Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Investor Presentation (August 2022)
39 slides from Allarity Therapeutics's investor presentation, Aug 29, 2022
Slide 1: Personalized Cancer Care. Realized.
Copyright © 2022 Allarity Therapeutics. All rights reserved. Nasdaq: ALLR Personalized Cancer Care. Realized. James G. Cullem, CEO H2 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 DRP ® companion diagnostics platform to achieve true, personalized cancer care. Robust pipeline of 3 clinical - sta
Slide 4: Our Pipeline – Making Good Drugs Better with DRP
4 Allarity Therapeutics Our Pipeline – Making Good Drugs Better with DRP ® PHASE 1/1b PHASE 2 PHASE 3 NDA STATUS/ PARTNER Dovitinib Pan - tyrosine kinase inhibitor Stenoparib PARP and tankyrase inhibitor Microtubule inhibitor US Approved and out - licensed to Allarity in EU 2X - 111 Doxorubicin in G
Slide 5: Unlocking the Value of a Focused Oncology Pipeline
5 Most advanced stage Phase 3 Phase 3 Phase 2 Phase 2 Phase 3 Phase 2 Number of assets in clinic 2 3 2 2 3 3 Peer Review Clinical validation publications 1 0 0 0 0 13 $1.0B $457M $252M $60M $57M $12M Kura Oncology Bioxcel Therapeutics Gritstone Bio Lantern Pharma Syros Pharma Allarity Unlocking the
Slide 6: Advancing a Clinical Stage Oncology Rx Pipeline Through Superior Companion Diagnostics
Advancing a Clinical Stage 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: e.g. Dovitinib
10 How We Create a Drug - Specific DRP ® Signature: e.g. 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 highly
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 Studied in 47 Clinical Trials
13 Allarity Therapeutics DRP ® Platform: Extensively Studied 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 in
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 . Unique, inhibitory profile. • Efficacy demonstrated in monotherapy Phase 3 Renal Cell Carcinoma ( mRCC ) trial 2 , and in Pha
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 (36%). If samples are ma crodissected to remove necrosis the median increases to 24.2 mo in the Dovitinib - DRP positive arm. Our Validated Dovitinib - DRP ® Identifies Re
Slide 17: Dovitinib: Potential Combination Therapy with Immune Checkpoint Inhibitors
17 Allarity Therapeutics 1. SVB Leerink analyst Daina Graybosch (FiercePharma) 2. NCT02811861 and NCT03517449 Dovitinib: Potential Combination Therapy with Immune Checkpoint Inhibitors ( e.g. PD - 1i) Strong Pre - clinical Evidence and Clinical Rationale for Combination of Dovitinib + Pembrolizumab.
Slide 18: Dovitinib: Combination Therapy Opportunity with Stenoparib
18 Allarity Therapeutics 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 Dovitinib: Combination Therapy Opportunity with Stenoparib (PA
Slide 19: Stenoparib: A Dual PARP and Tankyrase Inhibitor
19 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 3. Plummer et al. British Journal of Cancer (2020) 123:525 –
Slide 20: Our Stenoparib-DRP Identifies Responsive Patients
20 Allarity Therapeutics Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Our Stenoparib - DRP ® Identifies Responsive Patients Results of Phase I Trial Response rate below DRP ® cutoff of 50: 0% (0 of 7) Response rate without DRP: 15% (2/13) Response rate above DRP ® cuto
Slide 21: Stenoparib: Well Positioned in PARP Competitive Landscape
21 Allarity Therapeutics 1) Lars M. Wagner, “Profile of veliparib and its potential in the treatment of solid tumors.” Onco Targets Ther. 2015; 8: 1931 – 1939 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524591 2) NCT03878849 Stenoparib: Well Positioned in PARP Competitive Landscape Product Owner
Slide 22: Ixempra
22 Allarity Therapeutics • Exclusively in - licensed for EU from R - PHARM U.S. Microtubule Inhibitor, originally developed and marketed by Bristol Myers Squibb. • Approved & marketed in U.S. for the treatment of mBC: • in combination with capecitabine for the treatment of metastatic or locally adva
Slide 23: Ixempra DRP Nearly Doubles ORR in Neoadjuvant BC
23 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 24: Monetized Secondary Pipeline Programs
24 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 25: DRP Companion Diagnostics Can Support External Drug Programs
25 Allarity Therapeutics DRP® Companion Diagnostics Can Support External Drug Programs • Broad potential to partner with other oncology therapeutics developers (including Big Pharma) to develop drug - specific DRP ® companion Dx for their pipeline programs. • DRP ® companion Dx can be developed and
Slide 26: Evaluating Multiple Commercial Opportunities
26 Allarity Therapeutics Evaluating Multiple Commercial Opportunities Potential Regional Oncology Commercialization Partners Have Been Identified • Commercialization strategy: enter into marketing partnerships with leading regional oncology therapeutics companies to achieve optimal market penetratio
Slide 27: Pipeline Development 2022-2025
27 August 2022 Allarity Therapeutics – Confidential 27 Pipeline Development 2022 - 2025 Indication 2022 2023 2024 2025 H1 H2 H1 H2 H1 H2 H1 H2 Pediatric Osteosarcoma: Monotherapy (w/ OncoHeroes ) Combo Rx Study #2: TBD Potentially with PD - 1 inhibitor Ovarian Cancer (2 nd line or later): Combo Rx s
Slide 28: Leadership, I.P., & Strategic Milestones
Leadership, I.P., & Strategic Milestones
Slide 29: Our Senior Leadership Team
29 Thomas Jensen SVP of Investor Relations, Co - Founder Allarity Therapeutics Our Senior Leadership Team Marie Foegh, MD Chief Medical Officer Steen Knudsen, Ph.D Chief Scientific Officer, Co - Founder James G. Cullem, J.D. Chief Executive Officer (Interim since June 2022) Joan Y. Brown, CPA Chief
Slide 30: Our Scientific Advisory Board
30 Mansoor Raza Mirza, MD Allarity Therapeutics Our Scientific Advisory Board Ursula A. Matulonis, MD Roberto Pili, MD Dan von Hoff, JD Joyce A. O’Shaughnessy, MD Physician in Chief, Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona. Virginia G. Pipe
Slide 31: Our Board of Directors
31 Allarity Therapeutics Our Board of Directors Duncan Moore Chairman Partner in East West Capital Partners, Chairman of Lamellar Biomedical, Director at Braidlock Ltd, and Chair of the Advisory Board of the Scottish Life Sciences Assoc. GAIL J. MADERIS Non - Executive Director CEO of Antiva Bioscie
Slide 32: Strong & Expanding Intellectual Property Portfolio
32 Allarity Therapeutics • 16 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 appl
Slide 33: Upcoming Milestones to Deliver Significant Value Creation
33 H2 2022 – H1 2024 Allarity Therapeutics Upcoming Milestones to Deliver Significant Value Creation Delivering significant value over the next 15 - 20 months through multiple value - creating inflection points Dovitinib - Initiate 1 st combo Rx study (with Stenoparib) for OC in Q4 2022. - Anticipat
Slide 34: Key Investment Highlights
34 Allarity Therapeutics Advanced oncology pipeline with multiple mid - to - late clinical - stage drug candidates and opportunities for external partnering. Industry leading DRP ® companion Dx technology platform validated across more clinical trials than any other competitor. Key value inflection
Slide 35: James G. Cullem, Chief Executive Officer
James G. Cullem Chief Executive Officer +1 ( 978) 500 - 0863 jcullem@allarity.com allarity.com
Slide 36: FAQs About Our DRP Platform Technology
36 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 is
Slide 37: FAQs About Our DRP Platform Technology
37 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 38: DRP Platform: Clinical Validations, 32 Drugs/Combos
38 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 39: Publications of Clinical/Method Validation for Drug-Specific DRPs
39 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
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