Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Investor Presentation (May 2022)
38 slides from Allarity Therapeutics's investor presentation, May 27, 2022
Slide 1: Personalized Cancer Care. Realized.
Copyright © 2022 Allarity Therapeutics. All rights reserved. Nasdaq: ALLR Personalized Cancer Care. Realized. Steve R. Carchedi, CEO H1 2022
Slide 2: Legal Statement
2 Allarity Therapeutics Legal Statement This presentation is provided for informational purposes only and is subject to change. The information contained herein doe s n ot purport to be all - inclusive. The data contained herein is derived from various internal and external sources, and may rely upo
Slide 3: Company Snapshot: New Therapeutics for Unmet Cancer Needs
3 Allarity Therapeutics Company Snapshot: New Therapeutics for Unmet Cancer Needs We are building an oncology - focused pharmaceutical company using our world - class, highly validated companion diagnostics platform to achieve true, personalized cancer care. Robust pipeline of 3 clinical - stage can
Slide 4: Our Pipeline – Making Good Drugs Better with DRP
4 Allarity Therapeutics Our Pipeline – Making Good Drugs Better with DRP ® PHASE 1/2 PHASE 2 PHASE 3 NDA STATUS/ PARTNER Dovitinib Pan - tyrosine kinase inhibitor Type C FDA meeting in 2Q 2022* Stenoparib PARP and tankyrase inhibitor Microtubule inhibitor US Approved and out - licensed to Allarity i
Slide 5: Unlocking the Value of an Advanced Oncology Pipeline
5 Most advanced stage Phase 3 Phase 3 Phase 2 Phase 2 Phase 3 Phase 3 Number of assets in clinic 2 2 2 2 2 5 Peer Review Clinical validation publications 1 0 0 0 0 13 $1.1B $600M $303M $78M $74M $17M Kura Oncology Bioxcel Therapeutics Gritstone Bio Lantern Pharma Syros Pharma Allarity Unlocking the
Slide 6: Advancing a Phase 2/3 Oncology Rx Pipeline Through Superior Companion Diagnostics
Advancing a Phase 2/3 Oncology Rx Pipeline Through Superior Companion Diagnostics
Slide 7: Personalized Therapy Requires Predictive Diagnostics to Select Likely Responders
7 Allarity Therapeutics Personalized Therapy for Cancer Patients Requires Predictive Diagnostics to Select Likely Responders to a Given Drug Goal Personalized Medicine Low Average Patient Benefit High Average Patient Benefit Classical Drug Development Treat all of the patients Allarity Approach Trea
Slide 8: DRP is Distinct from Conventional Biomarker Technology
8 Allarity Therapeutics DRP ® is Distinct from Conventional Biomarker Technology Conventional Biomarker Approaches Largely Fail to Address Complex Tumor Biology and Mechanisms of Drug Response/Resistance Gene Mutation Sequencing Few drugs can be predicted with a single or a few mutations Drug Target
Slide 9: How We Approach the Complexity of Cancer
9 In vitro TRANSCRIPT -OMICS HUMAN SYSTEMS BIOLOGY In vitro Drug Response DATA Multi Gene DRP DRUG BLIND CLINICAL VALIDATION 14 How We Approach the Complexity of Cancer Cancer is Complex “Systems biology” is used to analyze all genes (~25,000) expressed in a cancer cell/tumor, without bias towards c
Slide 10: How We Create a Drug-Specific DRP Signature: example Dovitinib
10 How We Create a Drug - Specific DRP ® Signature: example Dovitinib Allarity Therapeutics Source: A Drug Response Predictor to Guide Treatment for Breast Cancer; Pharmacogenomics, Vol. 20, No.5 Editorial; Link: https://www.futuremedicine.com/doi/full/10.2217/pgs - 2018 - 0195 • Proprietary and hig
Slide 11: DRP Companion Diagnostics: Predicting a Cancer Patient's Drug Response
11 Compare patients’ tumor gene expression to DRP ® signature Allarity Therapeutics DRP ® Companion Diagnostics: Predicting a Cancer Patient’s Drug Response Identify patients with high DRP ® score for a given drug STRONG WEAK Patients’ biopsy samples Step 1 Step 2 Step 3 WEAK MODERATE STRONG PATIENT
Slide 12: DRP Sample Collection Kits
12 DRP ® Sample Collection Kits DRP ® Sample Collection Kits
Slide 13: DRP Platform: Extensively Validated in 47 Clinical Trials
13 Allarity Therapeutics DRP ® Platform: Extensively Validated in 47 Clinical Trials Cisplatin/LiPlaCis® Stenoparib IXEMPRA® Dovitinib Fulvestrant Belinostat 5 - FU Epirubicin Exemestane (+ dozens of other validations*) PROSPECTIVE CLINICAL TRIALS – PHASE 2 DRP® Clinical Impact 2 - 5 fold increase i
Slide 14: Primary Pipeline
Primary Pipeline Dovitinib Stenoparib IXEMPRA ®
Slide 15: Dovitinib
15 Allarity Therapeutics • Exclusively in - licensed from Novartis. Pan - Tyrosine Kinase Inhibitor (TKI), small molecule, targeted inhibitor of FGFR, VEGFR, and other RTKs • Efficacy demonstrated in Phase 3 Renal Cell Carcinoma ( RCC ) trial, and in Phase 2 studies spanning 4 additional cancers: ga
Slide 16: Our Validated Dovitinib DRP Identifies Responsive Patients
16 Allarity Therapeutics 1. NCT01223027; 49 out of 135 patients that consented to give biopsy that passed QC were DRP ® positive 2. Submitted to FDA April 1, 2021 Our Validated Dovitinib DRP ® Identifies Responsive Patients • Dovitinib DRP ® positive: • median 15.0 months OS at 50% DRP® score • medi
Slide 17: Dovitinib: Initial Market Opportunity in Kidney Cancer
17 Allarity Therapeutics 1. Source: reported sales (2019A) and eValuatePharma (2026E) 2. Source: EDISON analyst report (September 2020) + adjustment for DRP ® methodology impact Dovitinib: Initial Market Opportunity in Kidney Cancer 0 20 40 60 80 100 120 140 Dovitinib peak sales in RCC Sorafenib sal
Slide 18: Dovitinib: Exemplary Follow-On Market Opportunity in Liver Cancer
18 0 100 200 300 400 500 600 Dovitinib peak sales projection in HCC alone Sorafenib sales (2019) in HCC Dovitinib Peak Revenue Estimate in 1L HCC Allarity Therapeutics 1. Source: reported sales (2019A) and eValuatePharma (2026E) 2. Source: Estimated half of Sorafenib sales in HCC + adjustment for DR
Slide 19: Dovitinib: Evaluating Multiple Commercial Opportunities
19 Allarity Therapeutics Dovitinib: Evaluating Multiple Commercial Opportunities Potential Regional Oncology Commercialization Partners Have Been Identified • Dovitinib commercialization strategy: enter into marketing partnerships with leading regional oncology therapeutics companies to achieve opti
Slide 20: Stenoparib: A Dual PARP and Tankyrase Inhibitor
20 Allarity Therapeutics 1) PARP = Poly ADP - Ribose Polymerase, a critical cellular enzyme for repair of certain type of DNA strand breaks; Data comes fro m eValuatePharma 2) Under Eisai, stenoparib (2X - 121) was formally known as E7449 Stenoparib: A Dual PARP and Tankyrase Inhibitor Annual sales
Slide 21: Our Validated Stenoparib DRP Identifies Responsive Patients
21 Allarity Therapeutics Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Our Validated Stenoparib DRP ® Identifies Responsive Patients Results of Phase I Trial Response rate below DRP ® cutoff of 50: 0% All comers ORR: 15% Response rate above DRP ® cutoff of 50: 33% All 8
Slide 22: Stenoparib: Well Positioned in PARP Competitive Landscape
22 Allarity Therapeutics 1) Lars M. Wagner, Division of Pediatric Hematology/Oncology, University of Kentucky, Lexington, KY, USA, in “Profile of veli par ib and its potential in the treatment of solid tumors.” Onco Targets Ther. 2015; 8: 1931 – 1939. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC452
Slide 23: IXEMPRA
23 Allarity Therapeutics • Exclusively in - licensed for EU from R - PHARM U.S. Microtubule Inhibitor, originally developed and marketed by Bristol Myers Squibb. • Approved and marketing in U.S. for the treatment of mBC: • in combination with capecitabine for the treatment of metastatic or locally a
Slide 24: IXEMPRA DRP Nearly Doubles ORR in Neoadjuvant BC
24 IXEMPRA ® Arm Allarity Therapeutics 1) Perez et al (2007) in mBC patients resistant to anthracycline, taxane, and capecitabine 2) Thomas et al (2007) in mBC patients resistant to taxanes IXEMPRA ® DRP ® Nearly Doubles ORR in Neoadjuvant BC p C R N o _ p C R 0 2 0 4 0 6 0 8 0 1 0 0 Ixabepilone arm
Slide 25: Monetized Secondary Pipeline Programs
25 Allarity Therapeutics • We have monetized our prior secondary pipeline programs through external partnerships • LiPlaCis ® out - licensed to Chosa ApS (an affiliate of Smerud Medical Research Int’l) in April 2022 for further clinical & commercial development in connection with cisplatin - DRP ® c
Slide 26: Leadership, I.P., & Strategic Milestones
Leadership, I.P., & Strategic Milestones
Slide 27: Our Senior Leadership Team
27 James G. Cullem, JD Chief Business Officer Allarity Therapeutics Our Senior Leadership Team Marie Foegh, MD Chief Medical Officer Steen Knudsen, PhD Chief Scientific Officer, Co - Founder Steve R. Carchedi Chief Executive Officer (Joined September 2019) Jens E. Knudsen Chief Financial Officer (Jo
Slide 28: Advisory Board: World-Class Key Opinion Leaders
28 Advisory Board: World - Class Key Opinion Leaders Allarity Therapeutics DAN VON HOFF, MD Physician in Chief, Distinguished Professor at the Translational Genomics Research Institute ( TGen ) in Phoenix, Arizona. Virginia G. Piper Distinguished Chair for Innovative Cancer Research at HonorHealth.
Slide 29: Our Board of Directors
29 Allarity Therapeutics Our Board of Directors GAIL J. MADERIS Director Gail is currently CEO of Antiva Biosciences, Inc., and a Board member at Valitor, Inc., the BIO Emerging Companies governing group, and the U.C. Berkeley Foundation Board of Trustees. Earlier in her career, Gail was CEO at Five
Slide 30: Strong & Expanding Intellectual Property Portfolio
30 Allarity Therapeutics • 15 DRP ® patents granted covering 70 different oncology drugs • Additional DRP ® patent applications pending focused on primary pipeline • Recent USPTO allowance on 3 pending applications including our Dovitinib DRP ® • Patent strategy allows us to file new patent applicat
Slide 31: Upcoming Milestones to Deliver Significant Value Creation
31 H1 2022 – H1 2023 Allarity Therapeutics Upcoming Milestones to Deliver Significant Value Creation Delivering significant value over the next 12 - 15 months through multiple value - creating inflection points U.S. Nasdaq Listing & Strengthening of B/S - Nasdaq listed in December 2021 - Greater acc
Slide 32: Key Investment Highlights
32 Allarity Therapeutics Advanced oncology pipeline with multiple mid to late clinical - stage drug candidates and opportunities for external partnering. Key value inflection points in 12 - 18 months. Industry leading DRP ® companion Dx technology platform validated across more clinical trials than
Slide 33: James G. Cullem Chief Business Officer +1 ( 978) - 0863 jcullem@allarity.com Steve R.
James G. Cullem Chief Business Officer +1 ( 978) 500 - 0863 jcullem@allarity.com Steve R. Carchedi Chief Executive Officer +1 (908) 720 - 1786 scarchedi@allarity.com allarity.com
Slide 34: FAQs About Our DRP Platform Technology
34 FAQs About Our DRP ® Platform Technology Allarity Therapeutics What are the different filter rings in the graphic of how DRP® works? They represent ( i ) our proprietary correlation analysis, (ii) our proprietary clinical biopsy filter, and (iii) our final statistical refinement step. Q: A: Why i
Slide 35: FAQs About Our DRP Platform Technology
35 FAQs About Our DRP® Platform Technology Allarity Therapeutics Are DRP ® companion Dx validations based upon retrospective or prospective trial analysis? Both. We have completed 35+ retrospective validations (including blinded retrospective validations) and 1 prospective validation to date. Q: A:
Slide 36: DRP Platform: Clinical Validations, 32 Drugs/Combos
36 Allarity Therapeutics DRP ® Platform: 47 Clinical Validations, 32 Drugs/Combos Table 1. Overview of DRP clinical validations, with evidence level and clinical impact: 32 drugs or drug combinations, 47 clinical trials Level III: Retrospective Level II: Prospective with banked samples Level I: Pros
Slide 37: Publications of Clinical/Method Validation for Drug-Specific DRPs
37 Allarity Therapeutics Publications of Clinical/Method Validation for Drug - Specific DRP®’s List of peer-review publications describing clinical validation or method validation of DRPs for different drugs in different cancer types. Each DRP is specific to one drug. 1. Chen J, et al. A 71-gene sig
Slide 38: Dovitinib's Place in the 3rd Line RCC Treatment Landscape
38 Allarity Therapeutics Dovitinib’s Place in the 3 rd Line RCC Treatment Landscape NCCN GUIDELINES V 2.2022 - SEPTEMBER 8, 2021 CLEAR CELL RCC THERAPY BEYOND FIRST LINE Preferred Regimen Other Recommended Regimens Useful in Certain Circumstances Cabozantinib Axitinib Everolimus Lenvatinib + Everoli
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