Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Investor Presentation (November 2023)
42 slides from Allarity Therapeutics's investor presentation, Nov 13, 2023
Slide 1: Personalized Cancer Care. Realized.
Copyright © 2023 Allarity Therapeutics. All rights reserved. Nasdaq: ALLR Personalized Cancer Care. Realized. James G. Cullem, CEO H2 2023
Slide 2: Legal Statement
Legal Statement 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, and may rely upon
Slide 3: Revitalizing Former Big Pharma Therapeutics with Our DRP CDx Companion Diagnostics
Revitalizing Former Big Pharma Therapeutics with Our DRP ® CDx Companion Diagnostics Low Average Patient Benefit High Average Patient Benefit Classical Drug Development Treat all of the patients Allarity Approach Treat only patients sensitive to therapy RIGHTS INDICATION PHASE 3 PHASE 2 PHASE 1/1b G
Slide 4: Stenoparib: Lead Pipeline Program Phase 2 Monotherapy in Ovarian Cancer
Stenoparib: Lead Pipeline Program Phase 2 Monotherapy in Ovarian Cancer
Slide 5: Stenoparib: first-in-class PARP and Tankyrase inhibitor
5 0 5 10 15 20 25 2023 2028 $Bn • First - in - class small molecule targeted inhibitor of DNA damage repair enzymes (PARP) with dual Tankyrase inhibitor activity: • Tankyrases are involved in telomerase maintenance during tumor cell division and are active in the Wnt signaling pathway in tumor cells
Slide 6: Stenoparib: Potentially Best-in-Class in the PARPi Landscape
6 Allarity Therapeutics Corporate Overview Stenoparib: Potentially Best - in - Class in the PARPi Landscape “… the identification of reliable biomarkers will be critical for the success of this targeted agent” 1 Strong maintenance opportunity BBB penetration PARP trapping Multi - targeted (PARP/ Tan
Slide 7: Withdrawals of Indications for Approved PARPi's Create Opportunity
Withdrawals of Indications for Approved PARPi’s Create Opportunity • Manufacturers of the following PARP inhibitors have voluntarily withdrawn indications for heavily pretreated patients with BRCA - mutated advanced ovarian cancer due to safety concerns: • As a result of clinical trials evaluating n
Slide 8: Stenoparib-DRP CDx Identifies Responsive Patients
Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Stenoparib - DRP ® CDx Identifies Responsive Patients Response rate below DRP ® cutoff of 50: 0% (0 of 7) Response rate above DRP ® cutoff of 50: 33% (2 of 6) Response rate without DRP: 15% (2/13) All 8 histologies Stenopari
Slide 9: Stenoparib: Phase 2 Monotherapy Study in 2nd Line OC
Stenoparib: Phase 2 Monotherapy Study in 2 nd Line OC • Ongoing Phase 2 monotherapy study in advanced ovarian cancer (OC). • Patients with predicted high likelihood of responding to stenoparib using DRP ® CDx included in the study . • Open label, multicenter, single arm study evaluating stenoparib a
Slide 10: Stenoparib: Phase 1b Combination Study with Dovitinib in Solid Tumors
Stenoparib: Lead Pipeline Program Phase 1b Combination Study with Dovitinib in Solid Tumors
Slide 11: Dovitinib: Pan-Tyrosine Kinase Inhibitor
• Pan - Tyrosine Kinase Inhibitor (TKI), small molecule, targeted inhibitor of FGFR, VEGFR, and other RTKs . Unique, inhibitory profile. • Clinical activity demonstrated in monotherapy Phase 3 Renal Cell Carcinoma (mRCC) trial 2 , and in Phase 2 studies for gastrointestinal stromal tumors (GIST) 3 ,
Slide 12: Rationale for Stenoparib + Dovitinib Combination in Ovarian Cancer
mechanisms: 1. Liu JF et al (2022). Olaparib With or Without Cediranib Versus Platinum - Based Chemotherapy in Recurrent Platinum - Sensitive Ovarian Cancer (NRG - GY004): A Randomized, Open - Label, Phase III Trial. J Clin Oncol. 2022 2. Mirza MR et al (2019) Niraparib plus bevacizumab versus nirap
Slide 13: Stenoparib: Phase 1b Combo Study with Dovitinib in Solid Tumors
Stenoparib: Phase 1b Combo Study with Dovitinib in Solid Tumors Ongoing Phase 1b Combination Study: Potential Synergistic Benefit of Dovitinib + Stenoparib in Solid Tumors; Data Readout Anticipated in Q2 2024 Allarity Therapeutics 13 • Ongoing Phase 1b combination therapy study in advanced solid tum
Slide 14: Dovitinib-DRP CDx Identifies Dovitinib-Responsive Patients
1. NCT01223027; 49 out of 135 patients that consented to give biopsy that passed QC were DRP ® positive (36%). If samples are macrodissected to remove necrosis the median increases to 24.2 mo in the Dovitinib - DRP positive arm. Dovitinib - DRP ® CDx Identifies Dovitinib - Responsive Patients Doviti
Slide 15: Pediatric Clinical Development Collaboration with OncoHeroes
Pediatric Clinical Development Collaboration with OncoHeroes Phase 1 Trial Start for Dovitinib in Pediatric Osteosarcoma anticipated Q3 2024 Allarity Therapeutics 15
Slide 16: Allarity Therapeutics Corporate Overview
16 Allarity Therapeutics Corporate Overview H2 2021
Slide 17: Dovitinib: Potential Combo Study with Immune Checkpoint Inhibitor
Dovitinib: Potential Combo Study with Immune Checkpoint Inhibitor Strong Pre - clinical Evidence and Clinical Rationale for Combination of Dovitinib + a PD - 1 Inhibitor. Potential Phase 1b/2 Combination Study in Solid Tumor(s) in H1 2024. • Treatment setting = front - line to 3 rd line treatment in
Slide 18: Dovitinib in Endometrial Cancer
45 40 35 30 25 20 15 10 5 0 2023 2028 $Billion • There are over 400,000 new cases of Endometrial cancer (EC) annually. Incidence and mortality are increasing. • Immune checkpoint inhibitors have moved to front - line setting in EC, leaving only chemotherapy ( e.g., paclitaxel and carboplatin) for se
Slide 19: IXEMPRA Program Phase 2 Study in Metastatic Breast Cancer
IXEMPRA ® Program Phase 2 Study in Metastatic Breast Cancer
Slide 20: IXEMPRA (Ixabepilone): An Approved Microtubule Inhibitor
• I XEMPRA ® is a small molecule targeted inhibitor of microtubules ; interferes with tumor cell division. • Approved & marketed in U.S. for the treatment of mBC : • In combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients after failure of an ant
Slide 21: Phase 2 Monotherapy Study in Metastatic Breast Cancer
Phase 2 Monotherapy Study in Metastatic Breast Cancer • Ongoing Phase 2 monotherapy study in metastatic breast cancer (mBC) • Patients with predicted high likelihood of responding using the IXEMPRA ® - DRP ® CDx included in the study. • Study is open label, multicenter, single arm study. Evaluates I
Slide 22: IXEMPRA-DRP CDx Identifies Responsive Patients
IXEMPRA ® Arm 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 ® CDx Identifies Responsive Patients Ixempra ® DRP ® selected patients ORR 20% (CBR* 41% 0% 20% 40% 60% Resistant to an
Slide 23: IXEMPRA Early Clinical Results (Phase 2)
IXEMPRA ® Early Clinical Results (Phase 2) Potential to Substantially Improve Drug Benefit/Risk Ratio to Support Registration in Europe 36 mBC patients screened with DRP ® CDx (under prior higher cut - off score) and 5 treated with IXEMPRA ® : Observed in first 4 evaluable patients *: • Patient #1 p
Slide 24: Our DRP Companion Diagnostics Platform
Our DRP ® Companion Diagnostics Platform
Slide 25: DRP is Superior to Conventional Biomarker Technology
DRP ® is Superior to 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 Analysis Focus on drug wi
Slide 26: The DRP Platform Addresses the Complexity of Cancer
The DRP ® P latform Addresses the Complexity of Cancer Cancer is Very 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 targets or pathways. The Tumor Tells us What is Important Input is generate
Slide 27: DRP CDx: Predicting a Cancer Patient's Drug Response
Compare patients’ tumor gene expression to DRP ® signature PATIENTS’ TUMORS DRP ® CDx: Predicting a Cancer Patient’s Drug Response STRONG WEAK Patients’ biopsy samples PATIENTS’ TUMORS Step 1 Step 2 Step 3 WEAK MODERATE STRONG Identify patients with high DRP ® score for a given drug DRP + Allarity T
Slide 28: DRP Platform: Extensively Proven in Clinical Trials
DRP ® Platform: Extensively Proven 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) C
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Slide 30: DRP CDx can Support External Drug Development Programs
DRP ® CDx can Support External Drug Development 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 used to support : • Phase 1/1b
Slide 31: Monetizing Deprioritized Assets Through External Partnerships
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Slide 32: Our Leadership & SAB
eallarity THERAPEUTICS © Our Leadership & SAB
Slide 33: Our Senior Leadership Team
Thomas Jensen SVP of Investor Relations, Co - Founder Our Senior Leadership Team 0DULH )RHJK 0' &KLHI 0HGLFDO 2IILFHU Steen Knudsen, Ph.D. Chief Scientific Officer, Co - Founder James G. Cullem, J.D. Chief Executive Officer Joan Y. Brown, CPA Chief Financial Officer Allarity Therapeutics 33
Slide 34: Our Scientific Advisory Board
Mansoor Raza Mirza, MD Chief Oncologist at the Dept. of Oncology, Rigshospitalet, Cph. University Hospital, Denmark, and Medical Director of the Nordic Society of Gynecologic Oncology - Clinical Trial Unit. He is also Vice - Chairman of the Danish Society of Gynecologic Oncology. Our Scientific Advi
Slide 35: Our Board of Directors
Our Board of Directors Jerry McLaughlin Chairman CEO of Life Biosciences, Inc. Prior CEO and Board Member of Neos Therapeutics as well as previous CEO, President and Board Member of AgeneBio, Inc. -RVHSK 9D]]DQR 1RQ ([HFXWLYH 'LUHFWRU &)2 RI$EHRQD 7KHUDSHXWLFV ,QF 3UHYLRXV &)2 DW
Slide 36: I.P. & Strategic Milestones
allarity THERAPEUTICS © I.P. & Strategic Milestones
Slide 37: Broad Intellectual Property Coverage
Broad Intellectual Property Coverage Allarity Therapeutics 37 DRP ® CDx Formulations Methods of Use &RPSRVLWLRQ RI 0DWWHU ض ض ض ض Stenoparib ض ض ض Dovitinib ض IXEMPRA ® ض ض ض ض Novel Combinations • In addition to patent coverage, regulatory market exclusivity is available for these programs by ha
Slide 38: Pipeline Development 2023-2025
Pediatric Osteosarcoma: Mono - therapy (with OncoHeroes ) Combo Rx Study #2: TBD with immune checkpoint inhibitor (subject to additional funding) Pipeline Development 2023 - 2025 Metastatic Breast Cancer: Mono - therapy Dovitinib Ixempra Phase 2 (N=100) P ha s I n e t e r 1 i m b D a ( t a N = 30) P
Slide 39: Upcoming Milestones to Deliver Significant Value Creation
H2 2023 – H1 2025 Ongoing Prospective Clinical Validation of DRP ® CDx Upcoming Milestones to Deliver Significant Value Creation Potential catalytic events over the next 12 - 18 months at multiple value - creating inflection points STENOPARIB + DOVITINIB PHASE 1b DATA - Anticipated Phase 1b data rea
Slide 40: Comparable Public Equities
40 Comparable Public Equities $650M $120M $2M $44M $37M Alla rity Kura Oncology Acrivon The rapeutics Syros Pharma Lantern Pharma Phase 2 Phase 3 Phase 3 Phase 2 Phase 3 Most advanced stage 3 2 3 1 2 Number of assets in clinic 13 0 1 0 2 Peer Review Clinical validation publications Unlocking the Val
Slide 41: Key Investment Highlights
41 Allarity Therapeutics Multiple de - risked, former Big Pharma oncology assets in mid - clinical - stage pipeline with high development potential and opportunities for external partnering and/or program divestitures. Multiple value - driving inflection points within 12 - 18 months. Interim data re
Slide 42: James G. Cullem, Chief Executive Officer
James G. Cullem Chief Executive Officer +1 (978) 500 - 0863 jcullem@allarity.com allarity.com
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