University of Michigan

MARLBOROUGH, Mass., April 05, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company®, today announced it will highlight case studies featuring its Spatial Biology 2.0 Solutions that enable unprecedented speed and scale for spatial biology studies at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego, April 5 to 10. In addition, the company will showcase new applications of its PhenoCode™ Signature Panels and preliminary data from the Thermo Fisher ViewRNA assays on Akoya’s platforms. Presentations Showcase the Power of Spatial Biology 2.0 Industry-leading capabilities of the company’s spatial biology platforms will be presented during Akoya’s Spotlight Theater, titled “Spatial Biology 2.0: Spatial Insights and Precision Medicine at Unprecedented Scale” on Monday, April 8 at 3 PM (PST). The event will describe how researchers are revealing new insights into the tumor microenvironment, elucidating the mechanisms of cancer treatment response, and paving the way for spatial biology to impact patient outcomes. Deployment of Akoya’s PhenoCycler®-Fusion 2.0, PhenoImager® HT 2.0, and PhenoCode Panels across the research continuum, from ultrahigh-plex discoveries to actionable signatures, will be described by the presenters: Suzanne K. Coberly, MS MD, FCAP, Scientific Senior Director, Discovery & Translational Pathology, Oncogenesis TRC, Bristol Myers SquibbArutha Kulasinghe PhD, Scientific Director of the Queensland Spatial Biology Center in Brisbane, Group Leader at The University of QueenslandPascal Bamford, PhD, Senior Vice President, R&D and Laboratory Operations, Akoya Biosciences Dr. Kulasinghe will also present a talk entitled “Ultra high-plex profiling of the tumor microenvironment” on April 6 from 12:36 PM - 12:54 PM PT in Session MW14 - Choosing and Using Antibodies for Spatial Informed Protein Expression. He will discuss the development of ultrahigh-plex antibody panels for the comprehensive characterization of the tumor microenvironment. Spatial Biology 2.0 Solutions Displayed at Booth #247 Akoya Biosciences will demonstrate new uses of its PhenoCode Signature Panels for accelerating discovery and validation of spatial biomarkers using the PhenoImager HT 2.0 platform. The company will also present initial findings from the Thermo Fisher Scientific ViewRNA assays on the PhenoCycler-Fusion 2.0. PhenoCycler-Fusion 2.0: Offers automated multi-slide capabilities, allowing researchers to efficiently generate ultrahigh-plex, multiomic spatial phenotyping data for larger samples at exceptional speeds.PhenoImager HT 2.0: Features targeted PhenoCode Signature Panels and onboard spectral unmixing, simplifying biomarker development and validation workflows for large scale studies. Poster Presentations Several studies featuring Akoya’s Spatial Biology platforms will be described in the following posters: Monday, April 8: 9:00 AM – 12:30 PM Poster 1525: Integration of high-plex tumor-Immune phenotyping and checkpoint interactions for deeper spatial characterization of human cancer tissues. S. Bodbin, Navinci Diagnostics et al. Monday, April 8: 1:30 PM – 5:00 PM Poster 3623: Quantifying pharmacodynamic markers of radioligand therapies in tumor by multiplex immunofluorescence and automated quantitative analysis (AQUA) algorithms. J. Santos, Navigate BioPharma Services, Inc. et al. Poster 3651: Mutational analysis and spatial phenotyping to decipher racial disparities in pancreatic adenocarcinoma; D. J. Salas-Escabillas, University of Michigan et al. Poster 3763: Comparative spatial analyses of the tumor immune landscape in different mouse models of glioblastoma; D. Klymyshyn, Akoya Biosciences et al. Tuesday, April 9: 9:00 AM – 12:30 PM Poster 3988: Deep spatial immunophenotyping of lymphoid aggregates in pancreatic cancer using multi-omic integration of ultra high-plex proteomics and transcriptomics; D. Gong, Massachusetts Institute of Technology (MIT) et al. Poster 5503: Ultrahigh-plex spatial phenotyping of head and neck cancer tissue uncovers multiomic signatures of immunotherapy response; A. Pratapa, Akoya Biosciences et al. Poster 5504: Integrating ultrahigh-plex spatial phenotyping: From discovery to clinical applications, A. Pratapa; Akoya Biosciences et al. Tuesday, April 9: 1:30 PM – 5:00 PM Poster 5507: High-resolution spatial atlas reveals insight into spatial landscape of lung cancer and chronic lung diseases; R. Nandigama, Justus Liebig University et al. Poster 5508: Single-cell spatial landscape of the mutation-specific human lung tumor immune microenvironment; R. Nandigama, Justus Liebig University et al. Wednesday, April 10: 9:00 AM – 12:30 PM Poster 6738: Overlapping and distinct mechanisms of effective neoantigen cancer vaccines and immune checkpoint therapy; S. Keshari, UT MD Anderson Cancer Center et al. Poster 6872: A spatio-temporal approach to mapping the dynamics of cutaneous squamous cell carcinoma progression and immunotherapy response: A journey through TiME; N. Jhaveri, Akoya Biosciences et al. Network of CROs Providing Spatial Biology Services Continues to Grow Thirteen of Akoya’s twenty qualified CRO service providers will also be exhibiting at AACR. Akoya’s CRO network continues to grow rapidly, reflecting the demand for spatial phenotyping solutions across the biopharmaceutical industry. Offering biomarker testing services, these CROs enable drug developers and academic research institutions to accelerate the discovery and development of new immuno-therapies. Full details about Akoya’s AACR activities and poster presentations can be found here. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our expectations about the potential and utility of our products and services, the market demand for spatial phenotyping solutions and predictions regarding the future impact of spatial biology. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. About Akoya Biosciences As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The Company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com. Investor Contact: Priyam ShahSr. Director, Investor RelationsAkoya Biosciencesinvestors@akoyabio.com Media Contact: Christine Quern617-650-8497media@akoyabio.com

Initiation of Phase II clinical trial of OATD-01 (KITE) for the treatment of pulmonary sarcoidosis following approval from the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). World's first administration of a chitotriosidase 1 inhibitor (or placebo) to a patient with active pulmonary sarcoidosis as part of the Phase II OATD-01 clinical trial (proof-of-concept in human) at a hospital in the UK. First success in mRNA platform development - inhibited translation of pathogenic proteins in a cellular assay (in vitro proof-of-concept) - achieving an important discovery milestone in the development of a breakthrough small-molecule drug platform targeting mRNA. Further advances in the Phase I clinical trial of OATD-02, the first-in-class dual arginase inhibitor being developed for the treatment of cancer, systematic dose escalation and progression to a fourth cohort of patients with solid tumours, to determine the maximum tolerated dose and recommended dose for the next phase of trials. Further development of the most advanced project in the preclinical phase - the USP7 inhibitor programme for use in anti-cancer therapies using artificial intelligence tools and models. Warsaw, April 3, 2024. - Molecure S.A. ("Molecure", WSE ticker: MOC), a biotechnology company that discovers and develops drugs to the clinical stage and leverages its globally unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA function to treat a range of incurable diseases, has published its 2023 annual report. The report is available at: “2023 was an exceptional year for Molecure as we made significant progress in the development of both clinical and preclinical programmes, particularly in the area of small-molecule drugs targeting mRNA. We initiated clinical trials of our drug candidate, which was discovered and brought into clinical trials for cancer patients by Molecure. We have made significant progress with OATD-02, a dual arginase inhibitor, and will soon begin administering the drug (at a dose of 20 mg) to a fourth cohort of patients with solid tumors. We are also seeing an increase in biomarkers suggesting a pharmacodynamic effect in the absence of significant side effects. In 2023, our focus was also on preparing for a Phase II clinical trial for OATD 01, Molecure's flagship clinical programme. We obtained FDA and then MHRA approval to initiate a Phase II clinical trial of OATD-01 in patients with pulmonary sarcoidosis. It is noteworthy that we went through the whole procedure very smoothly, which demonstrates the high quality of our research and documentation. We are very pleased to report that the first patient has started dosing in a clinical trial at a clinical site in the UK. OATD-01 is a first-in-class chitinase inhibitor developed by Molecure scientists for the treatment of sarcoidosis, which will be administered to placebo-controlled patients. We are shortly awaiting Phase II clinical trial approvals for OATD-01 from regulatory authorities in Denmark, France, Greece, Germany and Norway. Last year was also a time to continue Molecure's transformation into a cutting-edge company, applying the latest generative and predictive artificial intelligence techniques to our early drug discovery programmes, including a platform of small-molecule drugs interacting directly with mRNA targets. We achieved our first major success with Proof-of-Concept in vitro, confirming the inhibition of protein translation with compounds targeting the mRNA encoding the protein. We also adopted an approach to identifying the most promising preclinical projects, aiming to maintain a balanced portfolio of projects with strong clinical and transactional potential. The last two years have been difficult for biotech companies due to the destabilisation of the geopolitical environment, inflation and interest rates, which slowed down partnership discussions and capital raising. Despite these difficulties, thanks to investors' faith in the potential of our programmes, we successfully completed a capital round and raised approximately PLN 50 million in growth funding from investors through a share issue. Our clinical development is incurring increasing costs, but we have our own funding and awarded grants that will allow us to continue with both clinical projects and those with the best earlier stage of development until at least early 2025. In parallel, we are applying for new grants to support projects and IT and computational methods, which will allow us to accelerate the development of programmes. We are confident that pursuing our mission will open up new treatment opportunities for patients and provide a significant return on investment for shareholders. We thank you for your trust to date and encourage you to continue working with us.” - said Marcin Szumowski, CEO of Molecure S.A. Presentation for investors The Company's presentation to investors will take place on 10th April 2024, at 2 pm (CEST) in an online meeting format, under the link: Selected key developments in 2023 and up to the date of publication of the financial report Strategy Update The Company's main strategic objectives in the area of R&D and business development are: Continued intensive clinical development of two key projects: completion of a Phase II study for OATD-01 in sarcoidosis and completion of a Phase I clinical trial for OATD-02 in oncology patients, with possible expansion to additional indications and combination therapies Further development of early preclinical stage projects, including the identification of 1-2 advanced lead compounds (candidates for preclinical development) and the introduction of a further programme to the clinical trial stage Accelerate the development of a breakthrough platform of small-molecule drugs targeting mRNA, including the achievement of in vitro PoC and the selection of lead molecules Increasing the efficiency of drug discovery processes (by reducing time and cost and lowering the risk of failure) through investment in machine learning and generative artificial intelligence (GenAI) technology Conclusion of at least 1 high-value partnership agreement for at least one clinical-stage project, as well as the establishment of a number of commercial collaborations, including profit-sharing, for earlier-stage programmes Investment expenditures, among others, for the implementation of the objectives set out in the Strategy in the period from 2024 to the end of 2025 have been set at approximately PLN 150 million. Successful completion of a public offering (SPO) Molecure has successfully raised gross proceeds of approximately PLN 50m from its public share offering from existing and new shareholders The funds raised from the SPO and expected grants will be used to fund the Company's growth plans and continue to build a balanced portfolio of breakthrough therapies including first-in-class drugs, including the completion of a Phase II study of OATD-01 in sarcoidosis and the completion of a Phase I clinical trial of OATD-02 in oncology patients, with the potential to expand into additional indications and combination therapies Phase II clinical trial approvals for OATD-01 and initiation of the trial Molecure has received approval from the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a Phase II clinical trial for OATD-01 in the US and UK. The proof-of-concept Phase II study is the first to administer the drug to patients with pulmonary sarcoidosis. The world's first patient administration of chitotriosidase inhibitor 1 (CHIT1) or placebo took place in March this year at the Royal Infirmary in Edinburgh. As part of the trial, patients will take a fixed dose of 25 mg OATD-01 or placebo daily in tablet form for 12 weeks Molecure has reapplied for permission to conduct a Phase II clinical trial of OATD-01 in EU countries: Denmark, France, Greece, Germany and Norway. In the previous coordinated assessment procedure, a refusal decision was issued by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the effect of the refusal was that, despite receiving approval from the ethics committees in Greece, Germany, France, Denmark, Poland and Norway, it was not possible to conduct the clinical trial in the requested EU countries, as Poland was reported in the application as the rapporteur country. In the re-proceeding, Molecure proposed Denmark as a rapporteur country in the application assessment process. Phase I clinical trial OATD-02 Achieving significant progress in the clinical development of OATD-02, an oral, potent and selective first-in-class arginase (ARG1 and ARG2) inhibitor, in cancer therapies March 2023 saw the administration of OATD-02 to the first oncology patient in a Phase I clinical trial to evaluate the safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors Continued systematic dose escalation and planned imminent commencement of administration in a fourth cohort of patients with solid tumors, to determine the maximum tolerated dose and recommended dose for the next phase of the study Development of the mRNA platform Molecure confirms the efficacy of small molecules in inhibiting the translation of pathogenic proteins achieving a key milestone in the development of a breakthrough platform of small-molecule drugs targeting mRNAs In vitro proof-of-concept (PoC) assay confirms inhibition of protein translation with compounds targeting the mRNA encoding the protein The PoC stage for the first molecule developed in the mRNA platform provides evidence of the effectiveness of Molecure's strategy to identify mRNA-binding compounds with therapeutic potential The success achieved in the development of the mRNA platform increases the likelihood of signing a collaboration agreement with partners working in this area Receipt of funding for a project to develop small-molecule drugs directly interacting with mRNA under the SMART pathway of the FENG programme (European Funds for a Modern Economy). The amount of funding is approximately PLN 32.5 million with a total project budget of approximately PLN 51.5 million. The project will be implemented between 2023 and 2028 Business Development In 2023, Molecure representatives held a total of 107 meetings with biotech industry representatives in Europe and the US (Basel, London, Boston, Munich), mainly with potential partners, investors and global pharmaceutical companies. OATD-01 (37 meetings), OATD-02 (25 meetings) and USP7 (23 meetings) attracted the most interest. As a result of the meetings held, the Company signed 11 non-disclosure agreements (CDAs) with interested companies. This year, representatives of the Company were present at the BIO-Europe conference in Barcelona, which took place from 18-20 March Key organisational changes in 2023 relevant to the growth and advancement of research programme Appointment of Dr Samson Fung - Chief Medical Officer to the Company's Board of Directors to support the clinical development of OATD-01 and OATD-02 Dr Zbigniew Zasłona has been promoted to Chief Scientific Officer from his previous role as VP Research Biology. Dr Zasłona remains a member of the Board of Directors of Molecure Summary of financial data in 2023 Operating income of PLN 1.3 million, up from PLN 1.6 million in 2022. Operating expenses were PLN 23.4 million, up PLN 4.8 million from 2022, due to the progressive advancement of the Company's programmes and pipeline expansion. Increase mainly due to an increase in salaries and wages, increasing early-stage research costs and third-party service costs Net loss in 2023 amounted to PLN 18.3 million compared to a net loss of PLN 15.3 million in the same period in 2022 As at 31 December 2023, Molecure had cash and cash equivalents of nearly PLN 64 million. As at the date of publication of the Annual Report (29 March 2024), the Company has approximately PLN 54 million at its disposal - the Company has a stable capital position necessary to continue to finance the Company's dynamic growth. In addition, contracted grant funding for the coming years amounts to PLN 32.5 million. The Company plans to obtain further grants for projects within the framework of the pipeline developed so far. *** About Molecure S.A. Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, using its own unique expertise in medicinal chemistry and biology to search for and develop first-in-class small-molecule drugs that, through direct modulation of previously unexplored protein and RNA targets, could provide therapies for many incurable diseases. Molecure has generated a diverse portfolio of seven distinct programmes with the support of leading academic research institutions around the world, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (MIBMiK). The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, which is ready to enter Phase II clinical trials. The Phase II study in sarcoidosis patients started in Q4 2023 in the US and the UK and will also continue in the EU and Norway, after gaining the appropriate regulatory approval. The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023. Molecure's headquarters and laboratories are located in Warsaw and Lodz. The company is listed on the Warsaw Stock Exchange (ticker: MOC). Detailed information can be found on: LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA

A new study looks at 110 years of income tax history across the U.S. and notes out-migration by wealthy Americans. After the introduction of the income tax in the United States, there has been a migration of higher income earners toward states with lower or no income tax, a new study reveals. This first-ever systematic analysis of 110 years of state income tax implementation throughout the United States also highlights the consequences of taxpayers fleeing to low or no-tax states. Published in the American Economic Journal: Economic Policy, the study is titled "The Introduction of the Income Tax, Fiscal Capacity, and Migration: Evidence from U.S. States" and was coauthored by Ugo Antonio Troiano, economist and associate professor at the University of California, Riverside. The analysis looks at pre-World War II and post-World War II personal income tax impacts. The state-level tax policies from 1900 to 2010 examined in the paper reveal that income tax adopting states increased revenue per capita by 12% to 17%, but that increase does not correspond to an increase in total revenues for the government in monetary terms. This is because the introduction of income tax in the post-World War II era led to out-migration by wealthy Americans. "Personal income tax means a tax upon labor income, first introduced for the purpose of redistribution of wealth," said Troiano, whose expertise includes politics and economics. "The idea was to provide services to poorer parts of the population and reduce inequality between low-income and high-income residents." According to study results, implementing higher taxes was not well accepted by many wealthy Americans -- their higher income allows them to be more mobile, and therefore able to seek new residency in states with lower personal income tax or no tax. Historically, mobility in the U.S. has been higher compared to European countries, mainly because people here speak the same language, making it easier to settle in a new city, Troiano said. The analysis also showed that out-migration began to slow down in the 1980s. Income taxes are important for states because they allow governments to increase revenue per capita, but pre-World War II, these tax policies came with waves of legal court challenges. Pennsylvania, for example, attempted to amend the state constitution eight times. Other states such as Indiana and Washington also tried, but all failed. To date, six states: Texas, Florida, Nevada, Washington State, Wyoming, and South Dakota, have never introduced permanent individual income tax. California introduced the personal income tax in 1935, it was one of 18 states that implemented the tax between 1930 and 1940. "In New Mexico, the legislature repealed its first income tax law in 1920. In Iowa, the state assembly passed an income tax bill in 1932 that was subsequently defeated in the state senate. In Colorado, the governor vetoed an income tax bill passed by the legislature in 1935. With the exception of Washington, however, all of these states would eventually introduce an income tax," the authors state in the paper. Through analyzing U.S. Census datasets, Troiano and his colleagues, Traviss Cassidy, assistant professor of economics at the University of Alabama, and Mark Dincecco, associate professor at the University of Michigan, found that wealthier Americans tended to move out of state when income taxes were too high, but remained when income tax increases were minimal. Troiano said that when states consider how to reduce income inequality, they should also be mindful of mobility responses. "Raising taxes too much might backfire, as the state might lose too many relatively wealthy contributors," Troiano said.