Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Investor Presentation (January 2022)
40 slides from Allarity Therapeutics's investor presentation, Jan 18, 2022
Slide 1: Personalized Cancer Care. Realized.
Copyright © 2022 Allarity Therapeutics. All rights reserved. N a sdaq: A L LR Personalized Cancer Care. Realized. Steve R. Carchedi, CEO H1 2022
Slide 2: Legal Statement
Legal Statement 1 /1 4 /2 0 2 2 Allarity Therapeutics 2 This presentation is provided for informational purposes only and is subject to change. The information contained herein does not purport to be all - inclusive. The data contained herein is derived from various internal and external sources, an
Slide 3: Company Snapshot: New Therapeutics for Unmet Cancer Needs
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 5 clinical - stage cancer therapeutics that ad
Slide 4: Our Pipeline – Making Good Drugs Better with DRP
Our Pipeline – Making Good Drugs Better with DRP ® PHASE 1/2 PHASE 2 PHASE 3 NDA STATUS/ PARTNER Dovitinib Pan - tyrosine kinase inhibitor Renal Cell Carcinoma Stenoparib PARP and tankyrase inhibitor Ovarian Cancer Microtubule inhibitor Metastatic Breast Cancer (EU) US Approved and out - licensed to
Slide 5: Unlocking the Value of an Advanced Oncology Pipeline
5 Most advanced stage Phase 3 Phase 3 Phase 2 Phase 3 Phase 3 Phase 2 Number of assets in clini c 2 2 2 2 5 2 Peer Review Clinical v a lidation publ ic a tio ns 1 0 0 0 13 0 $940M $625M $477M $223M $86M $79M Kura Oncology Bioxcel Therapeutics Gritstone Bio Syros Pharmaceuticals Allarity Lantern Phar
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
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 1 /1 4 /2 0 2 2 Allarity Therapeutics 7 Allari
Slide 8: DRP is Distinct from Conventional Biomarker Technology
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 T arget Analysis Focus on drug
Slide 9: How We Approach the Complexity of Cancer
In vitro T R A N S C RI PT - OMICS HU M AN S Y S T E M S BIOLOGY In vitro Drug Response DATA 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 current knowledge of relevant drug t
Slide 10: How We Create a Drug-Specific DRP Signature: example Dovitinib
How We Create a Drug - Specific DRP ® Signature: example Dovitinib 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 highly advanced statistical
Slide 11: DRP Companion Diagnostics: Predicting a Cancer Patient's Drug Response
Compare patients’ tumor gene expression to DRP ® signature PATIENTS’ TUMORS DRP ® Companion Diagnostics: Predicting a Cancer Patient’s Drug Response STRONG WEAK Patients’ biopsy samples PATIENTS’ TUMORS Step 1 Step 2 Step 3 WEAK M O DERATE STRONG Identify patients with high DRP ® score for a given d
Slide 12: DRP Sample Collection Kits
DRP ® Sample Collection Kits 1 /1 4 /2 0 2 2 Allarity Therapeutics 12
Slide 13: DRP Platform: Extensively Validated in Clinical Trials
DRP ® Platform: Extensively Validated in 47 Clinical Trials Cisplatin/LiPlaCis® Stenoparib IXEMPRA® (+ dozens of other validations*) PROSPECTIVE CLINICAL TRIALS – PHASE 2 DRP® Clinical Impact 2 - 5 fold increase in ORR or TTP between predicted sensitive and predicted resistant RETROSPECTIVE (BLINDED
Slide 14: U.S. FDA Will Accept Retrospective, Blinded cDx Validation
U.S. FDA Will Accept Retrospective, Blinded cDx Validation 1 /1 4 /2 0 2 2 Allarity Therapeutics 14 ”While prospective samples are preferred, well - characterized samples from banks can be used in your clinical validation study, provided that there is no collection or selection bias, and patient his
Slide 15: Primary Pipeline
Primary Pipeline Dovitinib Stenoparib IXEMPR A ®
Slide 16: Dovitinib overview
• 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: gastrointestinal stromal tu
Slide 17: Our Validated Dovitinib DRP Identifies Responsive Patients
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 • N=286 sorafenib, Hazard Ratio: 0.69; 95% Confidence Interval 0.48 - 0.99 in 50% DRP® score group (N
Slide 18: Dovitinib: Initial Market Opportunity in Kidney Cancer
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 US $M M 140 Dovitinib peak sales in RCC Sorafenib sales (2019) in RCC E
Slide 19: Dovitinib: Follow-On Market Opportunity in Liver Cancer
0 100 200 300 400 500 US $MM 600 Dovitinib peak sales projection in HCC alone Sorafenib sales (2019) in HCC Dovitinib Peak Revenue Estimate in 1L HCC 1. Source: reported sales (2019A) and eValuatePharma (2026E) 2. Source: Estimated half of Sorafenib sales in HCC + adjustment for DRP methodology impa
Slide 20: Dovitinib: Evaluating Multiple Commercial Opportunities
Dovitinib: Evaluating Multiple Commercial Opportunities Potential Regional Oncology Commercialization Partners Have Been Identified • Dovitinib commercialization strategy: enter into marketing partnerships with leading regional oncology therapeutics companies to achieve optimal market penetration in
Slide 21: Stenoparib: A Dual PARP and Tankyrase Inhibitor
1) PARP = Poly ADP - Ribose Polymerase, a critical cellular enzyme for repair of certain type of DNA strand breaks; Data comes from eValuatePharma 2) Under Eisai, stenoparib (2X - 121) was formally known as E7449 Stenoparib: A Dual PARP and Tankyrase Inhibitor Annual sales 1 (US$m) in indications ta
Slide 22: Our Validated Stenoparib DRP Identifies Responsive Patients
Clinical response Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Our Validated Stenoparib DRP ® Identifies Responsive Patients Response rate below DRP ® cutoff of 50: 0% Response rate above DRP ® cutoff of 50: 33% All comers ORR: 15% All 8 histologies DRP predicted 2X−12
Slide 23: Stenoparib: Well Positioned in PARP Competitive Landscape
1) Lars M. Wagner, Division of Pediatric Hematology/Oncology, University of Kentucky, Lexington, KY, USA, in “Profile of veliparib and its potential in the treatment of solid tumors.” Onco Targets Ther. 2015; 8: 1931 – 1939. https ://www .nc bi.nlm.nih.gov/pmc/articles/PMC4524591 Stenoparib: Well Po
Slide 24: Ixempra overview
• 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 advanced breast cancer in
Slide 25: IXEMPRA DRP Nearly Doubles ORR in Neoadjuvant BC
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 R e spons e Predicted Ixabepilone sensitivity pCR No_ pCR 0 20 4 0 60 80 1 00 Ixempra ® DRP ® se
Slide 26: Secondary Pipeline: Partnership Monetization
• We expect to monetize our secondary pipeline programs through partnerships • LiPlaCis ® and 2X - 111 out - licensed to Smerud Medical Research International in June 2020 for further clinical and commercial development in connection with each program’s DRP ® companion Dx. • LiPlaCis ® in late - sta
Slide 27: Leadership, I.P., & Strategic Milestones
Leadership, I.P., & Strategic Milestones
Slide 28: Our Senior Leadership Team
James G. Cullem, JD Chief Business Officer 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 (Joined November 2020) Thoma
Slide 29: Advisory Board: World-Class Key Opinion Leaders
Advisory Board: World - Class Key Opinion Leaders 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. Chief Scientific Officer fo
Slide 30: Our Board of Directors
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 Prime Therapeutics, Inc.
Slide 31: Strong & Expanding Intellectual Property Portfolio
• 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 applications as we develop DRP®’s
Slide 32: Upcoming Milestones to Deliver Significant Value Creation
H2 2021 – H2 2022 Upcoming Milestones to Deliver Significant Value Creation Delivering significant value over the next 12 - 15 months through multiple value - creating inflection points These timelines can be affected by the ongoing COVID - 19 pandemic U.S. Nasdaq Listing & Strengthening of B/S - Na
Slide 33: Key Investment Highlights
Advanced oncology pipeline with multiple mid to late clinical - stage drug candidates and opportunities for external partnering. Key value inflection points in 2022. Industry leading DRP ® companion Dx technology platform validated across more clinical trials than any other competitor. NDA for lead
Slide 34: James G. Cullem Chief Business Officer +1 (978) - 0863 jcullem@allarity.com Steve R. Carchedi
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 allari t y .com
Slide 35: FAQs About Our DRP Platform Technology
FAQs About Our DRP ® Platform Technology Q: What are the different filter rings in the graphic of how DRP® works? A: They represent (i) our proprietary correlation analysis, (ii) our proprietary clinical biopsy filter, and (iii) our final statistical refinement step. Q: Why is a 50% cut - off optima
Slide 36: FAQs About Our DRP Platform Technology
FAQs About Our DRP® Platform Technology Q: Are DRP ® companion Dx validations based upon retrospective or prospective trial analysis? A: Both. We have completed 35+ retrospective validations (including blinded retrospective validations) and 1 prospective validation to date. Q: Is there any special o
Slide 37: DRP Platform: Clinical Validations, Drugs/Combos
DRP ® Platform: 47 Clinical Validations, 32 Drugs/Combos Level III: Retrospective Level II: Prospective with banked samples Level I: Prospective or confirmatory Cisplatin/LiPlaCis Breast, ovarian, lung NSCLC Metastatic breast Fulvestrant Neoadjuvant breast Metastatic breast Dovitinib HCC, Breast Ren
Slide 38: Publications of Clinical/Method Validation for Drug-Specific DRPs
Publications of Clinical/Method Validation for Drug - Specific DRP®’s 1 /1 4 /2 0 2 2 Allarity Therapeutics 38 1. Chen J, et al. A 71 - gene signature of TRAIL sensitivity in cancer cells . (October 2011); Mol Cancer Ther , 10.1158/1535 - 7163. 2. Wang W, et al. Independent validation of a model usi
Slide 39: Dovitinib's Place in the 3rd Line RCC Treatment Landscape
Dovitinib’s Place in the 3 rd Line RCC Treatment Landscape 1 /1 4 /2 0 2 2 Allarity Therapeutics 39 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 Lenv
Slide 40: Stenoparib as potential anti-viral against COVID-19
• We are opportunistically exploring the potential of Stenoparib as an anti - viral against COVID - 19 • Dual Mechanism - of - Action on: • Virus replication: PARP may be important for the SARS - CoV - 2 viral capsid maturation, which is ADP ribosylated • “Cytokine storm”: PARP inhibitors limit the
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