Hexima Ltd · ASX:HXL
Hexima — ASX Small and Mid-Cap Conference 2021
18 slides from Hexima's conference presentation, Sep 14, 2021
Slide 1: ASX Small and Mid-Cap Conference Presentation
ASX Announcement 14 September 2021 For personal use only ASX Small and Mid-Cap Conference Presentation MELBOURNE, AUSTRALIA (14 September 2021): Hexima Limited (ASX:HXL) a clinical stage biotechnology company developing pezadeftide (formerly HXP124), as a potential new prescription topical treatment
Slide 2: Hexima Limited: A game-changing treatment for onychomycosis
SEPTEMBER 2021 For personal use only HEXIMA LIMITED (ASX:HXL) A game-changing treatment for onychomycosis 1
Slide 3: Disclaimer
DISCLAIMER For personal use only 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 “predi
Slide 4: Developing a novel topical product addressing a clear unmet need in a large and growing market
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 For personal use only CLINICAL-STAGE, LARGE AND GROWING NOVEL, PROPRIETARY PEZADEFTIDE ADDRESSES WELL-DEFINED INFECTIOUS DISEASE-FOCUSED MARKET WITH SUBS
Slide 5: Pezadeftide in action
PEZADEFTIDE IN ACTION For personal use only Click to play animation C ON S UMER- C EN TRI C DEVELOPMEN T S LI DE 5
Slide 6: Existing therapies do not meet consumer needs
EXISTING THERAPIES DO NOT MEET CONSUMER NEEDS For personal use only 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
Slide 7: Successful phase I/IIa clinical trial
SUCCESSFUL PHASE I/IIA CLINICAL TRIAL 12 12 For personal use only 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 (randomi
Slide 8: Primary endpoint: safety and tolerability
PRIMARY ENDPOINT SAFETY AND TOLERABILITY For personal use only 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
Slide 9: Effective and rapid anti-fungal activity
EFFECTIVE AND RAPID ANTI-FUNGAL ACTIVITY For personal use only 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
Slide 10: Pezadeftide rapidly cleared the affected nail area
PEZADEFTIDE RAPIDLY CLEARED THE AFFECTED NAIL AREA For personal use only 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
Slide 11: 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 , For personal use only 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 g
Slide 12: Patent filed on CompliancePak and associated mobile application
PATENT FILED ON COMPLIANCEPAK ASSOCIATED MOBILE APPLICATION For personal use only 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 • Complianc
Slide 13: Potential to deliver the preferred solution in a consumer-driven market
POTENTIAL TO DELIVER THE PREFERRED SOLUTION IN A CONSUMER-DRIVEN MARKET For personal use only 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
Slide 14: Australian phase IIb clinical trial
AUSTRALIAN PHASE IIB CLINICAL TRIAL H X P124-ONY-0 0 2 Enrolment For personal use only completed WEEK WEEK WEEK WEEK July 2021 13 24 36 40 • Multi-center, randomised, double blind, 12 WEEK DA I LY DOS I N G vehicle-controlled study • Primary endpoint safety and tolerability, 12 WEEK DA I L Y DOS I N
Slide 15: ~23M patients with onychomycosis in the US
~23M PATIENTS WITH ONYCHOMYCOSIS IN THE US OTC For personal use only ~ 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
Slide 16: Strong patent position
STRONG PATENT POSITION For personal use only 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 ind
Slide 17: Pezadeftide: a potential solution for a large and poorly served market
PEZADEFTIDE: A POTENTIAL SOLUTION FOR A LARGE AND POORLY SERVED MARKET For personal use only 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 loca
Slide 18: Contacts
CONTACTS For personal use only 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 m.aldridge@hexima.com.au n.vanderweerden@hexima.com.au hexima.com.au +1 650 452 4684 +61 407 039 983 C ORPORA TE PRES EN TA TI ON S LI DE 29