Hexima Ltd · ASX:HXL
Hexima — Investor Presentation (April 2022)
27 slides from Hexima's investor presentation, April 2022
Slide 1: Hexima Limited: A game-changing treatment for onychomycosis
HEXIMA LIMITED (ASX:HXL) A game-changing treatment for onychomycosis 1
Slide 2: Disclaimer
DISCLAIMER Summary information events and the future financial performance of Hexima. Forward looking words such as “expect”, “should”, “could”, “may”, This presentation has been prepared by Hexima Ltd and its subsidiaries (collectively “Hexima”). The information in this “predict”, “plan”, “will”, “
Slide 3: Developing a novel topical product addressing a clear unmet need
HEXIMA LIMITED (ASX:HXL) DE VE LOPING A NOVE L TOPIC A L PR ODUC T A DDR E S S ING A C L E A R UNME T NE E D IN A L A R GE A ND GR OWING MA R KE T CLINICAL-STAGE, LARGE AND GROWING NOVEL, PROPRIETARY PEZADEFTIDE ADDRESSES WELL-DEFINED INFECTIOUS DISEASE-FOCUSED MARKET WITH SUBSTANTIAL MOLECULE WITH
Slide 4: Experienced management team
EXPERIENCED MANAGEMENT TEAM PR OVE N TR A C K R E C OR D OF D E L IVE R ING VA LUE MICHAEL ALDRIDGE DR. NICOLE VAN DER WEERDEN PROF. MARILYN ANDERSON DR NANCY SACCO PHILLIP ROSE Chief Executive Officer Chief Operating Officer Chief Science Officer Chief Development Officer Chief Commercial Officer C
Slide 5: Pezadeftide in action
PEZADEFTIDE IN ACTION Click to play animation C ON S UMER- C EN TRI C DEVELOPMEN T S LI DE 5
Slide 6: Onychomycosis (fungal nail infection)
ONYCHOMYCOSIS (FUNGAL NAIL INFECTION) C OM M ON INF E C TIOUS D IS E A S E WITH A S IGNIF IC A NT H E A L TH C A R E B UR DE 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, at
Slide 7: Existing therapies do not meet consumer needs
EXISTING THERAPIES DO NOT MEET CONSUMER NEEDS C L E A R MA R K E T NE E D F OR A S A F E , C ONVE NIE NT A ND M OR E E F F E C TIVE TOPIC A L PR ODUC T TOPICAL Long treatments, ORAL DRUGS Better efficacy but potential TREATMENTS poor efficacy for serious adverse events Patients with Patients often s
Slide 8: Our solution: pezadeftide is a naturally occurring peptide
OUR SOLUTION: PEZADEFTIDE IS A NATURALLY OCCURRING PEPTIDE PEZADEFTIDE MOLECULE ITS UNIQ UE PR OPE R TIE S E NA B L E R A PID NA IL PE NE TR A TION A ND F UNGA L KILLING Pezadeftide is a potent broad-spectrum antifungal peptide that has evolved to kill fungal pathogens • Hydrophilic & highly soluble
Slide 9: 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 10: Specific and rapid fungicidal activity
SPECIFIC AND RAPID FUNGICIDAL ACTIVITY NOVEL FUNGICIDAL MODE OF ACTION ALLOWS RAPID RESOLUTION OF THE INFECTION R API D FU NGI CI DAL ACT I VI T Y 100% Pezadeftide kills fungal cells in 75% Percent dead cells less than 30 minutes via a novel mode of action 50% 25% • Pezadeftide is specific for funga
Slide 11: 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- COHORT 3 COHORT 4 controlled, ascending dose cohort study Pezadeftide 2% Pezadeftide 2% N=6 patients N=30 patients Patients treated nails daily with (randomised 2:1) (randomised 4
Slide 12: Primary endpoint: safety and tolerability
PRIMARY ENDPOINT SAFETY AND TOLERABILITY H X P124-ONY-0 0 1 – NO S YS TE M IC A B S OR PTION A ND NO LOC A L R E D NE S S OR IR R ITA TION Pezadeftide is safe and well tolerated NOLORD REM U GIPSU - R E LM ATED NNO O SSYY SSTT EMIC EMIC A D V EDOLOR RSE EVENTS TTO OXI XIC CIT I TY Sed do eiusmod Pez
Slide 13: 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 14: 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 15: 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% 26.0% Pezadeftide cleared the affected nail area more effectively than vehicle (formulation no
Slide 16: Rapid and dramatic improvement in appearance of nails
RAPID AND DRAMATIC IMPROVEMENT IN APPEARANCE OF NAILS Click to play animation NOTIC E A B LE IM PR OVE M E NT IN J US T 2 WE E KS , A L MOS T C LE A R IN 12 W E E KS Pezadeftide penetrates the nail to kill the fungus, allowing healthy, uninfected nail to grow out • Clear nail growth continues after
Slide 17: 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 18: 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 19: Phase II clinical trial
PHASE II CLINICAL TRIAL H X P124-ONY-0 0 2 Results Q2 2022 WEEK WEEK WEEK WEEK 13 24 36 40 • Multi-center, randomised, double blind, 12 WEEK DA I LY DOS I N G SHORT COURSE vehicle-controlled study • Primary endpoint safety and tolerability, 12 WEEK DA I L Y DOS I N G F OL L OWED B Y ON C E WEEK LY D
Slide 20: ~23M patients with onychomycosis in the US
~23M PATIENTS WITH ONYCHOMYCOSIS IN THE US OTC ~ 3M PA TIE NTS A R E TR E A TE D WITH OTC OR R X PR OD UC TS 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 product
Slide 21: 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 22: A highly compelling commercial opportunity
A HIGHLY COMPELLING C OMMERCIAL OPPORTUNITY C ONS E C TE TUR A D IPIS C ING E L IT, S E D DO E IUS MOD TE M POR INC IDID UNT M A GNA A L IQ UA . PE Z A D E F TID E C A N C A PTUR E M A R KE T S H A R E IN TOPIC A L, OR A L A ND OTC M A R KE TS Pezadeftide has the potential to STR ONG DIFFER ENTIATE
Slide 23: Pezadeftide is manufactured rapidly and economically
PEZADEFTIDE IS MANUFACTURED RAPIDLY AND ECONOMICALLY S C A LE -UP WITH E UR OPE A N C M O ON-TR A C K 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 t
Slide 24: Strong patent position
STRONG PATENT POSITION A D D ITIONA L PR OTE C TION VIA F OR M ULA TION PA TE NTS A ND M A R K E T E X C LUS IVITY F OR B IOLOGIC S Clearly defined growth strategy Granted patents Granted and 12-year US market (exp 2035) in major pending patents exclusivity on FDA • Develop independently in markets
Slide 25: Development plan
DEVELOPMENT PLAN WE LL-D E FINE D D E VE L OPM E NT PA TH END OF PII A ND MILE S TONE S MEETING GMP MANUFACTURE 2022 PH I/IIA CLINICAL TRIAL 2021 COMPLETED US CLINICAL PK SAFETY STUDY PHASE I I I TOXICOLOGY I ND- ENABLI NG TOXI COLOGY CHRONI C TOXI COLOGY STUDI ES SCALE- UP AT GMP GMP MANUFACTURE CO
Slide 26: 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 27: Contacts
CONTACTS M IC HAEL D R N IC O LE ALD RIDGE V AN D E R W E ERD E N C H IE F E X E C UTIVE OF F IC E R C H IE F OPE R A TING OF F IC E R [email protected] [email protected] hexima.com.au +1 650 452 4684 +61 407 039 983 C ORPORA TE PRES EN TA TI ON S LI DE 27