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HEXIMA LIMITED
ASX ANNOUNCEMENT
02 November 2021
2021 ANNUAL GENERAL MEETING - CEO'S PRESENTATION
MELBOURNE, AUSTRALIA (2 December 2021): Hexima Limited (ASX:HXL) provides the attached CEO Presentation to be delivered at today's Annual General Meeting commencing at 11.00am AEDT.
The AGM can be joined at https://meetings.linkgroup.com/HXL21
This announcement is authorised for release to ASX by Michael Aldridge, Managing Director & CEO.
Enquiries:
Dr Nicole van der Weerden Chief Operating Officer n.vanderweerden@hexima.com.au
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ABOUT HEXIMA
Hexima (ASX:HXL) is a clinical stage, anti-infectives focused biotechnology company engaged in the research and development of defensin peptides for applications as human therapeutics. Our lead product candidate, pezadeftide (HXP124) applied in a topical formulation, is a potential new prescription treatment for toenail fungal infections (or onychomycosis). Hexima is currently conducting an Australian phase IIb clinical trial testing pezadeftide for the treatment of onychomycosis. Hexima holds granted, long-life patents protecting pezadeftide in major markets globally. For additional information please visit www.hexima.com.au. You can also find us on Twitterand LinkedInor email us at info@hexima.com.au.
LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086 | 1 |
ersonal use only
MANAGING DIRECTOR & CHIEF EXECUTIVE OFFICER PRESENTATION
MR MICHAEL ALDRIDGE
MAJOR ACHIEVEMENTS FY2021
onlyMilestones & Achievements | |
• | Public Offering and listing on ASX |
use | o $3 million offering at A$0.20 per share |
• | Phase IIb clinical trial |
ersonal | o Initiation and completion of enrolment |
Intellectual property protection | |
• | |
• | Scientific Advisory Board |
o Australian, US and Japan KOLs |
CompliancePak
AGM 2021 | S L I D E 3 |
A U S T R A L I A N P H A S E I I B C L I N I C A L T R I A L
HXP124-ONY-002
Enrolment completed
only 12 WEEK
DAILY DOSING use
31 WEEK
DAILY DOSING
ersonalDAILY DOSING NOTE: DAILY DOSING PERIODS INCLUDE 1-WEEKWASHOUTS EVERY 6 WEEKS
HXP124-ONY-002 ANZCTR registration number: ACTRN12620000697987
WEEK | WEEK | WEEK |
24 | 36 | 40 |
NO DOSING | FOLLOW-UP VISITS |
WASHOUT PERIOD |
AGM 2021
July 2021
- Multi-center,randomised, double blind, vehicle-controlled study
- Primary endpoint safety and tolerability, secondary endpoints Mycological Cure and Clinical Efficacy
- Three active (2% pezadeftide) versus vehicle arms to test optimal dosing strategy
- Safety & efficacy assessed at 13, 24, 36 and 40 weeks, data expected Q2 2022
SLID 4
E
S t r o n g p a t e n t p o s i t i o n
ADDITIONAL PROTECTION VIA FORMULATION PATENTS AND MARKET
only | |
EXCLUSIVITY FOR BIOLOGICS | |
Clearly defined | |
use | |
growth strategy | |
• | Develop independently in |
US and EU (ICH) markets | |
• | License and collaborative |
ersonal |
development in Japan and potentially China - presently in preliminary discussions with multiple parties
Granted patents | Granted and | 12-year US market |
(exp 2035) in major | pending patents | exclusivity on FDA |
markets covering the | covering stabilising | approval likely available |
use of pezadeftide in | formulation for | as a biologic drug |
the treatment of | pezadeftide | |
onychomycosis |
AGM 2021 | SLIDE 5 |
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Hexima Limited published this content on 01 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 December 2021 22:50:05 UTC.