Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Merger or Acquisition (October 2021)
37 slides from Allarity Therapeutics's merger presentation, Oct 8, 2021
Slide 1: Personalized Cancer Care. Realized.
Copyright © 2021 Allarity Therapeutics. All rights reserved. NASDAQ FIRST NORTH (Stockholm): ALLR Personalized Cancer Care. Realized. Steve R. Carchedi, CEO H2 2021 Filed by Allarity Therapeutics, Inc. Pursuant to Rule 425 under the Securities Act of 1933, Subject Company: Allarity Therapeutics A/S.
Slide 2: Legal Statement
2 Allarity Therapeutics Legal Statement About this Presentation 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 s
Slide 3: Legal Statement (cont.)
3 Allarity Therapeutics Legal Statement (cont.) Forward - Looking Statements This document contains certain forward - looking statements within the meaning of the federal securities laws with respect to the proposed transaction between Allarity Therapeutics, Inc. (“Allarity US”) and Allarity Therape
Slide 4: Company Snapshot: New Therapeutics for Unmet Cancer Needs
4 Allarity Therapeutics Company Snapshot: New Therapeutics for Unmet Cancer Needs We are building an oncology - focused biopharmaceutical company using our world - class, highly validated companion diagnostics platform to develop personalized medicines. NDA submission anticipated in late Q4 2021 for
Slide 5: Our Pipeline – Making Good Drugs Better with DRP
5 Allarity Therapeutics Our Pipeline – Making Good Drugs Better with DRP ® PHASE 1/2 PHASE 2 PHASE 3 PRE - NDA STATUS/ PARTNER Dovitinib Pan - tyrosine kinase inhibitor Stenoparib * PARP and tankyrase inhibitor Microtubule inhibitor US Approved and out - licensed to Allarity in EU LiPlaCis Cisplatin
Slide 6: Advanced Pipeline and Proven DRP to Help Drive Valuation
6 Most advanced stage Phase 3 Phase 3 Phase 2 Phase 3 Phase 2 Phase 3 Number of assets in clinic 2 2 2 2 2 5 Peer Review Clinical validation publications 1 0 0 0 0 13 $1.4B $838M $584M $330M $155M $80M Kura Oncology BioXcel Therapeutics Gritstone Bio Syros Pharmaceuticals Lantern Pharma Allarity Adv
Slide 7: New and Highly Experienced Senior Leadership
7 James G. Cullem Senior Vice President, Corporate Development Allarity Therapeutics New and Highly Experienced Senior Leadership 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.
Slide 8: 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 9: Personalized Therapy Requires Predictive Diagnostics to Select Likely Responders
9 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 10: How We Approach the Complexity of Cancer
10 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
Slide 11: How We Create a Drug-Specific DRP Signature: example Dovitinib
11 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 12: DRP Companion Diagnostics: Predicting a Cancer Patient's Drug Response
12 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 13: Allarity's DRP Versus Conventional Biomarker Technology
13 Allarity Therapeutics Allarity’s DRP ® Versus 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 Targ
Slide 14: DRP Sample Collection Kits
14 DRP ® Sample Collection Kits
Slide 15: DRP Platform: Highly Validated in 35+ Clinical Trials
15 Allarity Therapeutics DRP ® Platform: Highly Validated in 35+ Clinical Trials Stat Measure STRONG CC>0.4 or HR<0.5 MODERATE CC<0.4 or HR>0.5 Cisplatin/LiPlaCis Fulvestrant Belinostat 5 - FU Stenoparib Epirubicin Exemestane Ixempra ® AML Breast Breast – Metastatic Breast – Neoadjuvant Colon Lung L
Slide 16: Primary Pipeline: Dovitinib, Stenoparib, IXEMPRA
Primary Pipeline Dovitinib Stenoparib IXEMPRA ®
Slide 17: Dovitinib: Pan-Tyrosine Kinase Inhibitor
17 Allarity Therapeutics • Exclusively in - licensed from Novartis. Pan - Tyrosine Kinase Inhibitor (TKI), small molecule, targeted inhibitor of FGFR, VEGFR, and other RTKs • GMP drug manufacturing contracts in place with FDA - approved vendors in US, Canada and EU • DRP ® evaluated Dovitinib in 5 d
Slide 18: Our Validated Dovitinib DRP Identifies Responsive Patients
18 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 19: Dovitinib: Initial Market Opportunity in Kidney Cancer
19 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 20: Dovitinib: Follow-On Market Opportunity in Liver Cancer
20 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 21: Dovitinib: Evaluating Multiple Commercial Opportunities
21 Allarity Therapeutics Dovitinib: Evaluating Multiple Commercial Opportunities Regional Oncology Commercialization Partners Have Been Identified • Dovitinib commercialization strategy: enter into marketing partnerships with leading regional oncology therapeutics companies to achieve optimal market
Slide 22: Stenoparib: A Dual PARP and Tankyrase Inhibitor
22 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 23: Our Validated Stenoparib DRP Identifies Responsive Patients
23 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 24: Stenoparib: Well Positioned in PARP Competitive Landscape
24 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 25: Stenoparib as a potential anti-viral against COVID-19
25 Allarity Therapeutics • 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”: P
Slide 26: IXEMPRA: Microtubule Inhibitor
26 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 27: IXEMPRA DRP Nearly Doubles ORR in Neoadjuvant BC
27 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 28: Monetizing Secondary Pipeline Programs Through Partnerships
28 Allarity Therapeutics • 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. •
Slide 29: Board, I.P., & Strategic Milestones
Board, I.P., & Strategic Milestones
Slide 30: Advisory Board: World-Class Key Opinion Leaders
30 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. Ch
Slide 31: Our Board of Directors
31 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 32: Strong & Expanding Intellectual Property Portfolio
32 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 33: Upcoming Milestones to Deliver Significant Value Creation
33 H2 2021 – H2 2022 Allarity Therapeutics 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 &
Slide 34: Key Investment Highlights
34 Allarity Therapeutics Advanced oncology pipeline with multiple 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 New Drug Application filing for lead dr
Slide 35: James G. Cullem SVP Corporate Development +1 ( 978) - 63 jcullem@allarity.com Steve R.
James G. Cullem SVP Corporate Development +1 ( 978) 500 - 0863 jcullem@allarity.com Steve R. Carchedi Chief Executive Officer +1 (908) 720 - 1786 scarchedi@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:
Allarity Therapeutics — Merger or Acquisition (October 2021) on 6ix