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PYC THERAPEUTICS LIMITED Call Transcript 2023

Jul 9, 2023

65640_rns_2023-07-09_fac916f5-4814-491c-8f31-5ad10b23e809.pdf

Call Transcript

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Q3 INVESTOR CALL

  • PYC provides advance notice to all shareholders of an invitation to join a special format investor update meeting/teleconference on Wednesday 27 September 2023 at 9am AWST (11am AEST)
  • The investor update will focus on progress in the ongoing human trials evaluating the safety and efficacy of the first investigational drug candidate to have progressed to clinical trials in a blinding eye disease called Retinitis Pigmentosa type 11 (RP11)
  • Professor Ian Constable will join PYC's Chief of Research and Development, Sri Mudumba, for the update to discuss progress in the RP11 trial

PERTH, Australia and SAN FRANCISCO, California – 10 July 2023

PYC provides advance notice to all shareholders of the Company's Q3 investor update occurring on Wednesday 27 September 2023 at 9am AWST (11am AEST). The update will adopt a special format dedicated to the progress of the Company's lead investigational drug candidate known as VP-001 through clinical trials. PYC's Chief of R&D, Sri Mudumba, will facilitate a discussion on this topic with Professor Ian Constable. Prof. Constable is an ophthalmologist and research clinician. He is a pioneer in the field of retinal gene therapy and was the founding managing director and is now patron of the Lions Eye Institute. Prof. Constable is a member of PYC's Scientific Advisory Board and is also a member of the Safety Review Committee for VP-001 in the Platypus clinical study (details of which are provided below).

Following the discussion on the Company's lead program, PYC's CEO, Rohan Hockings will provide an update on progress in the Company's:

  • Second drug development candidate a first-in-class therapy in another blinding eye disease called Autosomal Dominant Optic Atrophy that is expected to enter human trials next year; and
  • Third drug development candidate a first-in-class therapy for a neurodevelopmental disorder known as Phelan McDermid Syndrome.

Registration details for the update/call will be provided in early September.

About VP-001 – the first potential treatment for Retinitis Pigmentosa Type 11

RP11 is a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age. The disease affects ~1 in every 100,000 people and is caused by insufficient expression of the PRPF31 gene in the retina.

There are currently no treatment options available for patients with RP11 nor are there any in clinical development.

VP-001 is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina. VP-001 utilises PYC's proprietary drug delivery technology to overcome the major challenge for RNA drugs by ensuring that sufficient drug reaches its target inside the cells affected by RP11.

About the Platypus Clinical Study

The Platypus clinical study is a phase 1 open label study evaluating the safety and tolerability of a single dose of VP-001 to a single eye administered intravitreally in participants over the age of 18 with confirmed PRPF31 mutation-associated retinal dystrophy (RP11 patients).

Three groups of patients will be administered a single dose (low, mid & high dose) with each cohort consisting of 3 patients with RP11. The Safety Review Committee (SRC) for the study will review the safety data for each cohort of patients dosed with VP-001, 4 weeks after the first dose is administered. When the final patient in the relevant cohort has progressed through the SRC, the trial will progress to the next cohort/dosing group.

On completion of the dosing of the highest tolerated dose cohort, a 24-week safety followup assessment will be conducted to assess treatment-emergent serious adverse events.

About PYC Therapeutics

PYC Therapeutics (ASX:PYC) is a clinical-stage biotechnology company creating a new generation of RNA therapies to change the lives of patients with genetic diseases. The Company utilises its proprietary drug delivery platform to enhance the potency of precision medicines within the rapidly growing and commercially proven RNA therapeutic class. PYC's drug development programs target monogenic diseases – the indications with the highest likelihood of success in clinical development1.

The Company was the first to progress a drug candidate for a blinding eye disease of childhood into human trials and is now progressing multiple 'fast-follower' programs into the clinic. For more information, visit pyctx.com, or follow us on LinkedIn.

Forward looking statements

Any forward-looking statements in this ASX announcement have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations, and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company's control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed

2. Advancing Human Genetics Research and Drug Discovery through Exome Sequencing of the UK Biobank https://doi.org/10.1101/2020.11.02.20222232

or implied in this ASX announcement include known and unknown risks. Because actual results could differ materially to assumptions made and the Company's current intentions, plans, expectations, and beliefs about the future, you are urged to view all forward-looking statements contained in this ASX announcement with caution. The Company undertakes no obligation to publicly update any forward-looking statement whether as a result of new information, future events or otherwise.

This ASX announcement should not be relied on as a recommendation or forecast by the Company. Nothing in this ASX announcement should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

This ASX announcement was approved and authorised for release by the CEO of PYC Therapeutics Limited

CONTACTS:

INVESTORS and MEDIA [email protected]