PYC - General Discussion, page-935

Time is moving along and below I have listed a couple of conferences/meetings that PYC have indicated that they will be presenting at in the very near future…

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Retinal Therapeutics Innovation Summit 2025

Friday, May 2nd, 2025, 8:00 AM (MST)

The annual Retinal Therapeutics Innovation Summit 2025 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute.

Members of the medical and research communities will come together with representatives from the biotech and pharma industries to discuss rapidly emerging ocular therapies and strategize how to remove barriers toward clinical utility for the most advanced retinal disease therapies.

The Retinal Therapeutics Innovation Summit features presentations by leading experts on potential therapeutic approaches to treat retinal diseases and how best to deliver them to patients.

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ARVO 2025 Annual Meeting (Association for Research in Vision and Ophthalmology)

May 4 - 8 | Salt Lake City, Utah

The theme of the 2025 Annual Meeting addresses how vision research is continually being transformed by new information and technologies. Exponentially expanding computing power is giving rise to improved artificial intelligence and powerful big data. Increasingly sensitive and elegant molecular techniques, including CRISPR and mRNA technologies, as well as more sophisticated imaging modalities, virtual reality, and breakthroughs in gene therapy are catalyzing our research as we aim to treat, cure and ultimately prevent blinding eye diseases.

Why exhibit and market with ARVO?

• ARVO is globally-recognized and respected as a leading provider of quality content and research
• ARVO has a worldwide membership of 11,000 in more than 65 countries. Forty percent of ARVO members reside outside of the U.S.

Who attends the ARVO Annual Meeting?

• The ARVO 2024 Annual Meeting drew 11,600+ attendees, with nearly 80% of current ARVO members attending every year.
• Attendees include basic science researchers, clinical researchers, clinicians, surgeons, ophthalmology educators and students, and clinicians-in-training.
• Top fields of study and practice of attendees include retina, cornea, glaucoma, retinal cell biology, age-related macular degeneration, diabetic retinopathy, cataracts, dry eye, basic research and clinical private practice.

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In relation to RP11, I have taken on the task to review commentary from PYC’s most recent Investor Update webinar and with my best endeavour, (interpretation), have written what I am expressing below, underscored with an intention of accuracy. FYI, I have also intermingled some of my personal views as well, so read on, if you wish, with that in mind.

These abovementioned conferences/meetings offer a wide range of global and industry specific, (Ophthalmology), experts/participants an opportunity to have a highly informed view at how PYC’s RP11 data set has extended over time, as enrolled SAD and MAD patients have come back for follow-up appointments and evaluation.

Kindly note PYC presented at last years, 2024 ARVO meeting. A copy of last years’ ARVO presentation can be downloaded from PYC’s website. I anticipate that PYC will once again provide details covering their upcoming 2025 presentation to investors on their website, and through an official ASX announcement. RH seemed very upbeat at our recent Investor Update webinar, and for myself I feel growing confidence that the extended data will support a robust and positive outlook.

RH said patients are very keen to remain on the drug and the principal investigators are very keen for their patients to remain on drug as well.

RH also remarked that both patient and principal investigators keenness to extend is terrific and supports the basis to further extend RP11 studies to a 24-month follow-up window. PYC are looking to assess how long vision improvement can continue, such that it may possible to validate a very clear separation from the natural history of disease progression, which is in itself a very slow decline in visual function, and compare that to a 24-month continuation of improvement data in the treated eye versus untreated eye. That data is going to help PYC in a very material way to think through the design of how an accelerated, combined P2/P3 Registrational study may look like.

The more separation PYC get on the back of the improvement there, the shorter the duration of the registrational study will need to be, so that is a particular the piece of the puzzle that PYC are looking at from here.

In the first week of June 2025, PYC will have a meeting with the FDA to seek alignment in relation to the design of the RP11 registrational study. PYC do not need to fully finalize the design of the RP11 Registrational study at that meeting and no exact date for finalization has been forecast, I do however expect PYC won’t be wasting any undue time, (once there is clarity on alignment), to submit the Registrational trial design for FDA acceptance to proceed.

IMO, some highly promising and potentially exciting news may be coming our way in the reasonably near future. Best wishes to all.