Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Novogen — 29th Annual ROTH Conference (March 2017)
26 slides from Kazia Therapeutics's conference presentation, Mar 15, 2017
Slide 1: Presentation to 29th Annual ROTH Conference
Novogen Limití Presentation to 29th Annual ROTH Conference Dr James Garner Dana Point, CA Chief Executive Officer 14 March 2017 james.garner@novogen .com Version 1.0
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “ forward-looking statements ” within the meaning of the “ safe-harbor ” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the act
Slide 3: Novogen is a biotech company dedicated to driving sustainable, long-term growth in shareholder value
COMMERCIAL IN CONFIDENCE Novogen is a biotech company dedicated to driving sustainable, long-term growth in shareholder value Focus on unmet medical need Robust pipeline of novel therapies, targeting oncology patients poorly served by existing treatment options Financially sound Listed on ASX and NA
Slide 4: 2016 has been a transformative year for Novogen
COMMERCIAL IN CONFIDENCE 2016 has been a transformative year for Novogen 3Q 2016 Submission of Cantrixil 2Q 2016 IND4Q 2016 1Q 2016 Granting of patent for ATM Appointment of ScientificLicensing of GDC-0084 Appointment of CEO technology Advisory Boardfrom Genentech Granting of patent for SBP Conclusi
Slide 5: Novogen is listed on ASX and NASDAQ, and is well-funded
Novogen is listed on ASX and NASDAQ, and is well- funded Share Price (US$) 3.00 Cash at Bank*Debt NVGN~US$ 17 millionNil NASDAQ Biotech Index 2.50 Market CapitalisationUS$ 27 million 2.00 ASX:NRT ListingNASDAQ:NVGN (1:25 1.50 ratio) Average Daily VolumeASX:0.1% /day 1.00 NASDAQ:0.2% /day 0.50 Shares
Slide 6: Novogen has focused on oncology, with a clear strategy for building and managing a high-value portfolio
COMMERCIAL IN CONFIDENCE Novogen has focused on oncology, with a clear strategy for building and managing a high-value portfolio PartnersTightly focused on oncology, with a weighting to solid tumours Un-proven programs Assets in-licensed Significantly de-risked taken from preclinical Open-minded as
Slide 7: Novogen has built a strong management team with international experience in big pharma
Novogen has built a strong management team with international experience in big pharma Dr James Garner Chief Executive Officer & Managing Director Physician / MBA; Extensive pharma drug development experience Dr Gordon Hirsch Chief Medical Officer Physician / MBA; Twenty years of pharmaceutical indu
Slide 8: Our newly-appointed Scientific Advisory Board brings global expertise and experience to Novogen
Our newly-appointed Scientific Advisory Board brings global expertise and experience to Novogen Professor Sir Dr Karen ProfessorProfessor Murray Brennan Ferrante Peter GunningAlex Matter COMMERCIAL IN CONFIDENCE 7
Slide 9: Novogen now has a well-diversified portfolio of assets, stretching from preclinical to mid-stage clinical
Novogen now has a well-diversified portfolio of assets, stretching from preclinical to mid-stage clinical LeadPreclinicalIND-EnablingPhase IPhase IIPatent OptimisationProof-of-ConceptTox & CMCClinical TrialsClinical TrialsExpiry PI3K GDC-0084 GlioblastomaPhase II2032 2017 SBP TRXE-002-1 Ovarian Canc
Slide 10: Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer
GDC-0084 Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer Presentation Usually presents with non—specific symptoms (e.g. headaches, nausea) Rapid clinical progression to permanent neurological defect and coma Source: GLOBOCAN 2012 Epidemiology Approximately 12,500 incide
Slide 11: Current GBM standard of care is ineffective in ~65% of patients
Current GBM standard of care is ineffective in GDC-0084 ~65% of patients Standard of Care Debulking surgery Radiotherapy +Temozolomide (‘Stupp where possible temozolomidemaintenance therapy Regimen’) 6 weeks4w6 x 28-day cycles Temozolomide is clearly efficacious… …but only in ~35% of patients who ar
Slide 12: The PI3K / Akt / mTOR pathway is upregulated in the vast majority of GBM cases
The PI3K / Akt / mTOR pathway isupregulated in GDC-0084 the vast majority of GBM cases Select PI3K inhibitors Growth factor receptors Taselisib (Genentech) PI3K upregulated, or PTEN PI3K knocked out, in ~85% of GBM Buparlisib cases (Novartis) PIP2 PIP3PI3K dysregulation associated with worse prognos
Slide 13: GDC-0084 shows single-agent activity in preclinical models of glioblastoma
GDC-0084 GDC-0084 shows single-agent activity in preclinical models of glioblastoma Illustrative Dose-Dependent Activity in U87 Model General Findings ) 3 (mm Widespread activity in a range of PDX Vehicle models; appears unaffected by MGMT 0.03 mg/kg promotor status 0.45 mg/kg Volume 2.2 mg/kg 4.5 m
Slide 14: PI3K inhibitors are well-validated, with one marketed product and extensive clinical data
12 COMMERCIAL IN CONFIDENCE PI3K inhibitors are well-validated, with one GDC-0084 marketed product and extensive clinical data Zydelig (idelalisib) on market Other PI3K inhibitors in clinical trials Idelalisib (and programs such as Infinity Therapeutics and TG Therapeutics) specifically target the d
Slide 15: GDC-0084 shows consistent penetration of blood-brain barrier in multiple species
GDC-0084 shows consistent penetration of GDC-0084 blood-brain barrier in multiplespecies 100 100100100 GDC-0084 MALDI MS/MS (15 mg/kg) 0 000 U87 orthotopic GBM model Cresyl Violet Free Brain-to- Brain-to- CSF-to-Free Species Free Plasma Plasma Ratio Plasma Ratio Ratio Mouse 1.3 0.40- Rat 2.4 0.681.5
Slide 16: GDC-0084 is among the most advanced PI3K inhibitors in active development for GBM
COMMERCIAL IN CONFIDENCE GDC-0084 GDC-0084 is among the most advanced PI3K inhibitors in active development for GBM 212 17340 100% Non- Oncology (39) Discontinued 80% / No Development (79) 60% Other Oncology Indications (35) Oncology 40% (173) Discovery (54) 20% Ph I (17) Marketed Ph II (15)(1)Gliob
Slide 17: Genentech's phase I study established a GDC-0084 dose of 45mg and demonstrated acceptable safety
Genentech’s phase I study established a GDC-0084 dose of 45mg and demonstrated acceptable safety Phase I Study Population in phase I study (recurrent patients) had significantly more advanced disease than that proposed for phase II study (first-line patients) 47 patients enrolled at 4 centers (MD An
Slide 18: Time on study exceeded historical controls (~1 month) for the majority of patients
GDC-0084 Time on study exceeded historical controls (~1 month) for the majority of patients Taal et al, Lancet Oncology, 2015 shows one month survival in comparable lomustine-treated cohort COMMERCIAL IN CONFIDENCE 17
Slide 19: Response rate was consistent with a primarily cytostatic mode of action
Response rate was consistent witha GDC-0084 primarily cytostatic mode of action from lesions change of target Best % baseline CR / PR: 0 SD: 15 (35%) PD: 27 (63%) 18 COMMERCIAL IN CONFIDENCE
Slide 20: On FDG-PET, 7/27 patients (26%) had a metabolic partial response
On FDG-PET, 7/27 patients (26%)hada GDC-0084 metabolic partial response Tumor mean in Lesion Response Enhancing in Best Overall SUVmax Normal Brain Tissue in Brain Response Normal Overall SUV in Best Median 19 COMMERCIAL IN CONFIDENCE
Slide 21: Brain metastases from non-CNS tumors represent long-term upside potential
GDC-0084 Brain metastases from non-CNS tumors represent long-term upside potential Overview Example: Breast Cancer Estimated 100,000—200,000 ~30-44% of metastatic HER2- cases/year in US positive metastatic breast cancer patients have brain metastases ~10-25% adult cancer patients develop symptomatic
Slide 22: Ovarian cancer remains a disease of high unmet medical need
Ovarian cancer remains a disease of high Cantrixil unmet medical need High Incidence Poor Prognosis with Existing TherapiesGrowing and Evolving Market Five-Year SurvivalMarket Size (US$ ,000) Lung 1,200 0%50%100% Ovarian Cancer 1,000 17th most common Breast Stage 1$1,100M tumour worldwide 7th most c
Slide 23: Phase I study is designed to establish safety and tolerability, and explore potential efficacy
Phase I study is designed to establish safety Cantrixil and tolerability, and explore potential efficacy Trial Sites Patient Population Study DesignCompletion ~6 hospitals in United Women with Standard dose Forecast 18 month States and Australia confirmed ovarian escalation to establishstudy duratio
Slide 24: 2017 will be an important year for Novogen, with a rich series of value-driving events
COMMERCIAL IN CONFIDENCE 2017 will be an important year for Novogen, with a rich series of value-driving events Key Milestones for 2017 Initiation of GDC-0084 phase II study Full recruitment of Cantrixil phase I study Stage-up of Anisina for IND submission and phase I study Further progression of ea
Slide 25: Novogen now has a diversified portfolio and is positioned for growth
COMMERCIAL IN CONFIDENCE Novogen now has a diversified portfolio and is positioned for growth Focus on unmet need: pipeline of novel therapies, targeting oncology patients, poorly served by existing treatment options Building a sustainable model: leveraging oncology expertise, developing commerciall
Slide 26: Novogen
Novogen