Hexima Ltd · ASX:HXL
Hexima — Investor Presentation (November 2021)
39 slides from Hexima's investor presentation, Nov 1, 2021
Slide 1: Hexima Limited (ASX:HXL)
NOVEMBER 2021 HEXIMA LIMITED (ASX:HXL) A game-changing treatment for onychomycosis 1
Slide 2: Disclaimer
DISCLAIMER Summary information forward-looking statements. Any forward looking statements included in this presentation involve subjective judgment and This presentation has been prepared by Hexima Limited. and its subsidiaries (collectively “Hexima”). The information in this analysis and are subjec
Slide 3: Summary
SUMMARY Topic Discussion • Clinical stage, infectious disease focused biotechnology company engaged in the research and development of defensin peptides for applications as human therapeutics • Developing novel topical product candidate pezadeftide, a potential new prescription treatment for toenail
Slide 4: Developing a novel topical product addressing a clear unmet need in a large and growing market
HEXIMA LIMITED (ASX:HXL) D E V E LOP IN G A N OV E L T OP ICA L P ROD UCT A D D RE S S IN G A CLE A R UN M E T N E E D IN A L A RGE A N D GROWIN G M A RK E T CLINICAL-STAGE, LARGE AND GROWING NOVEL, PROPRIETARY PEZADEFTIDE ADDRESSES WELL-DEFINED INFECTIOUS DISEASE-FOCUSED MARKET WITH SUBSTANTIAL MOL
Slide 5: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM P ROV E N T RA CK RE CORD OF D E L IV E RIN G V A LUE MICHAEL ALDRIDGE PROF. MARILYN ANDERSON DR. NICOLE VAN DER WEERDEN DR. PETER WELBURN Chief Executive Officer Chief Science Officer Chief Operating Officer Chief Development Officer • CEO Peplin, sold to Leo Pharma in •
Slide 6: Pezadeftide in Action
PEZADEFTIDE IN ACTION Click to play animation C A P I T A L R A I S E P R E S EN TA TIO N SLIDE 6
Slide 7: Onychomycosis (Fungal Nail Infection)
ONYCHOMYCOSIS (FUNGAL NAIL INFECTION) COM M ON IN F E CT IOUS D IS E A S E WIT H A S IGN IF ICA N T HE A L T HCA RE BURD E N NAIL PLATE INFECTION Left untreated, the nail Infectious disease: risk factors Patients experience pain, IN NAIL BED becomes thick and brittle and include increasing age, athl
Slide 8: Existing Therapies Do Not Meet Consumer Needs
EXISTING THERAPIES DO NOT MEET CONSUMER NEEDS CL E A R M A RK E T N E E D F OR A S A F E , CON V E N IE N T A N D M ORE E F F E CT IV E T OP ICA L P ROD UCT TOPICAL Long treatments, ORAL DRUGS Better efficacy but potential TREATMENTS poor efficacy for serious adverse events Patients with Patients of
Slide 9: Our Solution: Pezadeftide Is a Naturally Occurring Peptide
OUR SOLUTION: PEZADEFTIDE IS A NATURALLY OCCURRING PEPTIDE PEZADEFTIDE MOLECULE IT S UN IQUE P ROP E RT IE S E N A BL E RA P ID N A IL P E N E T RA T ION A N D F UN GA L KILLIN G Pezadeftide is a potent broad-spectrum antifungal peptide that has evolved to kill fungal pathogens • Hydrophilic & highl
Slide 10: Topical Treatments Must Penetrate the Nail
TOPICAL TREATMENTS MUST PENETRATE THE NAIL PEZADEFTIDE PENETRATES NAILS FASTER AND MORE COMPLETELY THAN OTHER TOPICAL PRODUCTS Cumulative nail penetration PERMEATION MODEL 18% Percent of drug that penetrates the nail 16%1 14% SALINE-SOAKED NAIL COTTON WOOL 8% ADAPTER NAIL PLATE 9% INFECTION 7%2 IN N
Slide 11: Specific and Rapid Fungicidal Activity
SPECIFIC AND RAPID FUNGICIDAL ACTIVITY N O V E L F U N G I C I D A L M O D E O F A C T I O N A L L O WS RAPID RESOLUTION OF THE INFECTION R A PID F U N G ICID AL A CT IVIT Y 100% Pezadeftide kills fungal cells in 75% Percent dead cells less than 30 minutes via a novel mode of action 50% 25% • Pezade
Slide 12: Successful Phase I/IIa Clinical Trial
SUCCESSFUL PHASE I/IIA CLINICAL TRIAL 12 12 HXP124-ONY-001 – TRIAL DESIGN WEEKS WEEKS Randomised, double blind, vehicle-controlled, ascending dose cohort study C OH ORT 3 C OH ORT 4 Pezadeftide 2% Pezadeftide 2% Patients treated nails daily with pezadeftide (or N=30 patients N=6 patients vehicle) fo
Slide 13: Primary Endpoint Safety and Tolerability
PRIMARY ENDPOINT SAFETY AND TOLERABILITY HX P 1 2 4 - ON Y - 0 0 1 – N O S Y S T E M IC A BS ORP T ION A N D N O LOCA L RE D N E S S OR IRRIT A T ION Pezadeftide is safe and well tolerated NOL OR D RE U MGIPS - R EULM ATED N NOO S Y S T E M IC IC A D V EDROL S EORE V E N T S TTO OXX IICIT C I TY Sed
Slide 14: Effective and Rapid Anti-Fungal Activity
EFFECTIVE AND RAPID ANTI-FUNGAL ACTIVITY HXP124-ONY-001 – MYCOLOGICAL CURE RATE FOR COHORT 4 30 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Mycological Cure at 12 weeks 75.0% 69.0% Mycological cure* was achieved in 69% 60.0% of pezadeftide-treated nails in Cohort 4 within 12 weeks (vehicle 29%) 4
Slide 15: Pezadeftide Rapidly Cleared the Affected Nail Area
PEZADEFTIDE RAPIDLY CLEARED THE AFFECTED NAIL AREA HXP124-ONY-001 – CLEAR NAIL GROWTH FOR COHORT 4 30 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Clinical Efficacy over time 15% 14% Pezadeftide cleared the affected nail Proportion of patients with area more effectively than vehicle <10% affected
Slide 16: Extensive Nail Clearing in Just 12 Weeks
EXTENSIVE NAIL CLEARING IN JUST 12 WEEKS HXP124-ONY-001 – PERCENT CLEARING OF INFECTED NAIL AREA FOR COHORT 4 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Clearing of >40% of the infected nail area 30.0% 25.0% Pezadeftide cleared the affected nail area more effectively than vehicle (formulation no
Slide 17: Rapid and Dramatic Improvement in Appearance of Nails
C O R P ORA T E P R E S ENTA TIO N RAPID AND DRAMATIC IMPROVEMENT IN APPEARANCE OF NAILS Click to play animation N OT ICE A BLE IM P ROV E M E N T IN J US T 2 WE E KS , A L M OS T CLE A R IN 1 2 W E E KS Pezadeftide penetrates the nail to kill the fungus, allowing healthy, uninfected nail to grow ou
Slide 18: Patent Filed on CompliancePak Associated Mobile Application
PATENT FILED ON COMPLIANCEPAK ASSOCIATED MOBILE APPLICATION CompliancePak Mobile App benefits & benefits & highlights highlights CompliancePak Mobile app • No spill / difficult to misplace • Reinforces FDA use directions (with video) • Easy to open / child resistant • Compliance reminders / confirma
Slide 19: Potential to Deliver the Preferred Solution in a Consumer-Driven Market
POTENTIAL TO DELIVER THE PREFERRED SOLUTION IN A CONSUMER-DRIVEN MARKET Convenient, Effective, Safe, topical short course of best-in-class medication therapy mycological cure FOR PATIENTS WHO WANT FOR PHYSICIANS WHO WANT FOR PAYERS WHO WANT An easy-to-apply topical An effective product that will An
Slide 20: Australian Phase IIb Clinical Trial
AUSTRALIAN PHASE IIB CLINICAL TRIAL HX P 1 2 4 - ON Y - 0 0 2 Enrolment completed WEEK WEEK WEEK WEEK July 2021 13 24 36 40 • Multi-center, randomised, double blind, 12 WEEK DAILY DOSING vehicle-controlled study • Primary endpoint safety and tolerability, 1 2 W E E K D A I L Y D O S I N G F O L L OW
Slide 21: ~23M Patients with Onychomycosis in the US
~23M PATIENTS WITH ONYCHOMYCOSIS IN THE US OTC ~ 3 M P A T IE N T S A RE T RE A T E D WIT H OT C OR RX P ROD UCT S PRESCRIPTION 1m 20+m OTC 0.8m Target markets 1.2m ORAL UNTREATED TOPICAL Onychomycosis is an infectious disease which needs to be treated with a clinically-proven, safe and effective pr
Slide 22: A Promotionally Sensitive Market
A PROMOTIONALLY SENSITIVE MARKET ANTIFUNGAL WRITTEN SCRIPT JUBLIA® LAUNCH: A CASE STUDY IN DRAMATIC VOLUME (U.S., M) MARKET GROWTH 6 NUMBER OF WRITTEN SCRIPTS 1 (M) The sustained shift in the prescription 5 ORAL >> TOPICAL market from oral to topical agents 2X JUBLIA® demonstrates meaningful demand
Slide 23: A Highly Compelling Commercial Opportunity
A HIGHLY COMPELLING C OMMERCIAL OPPORTUNITY CON S E CT E T UR A D IP IS CIN G E L IT , S E D D O E IUS M OD T E M P OR IN CID ID UN T M A GN A A L IQUA . P E Z A D E F T ID E CA N CA P T URE M A RKE T S HA RE IN T OP ICA L, ORA L A N D OT C M A RKE T S Pezadeftide has the potential to STRON G DI FFE
Slide 24: Pezadeftide Is Manufactured Rapidly and Economically
PEZADEFTIDE IS MANUFACTURED RAPIDLY AND ECONOMICALLY S CA LE - UP WIT H E UROP E A N CM O ON - T RA CK PICTURED Fermenter and Chromatographic purification at European CMO Pezadeftide is produced in a yeast expression system with a highly competitive cost of goods • Pezadeftide has been manufactured
Slide 25: Strong Patent Position
STRONG PATENT POSITION A D D IT ION A L P ROT E CT ION V IA F ORM ULA T ION P A T E N T S A N D M A RKE T E X CLUS IV IT Y F OR BIOL OGICS Clearly defined growth strategy Granted patents Granted and 12-year US market (exp 2035) in major pending patents exclusivity on FDA • Develop independently in m
Slide 26: Development Plan
DEVELOPMENT PLAN WE LL- D E F INE D D E V E L OP M E N T P A T H END OF PII A N D M ILE S T ON E S MEETING FILE US IND GMP MANUFACTURE 2022 PH I/IIA CLINICAL TRIAL 2021 COMPLETED US CLINICAL P K S A F ETY S T U DY P H A SE I I I TOXICOLOGY I N D - ENABL IN G T OX I COL OGY C H RON IC T OX I COL OGY
Slide 27: Pezadeftide: A Potential Solution for a Large and Poorly Served Market
PEZADEFTIDE: A POTENTIAL SOLUTION FOR A LARGE AND POORLY SERVED MARKET POORLY SERVED MARKET NEW AND UNIQUE SAFE CONVENIENT EFFECTIVE Affects 14% of the Novel molecule with No systemic effects Easy to apply Efficiently penetrates population unique mode of action the nail No local redness or Short tre
Slide 28: Accelerating Growth Opportunities
A C C E L E R AT I N G G R O W T H O P P O R T U N I T I E S Hexima intends to apply the proceeds of this capital raising generally to the acceleration of its business plan, particularly into the US and other international markets • Secure executives and expertise with the necessary experience to co
Slide 29: Source and Expected Use of Funds
SOURCE AND EXPECTED USE OF FUNDS Comments $10 million placement SOURCE OF FUNDS ($ in millions) • $10 million capital raise, Cash on hand as of 30 June 2021 3.4 pro-forma as of 30 June 2021 FY2021 R&D Tax Receivable 3.7 • FY2021 R&D Tax Receivable has been Capital raised under the Offer 10.0 receive
Slide 30: Offer Details
OFFER D ETAILS Topic Discussion • Two-tranche Institutional Placement to raise approximately $10.0 million (the “Placement”) • Issue of approximately 31.3 million shares (“New Shares”), equivalent to approximately 24% of Hexima’s total current shares outstanding Offer Structure and Size • Approximat
Slide 31: Offer Timetable
OFFER TIMETAB LE Timetable Trading halt Thursday, 28 October Record date for SPP Friday, 29 October, 7:00 PM (AEDT) Announce Placement & SPP and recommence trading Monday, 1 November Placement settlement via DvP (Tranche 1) Thursday, 4 November Allotment of Placement shares (Tranche 1) Friday, 5 Nov
Slide 32: Key Risks
KEY RISKS C A P I T A L R A I S E P R E S EN TA TIO N SLIDE 32
Slide 33: Key Risks
KEY RISKS Key risks Development and Hexima is currently in the process of developing and commercialising its intellectual property and products. While Hexima’s program for its intellectual property and products are advanced to varying degrees, there commercialisation of Hexima’s are inherent uncerta
Slide 34: Key Risks (cont.)
KEY RISKS (CONT.) Key risks Ability to rely on and protect Hexima relies on owned intellectual property and its ability to develop and commercialise intellectual property, as well as third party intellectual property which is licensed or otherwise granted to Hexima relating to H e x i m a ’ s n e c
Slide 35: Key Risks (cont.)
KEY RISKS (CONT.) Key risks Competition may increase Hexima operates in a competitive environment. Hexima’s competitive position may decline if one or more competitive technologies or products, which are currently available, in development or may be developed or released in the future, prove more sa
Slide 36: Key Risks (cont.)
KEY RISKS (CONT.) Key risks Valuation, revenue and income Valuations of biotechnology and intellectual property before commercial use are inherently imprecise. No independent valuation has been completed of Hexima’s intellectual property portfolio or its products, as the risk Directors do not believ
Slide 37: Key Risks (cont.)
KEY RISKS (CONT.) Key risks Insurance Hexima has in place insurance which it considers appropriate to its circumstances. However, not all material risks relevant or applicable to Hexima and its business have been insured, as the relevant insurance may not be available or on terms which the Directors
Slide 38: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS Important Information Malaysia This presentation does not constitute an offer of securities in any jurisdiction in which it would be unlawful. In particular, this This presentation may not be distributed or made available in Malaysia. No approval from, or recognition
Slide 39: Contacts
CONTACTS MIC HAEL D R NIC OLE ALD RID GE VAN D ER WEERD EN CHIE F E X E CUT IV E OF F ICE R CHIE F OP E RA T IN G OF F ICE R m.aldridge@hexima.com.au n.vanderweerden@hexima.com.au hexima.com.au +1 650 452 4684 +61 407 039 983 C A P I T A L R A I S E P R E S EN TA TIO N SLIDE 39