Pioneering

Next-Generation Therapeutics

At MLS Bio, we are addressing the world's most critical health challenges through AI drug development platforms and innovative small-molecule therapies with our breakthrough compounds. We are targeting a new cellular mode of action, offering novel approaches to treatment in the most impactful global markets.

Strategic Focus in Oncology

We are advancing therapeutics for solid Cancers with
Prostate Cancer as our lead indication

Lead Asset

MLS 269, first in class small molecule CD151 inhibitor targeting cancer metastasis

Market Opportunity

USD$15.9B addressable prostate cancer therapeutics market

Stage

Proceeding to toxicology, Pre-IND FDA submission

Partnerships

The Prostate Cancer Clinical Trails Consortium

Our
Commitment

Our Global team of experienced medical researchers, commercialization, and technical experts are committed to developing treatments that are more effective, accessible, and better tolerated, delivering novel solutions and improving the lives of patients facing cancer and other life-threatening diseases worldwide.

With our robust pipeline, we aim to develop solutions in other high-impact global markets, bringing transformative therapies to market and delivering better outcomes for patients facing cancer and other life-threatening diseases.

The Science

01
Scientific Rationale

CD151, a tetraspanin family protein, is overexpressed in aggressive prostate cancer (PCa), promoting cell migration and invasion, hallmarks of metastasis.

It forms complexes with integrins (e.g., α3β1, α6β1), facilitating tumor cell motility, survival, and vascular invasion.

Experimental inhibition of CD151 results in a significant reduction in cancer cell migration and invasion in vitro and in vivo.

02
Innovative Mechanism of Action: MLS-269

MLS-269 selectively targets the CD151-integrin interface, disrupting critical signaling required for metastatic dissemination.

This host - directed therapeutic approach reduces tumor invasiveness without directly targeting tumor proliferation - highlighting the possibility of limiting drug resistance.

Tetraspanins, particularly CD151, regulate cell motility and promote tumour progression via integrin interactions. Despite their central role in cancer invasion and metastasis, they remain under-explored as therapeutic targets.

03
Clinical Significance

Addresses a key driver of cancer progression: metastatic spread.

First-in-class mechanism offers potential for: Survival extension in mCRPC and nmCRPC populations.

Pre-Clinical Validation: MLS 269 reduces prostate cancer tumors, sustained effect over time with body weight neutral or positive profile.

Indication expansion into other CD151-high malignancies (e.g., kidney, lung, pancreatic, breast).

Results suggest that CD151 could be a potential biomarker for prognosis and as a diagnostic in prostate cancer, where higher CD151 levels correlate with reduced survival.

04
Translation

First-in-class therapy innovation targeting cancer metastasis - the leading cause of cancer death - with the potential to significantly extend survival in treatment-resistant prostate and other major solid cancers.

Comprehensive preclinical package supports the application of Phase 1b-2 trials in prostate cancer. A robust translational foundation that de-risks progression to human studies.

Data (in-vivo) supports favourable tolerability when compared to standard of care treatments.

MLS-269 delivers a differentiated anti-metastatic profile in a market dominated by androgen signaling therapies - positioning it for premium pricing, partnership optionality, and potential platform expansion across solid tumors.

Addressing Challenges in
Advanced Cancer Care

Existing therapies provide only partial solutions, with limitations in tolerability and efficacy against resistant, late-stage disease

Limited Options for Advanced Cancer:

Existing therapies offer only modest benefit for advanced or metastatic disease.

High Treatment Costs:

Access to life-saving treatments remains cost-prohibitive for many patients.

Poor Tolerability:

Severe side effects reduce quality of life and limit treatment adherence.

MLS Bio is transforming patient outcomes by redefining the standard of care in prostate cancer — delivering new hope to patients with advanced disease by expanding treatment options, improving access, and ensuring quality of life through safer, more tolerable therapies

Clinical Significance

Addresses a key driver of prostate cancer progression: metastatic spread.

First-in-class mechanism offers potential for:

Survival extension in mCRPC and nmCRPC populations

Indication expansion into other CD151-high malignancies (e.g., kidney, lung, pancreatic, breast)

First-in-class therapy innovation targeting cancer metastasis - the leading cause of cancer death - with the potential to significantly extend survival in prostate and other major solid cancers.

Preclinical
Validation

Strong In Vivo Efficacy Demonstrated

Our preclinical studies show compelling results:

CD151 as a viable
therapeutic target

Data supports that CD151 is a functional driver of prostate cancer cell migration and invasion. Its overexpression in LNCaP cells, which normally express low endogenous CD151, significantly enhances aggressive phenotypes, highlighting CD151 as a viable therapeutic target in metastatic prostate cancer.

CD151 significantly suppresses both cell migration and invasion

CD151 is a critical regulator of metastatic potential in prostate cancer cells. Its silencing via siRNA significantly suppresses both cell migration and invasion, providing strong in vitro evidence that CD151 is a functional driver of prostate cancer aggressiveness and a promising therapeutic target.

MLS 269 Reduces
Prostate Cancer

MLS Anti-CD151 therapies demonstrate marked tumour suppression, outperforming existing leading therapies. Strong In vivo efficacy demonstrated, MLS 269 reduces prostate cancer tumours, with sustained effect over time.

Tolerability improved to standard of care

MLS Bio Anti-CD151 therapies demonstrated a body weight–neutral or positive profile, supporting favourable tolerability when compared to standard-of-care treatments.

Diagnostic Potential

Results illustrate CD151 correlation that suggests that it could be a potential biomarker for prognosis and as a diagnostic in prostate cancer, where higher CD151 levels correlate with reduced survival.

Conclusion:
MLS Anti-CD151 therapies demonstrate marked tumour suppression, outperforming existing leading therapies and validating CD151 as a promising therapeutic target in metastatic prostate cancer.

Pipeline

Our Development Portfolio

Leading with Oncology, Expanding Across
High-Impact Markets

MLS-269 Prostate Cancer (Lead Program)
  • Target: First-in-class CD151 tetraspanin inhibitor
  • Indication: Metastatic castration-resistant prostate cancer (mCRPC)
  • Stage: Proceeding to toxicology, Pre IND-FDA submission & Phase 1b/2 clinical trials.
  • Market Opportunity: $15.9B global prostate cancer therapeutics market
  • Regulatory Status: Pre IND FDA submission: fast track; breakthrough therapy; priority review
MLS-289 Broad-Spectrum Antiviral
  • Target: First in class viral entry inhibitor; in vivo reversing lung damage from infection.
  • Indication: Human Health - Broad-spectrum anti-viral, viruses: CMV and Corona Viruses
  • Stage: Proceeding to toxicology & Phase 1b/2 Clinical trials.
  • Market Opportunity: $85B+ antiviral market by 2030
  • Regulatory Status: MLS 289 has PRE–IND FDA approval
MLS-289 Animal Health
  • Target: First in class anti-viral agent inhibiting the function of CD181
  • Indication: Porcine Reproductive Respiratory Syndrome (PRRS) – all strains
  • Impact: Addresses >$2.5B in annual swine industry losses
  • Stage: Phase 1/2 large herd trials
  • Pathway: Accelerated regulatory pathways (APVMA, FDA-CVM)
  • Path to Market with Progressive Market Registrations and combination therapies.

  • Clear Platform Expansion Potential

  • MLS 269 Expected to be effective in multiple solid tumour cancers

  • Oncology Pipeline Comprehensive Expansion:
    A successful regulatory and clinical blueprint in prostate cancer de-risks expansion, into other solid tumours, enabling label extensions or new analogues across a high-value platform technology model.

Clinical Development

Development Timeline: Clear Path to Clinical Proof-of-Concept, Registration and Exit

Clinical Research Strategy

Toxicology Studies

MLS Bio’s Anti-CD151 therapies have shown strong tolerability in preclinical models, with animals maintaining or gaining weight. This supports high confidence in positive toxicology results, which are expected within 8–10 months and represent a key value-inflection milestone for the company.

Phase 1b/2 Clinical Trials

Evaluate safety, pharmacokinetics & preliminary anti-tumour efficacy in patients with advanced prostate cancer, establishing human data and a recommended dose for Phase 3 trials.

Clinical Partnership
Excellence

Prostate Cancer Clinical Trials 
Consortium (PCCTC)

Global clinical leadership

Memorial Sloan Kettering
Cancer Center

Leading clinical trial partnership

AusBiotech and BioMelbourne Network

National and state industry association support

Regulatory Advantages
Accelerating Access, Maximizing Value

FDA Breakthrough Therapy Designation and Priority Review

Accelerating time-to-market

Global Regulatory
Harmonization

ICH-aligned strategy for parallel submissions

Global Regulatory Affairs Strategy

Lead by Pace Analytical, USA. With deep experience across life sciences sectors, supports a clear route from discovery to clinic.

Our Team

The leadership and advisory at MLS Bio brings together internationally distinguished commercial and scientific expertise encompassing key capabilities for successful pharmaceutical commercialisation. The Board and executive leaders include key experts in financial and legal governance, intellectual property and global regulatory strategy together with commercially experienced professionals who have successfully scaled medical ventures to global exits, directed multi-billion-dollar investment funds, and advanced transformative therapies into international markets. Strengthened by a world-class Scientific Advisory Board—comprising pre-eminent oncologists, endocrinologists, infectious disease specialists, and translational medicine authorities. This combination of scientific rigor, commercial acumen, and governance discipline ensures that MLS Bio is uniquely positioned to advance a portfolio of breakthrough small-molecule therapeutics,  driving innovation to patient impact, while delivering sustainable value to investors.

Ms Penelope Lane

Managing Director & CEO

Penelope Lane B.Bus/B.Sc., MS, MPH (Int. Health Eco.), AICD — CEO & Managing Director of MLS Bio, global biotech leader with 20+ years’ experience translating science into health impact, scaling ventures, and securing international investment across five continents.

Details

Ms Penelope Lane B.Bus/B.Sc., MS, MPH (Int. Health Eco.), AICD

Chief Executive Officer & Managing Director MLS Bio

Penelope Lane is a global biotech and healthcare executive with over 20 years of leadership across five continents. As CEO and Managing Director of MLS Bio, she has assembled a world-class team advancing small-molecule therapeutics in oncology and infectious disease. Penelope previously scaled an Australian medical simulation venture through to a successful exit to Terumo Corporation and earlier led the WHO- and Gates Foundation-backed BlueStar health franchise across ten countries. She also founded Vert & Or Ventures, serves on global advisory boards (including Sheba Medical Center and RMIT), and is an active biotech investor.

Professor Albert Frauman

Founder, CMO, Executive Director

Professor Albert Frauman MD, FRACP, FACP — Physician-scientist and biotech founder; clinical pharmacology leader at University of Melbourne and Austin Health, with 40 years’ translational research expertise.

Details

Professor Albert Frauman MD, FRACP, FACP

Executive Director & Founder – Medical Director
A distinguished physician-scientist and translational biotech entrepreneur

Professor Albert Frauman is a physician-scientist and translational biotech entrepreneur with four decades of clinical and academic leadership. He is Chair in Clinical Pharmacology and Therapeutics at the University of Melbourne and Director of Clinical Pharmacology at Austin Health. A board-certified endocrinologist and fellow of multiple international medical colleges, he has authored more than 70 peer-reviewed papers on autoimmunity, viral infection, oncology, and pharmacovigilance. His research and translational expertise underpin MLS Bio’s programs in oncology and infectious disease.

James La Flamme

Chair of the Commercial Board

James LaFlamme, RPh, MS, FACHE — Healthcare executive with 30+ years’ global experience; founder of BioPharma Global and former senior leader at Coté Orphan, NCQA, and PwC.

Details

James LaFlamme. RPh, MS, FACHE

Chair of Commercial Board.
Pharmacist, Healthcare & Lifesciences Executive, Commercial & Regulatory Expertise

James LaFlamme is a senior healthcare executive with more than 30 years of experience across clinical, regulatory, and commercial domains. He is the founder and former Chief Executive Officer of BioPharma Global, where he led international operations and advisory services supporting drug developers focused on rare and underserved conditions. Under his leadership, the company was successfully acquired by Pace Analytical Life Sciences.

Previously, James served as Executive Vice President at Coté Orphan, directing global regulatory and business development strategy; held a senior role at the National Committee for Quality Assurance (NCQA) overseeing accreditation and recognition programs; and led healthcare advisory and transformation initiatives within PwC’s Public Sector Healthcare Advisory practice.

James holds a Bachelor of Science in Pharmacy from the University of Connecticut and a Master’s in Management from Indiana Wesleyan University. He is a Fellow of the American College of Healthcare Executives and serves on the Dean’s Advisory Board at the UConn School of Pharmacy.

Dr Jenny Petering

Independent Non-Executive Director

Dr Jenny Petering Ph.D., ITPA — NED, leading patent attorney and biotech IP strategist; Of Counsel at FB Rice, Senior Fellow at Melbourne Law Masters, and advisor to early-stage biotech innovators through AusBiotech, IPSANZ, IMNIS and Scale Angels.

Details

Dr Jenny Petering Ph.D., ITPA

Non-Executive Director – Life Science Intellectual Property Expert

Dr Jenny Petering is an Australian and New Zealand-registered patent attorney with extensive experience in biotechnology intellectual property. As Of Counsel with FB Rice, she manages complex international patent portfolios and advises on strategic IP planning, due diligence, and opposition proceedings. She has been recognised as an MIP IP Star (2019–2022) and listed in IAM Strategy 300 Global Leaders (2021–2025). Jenny holds a PhD in Molecular Biology from the University of Adelaide and a BSc (Hons) in Biochemistry & Genetics from Monash University. She is a Senior Fellow in the Melbourne Law Masters Program and a mentor through AusBiotech, IMNIS, and Scale Angels.

Ms Holly Stefl

Board Observer & Investment

Holly Stefl BSc — Commercial executive with 20+ years’ experience leading global growth strategies across pharmaceutical services and biotechnology in the US and Australia; expert in biotech services, clinical development and R&D funding strategies.

Details

Ms Holly Stefl BSc

Board Observer – Global Investment

Holly Stefl is a commercial executive with over 20 years of experience leading global growth strategies across pharmaceutical and biotech sectors in the US and Australia. She served as Chief Commercial Officer at Endpoints Capital, providing non-dilutive R&D funding to biotech companies. Previously, she was CCO at Agilex Biolabs, driving its growth and sale to Healius (ASX:HLS), and held senior roles at IQVIA, Quintiles, and an oncology biotech. Holly brings expertise in clinical operations, commercialisation strategy, and global drug development.

Mr Paul Scagliotti

Company Secretary & General Counsel

Paul Scagliotti BCom/BLaw, MLaw, FGIA — Leading commercial lawyer and company secretary; governance and compliance specialist with expertise in commercialisation transactions, IP strategy, and research partnership and investment structuring.

Details

Mr Paul Scagliotti BCom/BLaw, MLaw, FGIA

Company Secretary & Lawyer

Paul Scagliotti is an experienced commercial lawyer and company secretary with a strong record in corporate governance, regulatory compliance, and transaction advisory across biotech, higher education, and advanced manufacturing. He specialises in contract negotiation, intellectual property strategy, and investment structuring. A Fellow of the Governance Institute of Australia, Paul has served as General Counsel and CFO at Concepta Group and held senior legal roles at leading Australian universities. He is currently Director at Vert & Or Legal, providing strategic legal and governance advice to innovation-driven companies.

Adrain Hondros

Board Observer – Investor Representative.

Adrian Hondros BCom, Grad Dip App Fin, Grad Dip Prof Acc — Finance and strategy executive with 38+ years’ leadership across banking, insurance, construction and biotech; Founder of Hondros Consulting.

Details

Adrian Hondros BCom, Grad Dip App Fin, Grad Dip Prof Acc

Board Observer – Investor Representative

Adrian Hondros is an experienced financial services and strategy executive with nearly four decades of leadership experience across banking, insurance, construction, and biotechnology. Over the past three years (2022 – 2025) he has served as a Non-Executive Director of MLS Bio, where he has overseen and contributed to a period of significant transformational change, strengthening the company’s investment relationships and positioning it for growth. Adrian’s broader career includes senior executive roles at NAB and CBA, as well as serving as CEO of St Andrew’s Australia and Porter Davis Homes. As Founder and Managing Director of Hondros Consulting, he continues to advise boards and CEOs on leadership, strategy, and governance to achieve sustainable growth and deliver long-term value. “We are delighted that Adrian will continue to contribute his expertise and leadership to MLS Bio in his new role as Board Observer, ensuring the company continues to benefit from his experience and insights during this next stage of growth.” Professor Albert Frauman, Founding Director.

Ms Penelope Lane

Managing Director & CEO

Penelope Lane — CEO & Managing Director of MLS Bio, global biotech leader with 20+ years’ experience translating science into health impact, scaling ventures, and securing international investment across five continents.

Details

Ms Penelope Lane B.Bus/B.Sc., MS, MPH (Int. Health Eco.), AICD

Chief Executive Officer & Managing Director MLS Bio

Penelope Lane is a global biotech and healthcare executive with over 20 years of leadership across five continents. As CEO and Managing Director of MLS Bio, she has assembled a world-class team advancing small-molecule therapeutics in oncology and infectious disease. Penelope previously scaled an Australian medical simulation venture through to a successful exit to Terumo Corporation and earlier led the WHO- and Gates Foundation-backed BlueStar health franchise across ten countries. She also founded Vert & Or Ventures, serves on global advisory boards (including Sheba Medical Center and RMIT), and is an active biotech investor.

Professor Albert Frauman

Founder, CMO, Executive Director

Professor Albert Frauman — Physician-scientist and biotech founder; clinical pharmacology leader at University of Melbourne and Austin Health, with 40 years’ translational research expertise.

Details

Professor Albert Frauman MD, FRACP, FACP

Executive Director & Founder – Medical Director
A distinguished physician-scientist and translational biotech entrepreneur

Professor Albert Frauman is a physician-scientist and translational biotech entrepreneur with four decades of clinical and academic leadership. He is Chair in Clinical Pharmacology and Therapeutics at the University of Melbourne and Director of Clinical Pharmacology at Austin Health. A board-certified endocrinologist and fellow of multiple international medical colleges, he has authored more than 70 peer-reviewed papers on autoimmunity, viral infection, oncology, and pharmacovigilance. His research and translational expertise underpin MLS Bio’s programs in oncology and infectious disease.

Kerem Kaya

Kerem Kaya is a highly experienced finance and commercial executive with deep expertise across biotechnology, oncology, corporate finance, governance, and capital markets. He brings significant life-sciences financial leadership experience, including senior oncology finance roles and exposure to IPO, Nasdaq-readiness, investor relations, and corporate diligence processes.

Details

Kerem Kaya

Kerem Kaya is a senior finance and commercial executive with substantial experience across biotechnology, oncology, corporate finance, governance, capital markets, and investor-readiness. He brings a strong life-sciences finance background to MLS Bio, including senior oncology finance experience and exposure to IPO, Nasdaq-readiness, investor relations, corporate diligence, and growth-stage company development.

Kerem’s expertise spans strategic financial planning, board reporting, capital-raising preparation, financial governance, commercial analysis, and operational finance. His background in oncology and life-sciences finance provides MLS Bio with valuable sector-specific capability as the company advances its first-in-class small molecule therapeutic platform, with lead programs in oncology and infectious disease.

At MLS Bio, Kerem supports the company’s financial strategy, investor reporting, governance infrastructure, and capital markets readiness as it prepares for its next stage of growth. His appointment strengthens the company’s executive capability at a critical value-inflection point, as MLS Bio progresses towards toxicology, clinical development planning, global Scientific Advisory Board engagement, and international Series A investment.

Mr Paul Scagliotti

Company Secretary & General Counsel

Paul Scagliotti — Leading commercial lawyer and company secretary; governance and compliance specialist with expertise in commercialisation transactions, IP strategy, and research partnership and investment structuring.

Details

Mr Paul Scagliotti BCom/BLaw, MLaw, FGIA

Company Secretary & Lawyer

Paul Scagliotti is an experienced commercial lawyer and company secretary with a strong record in corporate governance, regulatory compliance, and transaction advisory across biotech, higher education, and advanced manufacturing. He specialises in contract negotiation, intellectual property strategy, and investment structuring. A Fellow of the Governance Institute of Australia, Paul has served as General Counsel and CFO at Concepta Group and held senior legal roles at leading Australian universities. He is currently Director at Vert & Or Legal, providing strategic legal and governance advice to innovation-driven companies.

Dr Brittany Ashton

Partner Patent Attorney Chemistry Team FB Rice

Pharmaceutical chemistry expert and patent attorney; advisor to biotech and pharma firms on IP protection and portfolio strategy.

Details

Dr Brittany Howard B.Med.Chem (Hon), GCRC, PhD Med.Chem., MIPLaw

Partner Patent and Trademark Attorney FB Rice

Dr Brittany Howard is a partner and patent attorney at FB Rice, specialising in pharmaceutical chemistry and intellectual property strategy. She advises biotech and pharma clients on patent prosecution, freedom-to-operate analysis, and portfolio commercialisation. Her scientific background in medicinal chemistry supports her role as a trusted advisor bridging research and commercial translation.

Mr Grant Dooley

Independent Non-Executive Director

Grant Dooley BA (Asian Studies) MIA — Global financial and investment leader and former CEO of Breakthrough Victoria, with deep expertise in global venture capital, funds management, capital formation and investment across Australia and Asia.

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Mr Grant Dooley BA (Asian Studies) MIA

Non-Executive Director – Global Investment & Venture Capital

Grant Dooley is a seasoned investment and fund-management executive with more than 20 years of experience leading large-scale capital deployment across infrastructure, venture capital, and sovereign funds. As the inaugural CEO of Breakthrough Victoria, he established and led a $2 billion innovation and commercialisation fund that deployed over $350 million across 27 companies and six university platforms. He previously served as CEO of ARA Infrastructure (Singapore), Executive Director at Hastings Funds Management, and Australian Consul-General in Guangzhou with DFAT. Grant brings deep expertise in global investment strategy, venture and private capital, and cross-border partnership governance.

Dr Hank Sciberras

Partner EY: Tax, Government Incentives

R&D tax and innovation funding expert helping biotech and med-tech companies translate science into sustainable business growth.

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Dr Hank Sciberras PhD

Partner EY Oceania

Dr Hank Sciberras is a partner at EY Oceania, specialising in R&D tax incentives, government funding programs, and research commercialisation. He works closely with emerging biotech and med-tech firms to optimise capital access and translate scientific innovation into sustainable business growth.

Kimberlee Wells

Investor & CEO TBWA

Global digital marketing leader specialising in biotech brand development, investor communications, and strategic positioning.

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Ms Kimberly Wells B.Bus.Mktg, A.Dip Digital Mktg, P. Grad, Leadership

Global Practice Lead TBWA Advertising

Kimberly Wells is the Global Practice Lead at TBWA Advertising and a senior digital marketing strategist with deep expertise in healthcare and biotech communications. She advises MLS Bio on global brand development, digital engagement, and investor relations strategies, leveraging her international experience in creative leadership and integrated marketing.

Mr Geoff Grisham

Lifesciences Technology Valuation Practice Lead

U.S.-based CFO advisor and financial strategist guiding biotech firms through growth, fundraising, and North American expansion.

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Mr Geoff Grisham B.A. Eco., ASA

CFO Advisor – USA

Geoff Grisham is a chartered corporate finance professional and senior financial advisor specialising in U.S. market operations. He provides CFO-level advisory to biotechnology and healthcare organisations, guiding financial modelling, fundraising, and strategic expansion within North American markets.

Charles J. Ryan, MD

Genitourinary Medical Oncologist - Memorial Sloan Kettering Cancer Center. Host – The Good News About Cancer Podcast

World-leading Oncologist, Medical Director of The Prostate Cancer Clinical Trials Consortium, and former CEO of The Prostate Cancer Foundation.

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Professor Charles J. Ryan, MD

Chair of Medical Oncology, Memorial Sloan Kettering Cancer Center
World-leading oncologist with expertise in prostate cancer and clinical trial leadership

Charles Ryan MD is a world leading genitourinary medical oncologist and internationally recognized prostate cancer researcher. With more than 25 years of experience, he has treated thousands of men with advanced and metastatic prostate cancer and led pioneering clinical trials that have shaped modern standards of care.

Formerly CEO of the Prostate Cancer Foundation, Dr. Ryan has also served as Chair of the NCI Prostate Cancer Task Force, and held the Thomas Perkins distinguished professorship at UCSF and the BJ Kennedy Chair at the University of Minnesota. He is the Medical Director of the Prostate Cancer Clinical Trials Consortium, previously held the position as Co-Chair of the National Cancer Institute’s Prostate Cancer Task Force, and led the design of clinical trials in advanced prostate cancer through the NCI's Alliance for Clinical Trials in Oncology. He has authored over 200 peer-reviewed publications, and wrote The Virility Paradox (2018), exploring the profound impact of testosterone on health and society.

At Memorial Sloan Kettering Cancer Center, Dr. Ryan delivers world-class care in prostate and genitourinary cancers, combining cutting-edge research, innovative therapies, and compassionate patient engagement.

Professor Albert Frauman

Founder, CMO, Executive Director

Professor Albert Frauman — Physician-scientist and biotech founder; clinical pharmacology leader at University of Melbourne and Austin Health, with 40 years’ translational research expertise.

Details

Professor Albert Frauman MD, FRACP, FACP

Executive Director & Founder – Medical Director
A distinguished physician-scientist and translational biotech entrepreneur

Professor Albert Frauman is a physician-scientist and translational biotech entrepreneur with four decades of clinical and academic leadership. He is Chair in Clinical Pharmacology and Therapeutics at the University of Melbourne and Director of Clinical Pharmacology at Austin Health. A board-certified endocrinologist and fellow of multiple international medical colleges, he has authored more than 70 peer-reviewed papers on autoimmunity, viral infection, oncology, and pharmacovigilance. His research and translational expertise underpin MLS Bio’s programs in oncology and infectious disease.

Rahul Aggarwal, MD

Details

Rahul Aggarwal, MD

Dr. Rahul Aggarwal is a medical oncologist and Associate Professor of Medicine in the Division of Hematology/Oncology at the University of California, San Francisco (UCSF) and Director of the UCSF STAND (Supportive Therapy in Androgen Deprivation) Clinic, which provides comprehensive care to patients who are receiving androgen deprivation therapy (ADT) for prostate cancer. He earned his medical degree from Yale University School of Medicine and completed his internal medicine residency at the University of Pennsylvania, followed by a hematology/oncology fellowship at UCSF. He is a member of the UCSF Helen Diller Family Comprehensive Cancer Center, where he has established himself as a leader in genitourinary oncology research and clinical care.

Dr. Aggarwal is as a member of UCSF’s Developmental Therapeutics Genitourinary Cancer Program and his research focuses on the molecular characterization and treatment of advanced prostate cancer, with a particular emphasis on aggressive variant prostate cancers, including neuroendocrine and treatment-emergent small cell prostate cancer. His laboratory and translational work integrate genomic and epigenomic profiling, circulating tumor DNA (ctDNA) analysis, and novel therapeutic strategies to improve outcomes for patients with castration-resistant prostate cancer (CRPC). He has led multiple clinical trials investigating novel agents and combination therapies and has been recognized with career development awards from organizations including the Prostate Cancer Foundation (PCF) and the American Society of Clinical Oncology (ASCO). His work has been published extensively in high-impact journals such as Cancer Discovery, Clinical Cancer Research, and the Journal of Clinical Oncology.

Emmanuel Antonarakis

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Emmanuel Antonarakis

Dr. Emmanuel S. Antonarakis is a medical oncologist who currently serves as the Clark Endowed Professor of Medicine and the Associate Director of Translational Research at the University of Minnesota Masonic Cancer Center. He earned his medical degree (MBBS) from Imperial College London School of Medicine in the UK. He completed his internal medicine residency and medical oncology fellowship at Johns Hopkins Hospital in Baltimore, Maryland, where he spent many years as a faculty member and rose to the rank of Professor of Oncology before moving to the University of Minnesota.

Dr. Antonarakis' research centers on the molecular biology and precision treatment of advanced prostate cancer, with a particular focus on androgen receptor splice variants (notably AR-V7), DNA repair deficiency, and biomarker-driven therapeutic strategies. His landmark work on the AR-V7 splice variant as a predictive biomarker for resistance to hormonal therapies in metastatic castration-resistant prostate cancer (mCRPC) has had a transformative impact on the field and has been published in the New England Journal of Medicine. He has received numerous awards, including the Prostate Cancer Foundation (PCF) Young Investigator Award, the American Society of Clinical Oncology (ASCO) Young Investigator Award, and the Patrick C. Walsh Prostate Cancer Research Fund Award. He has authored hundreds of peer-reviewed publications and has been a principal investigator on numerous clinical trials evaluating novel therapeutics for prostate cancer.

Andrew Armstrong

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Andrew Armstrong

Dr. Andrew J. Armstrong is a medical oncologist and Professor of Medicine, Surgery, and Pharmacology and Cancer Biology at Duke University School of Medicine. He also serves as the Director of Research in the Duke Cancer Institute Center for Prostate and Urologic Cancers. He earned his medical degree from the University of Virginia School of Medicine and a Master of Science in clinical research from Duke University. He completed his internal medicine residency at Massachusetts General Hospital (Harvard Medical School) and his hematology/oncology fellowship at Duke University Medical Center.

Dr. Armstrong's research interests span clinical and translational research in prostate cancer, with a focus on circulating tumor cells (CTCs), biomarker development, novel hormonal therapies, immunotherapy, and mechanisms of treatment resistance in metastatic castration-resistant prostate cancer (mCRPC). He has played a major role in numerous landmark clinical trials that have changed the standard of care for prostate cancer, including studies of enzalutamide, apalutamide, and combination approaches, and served as co-first author of the recently published Prostate Cancer Working Group 4 (PCWG4) recommendations. He has been recognized with several prestigious awards, including the Prostate Cancer Foundation (PCF) Challenge Award, the Department of Defense Physician Research Award, and multiple American Society of Clinical Oncology (ASCO) Merit Awards. Dr. Armstrong has authored hundreds of peer-reviewed manuscripts and serves on national guideline committees and editorial boards, contributing significantly to shaping treatment paradigms for advanced prostate cancer.

Deborah Enting, MBBS, PhD, FRCP

Details

Deborah Enting, MBBS, PhD, FRCP

Dr. Deborah Enting is a Consultant Medical Oncologist at Guy's and St Thomas' NHS Foundation Trust and a Senior Lecturer at King's College London in the UK. She obtained her medical degree (MBBS) and subsequently earned a PhD, with her advanced training and clinical practice focused on genitourinary oncology. She is a Fellow of the Royal College of Physicians (FRCP) and has built an extensive career in both the clinical management and research investigation of prostate and other urological cancers within the UK's National Health Service and academic system.

Dr. Enting's research interests include the treatment of advanced and metastatic prostate cancer, with particular attention to novel therapeutic agents, clinical trial design, and improving outcomes for patients with castration-resistant disease. She has been involved in numerous national and international clinical trials, contributing to the evidence base for new treatments in prostate cancer. She is also interested in patient experience, supportive care, and shared decision-making in oncology. Dr. Enting has published in respected journals and has contributed to national treatment guidelines. She is an active member of professional organizations including the European Society for Medical Oncology (ESMO) and plays a significant role in training the next generation of oncologists in the UK.

Laura Graham, MD

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Laura Graham, MD

Dr. Laura Graham is a medical oncologist and Assistant Professor of Medicine-Medical Oncology at the University of Colorado Anschutz Cancer Center, with expertise in genitourinary oncology. She earned her medical degree at Rush Medical College of Rush University Medical Center and completed her residency in internal medicine and fellowship training in hematology/oncology at the University of Washington, developing a clinical and research focus on prostate cancer throughout her training.

Dr. Graham's research focuses on developing more effective treatments for advanced prostate cancer and other genitourinary malignancies through innovative clinical trials and translational science. She is particularly interested in hormone-based therapies, immunotherapy combinations, and T-cell–directed approaches aimed at overcoming treatment resistance and improving durable responses. Notably, Dr. Graham leads national clinical trials focused on personalized, advanced prostate cancer treatments, including studies on high-dose testosterone and the "Triple Switch" trial for chemotherapy. Her work integrates patient care with laboratory investigation, including analyses of blood and tumor samples to better understand how therapies reshape the tumor immune microenvironment and to identify biomarkers that predict which patients are most likely to benefit. Dr. Graham collaborates closely with multidisciplinary academic teams, cooperative groups, and industry partners to accelerate the development of personalized therapies and to translate promising scientific discoveries into meaningful advances for patients with genitourinary cancers. She has presented her work at national and international meetings, including the American Society of Clinical Oncology (ASCO) Annual Meeting and the Genitourinary Cancers Symposium (ASCO GU), and has authored peer-reviewed publications in the field. Dr. Graham is recognized for her commitment to both clinical excellence and advancing the research landscape in prostate cancer

Andrew Hahn, MD

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Andrew Hahn, MD

Dr. Andrew W. Hahn is a medical oncologist specializing in genitourinary malignancies serving as Assistant Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center (MDACC). He completed his medical degree at the University of Tennessee Health Science Center and subsequent residency (University of Utah) and fellowship training (MDACC). He has held positions at institutions including the University of Utah/Huntsman Cancer Institute and the MDACC, where he has developed expertise in the clinical management and translational research of prostate and kidney cancers. Dr. Hahn also serves as a Scientific Review Content Expert, MDACC Scientific Review Committee.

Dr. Hahn's research interests center on biomarker development, genomic and molecular profiling, and precision medicine approaches in advanced prostate cancer and other genitourinary malignancies. His work has explored the use of circulating tumor DNA, gene expression signatures, and other molecular tools to guide treatment selection and predict outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC). He has been supported by young investigator awards and career development grants from organizations such as the Prostate Cancer Foundation (PCF), the Kidney Cancer Association, and the American Society of Clinical Oncology (ASCO). Dr. Hahn has authored numerous peer-reviewed publications and has presented his research at major national and international oncology conferences.

Alicia Morgans, MD, MPH

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Alicia Morgans, MD, MPH

Medical oncologist Dr. Alicia K. Morgans serves as Associate Professor of Medicine and Director of the Survivorship Program at Dana-Farber Cancer Institute and Harvard Medical School. She earned her medical degree from Vanderbilt University School of Medicine and a Master of Public Health (MPH) from the Harvard T.H. Chan School of Public Health. She completed her internal medicine residency at Brigham and Women's Hospital and her hematology/oncology fellowship at the Dana-Farber/Partners Cancer Care program. Prior to her current role at Dana-Farber, she served on the faculty at Vanderbilt-Ingram Cancer Center and Northwestern University Feinberg School of Medicine.

Dr. Morgans' research focuses on optimizing outcomes and quality of life for patients with advanced prostate cancer, with particular interests in patient-reported outcomes, survivorship, treatment decision-making, and the management of side effects associated with androgen deprivation therapy and novel hormonal agents. She is a recognized international leader in genitourinary oncology, serving on guideline panels and as a prolific contributor to medical education through peer-reviewed publications, invited lectures, and digital media platforms. She has received numerous awards, including recognition from the Prostate Cancer Foundation (PCF), the American Society of Clinical Oncology (ASCO), and the American Urological Association (AUA). She is a member of the advanced and localized prostate cancer treatment guidelines committee of the American Urologic Association (AUA) and is a member of the cardio-oncology committee of the American Heart Association. Since 2016, she has been President of the Medical Advisory Board for ZERO, a non-profit organization dedicated to supporting education and research funding for prostate cancer research.

Natalie Reizine, MD

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Natalie Reizine, MD

Dr. Natalie Reizine is a medical oncologist and Assistant Professor at the University of Illinois at Chicago. She completed her internal medicine residency with the concurrent Maclean Bioethics Fellowship at the University of Chicago in 2018. She also completed fellowships in Hematology/Oncology as well as Clinical Pharmacology and Pharmacogenomics at the University of Chicago in 2021. In her current position Dr. Reizine specializes in treating genitourinary cancers (including prostate, kidney, bladder, and germ cell tumors) as part of a multidisciplinary cancer team.

Dr. Reizine's research interests include translational and clinical research in prostate cancer, with a focus on novel therapeutic strategies, biomarker development, and understanding mechanisms of resistance in advanced disease. She is involved in clinical trials evaluating emerging treatments for metastatic castration-resistant prostate cancer (mCRPC) and is interested in precision medicine approaches to improve treatment selection. She has presented her work at national oncology conferences and has contributed to peer-reviewed literature in the field of genitourinary oncology. Dr. Reizine is committed to advancing prostate cancer research while providing comprehensive, patient-centered clinical care.

Kerry Schaffer, MD, MSCI

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Kerry Schaffer, MD, MSCI

Dr. Kerry Schaffer is a medical oncologist and serves as an Assistant Professor in the Department of Medicine, Vanderbilt Ingram Cancer Center. She earned her medical degree from the University of Virgina School of Medicine and completed internal medicine residency and hematology/oncology fellowship training at the University of Rochester Medical Center, developing a clinical and research interest in the treatment of advanced prostate cancer. Outside of direct patient care, her research works to address gaps in health care delivery.

Dr. Schaffer's research interests include clinical trials for advanced prostate cancer, health outcomes, and quality of life considerations for patients undergoing treatment for metastatic disease. She has been involved in studies examining novel therapeutic combinations and is interested in understanding how treatment impacts patients' functional status and wellbeing. She has presented at national conferences and has contributed to the peer-reviewed literature in genitourinary oncology. Dr. Schaffer is recognized for her dedication to evidence-based care and her efforts to improve the treatment experience for prostate cancer patients.

Michael Schweizer, MD

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Michael Schweizer, MD

Dr. Michael T. Schweizer is a medical oncologist and Associate Professor at the University of Washington School of Medicine and a member of the Fred Hutchinson Cancer Center (formerly Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance). He earned his medical degree from Oregon Health & Science University (OHSU) and completed his internal medicine residency at the University of Washington and his medical oncology fellowship at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, where he trained under leaders in prostate cancer research. He is board-certified in medical oncology and internal medicine.

Dr. Schweizer's research focuses on the development of novel therapeutic strategies for advanced prostate cancer, with particular interests in bipolar androgen therapy (BAT), epigenetic therapies, and overcoming resistance to androgen receptor-directed treatments. He has been a leader in clinical trials investigating high-dose testosterone therapy as a counterintuitive approach to re-sensitize castration-resistant prostate cancers (CRPCs) to hormonal treatments. His work has been published in high-profile journals including the Journal of Clinical Oncology, Lancet Oncology, and Clinical Cancer Research. He has received several career development awards, including support from the Prostate Cancer Foundation (PCF), the Pacific Northwest Prostate Cancer SPORE, and the Department of Defense Prostate Cancer Research Program. Dr. Schweizer is recognized nationally and internationally as an innovative clinical trialist and translational researcher in prostate cancer.

Ben Tran, MBBS, PhD, FRACP

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Ben Tran, MBBS, PhD, FRACP

Dr. Ben Tran is a medical oncologist and clinician-scientist at the Peter MacCallum Cancer Centre and the Royal Melbourne Hospital in Melbourne, Australia. He holds a medical degree (MBBS) and a PhD, and he is a Fellow of the Royal Australasian College of Physicians (FRACP). He completed his advanced oncology training in Australia and has undertaken additional research fellowships at international centers of excellence, contributing to his expertise in genitourinary oncology and translational cancer research.

Dr. Tran's research interests span the molecular characterization and treatment of advanced prostate cancer, with a focus on genomics, circulating tumor DNA (ctDNA), and biomarker-driven therapeutic strategies. He has contributed to landmark international clinical trials and collaborative genomic studies aimed at understanding the biology of metastatic castration-resistant prostate cancer (mCRPC) and identifying actionable molecular targets. He also has an interest in Real World Evidence generation/analysis, leading multi-site, multi-national clinical registries in genitourinary cancers. His work has been published in leading oncology and cancer research journals, including Nature, Cancer Discovery, and the Journal of Clinical Oncology. Dr. Tran has received competitive research funding from Australian and international organizations and is active in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Dr. Tran Chairs the Phase 1 group within Cancer Trials Australia, and the Testicular Germ Cell Tumour subcommittee within ANZUP, and is recognized as a key figure in prostate cancer research in the Australasian region.

Professor Christine McDonald

Director, Department of Respiratory and Sleep Medicine, Austin Health

Director of the Department of Respiratory and Sleep Medicine at Austin Health. Professorial Fellow at the University of Melbourne and Adjunct Professor at Monash University, with additional affiliations at RMIT University and the Victorian Translational Research Institute (VicTRI).

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Professor Christine McDonald AM, FAHMS

Director, Department of Respiratory and Sleep Medicine, Austin Health

Professor Christine McDonald AM FAHMS is an eminent physician-scientist specialising in respiratory and sleep medicine, with an illustrious career in clinical care, translational research, and academic leadership . She serves as the Director of the Department of Respiratory and Sleep Medicine at Austin Health and holds professorial appointments including Professorial Fellow at the University of Melbourne and Adjunct Professor at Monash University, with additional affiliations at RMIT University and the Victorian Translational Research Institute (VicTRI).

Her research centers on chronic lung diseases, pulmonary rehabilitation, oxygen therapy, and translational interventions from hospital to home settings, particularly in conditions like COPD and interstitial lung disease. She is the lead author of the current Thoracic Society of Australia and New Zealand (TSANZ) guidelines on domiciliary oxygen and has led NHMRC-supported clinical trials evaluating ambulatory oxygen in interstitial lung disease.

Recognized not just for her clinical and scientific impact but also for her commitment to education and mentorship, she was honoured in 2018 as a Member of the Order of Australia for her service to respiratory and sleep medicine as a clinician-researcher and administrator . Under her leadership, the Victorian Respiratory and Sleep team at Austin Health has received multiple prestigious awards for educational and research excellence.

Professor McDonald also contributes nationally through roles such as Editor in Chief of Respiratory Medicine Today, Chair of the COPD National Program for the Lung Foundation Australia, and membership on the COPD X Guidelines Committee.

Professor Ted Whittem

Scientific Advisory Board Chair - Veterinary Stream

Non-Executive Director Victorian Animal Aid Trust, former Dean College of Public Health, Medical and Veterinary Sciences – Jame Cook University, former Professor and Chair in Veterinary Clinical Sciences and Head of Melbourne Vet School University of Melbourne, consulting services to the veterinary pharmaceutical and veterinary clinical industries in Australia.

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Professor Ted Whittem BVSc, PhD, DACVCP, FANZCVS, GAICD

Veterinary Science & Clinical Pharmacology
Professor Ted Whittem is a distinguished veterinary scientist and leader in translational pharmacology and veterinary medicine

Professor Ted Whittem is a distinguished veterinary scientist and translational pharmacologist. Former Dean of the College of Public Health, Medical and Veterinary Sciences at James Cook University, he has authored over 20 studies on pharmacokinetics and pain management in animal health. He currently serves on the Animal Aid Board, contributing to governance and ethics in animal welfare. His expertise supports MLS Bio’s veterinary antiviral and pharmacology programs.

Partners

Building a network to accelerate our mission of MLS Bio has strategically developed a global ecosystem of world-class partners to accelerate the advancement of its pipeline. These strategic collaborations will strengthen the company’s scientific rigor, operational excellence, and international reach. This integrated network positions MLS Bio to accelerate the commercialisation of breakthrough science, bringing transformative therapies to patients and markets worldwide.

Academic

Med-Chem CMC / Regs / IP

Drug Formulation

Preclinical & Clinical

Government and
Industry Supporters

Clinical Excellence Partners

Prostate Cancer Clinical Trials Consortium (PCCTC) - Global clinical trial leadership

Memorial Sloan Kettering Cancer Center Leading cancer center partnership

Professional Services & Strategic Advisors

FB Rice

Comprehensive IP strategy development

Pace Analytical USA
Expert life-science regulatory partners advising on global regulatory strategy.

Intellectual
Property

Global Patent Portfolio

US & Australian Patents Granted

Maximise Patent Life: Regulatory Extensions

U.S. PTEs and European SPCs can extend exclusivity by up to 5 years

MLS-269's patents are active to 2041, an evergreen strategy to add 5–20 years, securing ROI

Strategic Filings and Prosecution: MLS Bio's integrated approach aligns patent prosecutionwith clinical milestones

MLS-269’s globally integrated patent extension strategy is a critical value driver extending revenue lifecycles, mitigating risks, enhancing investor returns, and strengthening positioning for strategic partnerships or acquisitions

Patent Strategy

View Patent Strategy

Investment
Thesis

MLS Bio offers investors a de-risked, high-upside opportunity with multiple exit pathways

Investor Insight:
MLS Bio’s scientifically unified platform unlocks multi-channel revenue, strategic global partnerships, and high-value exit flexibility, positioning the company as a scalable, multi-sector growth engine that creates:

Multi-channel revenue streams

Cross-sector investment appeal

Optionality for future growth, partnerships, or divestitures

MLS 269 – Prostate Cancer
MLS Bio offers investors a de-risked, high-upside opportunity with multiple exit pathways offering near-term value inflection and long-term upside in a $15 B+ global prostate cancer market.

Differentiated Competitive & Clinical Advantage

Targeting a Significant and Growing Market

Substantial Commercial and Pricing Opportunity

Regulatory and IP Positioning for Longevity

Platform Expansion Potential

Multiple Market Validated Exit Opportunities; through M&A or Strategic Partnerships

News & Updates

“MLS Bio is pioneering small-molecule therapeutics that transform outcomes in prostate cancer, addressing the urgent need for effective options in advanced and resistant disease”

Contact Us

Leadership
Penelope Lane - Managing Director, Chief Executive Officer

Email

penelope@mlsbio.com

Investor Relations
For investment opportunities and corporate updates:

Email

investors@mlsbio.com

Business Development & Partnerships
For strategic partnerships and licensing opportunities:

Email

partnerships@mlsbio.com

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Corporate Information

MLS Bio
Level 27, 101 Collins Street, Melbourne VIC 3000, Australia

Data Room Access

Comprehensive Data Room Available
Due Diligence scientific analysis, market information and financials available under CDA with suitable investor alignment.