Faron, etusivu

Results of the AGM

Faron Pharmaceuticals Ltd (“Faron” or the “Company”)

 

Results of the Annual General Meeting and Decisions of the Board of Directors

 

Company announcement, April 22, 2022 at 15:00 PM (EEST) / 13:00 PM (BST) /  8:00 AM (EDT) 

 

TURKU, FINLAND – The annual general meeting (“AGM”) of Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON) took place at Event Venue Eliel in Helsinki, Finland today, 22 April 2022.

 

The AGM was held through exceptional meeting procedures based on the temporary legislative act (375/2021, “Temporary Act“) approved by the Finnish parliament on 7 May 2021. The shareholders of the Company and their proxy representatives could participate in the AGM and use shareholder rights only by voting in advance, by submitting counterproposals in advance and by asking questions in advance.  

 

Decisions of the AGM

The AGM adopted the financial statements of the Company and resolved to discharge the members of the Board and the CEO of the Company from liability for the financial year 2021.

 

No dividend for the financial year 2021 will be paid and the losses of the Company for the financial year, amounting to EUR 21.2 million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

 

Composition and remuneration of the Board

The number of members of the Board was confirmed as seven. Frank Armstrong, Gregory Brown, John Poulos, Leopoldo Zambeletti, Markku Jalkanen and Anne Whitaker were re-elected to the Board and Erik Ostrowski was elected as a new member to the Board for a term that ends at the end of the next AGM.

 

The AGM resolved that the annual remuneration of the members of the Board remains unchanged.  Accordingly, an annual remuneration of EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the chair of the audit committee, a further annual remuneration of EUR 9,000 will be paid to the chair of the remuneration committee and a further annual remuneration of EUR 6,000 will be paid to the chair of the nomination committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the audit committee members, a further annual remuneration of EUR 5,000 will be paid to the remuneration committee members and a further annual remuneration of EUR 3,000 will be paid to the nomination committee members.

 

Meeting fees also remain unchanged and will be paid to the Board members as follows:

 

  • a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and
  • no meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent as the member’s place of residence.

 

In addition, all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

 

No remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

 

Auditor

Audit firm PricewaterhouseCoopers Oy (“PwC”) was re-elected as the Company’s auditor. PwC has appointed Panu Vänskä, authorised public accountant (KHT), as the key audit partner. It was decided that the auditor be remunerated in accordance with the invoice presented.

 

Proposed authorisations to the Board to decide on the issuance of shares, options or other special rights entitling to shares and on the issuance of shares without consideration to the Company

The AGM did not authorize the Board to resolve on the issuances of shares, options or other special rights entitling to shares, or on a share issue without consideration to the Company itself in accordance with the proposals by the Board to the AGM.

 

The Company has an existing authorisation to resolve on issuances of shares, options or other special rights entitling to shares of up to ten million (10,000,000) shares in the aggregate, pursuant to the resolution by the Annual General Meeting on 23 April 2021, which is effective until 30 June 2022. Of the aforementioned authorization, 6,636,842 shares may still be issued by the Company.

 

Decisions of the Board

At the meeting of the Board held following the AGM, Frank Armstrong was re-elected Chair of the Board.

In addition, the Board elected the Chairs and other members to the Board committees from among its members as follows:

 

  • Leopoldo Zambeletti was elected the Chair of the Audit Committee and Gregory Brown and Erik Ostrowski were elected as the other members of the Audit Committee.
  • Frank Armstrong was elected the Chair of the Nomination Committee and Anne Whitaker and Gregory Brown were elected as the other members of the Nomination Committee.
  • Anne Whitaker was elected as the Chair of the Remuneration Committee and Frank Armstrong, John Poulos and Leopoldo Zambeletti were elected as the other members of the Remuneration Committee.

Minutes of the AGM

The minutes of the AGM will be available on the Company’s website from 6 May 2022 at the latest.

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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 headquartered in Turku, Finland with additional offices in Zürich, Switzerland and US operations in Boston, Massachusetts. Further information is available at www.faron.com.

Result of AGM 2022

Faron Presents Results from Melanoma Cohort of MATINS Trial at 18[th] Congress of the European Association of Dermato-Oncology (EADO)

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Presents Results from Melanoma Cohort of MATINS Trial at 18th Congress of the European Association of Dermato-Oncology (EADO)

 

  • Compelling 30% clinical benefit rate seen following treatment with bexmarilimab in heavily pre-treated, checkpoint inhibitor refractory patient population
  • Analysis estimates 100% overall survival at 12-months for patients who experienced clinical benefit following treatment with bexmarilimab
  • Biomarker analysis shows melanoma patients with low baseline levels of inflammatory cytokines in blood and high Clever-1 positivity in tumor are more likely to benefit from treatment with bexmarilimab and experience significant increases in serum interferon gamma (INFy) during treatment

 

Press release, April 21, 2022 at 18:30 PM (EEST) / 16:30 PM (BST) / 11:30 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 that results from the melanoma cohort in the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the 18th Congress of the European Association of Dermato-Oncology (EADO), being held in Seville, Spain, April 21 to April 23, 2022.  

 

The melanoma cohort is one of the ten advanced treatment-resistant solid tumor types included in Part II (110 patients) of the MATINS study, which is investigating the potential of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, as a monotherapy. Bexmarilimab targets tumor associated macrophages, which are known to be immunosuppressive, make up nearly 50% of the tumor mass, and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. As previously communicated, melanoma is among five different tumor types from the original 10 studied to have shown the strongest clinical benefit rate (CBR = partial response or stable disease) – 30% – alongside gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%), following treatment with bexmarilimab.  

 

Data from 11 melanoma patients (including the full cohort of 10 patients in Part II and one additional patient with same dosing regimen from Part I) who were refractory to checkpoint inhibition are being presented at the congress. All patients were treated with 1mg/kg of bexmarilimab monotherapy, every three weeks. The median number of previous treatment lines was three, the median age of patients was 60.

 

  • Of the 11 patients, four experienced clinical benefit – one patient had a partial response after two cycles of bexmarilimab (tumor growth reduced by 40% from baseline) but was discontinued before a confirmatory scan was performed. Three patients had stable disease (i.e., clinical benefit rate of 30% in Part II).
     
  • Current estimates for 12-month survival in Part II melanoma cohort were 100% for the patients who experienced clinical benefit following treatment compared to 33.3% of non-CBR patients.

 

  • A preliminary biomarker analysis including the melanoma cohort showed that patients with higher intra-tumoral Clever-1 positivity and low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha were more likely to experience clinical benefit following treatment with bexmarilimab. Among those patients who experienced clinical benefit, a marked rise in serum IFNy levels was seen during treatment. IFNy is a necessary pro-inflammatory cytokine for response to checkpoint inhibitors like PD-1/L1, highlighting bexmarilimab’s combination potential.

 

“This rate of clinical benefit is particularly striking when you consider these are heavily pre-treated patients, all of whom were refractory to currently approved checkpoint inhibitor therapy,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “Bexmarilimab’s ability to ignite an immune response in these patients means that it may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1/L1 blockade.”

 

“Additionally, the biomarker analysis among melanoma patients is consistent with our broader analyses and suggests that two cytokines, which can be measured by a standard blood test as part of a patient’s routine care, could hold the key to understanding which patients will gain the greatest benefit from this novel immunotherapy. Knowing which patients are most likely to respond to treatment is key to both the development process and the successful roll out of new therapeutic approaches.”

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

 

 

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. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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 Presents Melanoma Data at EADO

Managers’ Transactions

Faron Pharmaceuticals Ltd.
(“Faron” or the “Company”)

 

Managers’ transactions

 

Company announcement, 8 April 2022 at 5:45 PM (EET) / 3:45 PM (GMT) / 10:45 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 Dr Markku Jalkanen, Chief Executive Officer of the Company, acquired 25,000 ordinary shares in Faron at a volume weighted average price of €2.8213 per share on 5 April, 2022. Following these purchases, Dr Jalkanen directly holds 2,125,565 ordinary shares in the Company, representing 3.99 per cent. of the Company’s issued share capital and has a combined interest with his spouse in 3,251,677 ordinary shares in the Company, representing 6.11 per cent of the Company’s issued share capital.

 

The notification below, which has been made in accordance with the requirements of the EU Market Abuse Regulation, provides further detail.                           

 

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Markku Jalkanen

2

Reason for notification

 

 

 

a.

Position/Status

Chief Executive Officer

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Ordinary shares

ISIN: FI4000153309
 

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

 

 Average

 

 

 

 

Price(s)

Volume(s)

 

€2.8213

25,000

 

Transaction details

(1): Volume: 91 Unit price: 2.84 EUR

(2): Volume: 167 Unit price: 2.825 EUR

(3): Volume: 192 Unit price: 2.825 EUR

(4): Volume: 16 Unit price: 2.825 EUR

(5): Volume: 16 Unit price: 2.825 EUR

(6): Volume: 509 Unit price: 2.825 EUR

(7): Volume: 40 Unit price: 2.825 EUR

(8): Volume: 116 Unit price: 2.825 EUR

(9): Volume: 129 Unit price: 2.825 EUR

(10): Volume: 688 Unit price: 2.825 EUR

(11): Volume: 192 Unit price: 2.825 EUR

(12): Volume: 167 Unit price: 2.825 EUR

(13): Volume: 16 Unit price: 2.825 EUR

(14): Volume: 132 Unit price: 2.825 EUR

(15): Volume: 169 Unit price: 2.825 EUR

(16): Volume: 1,063 Unit price: 2.825 EUR

(17): Volume: 175 Unit price: 2.825 EUR

(18): Volume: 283 Unit price: 2.825 EUR

(19): Volume: 889 Unit price: 2.82 EUR

(20): Volume: 97 Unit price: 2.82 EUR

(21): Volume: 466 Unit price: 2.8 EUR

(22): Volume: 1,487 Unit price: 2.8 EUR

(23): Volume: 1,267 Unit price: 2.8 EUR

(24): Volume: 97 Unit price: 2.8 EUR

(25): Volume: 1,267 Unit price: 2.8 EUR

(26): Volume: 206 Unit price: 2.8 EUR

(27): Volume: 77 Unit price: 2.82 EUR

(28): Volume: 153 Unit price: 2.82 EUR

(29): Volume: 40 Unit price: 2.82 EUR

(30): Volume: 77 Unit price: 2.82 EUR

(31): Volume: 14 Unit price: 2.82 EUR

(32): Volume: 100 Unit price: 2.82 EUR

(33): Volume: 17 Unit price: 2.82 EUR

(34): Volume: 139 Unit price: 2.82 EUR

(35): Volume: 14 Unit price: 2.82 EUR

(36): Volume: 184 Unit price: 2.82 EUR

(37): Volume: 55 Unit price: 2.82 EUR

(38): Volume: 31 Unit price: 2.82 EUR

(39): Volume: 55 Unit price: 2.82 EUR

(40): Volume: 129 Unit price: 2.82 EUR

(41): Volume: 86 Unit price: 2.82 EUR

(42): Volume: 55 Unit price: 2.82 EUR

(43): Volume: 98 Unit price: 2.82 EUR

(44): Volume: 117 Unit price: 2.82 EUR

(45): Volume: 153 Unit price: 2.82 EUR

(46): Volume: 117 Unit price: 2.82 EUR

(47): Volume: 153 Unit price: 2.82 EUR

(48): Volume: 17 Unit price: 2.82 EUR

(49): Volume: 100 Unit price: 2.82 EUR

(50): Volume: 69 Unit price: 2.82 EUR

(51): Volume: 184 Unit price: 2.82 EUR

(52): Volume: 86 Unit price: 2.82 EUR

(53): Volume: 86 Unit price: 2.82 EUR

(54): Volume: 184 Unit price: 2.82 EUR

(55): Volume: 98 Unit price: 2.82 EUR

(56): Volume: 270 Unit price: 2.82 EUR

(57): Volume: 270 Unit price: 2.82 EUR

(58): Volume: 100 Unit price: 2.82 EUR

(59): Volume: 270 Unit price: 2.82 EUR

(60): Volume: 270 Unit price: 2.82 EUR

(61): Volume: 68 Unit price: 2.835 EUR

(62): Volume: 25 Unit price: 2.835 EUR

(63): Volume: 17 Unit price: 2.835 EUR

(64): Volume: 104 Unit price: 2.835 EUR

(65): Volume: 43 Unit price: 2.835 EUR

(66): Volume: 85 Unit price: 2.835 EUR

(67): Volume: 14 Unit price: 2.835 EUR

(68): Volume: 31 Unit price: 2.835 EUR

(69): Volume: 18 Unit price: 2.835 EUR

(70): Volume: 71 Unit price: 2.835 EUR

(71): Volume: 9 Unit price: 2.835 EUR

(72): Volume: 104 Unit price: 2.835 EUR

(73): Volume: 31 Unit price: 2.835 EUR

(74): Volume: 47 Unit price: 2.835 EUR

(75): Volume: 89 Unit price: 2.835 EUR

(76): Volume: 76 Unit price: 2.835 EUR

(77): Volume: 75 Unit price: 2.835 EUR

(78): Volume: 21 Unit price: 2.835 EUR

(79): Volume: 10 Unit price: 2.835 EUR

(80): Volume: 68 Unit price: 2.835 EUR

(81): Volume: 97 Unit price: 2.835 EUR

(82): Volume: 75 Unit price: 2.835 EUR

(83): Volume: 75 Unit price: 2.835 EUR

(84): Volume: 43 Unit price: 2.835 EUR

(85): Volume: 85 Unit price: 2.835 EUR

(86): Volume: 68 Unit price: 2.835 EUR

(87): Volume: 143 Unit price: 2.835 EUR

(88): Volume: 85 Unit price: 2.835 EUR

(89): Volume: 43 Unit price: 2.835 EUR

(90): Volume: 9 Unit price: 2.835 EUR

(91): Volume: 71 Unit price: 2.835 EUR

(92): Volume: 18 Unit price: 2.835 EUR

(93): Volume: 135 Unit price: 2.835 EUR

(94): Volume: 47 Unit price: 2.835 EUR

(95): Volume: 89 Unit price: 2.835 EUR

(96): Volume: 182 Unit price: 2.835 EUR

(97): Volume: 21 Unit price: 2.835 EUR

(98): Volume: 68 Unit price: 2.835 EUR

(99): Volume: 97 Unit price: 2.835 EUR

(100): Volume: 153 Unit price: 2.835 EUR

(101): Volume: 75 Unit price: 2.835 EUR

(102): Volume: 43 Unit price: 2.835 EUR

(103): Volume: 228 Unit price: 2.835 EUR

(104): Volume: 43 Unit price: 2.835 EUR

(105): Volume: 94 Unit price: 2.835 EUR

(106): Volume: 71 Unit price: 2.835 EUR

(107): Volume: 147 Unit price: 2.835 EUR

(108): Volume: 6 Unit price: 2.835 EUR

(109): Volume: 47 Unit price: 2.835 EUR

(110): Volume: 271 Unit price: 2.835 EUR

(111): Volume: 68 Unit price: 2.835 EUR

(112): Volume: 271 Unit price: 2.835 EUR

(113): Volume: 75 Unit price: 2.835 EUR

(114): Volume: 271 Unit price: 2.835 EUR

(115): Volume: 143 Unit price: 2.835 EUR

(116): Volume: 71 Unit price: 2.835 EUR

(117): Volume: 147 Unit price: 2.835 EUR

(118): Volume: 918 Unit price: 2.835 EUR

(119): Volume: 175 Unit price: 2.835 EUR

(120): Volume: 73 Unit price: 2.815 EUR

(121): Volume: 358 Unit price: 2.8 EUR

(122): Volume: 168 Unit price: 2.8 EUR

(123): Volume: 129 Unit price: 2.8 EUR

(124): Volume: 120 Unit price: 2.835 EUR

(125): Volume: 103 Unit price: 2.835 EUR

(126): Volume: 272 Unit price: 2.835 EUR

(127): Volume: 58 Unit price: 2.835 EUR

(128): Volume: 133 Unit price: 2.835 EUR

(129): Volume: 803 Unit price: 2.835 EUR

(130): Volume: 1,034 Unit price: 2.835 EUR

(131): Volume: 167 Unit price: 2.83 EUR

(132): Volume: 79 Unit price: 2.83 EUR

(133): Volume: 137 Unit price: 2.83 EUR

(134): Volume: 51 Unit price: 2.82 EUR

(135): Volume: 46 Unit price: 2.82 EUR

(136): Volume: 68 Unit price: 2.82 EUR

(137): Volume: 541 Unit price: 2.82 EUR

(138): Volume: 200 Unit price: 2.82 EUR

(139): Volume: 200 Unit price: 2.82 EUR

(140): Volume: 400 Unit price: 2.81 EUR

(141): Volume: 8 Unit price: 2.8 EUR

(142): Volume: 14 Unit price: 2.8 EUR

(143): Volume: 27 Unit price: 2.8 EUR

(144): Volume: 7 Unit price: 2.8 EUR

(145): Volume: 85 Unit price: 2.8 EUR

(146): Volume: 43 Unit price: 2.8 EUR

(147): Volume: 71 Unit price: 2.8 EUR

(148): Volume: 4 Unit price: 2.8 EUR

(149): Volume: 22 Unit price: 2.8 EUR

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

25,000

 

Volume weighted average price of €2.8213

e.

Date of the transaction

5 April, 2022

f.

Place of the transaction

Nasdaq First North Growth Market

 

 

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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.

 

Faron Managers transactions 080422

Faron Closes HIBISCUS Trial

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Closes HIBISCUS Trial Due to Low COVID-19 Infection and Hospitalization Rates in the US and Reverts Resources to the Development of Bexmarilimab

 

  • Traumakine will be re-positioned for multiple indications in organ protection together with partnerships
  • Near term value inflections are expected from the accelerated development of Bexmarilimab

 

 

Company announcement, April 05, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 2:00 AM (EDT) 

Inside information

 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 announced that, due to low COVID-19 hospitalization rates and a shortage of patients not already receiving steroids, the Company is closing its Phase II/III HIBISCUS trial assessing Traumakine (Intravenous Interferon beta-1a; IFN beta-1a) as a first-line treatment for hospitalized COVID-19 patients who require low flow oxygen support. The Company’s decision was based on a recommendation from the HIBISCUS Independent Data Monitoring Committee (IDMC) to discontinue the study due to slow recruitment. The IDMC also informed the Company that there were no safety concerns related to treatment of enrolled patients.

 

“When the HIBISCUS trial was designed and initiated, infection and hospitalization rates were high across the U.S.,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “The emergence of the less severe Omicron variant and widespread vaccinations led to a significant decrease in the number of hospitalized patients requiring low flow oxygen support. While this was good news from a pandemic perspective, it, along with the widespread early use of steroids, severely limited our potential patient pool. As a result and based on a recommendation from the independent data monitoring committee, we made the decision to end patient enrollment in the HIBISCUS trial and re-focus immediate resources on the development of bexmarilimab.”

 

In January 2021, Faron announced that the US Department of Defense (DoD) had selected the HIBISCUS trial to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The DoD concurs with the IDMC and Faron that given the current environment the trial will not be able enroll in a timely manner and enrollment should be stopped. Faron will continue to partner with the 59th Medical Wing of the US Air Force and the DoD on preclinical studies to evaluate Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.

 

“We know that intravenous interferon beta-1a can up-regulate CD73, which reduces inflammation and prevents vascular leakage,” said Daniel S. Talmor, M.D., MPH, Chief of Anesthesia, Critical Care and Pain Medicine at Beth Israel Deaconess Medical Center and Principal Investigator of the HIBISCUS trial. “While the timing and scope of the HIBISCUS trial did not allow us to efficiently enroll patients, I believe strongly that Traumakine has the potential to become a powerful treatment option for patients who are at risk of developing major inflammation and look forward to continuing to work with Faron to advance this potentially first-in-class treatment approach in multiple settings.”

 

“We want to thank the patients, their caregivers, the investigators and everyone who participated in the HIBISCUS trial,” said Dr. Juho Jalkanen, Chief Operating Officer of Faron. “Data from this partially completed study will support our ongoing Traumakine development strategy, which we expect will include additional studies exploring its potential as a future treatment for multiple acute settings of ischemia and systemic inflammation leading to vascular dysfunction and organ damage. We expect ongoing Traumakine development efforts will be supported by both academic and industry collaborations.”

 

Traumakine is an investigational therapy developed by Faron for the potential treatment of conditions based on major inflammation and vascular dysfunction such as acute respiratory distress syndrome (ARDS), acute kidney injury, cardiac protection and ischemia reperfusion injury. The HIBISCUS trial opened enrollment and began recruiting patients at sites in the U.S. in August 2021. The trial was meant to enroll 140 patients who required low flow oxygen support, but not mechanical ventilation. Enrolled patients were randomized 1:1 across two study arms to assess the safety and efficacy of Traumakine compared to corticosteroid treatment with dexamethasone. As part of the trial protocol, corticosteroid treatment concomitantly with Traumakine was not possible in the study setting but was enabled in a sequenced manner following treatment with Traumakine. No treatment related safety concerns were reported among enrolled patients.

 

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

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

 

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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 Closes HIBISCUS Trial and Reverts Resources to the Development of Bexmarilimab 050422

Notice of Faron Pharmaceuticals Ltd’s AGM

Faron Pharmaceuticals Ltd (“Faron” or the “Company”)

Company announcement, March 25, 2022 at 11:00 AM (EET) / 09:00 AM (GMT) / 05:00 AM (EDT) 

NOTICE OF Faron pharmaceuticals LTD’s Annual GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company”) are notified of the Annual General Meeting (the “AGM”) to be held on 22 April 2022 at 12:00 p.m. EEST (Finnish time). The meeting venue is Event Venue Eliel, Töölönlahdenkatu 2, Helsinki, Finland. The shareholders of the Company may participate in the AGM and exercise their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in accordance with the instructions given in this notice and otherwise by the Company. It is not possible to participate in the AGM at the meeting venue.

The Board of Directors (the “Board”) has resolved on exceptional meeting procedures based on the temporary legislative act (375/2021, “Temporary Act“) approved by the Finnish parliament on 7 May 2021. In order to prevent the spread of the COVID-19 pandemic, the AGM will be held without shareholders’ and their proxy representatives’ presence at the meeting venue. This is necessary in order to ensure the health and safety of the shareholders, employees and other stakeholders of the Company as well as to organize the AGM in a predictable way allowing equal means for shareholders to participate while also ensuring compliance with the restrictions set by the authorities from time to time. For these reasons, shareholders and their proxy representatives can participate in the AGM and use shareholder rights only by voting in advance, by submitting counterproposals in advance and by asking questions in advance. Further instructions can be found in part C of this notice (Instructions for the Participants).

 

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting or participate in any vote, among other things, during the meeting. The webcast will be arranged only if it can be arranged in compliance with all regulatory rules and restrictions imposed by the authorities due to the COVID-19 pandemic.

 

The CEO of the Company will attend the meeting. The Chairman of the Board, the members of the Board, other management of the Company and the auditor will not attend the AGM.

 

  1. MATTERS ON THE AGENDA OF THE AGM

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

Attorney-at-law Riikka Rannikko shall act as the Chairman of the meeting. If due to weighty reasons Riikka Rannikko is not able to act as Chairman, the Board shall appoint another person it deems most suitable to act as Chairman.

 

  1. Election of persons to scrutinize the minutes and to supervise the counting of votes

The Company’s Corporate Counsel Kaisa Kyttä shall scrutinize the minutes and supervise the counting of the votes. In case Kaisa Kyttä would not be able to act as the person to scrutinize the minutes and to supervise the counting of the votes due to weighty reasons, the Board shall appoint another person it deems most suitable to act in that role.

  1. Recording the legality of the meeting

 

  1. Recording the attendance at the meeting and adoption of the list of votes

The shareholders who have voted in advance and who have the right to participate in the meeting pursuant to Chapter 5, Sections 6 and 6a of the Finnish Limited Liability Companies Act (624/2006, as amended; the “Companies Act”) will be recorded to have been represented at the meeting. The list of votes will be adopted according to the information provided by Euroclear Finland Oy (“Euroclear”) and Innovatics Ltd (“Innovatics”).

  1. Presentation of the financial statements, the Board’s report and the auditor’s report for 2021

As shareholders can only participate in the AGM by voting in advance, the financial statements, the Board’s report and the auditor’s report for 2021, published by the Company on 25 March 2022 and which have been made available on the Company’s website at https://www.faron.com/investors/general-meetings, will be deemed to have been presented to the AGM.

  1. Adoption of the financial statements

 

  1. Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The Board proposes that no dividend for the financial year 2021 will be paid and that the losses of the Company for the financial year, amounting to EUR 21.2 million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

  1. Resolution on the discharge of the members of the Board and the CEO of the Company from liability

 

  1. Resolution on the remuneration of the members of the Board

The Board proposes, on the basis of the proposal of the remuneration committee, that the annual remuneration of the members of the Board remain unchanged and that EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the chair of the audit committee, a further annual remuneration of EUR 9,000 will be paid to the chair of the remuneration committee and a further annual remuneration of EUR 6,000 will be paid to the chair of the nomination committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the audit committee members, a further annual remuneration of EUR 5,000 will be paid to the remuneration committee members and a further annual remuneration of EUR 3,000 will be paid to the nomination committee members.

The Board furthermore proposes that meeting fees will be paid to the Board members as follows:

  • a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and
  • no meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent as the member’s place of residence.

In addition, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

The Board also proposes, on the basis of the proposal of the remuneration committee, that no remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

  1. Resolution on the number of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that seven (7) members be elected to the Board.

  1. Election of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that Frank Armstrong, Gregory Brown, John Poulos, Leopoldo Zambeletti, Markku Jalkanen and Anne Whitaker be re-elected to the Board for a term that ends at the end of the next AGM. In addition, the Board proposes, on the basis of the proposal of the nomination committee, that Erik Ostrowski be elected as a new member to the Board for a term that ends at the end of the next AGM.

Erik Ostrowski (born 1972), citizen of the U.S., holds no other board memberships at the moment. He is independent of the Company and its significant shareholders. Information on the proposed new Board member is available on the Company’s website at https://www.faron.com/investors/general-meetings.

All proposed Board member candidates have given their consent for the election. The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as chair of the Board.

Information on the Board member candidates proposed to be re-elected are available on the Company’s website at https://www.faron.com/faron/leadership/board-directors.

  1. Resolution on the remuneration of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that the auditor be remunerated in accordance with the invoice presented.

  1. Election of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that PricewaterhouseCoopers Oy (“PwC”), a firm of authorised public accountants, continue to act as the Company’s auditor.

PwC has informed the Company that it will appoint Panu Vänskä, authorised public accountant (KHT), as the key audit partner.

  1. Authorising the Board to decide on the issuance of shares, options or other special rights entitling to shares

The Board proposes that the AGM authorise the Board to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Companies Act, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to ten million six hundred thousand (10,600,000) shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent of the existing shares and votes in the Company.

The authorisation would not exclude the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on February 28, 2022) or implementing business arrangements, investments or for other such purposes determined by the Board in which case a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

The Board would be authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares.

The authorisation would be effective until 30 June 2023.

  1. Authorising the Board to decide on the issuance of shares without consideration to the Company

The Board proposes that the AGM authorise the Board to resolve by one or several decisions on a share issue without consideration to the Company itself. The authorisation would consist of up to ten million six hundred thousand (10,600,000) shares in the aggregate, which corresponds to approximately twenty (20) per cent of the existing shares and votes in the Company.

The authorisation would not exclude the Board’s right to decide on the issuance of shares in deviation from the shareholders’ pre-emptive rights. The Board would be authorised to resolve on all other terms and conditions of the issuance of shares, including the right to issuances without consideration. Issuances without consideration require that there is an especially weighty financial reason for doing so from the Company’s point of view and observing the interests of all the shareholders of the Company.

The authorisation would be effective until 30 June 2023. The proposed authorisation does not revoke the share issue authorisations granted to the Board otherwise during this AGM.

 

  1. Closing of the meeting

 

  1. DOCUMENTS OF THE AGM

The proposals of the Board to the AGM and this notice are available on the Company’s website at https://www.faron.com/investors/general-meetings. The financial statements, the Board’s report and the auditor’s report for 2021 are available on the above-mentioned website no later than on 25 March 2022. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available to be viewed on the Company’s website from 6 May 2022 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

In order to prevent the spread of the COVID-19 pandemic, the AGM will be organized so that the shareholders and their proxy representatives are not allowed to be present at the meeting venue. The shareholders and their proxy representatives can participate in the meeting and use their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in the manner described below. Proxy representatives shall also vote in advance in the manner described below.

  1. The right to participate

Each shareholder who on the record date of the AGM, being 8 April 2022, is registered in the Company’s shareholders’ register held by Euroclear has the right to participate in the AGM. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders’ register. If you do not have a Finnish book-entry account, see section C.4 (Holder of nominee-registered shares (including depositary interest holders)) for all instructions on participating and voting in advance.

A shareholder may only participate in the meeting by voting in advance or by way of proxy representation and by submitting counterproposals and asking questions in advance in accordance with the instructions below.

  1. Registration and advance voting

Registration for the AGM and advance voting will begin on 4 April 2022 at 12:00 noon EEST (Finnish time) when the deadline for submitting counterproposals has passed. A shareholder entered in the Company’s shareholders’ register who wishes to participate in the AGM by voting in advance must register and vote in advance at the latest on 19 April 2022 at 10:00 a.m. EEST (Finnish time), by which time the registration shall be completed and votes need to be received.

A shareholder whose shares are registered on their Finnish book-entry account can register and vote in advance on certain items on the agenda of the AGM from 12:00 noon EEST (Finnish time) on 4 April 2022 until 10:00 a.m. EEST (Finnish time) on 19 April 2022 by the following means:

a) Through the Company’s website

The Finnish personal identity code or business ID as well as strong identification with Finnish or Swedish banking codes or mobile certificate is needed for electronic registration and advance voting. The terms and other instructions concerning electronic voting are available on the Company’s website at https://www.faron.com/investors/general-meetings.

b) By mail or email

The advance voting form and instructions relating to the advance voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings no later than on 4 April 2022 at 12:00 noon EEST (Finnish time). A shareholder may send the advance voting form available on the aforementioned website or corresponding information to Innovatics by regular mail to Innovatics Ltd, Annual General Meeting / Faron Pharmaceuticals Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland or by email to agm@innovatics.fi. If the shareholder participates in the meeting by sending the votes in advance by mail or email to the above-mentioned addresses, this constitutes registration for the AGM, provided that the above-mentioned information required for registration is provided. Additional information is also available through email at general.meeting@faron.com.

In connection with the registration, a shareholder or a proxy representative is required to provide the requested personal information such as the shareholder’s name, personal ID/date of birth and email address and/or phone number. The personal data given to the Company and Innovatics by shareholders and proxy representatives is only used in connection with the AGM and with the processing of related necessary registrations.

Additional information on the registration and advance voting is available during the registration period by telephone at +358 10 2818 909 on business days during 9:00 a.m. until 12:00 noon and from 1:00 p.m. until 4:00 p.m. (EEST).

  1. Proxy representative and powers of attorney

A shareholder may participate in the AGM and exercise their rights at the meeting by way of proxy representation. Also the proxy representative of a shareholder may only participate by voting in advance in the manner instructed above. Shareholders who do not vote in advance are requested, due to the COVID-19 pandemic, to exercise shareholders’ rights through a centralized proxy representative designated by the Company by authorizing attorney-at-law Anniina Järvinen from Hannes Snellman Attorneys Ltd, or a person appointed by her, to represent them at the AGM in accordance with the shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents. Further information on the designated proxy representative is available at the following website: www.hannessnellman.com/people/all/anniina-jaervinen/.

Shareholders may also participate in the AGM and exercise their rights at the meeting by way of another proxy representative. Proxy representatives must use strong electronic authentication when registering for the meeting and voting in advance online, after which they can register and vote in advance on behalf of the shareholder they represent. A proxy representative shall present a dated proxy document or otherwise in a reliable manner demonstrate their right to represent the shareholder at the AGM. Statutory right of representation may be demonstrated by using the suomi.fi e-Authorisations service which is in use in the online registration service. When a shareholder participates in the AGM by means of several proxy representatives representing the shareholder with shares at different securities accounts, the shares by which each proxy representative represents the shareholder shall be identified in connection with the registration for the AGM.

Proxy and voting instruction templates are available on the Company’s website at https://www.faron.com/investors/general-meetings on 4 April 2022 at the latest. The proxy representative of a shareholder shall deliver duly populated and signed proxy documents together with the signed and duly populated advance voting form in accordance with the instructions set out in the form primarily as an attachment in connection with the electronic registration and advance voting or alternatively through email to general.meeting@faron.com or as originals to the address Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of the registration period, by which time the proxy documents must be received.

If a shareholder delivers a proxy to the Company in accordance with the applicable instructions before the expiry of the registration and advance-voting period, this constitutes due registration for the AGM, provided that all required information is included in the proxy documents. In addition, proxy representatives must also vote in advance in the manner described in this notice.

Further information is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

  1. Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the AGM by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register maintained by Euroclear on the AGM’s record date of 8 April 2022. The right to participate in the AGM requires, in addition, that the shareholder on the basis of such shares has been registered into the temporary shareholders’ register maintained by Euroclear by 19 April 2022 at 10:00 a.m. EEST (Finnish time), at the latest. As regards nominee-registered shares this constitutes due registration for the AGM.

A holder of nominee-registered shares is advised to request necessary instructions regarding the registration in the temporary shareholders’ register of the Company, the issuing of proxy documents and registration for the AGM from their custodian bank in good time. A holder of nominee-registered shares shall note that custodian banks may apply deadlines for the registration and advance voting of holders of nominee-registered shares. The account management organisation of the custodian bank has to register a holder of nominee-registered shares into the temporary shareholders’ register of the Company at the latest by the time stated above and see to the voting in advance on behalf of a holder of nominee-registered shares.

Further information on holders of nominee-registered shares is available on the Company’s abovementioned website.

  1. Other instructions and information

Shareholders who hold at least one hundredth (1/100) of all the shares in the Company have the right to pose counterproposals concerning the matters on the agenda of the AGM to be placed for a vote. Such counterproposals shall be delivered to the Company by email to general.meeting@faron.com by no later than 1 April 2022 at 4:00 p.m. EEST (Finnish time), by which time the counterproposals must be received by the Company.

The shareholders shall in connection with the counterproposal present adequate evidence of their shareholding in the Company. The counterproposal is admissible for consideration at the AGM if the shareholders who have made the counterproposal have the right to attend the meeting and on the record date of the AGM represent at least one hundredth (1/100) of all shares in the Company. If a counterproposal will not be taken up for consideration at the AGM, the votes given in favour of the counterproposal will not be taken into account. The Company will publish possible counterproposals to be put to a vote on the Company’s website at https://www.faron.com/investors/general-meetings by no later than 4 April 2022.

A shareholder has the right to ask questions referred to in Chapter 5, Section 25 of the Companies Act with respect to the matters to be considered at the AGM. Such questions may be delivered by email to general.meeting@faron.com or by regular mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland by no later than 8 April 2022, by which time the questions must have been received.

Such questions by shareholders, the Company’s management’s answers as well as other counterproposals than those admissible for voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings on 13 April 2022 at the latest. In connection with asking questions, shareholders are required to provide adequate evidence of shareholding.

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting pursuant to Chapter 5, Section 25 of the Companies Act or participate in any vote, among other things, during the meeting. The attendance list of the AGM and voting results are determined solely based on the advance votes. Shareholders cannot thus exercise their voting rights when following the meeting through the webcast, i.e., votes must be cast in advance.

Changes in the share ownership following the record date of the AGM do not have an impact on the right to participate in the AGM nor on the number of votes of the shareholder.

On the date of this notice, 25 March 2022, the total number of shares and votes in the Company is 53,232,032.

Turku, 25 March 2022

FARON PHARMACEUTICALS LTD

Board of Directors

For more information please contact:

 

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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 headquartered in Turku, Finland with additional offices in Zürich, Switzerland and US operations in Boston, Massachusetts. Further information is available at www.faron.com.

NOTICE OF FARON PHARMACEUTICALS LTD’S ANNUAL GENERAL MEETING

Faron´s Annual Report 2021 Published

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Faron´s Annual Report 2021 Published

 

 

Company announcement, 25 March 2022 at 9.15 AM (EET) / 07:15 AM (GMT) / 03:15 AM (EDT)
 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 that its Annual Report for the year 2021 has been published today.

 

Faron Pharmaceuticals´ Annual Report 2021 and audited financial statements for the accounting period 1 January – 31 December 2021 have been published in English and its financial statements in Finnish, on the Company’s website https://www.faron.com/investors/results.

 

For more information please contact:
Media / Investor Contact
Faron Pharmaceuticals
Eric Van Zanten
Head of Communications
eric.vanzanten@faron.com
investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad 
Sandy Jamieson, Jo Turner
Phone: +44 207 213 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

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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.

 

 

 

Faron Annual Report 2021

Financial Statement January 1 to December 31 2021

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Financial Statement Release January 1 to December 31, 2021

 

Financial statement release March 25, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 03:00 AM (EDT) 

Inside information

 

2021 Highlights

  • Bexmarilimab shows compelling antitumor activity in multiple advanced treatment resistant solid tumor types as a monotherapy with strongest clinical benefit rate (partial response or stable disease) observed in five different tumor types – cutaneous melanoma (30%), gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%)
  • Biomarker analysis showed patients with low baseline levels of inflammatory cytokines in blood achieved significantly higher clinical benefit following treatment with bexmarilimab monotherapy
  • First patient dosed in Phase II/III HIBISCUS trial assessing Traumakine® as a first-line treatment for hospitalized COVID-19 patients
  • Balance sheet strengthened by two successful share placings totaling EUR 25.6 million gross, both including investment from European Investment Council (EIC) Fund, a breakthrough initiative from the European Commission
  • 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 2021 Financial Year

  • Landmark analysis estimates 70% nine-month overall survival rate (11 months from initiation of treatment) for Phase I/II MATINS study patients who benefited from treatment with bexmarilimab and 26% for patients who did not benefit from treatment
  • Secured a debt funding agreement with IPF Partners for up to EUR 30 million – EUR 10 million was accessed in February 2022, with an additional EUR 20 million available in the future, subject to certain conditions being met
  • 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

 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 announced audited full-year financial results for January 1 to December 31, 2021 (the “period”) and H2 2021 and provided an overview of recent corporate developments.

 

“I am extremely proud of the progress we made in 2021 across each of our pipeline programs and building our corporate infrastructure to support the ambitious plans we have for 2022 and beyond,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “Last year we accelerated the development of bexmarilimab as a monotherapy, where it has shown compelling antitumor activity in heavily pre-treated patients across multiple solid tumor types, while also progressing plans to study bexmarilimab in combination with standard of care in first-line solid tumors and in hematological malignancies. We also initiated a study of Traumakine as a first-line treatment for hospitalized COVID-19 patients without prior steroid treatment, which we believe could represent a significant step forward in the treatment of lung failure due to viral infections. 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 United States.”

 

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.

 

  • Compelling antitumor activity in multiple advanced solid tumor types was reported from patients enrolled in the completed Part I and ongoing Part II of the MATINS study, investigating bexmarilimab as a potential monotherapy in patients with solid tumors who have exhausted all treatment options. The strongest results were observed in cutaneous melanoma, gastric cancer, cholangiocarcinoma, hepatocellular carcinoma and breast cancer with a 30.0% — 40.0% clinical benefit rate (CBR) across these tumor types. 
  • Landmark analysis estimates 70% nine-month overall survival rate for MATINS patients who benefited from treatment with bexmarilimab and 26% for patients who did not benefit from treatment. Median overall survival has not yet been reached in the clinical benefit patient group.
  • Biomarker analysis shows patients with low interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) levels experienced significantly higher clinical benefit following treatment with bexmarilimab, which is opposite to what is usually seen with checkpoint inhibitors and other T cell activating agents, meaning bexmarilimab has the potential to bring the promise of immunotherapy to a much broader patient population compared to the relatively small percentage of cancer patients benefiting from checkpoint inhibitor therapies today.
  • A more than 100% increase in IFNy levels was seen after the first cycle of bexmarilimab treatment among patients who experienced clinical benefit. In certain patients, bexmarilimab is able to turn cold tumors into hot tumors and may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1 blockade.
  • Further clinical trials are planned to start in 2022 to investigate bexmarilimab’s potential in additional clinical settings, including in combination with anti-PD-1 therapy in selected advanced solid tumors and in combination with standard of care in hematological malignancies.
  • A key patent with claims protecting the composition of matter of bexmarilimab was granted by the United States Patent and Trademark Office and equivalent Japanese patent office. This patent family covers bexmarilimab’s binding sequences and Clever-1’s corresponding epitope – specific elements of the antibody-antigen binding site – with an expected expiry date, not including any potential extensions, of 2037. The European Patent Office also issued an allowance letter, which means that more than 80% of pharmaceutical markets are now covered with this patent family.
  • A new role for soluble Clever-1 was identified, related to its capacity to control T cell activation. The scientific findings, from tests on MATINS patients’ plasma, suggest that their high levels of free, soluble Clever-1 can act as a direct inhibitor of T cell activation, providing a greater immunosuppressive effect than previously expected and indicating broader applicability for bexmarilimab. A new patent application has been filed seeking protection for these inventions and related applications.

 

Traumakine – Faron’s investigational intravenous (IV) interferon beta-1a therapy, in development for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions.

 

  • Dosing commenced in the Phase II/III HIBISCUS trial investigating Traumakine in the treatment of hospitalized COVID-19 patients compared to corticosteroid treatment with dexamethasone. The US Department of Defense (DoD) selected the HIBISCUS trial to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
  • Building on Faron’s already strong IP portfolio for Traumakine, Faron signed a sub-license agreement covering a relevant manufacturing patent in the US. Faron also applied for patent protection relating to Traumakine’s induction of CD73 for organ protection, through the sequential use of IV interferon beta-1a followed by corticosteroids for the treatment of systemic inflammation.
  • 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%.
  • Partnership established with the 59th Medical Wing of the U.S. Air Force and U.S. Army and U.S. Army Institute of Surgical Research to explore the use of Traumakine for organ protection in combat wounds leading to multi-organ failure from ischemia and reperfusion.
  • New manufacturing process is progressing as planned in collaboration with AGC Biologics.

 

HAEMATOKINE – An AOC3 (amine oxidase copper containing 3) protein inhibitor targeting Vascular Adhesion Protein-1 (VAP-1) in development for use in regenerative medicine and to treat hematological malignancies.

 

  • Faron acquired rights for this potential use of AOC3 inhibitors and will be responsible for the future development of Haematokine and for the management, prosecution, maintenance and filing of patent applications.
  • The multidisciplinary journal Cellular and Molecular Life Sciences published research showing the inhibition of VAP-1 potentially supports the expansion of human hematopoietic stem cells (HSC), which are essential to the formation of new cells within blood. This approach has the potential to benefit a variety of conditions where an expansion of HSC is needed. This includes bone marrow transplantation, where approximately 25% of transplants fail due to poor expansion of transplanted cells.

 

Corporate Highlights

  • Balance sheet was strengthened by raising EUR 25.6 million gross through private placements of new ordinary shares. This includes two placements, which encompassed existing and new investors, including the European Innovation Council Fund, a breakthrough initiative from the European Commission. 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.
  • Anne Whitaker joined the Faron Board of Directors, bringing more than 25 years of experience in the life science industry, including senior leadership roles with large pharmaceutical, biotech and specialty pharma companies. Anne is the current Chairman of the Board for Aerami Therapeutics Holdings, Inc. Anne previously served as Chief Executive Officer of Novoclem Therapeutics, Inc., Executive Vice President at Bausch Health, President and Chief Executive Officer of Synta Pharmaceuticals and as President, North America Pharmaceuticals at Sanofi.
  • 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 (SNSE), a Nasdaq listed immuno-oncology company. 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 (MRUS) and Infinity Pharmaceuticals (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.
  • Faron hosted a virtual R&D Day in February 2022 presenting the Company’s plans to accelerate the development of bexmarilimab. The event was hosted by Dr. Markku Jalkanen, Chief Executive Officer, and members of the Global Management Team including Dr. Marie-Louise Fjällskog, Chief Medical Officer and Dr. Juho Jalkanen, Chief Operating Officer. External perspectives were provided by Dr. Tyler Curiel, Professor of Medicine and Microbiology, Immunology & Molecular Genetics at The University of Texas Health Science Center at San Antonio, United States and Dr. Maija Hollmén, Adjunct Professor of Tumour Immunology, Group Leader and Academy Research Fellow at the MediCity Research Laboratory, Institute of Biomedicine, University of Turku, Finland.

 

Impact of COVID-19

  • Despite the ongoing global pandemic, the Company was able to continue operations with limited disruptions. This included the successful planning and execution of its clinical trials, which proceeded as planned.
  • Additionally, Faron closely followed and strictly complied with the regulations and recommendations of the Finnish National Institute for Health and Welfare (THL) and other relevant local and international authorities to ensure the safety of its employees, study subjects and partners.

 

 Financial

  • On December 31, 2021, the Company held cash balances of EUR 6.9 million (2020: EUR 4.1 million).
  • Loss for the period for the financial year ended December 31, 2021 was EUR 21.2 million (2020: EUR 16.9 million).
  • Net assets on December 31, 2021 were EUR 2.9 million (2020: EUR -1.8 million).
  • In February 2021, the Company successfully raised a total of EUR 15.0 million gross (EUR 14.4 million net) from new and existing shareholders, through issuance of a total of 3,521,127 new ordinary shares. In September 2021, the Company successfully raised a total of EUR 10.6 million gross (EUR 10.1 million net) from new and existing shareholders, through issuance of a total of 2,763,158 new ordinary shares. Proceeds from both raises will be used to accelerate and expand the clinical development of the Company’s main drug candidates and to strengthen the Company’s balance sheet.
  • Post period, in February 2022, Faron 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 through additional tranches of EUR 5 million and EUR 15 million, subject to certain conditions being met.

 

 

Consolidated key figures, IFRS

 

EUR ’000

Unaudited

7-12/2021
6 months

Unaudited

7-12/2020
6 months

1-12/2021
12 months

1-12/2020
12 months

Revenue

0

0

0

0

Other operating income

4,927

1,379

6,137

2,122

Research and Development expenses

(8,361)

(8,345)

(17,369)

(13,879)

General and Administrative expenses

(7,250)

(2,543)

(9,876)

(4,897)

Loss for the period

(10,649)

(9,603)

(21,209)

(16,946)

 

 

Unaudited

7-12/2021
6 months

Unaudited

7-12/2020
6 months

1-12/2021
12 months

1-12/2020
12 months

 

 

 

 

 

Loss per share EUR

(0.21)

(0.22)

(0.42)

(0.37)

Number of shares at end of period

53,232,032

46,896,747

53,232,032

46,896,747

Average number of shares

51,836,953

44,606,204

50,723,964

45,712,111

 

 

 

EUR ’000

Unaudited

30 June 2021

Unaudited

30 June 2020

31 December 2021

31 December 2020

Cash and cash equivalents

6,967

11,627

6,853

4,108

Equity

2,813

7,313

2,919

(1,849)

Balance Sheet total

11,865

14,343

13,182

8,367

 

 

Board of Directors’ Proposal on the Dividend

The Group’s loss for the accounting period was EUR 21,208,864.89  (2020: EUR 16,946,261.84).

The Board of Directors does not recommend the payment of a dividend (2020: nil).

 

24 March 2022

Faron Pharmaceuticals Ltd

Board of Directors

 

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

 

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 2021, presentation, webcast details, and Annual Report 2021 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/2021-results

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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 2022

Faron’s financial statements for full year 2021 will be published today, 25 March 2022 and will also be available on the Company’s website at https://www.faron.com/investors/results. The half-year financial report for the period 1 January to 30 June 2022 is scheduled to be published on 25 August 2022. The Annual General Meeting is planned for 22 April 2022. 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) 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. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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.

 

 

Chairman’s Statement

During 2021, Faron has continued to make significant progress across the business. It has maintained its focus on pipeline delivery, including the initiation of clinical trials and generation of further clinical data. The Company has developed the management team with new hires and raised funds during the period, all of which has been achieved against the continued challenges of COVID-19.

 

A key priority for Faron has been to continue to advance its wholly-owned novel precision cancer immunotherapy candidate, bexmarilimab, through the Phase I/II MATINS clinical trial. Over the course of the year the Company has generated and presented further clinical data showing that heavily pre-treated, late-stage cancer patients who receive clinical benefit from bexmarilimab can achieve long term survival. Through the multiple cohorts tested to date, bexmarilimab has generated compelling efficacy data and has continually been shown to be safe and well-tolerated. Faron is continuing to analyze biomarker data from the trial to better understand which patients are most likely to respond.

 

The Company will continue to accelerate bexmarilimab through clinical development and is planning to study bexmarilimab in combination with other checkpoint inhibitors and as a treatment for hematological malignancies, in addition to the ongoing MATINS trial. The evolving data generated to date suggest bexmarilimab is an active drug with a novel mechanism of action which, I believe, has the potential to play a significant role in the future treatment of cancer patients.

 

2021 saw the COVID-19 pandemic continue to evolve. With the global call for research to identify potential therapies being widely answered by life science companies, including Faron, there has been unprecedented innovation in this space. Despite this, there is still a need for new therapeutic options to treat the serious complications of COVID-19, including acute respiratory distress syndrome (ARDS). As such, Faron was pleased to initiate the Phase II/III HIBISCUS trial, investigating Traumakine, Faron’s investigational intravenous (IV) interferon (IFN) beta-1a therapy, in hospitalized COVID-19 patients.

 

Faron has generated a wealth of data on the potential of Traumakine during its clinical development and we were pleased to publish data from the completed Phase II INFORAAA trial showing the up-regulation of CD73 in surgically operated ruptured abdominal aorta aneurysm (RAAA) patients. The results show the role of CD73 in organ protection and its ability to benefit patients undergoing major surgery, and we remain confident that Traumakine has potential beyond ARDS, across multiple indications, where there continues to be significant unmet medical need.

 

Despite the difficult funding environment due to COVID-19, Faron has successfully secured further investment over the period to progress its pipeline. This is testament not only to the potential of our product candidates but also to the expertise and credibility of the management team. The Board meets regularly to discuss the Company’s performance, review the clinical programs, discuss ongoing business strategy and assess the Company’s financial situation in order to continue to progress the pipeline and deliver value for shareholders.

 

On behalf of the Board, I would like to take this opportunity to thank all the staff at Faron, without whom we would not have achieved so much this year; my colleagues on the Board for their commitment to the Company; our partner organisations and steering committee members for their support and expertise; Faron’s investors for showing continued confidence in the Company and, importantly, the health professionals and patients across our trial network. I would also like to extend a warm welcome to Dr. Marie-Louise Fjällskog, our new Chief Medical Officer. Her knowledge and network will be invaluable to Faron as we continue to accelerate bexmarilimab through clinical development whilst progressing our other product candidates.

 

Finally, I would also like to thank the management team, particularly Dr. Markku Jalkanen, Chief Executive Officer, Toni Hänninen, Chief Financial Officer, and Dr. Juho Jalkanen, Chief Operating Officer, who also acted as interim Chief Medical Officer in 2021, for their leadership. Under their expert guidance, we are looking forward to another year of continued progress during 2022.

 

Dr. Frank Armstrong

Chairman

24 March 2022

 

 

Chief Executive Officer’s Review

Despite the ongoing challenges presented by a global pandemic, 2021 was another year of significant progress for our Company. Each of our pipeline assets moved forward and our quest to harness the power of the immune system to tackle cancer and inflammation is closer to being realized. We believe strongly that all three of our programs, bexmarilimab, Traumakine and Haematokine, have the potential to fundamentally change treatment paradigms and meaningfully improve patient outcomes.

 

Since Faron was founded, our focus has been to challenge the status quo and accelerate innovation. Incremental progress is not good enough. We exist to address areas of significant unmet need; areas where there are no currently approved treatment options, or, in the case of cancer, where far too many patients are not benefiting from recent advances.

 

Bexmarilimab has the potential to bring the promise of immunotherapy to many more patients and in 2021 we significantly advanced its development. Our Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab showed that patients across five different tumor types experienced disease control rates between 30% and 40%. The data also showed that heavily pre-treated, late-stage cancer patients who receive clinical benefit from bexmarilimab can achieve long term survival. These results are important, and the global community took notice when we presented the data at international cancer meetings including ESMO, ESMO-IO and ASCO.

 

We also learned a great deal in 2021 about which cancer patients are most likely to benefit from treatment with bexmarilimab and what happens in the tumor microenvironment when patients respond to treatment. Biomarkers, which are proteins or other substances that are made at higher amounts by cancer cells than normal cells, are a critical missing link in attempting to identify appropriate candidates for immunotherapy and tailoring immunotherapy treatment regimens. The biomarker analysis we conducted showed clearly that patients with low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) were more likely to experience clinical benefit following treatment with bexmarilimab. Patients with low levels of pro-inflammatory cytokines experiencing higher clinical benefit is opposite to what is usually seen with currently approved checkpoint inhibitors and other T-cell activating agents.

 

Our analysis also showed that among patients who experienced clinical benefit, IFNy levels increased over 100% after the first cycle of bexmarilimab treatment. Interferon gamma is a marker for inflammation which suggests bexmarilimab may amplify an immune response and serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1 blockade.

 

This enhanced understanding of who is most likely to respond to treatment with bexmarilimab and what happens in the tumor microenvironment allowed us to refocus and accelerate our development plan in 2021. In addition to the ongoing MATINS trial, we progressed plans to study bexmarilimab in combination with other checkpoint inhibitors and as a treatment for hematological malignancies. We are undertaking an ambitious strategy but given the data we have seen to date and our evolving understanding of which biomarkers will predict response to treatment, we believe bexmarilimab has the potential to broadly impact cancer care.

 

We have also been successful in obtaining 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 and the counter binding site of this antibody on Clever-1. Faron has also received an allowance letter from the European Patent Office, which now means that more than 80% of pharmaceutical markets are covered with this patent family.

 

Leading our bexmarilimab development efforts moving forward will be Dr. Marie-Louise Fjällskog, who joined Faron in January 2022 as our new Chief Medical Officer. We were thrilled to add someone of Marie-Louise’s caliber to our team. She has over 30 years of experience in clinical oncology, translational research, and drug development and has held senior R&D roles at several clinical stage biotech companies. She was also formerly Global Clinical Program Leader at the Novartis Institute for Biomedical Research where she led global development of oncology treatments targeting CDK4/6, BCL-2, PD-1, CSF-1 and CD73. 

 

In addition to bexmarilimab, 2021 proved to be an important year for Traumakine as well. Traumakine is our investigational intravenous interferon beta-1a therapy, which we are developing for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine works by up-regulating CD73, a critical enzyme which yields anti-inflammatory adenosine and can prevent fluid from building up in and around organs.

 

In August, dosing commenced in the Phase II/III HIBISCUS trial investigating Traumakine in the treatment of hospitalized COVID-19 patients. While hospitalizations and severity of disease have decreased since the initiation of this study, we continue to believe that Traumakine has the potential to become a powerful treatment option for patients who are at risk of developing ARDS as a consequence of a viral infection, such as COVID-19. This trial is supported the US Department of Defense through funding from the Coronavirus Aid, Relief, and Economic Security Act.

 

Additionally, research highlighting results from our Phase II INFORAAA clinical trial, which examined the effect of Traumakine on mortality of surgically operated ruptured abdominal aorta aneurysm (RAAA) patients, was published in the multidisciplinary journal Scientific Reports. Analysis showed that up-regulation of CD73 following treatment with Traumakine was associated with 100% survival compared to the expected mortality rate for operated RAAA patients, which is between 30-40%. Ischemia-reperfusion injury, tissue damage caused when blood supply returns to tissue after a period of oxygen depletion, is the main cause of death for operated RAAA patients. We believe Traumakine has the potential to prevent acute organ injury following major surgery and polytrauma by reducing inflammation and preventing vascular leakage. This could represent a significant advancement in patient care given there are currently no drugs approved for this condition.

 

Similar to the patent advancements we made with bexmarilimab, our intellectual property (IP) portfolio for Traumakine was also strengthened in 2021 by signing a sub-license agreement covering a relevant manufacturing patent in the US. In addition, we applied for patent protection relating to Traumakine’s induction of CD73 for organ protection, through the sequential use of IV interferon beta-1a followed by corticosteroids for the treatment of systemic inflammation. Adding these patent protections to our already strong IP portfolio will ensure we are able to move each of the potential indications forward with the ultimate goal of making this innovative drug available to patients in the coming years.

 

The third program in our pipeline is Haematokine, an investigational Vascular Adhesion Protein‑1 (VAP-1) inhibitor. Haematokine blocks VAP-1 enzymatic activity, which supports the expansion of human hematopoietic stem cells. This has the potential to benefit a variety of conditions where an expansion of hematopoietic stem cells is needed. Most notably, this includes bone marrow transplantation, where approximately 25% of transplants fail due to poor expansion of transplanted cells.

 

In November, the multidisciplinary journal Cellular and Molecular Life Sciences published research that aligns with our pre-clinical findings. Pre-clinical studies are continuing, and we believe Haematokine could have broad applicability, not just in hematological malignancies, but across the field of regenerative medicine.

 

Our focus for 2022 will be to accelerate bexmarilimab’s clinical development, which in addition to the ongoing MATINS trial will include the initiation of trials investigating bexmarilimab in a first line setting in combination with other checkpoint inhibitors and as a treatment for hematological malignancies. We have a responsibility to the millions of cancer patients across the globe currently not benefiting from existing treatment options to move this novel asset forward as quickly as possible. We will move with urgency because patients can’t wait.

 

I would like to thank our shareholders for their continued support of our Company and the management team. I would also like to express my profound gratitude to every Faronial, which is what we call our team members. They come to work each day committed to disrupting the current treatment landscape and fundamentally improving patient outcomes.

 

As critical as 2021 was, there is no doubt that 2022 will be the most important year in the history of our Company. There is also no doubt that with the team we have in place and with your continued support, we are positioned to exceed even our most ambitious goals.

 

Dr. Markku Jalkanen

Chief Executive Officer

24 March 2022

 

Financial Review

Despite challenging market conditions, we were able to conduct two successful fundraising rounds in 2021. Combined, they raised EUR 25.6 million gross and both rounds included new investors. Both also included investments by the European Investment Council (EIC) Fund, which is focused on investing in companies across Europe developing breakthrough and disruptive technologies. We were proud to become the first publicly listed company to receive an investment from the EIC Fund.

 

As a result of these fundraising efforts, the Company’s net cash flow in 2021 showed EUR 2.9 million positive. We were able to accomplish this while also increasing R&D and G&A expenditures.

 

Post period, in February 2022, Faron 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 non-dilutive 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.

 

Revenue and Other Operating Income

The Company’s revenue was EUR 0.0 million for the year ended 31 December 2021 (2020: EUR nil).

The Company recorded EUR 6.1 million (2020: EUR 2.1 million) of other operating income. This consisted of mainly of the result of the arbitration ruling in favor of Faron in its case against Rentschler Biopharma SE (EUR 3.8 million) and the rest consists of government grant and loan.

 

Research and Development Costs

R&D costs increased by EUR 3.5 million from EUR 13.9 million in 2020 to EUR 17.4 million in 2021. The costs of outsourced clinical trial services were decreased by EUR 0.9 million from EUR 4.4 to EUR 3.5 million. The cost of employee benefits was increased by EUR 0.4 million from EUR 2.9 to EUR 3.3 million, mainly driven by additional headcount.

 

General and Administration Costs

Administrative expenses increased by EUR 5.0 million from EUR 4.9 million in 2020 to EUR 9.9 million in 2021. The increase was mainly due to the EUR 3.1 million increase in other G&A costs, mainly driven by legal expenses, which were offset by other income. Further, employee benefits increased by EUR 1.0 million mainly driven by additional headcount.

 

Taxation

The Company’s tax credit for the fiscal year 2021 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 31 December 2021 was EUR 42.6 million (2020: EUR 38.2 million). The Company estimates that it can utilise most of these during the years 2020 to 2021 by offsetting them against future profits. In addition, Faron has EUR 70.1 million of

R&D costs incurred in the financial years 2010 – 2020 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 21.2 million (2020: EUR 16.9 million). Net loss for the year was EUR 21.2 million (2020: EUR 16.9 million), representing a loss of EUR 0.42 per share (2020: EUR 0.37 per share) (adjusted for the changes in number of issued shares).

 

Cash Flows

Net cash flow was EUR 2.9 million positive for the year ended 31 December 2021 (2020: EUR 2.8 million negative). Cash used for operating activities increased by EUR 4.7 million to EUR 22.2 million for the year, compared to EUR 17.5 million for the year ended 31 December 2020. This increase was mostly driven by an increase in R&D investments. Net cash inflow from financing activities was EUR 25.6 million (2020: EUR 14.8 million) mainly due to the successful equity placings completed in February 2021 and September 2021.

 

Fundraising

In February 2021, the Company successfully raised a total of EUR 15.0 million gross (EUR 14.4 million net) from new and existing shareholders, through issuance of a total of 3,521,127 new ordinary shares. In September 2021, the Company successfully raised a total of EUR 10.6 million gross (EUR 10.1 million net) from new and existing shareholders, through issuance of a total of 2,763,158 new ordinary shares. Proceeds from both raises will be used to accelerate and expand the clinical development of the Company’s main drug candidates and to strengthen the Company’s balance sheet. Post period, in February 2022, Faron 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.

 

Financial Position

As at 31 December 2021, total cash and cash equivalents held were EUR 6.9 million (2019: EUR 4.1 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”. The Company and its subsidiaries (the “Group”) are 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 Group’s commercial and development activities and generating a level of revenue adequate to support the Group’s cost structure.

The Group made a net loss of EUR 21.2 million during the year ended 31 December 2021. It had a positive equity of EUR 2.9 million including an accumulated deficit of EUR 116.265 million. As at that date, the Group had cash and cash equivalents of EUR 6.9 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 the Group together with known receivables will be sufficient to support the current level of activities into the fourth quarter of 2022. The Directors are continuing to explore sources of finance available to the Group and they believe they have a reasonable expectation that they will be able to secure sufficient cash inflows for the Group 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 the Company’s ability to continue as going concern. Should the Group 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

Headcount of the Company at the end of year was 37 (2020: 30).

 

Shares and Share Capital

During the period 1 January to 31 December 2021, the Company, using the share authorities granted at the Annual General Meeting held on 18 May 2020, issued a total of 3,521,127 new ordinary shares at an issuance price of EUR 4.26 per share. During the same period, the Company, using the share authorities granted at the Annual General Meeting held on 23 April 2021, issued a total of 2,763,158 new ordinary shares at an issuance price of EUR 3.80 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 2021 the total number of voting rights was 53,232,032.

 

Legal Proceedings

As announced by the Company on 9 November 2021, the arbitration tribunal appointed by the Arbitration Institute of the Stockholm Chamber of Commerce (SCC) ruled in favor of Faron in its case against Rentschler Biopharma SE (“Rentschler”). Faron was seeking damages from Rentschler for unfounded termination of an agreement concerning the manufacturing process for Traumakine. As a result of the favorable arbitration award, Rentschler was ordered to pay Faron EUR 3.8 million in damages. The parties were jointly and severally liable towards the arbitral tribunal and the SCC for the fees and expenses of the arbitral tribunal and the fees of the SCC, which were paid in equal shares. In addition, each party carried its own legal costs. A third-party recovery services provider funded the proceedings for Faron. The funder received compensation from Faron in accordance with the litigation funding agreement. 

 

Toni Hänninen

Chief Financial Officer

24 March 2022

 

 

 

Consolidated Income Statement, IFRS

 EUR ’000

Unaudited

7-12/2021
6 months

Unaudited

7-12/2020
6 months

1-12/2021
12 months

1-12/2020
12 months

Revenue

0

0

0

0

Other operating income

4,927

1,379

6,137

2,122

Research and development expenses

(8,361)

(8,345)

(17,369)

(13,879)

General and administrative expenses

(7,250)

(2,543)

(9,876)

(4,897)

Operating loss

(10,684)

(9,509)

(21,108)

(16,654)

Financial expense

(44)

(160)

(235)

(389)

Financial income

103

76

165

109

Loss before tax

(10,625)

(9,593)

(21,178)

(16,934)

Tax expense

(9)

(10)

(16)

(10)

Loss for the period

(10,634)

(9,603)

(21,194)

(16,944)

 

 

 

 

 

 

Other comprehensive loss

(15)

 

(15)

2

Total comprehensive loss for the period

(10,649)

(9,603)

(21,209)

(16,946)

 

 

 

 

 

Loss per ordinary share

 

 

 

 

Basic and diluted loss per share, EUR

(0.21)

(0.22)

(0.42)

(0.37)

 

 

Consolidated Balance Sheet, IFRS

EUR ’000

31 December 2021

31 December 2020

Assets

 

 

Non-current assets

 

 

Machinery and equipment

20

14

Right-of-use-assets

187

361

Intangible assets

899

565

Prepayments and other receivables

53

56

Total non-current assets

1,159

996

 

 

 

Current assets

 

 

Prepayments and other receivables

5,170

3,263

Cash and cash equivalents

6,853

4,108

Total current assets

12,023

7,371

 

 

 

Total assets

13,182

8,367

 

 

 

Equity and liabilities

 

 

 

 

 

Capital and reserves attributable to the equity holders of the Company

 

 

Share capital

2,691

2,691

Reserve for invested unrestricted equity

116,507

92,015

Accumulated deficit

(116,265)

(96,557)

Translation difference

(15)

2

Total equity

2,919

(1,849)

 

 

 

Non-current liabilities

 

 

Borrowings

2,918

2,728

Lease liabilities

16

199

Other liabilities

151

786

Total non-current liabilities

3,085

3,713

 

 

 

Current liabilities

 

 

Borrowings

429

122

Lease liabilities

184

176

Trade payables

2,229

2,115

Accruals and other current liabilities

4,336

4,090

Total current liabilities

7,178

6,503

 

 

 

Total liabilities

10,263

10,216

 

 

 

Total equity and liabilities

13,182

8,367

 

Consolidated Statement of Changes in Equity, IFRS

EUR ’000

Share capital

Reserve for invested unrestricted equity

Translation difference

Accumulated deficit

Total equity

Balance as at 31 December 2019

2,691

78,916

–

(79,997)

1,610

 

 

 

 

 

 

Comprehensive loss for the period

–

–

2

(16,946)

(16,944)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs EUR 1,004 thousand

–

13,098

–

–

13,098

Share-based compensation

–

–

–

386

386

 

–

13,098

–

386

13,484

 

 

 

 

 

 

Balance as at 31 December 2020

2,691

92,015

2

(96,557)

(1,849)

 

 

 

 

 

 

Comprehensive loss for the period

–

–

(15)

(21,194)

(21,209)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs EUR 1,067 thousand

–

24,492

–

–

24,492

Share-based compensation

–

–

–

1,487

1,487

 

–

24,492

–

1,487

25,980

Balance as at 31 December 2021

2,691

116,507

(15)

(116,265)

2,919

 

Consolidated Cash Flow Statement, IFRS

EUR ’000

Unaudited

7-12/2021
6 months

Unaudited

7-12/2020
6 months

1-12/2021
12 months

1-12/2020
12 months

Cash flow from operating activities

 

 

 

 

Loss before tax

(10,640)

(9,593)

(21,194)

(16,936)

Adjustments for:

 

 

 

 

Received grant

(745)

(587)

(1,387)

(587)

Depreciation and amortisation

165

153

307

283

Interest expense

128

56

216

149

Tax expense

6

10

16

10

Unrealised foreign exchange loss (gain), net

434

242

153

117

Share-based compensation

644

386

1,487

386

Adjusted loss from operations before changes in working capital

(10,008)

(9,333)

(20,402)

(16,578)

Change in net working capital:

 

 

 

 

Prepayments and other receivables

(-1259)

(1,631)

(1,919)

(1,097)

Trade payables

744

1,878

723

1,641

Other liabilities

24

(83)

(565)

(1,416)

Cash used in operations

(10,499)

(9,169)

(22,163)

(17,450)

Taxes paid

(1)

(1)

(16)

(1)

Interest paid

(10)

1

(40)

(28)

Net cash used in operating activities

(10,508)

(9,169)

(22,218)

(17,479)

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

Payments for intangible assets

(76)

(60)

(461)

(137)

Payments for equipment

(6)

(3)

(13)

(5)

Net cash used in investing activities

(81)

(63)

(473)

(142)

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

Proceeds from issue of shares

10,515

106

25,559

14,103

Share issue transaction cost

(405)

(52)

(1,067)

(1,004)

Proceeds from borrowings

145

630

662

630

Repayment of borrowings

–

–

(122)

(122)

Proceed from grants

750

1,375

750

1,375

Payment of lease liabilities

(95)

(104)

(191)

(195)

Net cash from financing activities

10,910

1,955

25,590

14,787

 

 

 

 

 

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

320

(7,277)

2,899

(2,834)

Effect of exchange rate changes on cash and cash equivalents

(434)

(242)

(153)

(117)

 

 

 

 

 

Cash and cash equivalents at 1 January

6,967

11,627

4,108

7,059

Cash and cash equivalents at 31 December

6,853

4,108

6,853

4,108

 

 

Faron Financial Statement Release January 1 to December 31, 2021

Faron Publishes Research From INTEREST Trial

Faron Pharmaceuticals Ltd

(“Faron” or “Company”)

 

 

Faron Publishes Research Identifying Gene Mutation in Interferon Receptor that Contributes to Corticosteroid Response and Outcome in ARDS and COVID-19 Patients

 

  • Single nucleotide polymorphism identified during analysis of data from Phase III INTEREST trial of Traumakine
  • Gene mutation in interferon alpha/beta receptor (IFNAR2) is associated with better outcomes among intravenous interferon beta-1a treated ARDS patients, irrespective of prior treatment with glucocorticosteroids
  • Analysis of COVID-19 Host Genetics Initiative database indicates mutation is associated with less hospitalization for COVID-19

 

Press Release, March 14, 2022 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 the publication of research identifying a novel disease association between a single nucleotide polymorphism (SNP) in the interferon alpha/beta receptor (IFNAR2) and the outcomes of acute respiratory distress syndrome (ARDS) and COVID-19 patients treated with corticosteroids.

 

The research, which is available here:  https://medrxiv.org/cgi/content/short/2022.03.10.22272123v1, builds on Faron’s initial 2018 findings from its completed Phase III INTEREST trial investigating the potential of the Company’s investigational intravenous interferon (IFN) beta-1a therapy, Traumakine, in ARDS patients. Overall results from that trial identified a deleterious effect of glucocorticosteroids when given together with intravenous IFN beta-1a therapy. A post hoc genetic analysis by the Company found that patients receiving Traumakine and carrying the SNP rs9984273 (C/T) in subunit 2 of INFAR2 showed a substantial reduction in mortality compared to patients without the gene mutation.

 

The newly published research, authored by Faron and academic colleagues, details further analyses carried out to determine the effects of the SNP gene mutation on the immune status of ARDS patients when given glucocorticosteroids. The team’s findings suggest that administering glucocorticosteroids to ARDS patients receiving IFN beta-1a therapy is not harmful, if they carry the mutation. However, in patients without the mutation, glucocorticosteroid use was associated with high levels of interferon gamma, an indicator of increased inflammation instead of immune suppression, which is associated with poor outcomes in ARDS and COVID-19 patients.  

 

Using data from the COVID-19 Host Genetics Initiative database, an international human genetics research platform led by researchers from the Institute for Molecular Medicine Finland, Helsinki, the team also explored the impact of the SNP on COVID-19 disease severity and found that carrying the mutation was associated with milder disease, with less hospitalization when comparing hospitalized and non-hospitalized COVID-19 patients.

 

SNP rs9984273 is a relatively common polymorphism according to available data (REF: https://www.ncbi.nlm.nih.gov/snp/rs9984273#frequency_tab), carried by approximately 45% of people with African origin, 34% of Caucasians and 10% of Asians. This difference in the appearance of this SNP makes some populations much more vulnerable for steroid use.

 

“Endogenous interferon-beta production is one of the body’s main first lines of defense against viral infection and it is widely hypothesized that dosing patients with interferon-based therapies can further strengthen this natural defense if given early enough,” said Juho Jalkanen, M.D., Ph.D., Chief Operating Officer of Faron, and lead author of the newly published research. “However, our studies have shown that glucocorticosteroids can block this therapeutic effect and may have a potentially negative impact on patient survival.”

 

“Our research also shows that a relatively common polymorphism, which until now has not been recognized as having any clinical significance, actually plays a critical role in disease states where interferons and glucocorticosteroids have an impact on mortality. These findings will support our continued research into the potential of intravenous interferon beta-1a therapy as a future treatment for ARDS and other acute settings of systemic inflammation leading to capillary leak.”

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

+1 (610) 529-6219

 

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

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

faron@consilium-comms.com

 

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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 headquartered in Turku, Finland with additional offices in Zürich, Switzerland and US operations in Boston, Massachusetts. 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 Publishes Research Identifying Gene Mutation in Interferon Receptor 140322

Presentation of Biomarker Data at AACR 2022

Faron Pharmaceuticals Ltd

(“Faron or Company”)

Faron Announces Upcoming Presentation of Biomarker Analysis from Patients in MATINS Trial at AACR Annual Meeting 2022

  • Analysis tested performance of baseline cytokine serum IFNy and TNFa levels to identify patients that experienced disease control following bexmarilimab treatment compared to those that did not
  • Patients with low baseline IFNy and TNFa levels found to experience significantly higher clinical benefit following bexmarilimab treatment
  • Bexmarilimab’s unique mode of action could serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1 blockade

Press Release, March 9, 2022 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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 that an analysis of biomarker data from patients treated with bexmarilimab as part of the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held in New Orleans, US, from April 8 – 13, 2022. These data (Abstract #2767) will be featured in the “Biomarkers Predictive of Therapeutic Benefit” session on Tuesday April 12, 2022 from 9:00 AM – 12:30 PM.

Top line data from the biomarker analysis, which was announced by the Company in December 2021, showed that patients with low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) were more likely to experience clinical benefit following treatment with bexmarilimab, Faron’s wholly-owned investigational precision immunotherapy asset. Data scheduled for presentation at AACR includes more detailed analysis of 30 patients across three tumor types (advanced gastric cancer, cutaneous melanoma and cholangiocarcinoma) showing:

  • Mean levels of IFNy were 5.11 pg/ml (SD +/- 4.99 pg/ml) in patients who experienced a clinical benefit versus 13.07 pg/ml
    (SD, +/- 13.26) in patients who did not experience a clinical benefit with bexmarilimab
  • Mean levels of TNFa were 0.96 pg/ml (SD, +/- 0.74 pg/ml) in patients who experienced a clinical benefit versus 2.37 pg/ml
    (SD, +/- 1.43 pg/ml) in patients who did not experience a clinical benefit with bexmarilimab

The conclusion from the analysis is that, when used together, IFNy and TNFa are highly predictive of response to bexmarilimab (P < 0.0001), and patients with low IFNy and TNFa levels experienced significantly higher clinical benefit following treatment with bexmarilimab. Patients with low levels of pro-inflammatory cytokines experiencing higher clinical benefit is opposite to what is usually seen with currently approved checkpoint inhibitors and other T cell activating agents.

“Understanding which patients are most likely to benefit from immunotherapy treatment is key to tackling cancer,” said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS trial. “This biomarker analysis shows that IFNy and TNFa, which can both be measured by a standard blood test, perform well in identifying patients likely to respond to bexmarilimab and could offer the potential to personalize a patient’s therapy and, ultimately, improve their outcome. This is especially important in earlier treatment line settings and with combination regimens.”

“This analysis continues to strengthen our understanding of what happens in the tumor microenvironment when patients are treated with bexmarilimab,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “It provides a strong biological rational to guide our ambitious development program exploring bexmarilimab’s potential as a monotherapy and in combination with other therapies, only increasing our confidence of the potential impact this novel macrophage-targeting immunotherapy could have on cancer care. Bexmarilimab’s ability to ignite immune reaction could become a significant new tool to increase the stagnated response levels of the currently available and widely used anti-PD-(L)1 treatments.”

The ongoing open label Phase I/II MATINS clinical trial is investigating the safety and efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. In the MATINS trial, bexmarilimab is being investigated as a potential monotherapy in patients with solid tumors who have exhausted all other treatment options. Landmark overall survival (OS) data presented at the Company’s R&D Day in February from patients in Part I/II of the trial who received three courses of treatment and had their scheduled tumor imaging at cycle four (n=92) estimated that 70% of disease control rate (DCR = partial response + stable disease rate) patients were alive at nine months after the landmark (that is, approximately 11 months from initiation of treatment) compared to 26% of non-DCR patients. The most DCR among Part II cohorts was observed in cutaneous melanoma (30%), gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%) patients. Treatment with bexmarilimab continues to be well tolerated with no new safety signals reported and no treatment related adverse events resulting in a decrease or modification of dosing.

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

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

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. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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.

Presentation of Biomarker Data at AACR 2022

Notice of 2021 Full-Year Results and Annual Report

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Notice of 2021 Full-Year Results and Annual Report

 

Press Release, March 7, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 02:00 AM (EST)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), 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, will publish its audited full-year results for the twelve months ended December 31, 2021 on Friday, March 25, 2022 at 9:00 am EET, 7:00 am GMT, 3:00 am EDT. The Annual Report 2021, including audited financial statements for the full year, will be published on the same day.

 

A virtual briefing and Q&A session for analysts 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 on the day of results. The Full-year results release for 2021, presentation, webcast details, and Annual Report 2021 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

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

 

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 untreatable solid tumors, 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 in global trials as a potential treatment for hospitalized patients with COVID-19 and with 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.

 

220303 2021 Full Year Results - Date and Time Announcement
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