Hi all
I watched the webinar live, my reflections are from what I can remember. At the risk of sounding like an up-ramper, I found the QandA to be reassuring. That's not to say I don't have some concerns, but overall I believe it was a net positive and it did exceed my expectations (which were low).
Lack of Trust
The main element destroying the SP is a lack of trust in management. Shareholders feel they've been misled numerous times with golden geese and full dance cards and the perpetual heralding of 'beautiful data'. In the very least this webinar made an attempt at confronting shareholder questions directly and is a step in the direction at rebuilding trust. There's a very long way to go.
azer-cel
Clearly azer-cell is the front-runner. Leslie said they were not going to waste meetings with the FDA so when they decide they have adequate data to direct a phase 2 they will liaise with the FDA. PH reminded us there are 4 patients who have been cured, the longest going on a full year, who would otherwise be dead. This is significant reminder, albeit already known. Will the phase 2 be guided by cohort B with the introduction of IL-2? Most likely. BG also stated there may be multiple arms with CNS lymphoma mentioned.
Timeline & Cost- BG clearly stated the azer-cel phase 2 will take 2-3 years to complete and roughly $30 million USD. While continuing to amass data, we might expect the phase 2 to start mid-late 2026, and run until 2028 or 2029. That is important information to know. The market hears things like "trials at lightning speed" but may not have a considerable grasp or understanding on what that means. At least now we know that our most advanced asset is still 3-4 years away from completing phase 2.
Commercialisation
BG stated they were in talks with BP regarding multiple products. They are actively seeking an outcome for Her-Vaxx / PD1-vaxx. PH stated they weren't going to just accept the first offer that comes across the table. They are looking to structure a deal which maintains considerable upside for Imugene. This is an important and reassuring point. If we have to wait longer for a better deal then, from my perspective, that is preferable. Obviously the company will need to be balancing this timeline against our cash reserves and significant overhead costs.
Staffing reduction - to me this was a bit of a stunt. Sounds good, but in reality they got rid of the manufacturing facility which we already knew about.
Talent - to attract and retain world-class talent they have to be renumerated handsomely. That's the nature of the game we are playing in. I accept that. There is a committee of 3 independent directors who set the remuneration schedule - neither PH or LC sit on that committee. Additionally, the remuneration package needs to be endorsed by shareholders at the AGM.
CF33 - LC mentioned a disease control rate, across all solid tumours, of 60%. I believe that is new information. Like the cholangiocarcinoma poster presentation last week, this information is somewhat disappointing. I was hoping for knockout data which showed numerous compete responses across numerous indications. That seems not to have eventuated. LC was very clear that they are continuing to pursue cholangiocarcinoma. I believe this is due to the limited treatments available. LC mentioned only 8% of CCA patients are responsive to treatments. This seems like a promising space. Imugene have also seen some responses in melanoma.
onCARlytics
This is dose escalating. They have seen "some" flagging of CD-19 in low doses. This doesn't seem overly confident. They expect as doses increase they will see more of the CD-19 response. If there are early signals in the combo arm with blincyto then Amgen must surely have some interest. PH stated they were looking for a partnership which would best take products forward while continuing significant upside for Imugene. onCARlytics remains the potential paradigm-shifting product.
Dodged questions
I asked why the CCA poster data wasn't announced to the market. LC stated that the CR patient was already known and that the disease control rate was already known, which meant in their view it didn't require an ASX announcement. I disagree completely. I believe the data, although it may be clinically useful, isn't the show-stopper we were hoping for and it has been released through the backdoor. I believe it was
@reon1 who mentioned CF33 may have some clinical benefit, but it's not the one-stop cure we have all been hoping for. I tend to agree with this assessment. I would be very interested to hear Yuman Fong's interpretation of these results.
The other major dodged question was around capital raising. PH went straight to the 2023 cap raise in his answer and failed to discuss the December 2024 cap raise. This is a likely a reflection that it wasn't a great raise. Not a good look and is somewhat concerning.
Overall
- I'm feeling disappointed in the CCA poster data itself, and how it was softly released via a backdoor poster presentation. I believe it to have clinical benefit but it's not the knockout data one had hoped for.
@reon1 said they were most likely waiting for another CR which hasn't eventuated - again, I agree.
- The three presenters appeared to answer all questions and fronted shareholders for 50 minutes. Although there were some dodged questions, they fronted which I believe to be net positive.
- Imugene still has multiple shots on goal and I believe there is considerable upside. A commercial outcome for any of its 5 products would certainly turn sentiment around and assist funding for future trials.
- Presenters reiterated there has been no negative data and no trial failures to date. This is an important point to remember as a shareholder who is holding through these times.
- The most reassuring aspect to me is that they have provided a timeframe - 3-4 years. We wait for more data, we wait for the possibility of a commercial conversion, but at least we wait knowing that this will likely take years to play out.
There's always a niggle at the back of our minds saying "a deal could be around the corner". And with the additional accumulation of data, the chances of a favourable deal improve. One deal and this entire ship turns around. It's what keeps us all holding on.
My thoughts and opinions.
All the best to holders and patients. Chur.
Shornbra
(20min delay)