Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2022)
29 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 30, 2022
Slide 1: Chairman's Address at 2022 Annual Meeting of Shareholders
Neuren (NEU) - ASX Announcement 30 May 2022 Chairman’s Address at 2022 Annual Meeting of Shareholders For personal use only Since our Annual Shareholders’ Meeting last year, we have made substantial progress on the key areas that we have consistently said are of high importance to the success of Neu
Slide 2: Chairman's Address (continued)
The market responded very positively to the Phase 3 trial results news, our share price lifted materially and despite the extremely volatile environment for biotech valuations across the world we have not suffered the same severe declines that many others have over the last For personal use only sev
Slide 3: Chairman's Address conclusion and About Neuren
are being deployed in line with our plans and we are confident that it was the right move to secure these funds to avoid any unnecessary delay or risk in pursuing the full development potential of NNZ-2591. For personal use only We continue to expand our investor relations activities and in my opini
Slide 4: Forward-looking Statements
Forward-looking Statements This announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual For personal use only results, performance or achievements of Neuren to be mat
Slide 5: Annual Shareholders' Meeting May 2022
For personal use only ANNUAL SHAREHOLDERS’ MEETING 30 May 2022 1
Slide 6: Improving the Lives of People with Neurodevelopmental Disabilities
For personal use only IMPROVING THE LIVES OF PEOPLE WITH NEURODEVELOPMENTAL DISABILITIES Annual Shareholders’ Meeting 30 May 2022 1
Slide 7: Forward Looking Statements
FORWARD LOOKING STATEMENTS For personal use only This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Neuren can give no assurance that these expe
Slide 8: Stock Information
STOCK INFORMATION (ASX: NEU) For personal use only Current analyst risk-adjusted valuations per Current share register share: A$8.10, A$6.65, A$6.21, A$5.10 composition (126 million quoted shares – top 20 hold 52 week price range: A$1.20 - A$4.68 52%) Institutions, 30% Management, 7% Retail, 63% A$3
Slide 9: Three Key Drivers Transforming Near Term Value
THREE KEY DRIVERS TRANSFORMING NEAR TERM VALUE For personal use only Realise Neuren’s share Implement commercial Confirm efficacy of of trofinetide value in strategy for trofinetide NNZ-2591 in Phase 2 the US through Acadia’s ex-North America, trials for 4 valuable New Drug Application using US data
Slide 10: Key Milestones in Next Months
KEY MILESTONES IN NEXT 18 MONTHS For personal use only Prader-Willi syndrome Phase 2 trial results (H2 2023) Phase 2 trial results in Angelman, Phelan-McDermid and Pitt Hopkins syndromes (H1 2023) Approval of NDA for Rett syndrome (Q1 2023) Commercial partnerships ex-North America for Rett s
Slide 11: Trofinetide for Rett Syndrome - Anticipating Large Near-Term Cash Flows
For personal use only TROFINETIDE FOR RETT SYNDROME - ANTICIPATING LARGE NEAR-TERM CASH FLOWS 6
Slide 12: Rett Syndrome Phase 3 and NDA
RETT SYNDROME PHASE 3 AND NDA Acadia plans to submit NDA mid-2022; Orphan Drug qualifies for 6 months Priority For personal use only Review, which means potential for approval in Q1 2023 NDA based on pivotal efficacy from positive Phase 3 trial, supportive efficacy from Neuren’s positive Phase 2
Slide 13: Rett Syndrome Opportunity
RETT SYNDROME OPPORTUNITY For personal use only Estimates US Europe Japan China urban Other Asia Potential patients1 10,000 13,000 3,000 28,000 6,000 Patients currently identified 5,000 4,000 1,000 2,000 ‘00s 1 Potential patient estimates derived by applying the mid-point of the published prevalence
Slide 14: NNZ-2591 Provides Very Large Potential Upside
For personal use only NNZ-2591 PROVIDES VERY LARGE POTENTIAL UPSIDE LEVERAGING THE TROFINETIDE EXPERIENCE 9
Slide 15: Five Times Larger Opportunity for NNZ-2591
FIVE TIMES LARGER OPPORTUNITY FOR NNZ-2591 Disorder Gene Published prevalence Potential patients For personal use only mutation estimates US1 Europe1 Asia1, 2 Phelan- SHANK3 1/8,000 to 1/15,000 males and 22,000 28,000 81,000 McDermid females Angelman UBE3A 1/12,000 to 1/24,000 males 14,000 18,000 52
Slide 16: NNZ-2591 Has Ideal Attributes Leading into Phase 2
NNZ-2591 HAS IDEAL ATTRIBUTES LEADING INTO PHASE 2 For personal use only Novel mechanism of action Clear and consistent efficacy in mouse models of each syndrome Biochemical effects in the brain and optimum dose confirmed Demonstrated high oral bioavailability and blood-brain barrier penetra
Slide 17: Consistent Efficacy and Dose Response in Phelan-McDermid Model
CONSISTENT EFFICACY AND DOSE RESPONSE IN PHELAN- MCDERMID MODEL PMS is caused by a deletion or other change in the 22q13 region of chromosome 22, For personal use only which includes the SHANK3 gene, or a mutation of the gene. In the shank3 knockout mouse model, wild type mice and knockout mice were
Slide 18: Consistent Efficacy and Dose Response in Phelan-McDermid Model
CONSISTENT EFFICACY AND DOSE RESPONSE IN PHELAN- MCDERMID MODEL For personal use only Motor function Anxiety Repetitive behavior Daily living Daily living 13
Slide 19: Biochemical Effects Confirmed in Shank3 Model
BIOCHEMICAL EFFECTS CONFIRMED IN SHANK3 MODEL For personal use only In biochemical testing, NNZ-2591 was shown to normalise the abnormal length of dendrite spines between brain cells, the excess activated ERK protein (pERK) and the depressed level of IGF-1 in shank3 knockout mice. 2000 4 16000 Dendr
Slide 20: Key Features of First Phase 2 Trials
KEY FEATURES OF FIRST PHASE 2 TRIALS For personal use only Expedite data across 4 indications that enables subsequent trials to be designed as registration trials and prepare for Phase 3 in parallel Prioritising speed to data: Angelman in Australia, Phelan-McDermid and Pitt Hopkins in US Up to
Slide 21: Conclusion
For personal use only CONCLUSION 16
Slide 22: Treating Neurodevelopmental Disorders
TREATING NEURODEVELOPMENTAL DISORDERS For personal use only Rett Fragile X Phelan- Angelman Pitt Hopkins Prader-Willi McDermid MECP2 FMR1 SHANK3 UBE3A TCF4 15q11-q13 Neuren’s drugs target the critical Impaired communication between role of IGF-1 in this neurons, abnormal formation/pruning upstream p
Slide 23: Leading Pipeline in Neurodevelopmental Disorders
LEADING PIPELINE IN NEURODEVELOPMENTAL DISORDERS For personal use only Commercial Compound Indication Preclinical Phase 1 Phase 2 Phase 3 Partner Rett syndrome1 (North America) Trofinetide Fragile X syndrome1 (North America) Phelan- McDermid syndrome2 Angelman Commence H1 2022 syndrome2 Results H1 2
Slide 24: Key Milestones in Next Months
KEY MILESTONES IN NEXT 18 MONTHS For personal use only Prader-Willi syndrome Phase 2 trial results (H2 2023) Phase 2 trial results in Angelman, Phelan-McDermid and Pitt Hopkins syndromes (H1 2023) Approval of NDA for Rett syndrome (Q1 2023) Commercial partnerships ex-North America for Rett s
Slide 25: Contact
For personal use only CONTACT Jon Pilcher, CEO jpilcher@neurenpharma.com +61 438 422 271 20
Slide 26: Resolutions Proxy Votes Received: Resolution 1
RESOLUTIONS PROXY VOTES RECEIVED For personal use only Total % Lodged For Lodged Open Lodged Against Available issued Votes capital Resolution 1 Votes % Votes % Votes % RE-ELECTION OF DIANNE ANGUS AS A DIRECTOR 42,542,037 99.62 161,569 0.38 250 0.00 42,703,856 33.11 1
Slide 27: Resolutions Proxy Votes Received: Resolution 2
RESOLUTIONS PROXY VOTES RECEIVED For personal use only Total % Lodged For Lodged Open Lodged Against Available issued Votes capital Resolution 2 Votes % Votes % Votes % RE-ELECTION OF JENNY HARRY AS A DIRECTOR 42,542,037 99.62 161,569 0.38 250 0.00 42,703,856 33.11 2
Slide 28: Resolutions Proxy Votes Received: Resolution 3
RESOLUTIONS PROXY VOTES RECEIVED For personal use only Total % Lodged For Lodged Open Lodged Against Available issued Votes capital Resolution 3 Votes % Votes % Votes % AUTHORISATION TO FIX AUDITOR FEES AND EXPENSES 42,478,671 99.48 161,805 0.38 59,918 0.14 42,700,394 33.11 3
Slide 29: Resolutions Proxy Votes Received: Resolution 4
RESOLUTIONS PROXY VOTES RECEIVED For personal use only Total % Lodged For Lodged Open Lodged Against Available issued Votes capital Resolution 4 Votes % Votes % Votes % INCREASE TO NON-EXECUTIVE DIRECTOR FEE POOL 38,554,653 98.66 140,766 0.36 384,856 0.98 39,080,275 30.30 4
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