The long Sunday Post, as promised
Vaxinia, obligations, JP Morgan and throwing caution to the wind, by WMHB
In certain instances listed biotechnology companies may be in a position to withhold price sensitive data, until it is peer reviewed, or presented at an industry (i.e., medical) conference. However in the main clinical data that may be deemed price sensitive needs to be disclosed immediately, as it comes to hand.
The continuous disclosure obligations in the Corporations Act 2001 are fundamental to maintaining the integrity of the market by ensuring transparency and equal access to information.
Listed companies must disclose material price sensitive information on a timely basis and comply with listing rules of the relevant market.
Imugene need to be careful, particularly when it comes to their flagship candidate, Vaxinia , and the disclosure of ongoing trial results. LC and her administrative team may have been impressed with Professor Yuman Fongs interviews on US TV late in 2022 and subsequent statements to shareholder conferences in March, pertaining to the prospective efficacy of Vaxinia, but I expect they were not. If shareholders or the public perceive the company are withholding clinical information that could or perhaps should have been released to the market, the BOD could potentially be held liable. A few years ago the ASX gave LC and PH some please explain notifications surrounding discussions had publicly, prior to sensitive data being released. Of course the matter was pursued no further, as they were found to have adhered to all the necessary procedures and protocols to which they are bound by the ASX.
Let me give you a hypothetical example of what may lead IMU Management into hot water, if indeed results are released as and when they choose, rather than as and when the regulators deem they should be announced. Recently my fellow poster @Steini took umbrage at the Boards decision to conduct a Capital raise in September 2023, when at the time they may (or may not) have been aware of Vaxinia’s pending success. When the results were ultimately released on November 6, they highlighted Vaxinia’s success in treating gastrointestinal cancer patients. The stock proceeded to rise from .52 cents, to 11.5 cents, in less than a week. In other words the SP rose over 100 percent in a week. @Steini subsequently questioned why the BOD failed to wait until Vaxinia’s successful results were made public and then raise. He was inferring that by raising at 8.4 cents, and even lower figures, (i.e., when the public share price participation for the capital raise was complete), the directors had effectively sold off a portion of the company for a fraction of what it should have been worth. In other words he was suggesting they would have had to sell far less shares in the company had the market been aware of the pending Vaxinia results and the capital raise proceeded at a higher strike price.
In retrospect the Imugene board would state they had planned the CR prior to becoming aware of the results, and that if they had not acted with haste they made have missed the opportunity to purchase what could be the worlds first FDA approved allogeneic therapy, in azer cel, a product which they would argue may have been snapped up from Precision whilst they were procrastinating. Yet it’s a close call. The reason being some of the directors at IMU actually acquired shares in IMU as a consequence of the capital raise. Could it be said they purchased their shares at a lower price than they should have, given the state of play in the Vaxinia Trial? On August 18, 2023, when the Board commenced positioning the CR to the public, a bile duct cancer patient would have been cancer free for more than 200 days. The trial supervisors may at that stage have been aware of a disease stabilisation in the bile duct indication. Approximately 100 days later the FDA approved a fast track designation and priority review status for the bile duct indication. They obviously deemed the Vaxinia results as significant.
Imugene has had no shortage of journalists such as Tom Richardson from the AFR prepared to take a shot over the bow of the good ship IMU. Now more than ever as Yuman’s unique virus’s results come to fruition they are sure to be monitoring its every step. All’s fair in love and war,until someone perceives they have made a monetary loss at the expense of information being with held that is. Taking the recent CR raise as an example, many shareholders may not have even participated in the CR. In fact I’m sure they didn’t. Would they have participated if made aware of the progression in the Vaxinia trial with respect to the bile duct and more broadly speaking gastrointestinal patients? I’m confident they would have. My fellow poster @Footmax is on record here saying he purchased IMU off market, as opposed to participating in the SPP via the CR. Now I’m sure if he had not, as others did not, they may well not choose to take action against the IMU Board for a potential monetary loss,but what heaven forbid if any of these said shareholders passed? In years to come would their estate(s) hold the same view and allegiance to the board of IMU in probate? I’m not sure they would, particularly if there were large sums involved. If Vaxinia records similar results as they did on November 6 in the year to come, and the SP propels north to $5, those on the outside may well ponder whether or not they would have participated in the CR had they been informed of Vaxinia’s initial success prior to the raise.
It’s all hypothetical and I am no way inferring the Board of IMU has and would ever fail to disclose or withhold price sensitive data, there is simply too much at stake. But my point is that many posters on this thread have suggested “IMU has no set obligation to report on trials at any particular time”. I totally disagree with these comments. Medical conferences aside, if they are in possession of biopsies from the Vaxinia Trial, that have been subsequently peer reviewed, which may be deemed as price sensitive to the market, they MUST DISCLOSE and are duty bound to do so. They are obliged to under the Corporations Act. So with respect to the 34 Vaxinia patients already treated, or as LC suggested in her Proactive Investor interview with Dr Paul Woodard thereafter “36 or 37 patients," the company is under an obligation to release trial information which may be deemed as price sensitive information, as soon as it comes to hand. The longer the trial progresses the more IMU's BOD need to prepare for scrutiny, particularly when one takes into consideration how many options and shares in the company they hold on a personal level.
It is in Imugene’s best interest to disclose information through company announcements in a clear, concise and timely manner. Historically when they have done so, such as in 2021 when they released specific patient data from their PD1 Vaxx Trial into late stage lung cancer patients, the SP has appreciated accordingly. Then in June 2022 when specific information correlating the OSR data in the Phase 2 Trial for their B cell Vaccine Her Vaxx was released to the market by way of company announcement, the SP appreciated as a result. Whilst it goes without saying the clear and concise manner in which the recent Vaxinia results were conveyed to the market, went a long way toward the subsequent price appreciation in early November 2023 (see above). With statements such as “7 patients with gastrointestinal cancers who received CF33-hNIS alone including 3 colorectal cancer, 2 bile duct,1 pancreatic and 1 liver cancer showed positive treatment effects, with a disease control rate [all CR, PR and SD) of 86%,” the market could be in no doubt as to what had occurred in the ongoing trial to date. Therefore just as it is in their best interests from a fiduciary standpoint to release data expeditiously, I do believe it is incumbent upon them to release clinical data in a clear, concise and timely manner, for this data is more often than not price sensitive. It does alter shareholder value, one way or another, and as their role as stewards of the company is to create to shareholder valuethese responsibilities cannot in any way be ignored or delayed.
On a personal level I would like to see announcements bring with them more detail, as noted in earlier posts. I draw readers attention to Imugene’s competitors, including stocks listed on the Nasdaq such as Replimune, who provide extensive information upon the release of price sensitive data. I would be encouraging Imugene to do likewise with regard to forthcoming Vaxinia clinical trial results, given the curiosity and interest surrounding Yuman Fongs unique therapy. It is important to circumvent any confusion or misunderstanding. Clarity is of the essence as we reach the pointy end of proceedings. Too often have Imugene opened the door on misinterpretation, when discussing or outlining clinical trial data, dates and detail.
I would suggest as @Taureanbull does in his recent post the JP Morgan Conference is much more than a walk in the investment park for Imugene. The company must take the horse by the bit and step up without missing the opportunity that awaits them. Healthcare researchers, investors, stock analysts, private equity firms, fund managers and sophisticated investors all grace the hallways of JP Morgan’s Conference, in search of that one soundbite which may turn the page for them. Much of Imugene’s value proposition lies ahead of them, in the opportunity to link such therapies as Vaxinia, Oncarlytics and Azer Cel together, as forecast by Dr Paul Woodard in the aforementioned Proactive Investor video. However they must seize the moment today through delivering details pertaining to what they know of their immunotherapies thus far. Big Pharma spend big money on large clinical trials with huge numbers of participants. Imugene is not currently in that theme park. But where they are situated is in a safe, low cost position, having the potential to combine multiple drugs to produce efficacious vaccines with the prospect of meeting a significant number of unmet needs. Vaxinia, PD1 Vaxx and CF33 fall firmly within these parameters. Therefore it is imperative on Wednesday of this week the company makes every post a winner in presenting as much data as humanly possible on their flagship candidate Vaxinia, in conjunction with meaningful updates on their Azer Cel, Oncarlytics and B cell products.
Imugene does not currently derive revenue, but it presents a strong value proposition for those attending the JP Morgan Conference.
In simplistic terms Imugene:
- Are sure to have products and services in demand, as they meet a huge unmet need.
- Have performed well in the past, through the development of a number of safe vaccines capable of producing immune responses in late stage cancer patients
- Have talented, experienced managers in charge, overseeing the ongoing development of their pipeline
- Are ideally positioned for growth and profitability, within the lucrative solid tumour market and
- Have little or no debt with ample cash on hand to see their current crop of clinical trials through to completion.
It is these factors that need relaying to the captive audience present this Wednesday in San Francisco.
Taking it a step further, if you can bear with me a little longer, I’d like to see Imugene no longer just trust the science, but back it. Set goals in support of their products and communicate them with their audience. “Our near term goal is to attain a Fast Track designation and Priority Review for one or of these abc gastrointestinal indications. Our intermediate goal is to achieve a registration trial for these gastrointestinal cancer indications, with our long term goal being to obtain FDA approval and eventually market share in these gastrointestinal solid tumour markets. The estimated market value is forecast to be xyz in 2030, and our forecast projected earnings were we successful in obtaining our long term goals would be 123, if were to obtain 1% market share, 456 in the event of a 10% market share and so on and so forth”. Look I am not bound by fiduciary duty, obligations or the responsibilities of the IMU BOD. It is easy for me to make suggestions. That said at some stage the BOD is going to be required to back one treatment arm over the other. They are going to be required to choose between cancer indications, as well as short, intermediate and long term goals. Why not lay their cards on the table now and spell out a plan, or strategy at the very least. Create some visibility,a sense of purpose. Give attendees at the JP Morgan Conference a reason to invest, as opposed to a science lecture. Let’s face it, the ideologue of “trust the science” has borne little share price fruit thus far. Why not incept a “back the science” approach. If forecasts, goals, trial approvals, forecast projections and market share figures are not met, then so be it. No one was ever hung out to dry for forward thinking. Just amend your future plans to suit the situation.
Whatever the outcome, irrespective of when the results in the current Vaxinia (MAST) Trial are released, I wouldn’t miss the jump if they are positive. I rang friends straight away in early November after the announcement and luckily they heeded the call. I have a sneaking suspicion should the ensuing Vaxinia results produce additional immune responses, we may not have as much time to “get on” this time around.
Best of luck to all holders and Imugene personnel for the week ahead.
DYOR Seek investment advice as and when required Opinions only
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