Breakeven Date Change • Jul 28
Forecast to breakeven in 2029 The 5 analysts covering PYC Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$77.9m in 2029. Average annual earnings growth of 3.7% is required to achieve expected profit on schedule. New Risk • Jul 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 16% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (69% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (AU$91m net loss in 3 years). Annuncio • Jul 08
Pyc Therapeutics Limited Announces Appointment of Thomas Ulmer as Chief Financial Officer PYC Therapeutics Limited announced the appointment of Mr. Thomas Ulmer as the Company’s Chief Financial Officer. Mr. Ulmer has 20 years of international leadership experience across biotechnology, pharmaceuticals and healthcare. Most recently he served as Chief Financial Officer of Cell Therapies Pty Ltd. and previously as Chief Executive Officer of PKG Health. Prior to this, Mr. Ulmer was Chief Financial Officer of Immatics N.V. (NASDAQ: IMTX), where he played a key role in the company's NASDAQ listing and establishment as a US-listed biotechnology company. Earlier in his career he held senior finance leadership roles with Allergopharma and Merck Group. Mr. Ulmer holds an MBA from Justus Liebig University, Germany, and is a Fellow of CPA Australia. Breakeven Date Change • Jun 30
Forecast to breakeven in 2029 The 4 analysts covering PYC Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$77.9m in 2029. Average annual earnings growth of 5.8% is required to achieve expected profit on schedule. Annuncio • Jun 15
PYC Therapeutics Announces Company Secretary Changes, Effective June 15, 2026 PYC Therapeutics Limited advised that Mr. Stephen Ledger and Mr. Jonathan Riley had been appointed as joint Company Secretaries of the Company effective June 15, 2026. Mr. Ledger is an experienced Company Secretary who holds a Bachelor of Commerce from the University of Western Australia. He currently serves as a Non-Executive Director for Bertling Logistics Australia and ArcelorMittal Projects Australia, and is Founder and Executive Director of Ledger Financial Group. Mr. Riley is an experienced legal counsel who holds a Bachelor of Laws and Bachelor of Science (Pharmacology) from the University of Western Australia. Prior to joining PYC, Mr. Riley held a senior legal role at CSL Limited in Melbourne. For the purposes of ASX Listing Rule 12.6, Mr. Ledger will be responsible for communications with ASX in relation to Listing Rule matters. Mr. Daniel Coletta has resigned as Company Secretary effective June 15, 2026. New Risk • Apr 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: AU$48m Forecast net loss in 3 years: AU$3.7m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (AU$3.7m net loss in 3 years). Recent Insider Transactions • Mar 28
CEO & Executive Director recently bought AU$100k worth of stock On the 24th of March, Rohan Hockings bought around 83k shares on-market at roughly AU$1.21 per share. This transaction amounted to 39% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Rohan has been a buyer over the last 12 months, purchasing a net total of AU$300k worth in shares. Price Target Changed • Mar 20
Price target increased by 9.9% to AU$3.65 Up from AU$3.32, the current price target is an average from 5 analysts. New target price is 175% above last closing price of AU$1.33. Stock is up 5.6% over the past year. The company is forecast to post a net loss per share of AU$0.071 next year compared to a net loss per share of AU$0.10 last year. Annuncio • Mar 10
PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 600 million. PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 600 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 272,740,242
Price\Range: AUD 1.5
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 31,197,631
Price\Range: AUD 1.5
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 85,489,067
Price\Range: AUD 1.5
Discount Per Security: AUD 0.075
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,573,060
Price\Range: AUD 1.5
Discount Per Security: AUD 0.075
Transaction Features: Rights Offering; Subsequent Direct Listing Breakeven Date Change • Mar 07
No longer forecast to breakeven The 4 analysts covering PYC Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$60.0k in 2028. New consensus forecast suggests the company will make a loss of AU$42.4m in 2028. Major Estimate Revision • Mar 03
Consensus EPS estimates upgraded to AU$0.10 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -AU$0.136 to -AU$0.10 per share. Revenue forecast unchanged from AU$20.0m at last update. Biotechs industry in Australia expected to see average net income growth of 3.2% next year. Consensus price target of AU$3.30 unchanged from last update. Share price was steady at AU$1.49 over the past week. Breakeven Date Change • Feb 24
No longer forecast to breakeven The 4 analysts covering PYC Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$16.7m in 2028. New consensus forecast suggests the company will make a loss of AU$47.2m in 2028. New Risk • Feb 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 43% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Major Estimate Revision • Feb 07
Consensus EPS estimates fall by 12% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -AU$0.129 to -AU$0.144 per share. Revenue forecast of AU$20.0m unchanged since last update. Biotechs industry in Australia expected to see average net income decline 14% next year. Consensus price target broadly unchanged at AU$3.53. Share price fell 6.3% to AU$1.50 over the past week. Annuncio • Feb 04
PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 128.233601 million. PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 128.233601 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 85,489,067
Price\Range: AUD 1.5
Discount Per Security: AUD 0.09
Transaction Features: Subsequent Direct Listing Recent Insider Transactions • Nov 27
CEO & Executive Director recently bought AU$198k worth of stock On the 26th of November, Rohan Hockings bought around 133k shares on-market at roughly AU$1.49 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Rohan's only on-market trade for the last 12 months. Annuncio • Oct 18
PYC Therapeutics Limited, Annual General Meeting, Nov 18, 2025 PYC Therapeutics Limited, Annual General Meeting, Nov 18, 2025. Location: at the auditorium, the harry perkins institute of, medical research, qeii medical centre, 6 verdun street, nedlands, western australia Australia Annuncio • Sep 22
Pyc Therapeutics Limited Announces Board Changes PYC Therapeutics Limited announced appointment of Professor Ian Jeffrey Constable effective 21 September 2025. cessation of Dr Rohan Hockings effective 16 September 2025, MICHAEL ROSENBLATT effective 21 September 2025, and JASON HADDOCK effective 21 September 2025 as Director. Major Estimate Revision • Sep 04
Consensus EPS estimates fall by 17% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -AU$0.109 to -AU$0.128 per share. Revenue forecast of AU$20.0m unchanged since last update. Biotechs industry in Australia expected to see average net income decline 14% next year. Consensus price target of AU$3.42 unchanged from last update. Share price was steady at AU$1.27 over the past week. Annuncio • Aug 30
PYC Therapeutics Limited Auditor Raises 'Going Concern' Doubt PYC Therapeutics Limited filed its Annual on Aug 28, 2025 for the period ending Jun 30, 2025. In this report its auditor, PricewaterhouseCoopers LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern. Breakeven Date Change • Jun 30
Forecast to breakeven in 2028 The 5 analysts covering PYC Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$129.9m in 2028. Average annual earnings growth of 24% is required to achieve expected profit on schedule. Annuncio • Apr 10
PYC Therapeutics Limited Announces First Subject in Phase 1A Single Ascending Dose (Sad) Study of PYC -003 PYC Therapeutics Limited announced that the first subject in a Phase 1a Single Ascending Dose (SAD) study of PYC-003 in healthy volunteers has been dosed with the drug candidate. The subject received a 0.4 mg/kg dose of PYC-003 intravenously. Seven additional healthy volunteers will receive either the drug candidate at the same dose or a placebo control over the coming weeks. A meeting of the Safety Review Committee (SRC) overseeing this clinical trial will occur in June/July4 to review the 4-week follow-up data from all subjects in this cohort and an anticipated request to escalate dosing in cohort 2 of the SAD to 1.2 mg/kg5. Part B of this Phase 1a study will evaluate the safety/tolerability and efficacy profile of PYC-003 in patients with PKD - this part of the trial is expected to commence in third quarter 20256. Parts A and B of the SAD will be followed by an Open-Label Extension (OLE) study facilitating repeat dosing and evaluation of the optimal dosing regimen of PYC-003 alongside a Phase 1b Multiple Ascending Dose (MAD) study to evaluate the safety/t tolerability and efficacy profile of PY-003. New Risk • Mar 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 30% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Annuncio • Feb 18
PYC Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 145.814913 million. PYC Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 145.814913 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 116,651,930
Price\Range: AUD 1.25
Transaction Features: Rights Offering Major Estimate Revision • Feb 18
Consensus EPS estimates upgraded to AU$0.089 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -AU$0.101 to -AU$0.089 per share. Revenue forecast unchanged from AU$7.00m at last update. Biotechs industry in Australia expected to see average net income growth of 8.9% next year. Consensus price target down from AU$8.75 to AU$3.32. Share price fell 2.7% to AU$1.29 over the past week. Price Target Changed • Nov 25
Price target increased by 165% to AU$8.75 Up from AU$3.30, the current price target is an average from 4 analysts. New target price is 373% above last closing price of AU$1.85. Stock is up 126% over the past year. The company is forecast to post a net loss per share of AU$0.10 next year compared to a net loss per share of AU$0.096 last year. New Risk • Nov 15
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$88.7m (US$57.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$13m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (AU$88.7m market cap, or US$57.3m). Price Target Changed • Oct 24
Price target increased by 8.2% to AU$0.33 Up from AU$0.30, the current price target is an average from 4 analysts. New target price is 74% above last closing price of AU$0.19. Stock is up 217% over the past year. The company is forecast to post a net loss per share of AU$0.01 next year compared to a net loss per share of AU$0.0096 last year. Annuncio • Oct 14
PYC Therapeutics Limited, Annual General Meeting, Nov 13, 2024 PYC Therapeutics Limited, Annual General Meeting, Nov 13, 2024. Location: at the auditorium, the harry perkins institute of, medical research, qeii medical centre, 6 verdun street, nedlands, western australia Australia Price Target Changed • Sep 04
Price target increased by 9.1% to AU$0.30 Up from AU$0.28, the current price target is an average from 4 analysts. New target price is 140% above last closing price of AU$0.13. Stock is up 123% over the past year. The company is forecast to post a net loss per share of AU$0.0098 next year compared to a net loss per share of AU$0.0096 last year. Board Change • Sep 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Member of Ophthalmology Clinical Advisory Board David Birch was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Jun 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$32m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (37% increase in shares outstanding). New Risk • Jun 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 18% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$29m net loss in 3 years). Shareholders have been diluted in the past year (37% increase in shares outstanding). Price Target Changed • May 21
Price target decreased by 15% to AU$0.29 Down from AU$0.34, the current price target is an average from 3 analysts. New target price is 179% above last closing price of AU$0.10. Stock is up 78% over the past year. The company is forecast to post a net loss per share of AU$0.0072 next year compared to a net loss per share of AU$0.0071 last year. Annuncio • May 01
PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 74.657302 million. PYC Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 74.657302 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 499,999,999
Price\Range: AUD 0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 168,509,482
Price\Range: AUD 0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 70,600,000
Price\Range: AUD 0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 194,106,793
Price\Range: AUD 0.08
Transaction Features: Regulation S; Rights Offering Breakeven Date Change • May 01
Forecast to breakeven in 2026 The 2 analysts covering PYC Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$14.1m in 2026. Average annual earnings growth of 38% is required to achieve expected profit on schedule. Annuncio • Mar 14
PYC Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 74.657343 million. PYC Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 74.657343 million.
Security Name: Ordianry Shares
Security Type: Common Stock
Securities Offered: 933,216,784
Price\Range: AUD 0.08
Transaction Features: Rights Offering New Risk • Nov 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$25m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$25m free cash flow). Earnings are forecast to decline by an average of 6.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$28m net loss in 3 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). Annuncio • Nov 15
Pyc Therapeutics Announces the Results of A Study Conducted in Human 3-Dimensional Models Derived from Patients with End-Stage Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease PYC Therapeutics announced the results of a study conducted in human 3-dimensional models derived from patients with end-stage renal failure due to Autosomal Dominant Polycystic Kidney Disease (PKD). The results demonstrate that an investigational drug candidate designed by PYC (known as PYC-003) to address this disease at its root cause is effective. These 3D patient-derived cyst models represent the 'gold-standard' pre-clinical assay for evaluating drug candidates in this indication. PYC-003 is the fourth program in the Company's development pipeline – joining three other first-in-class RNA drug candidates with disease-modifying potential currently progressing into or through human trials. PYC plans to accelerate PYC-003 into human trials following these results. An Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to enable the commencement of human trials for this drug candidate is planned for H2 2024. PYC-003 is expected to have an accelerated pathway through human trials due to the extent of the unmet patient need in PKD. A New Drug Application in support of this candidate could be submitted following two clinical trials rather than the conventional three. PKD is a monogenic disease (meaning that it is caused by a mutation in a single gene). Drugs targeting monogenic diseases have the highest likelihood of demonstrating efficacy in clinical trials[12] and lower probability of off-target safety issues. PKD affects 1 in every 1,000 people across the globe. There are currently no drugs available that address the underlying cause of the disease and approximately 50% of PKD patients will progress to end-stage renal failure by the age of 60. PKD is characterised by the formation of multiple fluid filled cysts throughout the kidney and, to a lesser extent, other organs. Progression of the cyst frequency and volume over time ultimately leads to destruction of the internal architecture and function of the kidney. The data demonstrating that PYC-003 is effective in 3D patient-derived cyst models complements existing data from animal models highlighting the ability of this drug candidate to reach the cells affected in PKD[14]. PYC's drug delivery platform has already demonstrated the ability to deliver an RNA therapy to the target cells affected by the disease in vivo in high concentration. Annuncio • Oct 24
PYC Therapeutics Limited, Annual General Meeting, Nov 24, 2023 PYC Therapeutics Limited, Annual General Meeting, Nov 24, 2023, at 09:00 W. Australia Standard Time. Location: The Harry Perkins Institute of Medical Research, QEII Medical Centre, 6 Verdun Street, Nedlands Western Australia Australia Agenda: To consider annual report; to consider remuneration report; to consider re-Election of Dr Michael Rosenblatt; to consider re Approval of Long Term Incentive Plan; and to consider re-insertion of proportional takeover provisions. New Risk • Aug 31
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$26m free cash flow). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (AU$21m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Annuncio • Aug 12
PYC Therapeutics Limited Announces US FDA Designates PYC's Lead as a Fast Track Development Program PYC Therapeutics Limited announced that the VP-001 program, the first investigational drug candidate designed to address Retinitis Pigmentosa type 11 (RP11) to progress to human trials, has received Fast Track designation from the US Food and Drug Administration (FDA). The Fast Track process is "designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need" with Fast Track status " often leading to earlier drug approval and access by patients". Benefits of the Fast Track designation include: Increased frequency of meetings with the FDA to discuss the drug's development plan; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and The potential for a Rolling Review in support of a New Drug Application. PYC will utilise the Fast Track designation to work with the FDA on advancing this important drug program towards patients on an accelerated timeline. New Risk • Jul 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$26m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$21m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (7.4% increase in shares outstanding). Significant insider selling over the past 3 months (AU$550k sold). Recent Insider Transactions • Jun 29
Non-Executive Chair of the Board recently bought AU$85k worth of stock On the 26th of June, Alan Tribe bought around 2m shares on-market at roughly AU$0.053 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Alan has been a buyer over the last 12 months, purchasing a net total of AU$219k worth in shares. Annuncio • Jun 02
PYC Therapeutics Limited, Annual General Meeting, Jul 05, 2023 PYC Therapeutics Limited, Annual General Meeting, Jul 05, 2023, at 10:00 W. Australia Standard Time. Location: The Harry Perkins Institute of Medical Research QEII Medical Centre, 6 Verdun Street Nedlands Australia Agenda: To consider Ratification of prior Share issue under Placement; to consider Approval of Director Alan Tribe's participation in Placement; to consider Approval of Director Rohan Hockings' participation in Placement; to consider Approval to issue Non-Director Tranche 2 Shares. Annuncio • Jun 01
Pyc Appoints Andrew Taylor as Joint Company Secretary PYC advises the appointment of the company's Chief Financial Officer Mr. Andrew Taylor as joint Company Secretary effective immediately. Andrew is a chartered accountant and holds a Bachelor of Commerce degree from theUniversity of Western Australia and a Graduate Diploma of Applied Finance. He has over 13 years' experience in big 4 and ASX listed companies with international operations. Annuncio • Feb 03
PYC Therapeutics Limited Announces the Submission of Investigational New Drug Application with the US Food and Drug Administration PYC Therapeutics Limited announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) in support of its lead drug candidate known as VP-001. The FDA has a period of 30 days to review an IND application. In the event the IND is accepted, VP-001 will be the first investigational drug candidate with the potential to modify the course of Retinitis Pigmentosa type 11 to progress into clinical trials. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Judy Lieberman is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Annuncio • Nov 07
PYC Therapeutics Limited Announces Successful Toxicology Studies Pave Way for Human Trials PYC Therapeutics Ltd. announced that it has completed single-dose Good Laboratory Practice (GLP) toxicology studies to enable progression of its investigational drug candidate (VP- 001) for the treatment of Retinitis Pigmentosa type 11 (RP11) into first in human studies. PYC combines two complementary platform technologies - RNA drug design capabilities and a proprietary drug delivery technology - to create a new generation of RNA therapeutics to change the lives of patients with genetic diseases. The results of the single-dose GLP toxicology studies showed no observed adverse effects at any of the assessed doses. The competitive advantages of PYC's proprietary RNA therapeutics platform for the treatment of retinal disease are now apparent across both efficacy and safety/tolerability dimensions. These toxicology studies were completed under GLP conditions, a standard required for submissions to regulatory bodies including the United States (US) Food and Drug Administration (FDA). PYC anticipates filing an Investigational New Drug (IND) application in support of VP-001 in Fourth Quarter 2022 and, if successful, progressing to human clinical trials in First Quarter 2023. Two single-dose GLP toxicology studies were conducted, one in rabbits and the other in non-human primates (NHPs). In each case, low, medium, and high doses of VP-001 were administered and evaluated following a single dose of VP-001 in addition to a control group. All dosing was bilateral, and administration of VP-001 was by injection into the vitreous of the eye, the same route of administration anticipated to be used in human clinical trials. The single-dose animal evaluations were conducted for a duration of 12 weeks. The information reported here contains data through completion of the studies at week 12 following single doses of VP-001 at each of the three doses assessed in both species. Safety results from the GLP toxicology study in rabbits, which were administered at up to 10 µg/eye of VP-001, showed that no drug-related mortality, changes in health and behaviour or visual function were observed through the 12-week study period. Transient anterior segment inflammation was observed in some animals administered 10 µg/eye, the higher dose evaluated, on Day 3 that rapidly resolved by Day 8. Safety results from the GLP toxicology study in NHPs, which were administered up to 50 µg/eye of VP-001, showed that no drug-related mortality, changes in health and behaviour or visual function were observed through the 12-week study period. Transient anterior segment inflammation, on Days 3 through 15, which was observed in animals administered 50 µg/eye, the higher dose, resolved by week 4. All doses tested in these single-dose GLP toxicology studies in rabbits and NHPs were well tolerated and safe through-out the 12-week study. The higher tested dose of VP-001 in each species was considered to be the no observed adverse effect level (NOAEL) for the purpose of submitting the IND application. These results represent the final piece of PYC's non-clinical data pack required for the IND in support of VP-001. Progression of VP-001 into a combined phase 1/2 clinical study will represent the first potentially disease-modifying therapy for RP11 to progress into clinical development. PYC is looking forward to completing its transition to a clinical-stage and multi-asset drug development company, and to scaling its drug discovery and development capabilities across multiple programs within its pipeline to change the lives of patients with major unmet needs in rare genetic diseases. Annuncio • Oct 14
PYC Therapeutics Limited, Annual General Meeting, Nov 23, 2022 PYC Therapeutics Limited, Annual General Meeting, Nov 23, 2022, at 10:00 W. Australia Standard Time. Location: The Harry Perkins Institute of Medical Research, QEII Medical Centre, 6 Verdun Street Nedlands Western Australia Australia Agenda: To consider the Annual Report of the Company for the financial year ended 30 June 2022 which includes the Financial Report, Directors' Report and Auditor's Report; to consider remuneration report; to re-election of Mr. Alan Tribe; and to Approval of 10% Placement Capacity. Annuncio • Sep 27
PYC Therapeutics Limited Announces Central Nervous System Drug Program Added to PYC Pipeline PYC Therapeutics combining two complementary platform technologies: - RNA drug design capabilities; and - a proprietary drug delivery technology. Together they are being developed to create a new generation of RNA therapeutics to change the lives of patients with genetic diseases. PYC is adding a third investigational drug program for the treatment of Phelan McDermid Syndrome (PMS) to its pipeline. PMS is a neurodevelopmental disorder characterised by developmental and speech delays, behavioural problems and compromised ability to perceive pain and regulate body temperature. The creation of a disease-modifying therapy for patients with PMS represents an area of major unmet patient need. Effective treatment of the underlying cause of this disorder would represent a life-changing paradigm for PMS patients and their families. Consistent with PYC's strategy, PMS is a monogenic disease in which the underlying cause is insufficient expression of the SHANK3 gene in the target cell (neurons) in the brain. The new pipeline addition represents PYC's first program in the Central Nervous System (CNS) - demonstrating the scalability of the Company's platform technology into target tissues beyond the eye. The underlying cause of PMS in the majority of patients is a deletion or mutation affecting one copy of the SHANK3 gene, causing a ~50% decrease in expression of the SHANK3 protein. It is this deficiency of SHANK3 expression in neuronal cells in the brain that causes PMS. PYC has designed and validated an RNA therapeutic capable of increasing SHANK3 expression in cells by ~2-3 fold. The extent of protein upregulation observed in these in vitro studies is sufficient to correct the underlying SHANK3 protein deficiency that causes PMS. Recent Insider Transactions • Aug 09
Non-Executive Chair of the Board recently bought AU$103k worth of stock On the 3rd of August, Alan Tribe bought around 2m shares on-market at roughly AU$0.061 per share. This was the largest purchase by an insider in the last 3 months. This was Alan's only on-market trade for the last 12 months. Annuncio • May 10
PYC Therapeutics Limited Announces Exemplary PK Study Results Move RP11 Program Closer to First in Human Trials PYC Therapeutics announced that it has combining two complementary platform technologies: RNA based drug design; and a proprietary drug delivery technology. Together they are being developed to create a new generation of RNA therapeutics to change the lives of patients with genetic diseases. With the successful completion of pharmacokinetic (PK) studies in Non-Human Primates (NHPs), the Company has now established that this new generation of RNA therapeutic has an attractive PK profile for the treatment of blinding eye diseases of the retina. The results were generated in PYC's most advanced investigational drug candidate currently being developed to treat patients with an inherited blinding eye disease called Retinitis Pigmentosa type 11 (RP11). This program is the first in PYC's pipeline of next generation RNA therapies progressing towards clinical development. There are no approved therapies for RP11 nor are there any investigational entities specifically targeting RP11 currently in clinical trials. PYC is on track to submit an Investigational New Drug application (IND) in support of its RP11 drug candidate with the US Food and Drug Administration in the second half of this year. The Good Laboratory Practice toxicology studies required to support this IND have already commenced. A successful IND will be followed by commencement of `first in human' studies marking the transition of PYC to a clinical stage Company with the first product borne out of its next generation platform for the creation of novel RNA therapeutics. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Judy Lieberman is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Annuncio • Jul 15
PYC Therapeutics Limited Enters into the Next Phase of Preclinical Development for VP-001 PYC Therapeutics Limited announced that it has entered into the next phase of preclinical development for VP-001, its lead candidate for the treatment of Retinitis Pigmentosa type 11 (RP11). The Company has commenced larger animal studies in rabbits, with non-human primate (NHP) studies expected to begin later in Third Quarter 2021. Data is expected to be released in early Fourth Quarter 2021. Building on earlier data, these studies will provide important information about the safety and tolerability (including defining the maximum tolerated dose ahead of the clinical trial), pharmacokinetic properties (informing the planned dosing interval in the clinical trial) and biodistribution of VP-001 in larger animal eyes. Data from these studies will provide the critical inputs enabling the Company to initiate formal Good Laboratory Practice (GLP) toxicity studies which is the final step of preclinical development. Subsequent to the GLP studies, PYC anticipates submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in mid-2022 before commencing clinical development. Annuncio • Jun 30
PYC Therapeutics Announces Comprehensive Preclinical Results Demonstrating VP-002 Program's Potential as the First Disease Modifying Therapy for Autosomal Dominant Optic Atrophy PYC Therapeutics released a comprehensive summary of preclinical findings supporting the potential of PYC's VP-002 program as the first disease modifying therapy for patients suffering from Autosomal Dominant Optic Atrophy (ADOA). PYC's PPMO technology used in the VP-002 program significantly increases levels of OPA1 protein and corrects major functional deficits that underly ADOA. Building on recent announcements relating to the VP-002 program, further optimized lead candidates have shown an even more potent ability to increase the OPA1 protein to greater than 1.5-fold. These data support continued development of the program toward clinical trials, which are estimated to initiate in the first half of 2023. Together with VP-001, PYC's development program for Retinitis Pigmentosa type 11, the Company is now progressing two lead programs towards clinical trials, both of which could be the first disease modifying therapies for two important inherited retinal diseases. This approach also underscores the breadth of potential application of the Company's PPMO technology which PYC will continue to apply towards additional programs within and outside of ocular diseases. ADOA is a genetic disease that causes progressive blindness affecting approximately 1 in 30,000 people globally. The majority of ADOA cases are caused by loss of function mutations in the OPA1 gene, leading to haploinsufficiency of the OPA1 protein. The VP-002 program aims to treat ADOA through the upregulation of the target OPA1 protein. Highlights from PYC's preclinical research, which includes both in vivo assessments together with assessments in cells derived from four different patients with OPA1 ADOA, underscore the potential of the VP-002 program as the first disease modifying approach for the treatment of OPA1 ADOA. To-date, the Company has demonstrated the ability of PYC's PPMOs to: Increase the target OPA1 protein by greater than 1.5-fold in a dose-dependent and mutation agnostic manner; Increase mitochondrial bioenergetics and adenosine triphosphate (ATP) production in a dose-dependent and mutation agnostic manner; Protect cells from apoptosis in a dose-dependent and mutation agnostic manner, rescuing the critical functional deficit observed in ADOA patients to near healthy levels; and Effectively reach target retinal ganglion cells in vivo, compared to alternative antisense oligonucleotide (ASO) approaches that have demonstrated limited ability to reach these cells at much higher doses. Recent Insider Transactions Derivative • Jun 16
CEO & Director exercised options to buy AU$1.6m worth of stock. On the 10th of June, Rohan Hockings exercised options to buy 10m shares at a strike price of around AU$0.039, costing a total of AU$390k. As of today, Rohan currently holds no shares directly. Company insiders have collectively bought AU$471k more than they sold, via options and on-market transactions, in the last 12 months. Annuncio • Jun 08
PYC Therapeutics to Develop A New Generation of RNA Therapeutics PYC Therapeutics to develop a new generation of RNA therapeutics to change the lives of patients with inherited diseases. announced that studies in patient-derived cells show that its second drug candidate for Autosomal Dominant Optic Atrophy (ADOA) has rescued the critical functional deficit that causes blindness in patients with this disease5 for background information on ADOA and the functional deficits associated with this disease). ADOA is an orphan disease characterised by loss of vision in both eyes beginning in early childhood and often progressing to legal blindness in adulthood. The majority of ADOA cases are caused by mutations in a gene called Optic Atrophy 1 (OPA1), leading to a deficit of OPA1 protein. The OPA1 protein is crucial for healthy functioning of the cell's powerhouses called mitochondria. The mitochondrial dysfunction in ADOA patients can cause death of the retinal cells that transmit visual signals to the brain. Mitochondrial dysfunction results in decreased levels of ATP, the principal molecule for storing and transferring energy within cells. The decreased ATP levels, in turn, result in greater vulnerability of the Retinal Ganglion Cells (RGCs) and it is RGC death in response to stressful stimuli that represents the underlying cause of blindness in ADOA PYC's drug candidate works by increasing OPA1 protein levels in patient cells. The increase
in OPA1 protein rescues mitochondrial function, increases ATP levels and enhances resistance to cell death. This drug candidate therefore has the potential to slow or even halt vision loss in ADOA patients. Annuncio • May 19
PYC Therapeutics Limited Announces Second Investigational Drug Candidate Restores the Levels of the Target Protein Towards Normal in Models Derived from Patients with the Indicated Disease Autosomal Dominant Optic Atrophy PYC Therapeutics Limited announced that its second investigational drug candidate restores the levels of the target protein (OPA1) towards normal in models derived from patients with the indicated disease Autosomal Dominant Optic Atrophy (ADOA). ADOA is an orphan indication with no preventative or curative therapies currently available to patients. This investigational drug will now be assessed in functional models to determine whether the increase in OPA1 protein successfully rescues the behavioural deficits seen in cells from ADOA patients that lead to loss of vision. These results are expected over coming weeks. Positive outcomes in these models will see the program accelerated towards first in human studies to improve the lives of patients with this progressive and blinding disease. The target cells for PYC's OPA1 (ADOA) program are the Retinal Ganglion Cells (RGCs) within the retina. The RGCs make up the optic nerve that enables the transmission of visual signals from the retina to the brain. The majority of cases of ADOA are caused by insufficient levels of OPA1 protein in the RGCs. The decreased levels of OPA1 protein cause the RGC's energy production system (the mitochondria) to function at lower levels. The consequence of this inadequate performance by the mitochondria is insufficient production of a molecule called ATP the principal molecule for storing and transferring energy within cells. The decreased levels of ATP within the RGCs leaves them vulnerable to cell death under stress. The death of the RGCs ultimately results in the progressive loss of vision seen in patients with ADOA due to the interruption of the communication between the retina and brain. An attractive disease-modifying strategy to treat ADOA is therefore to increase the levels of the OPA1 protein to prevent the process that leads to cell death. The efficacy of this investigational therapeutic (a cell penetrating Peptide-PMO conjugate also known as a PPMO) was assessed in cells derived from 4 different patients, each of whom has ADOA due to a mutation in the OPA1 gene. The results show that the PPMO corrected OPA1 protein levels in the patient-derived cells towards the level of this protein that is observed in individuals not affected by this disease. This investigational therapy will now be assessed for the ability to rescue the functional deficits observed in cells from ADOA patients. These assays focus on the ability of the cells to: produce increased levels of ATP in response to treatment with the drug (ATP production is decreased in ADOA); and resist programmed cell death (apoptosis) under stress (sensitivity to apoptosis is increased in ADOA). In addition to assessing the ability of the current lead PPMO sequence to address the functional deficits observed in ADOA patients, PYC has further optimised the sequence of the oligonucleotide (or PMO) that forms part of this investigational therapy, leading to a 2-3 fold improvement in OPA1 protein upregulation when compared to the results presented above. These `second generation' sequences will now be assessed in conjunction with PYC's proprietary delivery technology and are expected to form part of the final optimised OPA1 therapeutic. Successful functional studies over coming weeks will see this program accelerate towards first in human testing. This therapy is expected to benefit from a rapid Investigational New Drug (IND)-enabling pathway due to the synergies between this program and PYC's lead drug program the world's first disease-modifying therapy for patients with Retinitis Pigmentosa type 11. Annuncio • Mar 17
PYC Therapeutics Limited Appoints Michael Rosenblatt, MD, to Its Board of Directors PYC Therapeutics announced the appointment of Michael Rosenblatt, MD, to its Board of Directors. Dr. Rosenblatt is a Senior Partner at Flagship Pioneering and the former Chief Medical Officer of Merck, one of the world's leading global biopharmaceutical companies. He currently serves on the Board of Directors of the Flagship companies Rubius Therapeutics, Cygnal Therapeutics and Ohana Biosciences. Annuncio • Mar 03
PYC's Lead Investigational Drug, VP-001, Demonstrates Another Key Functional Improvement in Patient-Derived Models - a First for Any Rp11 Treatment to-Date PYC Therapeutics announced that the Company's lead investigational drug, VP-001, for the treatment of RP11 has restored function of the Retinal Pigment Epithelium, the target cells for the therapy, in patient-derived models of the disease. The Retinal Pigment Epithelium (RPE) cells create a barrier around the outside of the eye when the RPE cells join together through 'tight-junctions' that form between individual RPE cells. This 'layer' of RPE cells form the outer Blood-Retina Barrier (BRB) (Figure 1) that prevents fluid from leaking into and damaging the retina. In patients with RP11, two elements of the RPE function are lost: The functionality of individual RPE cells (PYC's VP-001 has previously shown effectiveness in correcting this loss of function, see ASX announcements of April 1 and December 16, 2020); and The role of the RPE monolayer in the BRB. The barrier function of this monolayer is created through tight-junctions that form between all the RPE cells. If only a few of these tight-junctions fail, then the integrity of the whole BRB is comprised – just like taking a few bricks out of a dam wall. VP-001 has now demonstrated an ability to restore the integrity of the blood-retina barrier that is lost in patients with the disease, in models derived from patients with RP11 (Figure 2). This development indicates that VP-001 can more comprehensively address the mechanisms of the disease that lead to visual loss in patients with RP11 than alternative therapies tested to-date. These data provide the first evidence of restoration of the barrier function of the RPE monolayer and add to the previously released efficacy data for VP-001 demonstrating an ability to correct the functional deficits seen in individual RPE cells in patients with RP11 (see ASX announcements of April 1 and December 16, 2020). This achievement differentiates PYC's RNA approach from Adeno-Associated Virus (AAV) delivered DNA therapies directed towards the treatment of RP11 that have not been able to demonstrate an improvement in these functional endpoints in non-clinical testing. In addition to the results supporting improved barrier function of the RPE monolayer, correction of the morphology (the 'structure' of the cell) is shown after treatment with VP-001. This quantifies the visual evidence of the improvement PYC demonstrated after treatment with VP-001. Annuncio • Feb 23
PYC Therapeutics Names Glenn Noronha as Chief Development Officer PYC Therapeutics announced the appointment of Glenn Noronha, as Chief Development Officer. Dr. Noronha will oversee the Company’s translational clinical development, regulatory, manufacturing and preclinical development activities as it advances its pipeline of multiple drug candidates which is initially focused on inherited ocular diseases. Dr. Noronha brings to PYC over 20 years of progressive leadership and research experience across both small and large biotechnology and pharmaceutical companies, with deep expertise in development of ophthalmology drug candidates, through his positions at BridgeBio Pharma, Clearside Biomedical and Alcon, formerly the ophthalmology subsidiary of Novartis. He has a proven track record of success with developing, implementing and executing drug development strategy and creating successful business and research and development roadmaps. Dr. Noronha has been involved with 8 Investigational New Drug (IND) applications, and 3 New Drug Applications (NDA) with the U.S. Food and Drug Administration (FDA). Recent Insider Transactions • Feb 20
Non-Executive Chair of the Board recently bought AU$81k worth of stock On the 17th of February, Alan Tribe bought around 600k shares on-market at roughly AU$0.14 per share. This was the largest purchase by an insider in the last 3 months. This was Alan's only on-market trade for the last 12 months. Annuncio • Dec 18
PYC Therapeutics Limited Announces Visual Evidence of Lead Drugs Efficacy PYC Therapeutics Limited announced that its lead drug program, VP-001, has proven effective in correcting a critical structural deficiency in patient-derived models. PYC conducted these experiments in retinal pigmented epithelium cells (RPE) differentiated from patient-derived iPSC - this model allows PYC to have a surrogate of the patient's eye in a dish. These models have been shown to recapitulate the disease state of humans and they are viewed as the gold standard in preclinical efficacy readouts for genetic eye disease. Healthy RPE has a well-defined isotropic structure (looks like well defined brick pavers, all the same dimensions and similar shape), and dense microvilli (they look `hairier', and that `hair' is finer and
appears to connect between cells). RP11 Patient RPE cells lack well developed isotropic structure and `microvilli' that are required for the RPE to conduct their critical function of maintaining the photoreceptor cells. When treated with a single dose of VP-001, the patient iPSC derived RPE showed improvement in both isotropic structure and microvilli health when assessed 28 days after treatment (only time point assessed). This was demonstrated across 2.5µM, 5µM, and 10µM doses of VP-001. This result follows two other critical readouts for VP-001 earlier this year that showed improvement in phagocytosis, and cilia incidence and length for treated RPE derived from patient iPSC. PYC is focused on continuing to build out the efficacy profile of VP-001 to enable optimal dosing in the clinic, while also delivering large animal toxicity studies in the first half of 2021. Annuncio • Dec 12
PYC Therapeutics Limited Appoints Sahm Nasseri as CEO of Us Operations and as Director of the Board PYC Therapeutics, announced the appointment of Sahm Nasseri as CEO of PYC's US Operations and as a Director of the Board of PYC Therapeutics. Sahm's appointment is a critical step for the Company as it continues to build out translational and clinical development capabilities along with the Company's corporate presence in the US to support acceleration of PYC's pipeline of life-changing drugs into human testing. PYC's US base will position the Company well in driving its important scientific innovations into clinical development through closer engagement with partners, scientific leaders, regulators and prospective investors. Sahm brings an extensive background in commercial drug development from his roles over the past 7 years while in the USA with Merck & Co. Prior to Merck, Sahm was a consultant with McKinsey & Company in Sydney. Annuncio • Oct 13
PYC Therapeutics Announces to Developing New Treatments for Severe Unmet Patient Needs PYC Therapeutics announced to developing new treatments for severe unmet patient needs. The company advises that Vision Pharma Pty Ltd. (PYC's 90% owned joint venture with the Lions Eye Institue) has filed for patent protection for a precision medicine for the treatment of Autosomal Dominant Optic Atrophy (ADOA) caused by mutations in the Optic Atrophy 1 (OPA1) gene. This drug will become the third program in PYC's drug development pipeline and is expected to have a rapid path into clinical development due to the ability to leverage both the Cell Penetrating Peptide (CPP) delivery technology and Antisense Oligonucleotide (ASO) backbone chemistry used in more advanced lead drug program. This third drug program will be known as VP-002. VP-002 benefits from the large body of work PYC has already conducted in pre-clinical development of its technology for delivering ASO drugs to the retina for blinding eye diseases. The company has already generated evidence that: The company proprietary drug delivery technology can successfully deliver a drug cargo into the target cell of interest in ADOA (the Retinal Ganglion Cells) in animal models; and the lead oligonucleotide sequence for this program can achieve a >100% increase in OPA1 protein levels in fibroblasts derived from patients with ADOA caused by OPA1 deficiency. These results hold significant promise for OPA1 ADOA patients and the program will now be progressed into advanced pre-clinical models to evaluate the efficacy of the candidate in complex patient-derived and/or animal models. Annuncio • Oct 10
Doug Huey Not to Seek Re Election At PYC Therapeutics Limited PYC Therapeutics Limited announced that Doug Huey will not seek re-election as a Director of the Company at the upcoming Annual General Meeting on 6 November 2020 and will step down as a director on that date. Annuncio • Oct 08
PYC Therapeutics Limited Develops New Treatments for Severe Unmet Patient Needs PYC Therapeutics developing new treatments for severe unmet patient needs. PYC and partners at the Lions Eye Institute (LEI) are developing the first disease-modifying therapy (a drug known as VP-001) for patients with Retinitis Pigmentosa type 11 (RP11) through joint venture Vision Pharma Pty Ltd. (PYC 90% shareholder; LEI 10% shareholder). The Company advises that its lead drug program has proven effective in the critical patient-derived models designed to assess whether the treatment will be applicable to all patients with RP11. RP11 is caused by a mutation in the PRPF31 gene which leads to abnormally low levels of PRPF31 protein in the Retinal Pigment Epithelium (RPE) and photoreceptors in the eye. Correcting the levels of PRPF31 protein inside the target cells should, therefore, lead to correction of the disease process as a whole. There is substantial evidence that this downstream disease correction does translate into reality in the context of RP11 specifically 3. It is for this reason that drug development programs addressing monogenic diseases (diseases caused by a mutation in a single gene like RP11) are so highly sought after in the pharmaceutical industry. Value crystallises early in genetic medicine programs because of the far greater propensity for success in progression from phase 1 clinical studies through to market for these drug pograms 4. Annuncio • Oct 06
PYC Therapeutics Limited Files for Intellectual Property Protection for the New Drug Candidate PYC Therapeutics Limited PYC has now filed for intellectual property protection for this new drug candidate. This development begins to demonstrate the range of applications in which PYC's Cell Penetrating Peptide drug delivery technology and Anti Sense Oligonucleotide drug design capability can be used. PYC Therapeutics, is a precision medicine company developing new treatments for severe unmet patient needs. The Company advises that it has filed for patent protection for a precision medicine for the treatment of the leading cause of vision loss in adults aged 20-74 years, Diabetic Retinopathy (DR), with potential further application in neovascular Age-related Macular Degeneration (nAMD). This drug will become the second program in PYC's pipeline and is expected to have a rapid path into clinical development due to the ability to leverage both the Cell Penetrating Peptide (CPP) delivery technology and backbone chemistry for the Anti Sense Oligonucleotide (ASO) used in lead drug program. Proliferative retinal diseases (including diabetic retinopathy and nAMD) are characterised by new blood vessel growth in the retina that destroys the retinal tissue and consequently, sight. This new blood vessel growth is caused by a protein called Vascular Endothelial Growth Factor (VEGF). Antibodies that inhibit VEGF are the current gold standard treatment for proliferative retinal diseases and provide exceptional validation of VEGF as a drug target. Recently, the importance of an additional `pro-survival' role of VEGF has been recognised. VEGF supports the maintenance and viability of delicate cells in the retina, specifically the retinal nerve cells. VEGF inhibitors successfully stop the destruction of retinal tissue due to new blood vessel growth but they also remove this critical `pro-survival' signal and are suspected of causing the retinal nerve cells to die over time. A better therapeutic strategy than simply inhibiting VEGF is, therefore, to stop the new blood vessel growth (ie. replicate the outcomes of the current gold standard treatments) whilst retaining the `pro-survival' function of VEGF. Achieving this outcome would improve the treatment options for the ~50% of Diabetic Retinopathy patients who fail to respond to currently available therapies3. A mechanism to achieve these objectives has been identified through switching from the `pro' new blood vessel isoform of VEGF protein (VEGF165a) to the `anti' new blood vessel isoform of VEGF protein (VEGF165b) (a protein isoform is coded for by the same gene, but due to different RNA-splicing the proteins have different or opposing functions). This type of approach has recently been recognised in one of the leading ophthalmology journals as an `excellent therapeutic strategy'4. PYC's drug candidate acts to promote expression of VEGF165b over VEGF165a during RNA splicing. This therapeutic strategy is known as `splice switching'. This increases the proportion of the `favourable' VEGF over the `unfavourable' (`pro-blood vessel growth') VEGF. The mechanism of action of this new drug program aligns perfectly to PYC's strategy of pursuing the unique advantages of Antisense Oligonucleotides (ASOs) to alter splicing isoforms (a mechanism that is not available to other modalities outside of certain small molecule drugs that can not achieve the same degree of specificity as ASOs). PYC has designed and validated an ASO with the ability to successfully achieve this `isoform switch' and has filed for intellectual property protection for the preferred ASO sequences identified. Annuncio • Aug 19
PYC Therapeutics Limited Announces CEO Changes PYC Therapeutics announced a re-structuring of the Company's executive team. Dr. Rohan Hockings, previously the Managing Director of the Company's Australian operations will resume the role of Chief Executive Officer of the company and Douglas Huey, previously the Chief Executive Officer of the company will assume the role of Managing Director of the company's US operations (PYC Therapeutics LLC).