Thank you @Footmax for your reply wherein you asked of me,
Just a quick question - and basically, just your gut feeling as no one can give a definitive answer.
What chance do you give the possibility of some sort of commercial deal over the next 12 months given the amount of data that should be forthcoming from the current trials?
In an “off the cuff” answer to your question tonight I thought I’d place my reply on a thread where it belongs, herein. In doing so I should from the outset state that I am of the opinion Professor Yuman Fong’s CF33 and Vaxinia are going to prove successful in providing significant benefit to cancer patients. This opinion is based on my research and understanding of these oncolytic viruses, together with a number presentations from the founder, inventor and innovator Professor Yuman Fong himself, in addition to Saul Priceman M.D, Imugene’s Leslie Chong and Dr Jakob Dupont.
In answering your question I draw your attention to Brooke Wilson and her colleagues from the University of New South Wales and the Collaboration for Cancer Outcomes, Research and Evaluation at the Ingham Institute for Applied Medial Research, Australia. Brooke noted in an article at cancerworld.net in 2019 “The rising cancer burden and the increasing demands for chemotherapy globally will be major health crises during the next 20 years. The gap between available service provision and demand is substantial, especially in low-income and middle-income countries. Strategic investments to expand capacity for chemotherapy delivery globally are urgently needed”. The same article highlights the fact that globally 57.7% of new cancer cases (9.8 million out of 17 million) required chemotherapy in 2018. In 2040, the number of new cases of cancer will rise to 26 million, of which 53% (15 million)—+5.2 million new cancer cases from 2018—are expected to need chemotherapy.
I therefore believe that if Professor Yuman Fongs CF33, Vaxinia, Oncarlytics arm is to one day become human therapy as he has suggested and thereby replace the existing standard of care, that being chemotherapy, these are the statistics we need to pay close attention to when structuring a potential deal and long term commercial outcomes. Imugene's oncolytic virus treatment is thus far proving to be less invasive and costly when compared to chemotherapy. The side effects of both treatments must be considered as well. Unlike Imugene’s oncolytic viruses chemotherapy often leaves patients with unpredictable mood swings and can induce fatigue, loss of appetite, nausea, bowel issues such as constipation or diarrhoea, hair loss, mouth sores, skin and nail problems. Quality of life for patients must be considered as well. Let’s not forget that when administered intravenously CF33 and Vaxinia can reduce hospital time for cancer patients and in turn significantly cut healthcare costs. Reduced hospital time and medical care hours could assist governments and regulatory authorities in slashing the financial burden associated with cancer care.
Therefore if successful in existing trials, as outlined by Professor Fong in recent Australian presentations, Imugene’s oncolytic viruses are attractive to not only Big Pharmaceuticals looking to increase revenue and product runways, but perhaps more importantly to governments and health authoritiesglobally. Having ticked the boxes in the current clinical trials, and assuming they receive “breakthrough therapy” status at the consent of America’s FDA, surely a deal shall arrive in Bligh Street either later this year or early in 2024. Should Oncarlytics obtain FDA approval for a Phase 1 trial into humans the stakes on offer may well be higher, as CAR T and allogenic therapy providers join the foray. Could a deal appear earlier than Q4 2023? Maybe. But such a deal may be to the detriment of Team Imugene as they continue throughout 2023 to dot their “I’s” and cross their “T’s” in their existing trials at higher and therein more efficacious dosage rates.
Who in my opinion are the prime contenders for a seat at the table? Well Merck, Pfizer and Roche are prime contenders given their existing collaborations with Imugene. That said I wouldn’t be ruling anyone in Big Pharma out. Cancer care is a growing market segment as outlined above, with the solid tumour market offering huge returns from the late 2020’s onward for those with treatment products to suit. Either in combination or stand alone Imugene’s oncolytic viruses are unique in that they not only only attack cancer cells, but in doing so produce limited if any side effects. Once the first FDA approval is granted surely a raft of CF33, Vaxinia and Oncarlytics approvals will follow, extending the associated revenue base exponentially.
But back to your question @Footmax. I anticipate a healthy upfront payment offer hitting Imugene CEO Leslie Chong’s desk early in Q4 2023 with a view to offering marketing and sales infrastructure in return for access to Professor Fongs wonder drugs. By that stage CF33 and Vaxinia are designated to have produced clinical trial results at close to their optimal biological dosage rates. I would assume milestone payments would be placed on the table upon future FDA approvals wherein a 50% revenue split could be negotiated by Imugene’s business aficionado’s. The offer could come as late as March or even June 2024, though at such a time the acquirer could run the risk of fronting up to a healthy dutch auction were they to wait for all Imugene’s chickens to come home to roost. Although Big Pharma would traditionally prefer to pay more for the right oil without taking undue risk, given the quantum of revenue on offer I think a move early in Q4 2023 would be their preferred offer date.
Does Big Pharma wish to take a share in the drugs as outlined above, or alternatively take a stake in Imugene the company? I like the idea of Big Pharma taking a stake in Imugene, but on Imugene’s terms. As a shareholder I would prefer a Genentech/Roche Therapeutics style deal where Imugene maintains management, research and structural control until such a time as their full potential is realised. Let their Big Pharma partner do the heavy lifting when it comes to what they do best, sales and marketing, through their existing manufacturing and distribution channels. From where I sit an outright takeover, such as the recent Pfizer/Seagen deal holds little long term appeal for existing IMU shareholders. Keep in mind I am of the opinion at $8-10 Billion USD in annual revenue forecast in 2030, Seagen looks to have less prospective revenue potential than Imugene.
Whether its Q4 this year or Q1 next year can Imugene cut a deal? Even with the scientific evidence in the bag the jury is still out. They haven’t cut one yet. Perhaps the path of least resistance for them is to announce an FDA approval for CF33 and/or Vaxinia with a view to releasing the drug through oncologists in a registrational style trial where the drugs can slowly gain impetus as Keytruda did, prior to reaching it’s current lofty heights, of $20 bn USD in annual peak sales. With such an approval being accompanied by a NASDAQ listing in the US Imugene’s market awareness could be enhanced and additional funds could result in increased share value value for those on the IMU register. However as Big Pharma are best placed to take CF33, Vaxinia and thereafter Oncarlytics to market, fast track FDA approval and a Big Pharma roll out is my preferred option. Speed to market is of the essence in an ever changing medical climate, in which governments are more prepared now than ever to throw money at the cancer problem. The time taken for Imugene to get their forthcoming PD1 Vaxx and Phase 2 HerVaxx combination trials into play tells me that despite their best efforts Imugene are much slower than Big Pharma in making things happen, irrespective of how much money they have in the bank. Whether its Prescient Therapeutics (ASX : PTX) or Enhertu, there are more and more players entering an over crowded space. The time to strike is now, when the iron is hot. Collect the data, collate it, join all your ducks in a row and hit the pavement in search of the best deal. Let’s face it, you are offering keys to the door of the holy grail of cancer, that being the solid tumour market. Is that a hard sell? In essence no, but the devil’s in the detail. Cutting a deal to incorporate all the permutations and combinations associated with Professor Fong and Saul Priceman's innovative products is the hard part. The future revenue streams and potential out licensing agreements appear endless. I’d like to say I’m glad it’s not me hitting the pavement, but then again, I do enjoy a challenge.
Best of luck to all LTH’s
DYOR Seek investment advice as and when required Opinions Only
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