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DUBLIN, Oct. 31, 2023 /PRNewswire/ -- The  "Global Precision Medicine Business Investment Opportunities" report is now available at ResearchAndMarkets.com. This report furnishes a data-centric perspective on the burgeoning precision medicine industry, emphasizing its potential, growth trajectory, and influential trends. Precision medicine is redefining healthcare, equipping medical professionals with tools to predict disease risk, make accurate diagnoses, and devise customized treatment plans. The report underscores that its application is not just a North American phenomenon. For instance, global initiatives such as the UK Biobank and BioBank Japan echo the paradigm shift towards precision medicine. While the allure of AI and precision medicine is palpable, challenges remain, particularly in data harmonization and meeting regulatory, privacy, and sociocultural mandates. Key Highlights:
Precision Medicine market is projected to grow at a CAGR of 11.3% from 2023 to 2027, reaching a valuation of US$126.481 billion by 2027. Increasing prevalence of chronic diseases, demand for personalized medicine, and technological breakthroughs are driving this growth. The oncology segment is predicted to command the largest market share, powered by precision medicine's transformative role in cancer treatment. Big data analytics, notably the tool developed by the University of Michigan Rogel Cancer Center, are revolutionizing the precision medicine landscape. Collaborations and acquisitions, such as the partnership between Kaiku Health and Novartis and the acquisition by Stalicla, underline industry dynamism. Spotlight on Market Dynamics:
Invitae has obtained commercial coverage approval from Blue Shield of California for its Personalized Cancer Monitoring (PCMT) assay, marking a significant development in post-surgical cancer treatment monitoring. Invitae and Epic have joined forces. Leveraging Epic's diagnostic suite, Aura, the collaboration will expedite the provision of genetic insights to inform treatment decisions within the Epic ecosystem. Stalicla has acquired rights from Novartis to develop the drug mavoglurant, earmarked for substance use and neurodevelopmental disorders. Deep Dive into Research Initiatives:
Recent introductions to the research landscape include the IGNITE program, championing the integration of genomic studies in clinical practice, and CSER-2, funded by the NHGRI and NCI, to embed genomic sequencing in clinical settings. Precision Medicine: Segmented Analysis
The report segments the precision medicine market across various parameters, from technology platform, drug types, and sequencing technology to end-users. These insights encompass market share analyses by region, covering North America, Europe, Asia-Pacific, and more, and by key players in the industry, such as Bayer AG, BioNTech SE, and Moderna, Inc. The report's design offers clarity, categorizing the insights into six modules: Investment Landscape, Clinical Trial Data, Patent Data Analysis, Competitive Landscape, Market Size and Forecast, and Regulatory Outlook. Potential stakeholders will gain an in-depth understanding of market dynamics, competitive landscapes, clinical trials, precision medicine patents, financial deals, and strategic insights. For more information about this report visit https://www.researchandmarkets.com/r/kvrvl7
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A New Era of Healthcare: Global Precision Medicine Trends and Forecasts 2023-2027

06/07/2023 | 06:42am EDT
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(Alliance News) - Evgen Pharma PLC on Wednesday reported a widened annual loss and said its Chief Financial Officer Richard Moulson will retire in late July. The Cheshire, England-based clinical stage drug development company said it generated revenue of just GBP442,000 for the year ended March 31, compared to none the year prior. This came from an out-licensing deal with Stalicla for the rights to its SFX-01 asset in the treatment of neurodevelopmental disorders and schizophrenia. Evgen noted it does not have any approved or revenue generating products. However, if the out-licensing deal with Stalicla is successful, it will generate milestone payments of USD160.5 million and a double-digit royalty on sales. Evgen's annual pretax loss widened to GBP5.0 million from GBP3.2 million a year prior, as total operating expenses grew 72% to GBP5.5 million from GBP3.2 million. Chief Executive Officer Huw Jones said: "The last year has seen substantial progress in both our science and in our stated aim of out-licensing our technology in cash-generating partnerships. Of particular note is our partnership with Stalicla in autism spectrum disorder that could generate substantial non-dilutive income over a long period." On Wednesday, Evgen also said Chief Financial Officer Moulson will retire at the company's annual general meeting in late July after six years in the role. Evgen added that the search for a replacement is underway. CEO Jones commented: "I would like to express my sincere thanks to our CFO Richard, who is retiring at the AGM. His steadfast support and well considered judgements have been invaluable both to the company and to me personally." Shares in Evgen were down 4.3% at 3.78 pence each in London on Wednesday morning. By Sabrina Penty, Alliance News reporter

Evgen Pharma confident amid Stalicla deal; CFO Moulson to retire

Agreement for the Development of Electroencephalogram (EEG) as a Biomarker for Subgroups of Patients with ASD
The combination of STALICLA and Firefly Neurosciences’s machine learning platforms and know-how will further strengthen the development of precision medicine for these patients
Geneva, Switzerland – 27 March 2023, STALICLA SA and Firefly Neuroscience today announced a partnership to further validate EEG-based biomarkers in biologically enriched subgroups of patients with Autism Spectrum Disorder (ASD). This follows the successful completion of STALICLA’s Phase 1b clinical trial for its lead asset STP1 where EEG measurement was shown to be a powerful predictor of efficacy. STALICLA and Firefly Neuroscience will leverage their technological platforms including the Databased Endophenotyping Patient Identification (DEPI) platform and the FDA-cleared Brain Network Analytics (BNA™) platform respectively to further advance EEG validation in two upcoming Phase 2 clinical trials, sponsored by STALICLA. Applying BNA™ to the DEPI-driven biologically enriched subgroups of patients with ASD is expected to establish and expand EEG as a biomarker in the field of ASD. EEG measurements will reinforce the DEPI stratification capacity and prediction of treatment response in patients with a behavioral diagnosis of ASD. STP1 is a tailored treatment candidate for ASD-Phenotype 1, the first DEPI-enriched subgroup of patients. STP1 positive target engagement was demonstrated by specific EEG signal modulation in brain areas of interest. Lynn Durham, STALICLA’s CEO & Founder, commented: “STALICLA is thrilled to partner with Firefly Neuroscience to advance an EEG-based treatment response marker in the NDD population. STALICLA will leverage its DEPI platform and Firefly Neuroscience’s technology to reinforce its leadership in precision medicine for neurodevelopmental disorders with rapid implementation of precision EEG in our upcoming two phase 2 programs in Autism Spectrum Disorder.”
Jon Olsen, Firefly Neuroscience’s CEO, commented: “Firefly Neuroscience is excited to partner with STALICLA on the advancement of treatment for people with ASD. Using BNA™ to target sub-groups of patients for precision medicine treatment in the CNS space is a core focus for the company. The fact that BNA™ is FDA cleared and used by clinicians in the United States to support therapy decisions for people with mental disorders puts us in a very strong position to build a referral network in support of the commercialization of novel drugs and therapies for the treatment of NDD diseases.”
STALICLA has developed and validated a machine learning platform, DEPI, allowing ASD subgroup identification and precision medicine treatment candidate selection. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with ASD and their tailored treatments STP1 and STP2. Both STP1 and STP2 are planned to enter Phase 2 clinical trials in 2023. Firefly Neuroscience’s BNA™ platform is a patented technology that provides an objective, quantified assessment of cognition (brain function). It measures brain function and compares it to an FDA-cleared, normative, age-matched database using proprietary AI and advanced signal processing technology. Firefly Neuroscience’s AI platform (‘Fly-AI’) will help develop future biomarkers and companion diagnostics allowing for the expansion of existing pharma collaborations and partnerships to make the development of new CNS drugs more efficient. About STALICLA
STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders. STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder (ASD) and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential. The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates. STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform. For further information, please visit: https://stalicla.com/
About Firefly Neuroscience
Firefly Neuroscience leverages technical advances in computing and AI to deconstruct, analyze, and compare electroencephalograms (EEG), making them clinically useful for front-line clinicians to objectively measure, monitor, and manage brain function. Building on over a decade of research, the product has received FDA clearance and is commercially used in American clinics since mid-2022. With BNA™, clinicians and their patients can now make informed, objective therapy and disease management decisions, track changes over time and improve therapy compliance. It takes the guesswork and subjectivity out of managing mental illnesses and cognitive disorders- as one can only effectively manage what can accurately be measured. Firefly Neuroscience’s AI platform (‘Fly-AI’) has been built to develop future biomarkers and companion diagnostics (pharma) allowing for the expansion of existing pharma collaborations to bring new drugs to market. It has been used with leading companies such as Novartis, Takeda, and Purdue and is poised to revolutionize the required objective measurement for effective CNS drug development. For further information, please visit: https://fireflyneuro.com
   Contacts

STALICLA and Firefly Neuroscience enter Partnership Agreement for the Development of Electroencephalogram (EEG) as a Biomarker for Subgroups of Patients with ASD

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Partnership Agreement for the Development of Electroencephalogram (EEG) as
a Biomarker for Subgroups of Patients with ASD
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The combination of STALICLA and Firefly
Neurosciences’s machine learning platforms and know–how will further strengthen the development of precision medicine for these patients
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March
2023, STALICLA SA and Firefly Neuroscience today announced a partnership to further validate EEG-based biomarkers in biologically enriched subgroups of patients with Autism Spectrum Disorder (ASD). This follows the successful completion of STALICLA’s Phase 1b clinical trial for its lead asset STP1 where EEG measurement was shown to be a powerful predictor of efficacy. Advertisement 2
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STALICLA and Firefly Neuroscience will leverage their technological platforms including the Databased Endophenotyping Patient Identification (DEPI) platform and the FDA-cleared Brain Network Analytics (BNA™) platform respectively to further advance EEG validation in two upcoming Phase 2 clinical trials, sponsored by STALICLA. Applying BNA™ to the DEPI-driven biologically enriched subgroups of patients with ASD is expected to establish and expand EEG as a biomarker in the field of ASD. EEG measurements will reinforce the DEPI stratification capacity and prediction of treatment response in patients with a behavioral diagnosis of ASD. STP1 is a tailored treatment candidate for ASD-Phenotype 1, the first DEPI-enriched subgroup of patients. STP1 positive target engagement was demonstrated by specific EEG signal modulation in brain areas of interest. Article content
Article content
Lynn Durham, STALICLA’s CEO & Founder, commented:
“STALICLA is thrilled to partner with Firefly Neuroscience to advance an EEG-based treatment response marker in the NDD population. STALICLA will leverage its DEPI platform and Firefly Neuroscience’s technology to reinforce its leadership in precision medicine for neurodevelopmental disorders with rapid implementation of precision EEG in our upcoming two phase 2 programs in Autism Spectrum Disorder.”
Jon Olsen, Firefly Neuroscience’s CEO, commented:
“Firefly Neuroscience is excited to partner with STALICLA on the advancement of treatment for people with ASD. Using BNA™ to target sub-groups of patients for precision medicine treatment in the CNS space is a core focus for the company. The fact that BNA™ is FDA cleared and used by clinicians in the United States to support therapy decisions for people with mental disorders puts us in a very strong position to build a referral network in support of the commercialization of novel drugs and therapies for the treatment of NDD diseases.”
Advertisement 4
Article content
STALICLA has developed and validated a machine learning platform, DEPI, allowing ASD subgroup identification and precision medicine treatment candidate selection. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with ASD and their tailored treatments STP1 and STP2. Both STP1 and STP2 are planned to enter Phase 2 clinical trials in 2023. Firefly Neuroscience’s BNA™ platform is a patented technology that provides an objective, quantified assessment of cognition (brain function). It measures brain function and compares it to an FDA-cleared, normative, age-matched database using proprietary AI and advanced signal processing technology. Firefly Neuroscience’s AI platform (‘Fly-AI’) will help develop future biomarkers and companion diagnostics allowing for the expansion of existing pharma collaborations and partnerships to make the development of new CNS drugs more efficient. Advertisement 5
Article content
About STALICLA
STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders. STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder (ASD) and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential. The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates. STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform. Advertisement 6
Article content
About Firefly Neuroscience
Firefly Neuroscience leverages technical advances in computing and AI to deconstruct, analyze, and compare electroencephalograms (EEG), making them clinically useful for front-line clinicians to objectively measure, monitor, and manage brain function. Building on over a decade of research, the product has received FDA clearance and is commercially used in American clinics since mid-2022. With BNA™, clinicians and their patients can now make informed, objective therapy and disease management decisions, track changes over time and improve therapy compliance. It takes the guesswork and subjectivity out of managing mental illnesses and cognitive disorders- as one can only effectively manage what can accurately be measured. Firefly Neuroscience’s AI platform (‘Fly-AI’) has been built to develop future biomarkers and companion diagnostics (pharma) allowing for the expansion of existing pharma collaborations to bring new drugs to market. It has been used with leading companies such as Novartis, Takeda, and Purdue and is poised to revolutionize the required objective measurement for effective CNS drug development. For further information, please visit: https://fireflyneuro.com
   Contacts

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Stalicla secures CRADA on strong cocaine abuse data

Firefly Neuroscience provides clinicians with quantitative and object measurements to aid patients suffering from mental illnesses with brain mapping technology. Its brain network analytics technology provides an objective assessment of cognition. It was formerly known as Elminda. The company was founded in 2006 and is based in TBuffalo, New York. In November 2023, Firefly Neuroscience merged with WaveDancer.

Firefly Neuroscience

2023 , STALICLA SA and Firefly Neuroscience today announced a partnership to further validate Development of Electroencephalogram-based biomarkers in biologically enriched subgroups of patients with Autism Spectrum Disorder .

National Institute on Drug Abuse (NIDA) is the lead federal agency supporting scientific research on drug use and addiction. The company offers services such as NIDA research programs and activities, clinical research, NIH policies and guidance, research data, measures, and resources, research training and career development, and more. The company was founded in 1974 and is based in Gaithersburg, Maryland.

The National Institute on Drug Abuse

Novartis (NYSE: NVS) researches, develops, manufactures, and markets healthcare products. It provides ophthalmology, neuroscience, immunology, hepatology, dermatology, respiratory, cardiovascular, renal, and metabolism medicine products. The company was founded in 1996 and is based in Basel, Switzerland.

Novartis

Evgen is a clinical stage drug development company operating in the pharmaceutical industry. The company's main focus is on the development of sulforaphane-based medicines, which are used for the treatment of cancer and inflammatory diseases. Evgen primarily sells to the healthcare industry. It is based in Liverpool, England.

Evgen

Université de Genève

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STALICLA is a patient-centric biotech company on a mission to identify, develop and bring precision medicine to patients with neurodevelopmental disorders, with a first application in autism spectrum disorder.

Date	Round	Amount	Investors	Valuation Valuations are submitted by companies, mined from state filings or news, provided by VentureSource, or based on a comparables valuation model.	Revenue	Sources
2/3/2020	Series A - II	$8M	Undisclosed Investors	$99M	0 FY undefined	2
1/11/2019	Series A	$99M	Subscribe to see more	$99M	0 FY undefined	10

Date	2/3/2020	1/11/2019
Round	Series A - II	Series A
Amount	$8M	$99M
Investors	Undisclosed Investors	Subscribe to see more
Valuation	$99M	$99M
Revenue	0 FY undefined	0 FY undefined
Sources	2	10

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