EX-99.2 3 ea166296ex99-2_allarity.htm UPDATE TO COMPANY OVERVIEW PRESENTATION

Exhibit 99.2

 

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

 

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 assumptions, stated or otherwise, and forward - looking statements discussed below. No representation is made as to the reasonableness of the assumptions made within or the accuracy or completeness of any forward - looking statements, modeling or any other information contained herein. Allarity Therapeutics, Inc. (collectively “Allarity Therapeutics,” “Allarity,” or the “Company”) assume no obligation to update the information in this presentation. This material is not for the benefit of, and does not convey any rights or remedies for the benefit of, any holder of securities or any other person. This material is not intended to provide the basis for evaluation of any transaction and does not purport to contain all information that may be required and should not be considered a recommendation or opinion of any kind with respect to any transaction. No Offer or Solicitation. This material shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Forward - Looking Statements. This presentation contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward - looking statements provide Allarity’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward - looking statements, but the absence of these words does not mean that a statement is not forward - looking. These forward - looking statements include, but are not limited to, statements relating to estimated time periods for interim data read outs for our ongoing and prospective clinical trials and value inflection points, any resubmission of the NDA for dovitinib and PMA for the drug - specific DRP ® companion diagnostic for dovitinib, and ongoing clinical trials for stenoparib and IXEMPRA ® . Any forward - looking statements in this presentation are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward - looking statements. These risks and uncertainties include, but are not limited to, the risk that that the Company is unable to raise sufficient capital to fund its ongoing and prospective clinical trials and operations, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for dovitinib, the drug - specific DRP ® companion diagnostic for dovitinib, or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the risk that the current COVID - 19 pandemic will impact the Company’s current and future clinical trials and the timing of the Company’s preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward - looking statements, see the section entitled “Risk Factors” in our annual report on Form 10 - K on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www . sec . gov , and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission . All information in this presentation is as of the date of the presentation , and the Company undertakes no duty to update this information unless required by law . Any financial projections in this presentation are forward - looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of which are beyond Allarity’s control. While all projections are necessarily speculative, Allarity believes that the preparation of prospective financial information involves increasingly higher levels of uncertainty the further out the projection extends from the date of preparation. The assumptions and estimates underlying the projected results are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the projections. The inclusion of projections in this communication should not be regarded as an indication that Allarity or their representatives, considered or consider the projections to be a reliable prediction of future events.

 

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 (acquired from big pharma) that address significant oncology markets Pursuing combination therapy programs to drive therapeutic success and value Drug Response Predictor (DRP ® ) platform creates drug - specific, companion diagnostics to select and treat likely responder patients Developed and clinically validated over 15 years U.S. Nasdaq listed (December 2021) Anchored by a $20M institutional investment (U.S.) Allarity Therapeutics 3

 

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 line Metastatic Breast Cancer US Approved and out - licensed to Allarity in EU 2X - 111 Doxorubicin in GSH - linked liposome enabling BBB penetration P r i m a r y B r a i n C ancer (Glioblastoma) Each program will be advanced with a drug - specific DRP ® companion diagnostic to select and treat patients most likely to benefit from treatment. Primary Pipeline Allarity Therapeutics 4 Se c onda ry P i pe li ne

 

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 Approach Treat only patients sensitive to therapy

 

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 testing data from cancer cell lines. Our DRP ® engine then applies the system biology analysis as a “filter” of human tumor biopsy data, to yield a 50 to 400 gene DRP ® signature for that specific drug. Graph of all 680 non - redundant proteins Allarity Therapeutics 6

 

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 drug DRP + Allarity Therapeutics 7

 

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) CLINICAL TRIALS – PHASE 2/3 Allarity Therapeutics 8 Dovitinib F u l v e s tr ant Belinostat 5 - FU RCC – metastatic AML Breast Breast – Metastatic Lung Lung – NSCLC Ovarian Renal 2 - 5 fold increase in ORR or TTP between predicted sensitive and predicted resistant Epirubicin Exemestane Breast – Neoadjuvant Colon Solid Tumors Phase 2 study (n=37) completed – late - stage metastatic BC Phase 2 study (n=30) underway – 3 rd line ovarian cancer Phase 2 study (n=60) underway – 2 nd line metastatic BC

 

• 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 additional cancers: gastrointestinal stromal tumors (GIST) 3 , liver (HCC) 4 , breast 5 , endometrial 6 • Potential tumor vascular normalization that can potentiate delivery and benefit of other anti - cancer agents. • DRP ® cDx evaluated in 5 different cancers including RCC, GIST, liver, metastatic breast, and endometrial. • GMP drug manufacturing contract in place with LONZA. • Development strategy potentially similar to Lenvatinib (Lenvima®) by expanding approved mono - therapy indications as well as combo therapy, such as approvals with immune checkpoint inhibitors ( e.g. PD - 1 inhibitors). 1) Source: reported sales (2019A) and eValuatePharma (2026E) 2. NCT01223027 3. NCT01478373 4. NCT01232296 5. NCT01528345 and NCT00958971 6. NCT01379534 Dovitinib: A Pan - Tyrosine Kinase Inhibitor (TKI) 0 10 20 30 40 50 60 U S$ Bn 70 2019A Breast cancer Liver cancer Endometrial cancer 2026E Renal Cell Carcinoma GIST Annual sales 1 in 5 large indications where Dovitinib has shown clinical activity Dovitinib - DRP ® Validated in 3rd line mRCC; Broad Combination Therapy Potential Allarity Therapeutics 9

 

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 - Meier Plot – Overall Survival – Entire arms Dovitinib - DRP ® (58 mRNAs) Identified Patients with Overall Survival (OS) Benefit in Novartis Phase 3 in 3 rd line RCC 1 DRP selects survivors in dovitinib arm but not in sorafenib arm HR = 0.96 (95%CI 0.75 - 1.22) • Dovitinib - DRP ® positive: • median 15.0 mo. OS (95%CI 12.9 - 26.3) • Dovitinib - DRP ® negative: • median 9.1 mo. OS (95% CI 7.6 - 13,2) • Hazard Ratio: • 0.60 (95% CI 0.39 - 0.91) • Dovitinib - DRP ® does not select Sorafenib responders Allarity Therapeutics 10

 

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 later Ovarian Cancer Initiation of Phase 1b Dosing Study Anticipated by Early Q4 2022 • Treatment setting = 2 nd line or later therapy in ovarian cancer (OC). • Prior clinical trials have shown promising synergy between PARPi and TKIs . • Stenoparib (a unique dual PARPi and Tankyrase inhibitor) has shown promising monotherapy activity against OC and pancreatic cancer in prior Phase 1 clinical trial. • Validated Stenoparib - DRP ® and Dovitinib - DRP ® cDx’s will be used to select likely responder patients. • Global PARP market projected to reach $9 Billion by 2027 for use in ovarian cancer. • DRP ® on label as mandatory companion Dx allows for drug pricing premium . • Potential to expand combination of Dovitinib + Stenoparib to pancreatic cancer, among other indications. Annual sales 1 (US$m) in indications targeted by Stenoparib with DRP ® 0 2, 0 00 4, 0 00 6, 0 00 8, 0 00 1 0 ,000 1 2 ,000 2 0 19A 2 0 26E O v ar i an c a n c er Pancreatic cancer 2. Under Eisai, stenoparib (2X - 121) was formally known as E7449 Allarity Therapeutics 11

 

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 1b/2 Study of this Combination in mRCC Setting in mid - 2023. • Treatment setting = metastatic RCC following failure of prior treatment. • Current standard of care is TKI or TKI plus Immune Checkpoint inhibitor. • Pembrolizumab peak sales projections in adjuvant RCC = ~$1.2 billion. 1 • Mouse models (unpublished) have shown combo Rx benefit of Dovitinib and anti - PD - 1 . • Pembrolizumab has shown clinical synergy with other TKIs like Lenvatinib (LENVIMA ® ). 2 • V a lid a t e d D o v itinib - DR P ® c D x de v e l ope d f o r m e t a s t a t i c RC C w il l b e u s e d to s e l e c t t ho s e patients most likely to benefit from the combination of Dovitinib and Pembrolizumab. • DRP ® on label as mandatory companion Dx allows for drug pricing premium . Allarity Therapeutics 12

 

• Global PARP market projected to reach $9 Billion by 2027 for use in ovarian cancer 1. PARP = Poly ADP - Ribose Polymerase, a critical cellular enzyme for repair of certain type of DNA strand breaks; Data comes from eValuatePharma 2. Under Eisai, stenoparib (2X - 121) was formally known as E7449 3. Plummer et al. British Journal of Cancer (2020) 123:525 – 533 4. NCT03878849 Stenoparib: A Dual PARP and Tankyrase Inhibitor Annual sales 1 (US$m) in indications targeted by Stenoparib with DRP ® 0 2, 0 00 4, 0 00 6, 0 00 8, 0 00 1 0 ,000 1 2 ,000 2 0 19A 2 0 26E O v ar i an c a n c er Pancreatic cancer • Exclusively in - licensed from Eisai . First - in - class small molecule targeted inhibitor of DNA damage repair enzymes (PARP) with dual Tankyrase inhibitor activity (Wnt signaling). • Stenoparib has shown promising monotherapy activity against OC and pancreatic cancer in prior Phase 1 clinical trial. • Validated Stenoparib - DRP ® cDx showed ability to identify patients that benefited in Phase I study. 3 • Ongoing Phase 2 monotherapy study in OC 4 – started at Dana - Farber Cancer Institute (U . S . ) . Ongoing opening of new sites in U . S . and EU in 2022 to accelerate enrollment . 20.7% CAGR Ongoing Phase 2 Monotherapy Study in 2 nd Line OC with Anticipated Interim Data Readout Late Q4 2022 Allarity Therapeutics 13

 

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 histologies Stenoparib DRP ® (414 mRNAs) Predicts Drug Response in Biopsies from the Eisai Phase 1 trial Results of Phase I Trial Allarity Therapeutics 14

 

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 Approved BRCA غ غ غ ض غ ض Niraparib Approved BRCA/HRD غ غ غ ض غ ض Veliparib Phase 3 BRCA غ غ غ غ غ غ Rucaparib Approved BRCA غ غ ض ض غ ض Talazoparib Approved BRCA ض غ غ ض غ ض Stenoparib Phase 2 2 DRP ® ض ض ض ض ض ض “… the identification of reliable biomarkers will be critical for the success of this targeted agent” 1 Allarity PARP inhibitor (Stenoparib) with exclusive DRP ® : a novel, multi - targeted drug (Tankyrase and PARP inhibition) with improved efficacy, low myelotoxicity, and less drug resistance resulting in improved patient outcomes Value Proposition 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 Allarity Therapeutics 15

 

• 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 patients after failure of an anthracycline and a taxane. • as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline, a taxane, and capecitabine. • Ongoing Phase 2 , DRP ® - guided monotherapy trial 1 in EU for treatment of mBC as monotherapy per the U . S . label ; Ongoing expansion of trial sites to accelerate enrollment . • R - PHARM providing free drug supply to support Phase 2 trial. • R - PHARM has first buy - back option following Phase 2 completion at FMV. • Pre - agreed license terms for Allarity in event R - PHARM does not re - acquire program. IXEMPRA ® (Ixabepilone): A Microtubule Inhibitor IXEMPRA® Approved in U.S. for 2 nd Line Metastatic BC; Phase 2 Monotherapy Trial for mBC Ongoing in EU; Interim Data Readout Anticipated End of Q1 2023 Ixempra ® in the U.S. 4.1 5.7 Capecitabine Ixempra + Capecitabine Sales reached U S $ 1 17m Progression Free Survival (months) 1) NCT04796324 Allarity Therapeutics 16

 

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 taxane No previous taxane therapy Estimated ORR in DRP+ patients With previous adjuvant anthracycline therapy Ixempra ® unselected pati ORR 11 ents .5 1 - 12% 2 N=138, p=0.0004 Validated IXEMPRA ® DRP ® (190 mRNAs) more Accurately Predicts Response to this Drug Based upon Published Biopsy Data from a Trial of Ixabepilone in Neoadjuvant BC * CBR refers to Clinical Benefit Rate (CR+PR+SD>6months) 2) Thomas et al (2007) in mBC patients resistant to taxanes Allarity Therapeutics 17

 

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 Dat a I nt e r i m Data C o mbo R x S t u dy #2 : T B D P o tenti a lly w i th P D - 1 inhibit o r Dosing (N=30) Phase 2 (N=100+) I nt e r i m Dat a I nt e r i m Data Ov a r ia n C ance r ( 2 n d l in e o r l a t e r): C o mbo Rx s tudy with Sten o par ib Phase 1b (N=<36) Phase 2 (N=100+) Stenoparib Ov a r ia n C ance r: M o n o th e rap y Data I nt e r i m I D n a t e t a r i m D ata P2 P e d ia tr i c In d ica t io n T B D M o n o the rap y ( w / O nco H e r oe s) P1b P2 I nt e r i m Data Ixempra M e t a st a t i c B r ea st C ancer Monotherapy P2 I n te r i m D a ta

 

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 Officer (Interim since June 2022) Allarity Therapeutics 19

 

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 Advisory Board Ursula A. Matulonis, MD Chief and Director of the Division of Gynecologic Oncology at DFCI. Professor of Medicine at Harvard Medical School. First recipient of Brock - Wilson Family Chair at DFCI. Roberto Pili, MD Roberto Pili, MD, is associate dean for cancer research and integrative oncology and professor and chief of the Division of Hematology/Oncology in the Department of Medicine. He is also the founder of the UB Cancer Research Consortium. Dan von Hoff, JD 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. Chief Scientific Officer for US Oncology Research Joyce A. O’Shaughnessy, MD Co - Chair of Breast Cancer Research and Chair of Breast Cancer Prevention Research at Baylor - Sammons Cancer Center and for The US Oncology Network. Allarity Therapeutics 20

 

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 member at Valitor, Inc., and the U.C. Berkeley Foundation Board of Trustees. Previous CEO of Five Prime Therapeutics, Inc. David A. Roth Non - Executive Director CMO of Syros Pharmaceuticals, Inc. Prior CMO of Infinity Pharmaceuticals, Inc., and SVP, Clinical Development & Medical Affairs, at Infinity Pharmaceuticals. Søren Gade Jensen Non - Executive Director Søren is currently Member of the European Parliament. Previously, he served as Minister of Defense of Denmark, and as member of the Danish parliament. James G. Cullem CEO, Executive Director CEO of Allarity Therapeutics. (interim). Prior roles include CBO, and SVP of Corporate Development in Allarity Therapeutics Inc., and its predecessor. Thomas Jensen SVP, Executive Director SVP, Investor Relations of Allarity Therapeutics. Prior roles at Allarity include SVP, Information Technology and CTO in both Allarity Therapeutics, and its predecessor. Allarity Therapeutics 21

 

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 H2 2023. - Initiate pediatric study in osteosarcoma by end of 2022 - Initiate 2 nd combo Rx study by H2 2023. Stenoparib - Initiate 1 st combo Rx study (with Dovitinib) for OC in Q4 2022. - Anticipated interim Phase 2 data readout in ongoing OC monotherapy study end of 2022. - Evaluate additional combo Rx study opportunities in 2023. IXEMPRA ® Allarity Therapeutics 22 - Anticipated interim Phase 2 mBC data readout in Q2 2023. - Potential program exit to strategic partner in H2 2023.

 

James G. Cullem Chief Executive Officer +1 (978) 500 - 0863 jcullem@allarity.com allarity.com