Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Ladenburg Healthcare Conference September 2022
23 slides from Allarity Therapeutics's conference presentation, Sep 26, 2022
Slide 1: Personalized Cancer Care Realized
Copyright © 2022 Allarity Therapeutics. All rights reserved. N a s da q : ALLR Personalized Cancer Care Realized James G. Cullem, CEO Ladenburg Healthcare Conference September 2022
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: 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 DRP ® companion diagnostics platform to achieve true, personalized cancer care. Robust pipeline of 3 clinical - stage cancer therapeutics (
Slide 4: Our Pipeline – Making Good Drugs Better with DRP
Our Pipeline – Making Good Drugs Better with DRP ® PHASE 1/1b PHASE 2 PHASE 3 NDA STATUS/ PARTNER Dovitinib Pan - tyrosine kinase inhibitor Combination Rx with Stenoparib – 2 nd + line Ovarian Cancer Stenoparib P A R P and tan k y r a s e inhibitor 3 nd line Ovarian Cancer Microtubule inhibitor 2 nd
Slide 5: 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 Go al Pe r s ona li z e d Medicine Low Average Patient Benefit High Average Patient Benefit Classical Drug Development Treat all of the patients Allarity Therapeutics 5 A ll a r i ty
Slide 6: How We Approach the Complexity of Cancer
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 targets or pathways. The Tumor Tells us What is Important Input is generated by taking drug te
Slide 7: 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 W EAK Patients’ biopsy samples PATIENTS’ TUMORS Step 1 Step 2 Step 3 W EAK MODERATE STRONG Identify patients with high DRP ® score for a given d
Slide 8: DRP Platform: Extensively Studied in Clinical Trials
DRP ® Platform: Extensively Studied 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 9: Dovitinib overview
• 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 Phase 2 studies spanning 4 a
Slide 10: 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 (36%). If samples are macrodissected to remove necrosis the median increases to 24.2 mo in the Dovitinib - DRP positive arm. Our Validated Dovitinib - DRP ® Identifies Responsive Patients Kaplan -
Slide 11: Dovitinib: Combination Therapy Opportunity with Stenoparib
1. PARP = Poly ADP - Ribose Polymerase, a critical cellular enzyme for repair of certain type of DNA strand breaks; Data comes from eValuatePharma Dovitinib: Combination Therapy Opportunity with Stenoparib (PARPi) Potential Synergistic Therapeutic Benefit of Dovitinib + Stenoparib in 2 nd line or la
Slide 12: Dovitinib: Potential Combination Therapy with Immune Checkpoint Inhibitors
1. SVB Leerink analyst Daina Graybosch (FiercePharma) 2. NCT02811861 and NCT03517449 Dovitinib: Potential Combination Therapy with Immune Checkpoint Inhibitors ( e.g. PD - 1i) Pre - clinical Evidence and Clinical Rationale for Combination of Dovitinib + Pembrolizumab. Potential Initiation of Phase 1
Slide 13: Stenoparib: A Dual PARP and Tankyrase Inhibitor
• Global PARP market projected to reach $9 Billion by 2027 for use in ovarian cancer 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 3.
Slide 14: Our Stenoparib-DRP Identifies Responsive Patients
Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Our Stenoparib - DRP ® Identifies Responsive Patients R es pon s e r a te below DRP ® cutoff of 50: 0% (0 of 7) R es pon s e r a te above DRP ® cutoff of 50: 33% (2 of 6) Response rate without DRP: 15% (2/13) All 8 histologi
Slide 15: Stenoparib: Well Positioned in PARP Competitive Landscape
Stenoparib: Well Positioned in PARP Competitive Landscape Product Owner Stage R esponse b i o m a r ker Export Resistance (PgP mediated) Absence of M y e l o t ox i c i t y (Myelotox) Multi - targeted (PARP/ Tankyrase) PARP trapping BBB penetration Strong m a i n t enance opportunity Olaparib Approv
Slide 16: IXEMPRA overview
• 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 advanced breast cancer in pat
Slide 17: IXEMPRA DRP Nearly Doubles ORR in Neoadjuvant BC
IXEMPRA ® Arm 1) Perez et al (2007) in mBC patients resistant to anthracycline, taxane, and capecitabine IXEMPRA ® DRP ® Nearly Doubles ORR in Neoadjuvant BC Ixempra ® DRP ® selected patients ORR 20% (CBR* 41%) 0% 2 0 % 4 0 % 6 0 % Resistant to anthracycline, taxane and capecitabine Resistant to tax
Slide 18: Pipeline Development 2022-2025
A ugu s t 2022 Allarity Therapeutics – Confidential 1188 Pipeline Development 2022 - 2025 Indication 2022 2023 2024 2025 H1 H2 H1 H2 H1 H2 H1 H2 Dovitinib I nt e r i m Dat a I nt e r i m Data P e d ia tr i c Ost eo s a r co m a : M o n o the rap y ( w / O nco H e r oe s ) P1b Phase 2 I nt e r i m Da
Slide 19: Our Senior Leadership Team
Tho ma s Je n se n SVP of Investor Relations, Co - Founder 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) J o a n Y . B r o w n , C P A Chief Financial
Slide 20: 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 21: Our Board of Directors
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 Biosciences, Inc., and a Board m
Slide 22: Upcoming Milestones to Deliver Significant Value Creation
H2 2022 – H1 2024 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. - Anticipated Phase 1b data readout
Slide 23: 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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