taxation

The Company’s tax credit for the fiscal year 2022 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible expenses. The total amount of cumulative tax losses carried forward approved by tax authorities on December 31, 2022 was EUR 47.1 million (2021: EUR 41.0 million). The Company estimates that it can utilize most of these during the years 2023 to 2033 by offsetting them against future profits.

In addition, the Company has EUR 91.8 million of R&D costs incurred in the financial years 2010 – 2022 that have not yet been deducted from taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

 

Losses

Loss before income tax was EUR 28.7 million (2021: EUR 21.2 million). Comprehensive loss for the year was EUR 28.7 million (2021: EUR 21.2 million), representing a loss of EUR 0.52 per share (2021: EUR 0.42 per share).

 

Cash Flows

Net cash flow was EUR 0.1 million positive for the year ended December 31, 2022 (2021: EUR 2.7 million positive). Cash used for operating activities increased by EUR 0.8 million to EUR 23.0 million for the year, compared to EUR 22.2 million for the year ended December 31, 2021. This increase was mostly driven by an increase in R&D investments. Net cash inflow from financing activities was EUR 23.5 million (2021: EUR 25.6 million) mainly due to the successful equity placings completed in June 2022 and October 2022 as well as the proceeds from borrowings of the loan with IPF Partners.

 

Fundraising

In June 2022, the Company successfully raised a total of EUR 5.0 million gross (EUR 4.8 million net) from new and existing shareholders, through issuance of a total of 3,318,421 new ordinary shares to itself without consideration. 2,006,621 of those shares were conveyed to investors. In October 2022, the Company successfully raised a total of EUR 8.4 million gross (EUR 8.2 million 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 were used to accelerate clinical development of the Company’s main drug candidate, continue the CMC process and US buildup and to strengthen the Company’s balance sheet. In February 2022, the Company secured a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future, subject to certain conditions being met.

Post period, in January 2023, the Company successfully raised a total of EUR 12.0 million gross through and issuance of 3,692,308 ordinary shares to itself without consideration which were conveyed to investors.

 

Financial Position

As of December 31, 2022, total cash and cash equivalents held were EUR 7.0 million (2021: EUR 6.9 million).

 

Going Concern

As part of their going concern review, the Directors have followed the Finnish Limited Liability Companies Act, the Finnish Accounting Act and the guidelines published by the Financial Reporting Council entitled “Guidance on the Going Concern Basis of Accounting and Reporting on Solvency and Liquidity Risks – Guidance for directors of companies that do not apply the UK Corporate Governance Code”. Faron is subject to a number of risks similar to those of other development stage pharmaceutical companies.

These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil the Faron’s commercial and development activities and generating a level of revenue adequate to support Faron’s cost structure.

Faron made a net loss of EUR 28.7 million during the year ended December 31, 2022. It had a negative equity of EUR 11.4 million including an accumulated deficit of EUR 143.7 million. As of that date, Faron had cash and cash equivalents of EUR 7.0 million.

The Directors have prepared detailed financial forecasts and cash flows looking beyond 12 months from the date of the approval of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that are expected to prevail over the forecast period. The Directors estimate that the cash held by Faron together with known receivables will be sufficient to support the current level of activities into the third quarter of 2023. The Directors are continuing to explore sources of finance available to Faron and they believe they have a reasonable expectation that they will be able to secure sufficient cash inflows for Faron to continue its activities for not less than 12 months from the date of approval of these financial statements; they have therefore prepared the financial statements on a going concern basis. Because the additional finance is not committed at the date of issuance of these financial statements, these circumstances represent a material uncertainty that may cast significant doubt on Faron’s ability to continue as going concern. Should Faron be unable to obtain further finance such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts, to provide for further liabilities that might arise.

 Headcount

Faron’s headcount at the end of year was 40 (2021: 37).

 Shares and Share Capital

During the period January 1 to December 31, 2022, the Company, using the share authorities granted at the Annual General Meeting held on April 23, 2021, issued a total of 3,318,421 new ordinary shares to itself without consideration and conveyed 2,006,621 of those shares at an issuance price of EUR 2.49 per share to investors. During the same period, the Company, using the share authorities granted at the Extraordinary General Meeting held on July 7, 2022, issued a total of 3,229,932 new ordinary shares to itself without consideration. Those shares and the existing treasury shares were conveyed to investors at an issuance price of EUR 1.85 per share.

The subscription price net of costs was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased. The Company has no shares in treasury; therefore at the end of 2022 the total number of voting rights was 59,805,383.  

Toni Hänninen

Chief Financial Officer

March 2, 2023

 

Consolidated Income Statement, IFRS

 EUR ’000

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Other operating income

318

4,927

803

6,137

Research and development expenses

(10,683)

(8,361)

(20,730)

(17,369)

General and administrative expenses

(3,697)

(7,250)

(7,498)

(9,876)

Operating loss

(14,062)

(10,684)

(27,426)

(21,108)

Financial income

(596)

103

96

165

Financial expense

(970)

(44)

(1,400)

(235)

Loss before tax

(15,628)

(10,625)

(28,730)

(21,178)

Tax expense

19

(9)

0

(16)

Loss for the period

(15,609)

(10,634)

(28,730)

(21,194)

 

 

 

 

 

Other comprehensive gain/loss

6

(15)

17

(15)

Total comprehensive loss for the period

(15,603)

(10,649)

(28,713)

(21,209)

 

 

 

 

 

Loss per ordinary share

 

 

 

 

Basic and diluted loss per share, EUR

(0.27)

(0.21)

(0.52)

(0.42)

 
 

Consolidated Balance Sheet, IFRS

 

 

EUR ‘000

31 December 2022

31 December 2021

Assets

 

 

Non-current assets

 

 

Machinery and equipment

13

20

Right-of-use-assets

314

187

Intangible assets

1,154

899

Prepayments and other receivables

60

53

Total non-current assets

1,541

1,159

 

 

 

Current assets

 

 

Prepayments and other receivables

2,740

5,170

Cash and cash equivalents

6,990

6,853

Total current assets

9,730

12,023

 

 

 

Total assets

11,271

13,182

 

 

 

Equity and liabilities

 

 

 

 

 

Capital and reserves attributable to the equity holders of Faron

 

 

Share capital

2,691

2,691

Reserve for invested unrestricted equity

129,544

116,507

Accumulated deficit

(143,713)

(116,265)

Translation difference

2

(15)

Total equity

(11,476)

2,919

 

 

 

Provisions

 

 

Other provisions

158

0

Total provisions

158

0

 

 

 

Non-current liabilities

 

 

Borrowings

11,102

2,918

Lease liabilities

163

16

Other liabilities

853

151

Total non-current liabilities

12,118

3,085

 

 

 

Current liabilities

 

 

Borrowings

1,851

429

Lease liabilities

153

184

Trade payables

6,014

2,229

Accruals and other current liabilities

2,453

4,336

Total current liabilities

10,471

7,178

 

 

 

Total liabilities

22,748

10,263

 

 

 

Total equity and liabilities

11,271

13,182

 

Consolidated Statement of Changes in Equity, IFRS

EUR ‘000

Share capital

Reserve for invested unrestrict-
ed equity

Trans-
lation
difference

Accumu-lated deficit

Total equity

 

 

 

 

 

 

Balance as at 31 December 2020

2,691

92,015

2

(96,557)

(1,849)

 

 

 

 

 

 

Comprehensive loss for the year 2021

0

0

(15)

(21,194)

(21,209)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

24,492

0

0

24,492

Share-based compensation

0

0

 0

1,487

1,487

 

0

24,492

0

1,487

25,980

 

 

 

 

 

 

Balance as at 31 December 2021

2,691

116,507

(15)

(116,265)

2,919

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss for the year 2022

0

0

17

(28,730)

(28,713)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

13,037

0

0

13,037

Share-based compensation

0

0

0

1,297

1,297

Other movements

 0

0

0

(16)

(16)

 

0

13,037

17

(27,448)

(14,395)

 

 

 

 

 

 

Balance as at 31 December 2022

2,691

129,544

2

(143,713)

(11,476)

 

Consolidated Cash Flow Statement, IFRS

EUR ‘000

Unaudited

Unaudited

1-12.2022

1-12.2021

7-12.2022

7-12.2021

12 months

12 months

6 months

6 months

 

 

Cash flow from operating activities

 

 

 

 

Loss before tax

(15,628)

-10,64

(28,730)

(21,194)

Adjustments for:

 

 

 

 

Received grant

(388)

(745)

(803)

(1,387)

Depreciation and amortization

149

165

300

307

Change in provision

(158)

0

(158)

0

Financial items

787

 

1,304

0

Interest expense

0

128

0

216

Tax expense

19

6

0

16

Unrealized foreign exchange loss (gain), net

0

434

0

153

Share-based compensation

632

644

1,297

1,487

Adjusted loss from operations before changes in working capital

(14,587)

(10,008)

(26,790)

(20,402)

Change in net working capital:

 

 

 

 

Prepayments and other receivables

2,045

(-1259)

2,864

(1,919)

Trade payables

(657)

744

719

723

Other liabilities

2,197

24

1,183

(566)

Cash used in operations

(11,001)

(10,499)

(22,023)

(22,163)

Taxes paid

0

(1)

0

(16)

Transaction costs related to loans and borrowings

0

0

(165)

0

Interest received

11

0

11

0

Interest paid

(708)

(10)

(816)

(40)

Net cash used in operating activities

(11,698)

(10,508)

(22,993)

(22,218)

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

Payments for intangible assets

(218)

(76)

(385)

(461)

Payments for equipment

0

(6)

(0)

(13)

Net cash used in investing activities

(218)

(81)

(385)

(473)

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

Proceeds from issue of shares

8,923

10,515

13,445

25,559

Share issue transaction cost

(174)

(405)

(365)

(1,067)

Proceeds from borrowings

(0)

145

10,389

662

Repayment of borrowings

0

0

(105)

(122)

Proceed from grants

231

750

231

750

Payment of lease liabilities

(20)

(95)

(116)

(191)

Net cash from financing activities

8,959

10,910

23,478

25,590

 

 

 

 

 

Net increase (+) / decrease (-) in cash and cash equivalents

(2,946)

320

137

2,899

Effect of exchange rate changes on cash and cash equivalents

11

(434)

37

(153)

 

 

 

 

 

Cash and cash equivalents at 1 January / 1 July

9,936

6,967

6,853

4,108

Cash and cash equivalents at 31 December

6,990

6,853

6,990

6,853

 

 

 

 

 

 

Update to Faron’s Financial Calendar for 2023

Faron Pharmaceuticals Oy
(“Faron” or “Company”)

 

Update to Faron’s Financial Calendar for 2023

 

Company announcement, February 6, 2023 at 1:00 PM (EST) / 6:00 PM (GMT) / 8:00 PM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces an update to its financial reporting calendar for 2023.

 

The Company’s financial statement release for the full year 2022 and Annual Report 2022, including financial statements for the full year, will now be published on Friday, March 3, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET), rather than on Thursday, March 2, 2023, as had been previously communicated.

 

The publication date of Tuesday, August 29, 2023, for Faron’s half-year financial report for the period January 1 to June 30, 2023, remains unchanged, as does the date for the Company’s annual general meeting, which is planned to be held on Friday, March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

Full Year Results Virtual Briefing

Following publication of Faron’s financial statement release for the full year 2022 on Friday, March 3, 2023, Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts on the day at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET).

 

The full year results press release for 2022, presentation, virtual briefing 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.

 

For more details about the analyst briefing, please contact Faron@consilium-comms.com.

 

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Notice of 2022 Full-Year Results and Annual Report

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Notice of 2022 Full-Year Results and Annual Report

 

Press release, February 6, 2023 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, will publish its audited full-year results for the twelve months ended December 31, 2022, on Thursday, March 2, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET). The Annual Report 2022, including audited financial statements for the full year, will be published on the same day.

 

Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET) on the day of results.

 

The full-year results press release for 2022, presentation, virtual briefing 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.

 

For more details about the analysts’ briefing, please contact Faron@consilium-comms.com.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of ischemic and hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward-Looking Statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

 

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii:

Faron Pharmaceuticals Ltd

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

 

An acquisition or disposal of financial instruments

 

An event changing the breakdown of voting rights

X

Other (please specify) iii: (Decrease of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

Name

Tom-Erik Lind

City and country of registered office (if applicable)

 

4. Full name of shareholder(s) (if different from 3.) v

Name

 

City and country of registered office (if applicable)

 

5. Date on which the threshold was crossed or reached vi:

27.01.2023

6. Date on which issuer notified (DD/MM/YYYY):

30.01.2023

7. Total positions of person(s) subject to the notification obligation

 

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer (8.A + 8.B) vii

Resulting situation on the date on which threshold was crossed or reached

5.77%

 

5.77%

3,666,647

Position of previous notification (if

applicable)

6.13%

 

6.13%

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

3,666,647

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

3,666,647

5.77%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

Number of voting rights

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8.B.2

 

 

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv

 

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Tom-Erik Lind

5.77%

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10. In case of proxy voting, please identify:

Name of the proxy holder

 

The number and % of voting rights held

 

The date until which the voting rights will be held

 

 

11. Additional information xvi

Faron share issue per 27.01.2023

 

Place of completion

Bangkok, Thailand

Date of completion

27.01.2023

 

 

 

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

 

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii:

Faron Pharmaceuticals Ltd

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

 

An event changing the breakdown of voting rights

 

Other (please specify) iii: (Increase of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

Name

Varma Mutual Pension Insurance Company

City and country of registered office (if applicable)

Helsinki, Finland

4. Full name of shareholder(s) (if different from 3.) v

Name

 

City and country of registered office (if applicable)

 

5. Date on which the threshold was crossed or reached vi:

27.01.2023

6. Date on which issuer notified (DD/MM/YYYY):

27.01.2023

7. Total positions of person(s) subject to the notification obligation

 

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer (8.A + 8.B) vii

Resulting situation on the date on which threshold was crossed or reached

4.16%

 

4.16%

2,641,503

Position of previous notification (if

applicable)

3.16%

 

3.16%

 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

2,641,503

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

2,641,503

4.16%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

Number of voting rights

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8.B.2

 

 

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv

 

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Varma Mutual Pension Insurance Company

4.16%

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10. In case of proxy voting, please identify:

Name of the proxy holder

 

The number and % of voting rights held

 

The date until which the voting rights will be held

 

 

11. Additional information xvi

Faron share issue per 27.01.2023

 

Place of completion

Helsinki, Finland

Date of completion

27.01.2023

 

 

 

 

Results of Placing

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Announcement of the Results of Placing, the Issue Price and registration of Placing Shares with the Trade Register

 

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 26 January 2023 regarding the proposed issue of new ordinary shares in the Company to the Company itself without consideration and placing of treasury shares in the Company (the “Launch Announcement“), unless the context provides otherwise.

 

Company announcement, 27 January 2023 at 7:00 a.m. GMT / 9:00 a.m. EET

Inside information

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces today that the Bookbuild, announced on 26 January 2023, is now closed. The Placing comprises of the issuance of 3,692,308 Placing Shares to Faron itself without consideration, which have today been registered in the Finnish Trade Register, and subsequent conveyance of these Placing Shares, to investors at the Issue Price of EUR 3.25 per Placing Share. The Issue Price represents a 13.9% discount to the close price on 26 January 2023 on NASDAQ Helsinki First North Growth and a 75.7% premium to the last share issue completed on 14 October 2022. The payment and settlement (delivery against payment of the Issue Price in full) of the Placing Shares is expected to be completed on or about 31 January 2023. Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”) acted as sole bookrunner and lead manager in the Placing.

 

The Placing Shares conveyed to investors amount to approximately 6.2% of the issued shares and votes in the Company, immediately prior to the Placing. The Company has raised aggregate gross proceeds of approximately EUR 12.0 million in the Placing. The Placing was supported by new investors and existing shareholders such as local long-only institutional investors and family offices, Mr. Timo Syrjälä and The Leukemia & Lymphoma Society Therapy Acceleration Program®. With these proceeds and the current level of activities the Company has sufficient working capital into Q3 2023.

 

“We are extremely pleased with the results of this oversubscribed Placing and the support we received from new and existing investors, especially the second investment from LLS (The Leukemia & Lymphoma Society).” said Toni Hänninen, Chief Financial Officer of Faron. “These funds allow us to accelerate our bexmarilimab pipeline further, including the acceleration of our BEXMAB study and the initiation of our recently approved BEXCOMBO study in 2023. Additionally, we are further strengthening our presence and building the team in the US as previously communicated.”

 

“We are excited to make an additional investment in Faron and to continue the partnership to leverage our expertise and network to help advance their development of bexmarilimab,” said Lore Gruenbaum, PhD, Vice President, The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP). “There is a critical need to develop new treatment options for blood cancer patients and novel combination therapies, like those being explored by Faron, are particularly promising because they can work synergistically to not only treat the cancer, but also activate a systemic response by the patient’s own immune system.”

 

Use of Proceeds and registration of Placing Shares in the Trade Register

The primary reason for conducting the Placing was to accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab. Some of the proceeds will also be used to advance bexmarilimab commercial scale production, to support general corporate purposes and other pipeline development, and to strengthen the Company’s balance sheet. Raising of at least EUR 8.0 million was also required to secure that the Company meets all its financial and operational covenants by 31 January 2023, as per agreed waivers with IPF Partners.

 

A total of 3,692,308 Placing Shares have been issued and registered in the Finnish Trade Register today on 27 January 2023. Following the issuance, the aggregate number of ordinary shares in the Company is 63,497,691. As a part of the Placing, the 3,692,308 Placing Shares are further conveyed to investors with payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about 31 January 2023. The Placing Shares confer a right to dividends and other shareholder rights from the payment and settlement to investors. One Placing Share entitles the holder to one vote in the general meeting of the Company. Following, and subject to, the completion of the settlement in full, the Company will have no shares in treasury and therefore, the total number of voting rights in Faron will be 63,497,691 (the “New Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the New Number of Shares and Votes of the Company.

 

Trading in the Placing Shares is expected to commence on First North and AIM latest on or about 31 January 2023.

 

Related Party Transaction

Timo Syrjälä, an existing shareholder in the Company, has subscribed for 400,000 Placing Shares in aggregate, for an aggregate subscription value of EUR 1,300,000 at the Issue Price. Following the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä, will be  12,767,825 shares, representing  20.11 % of the New Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. The Directors of the Company, all of whom are independent of Mr Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

yrjo.wichmann@faron.com
Phone: +358 (0) 40 5868 979

 

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

 

Cairn Financial Advisers LLP, Nominated Adviser

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

 

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

About The Leukemia & Lymphoma Society® and Therapy Acceleration Program® (TAP)
The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease, and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic venture philanthropy initiative that builds business alliances and collaborations with biotechnology companies to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage preclinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. LLS TAP accepts funding applications on a rolling basis from companies with innovative science that has a high potential to improve patient lives. To learn more, visit  https://www.lls.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.

 

IMPORTANT INFORMATION

 

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

 

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

 

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

 

Caution regarding forward-looking statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward-looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Proposed Issue and Placing

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Proposed Issue and Placing of approx. EUR 11.0 million by way of an accelerated book-building

 

 

Company announcement,26 January 2023 at 4:30 p.m. GMT / 6:30 p.m. EET

Inside information

 

KEY HIGHLIGHTS

  • A proposed private placement of newly issued treasury shares (“Placing Shares”) to raise approximately EUR 11.0 million, to be conducted by way of an accelerated book-building, directed to a limited number of institutional and other investors.
  • The Leukemia & Lymphoma Society Therapy Acceleration Program® (“LLS TAP”) and Mr Timo Syrjälä have provided non-binding indications for a substantial amount of the placing, subject to the minimum total amount of EUR 8.0 million being raised and certain other customary conditions.
  • The placing is conditional upon raising a minimum of EUR 8.0 million. Subject to the Company raising the minimum amount, the Company will have sufficient funding for its working capital needs into May 2023 and be able to meet its financial and operational covenants by 31 January 2023, as per agreed waivers with IPF Partners. The total cash and cash equivalents held by the Company as of 31 December 2022 was ca. EUR 7.0 million.
  • Significant majority of the net proceeds of the placing would be used for the acceleration of the bexmarilimab clinical development program and manufacturing.
  • Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”) is acting as sole bookrunner and lead manager in the placing.

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces a proposed private placement to raise approximately EUR 11.0 million before expenses to a limited number of institutional investors and other investors (“Placing”). Carnegie is acting as sole bookrunner and lead manager in the Placing.

 

The Placing will be conducted in a private placement by way of an accelerated book-building process in which selected investors may submit bids for the Placing Shares (the “Bookbuild”). The subscription price per Placing Share is to be determined on the basis of the bids received in the Bookbuild in EUR. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 a.m. EET on 27 January 2023 at the latest. The Bookbuild may be discontinued or extended at any time during the book-building process. Following the close of the Bookbuild, the Board of Directors of Faron (the “Board“) will first make the decision to issue the relevant number of treasury shares to Faron itself without consideration, followed by the decision to then convey such Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be conveyed to investors and the subscription price per Placing Share (the “Issue Price“), subject to the registration of the Placing Shares in the Finnish Trade Register. The Company has received non-binding indications of interest from potential investors to subscribe for the Placing Shares under the Placing during a pre-marketing process. In addition, the Company has obtained non-binding indications for a substantial amount of the Placing from LLS TAP and Mr. Timo Syrjälä, both subject to certain customary conditions.

 

As soon as practicable after the close of the Bookbuild, and following receipt of binding commitments from investors, an announcement will be made on the final number of the Placing Shares to be issued first to Faron itself without consideration and then to be conveyed to investors in the Placing, the expected registration date of the Placing Shares and the Issue Price.

 

Further details on the terms and conditions of the Placing are set out below. The Placing Shares are expected to be admitted to trading on Nasdaq First North Growth Market Finland (“First North”) and AIM (“AIM”) in London as set out below.

 

“This fundraise will enable us to accelerate our ambitious bexmarilimab development program, with a specific focus on advancing our combination trials in both solid tumors and hematologic malignancies,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “Far too many patients are not benefiting from recently approved treatments because their immune system simply does not recognize and mount a defense against their cancer. By converting highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages, bexmarilimab is capable of igniting an immune response in these patients, which we think will be amplified when used as part of a combination regimen.”

 

REASONS FOR THE PROPOSED PLACING

 

The development of bexmarilimab has advanced significantly over the past 12 – 18 months and the furthering of its development provides an opportunity to build additional value for shareholders. The proceeds of the Placing are to be used to advance the development of the Company’s pipeline of drug candidates and to strengthen the financial position of the Company. Raising at least EUR 8.0 million is required to secure that the Company meets all its financial and operational covenants by 31 January 2023, as per agreed waivers with IPF Partners.

 

  • Bexmarilimab Development (approximately 87%)
    • Complete Part I of the BEXMAB combination trial with AML/MSD patients with an anticipation to accelerate the most promising indication
    • Initiate BEXCOMBO with PD-1 blockade that was recently approved by FIMEA
    • Conclude MATINS trial for FDA Meeting to obtain advice for pivotal pathway with last line cancer patients
    • Advance bexmarilimab commercial scale production
  • US Buildup (approximately 5%)
    • Build medical and regulatory capabilities in the US
    • Build IR and US IPO readiness functions
  • Pipeline – other (approximately 8%)
    • Traumakine and Haematokine development
  • Strengthening of financial position
    • Maintaining sufficient cash position to meet any additional requirements from changes in operational activities, especially clinical trials expansion

 

In addition to the above, Faron is in negotiations with its lender, IPF Partners (“IPF”) on the utilization of the second EUR 5.0 million tranche of the agreed loan commitment. Advanced discussions are expected to start immediately upon the closing of the Placing with the current aim to draw the second tranche during H1 2023. The second tranche would be conditional on, among other things, Faron receiving FDA approval on the continuation of the MATINS trial, which is currently expected in late March – April 2023, and minimum overall funding requirement.

 

Under the terms of the facilities arrangement with IPF, the Company is required to maintain a minimum cash

balance of EUR 6.0 million while maintaining three months cash runway.

 

 

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

 

  • Faron intends to raise approximately EUR 11.0 million by offering Placing Shares to a limited number of institutional and other investors in the Placing. The Company has an authorization to offer a maximum of 6,458,270 Placing Shares in the Company.
  • The Company has received non-binding indications for a substantial amount of the Placing from LLS and Mr. Timo Syrjälä, both subject to certain customary conditions.
  • The placing is conditional upon raising a minimum of EUR 8.0 million. With the minimum amount, the Placing Shares issued would correspond to at least approximately 3.4% of all the shares and voting rights in the Company immediately prior to the Placing.
  • Subject to the Company raising the minimum amount of EUR 8.0 million, the Company will have sufficient funding for its working capital needs until May 2023. The minimum amount is required to secure that the Company meets all its financial and operational covenants by 31 January 2023, as per agreed waivers with IPF.
  • IPF has agreed to waive certain covenants under the terms of the facilities agreement until completion of the Placing, subject to the Company raising a minimum of EUR 8.0 million by 31 January 2023, amongst other conditions. Under the terms of the facilities arrangement with IPF, the Company is required to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway.
  • The Placing Shares will be offered by way of an accelerated book building placement to institutional investors outside of the U.S. in accordance with Regulation S of the U.S Securities Act and in a private placement in the U.S. to a limited number of qualified institutional buyers, or QIBS, pursuant to an exemption from registration under the U.S. Securities Act.
  • The Company intends to enter into a lock-up undertaking for a period of 90 days with customary and certain other exemptions, including the possibility to issue further shares, with the prior written consent of Carnegie, who has agreed to provide such consent as long as any such further issue is at least at the prevailing market price, is made to qualifying long-only investors (in the reasonable opinion of Carnegie) and is within the existing authorities granted at the Company’s Extraordinary General Meeting held on 7 July 2022 (taking into account the authorities used in connection with the contemplated Placing). The Company’s existing authorities, without factoring in the authorities used in connection with the proposed Placing, equate to the conveyance of up to 6,458,270 shares in total.
  • Carnegie acts as sole bookrunner and lead manager.

 

The proposed Placing is being carried out within the authorisation granted to the Board by shareholders at the Company’s Extraordinary General Meeting held on 7 July 2022 to issue up to a total of 11,000,000 new ordinary shares in the Company as well as to convey up to the same maximum number (11,000,000) of treasury shares in the possession of the Company, in a directed share issue and in deviation from the shareholders’ pre-emptive rights. A total of 3,229,930 new ordinary shares have been issued and conveyed by the Company and up to 600,000 new shares are reserved for share issuances based on the exercise of warrants pursuant to the funding arrangement entered into by Faron with IPF Partners, as disclosed on 28 February 2022. In addition, a further 1,311,800 treasury shares have been conveyed by the Company within the outstanding authority. Therefore pursuant to the outstanding authority, the Company may issue and further convey up to a maximum of 6,458,270 ordinary shares, which represents approximately 10.8 per cent of all the issued shares and votes in the Company immediately prior to the Placing.

 

The Placing, arranged by Carnegie, will be conducted in a private placement by way of the Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Placing Shares. The Issue Price is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EET a.m. on 27 January 2023 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board will make the decision to issue the relevant number of new Placing Shares to the Company itself and subsequently convey the Placing Shares to the investors in the Placing, including deciding upon, as applicable, the acceptance of the received bids, the number of Placing Shares to be conveyed and the Issue Price. As soon as practicable after the close of the Bookbuild, receipt of binding commitments from investors and the Board having resolved on carrying out the Placing, an announcement will be made on the final outcome of the Bookbuild and, as applicable, the number of the Placing Shares to be issued to the Company itself and then conveyed to investors, the Issue Price as well as the expected registration date of the Placing Shares.

 

In connection with the proposed Placing, the Company has entered into a placing agreement with Carnegie (the Placing Agreement“). Pursuant to the terms of the Placing Agreement, the sole bookrunner has agreed to use its reasonable endeavours to procure the subscription of Placing Shares. In addition, the Company has obtained non-binding indications from the LLS TAP and Mr. Timo Syrjälä, both subject to certain customary conditions.

 

The Placing Agreement contain customary warranties and an indemnity from the Company in favour of the sole bookrunner. The Placing Agreement also contain provisions which enable the sole bookrunner to terminate its Placing Agreement in certain circumstances before the completion of the Bookbuild, the Board’s resolution on carrying out the Placing and the settlement of the Placing Shares to investors, including where there has been a material breach of any of the warranties contained in the Placing Agreement or where there is a material adverse change, e.g., in the business or financial affairs of the Company. The Company has agreed to pay the sole bookrunner certain commissions and fees in connection with the Placing. Pursuant to the terms of the Placing Agreement, the sole bookrunner shall collect payment of the gross Issue Price from the investors in respect of the Placing Shares allocated in the Placing, paying such amounts to the Company on behalf of the investors and organizing the delivery of the Placing Shares to the investors against payment of the Issue Price in full (DVP).

 

 The Placing is conditional upon, inter alia:

  • the Placing Agreement having become unconditional in all respects;
  • binding commitments corresponding to gross proceeds of at least the minimum amount of EUR 8 million being received from investors;
  • the Board resolving to carry out the Placing at the Issue Price and the Company and sole bookrunner entering into a separate pricing agreement confirming the Issue Price and the number of the Placing Shares; and
  • the Placing Shares being issued and being registered with the Finnish Trade Register.

In connection with the Placing, Faron has entered into a lock-up undertaking for a period of 90 days with customary and certain other exemptions, including the possibility to issue further shares, with the prior written consent of Carnegie, who has agreed to provide such consent as long as any such further issue is at least at the prevailing market price, is made to qualifying long-only investors (in the reasonable opinion Carnegie) and is within the existing authorities granted at the Company’s Extraordinary General Meeting held on 7 July 2022 (taking into account the authorities used in connection with the contemplated Placing). The Company’s existing authorities, without factoring in the authorities used in connection with the proposed Placing, equate to the conveyvance of up to 6,458,270 shares in total.

Subject to all conditions being met, the Placing Shares are expected to be entered in the Finnish Trade Register approximately on 27 January 2023.

 

ISSUE OF THE PLACING SHARES AND ADMISSION TO TRADING

 

The Placing Shares are expected to be issued in one tranche to the Company itself as treasury shares and subsequently conveyed to the investors, and applications will be made for the admission of the Placing Shares to trading on First North and AIM with said admissions expected to become effective and trading to commence on or around 31 January 2023 (the “Admissions“). The dates above may be subject to change.

 

A further announcement will be made to confirm the outcome of the Placing (subject to, inter alia, satisfaction of the above conditions) and to confirm the expected timing of issue of the Placing Shares to the Company itself and subsequent issuance to investors, and the Admissions.

 

Upon registration with the Finnish Trade Register and further conveyance of the Placing Shares to investors (DVP), the Placing Shares will rank pari passu in all respects with the existing shares of the Company.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY (“FARON”) PURSUANT TO THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE DIRECTED ONLY AT, IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA, PERSONS WHO ARE “QUALIFIED INVESTORS” AS DEFINED IN ARTICLE 2(E) OF THE EU PROSPECTUS REGULATION (WHICH MEANS REGULATION (EU) 2017/1129) (THE “PROSPECTUS REGULATION”). THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

 

IN ADDITION, IN THE UNITED KINGDOM, THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF THE PROSPECTUS REGULATION AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON, TOGETHER WITH QUALIFIED INVESTORS AS DEFINED IN THE PROSPECTUS REGULATION, BEING REFERRED TO AS A “RELEVANT PERSON”).

 

ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

 

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE PROSPECTUS REGULATION FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS REGULATION FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE PLACING SHARES THAT ARE TO BE SUBSCRIBED FOR PURSUANT TO THE TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT OR ANY DOCUMENTS RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

 

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WILL BE MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma. Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

About The Leukemia & Lymphoma Society and Therapy Acceleration Program® (TAP)
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families.  LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage preclinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. LLS TAP accepts funding applications on a rolling basis from companies with innovative science that has a high potential to improve patient lives. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.

 

 

IMPORTANT INFORMATION

 

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

 

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

 

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

 

Caution regarding forward-looking statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward-looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

BEXMAB study update

Faron Pharmaceuticals Oy

(“Faron or Company”)

 

Inside Information: Encouraging Additional Data for Bexmarilimab for the Treatment of Hematological Malignancies

 – BEXMAB Study Update

 

  • Objective response observed in 3 out of 5 patients in the first doublet cohort
  • 2 of the 3 responders were refractory to prior azacitidine monotherapy
  • No additional adverse events observed adding bexmarilimab to standard of care
  • Rapid enrollment into both doublet and triplet combinations
  • CMO Marie-Louise Fjällskog to discuss further details at The Leukemia & Lymphoma Society (LLS) Therapeutic Acceleration Program (TAP) virtual panel on January 18, 2023

Company announcement, January 16, 2023 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EEST)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces objective responses in 3 out of 5 patients dosed in the first doublet cohort of the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly-owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

 The responses from these patients are further defined as:

  • Complete remission (CR) with incomplete blood count recovery (CRi) in a patient with relapsed/refractory acute myeloid leukemia (AML) observed after 4 treatment cycles
  • CR in a patient with previously untreated myelodysplastic syndrome (MDS) observed after 6 cycles of treatment
  • Partial remission (PR) in a patient with MDS with prior failure to azacitidine observed after 2 treatment cycles

“The additional BEXMAB data indicates that bexmarilimab contributed to positive responses in the refractory setting where patients failed standard of care,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “We are excited about the initial promising results and look forward to gathering additional clinical data for more robust read-outs.”

The primary objective of the BEXMAB study (https://www.clinicaltrials.gov/ listing: NCT05428969) is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing preliminary efficacy as well as bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

The first cohort dosed at 1mg/kg of bexmarilimab has been completed for the doublet, and currently enrollment is ongoing into the 3mg/kg cohort. The Company has opened the first triplet cohort with bexmarilimab (1mg/kg), azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy.

In December 2022, the Company announced for the first cohort that the azacitidine-refractory AML patient achieved a CR, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles. It was also announced that another patient demonstrated a PR, and this patient now has become a CR.  

The safety profile remains strong. In December, the Company announced that bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine. The 5-patient doublet arm at 3mg/kg is fully enrolled, with the triplet arm at three patients recruited. All sites are in Finland, but the Company anticipates sites in the U.S. to be opened during Q1 2023 to speed up recruitment even further.

Marie-Louise Fjällskog will discuss the most recent BEXMAB findings at the LLS TAP virtual panel on January 18. The panel, titled “European Partners: Dream Big, Make Bold Progress”, will highlight companies that have worked in close collaboration with the LLS TAP program, including Faron, to advance their therapeutic portfolios. Register at this link: https://na.eventscloud.com/website/49472/welcome/.

“We are incredibly proud of our work with the LLS TAP,” said CEO Markku Jalkanen. “The leadership in hematological malignancies has provided us with not only financial assistance but also invaluable advice and connections to progress the bexmarilimab program, especially in the U.S.”

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

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanised antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About BEXMAB

The BEXMAB study is a first-in-human, open label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplatic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Directly targeting CLEVER-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective. CLEVER-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward-Looking Statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

Faron’s Financial Calendar for 2023

Faron Pharmaceuticals Oy
(“Faron” or “Company”)

 

Faron’s Financial Calendar for 2023

 

Company announcement, December 23, 2022 at 9.00 am (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces the following dates for the Company’s financial reporting in 2023:

 

March 2 Financial statement release for the full year 2022 and Annual Report 2022 including financial statements for the full year

August 29  Half-year financial report for the period January 1 to June 30, 2023

 

The annual general meeting is planned to be held on March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

BEXMAB Study Update

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

 

Inside Information: Deepening Response of Bexmarilimab in Combination with SoC in Hematological Malignancies

BEXMAB Study Update

      Partial responder becomes complete responder with complete remission of blasts in blood and bone marrow followed by normalization of blood counts

      Second patient demonstrated a partial response

      Stable disease observed in the other treated patients

      Two patients enrolled in second cohort with increased bexmarilimab dose with azacitidine

      Enrolment initiated in the triplet cohort combining bexmarilimab with azacitidine and venetoclax

 

Company announcement, December 5, 2022 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces a further update on the Company’s Phase I/II BEXMAB study, investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

In this latest update from the ongoing, open-label clinical trial, the Company reports that:

      An azacytidine-refractory acute myeloid leukemia (AML) patient with partial responses as communicated on October 31, 2022, achieved a complete remission, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles.

      The second patient, recently diagnosed with myelodysplastic syndrome (MDS), showed early signs of efficacy, with reduced blast counts. This pattern is similar to the first patient and as such the patient could be considered a partial responder.

      The remaining patients of the first cohort have reported stable disease (SD) status.

      Bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine.

      Study expansion to major hematological US centers is ongoing.

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing bexmarilimabs pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity. The initial treatment efficacy is followed by measuring cancer cell blast number in blood and bone marrow.

The BEXMAB study has opened the second predefined weekly dosing level of 3mg/kg and the start of dosing in the new triplet cohort combining bexmarilimab with azacitidine and venetoclax.

“We continue to be encouraged by the promising early data observed in this trial, notably the patients who have already shown control of blast counts in blood and bone marrow,” said Dr. Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “These observations support the potential for synergy of bexmarilimab in combination with standard of care. In addition, patient recruitment has started in the first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients deemed unsuitable for conventional chemotherapy. “

This and other earlier data will be shared with the current BEXMAB study group and potential new US study site investigators who will convene for the 64th American Society for Hematology (ASH) meeting in New Orleans, Louisiana from December 10-13, 2022.

Further details of the BEXMAB study are available on ClinicalTrials.gov (Identifier: NCT05428969).

 

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

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Financing and Investor Relations

Yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimabtargets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About BEXMAB

The BEXMAB study is a first-in-human open label phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Based on initial safety data, there is potential for expansion to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective.

 About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 Forward-Looking Statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

 A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

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