Developing Advanced Oncology Therapies for Rare Unmet Medical Needs Copyright © 2022 Kintara Therapeutics, Inc. CONFIDENTIAL Corporate Presentation January 2022 Exhibit 99.1
Forward Looking Statements 2 This presentation contains forward-looking statements based upon Kintara’s current expectations. This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. Kintara has based these forward-looking statements largely on its then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Kintara’s control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with the impact of the COVID-19 pandemic; (ii) risks and uncertainties relating to Kintara’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of Kintara’s products and technology; the availability of substantial additional funding for Kintara to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, Kintara’s business, research, product development, regulatory approval, marketing and distribution plans and strategies, and (iii) those risks detailed in Kintara’s most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by Kintara from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Kintara cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued “forward-looking statement” constitutes a reaffirmation of that statement.
Late-stage Oncology Company with Two De-Risked Product Candidates 3 VAL-083: A first-in-class small molecule with unique MOA (MW = 147)
Pivotal, pre-eminent GBM AGILE International registrational study for three GBM patient subtypes initiated January 2021
~$1B1 market opportunity in lead program: Glioblastoma Multiforme (GBM)
Multiple shots on goal via parallel enrollment of three GBM patient subtypes
Over 1,200 patient safety database via ~40 prior studies
REM-001: 2nd generation photodynamic therapy platform
15-patient confirmatory study planned for Q2 2022, prior to Phase 3 trial
~$500M2 market in lead program: Cutaneous Metastatic Breast Cancer
Extensive Phase 2/Phase 3 efficacy data (80% complete responses across four trials)
Over 1,100 patient safety database
Multiple follow-on indications with existing orphan designations and/or approved INDs
1GlobalData November 2018
2Charles River Associates April 2018
Kintara Product Pipeline – Multiple Shots on Goal 4 VAL-083: Glioblastoma multiforme Registrational Study (GCAR/AGILE) in newly-diagnosed and recurrent patients REM-001: Cutaneous Metastatic Breast Cancer Fifteen patient confirmatory study leading into Pivotal Study REM-001: Recurrent Basal Cell Carcinoma Nevus Syndrome VAL-083: Ovarian Cancer LEAD INDICATIONS FOLLOW-ON INDICATIONS ODD FTD ODD ODD ODD = Orphan Drug Designation
FTD = Fast Track Designation PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 Q2 2022: Projected first patient enrolled in 15-patient study
VAL-083: GBM Opportunity 5 >$800M market growing to $1.4B in 20271
~30,000 newly-diagnosed patients in US/EU
~14,000 recurrent patients in US/EU
GBM AGILE Phase 2/Phase 3 international registration study:
FDA approved & strongly endorsed adaptive design
Involvement from numerous KOLs
Partnership with Global Coalition for Adaptive Research (GCAR)
Kintara is the only company currently approved, and enrolling in all three GBM AGILE patient subtypes:
Newly-Diagnosed Unmethylated (>60% of GBM patients)
Newly-Diagnosed Methylated (<40% of GBM patients)
Recurrent 1GlobalData November 2018 Survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8. PMID: 29251870. Lyne SB, Yamini B. An Alternative Pipeline for Glioblastoma Therapeutics: A Systematic Review of Drug Repurposing in Glioblastoma. Cancers (Basel). 2021;13(8):1953. Published 2021 Apr 18. doi:10.3390/cancers13081953
VAL-083 Mechanism of Action 6 VAL-083’s unique mechanism of action creates inter-strand DNA cross-links at the N7 position of guanine, resulting in double-strand DNA breaks and cancer cell death via apoptosis Mechanism of VAL-083 via crosslinks at N7 of guanine Mechanism of temozolomide (TMZ) via alkylation at O6 of guanine 2 guanine bases on DNA VAL-083 VAL-083 – interstrand crosslink (ICL) temozolomide converts to active state
(MTIC) at physiological pH guanine base on DNA alkylation of O6 guanine VAL-083’s unique DNA targeting mechanism circumvents MGMT-mediated chemoresistance and differentiates it from other therapies used in the treatment of GBM, including TMZ.
VAL-083 vs Standard-of-Care TMZ 7
VAL-083: Clinical Data - Phase 2 Studies Top Line Results 8 Open label Phase 2 studies in unmethylated patients; treatment dose for GCAR GBM AGILE Study; 1Hegi et al N Eng J Med (2005)
2Tanguturi et al. NeuroOncol (2017)
3Alnahhas et al. Neurooncol Adv (2020)
4Wick et al N.Eng.J.Med (2017)
VAL-083: FDA Approved Expedited Development and Registration Pathway 9 1Comparable to MDACC Phase 2 trial – adjuvant cohort
2Comparable to MDACC Phase 2 Trial – recurrent cohort Nov 2021 31 sites active, including Canadian site, for VAL-083 treatment arm Jan 2021 First site initiated for VAL-083 treatment arm May 2021 15 sites active for VAL-083 treatment arm By end of 2023 Top line results 12 months after last patient enrolled Aug 2021 26 sites active for VAL-083 treatment arm Collaboration with the Global Coalition for Adaptive Research (GCAR)
Founded in 2017 by world’s foremost clinical, translational, basic science investigators, and health authorities
Sponsor of innovative and complex platform trials utilizing adaptive design
Prior success via I-SPY with similar design for breast cancer
GBM Adaptive Global Innovative Learning Environment (AGILE) Study
International effort in newly-diagnosed and recurrent glioblastoma
Master Protocol with three or more experimental arms versus a common control
Primary endpoint: overall survival
“Seamless” transition to Stage 2, with Stage 1 patients included in final analysis
Final analysis 12 months after last patient randomized
150 to 200 Patients Maximum Stratified by Three Subtypes
Newly-diagnosed methylated
Newly-diagnosed unmethylated1
Recurrent2
GCAR/GBM AGILE Advantages 10 Utilized non-profit funding to design and initiate GBM trial (1st patient enrolled: June 2019)
Principals successful in platform and adaptive design paradigm per highly successful breast cancer trial
(I-Spy): 10-year trial, 16 compounds tested, three received FDA accelerated approval
Regulatory buy-in at highest level with strong FDA support
Rapid study startup and patient enrollment
Turn-key solution
31 sites currently enrolling Kintara arm:
Includes one site in Canada
Expanding into additional sites in the EU in the near future
Shared control group:
Contains costs and accelerates speed of study
Has been enrolling for over two years
Provides significant time and cost savings vs. multiple trials
Avoids company scale up of fixed expenses for trial execution
GCAR: GBM AGILE Major Clinical Sites/Investigators 11 Principal Investigators of Kintara's arm of the GBM AGILE study: Dr. James Perry Professor of Neurology University of Toronto Sunnybrook Research Institute Dr. John de Groot Division Chief Neuro Oncology Division Department of Neurological Surgery University of California San Francisco With 40 sites enrolling, GBM AGILE includes Key Opinion Leaders and leading clinical sites: MD Anderson Cancer Center - Houston Memorial Sloan Kettering Center - New York Mayo Clinic Cancer Center - Jacksonville Henry Ford Health System - Detroit Mount Sinai - New York Dana Farber Cancer Institute - Boston Cleveland Clinic - Cleveland Duke University Medical Center - Durham “GBM AGILE is an innovative clinical trial approach that enables us to simultaneously and dynamically study the effects of multiple new drug candidates. With the inclusion of paxalisib and VAL-083 for newly-diagnosed unmethylated and recurrent GBM patients, as well as VAL-083 for the additional methylated GBM patient group, we are excited to offer all GBM patients access to these latest therapies.”
- Dr. James Perry
VAL-083: FDA Approved Expedited Development and Registration Pathway 12 Current Clinical Status
January 2021:
Kintara jumps on “a fast-moving train” with GBM AGILE
Current patient enrollment better than initially anticipated
GBM AGILE/Kintara initiate patient randomization joining Bayer’s regorafenib, and Kazia’s paxalisib as the three compounds in this trial
Kintara’s VAL-083 is the only drug currently participating in all three patient subtypes:
Newly-diagnosed MGMT-unmethylated (>60% of GBM patients)
Newly-diagnosed methylated (<40% of GBM patients) — Kintara / VAL-083 only
Recurrent
REM-001: 2nd Generation Light Activated Cancer Therapy CMBC Overview 13 1Source (a): Saika et al, 2009; Kamaraju et al, 2016; Vano-Galvan et al, 2009; GlobalData Report on Metastatic Breast Cancer; Schoenlaub et al, 2001
2Charles River Report April 2018 Cutaneous Metastatic Breast Cancer is a major unmet medical need
Up to 40,000 patients in the U.S.1, representing $500M market opportunity2
Clinical aspects: Highly morbid form of breast cancer
Bleeding, infectious and malodorous lesions on chest wall, neck and back
Narcotics for pain control
Limited current therapies
Chemotherapy: generally non-responsive
Radiation: dose limiting toxicities, lesions are often refractory to radiation
Photodynamic Therapy Mechanisms of Action 14 PDT induces elimination of diseased cells by
immune response, apoptosis, antiangiogenesis and necrosis
REM-001: High Response Rates in CMBC 15 Second Generation Photodynamic Therapy
Light activated cancer therapy
Extensive data from prior Phase 2/Phase 3 clinical trials
149 patients treated in 4 trials
80% complete response rate in 674 evaluable lesions
Localized Outpatient Treatment
IV drug infusion accumulates in tumors
Activated by simple red light
Safety database ~1,100 patients
Previous trial experience used to optimize current trial design
REM-001: CMBC Development Plan 16 Development plan optimized for success while minimizing cost
Phase 3 ready
Initial open-label, 15-patient study to confirm lower dose and optimize trial design
Leverages prior data indicating lower dose can improve outcome
Faster healing
Less photosensitivity
De-risks full Phase 3 study
Anticipated study start in Q2 2022
Indication Expansion Opportunities 17 VAL-083
Platinum resistant Ovarian Cancer1
Non-Small Cell Lung Cancer1
Other Solid Tumors, including pediatric indications
REM-001
Other Cutaneous Metastatic Cancers
Recurrent Basal Cell Carcinoma Nevus Syndrome2
Locally Advanced Basal Cell Carcinoma (laBCC)
Peripheral Lung Cancer
Hemodialysis Arteriovenous (AV) Access 2Demonstrated positive results in prior sponsor’s Phase 2 study 1Prior Phase 1 and Phase 2 studies completed by NCI
Barriers to Competition 18 GBM Orphan drug designation in US and EU
Seven years market exclusivity after approval in US
10 years market exclusivity after approval in Europe
Fourteen patent families
Claims to methods of use, dosing and administration, combinations, manufacturing, analytical methods, and methods of synthesis
Fourteen US granted patents and forty-five patents granted worldwide
Expiry dates range from 2031 to 2038
Ovarian Cancer Orphan Drug Designation in US New Chemical Entity
Five years data exclusivity after approval in US
8+2+1 Regime in Europe
Combination Product Regulatory Pathway
REM-001 and Laser Device
Follow-on Indication Orphan Drug Designations in US
Basal cell carcinoma nevus syndrome (BCCNS)
Hemodialysis access grafts VAL-083 REM-001
Upcoming Milestones/Value Inflection Events 19 Q1 2021
Commence Enrollment - GCAR GBM AGILE International Registrational Study
Q2 2021
AACR Posters – Data updates for Phase 2 GBM Studies
Top Line Results - Phase 2 Recurrent GBM Study
Q3 2021
Top Line Results - Phase 2 Newly Diagnosed Adjuvant GBM Study
Q4 2021
First site in Canada – GCAR GBM AGILE International Registrational Study
Q1 2022
First site in the EU – GCAR GBM AGILE International Registrational Study
Q2 2022
Initiate 15-patient CMBC confirmatory trial
Q2 2023
Top line results from 15-patient CMBC confirmatory trial
By end of 2023
Top line results 12 months after last patient randomized - GCAR GBM AGILE International Registrational Study
Seasoned Biopharma Leadership Team 20
Scientific Advisory Boards 21 GBM Scientific Advisory Board CMBC Scientific Advisory Board Dr. John de Groot Groot (PI for Kintara/VAL-083 in GBM AGILE)
University of California San Francisco
Division Chief Neuro Oncology Division, Department of Neurological Surgery
Dr. Timothy Cloughesy (Overall PI for GBM AGILE)
David Geffen School of Medicine (UCLA)
Professor of Neurology UCLA Brain Research Institute and Jonsson Comprehensive Cancer Center
Member
Dr. Napoleone Ferrara
University of California, San Diego
World renowned scientist and Distinguished Professor of Pathology and a Distinguished Adjunct Professor of Ophthalmology and Pharmacology
Dr. David Reardon
Dana-Farber Cancer Institute
Clinical Director of the Center for Neuro-Oncology Harvard Medical School
Professor of Medicine
Dr. Nicholas Butowski
UCSF Medical Center
Neuro-oncologist
Brain Tumor Center
Director of Translational Research in Neuro-Oncology and Researcher Mario Lacouture, MD
Memorial Sloan Kettering Cancer Center
Director, Oncodermatology Program
Leading expert in treatment of cutaneous metastases in cancer
Thomas S. Mang, PhD
University at Buffalo (UB) School of Dental Medicine*
Director of Research for Oral and Maxillofacial Surgery Department
Recognized PDT expert and prior clinical work with REM-001 Therapy
Stephen B. Solomon, MD
Memorial Sloan Kettering Hospital Chairman, Interventional Radiology and Co-Director, Image-Guided Intervention
Specializes in image-guided interventions in cancer
Leonard A. Farber, MD
Weill Cornell Hospital*
Radiation Oncologist
Specialties include adult radiation oncology for breast cancer patients
Experience in treating CMBC and recurrent basal cell carcinoma
*Prior affiliations
Investment Highlights 22 Late-stage oncology company with two highly de-risked assets for underserved indications
VAL-083
Initiated GBM AGILE International Registrational Study: January 2021 with VAL-083 as the only trial arm enrolling all three GBM AGILE patient subtypes
Accelerated clinical pathway with strong regulatory support and 31 sites enrolling in Kintara arm
>$1B market opportunity1
REM-001 — Light activated cancer therapy diversifies late-stage oncology pipeline
80% complete responses across four clinical trials to date in CMBC
15-Patient confirmatory study initiation planned for Q2 2022, prior to Phase 3 trial
$500M market opportunity2
Significant upcoming milestones/value inflection events
Q1 2022: First site in the EU – GCAR GBM AGILE International Registrational Study
Q2 2022: Initiate 15-patient CMBC confirmatory trial
Q2 2023: Top line results from 15-patient CMBC confirmatory trial
By end of 2023: Top line results from GCAR GBM AGILE Study 12 months after last patient randomized
1GlobalData November 2018
2Charles River Associates April 2018
