Contact: Dr Brad Walsh Mobile: +61 413 231 296 Ground ... · Contact: Dr Brad Walsh Mobile: +61 413...
Transcript of Contact: Dr Brad Walsh Mobile: +61 413 231 296 Ground ... · Contact: Dr Brad Walsh Mobile: +61 413...
Contact: Dr Brad WalshMobile: +61 413 231 296
Ground Floor, 75 Talavera Rd Macquarie Park, NSW 2113 Australia
www.glytherix.com
1 Confidential
• This presentation was prepared primarily for the general information of potential investment/commercial partners. This presentation is not an offer or invitation to subscribe for or purchase securities.
• This presentation does not purport to summarize all information that an investor should consider when making an investment decision. None of GlyTherix Ltd (GlyTherix) or their respective directors, employees or advisers warrant or represent the accuracy or completeness of the information contained in this presentation. Except for any statutory liability that cannot be excluded, GlyTherix and their respective directors, employees and advisers disclaim all responsibility and liability for any loss or damage that may be incurred by any recipient relying on the information in the presentation whether that loss or damage is caused by any fault or negligence on the part of GlyTherix or any of their directors, employees or advisers, or otherwise.
• To the extent that the presentation contains any forecasts, projections or other forward looking statements, those statements involve known and unknown risks, uncertainties and other facts that may cause actual results, performance or achievements to be materially different from those expressed or implied by those statements. There can be no guarantee that actual results, performance or achievements will be as stated.
• You represent and confirm by attending and/or by retaining this presentation, that you accept these conditions
Forward Looking Statements
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• Theranostic that targets patients with Glypican-1 (GPC-1) expressing tumours with a high degree of specificity and no off-target binding
• Cell surface cancer protein GPC-1 expressed in prostate, bladder, pancreatic, esophageal, ovarian, breast, glioblastoma and other tumors
• Safety studies have show clinically relevant doses of antibody do not induce adverse events
• Extensive IP portfolio that strongly protects the technology from competition and offers long term coverage
• Strong early licensing prospects - good engagement with several large pharma companies
• Influential thought leadership - Clinical Advisory Panel membership by world renowned clinicians and academics
Value Proposition
• $3M Government Grant awarded 22 June 2020
• Matched with $3M from R&D Tax Incentive loan facility
• Funds raised will be used to quickly reach next value inflection point by:ü Manufacturing clinical batch of GMP grade
Miltuximab®ü Completing Phase 1 theranostic trialü Extend to other cancer indications with further pre-
clinical studies
Current US$5M-20M Capital Raising
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Investors in Similar Companies Have Seen Huge Value Generation and Huge ROI
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Company Price Acquirer Clinical trial stage at acquisition
Advanced Accelerator Applications 3.9 B Novartis -2018 Marketed & Phase 1/2
Endocyte 2.1 B Novartis 2018 Phase 2/3 Blue Earth Diagnostics 450 M Bracco Imaging Spa - 2019 Commercial stage products
Algeta ASA 2.9 B Bayer - 2014 Commercial stage products Sirtex Medical Ltd 1.2 B China Grand Pharma -2018 Commercial stage products
Many of These Comparables Are at a Similar Stage to GlyTherix
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Company Market Cap USD Enterprise Val IP Portfolio Clinical trial stage
Actinium Pharma (NYSE) 97 M 88 M Targeted Radio- immunotherapy Phase 3 trial lead drug
Immutep* (NASDAQ/ASX) 85 M 72 M LAG-3 checkpoint inhibitor Phase 1/2
Celsion (NASDAQ) 82 M 76 M Cytokine immunotherapy Phase 3 and Phase 1/2
OSE Immuno (Paris SE) 99 M 72 M IO in solid tumours Phase 1/2
4SC AG* (XETRA) 85 M 52 M IO in blood cancers Phase 1/2
Mustang Bio* (NASDAQ) 183 M 128 M CAR-T immunotherapy/gene therapy Phase 1
Jounce Therap.* (NASDAQ) 156 M 82 M Cancer immunotherapies Phase 2
Tyme Technol.* (NASDAQ) 197 M 171 M Solid tumours anticancer therapies Phase 1
Nordic* Nanovectors (NOR) 139 M 109 M Blood cancer radioimmunotherapies Phase 1/2
Alligator Biosciences (SWE) 72 M 56M IO for solid tumours Phase 1
Cantargia AB* (SWE) 165 M 160 M CAN04 MAb against solid tumours Phase 2
Progenics Pharma. (USA) 415 M 386 MRadioimmunotherapies/theranostics Commercial stage
Telix Pharma (ASX) 250 M 216 M Molecular targeted radiotherapy Clinical stage
Autolus Therap. (NASDAQ) 684 M 441 M CAR-T in blood/solid tumours Phase 1/2
Immunomedics (NASDAQ) 21 B 20 B ADC & RIT against solid tumours Commercial Stage
• GlyTherix intends to commercialize its technology either by licensing or trade sale to a large pharmaceutical or biotech company capable of taking the drug through regulatory approvals and into the global market
• Alternatively, additional Clinical and Pre-Clinical data generated can be used to support a US IPO (c.2022)
• GlyTherix continues to engage with Key Opinion Leaders (KOLs) and potential licensees ensuring drug development meets clinical, commercial and patient expectations
• GlyTherix is producing sufficient clinical grade drug to commence Phase 1 trial(s) in the US and elsewhere - a compelling value proposition for potential licensees and partners
Pathway to Shareholder Returns
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Technology and Data to Date
• GPC-1 is a cancer cell-surface protein making it ideal for targeting by cell-killing agents
ü Expressed in a variety of solid tumors and critically involved in cancer processes
ü Associated with both poor prognosis and resistance to standard of care treatments
ü Not expressed in normal tissue
• Miltuximab® is our proprietary antibody to GPC-1
ü shown to be safe in First-in Human clinical trial
ü No drug related adverse events
ü Evidence of targeting in prostate cancer patients
Miltuximab® Targets Novel Tumor Antigen Called Glypican-1 (GPC-1)
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GPC-1 is a Target on Solid Tumors with High Unmet Need
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• Glypican 1 cell surface density was determined using the QIFIKIT
• QIFIKIT has beads labelled with known numbers of monoclonal antibodies
• Cells are stained with a monoclonal antibody that recognises the antigen of interest
• Number of antigen molecules can be calculated based on the fluorescence intensity of the stained sample, as compared to a calibration curve of beads.
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First-in-Human, First-in-World Miltuximab® Study Demonstrated Safety and Targeting
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Trial Objectives Key Outcomes
Primary endpoint(Safety & tolerability)
• Primary endpoint of the study met in all patients• Single doses up to 25 mg (0.01 to 0.33 mg/kg) presented no drug related
adverse reactions
Secondary endpoint(Dosimetry and Targeting)
• Targeting present in more advanced metastases• Best timepoint 48 hr post-infusion and dosing at 24 mg increases blood half-life
Radioactive Dose Predictions • Amount dosed well below published safety limit• Higher energy isotopes (89Zr- or 177Lu-Miltuximab®) can increase tumor dosage
P2: Foot Uptake in Bone Mets at 24h
Sabanathan et al, Safety and tolerability of Miltuximab -a first in human study in patients with advanced solid malignancies EJNMMI Res (submitted)
P7: Cranial Uptake in Bone Mets at 48h
Theranostic Imaging Product Ready - 89Zirconium-Miltuximab®
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a b
b. Biodistribution of drug 7 days after injection by ex vivo analysis of organs
• Manufacturing process already established by company
• This product has been shown to target prostate tumor xenografts in vivo
• Next step - delivery to patients to show where tumors are located and who is suitable for therapy with Miltuximab®
a. Drug targets human prostate tumor xenograft in mouse
Theranostic Drug Product Ready – 177Lutetium-Miltuximab
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a b
Yeh et al EJNMMI 10:46, 2020
177Lu-Miltuximab® used in vivo in a prostate tumor model demonstrated: ü Specific targeting and retention in tumor ü Excellent safety profileü Dose-dependent inhibition of tumor growthü Improved animal survival
Miltuximab® Targets Brain Cancer
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• Binding to and internalization of Miltuximab® has been observed for patient derived GBM 998 cells by fluorescence microscopy in live (left) and fixed (right) cells
• Targeting of Miltuximab-IR800 to brain tumors (U-87) showed specific tumor uptake and retention as compared to labelled isotype control in vivo
C.
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Next Steps
Antibody Manufacturing Phase 1 StudyFurther Preclinical
GlyTherix Led Manufacturing Consortium is Making GMPMiltuximab® and Will Run a New Trial
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CSIRO/UTS(MAb Production)
GlyTherix(Industry Lead)
GE(Manufacturing & Imaging)
ANSTO(Clinical RIT production)
Auspep(Conjugation)
MQ/MMI(Clinical Delivery/Validation)
KeyGE: GE HealthcareCSIRO: Commonwealth Scientific and Industrial Research OrganizationUTS: Univ. of Technology, Sydney ANSTO: Australian Nuclear Science and Technology OrganizationMQ: Macquarie UniversityMMI: Macquarie Medical Imaging Mab: Monoclonal antibodyRIT: Radioimmunotherapy
M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18
Indicative Gantt Chart for Miltuximab® Manufacturing
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MAb ProductionConjugation Production
Radiolabelling Development
Phase I Clinical Study
Radiolabelling for Trial
Miltuximab® Phase I Basket Trial
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TX DOSE 1177Lu-Miltuximab®
TX DOSE 2177Lu-Miltuximab®
TX DOSE 3177Lu-Miltuximab® FOLLOW UPSCREENING
185 MBq 89Zr-Miltuximab®
GPC-1 -ve
GPC-1 +ve370 MBq 555 MBq 1100 MBq
555 MBq 1100 MBq 1665 MBq
1100 MBq 1665 MBq 1665 MBq
1665 MBq 1665 MBq 1665 MBq
Cohort 1
Cohort 3
Cohort 4
Cohort 2
ProstateGlioblastomaPancreasBladder
US$5-20M Raise – Spend to Achieve Major Value InflectionClinical and Pre-Clinical Programs Stage Amount - AUD Outcome
Antibody engineering program GMP batchShake and Bake Kit 5.5M Humanized GMP Mab
Radio-immunotherapy program 89Zr/177LuProstate, pancreas, bladder, glioblastoma Phase I trial 6.5M Theranostic data
Pre-clinical studies Ongoing 2.25M Additional indications
Staff, space, KOLs, administration - 2 yrs Overheads etc 3.5M
Unallocated funds (Runway) 2.25M
Subtotal Sub Total 20M
Less
CRC-P Government Grant (non-dilutive) 3.0MR&D Tax Rebate @ 43.5% of 14.25 million (non-dilutive) 6.2M
Balance – to be funded by new equity 10.8M (7.5M USD)
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Company Profile PipelineIntellectual Property
• Research Partnershipsü Weill Cornellü Univ. Michiganü Univ. Queenslandü Univ. Technology Sydneyü Macquarie Univ.ü Garvan Inst. of Medical Research
• Based at Macquarie University
• Unlisted Private Company
Company Profile
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Highly Experienced Executive Management
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Dr Yanling Lu (CMC Manager) - Yanlingcompleted her PhD in Physical Biochemistry atthe University of Nottingham in collaborationwith Cambridge Antibody Technology and UCB-Celltech. Thereafter she joined Medimmune as aSenior Research Scientist in BioprocessDevelopment leading formulation, analyticalmethod development and stability testing.Yanling is conversant with regulatoryrequirements and is passionate in CMC projectmanagement.
Dr Maria Lund (Preclinical Manager) - Mariacompleted her PhD in Immunology at theUniversity of Technology Sydney. Her doctoralwork identified a novel peptide therapeutic forautoimmune disease, which led to the spin outof a company to commercialise this therapy. Shehas extensive background in early stage drugdevelopment and preclinical testing, includingdevelopment of an antibody therapy now inPhase 2 clinical trials.
Dr Brad Walsh (CEO) - founded Minomic raising over A$26 millionto commercialize its first major product, MiCheck, as well asdeveloping a pipeline of new diagnostics for other cancers. He hasa PhD in protein chemistry and has led research groups ingovernment agencies, universities and hospitals. He played a keypart in establishing a major national research facility beforeforming Minomic in 2007. He has a long history ofcommercialization and his products are being sold by majorcorporations, such as Bio-Rad Laboratories.
David Burdis (CFO / Company Secretary) - is a seasoned financialprofessional having worked in the telecommunications, chemical,and financial services industries. He has held various senior/boardpositions, for both listed and unlisted companies, in Australia, theUK and Hong Kong, including Swire Blanch Limited and OAMPSLimited. His extensive consulting background includes provision ofservices to industry and government as well as expert witnessevidence.
Dr Douglas Campbell (Head of Research and Development) -leads Minomic’s scientific team. He has been instrumental inbuilding Minomic’s intellectual property estate and designing allthe clinical trials. He has nearly 20 years of experience inbiomedical research with a particular focus on oncology. Prior toMinomic he was involved in the development of a novel antibody(MDX-1097) from pre-clinical to Phase 2 clinical trials.
Many Addressable Indications With Large Unmet Needs
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Cancer 2018 New Cases Diagnosed
% All Cancers*
% Mortality Rate Per Annum GPC-1 Key Reference
Prostate 1,276,106 7.1 28.1 Russell et al Cancer Immunol. Immunother. (2004) 53: 995-1004
Breast 2,088,849 11.6 30.0 Matsuda et al Cancer Res 2001;61:5562-69
Bladder 549,393 3.0 36.4 Walker et al, J Urol. (1989) 142: 1578-83
Pancreas 458,918 2.5 94.2 Lu et al, Cancer Medicine (2017) 6:1181
Glioblastoma 154,362 1.6 81.2 Saito et al J. W.Neurosurg.(2017) 105: 282
Esophagus 572,034 3.2 88.9 Harada et al Oncotarget (2017) 8:24741
Ovary 295,414 1.6 62.6 GlyTherix data
Total 5,242,151Source: http://gco.iarc.fr/today/home *excl. non-melanoma skin cancers
Main Pipeline Indications Now Entering Phase 1
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Pre-Clinical Development
Clinical Phase I
Clinical Phase III
First In Human
Clinical Phase II
Indication
Prostate
Bladder
Pancreas
Glioblastoma
Breast
Ovary
Esophagus Published data
Wide Pipeline of Molecules in Development
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• PCT completed for all patents
• IP counsel: Spruson & Ferguson (Sydney office AU)
• When granted, patent coverage will run to a minimum of 2035
• Further patents expected to be lodged over the next 18 months
Miltuximab® Patent Estate - Robust, Multilayered Claims, Long Life
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Patent Family Stage of Development
1. Cell Surface Prostate Cancer Antigen for Diagnosis Registered US, CN, SG, EU, JP. National Phase process continuing: AU, CA, HK, KR
2. Monoclonal ANTI-GPC-1 Antibodies and Uses Thereof Registered US, EU, JP, SG. National Phase process continuing: AU, CN, CA, HK and KR
3. Glypican Epitopes and Uses Thereof Registered EU, JP, AU. National Phase process continuing: CN, CA, HK, KR, SG and US
4. Therapeutic antibodies and Uses Thereof National Phase process continuing: AU, CN, CA, EU, HK, JP, KR, SG and US