Allarity Therapeutics, Inc. · NASDAQ:ALLR
Allarity Therapeutics — Investor Presentation (December 2023)
45 slides from Allarity Therapeutics's investor presentation, Dec 6, 2023
Slide 1: Personalized Cancer Care. Realized.
&RS\ULJKW‹ $OODULW\7KHUDSHXWLFV$OOULJKWVUHVHUYHG 1DVGDT$//5 Personalized Cancer Care. Realized. James G. Cullem, CEO H2 2023
Slide 2: Legal Statement
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 upon
Slide 3: Revitalizing Former Big Pharma Therapeutics with Our DRP CDx
3 Allarity Therapeutics 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 $OODULW\$SSURDFK 7UHDW RQO\ SDWLHQWVVHQVLWLYHWRWKHUDS\ RIGHTS INDICATION PHASE 3
Slide 4: Stenoparib: 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 “… the identification of reliable biomarkers will be critical for the success of this targeted agent” 1 Stenoparib: Potentially Best - in - Class in the PARPi Landscape Strong maintenance opportunity BBB penetration PARP trapping Multi - targeted (PARP/ Tan
Slide 7: Withdrawals of Indications for Approved PARPis Create Opportunity
7 Allarity Therapeutics 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Indications for Approved PARPi’s Create Opportunity • Manufacturers of the following PARP inhibitors have voluntarily withdrawn indications for heavily pretreated patients with BRCA - mutated advanced ovarian cancer due to safety concerns: • As a result of clin
Slide 8: Stenoparib-DRP CDx Identifies Responsive Patients
8 Allarity Therapeutics Plummer et al, ASCO 2018, Plummer et al, Br J Cancer 123(4):525 - 533, 2020 Stenoparib - DRP ® CDx 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 ® cutof
Slide 9: Stenoparib: Phase 2 Monotherapy Study in 3rd Line OC
9 Allarity Therapeutics Stenoparib: Phase 2 Monotherapy Study in 3 rd Line OC • Ongoing Phase 2 monotherapy study of Stenoparib ( formerly 2X - 121, E7449 ) in advanced ovarian cancer (OC). • Patients with predicted high likelihood of responding to stenoparib using DRP ® CDx included in the study .
Slide 10: Stenoparib Early Clinical Results (Phase 2)
10 Allarity Therapeutics * CR unconfirmed , target lymph nodes turning normal. This patient also has CA125 CR unconfirmed Unpublished preliminary data. Not yet fully source data verified. Stenoparib Early Clinical Results (Phase 2) Change in Stenoparib Dosing from QD (600 mg) to BID (200 mg, 400 mg)
Slide 11: Stenoparib Successful Phase 2 Dose Optimization
11 Stenoparib Successful Phase 2 Dose Optimization Allarity Therapeutics Kaplan - Meier Shows Large Difference in PFS in QD and BID populations 0 50 100 150 0 . 0 0 . 2 0 . 4 0 . 6 0 . 8 1 . 0 Interim Analysis Days P r o g r e s s i o n f r e e s u r v i v a l BID (N=5) QD (N=13) All evaluable patie
Slide 12: Stenoparib Has Low Myelotoxicity
12 Stenoparib Has Low Myelotoxicity Allarity Therapeutics Stenoparib QD+BID (N=42) 1 Niraparib QD (N=463) 2 Grade 3 - 4 Grade 1 - 4 0% 2% Neutropenia 7% 21% Anemia 0% 0% Thrombocytopenia Grade 3 - 4 Grade 1 - 4 13% 20% Neutropenia 27% 51% Anemia 28% 52% Thrombocytopenia Potential Best - in - Class S
Slide 13: Stenoparib: Phase 1b Combination Study with Dovitinib in Solid Tumors
Stenoparib: Lead Pipeline Program Phase 1b Combination Study with Dovitinib in Solid Tumors
Slide 14: Dovitinib: pan-tyrosine kinase inhibitor
14 Allarity Therapeutics • 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
Slide 15: Dovitinib can turn HRP tumors into HRD tumors
15 Allarity Therapeutics • PARP inhibitors have traditionally been targeted at homologous repair deficient (HRD) tumors, including those carrying mutations in BRCA1/2. This is called synthetic lethality. • Homologous repair proficient (HRP) tumors have been excluded from PARPi treatment because of l
Slide 16: Stenoparib: Phase 1b Combo Study with Dovitinib in Solid Tumors
16 Allarity Therapeutics 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 H1 2024 * • Ongoing Phase 1b combination therapy study in advanced solid t
Slide 17: Dovitinib-DRP CDx Identifies Dovitinib-Responsive Patients
17 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. Dovitinib - DRP ® CDx Identifies Dovitinib -
Slide 18: Pediatric Clinical Development Collaboration with OncoHeroes
18 Allarity Therapeutics Pediatric Clinical Development Collaboration with OncoHeroes Phase 1 Trial Start for Dovitinib in Pediatric Osteosarcoma anticipated Q3 2024
Slide 19: Future Clinical Opportunities: Novel Combinations of Stenoparib & Dovitinib
19 Allarity Therapeutics Corporate Overview H2 2021 Future Clinical Opportunities Novel Combinations of Stenoparib&Dovitinib
Slide 20: Dovitinib: Potential Combo Study with Immune Checkpoint Inhibitor
20 Allarity Therapeutics 1. SVB Leerink analyst Daina Graybosch (FiercePharma) 2. NCT02811861 and NCT03517449 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/
Slide 21: Endometrial cancer opportunity for dovitinib
21 0 5 10 15 20 25 30 35 40 45 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
Slide 22: IXEMPRA Program Phase 2 Study in Metastatic Breast Cancer
IXEMPRA ® Program Phase 2 Study in Metastatic Breast Cancer
Slide 23: IXEMPRA (Ixabepilone): An Approved Microtubule Inhibitor
23 Allarity Therapeutics • 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 patient
Slide 24: Phase 2 Monotherapy Study in Metastatic Breast Cancer
24 Allarity Therapeutics 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, sing
Slide 25: IXEMPRA-DRP CDx Identifies Responsive Patients
25 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 ® CDx Identifies Responsive Patients p C R N o _ p C R 0 2 0 4 0 6 0 8 0 1 0 0 Ixabepilone arm
Slide 26: IXEMPRA Early Clinical Results (Phase 2)
26 IXEMPRA ® Early Clinical Results (Phase 2) Allarity Therapeutics 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 partial responder: tumor shrinkage of 66% . • Patient #2 partial resp
Slide 27: Our DRP Companion Diagnostics Platform
Our DRP ® Companion Diagnostics Platform
Slide 28: DRP is Superior to Conventional Biomarker Technology
28 Allarity Therapeutics 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
Slide 29: The DRP Platform Addresses the Complexity of Cancer
29 In vitro TRANSCRIPT -OMICS HUMAN SYSTEMS BIOLOGY In vitro Drug Response DATA Multi Gene DRP DRUG BLIND CLINICAL VALIDATION 14 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, wi
Slide 30: DRP CDx: Predicting a Cancer Patient's Drug Response
30 Compare patients’ tumor gene expression to DRP ® signature Allarity Therapeutics DRP ® CDx: 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 PATIENTS’ TUMORS DRP + PA
Slide 31: DRP Platform: Extensively Proven in 47 Clinical Trials
31 Allarity Therapeutics DRP ® Platform: Extensively Proven 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 O
Slide 32: References
32 Allarity Therapeutics ϭ͘ ŚĞŶ:͕ĞƚĂů͘ ϳϭ Ͳ ŐĞŶĞ ƐŝŐŶĂƚƵƌĞ ŽĨdZ/> ƐĞŶƐŝƚŝǀŝƚLJ ŝŶĐĂŶĐĞƌ ĐĞůůƐ ͘; KĐƚŽďĞƌ Ϯϱ ͕ ϮϬϭϭ Ϳ͖ DŽůĂŶĐĞƌ dŚĞƌ ͕ ϭϬ͘ϭϭϱϴ ͬ ϭϱϯϱ Ͳ ϳϭϲϯ ͘ Ϯ͘ tĂŶŐt͕ĞƚĂů͘ /ŶĚĞƉĞŶĚĞŶƚ ǀĂůŝĚĂƚŝŽŶ ŽĨĂŵŽĚĞů ƵƐŝŶŐ ĐĞůů ůŝŶĞ ĐŚĞŵŽƐĞŶƐŝƚŝǀŝƚLJ ƚŽ ƉƌĞĚŝĐƚ ƌĞƐƉŽŶƐĞ ƚŽ ƚŚĞƌĂƉLJ ͘ : EĂƚů ĂŶĐĞƌ /ŶƐƚ ͘ ϮϬϭϯ ^ĞƉ ϰ
Slide 33: DRP CDx can Support External Drug Development Programs
33 Allarity Therapeutics 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
Slide 34: Monetizing Deprioritized Assets Through External Partnerships
34 Allarity Therapeutics • DRP ® CDx for 5 - FU out - licensed to FivepHusion : • Clinical development partnership to support patient selection for Deflexifol Œ in unresectable metastatic colorectal cancer. Allarity eligible to receive regulatory milestone payments. • Additional prospective validati
Slide 35: Our Leadership & SAB
aeallarity ae Our Leadership & SAB
Slide 36: Our Senior Leadership Team
36 Thomas Jensen SVP of Investor Relations, Co - Founder Allarity Therapeutics Our Senior Leadership Team Marie Foegh, MD Chief Medical Officer 6WHHQ.QXGVHQ3K' &KLHI6FLHQWLILF2IILFHU &R )RXQGHU James G. Cullem, J.D. Chief Executive Officer Joan Y. Brown, CPA Chief Financial Officer
Slide 37: Our Scientific Advisory Board
37 Mansoor Raza Mirza, MD Allarity Therapeutics Our Scientific Advisory Board Ursula A. Matulonis, MD 5REHUWR3LOL0' 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. Piper D
Slide 38: Our Board of Directors
Allarity Therapeutics 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. Joseph Vazzano Non - Executive Director CFO of Abeona Therapeutics, Inc. Previous
Slide 39: I.P. & Strategic Milestones
aeallarity ae I.P. & Strategic Milestones
Slide 40: Broad Intellectual Property Coverage
40 Allarity Therapeutics Broad Intellectual Property Coverage DRP ® CDx Formulations Methods of Use Composition of Matter ✓ ✓ ✓ ✓ Stenoparib ✓ ✓ ض Dovitinib ✓ IXEMPRA ® ✓ ✓ ✓ ✓ Novel Combinations • In addition to patent coverage, regulatory market exclusivity is available for these programs by havin
Slide 41: Pipeline Development 2023-2025
41 Pediatric Osteosarcoma: Mono - therapy (with OncoHeroes ) Combo Rx Study #2: TBD with immune checkpoint inhibitor (subject to additional funding) Allarity Therapeutics 41 Pipeline Development 2023 - 2025 2025 2024 2023 2022 Indication H2 H1 H2 H1 H2 H1 H2 H1 Ovarian Cancer: Mono - therapy Ovarian
Slide 42: Upcoming Milestones to Deliver Significant Value Creation
42 H2 2023 – H1 2025 Allarity Therapeutics 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 readout of combination study in
Slide 43: Unlocking the Value of a Mid Clinical-Stage Oncology Pipeline
43 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 $650M $120M $44M $37M $2M Kura Oncology Acrivon Therapeutics Syros Pharma Lantern Pharma Allarity Unlocking the Value of a Mid Clinical - Stage
Slide 44: Key Investment Highlights
44 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 45: 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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