It's now one year on from a time when Imugene promised investors so much, only to deliver so little in 2022. In 2021 Imugene had brought in supposed corner stone investors who would presumably provide them with additional funding moving forward. They had gazetted a number of trials for their first drug, Her Vaxx, including collaborations with Merck Germany, Pfizer and Merck. The Professor Kaumaya licensed PD1 Vaxx, in addition to their B Cell drug Her Vaxx, had exhibited signs of not only safety and tolerability, but strong efficacy signals, in a Phase 1 trial with lung cancer participants in Melbourne. Added to which the company was included in the ASX 200 and according to senior management was in discussions with several leading industry players, or dance partners as they referred to them. There were strategic partnerships with Eureka Therapeutics and Celularity, set to be cemented in commercial agreements at the conclusion of a preclinical analysis with Imugene’s then newly acquired Oncarlytics platform. Yet despite all this upbeat hyperbole 2022 brought with it a failure to deliver on the communication and commercialisation front. The collaborations themselves failed to materialise into anything financially substantial, leaving investors somewhat lethargic and unsure of the road map ahead. With a further capital raise at next to year low share price levels to once again undisclosed investors and without any clear direction from the company Chairman Paul Hopper, people starting looking around for someone or something to blame. The macro economic downturn in 2022 was a prime target for investors, though despite a fall in stock prices globally, IMU was marching to its own beat, independent of the market, and decided to fall much further than the majority of stocks in the ASX 200.
Given that company management was unable to deliver clear guidance on the pending B cell trials and on the financial nature of collaborations with Big Pharma, Eureka and Celularity, not to mention Hoppers junior biotech, Arovella, Imugene's share price continued to dawdle along throughout 2022. Low daily volumes and little institutional support were par for the course in 2022, when it came to IMU. So from a public perspective the rudderless ship that was Imugene continued following the so called science into the mire, leaving investors to divine for an outcome themselves. Though luckily for them Imugene was able to turn to two exceptional individuals, Professor Yuman Fong and Dr Saul Priceman, both esteemed medical practitioners from the exemplary City Of Hope Cancer Research Centre. Upon their visiting Australia in late 2022, investors were made aware that without Fongs ingenious oncolytic viral invention, CF33, T cells and other allogenic medications were on their own incapable of impacting upon solid tumors within cancer patients. But with the addition of Priceman's Oncolytic/CD19 platform in combination with Fong’s CF33, Car T’s and allogenic therapies proved extremely successful in killing tumours across multiple cell lines, including liver, pancreatic and breast cancer. This was manna from heaven for the Imugene investors who were able to “hear it from the horses mouth” as it were, in both Melbourne and Sydney.
Everything started to come together for long term investors who had shown faith in the company management and their “follow the science” mantra. A Yuman Fong television interview on late night news in the US in which he suggested he was convinced CF33’s potent parental virus, Vaxinia, would one day become “human therapy," sent shock waves through the IMU family, as they realised both Fong and their own dreams may soon come become a reality. For Imugene was already dosing the second cohort in the Phase 1 trial of its cancer-killing virus, VAXINIA. Added to which the study was being conducted with a statistically relevant number of participants, (that being over 100), targeting a plethora of solid tumours in the process across sites in both the US and Australia. Then to add some custard to the dessert on offer from Fong and Priceman, investors were made aware that Fongs fears were allayed when it came to his only concern regarding CF33 and Vaxinia. Initially Professor Fong had been unsure whether his viruses would be safe when infused into patients. Alas both drugs were deemed to be safe and tolerable by the FDA in their subsequent trials into humans throughout 2021 and 2022, and in doing so putting Professor Fong and investor fears finally to bed. So it was full steam ahead for Professor Fong, who was now able to dose patients in his Vaxinia trial with pembrolizumab (i.e., Keytruda), without the need to revisit the FDA once more. Meanwhile Saul Priceman was able to speak of a world in which future Phase 1 Oncarlytics in human trials were just around the corner. Now that would be something for Big Pharma to salivate over.
So perhaps investors were then able to digest the science that lay before them at Imugene. Firstly Her Vaxx was finally able to be administered into gastric cancer patients at its optimal biological dosage rate, that being twice that administered during its former trial, which in itself was shown to extend life by up to 5.9 months in late stage cancer patients (i.e., in June 2022). And like the aforementioned Vaxinia trial, pembrolizumab (Keytruda) was being added into the Her Vaxx mix. Secondly Professor Kaumaya’s PD1 Vaxx was shown in Swiss trials to exhibit outstanding results when utilised pre clinically with Her Vaxx, adding another string to Imugene's B cell bow. Long term holders began to salivate themselves at the potential for Imugene to combine their own B cell drugs with one another, as opposed to Big Pharma drugs which were prone to producing extensive side effects within cancer patients. That said they began to look forward to the forthcoming PD1 Vaxx combination trial with Roche's successful cancer vaccine Tercentriq, in order to visualise what promise that combination would afford lung cancer patients worldwide, in desperate need of a solution to their catastrophic situation. Thirdly they began to await confirmation CF33 was in fact safe and tolerable within humans, at the forthcoming ESMO Conference on December 9. Long term holders were confident that Professor Fong’s CF33 and even more so Vaxinia, were capable of obliterating tumours in humans, as these oncolytic viruses had wiped out cancer across the NCI-60 (Human Tumor Cell Lines Screen) during preclinical trials years before. They simply needed to see in black and white that the viruses were safe and tolerable when injected into humans.
The pieces of the science puzzle began coming together. An abundance of skilled and qualified staff joined the Imugene team to ensure their clinical trials were executed in an expeditious and professional manner. The fruits of Professor Fong, Wiedermann and Kaumaya's hard labour were all coming to fruition. 2022 was turning out to be not so bad after all. The commercial and financial gravity of the situation simply needed to catch up to the science. Maybe it was time the share price did the same.
DYOR - Seek investment advice as and when require - Opinions only