IMU 4.00% 4.8¢ imugene limited

Lay of the Land, page-7

  1. 428 Posts.
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    Apologies, I asked the mods to delete so I could repost without the spacing issues, then realised it was 1:30 am and asked the to cancel. BUt alas. See post below hopefully now with no spacing issues.

    Ok, so I wanted to provideany newcomers an IMU ‘lay of the land’ so to speak and perhaps a refresher forthose needing it. I have been a holder for circa 6 years now but have gone alittle earlier as that was the info, I used to make my initial decision toinvest. Of course, my conviction has grown (and been tested!) as things haveprogressed. I am not an expert in medicine and although I have done weeks’worth of reading, I’m certainly fallible and my attempts to provide a layman’sexplanation may not be 100% accurate, but you should get the gist of it. Thebelow is not advice, and all has come from announcements or otherwise I havereferenced.

    The timeline below shows a commendable example of acompany doing what they said they were going to do and continuing to kick goalsand do the right thing by shareholders. We do have a lot of shares on issue,however, we also have multiple therapies that on their own company makers. Notto mention that it takes a very long time to through trials.

    2013: Market Cap ~$10m by year end

    · IMU buys Biolife Sciences who own Her-Vaxxwhich was now FDA Phase 2 ready. Phase one showed success in creating HER-2 antibodies.

    “HER-Vaxx’s further developmentis directed towards providing a natural, potentially more potent alternative toRoche’s popular Herceptin…. annual sales in excess of $US6.9 Billion”

    · Dr Axel Hoos becomes non exec director. (Hewas VP, Oncology R&D at GSK back then too). IMU being his only board seatworldwide. Axel was the one who initially identified Her-Vaxx in 2012 through BiolifeScience

    2014: Market Cap ~$12m

    · Commence FDA IND process for Gastric Cancervaccine.

    · Commence manufacture of vaccine

    · HER-Vaxx patent granted for US

    · Formulation of Her-Vaxx development throughBachem AG.

    2015: Market Cap ~$17m

    · HER-Vaxx re-formulation results in TEN-FOLDincrease in antibodies and early onset response

    · Improved manufacturing – cheaper, simpler,and more reliable

    · IMU applies for new HER-Vaxx patent providing6 more years on the market at PEAK sales. Coverage until 2036

    · New formulation found to be superior (morerapid and greater anti-cancer antibody production) to Herceptin in Breast Cancertumour model. Half dose of HER-Vaxx more effective than Herceptin with equal dosebeing “70% greater”.

    · Leslie Chong appointment as COO

    2016: Market Cap ~$22.5m

    · Partnership to develop Mimotope Immuno-Oncologyplatform.

    This is particularly exciting sincemimotope cancer vaccines are set to be part of the next wave of the immuno-oncologyrevolution in cancer therapy”

    · HER-Vaxx Phase 1b/2 Gastric cancer studystarts recruitment. Phase 2 to recruit 68 patients

    · Leslie Chong appointed CEO

    · Herceptin sales at $8 billion US and growing

    2017: Market Cap ~$55m

    · First patient dosed for Phase 1b/2 HER-VaxxGastric cancer trial

    · Initial indications show strong antibody responsein trial

    · Institutional shareholders Platinum

    · Scientific Advisory Board (SAB) furtherexpanded:

    Imugene’s SAB now includes some of the world's leading experts in cancerimmuno-oncology therapy:

    o SAB Chairman: Prof Dr Christoph Zielinski,Chairman, Comprehensive Cancer Centre in Vienna,

    o Prof Dr Ursula Wiedermann, ChiefScientific Officer, co-inventor of HER-Vaxx, Professor of Vaccinology at theMedical University of Vienna.

    o Dr Neil Segal, medical oncologist atMemorial Sloan Kette
    ring Cancer Center New York

    o Dr Yelena Janjigian, medical oncologistat the Memorial Sloan Kettering Cancer Center New York

    o Prof Peter Schmid, Chair of CancerMedicine at Barts Cancer Institute, Queen Mary University London

    2018: Market Cap ~$75m

    · Cancer vaccine shows further promise ingastric cancer trial and Cohort Review Committee

    · IMU announce new Anti-PD-1 Mimotope vaccineready for development (following 18 months development) check-point inhibitormarket dominated by two monoclonal antibody drugs, Opdivo and Keytruda(marketed by Merck). USD4.95B and USD3.81 respectively with double digit growth.

    “On announcing our mimotope program in January 2016we were cautiousgiven the early stage of the research. However, the progress made by the entireteam raises the anticipation that a paradigm shift in cancer treatment is inplay.”

    · New Patent filed for PD1-Vaccine

    · Arginine modulator demonstrates activity inmelanoma cancer model

    · Acquired PD-1 cancer vaccine KEY-Vaxx fromOhio State University

    · Completes Phase 1b trial recruitment

    · President of ESMO, Dr Josep Tabernero joins SAB.

    “The European Society forMedical Oncology (ESMO) is the world’s leading professional organisation formedical oncology with 18,000 members representing 150 countries”

    · IMU Advances to Phase 2 in Gastric Cancer trial

    · IMU meets endpoints in Phase 1b Gastric cancertrial

    2019: Market Cap ~$83m

    · B-Vaxx Phase 1 Data published in prestigious ClinicalCancer research journal.

    · Presentations of KEY-Vaxx, B-Vaxx, HER-Vaxx,and mimotope PD-1 Vaccine data at American Associated for Cancer Research (AACR)

    · HER-Vaxx cancer vaccine trial shows patientshave maintained strong and high levels of HER-2 targeting antibodies indicatinga durable response is present with NO RESISTANCE DEVELOPED (Incumbent billion-dollarPA monoclonal T-Cell patients have shown to build resistance).

    · IMU enhances portfolio with CF33 oncolyticvirus from City of Hope

    · City of Hope researchers receive US Defencegrant to study CF33

    · Oncolytic Virus SAB established withProfessor Fong as Chariman

    · CF33 manufacturing commences

    2020: Market Cap ~$528m

    · HER-Vaxx Patent granted in US.

    “This will protect it in the world’s largest pharmaceutical market until 2036”

    · IMU receives second independent ethics approvalto start Phase 1 clinical trial of PD1-Vaxx

    · CEO Leslie Chong exercises 27 million optionsat an exercise price of $405,000

    · IMU receives third PD1-Vaxx trial approval inAustralia

    · Patent granted for HER-1, HER-2, and HER-3 inUS

    · IMU receives FDA Investigational New Drug(IND) approval to initiate Phase 1 clinical trial of PD1-Vaxx

    · Mann family become substantial holder, buyingcirca 250 million shares for a consideration of $13M+

    · HER-Vaxx shows positive overall survival in trial.Hazard ratio of 0.418. Showing a reduced risk of death of 58.2% in the HER-Vaxxplus chemo group compared to chemo alone. The median overall survival (OS) forpatients receiving HER-Vaxx plus chemo was 14.2 months, compared to 8.8 months.ALL WITH NO ADDED TOXICITY. Independent Data Monitoring Committee (IDMC)confirms favourable survival outcome and advises TO LOWER THE NUMBER OFPATIENTS REQUIRED FOR STUDY COMPLETION. This was advised as it would beunethical to continue enrolling for a trial of a therapy that obviously works andhas no adverse effects.

    · First patient dosed in PD1-Vaxx clinicaltrial

    · IMU enrols first cohort of PD1-Vaxx trial

    2021: Market Cap????

    · IMU complete recruitment to HER-Vaxx Phase 2Gastric cancer.

    · Dose escalation in PD1-Vaxx Phase 1 clinicaltrial

    · IMU commences cohort 2 dosing in Phase 1PD1-Vaxx

    · IMU to present HER-Vaxx Phase 2 data at AACR

    · IMU to present Oncolytic virus Data at AACR… Presentationcalled ‘Subcutaneous Intratumoral Administration of a Novel OncolyticVirus Leads to Eradication of Peritoneal Disseminated Pancreatic Cancer in NudeMice.

    Anticipated future announcements (order notaccurate)

    · Update on HER-Vaxx Phase 2 (AACR which is on10 April, so maybe released 11 April here?!)

    · 3rd Cohort escalation in PD1-VaxxPhase 1 trial (estimate by end of April)

    · Results of HER-Vaxx Phase 2 (the longer thistakes the better, as the patients are still alive and therefore end results notfinalised)

    · CHECKvacc FDA IND clearance (no idea!)

    · PD1-Vaxx Maximum feasible dose identified (estimateby June)

    · VAXINIA FDA IND clearance (no idea)

    · CHECKvacc Triple Negative Breast Cancer 1sPatient Dosed

    · VAXINIA 1st Patient dosed

    Ok, so what do all these acronyms/therapies mean??

    Summary of our pipeline:

    Before going into the individual therapies, I thought it’dmake sense to provide some basics:

    https://hotcopper.com.au/data/attachments/3004/3004019-7d98e35436609b368f3496a10527caf5.jpg
    https://hotcopper.com.au/data/attachments/3004/3004020-fa622483c6732e5e62dad3fe63ae42ea.jpg

    Now our therapies:

    https://hotcopper.com.au/data/attachments/3004/3004022-5db3d7a7ca6608110a20dcfaadf9f435.jpg

    HER-Vaxx

    Status: Phase 2 Trial almostcomplete

    Key points: HER-2 stimulates cancer cells to grow and appears in 20-30%of patients with cancers such as gastric, breast, ovarian and pancreatic. HER-2overexpression cancers have a poor prognosis. HER-Vaxx aims to stimulate the body’simmune system, namely B Cells to produce antibodies that target only thosecancer cells with HER-2 on their surface.

    There are over one million cases of gastric cancer diagnosedworldwide each year (5th most), unfortunately there is poor prognosis forpatients as there is close to 783,000 deaths (3rd most deadly) from it each year.Breast cancer there are 2.3 million new cases each year with circa 640,000deaths (WHO).

    HER-Vaxx could have a significantly more convenient dosingregime over Herceptin’s weekly and lengthy infusions. But also, some patientshave built resistance to incumbent T Cells monoclonal therapies in the market:Herceptin and Perjeta.

    Market size: Itis a very large market. A good gauge for market is sales of other HER-2 but inmany places, Herceptin is not available or not affordable however, current salesfor Herceptin are circa $7 billion USD (Fierce Pharma). With, Herceptin hasa bunch of nasty side effects, costs a lot more to make and needs to beadministered more frequently that HER-Vaxx. You could assume this wouldtranslate to a larger market and higher sales.

    PD1-Vaxx

    Status: Cohort 2 doseescalation. Initial response from Leslie has been very positive.

    Key points: The company’sPD1-Vaxx is a B-cell immunotherapy, peptide cancer vaccine designed to treattumours such as lung cancer by interfering with PD-1/PD-L1 binding andinteraction, and produce an anti-cancer effect like Keytruda, Opdivo and theother immune checkpoint inhibitor monoclonal antibodies that are transformingthe treatment of a range of cancers.

    Market size: Again, best estimates here would be incumbent monoclonal antibodies Keytruda, Opdivo. Sales for Keytruda in 2019 were circa $3.7Billion. Opdivo sales in 2019 hit $1.8 billion (Fierce Pharma).


    CF33 – VAXinia (CF33+hNIS) + CHECKVACC (CF33+hNIS+antiPD-L1)

    Status: Phase 1 trials Pre INDapproval

    Key points: Cancer killing viruses.They do so by infecting cancer cells (only), replicate in, and killing cancercells, while sparing healthy cells. IMU have further developed the CF33 virus to include another compound that enables tracking of CF33 and radioiodine therapy. Perhaps more notable, CHECKvacc is ‘armed’ with a checkpoint inhibitor, anti-PD-L1 which may enhance anti-cancer immunotherapy.

    Market size: Thereare not any incumbent Oncolytics Viruses being sold yet (from what I can see),however it’s a cutting-edge space will a lot happening. With that being said,recent deals in the space are a good place to start. See below table.

    https://hotcopper.com.au/data/attachments/3004/3004029-715430ad8d5f9024628f87f28b14d167.jpg

    CF33 has been found to outperform both AMGEN & GENELUXviruses in mice. See below total deal worth for Amgen was $1billion US. Plus,CF33 was touted as being far better than Viralytics OV and that was bought byMerck for $394m US, a 160% premium ($1.75 per share after VLA closed at 61.5 centsafter close).


    https://hotcopper.com.au/data/attachments/3004/3004033-e2e1978a177186d829ff7d3916702e64.jpg

    Mimotope platform.

    Although its not often discussed, the mimotope platform isextremely valuable to big pharma. Like our B-Cell therapies in HER-Vaxx and PD1-Vaxxthat have specific cancer targets (HER-2 & PD1 respectively) that allowthem to be effective cancer killers, there are many different cancer types thatcan be targeted through the mimotope platform. Each one (see below pipeline) worth$100m in yearly sales if not billions.

    https://hotcopper.com.au/data/attachments/3004/3004039-d0d52a3b3f8a85ca715ff85f1cbcc7af.jpg


    You just need to look at the current yearly monoclonal therapysales (below) to see the potential with this platform. Not to mention that theB-Cell approach thus far has been to be found more effective, cheaper to make,easier to administer and last but least important, no toxicity and adverseeffects. Which is huge!

    It must be said, IMU would unlikely be able to see thesethrough without a big deal coming in to fund them. And perhaps even with a deal,may make more sense in the hands of a big pharma with deep pockets. Why would abig pharma want it?! Well, to be able to get better results than incumbent therapiesearning $60 billion in sales currently per year, that’s why!

    https://hotcopper.com.au/data/attachments/3004/3004041-fead1aee106c752bafc39caaeec8283c.jpg

    Ok I think that will do for now. I am working on a model totry get a better idea of intrinsic value that id be happy to share, assumingpeople find the above value also.

    Through my research, much of which is above, I feel wehave not seen anything yet with regards to IMU, although a MC of $1.5 B would be(even more so) life changing I quietly believe there is potential for it to be muchmuch higher, all IMO of course.

 
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