Nycomed

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

Summary Highlights (including post-period events) The US Food and Drug Administration (FDA) granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).The latest data from the Phase I/II BEXMAB study reinforces bexmarilimab’s potential to improve the therapeutic benefit for patients with aggressive hematological malignancies who do not respond to the current standard of care (SoC). Compelling data with objective responses were observed in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort. Eight of fifteen objective responses were observed across all three doublet dosing cohorts, with one patient still on treatment after 13 months. Continued efficacy signals with the prolonged duration of responses thus far support advancement to Phase II in Q4 2023 in relapsed/refractory AML and myelodysplastic syndromes (MDS) patients failing hypomethylating agents (HMAs). New biomarker data presented at the EHA2023 Congress indicates that bexmarilimab’s mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow. This mechanism results in notable increases in T and NK cells, along with enhanced antigen presentation. The Phase II BEXCOMBO protocol has been approved by the FDA.The Board was strengthened with the addition of Tuomo Pätsi, and the Leadership team was enhanced with the appointment of James O’Brien, CPA, MBA, as Chief Financial Officer. Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron. Cash position was strengthened through two private placements directed to institutional and other investors, successfully raising EUR 18.6 million.Virtual briefing and Q&A to be held today at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST). TURKU, Finland and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period"). "I am extremely proud of the progress we made in the first half of 2023,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “We continued to execute on advancing our clinical Phase I/II BEXMAB study of bexmarilimab, our wholly-owned immunotherapy asset, in hematological malignancies. To date, we achieved strong objective responses across all three cohorts in relapsed/refractory to SoC patients, including objective responses in three of five patients receiving the high dose. Based on this compelling data, we are advancing into the Phase II portion of the study and actively preparing for regulatory submission in the first half of 2025. The recent FDA Orphan Drug Designation for bexmarilimab in AML further reaffirms our program by offering important clinical development and commercialization benefits. We also strengthened our cash position and welcomed a former Board member as a transactional advisor. I am excited for what the future holds." Pipeline Highlights Bexmarilimab – Faron’s wholly-owned, novel precision cancer immunotherapy candidate, in Phase I/II development for relapsed/refractory AML and MDS. The FDA has granted ODD for bexmarilimab for the treatment of AML.Updated data from the Phase I/II BEXMAB study showed objective responses (OR) with complete remission of blasts in the bone marrow (mCR) in three of five patients in the 6 mg/kg bexmarilimab + azacitidine cohort. In addition, one of the three patients achieved complete recovery of blood counts i.e., complete remission (CR). Eight of fifteen ORs were observed across all three doublet dosing cohorts. Four of the eight patients across the three doublet dosing cohorts (1, 3, and 6 mg/kg) had failed prior SoC hypomethylating agents (HMAs). All three patients with MDS and prior HMA failure demonstrated ORs (partial response (PR), mCR, and CR) across the dosing cohorts. Four patients out of six in the triplet dosing cohort treated with azacitidine, venetoclax, and bexmarilimab have shown objective responses. The updated BEXMAB data supports advancement to Phase II in Q4 2023 in SoC relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA). Biomarker data presented at the European Hematology Association 2023 Hybrid Congress showed bexmarilimab’s mode of action in AML/MDS is supported with durable Clever-1 target engagement in the bone marrow, with increases observed in T and NK cells, and antigen presentation. The Company presented two posters at the American Association for Cancer Research Annual Meeting 2023 on its Phase I/II MATINS study of bexmarilimab in solid tumors and published a manuscript via medRxiv. The findings from MATINS, which have established strong foundations for Faron’s ongoing development program, indicate that bexmarilimab monotherapy facilitates macrophage conversion, and induces changes in the tumor microenvironment resulting in disease control and prolonged survival in late-stage cancer. Furthermore, targeting Clever-1 with bexmarilimab is well-tolerated. A positive Phase I/II meeting with the FDA supported bexmarilimab’s development in solid tumors. Preparations are ongoing for the initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade, aimed at improving the clinical benefits from standard-of-care PD-1 blockade. The first, proof-of-concept cohort under the investigation will be in head and neck cancer, followed by bladder and non-small cell lung cancers. Patient cohorts will comprise between 15 and 40 subjects, with the opportunity for subgroup enrichment. Corporate Highlights The cash position has been strengthened through two private placements directed to institutional and other investors to raise EUR 18.6 million in January 2023 (EUR 12.0 million) and in June 2023 (EUR 6.6 million), which settled in early July 2023.James O’Brien, CPA, MBA, joined as Chief Financial Officer. Mr. O'Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. His appointment highlights Faron's progression towards becoming a global biopharmaceutical company.Mr. Tuomo Pätsi joined the Board as a Non-Executive Director of the Company. Dr. Gregory B. Brown stepped down from his position as a Non-Executive Director. Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development, and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was until recently the Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.Mr. Leopoldo Zambeletti, who joined Faron's Board as a Non-Executive Director in September 2015, stepped down to take on a business development consulting role within Faron. He is a highly respected figure within the life sciences and investment banking industries and, since 2013, has been an independent strategic advisor to life science companies on mergers and acquisitions, out-licensing deals, and financing strategy. Half-Year Financial Results Cash balances of EUR 6.3 million on June 30, 2023 (2022: EUR 9.9 million). The Company raised EUR 6.6 million at the end of June which had not been settled until July 2023. The Company entered the third quarter with EUR 12.8 million and has funds sufficient to support operations into Q4 2023.Operating loss of EUR 12.8 million for the six months ended June 30, 2023 (2022: EUR 13.4 million).Net assets of EUR -9.5 million on June 30, 2023 (2022: EUR -5.2 million).The cash position has been strengthened by two private placements directed to institutional and other investors to raise EUR 18.6 million.On June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. On June 30, 2023, and August 28, 2023, the Company was in compliance with all covenants while holding cash balances of EUR 6.3 million and EUR 9.1 million, respectively. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the year end of 2023. Consolidated key figures, IFRS EUR’000UnauditedUnaudited Audited 1-6/20231-6/20221-12/2022 6 months6 months 12 monthsRevenue0 0 0 Other operating income0 485 803 Research and Development expenses(8 518)(10 047)(20 730)General and Administrative expenses(4 294)(3 801)(7 498)Loss for the period(13 730)(13 121)(28 730) UnauditedUnaudited Audited 1-6/20231-6/20221-12/2022 6 months6 months 12 monthsLoss per share, EUR(0.22)(0.25)(0.52)Number of shares at end of period66 161 373 56 575 453*59 805 383 Average number of shares62 985 028 53 235 643 55 229 835 EUR’000Unaudited Unaudited Audited 30 Jun 202330 Jun 202231 Dec 2022Cash and cash equivalents6 315 9 936 6 990 Equity(9 483)(5 194)(11 476)Balance sheet total12 836 16 729 11 271 * of which 1,311,800 were held in treasury August 29, 2023Faron Pharmaceuticals Board of Directors This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR"). Conference call informationA virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and James O’Brien, Chief Financial Officer, today, August 29, 2023, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST) on the day of results. Webcast registration link: https://faron.videosync.fi/h1-2023 The half-year report, presentation, and a replay of the webcast will be available on the Company's website at https://www.faron.com/investors. For more information please contact: Investor Contact LifeSci Advisors Daniel Ferry Managing Director daniel@lifesciadvisors.com +1 (617) 430-7576 Media Contact Faron Pharmaceuticals Jennifer C. Smith-Parker Head of Communications Jennifer.Smith-Parker@faron.com Cairn Financial Advisers LLP, Nomad Sandy Jamieson, Jo Turner Phone: +44 (0) 207 213 0880 Peel Hunt LLP, Broker Christopher Golden, James Steel Phone: +44 (0) 20 7418 8900 Sisu Partners Oy, Certified Adviser on Nasdaq First North Juha Karttunen Phone: +358 (0)40 555 4727 Jukka Järvelä Phone: +358 (0)50 553 8990 About Bexmarilimab Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e., helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care. About BEXMAB The BEXMAB study is a first-in-human, open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. About BEXCOMBO The Phase BEXCOMBO study will be aimed at testing bexmarilimab with PD-1 blockade. The study’s purpose is to improve standard-of-care PD-1 response rates. The indications targeted are head and neck cancer as the first cohort to gain proof-of-concept data, followed by bladder cancer and non-small cell lung cancer. Patient cohorts will number between 15 and 40 subjects, with allowed enrichment of subgroups. We see development in this space as key to addressing an unmet medical need, as clinical data show that up to 80% of cancer patients do not respond to single agent PD-1 blockade. Planning continues for trial initiation. About Faron Pharmaceuticals Ltd. Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the 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 and Chief Executive Officer's Review IntroductionThe first half of 2023 has been a period of significant progress for Faron. Most notably, we continued to accelerate our ambitious bexmarilimab development program. The most recent data from the Phase I/II BEXMAB study in relapsed/refractory myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients builds upon earlier positive data. These findings set a clear trajectory for further bexmarilimab clinical and regulatory development, bringing the promise of treatment to patients who do not respond to currently approved standard-of-care treatments. BexmarilimabDriving the clinical development of bexmarilimab continues to be Faron’s top priority. Since we recruited the first patient in our Phase I/II BEXMAB study in June 2022, we have continued to see positive data that indicates truly life-changing therapeutic potential for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients refractory to standard of care (SoC). Most recently, we reported compelling data of objective responses in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort, and eight of 15 objective responses observed in all three doublet dosing cohorts with patient still on treatment after 13 months. We intend to have additional Phase I data in Q4 2023. Yet even now, the updated data supports the advancement to the Phase II portion in the Q4 2023 focusing on SoC relapsed/refractory acute AML and MDS patients failing hypomethylating agents (HMA). Furthermore, we announced plans to file the Company’s first Biologics License Application (BLA) to the FDA in H1 2025. This opportunity is so exciting because we know that certain blood cancer cells carry significant amounts of cell surface Clever-1, which may limit the body’s ability to mount an immune response. In fact, research has shown a clear survival benefit among certain blood cancer patients with low Clever-1 expression. By adding bexmarilimab to standard of care we expect to downregulate Clever-1 expression, thereby increasing antigen presentation and allowing the immune system to better identify and kill cancer cells. This could result in a deeper and more durable clinical benefit compared to what most patients experience with currently approved treatments. The FDA has recognized the importance of addressing the unmet needs of this population and granted bexmarilimab ODD for the treatment of AML. AML is the most common leukemia among the adult population and accounts for about 80% of all cases. As bexmarilimab advances and Faron expands into a global pharmaceutical company, we hired James O’Brien, CPA, MBA, as Chief Financial Officer (CFO). Mr. O'Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. Most recently, Mr. O'Brien served as the CFO of Cognition Therapeutics, Inc., a clinical-stage biopharmaceutical company which successfully completed an IPO in October 2021, raising USD 52 million. He previously served as Executive Vice President of Finance with Enzo Biochem, Inc. Earlier in his career, he held positions with increasing responsibilities at pharmaceutical companies including Actavis PLC (now AbbVie, Inc.), the US subsidiary of Swiss company Nycomed, which has since been acquired by Takeda Pharmaceuticals, and Bristol Myers Squibb. In terms of other plans for bexmarilimab, we anticipate initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade. The trial is aimed at improving standard-of-care PD-1 response rates. Head and neck cancer would be the first cohort indication to gain proof-of-concept data, followed by bladder cancer and non-small cell lung cancer. Patient cohorts will number between 15 and 40 subjects, with allowed enrichment of subgroups. We see development in this space as key to addressing an unmet medical need, as clinical data show that up to 80% of cancer patients do not respond to single agent PD-1 blockade and evolving data suggest that promoting pro-inflammatory cytokines, such as IFN-gamma (ɣ), is necessary for effective responses to these agents. Because bexmarilimab induces IFN-ɣ upregulation, which is required for immune modulation in the tumor microenvironment, BEXCOMBO offers the potential to expand the population of PD-1 responders and provide meaningful benefit to more patients. Financial review Faron entered 2023 having completed a EUR 12.0 million equity financing in January 2023. In June, we completed our second equity financing, bringing the year-to-date total to EUR 18.6 million. The capital raised through the private placements is instrumental in advancing our bexmarilimab research and development program, accelerating the progress of our pipeline, and bringing us closer to delivering life-changing therapies to tackle aggressive hematological malignancies. Faron’s shareholders continue to be extremely supportive of our clinical development programs and achieving our objectives. Faron’s recent financial performance has been marked by a strategic emphasis on capital efficiency, a key element of extending our cash runway, while having the strength and ability to advance our clinical development programs. This capital efficiency has allowed us to achieve more with our available resources, fostering a culture of innovation while maintaining a prudent financial approach. By allocating resources thoughtfully and embracing a culture of continuous improvement, we are dedicated to maximizing the impact of our efforts and achieving our mission. The balance between achieving clinical milestones and responsible fiscal management underscores our dedication to creating a sustainable, long-term value for all stakeholders. During the period, nearly 70% of all spending was directly supportive of our bexmarilimab clinical development program. Faron maintained General and Administrative expenses at 2022 levels excluding one-time items and financing expenses. Statement of comprehensive incomeThe operating loss for the six months ended June 30, 2023, was EUR 12.8 million (six months ended 30 June 2022: loss of EUR 13.4 million). No revenue was generated during the period or prior period. Research and development expenses decreased by EUR 1.5 million to EUR 8.5 million (2022: EUR 10.0 million). General and administrative expenses increased by EUR 0.5 million to EUR 4.3 million (2022: EUR 3.8 million). The loss for the period was EUR 13.7 million (2022: loss of EUR 13.1 million) and the basic and diluted loss per share was EUR 0.22 (2022: loss per share of EUR 0.25). Statement of financial position and cash flowsAs of June 30, 2023, net assets amounted to EUR -9.5 million (June 30, 2022: EUR -5.2 million). The net cash flow for the first six months in 2023 was EUR -0.7 million (2022: EUR 3.1 million). As of June 30, 2023, total cash and cash equivalents held were EUR 6.3 million (2022: EUR 9.9 million). CorporateFaron’s Annual General Meeting (AGM) was held on March 24, 2023. The AGM adopted the financial statements of the Company and re-elected audit firm PricewaterhouseCoopers Oy ("PwC") as the Company's auditor. Additionally, the number of members of the Board was confirmed as seven. Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski were re-elected to the Board and Tuomo Pätsi was elected as a new member to the Board for a term that ends at the end of the next AGM. In June 2023 Leopoldo Zambeletti stepped down from his position in Faron’s Board due to his appointment as the Company’s business development consultant. Summary & outlookOur focus for the remainder of 2023 continues to be the acceleration of bexmarilimab’s clinical development. Faron plans to seek FDA advice during Q3 2023 on bexmarilimab’s progress. The completion of dose escalation, readout of enrichment cohorts, and initiation of phase II BEXMAB part are expected in Q4 2023. We are committed to changing the treatment paradigm for those with limited treatment options. On behalf of the Board, we would like to thank our shareholders, existing and new, for their support of Faron. We would also like to thank our employees for their continued commitment to our mission and the patients we serve. We look forward to updating the market on our progress throughout the course of the year. Dr Markku JalkanenChief Executive Officer Dr Frank ArmstrongChairman Consolidated Income Statement, IFRS EUR’000Unaudited1-6/20236 monthsUnaudited1-6/20226 monthsAudited1-12/202212 monthsRevenue0 0 0 Other operating income0 485 803 Research and development expenses(8 518)(10 047)(20 730)General and administrative expenses(4 294)(3 801)(7 498)Operating loss(12 812)(13 364)(27 426)Financial income0 692 96 Financial expense(918)(430)(1 400)Loss before tax(13 730)(13 102)(28 730)Tax expense0 (19)0 Loss for the period(13 730)(13 121)(28 730)Translation difference0 11 17 Comprehensive loss for the period attributable to the equity holders of the Parent company(13 730)(13 110)(28 713) Loss per ordinary share Basic and diluted loss per share, EUR(0.22)(0.25)(0.52) Consolidated Balance Sheet, IFRS EUR’000UnauditedUnauditedAudited 30 Jun 202330 Jun 202231 Dec 2022Assets Non-current assets Machinery and equipment10 17 13 Right-of-use-assets272 98 314 Intangible assets1 127 1 011 1 154 Prepayments and other receivables60 53 60 Total non-current assets1 469 1 179 1 541 Current assets Prepayments and other receivables5 052 5 614 2 740 Cash and cash equivalents6 315 9 936 6 990 Total current assets11 367 15 550 9 730 Total assets12 836 16 729 11 271 EUR’000UnauditedUnauditedAudited 30 Jun 202330 Jun 202231 Dec 2022Capital and reserves attributable to the equity holders of the Parent company Share capital2 691 2 691 2 691 Reserve for invested unrestricted equity144 778 120 839 129 544 Accumulated deficit(156 955)(128 726)(143 713)Translation difference2 2 2 Total equity(9 483)(5 194)(11 476) Provisions Other provisions0 0 158 Total provisions0 0 158 Non-current liabilities Borrowings10 892 12 250 11 102 Lease liabilities163 0 163 Other liabilities702 539 853 Total non-current liabilities11 757 12 789 12 118 Current liabilities Borrowings2 304 0 1 851 Lease liabilities119 106 153 Trade payables6 002 7 791 6 014 Accruals and other current liabilities2 137 1 238 2 453 Total current liabilities10 562 9 135 10 471 Total liabilities22 319 21 924 22 748 Total equity and liabilities12 836 16 729 11 271 Consolidated Statement of Changes in Equity, IFRS EUR’000 Share capitalReserve forinvestedunrestrictedequityTranslationdifferenceAccumulateddeficitTotal equity Balance as at31 December 2021 (Audited) 2 691116 507-15-116 265 2 919 Comprehensive loss for the last six months 20220011-13 121 -13 110 Transactions with equity holders of the Parent company Issue of ordinary shares 04 33200 4 332 Share-based compensation 000665 665 04 3320665 4 997 Balance as at 30 June 2022 (Unaudited) 2 691120 8392-128 726 -5 194 Comprehensive loss for the year 2022 0017(28 730)(28 713) Transactions with equity holders of the Company Issue of ordinary shares, net of transaction costs013 03700 13 037 Share-based compensation 0001 297 1 297 Other movements 000(16)(16) 013 03717(27 448)(14 395) Balance as at31 December 2022 (Audited) 2 691129 5442(143 713)(11 476) Comprehensive loss for the last six months 2023000(13 730)(13 730) Transactions with equity holders of the Company Issue of ordinary shares, net of transaction costs015 23300 15 233 Share-based compensation 000489 489 015 2330(13 241)1 992 Balance as at 30 June 2023 (Unaudited) 2 691144 7782(156 955)(9 483) Consolidated Cash Flow Statement, IFRS €’000Unaudited1-6/20236 monthsUnaudited1-6/20226 monthsAudited1-12/202212 monthsCash flow from operating activities Loss before tax(13 730)(13 102)(28 730)Adjustments for: Received grants0 (415)(803)Depreciation and amortization174 151 300 Change in provision(158)0 (158)Financial items918 529 1 304 Tax expense0 (19)0 Share-based compensation489 665 1 297 Adjusted loss from operations before changes in working capital(12 308)(12 191)(26 790)Change in net working capital: Prepayments and other receivables (increase -)1 028 819 2 864 Trade payables (increase +)(8)1 211 719 Other liabilities (increase +)(272)(1 014)1 183 Cash used in operations(11 561)(11 175)(22 023)Income taxes paid0 0 0 Transaction costs related to loans and borrowings0 0 (165)Interest received0 0 11 Interest paid(782)(108)(816)Net cash used in operating activities(12 343)(11 283)(22 993) Cash flow from investing activities Payments for intangible assets(68)(167)(385)Payments for tangible assets0 0 (0)Net cash used in investing activities(68)(167)(385) Cash flow from financing activities Proceeds on issue of shares12 077 4 331 13 445 Share issue transaction cost(648)0 (365)Proceeds from borrowings64 10 389 10 389 Repayment of borrowings0 (108)(105)Proceeds from grants382 0 231 Payment of lease liabilities(84)(96)(116)Net cash from financing activities11 791 14 516 23 478 Net increase (+) / decrease (-) in cash and cash equivalents(675)3 083 137 Effect of exchange rate changes(55)17 37 Cash and cash equivalents at 1 January6 990 6 853 6 853 Cash and cash equivalents at the end of period6 315 9 936 6 990 Notes to the interim financial report1. Corporate information Faron Pharmaceuticals Ltd (the “Company”) is a clinical stage biopharmaceutical company incorporated and domiciled in Finland, with its headquarters at Joukahaisenkatu 6, 20520 Turku, Finland. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. The Company has been listed on the London Stock Exchange's AIM market since November 17, 2015, with a ticker FARN, and since December 3, 2019, the Company has been listed on the Nasdaq First North Growth Market with a ticker FARON. 2. Summary of significant accounting policies 2.1. Basis of preparation The unaudited H1 interim financial report has been prepared in accordance with the International Financial Reporting Standards of the International Accounting Standards Board (IASB) and as adopted by the European Union (IFRS) and the interpretations of the International Financial Reporting Standards Interpretations Committee (IFRIC). The principal accounting policies applied in the preparation of these interim financial report is set out below. The Company has consistently applied these policies to all the periods presented, unless otherwise stated. The areas of the report involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the interim financial report, are disclosed in note 2.2. The unaudited interim financial report incorporates the parent company, Faron Pharmaceuticals Ltd, and all subsidiaries (the “Group”). All amounts are presented in thousands of euros, unless otherwise indicated, rounded to the nearest euro thousand. 2.2. Going concern The Group has forecasted its estimated cash requirements over the next twelve months. To make these forecasts the Group has made a number of assumptions regarding the quantity and timing of future expenditure and income as well as other key factors. Though these estimates have been made with caution and care, they continue to contain a significant amount of uncertainty. The Group also has debt obligations which carry financial covenants that could adversely impact the Group’s liquidity and operating flexibility. Based on the forecast the Group believes that it has adequate financial resources to continue its operations until the year end of 2023.  The Group has taken several actions to secure further financing during the rest of the year 2023. The Directors believe that the Group can gain access to further resources to sustain operations over the next 12 months. Therefore, this unaudited financial report has been prepared on a going concern basis. At this stage the Group cannot disclose any of these options. Because the additional finance is not committed at the date of issuance of this H1 2023 report, these circumstances represent a material uncertainty that may cast significant doubt on the Group’s ability to continue as a 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. 2.3. Financial covenants At June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. At June 30, 2023, and August 28, 2023, the Company is in compliance with all covenants while holding cash balances of EUR 6.3 million and EUR 9.1 million, respectively. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the year end of 2023. 3. Subsequent events The settlement of the second private placement during the period announced on June 29, 2023, was completed early July 2023.In its meeting on August 28, 2023, the Board of Directors of the Company approved the publishing of this interim financial report.

LUND, SWEDEN / ACCESSWIRE / May 23, 2023 / BioInvent International (STO:BINV) Experienced regulatory affairs leader who has worked on all stages of product development Will play important role in progress of pipeline of four assets in five clinical trials Lund, Sweden - May 23, 2023 - BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces the appointment of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs. Lindvig, an experienced regulatory affairs leader who has worked across all stages of product development and has hands-on experience of the US and EU regulatory systems, will join on June 12, 2023, be part of the BioInvent management team and report to CEO Martin Welschof. "I am very pleased to welcome Ingunn Munch Lindvig to BioInvent. As our new Senior Vice President Regulatory Affairs, Ingunn's expertise in product development and working with regulatory authorities will play an important role as we progress our exciting pipeline. Her experience on the regulatory implications of development plans in clinical, preclinical and manufacturing, as well as in marketing strategies and product pro will help to drive the progress of our four clinical-stage products through development and towards market," said Martin Welschof, CEO of BioInvent. Lindvig joins from Norwegian biotech company Circio, where she was Vice President and Head of Regulatory Affairs since 2019. She was previously Head of Regulatory Affairs at Nordic Nanovector and also held senior regulatory positions at Photocure and Nycomed/GE Healthcare. She holds a PhD in biology from the University of Oslo. About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . Follow on Twitter: @BioInvent. BioInvent International AB (publ) Co. Reg. No. Org nr: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 Attachments BioInvent strengthens management with appointment of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs SOURCE: BioInvent International View source version on accesswire.com: