Earnings release
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pyctx.com | ACN 098 391 961 1 27 OCTOBER 2025 Q3 2025 SHAREHOLDER UPDATE • PYC is a biotechnology company developing a pipeline of precision medicines designed to change the lives of patients who have genetic diseases and no treatment options available today • Progress was made in all four of the Company’s drug development programs through Q3 2025 including: Clinical-stage pipeline o Polycystic Kidney Disease (PKD) ▪ Progression into Part B of the Single Ascending Dose (SAD) study in PKD patients1; ▪ Presentation of the safety data from Part A of the SAD study at the Australian and New Zealand Society of Nephrology conference2. o Lead blinding eye disease (RP113) ▪ Progression into an Open Label Extension (OLE) of the Multiple Ascending Dose (MAD) study in RP11 patients; and ▪ Preparation for a Type D meeting with the US Food and Drug Administration (FDA) to align on a registrational trial design4. o Second blinding eye disease (ADOA5) ▪ Presentation of data from the SAD study at the Neuro- Ophthalmology Society of Australia conference6; and ▪ Progression into a global MAD study directed towards establishing clinical proof of concept for this drug candidate in ADOA7. Pre-clinical stage pipeline o Neurodevelopmental Disorder (PMS8) ▪ Generation of Non-Human Primate (NHP) data to complement the outcomes previously generated in patient-derived models9 and 1 See ASX announcement of 7 July 2025 2 See ASX announcement of 29 August 2025 3 Retinitis Pigmentosa type 11 4 This meeting is currently expected to occur in Q1 2026 5 Autosomal Dominant Optic Atrophy 6 See ASX announcement of 5 September 2025 7 See ASX announcement of 21 October 2025 8 Phelan-McDermid Syndrome 9 See ASX announcement of 27 June 2025
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pyctx.com | ACN 098 391 961 2 confirm progression into formal Investigational New Drug (IND) enabling studies10; and ▪ Presentation of the pre-clinical data pack supporting this drug candidate at the Oligonucleotide Therapeutic Society meeting11 • PYC is now preparing for upcoming human safety and efficacy read-outs across all four programs with data expected in: o CY25 for the RP11 program; o CY26 for the PKD and ADOA programs; and o CY27 for the PMS program12 PERTH, Australia and SAN FRANCISCO, California – 27 October 2025 PYC Therapeutics Limited (ASX:PYC) (PYC or the Company) is a precision medicine Company creating life-changing RNA therapeutics for patients who have severe unmet medical needs. PYC has a pipeline of four first -in-class drug candidates with three of these programs having advanced into human trials. The Company today updates shareholders on progress made in delivering the operational roadmap through the third quarter of 2025. Vision, strategy, and implementation roadmap PYC’s vision is to create life -changing impact for patients with genetic disease through the discovery and development of drugs that address the underlying cause of indications for which there are no treatments available today. The Company’s strategy sees it developing drugs for four diseases (see Figure 1) in which an RNA therapeutic holds significant potential for patient- impact13. The roadmap for clinical development of these four drug candidates and the progress expected in each development program in 2025 have previously been set out in detail 14. PYC has advanced all four of its drug development programs through important milestones in Q3 CY25 (as detailed below). 10 See ASX announcement of 13 October 2025 11 See ASX announcement of 13 October 2025 12 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025 13 Diseases caused by haploinsufficiency are particularly well -suited to being addressed by an RNA therapeutic due to this modality’s ability to precisely increase gene expression without the risk of over -expressing the target gene 14 See ASX announcements of 17 February 2025 and subsequent investor update materials
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pyctx.com | ACN 098 391 961 3 Figure 1. PYC’s drug development pipeline Polycystic Kidney Disease (PKD) PYC is developing a drug candidate that addresses the underlying cause of polycystic kidney disease for the >10 million people worldwide15 who suffer from this condition and who have no treatment options available to them. Q3 progress PYC is progressing through a combined Phase 1a/1b clinical study ahead of an anticipated registrational Phase 2/3 trial16. The Company has now progressed to dosing healthy volunteers in cohort 4 in Part A of the SAD as well as completing dosing in cohort 1 of Part B of the SAD in PKD patients. Expected progress in Q417 PYC will now: i) Await the outcome of the Safety Review Committee (SRC) for cohort B1 and A4 of the SAD18; and ii) Continue to escalate dosing in Part B of the study in PKD patients19. Human safety and initial efficacy data in PYC’s PKD program is expected to be available within the coming 12 months20 with the multiple dose study data in particular expected to be insightful across both dimensions. 15 Harris PC, Torres VE. Polycystic Kidney Disease, Autosomal Dominant. 2002 Jan 10 [Updated 2022 Sep 29]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews. Seattle (WA): University of Washington, Seattle; 1993 -2023. 16 Subject to successful outcomes in the 1a/1b study and regulatory approval 17 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025 18 See ASX announcement of 29 August 2025 for more details 19 Pending successful outcomes of the SRC. PYC may also consider continued escalation of dosing in Part A of the study in the ev ent of favourable SRC Outcomes upon the review of safety data from cohort A4. 20 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025
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pyctx.com | ACN 098 391 961 4 Retinitis Pigmentosa type 11 (RP11) Q3 progress The Company’s most advanced asset is a drug candidate that addresses the underlying cause of a blinding eye disease of childhood (known as RP11) for which there are no treatments available. PYC presented the latest data from its ongoing phase 1/2 trials in RP11 at the Foundation Fighting Blindness Retinal Therapeutics Innovation Summit and again at the Association for Research in Vision and Ophthalmology conference in the U.S. in May 21. Data from these clinical trials demonstrate improved vision in RP11 patients following treatment with PYC’s investigational drug candidate and support progression of this program into registrational trials. PYC engaged the US FDA in June 202522 and aligned with the Agency on the framework for a registrational trial to support a New Drug Application (NDA) for this drug candidate. Expected progress in Q423 In the final quarter of CY 2025, PYC expects to: i) Release updated data from the Company’s open label extension of the ongoing MAD study; and ii) Submit a briefing book to the US FDA ahead of a Type D meeting in which the Company expects to align on the final details of a registrational trial design24. Autosomal Dominant Optic Atrophy (ADOA) PYC’s drug candidate for ADOA is the most -advanced clinical-stage drug candidate for the 1 in every 35,00025 people affected by this progressive and irreversible blinding eye disease. Q3 progress PYC completed dosing in a Phase 1 Single Ascending Dose (SAD) study and has now progressed into a global repeat dose study in patients with ADOA26. Expected progress in Q427 In Q4, PYC expects to enrol multiple patient cohorts in the repeat dose study and initiate additional sites in support of efficient execution of this study directed towards establishing clinical proof of concept for PYC-001 in ADOA. Phelan-McDermid Syndrome (PMS) PYC is developing a drug candidate that addresses the underlying cause of a severe neurodevelopmental disorder known as Phelan-McDermid Syndrome (PMS). 21 See ASX announcement of 28 April 2025 22 See ASX announcement of 23 June 2025. The FDA is the United States Food and Drug Administration. 23 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025 24 The meeting is currently expected to occur in Q1 2026 25 Yu-Wai-Man, P. et al. The Prevalence and Natural History of Dominant Optic Atrophy Due to OPA1 Mutations Ophthalmology. 2010;117(8):1538-46 doi: 10.1016/j.ophtha.2009.12.038 26 See ASX announcement of 21 October 2025 27 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025
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pyctx.com | ACN 098 391 961 5 Q3 progress PYC presented data at the PMS Global Congress in Q2 demonstrating that its drug candidate for PMS restores the missing gene expression in brain cells that causes this disorder 28. In Q3, the Company generated complementary data in Non -Human Primates (NHPs) that support progression of PYC-002 into IND-enabling studies. The Company’s objective here is to submit an IND filing and initiate clinical trials for this drug candidate in the US in H2 2026 with human safety and early efficacy data expected in 202729. Funding and Cash Runway As of 30 September 2025, the Company had $135 million of cash on hand with an estimated additional $20 million expected to be received in Q1, 2026 attributable to the R&D rebate applicable to FY2530. Research and development payments during the quarter related to the continuation of clinical studies, studies to support clinical trial regulatory submissions and progression of discovery programs. Related Party Payments Section 6 of the Appendix 4C released today discloses payments to related parties of $157k, reflecting fees paid to executive and non-executive directors during the quarter. 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 pr ecision 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 development31. For more information, visit pyctx.com, or follow us on LinkedIn. PYC’s drug development programs Retinitis Pigmentosa type 11 • A blinding eye disease of childhood affecting 1 in every 100,000 people32 • Currently progressing through phase 1/2 clinical trials with preparation under way for a potentially registrational trial to commence in 202633 28 See ASX announcement of 27 June 2025 29 Subject to the risks and uncertainties set out in the Company’s ASX disclosures of 17 February 2025 30 Subject to the successful registration of R&D activities with AusIndustry and lodgement of FY25 income tax return with ATO. 31 Advancing Human Genetics Research and Drug Discovery through Exome Sequencing of the UK Biobank https://doi.org/10.1101/2020.11.02.20222232 32 Sullivan L, et al. Genomic rearrangements of the PRPF31 gene account for 2.5% of autosomal dominant retinitis pigmentosa. Inv est Ophthalmol Vis Sci. 2006;47(10):4579 -88 33 Subject to the risks and uncertainties outlined in the Company’s ASX disclosures of 17 February 2025
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pyctx.com | ACN 098 391 961 6 Autosomal Dominant Optic Atrophy • A blinding eye disease of childhood affecting 1 in every 35,000 people34 • Currently progressing through clinical trials with human safety and efficacy read -outs anticipated in 202635 Autosomal Dominant Polycystic Kidney Disease • A chronic kidney disease affecting 1 in every 1,000 people 36 that leads to renal failure and the need for organ transplantation in the majority of patients • Currently progressing through clinical trials with human safety and efficacy read -outs anticipated in 202637 Phelan McDermid Syndrome • A severe neurodevelopmental disorder affecting 1 in every 10,000 people38 • PYC will initiate Investigational New Drug (IND) -enabling studies in 2025 to facilitate progression into human trials (expected to commence in 202639) 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 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 Board of PYC Therapeutics Limited 34 Yu-Wai-Man, P. et al. The Prevalence and Natural History of Dominant Optic Atrophy Due to OPA1 Mutations Ophthalmology. 2010;117(8):1538-46 doi: 10.1016/j.ophtha.2009.12.038 35 Subject to the risks outlined in the Company’s ASX announcement of 14 March 2024 36 Harris PC, Torres VE. Polycystic Kidney Disease, Autosomal Dominant. 2002 Jan 10 [Updated 2022 Sep 29]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews. Seattle (WA): University of Washington, Seattle; 1993 -2023. 37 Subject to the risks outlined in the Company’s ASX announcement of 14 March 2024 38 Phelan-McDermid Syndrome Foundation. https://pmsf.org/about -pms/ 39 Subject to the risks and uncertainties outlined in the Company’s ASX disclosures of 17 February 2025 CONTACT US Investor relations and media contact investor@pyctx.com
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pyctx.com | ACN 098 391 961 7 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Name of entity PYC THERAPEUTICS LIMITED ABN Quarter ended (“current quarter”) 48 098 391 961 30 September 2025 Consolidated statement of cash flows Current quarter $A’000 Year to date 3 months) $A’000 1. Cash flows from operating activities 1.1 Receipts from customers 1.2 Payments for (18,185) (18,185) (a) research and development (b) product manufacturing and operating costs - - (c) advertising and marketing - - (d) leased assets (12) (12) (e) staff costs (555) (555) (f) administration and corporate costs (566) (566) 1.3 Dividends received (see note 3) - - 1.4 Interest received 1,348 1,348 1.5 Interest and other costs of finance paid - - 1.6 Income taxes paid - - 1.7 Government grants and tax incentives 522 522 1.8 Other - - - 1.9 Net cash from / (used in) operating activities (17,448) (17,448) 2. Cash flows from investing activities - - 2.1 Payments to acquire: (a) entities (b) businesses - - (c) property, plant and equipment (207) (207) (d) investments - - (e) intellectual property - - (f) other non-current assets - -
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pyctx.com | ACN 098 391 961 8 Consolidated statement of cash flows Current quarter $A’000 Year to date 3 months) $A’000 2.2 Proceeds from disposal of: - - (a) entities (b) businesses - - (c) property, plant and equipment - - (d) investments - - (e) intellectual property - - (f) other non-current assets - - 2.3 Cash flows from loans to other entities - - 2.4 Dividends received (see note 3) - - 2.5 Other (provide details if material) - - 2.6 Net cash from / (used in) investing activities (207) (207) 3. Cash flows from financing activities - - 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 3.2 Proceeds from issue of convertible debt securities - - 3.3 Proceeds from exercise of options - - 3.4 Transaction costs related to issues of equity securities or convertible debt securities - - 3.5 Proceeds from borrowings - - 3.6 Repayment of borrowings (leases) (98) (98) 3.7 Transaction costs related to loans and borrowings - - 3.8 Dividends paid - - 3.9 Other (provide details if material) - - 3.10 Net cash from / (used in) financing activities (98) (98) 4. Net increase / (decrease) in cash and cash equivalents for the period 153,050 153,050 4.1 Cash and cash equivalents at beginning of period 4.2 Net cash from / (used in) operating activities (item 1.9 above) (17,448) (17,448) 4.3 Net cash from / (used in) investing activities (item 2.6 above) (207) (207) 4.4 Net cash from / (used in) financing activities (item 3.10 above) (98) (98)
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pyctx.com | ACN 098 391 961 9 Consolidated statement of cash flows Current quarter $A’000 Year to date 3 months) $A’000 4.5 Effect of movement in exchange rates on cash held (219) (219) 4.6 Cash and cash equivalents at end of period 135,078 135,078 5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Current quarter $A’000 Previous quarter $A’000 5.1 Bank balances 135,078 153,050 5.2 Call deposits - - 5.3 Bank overdrafts - - 5.4 Other (provide details) - - 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 135,078 153,050 6. Payments to related parties of the entity and their associates Current quarter $A'000 6.1 Aggregate amount of payments to related parties and their associates included in item 1 (157) 6.2 Aggregate amount of payments to related parties and their associates included in item 2 - Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments During the quarter $157k directors remuneration was paid, which was included in item 1.2.
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pyctx.com | ACN 098 391 961 10 7. Financing facilities Note: the term “facility’ includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. Total facility amount at quarter end $A’000 Amount drawn at quarter end $A’000 7.1 Loan facilities - - 7.2 Credit standby arrangements - - 7.3 Other (please specify) - - 7.4 Total financing facilities - - 7.5 Unused financing facilities available at quarter end - 7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. N/A 8. Estimated cash available for future operating activities $A’000 8.1 Net cash from / (used in) operating activities (Item 1.9) (17,448) 8.2 Cash and cash equivalents at quarter end (Item 4.6) 135,078 8.3 Unused finance facilities available at quarter end (Item 7.5) - 8.4 Total available funding (Item 8.2 + Item 8.3) 135,078 8.5 Estimated quarters of funding available (Item 8.4 divided by Item 8.1) 7.74 8.6 If Item 8.5 is less than 2 quarters, please provide answers to the following questions: 1. Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? Answer: n/a 2. Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? Answer: n/a 3. Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? Answer: n/a
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pyctx.com | ACN 098 391 961 11 Compliance statement 1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. 2 This statement gives a true and fair view of the matters disclosed. 27 October 2025 Date: ................................................................................... The Board of PYC Therapeutics Limited Authorised by: ................................................................................... (Name of body or officer authorising release – see note 4) Notes 1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entit y’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so. 2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report. 3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity. 4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [ name of board committee – eg Audit and Risk Committee ]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”. 5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations , the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity hav e been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair vie w of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal co ntrol which is operating effectively.