Xilio Therapeutics, Inc. · NASDAQ:XLO
Xilio Therapeutics — Q3 2022 Earnings Presentation
37 slides from Xilio Therapeutics's earnings presentation, Nov 9, 2022
Slide 1: Unleashing the Potential of Immuno-Oncology Therapies
1 Placeholder area for citations and references Unleashing the Potential of Immuno - Oncology Therapies November 9, 2022 © 2022 Xilio Therapeutics, Inc.
Slide 2: Forward-Looking Statements
2 Placeholder area for citations and references Forward - Looking Statements This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , as amended, including, without limitation, statements regarding plans, timing and expectat
Slide 3: Clinical-Stage Company Positioned for Multiple Anticipated Milestones Through 2023
3 Placeholder area for citations and references Xilio is a Clinical - Stage Company, Well - Positioned for Multiple Anticipated Milestones Across 3 Clinical Programs Through 2023 RP2D: recommended Phase 2 dose * Plan to evaluate XTX101 as a monotherapy for the treatment of advanced solid tumors and
Slide 4: The Promise and Pitfalls of Immuno-Oncology Therapy
4 Placeholder area for citations and references The Promise and Pitfalls of Immuno - Oncology Therapy • Immuno - oncology (IO) therapies have transformed the treatment landscape and long - term outlook for some patients with advanced cancer - IO treatments are primarily available for “hot” tumors, w
Slide 5: Xilio believes the next revolution in IO cancer therapies
5 Placeholder area for citations and references Xilio ( ex - il - ee - oh) believes the next revolution in IO cancer therapies will trick tumors into activating their own treatments , while simultaneously sparing healthy tissues and cells We are here to pursue that promise for patients 2016 XLO ~100
Slide 6: Pioneering Tumor-Activated Immuno-Oncology Therapies
6 Placeholder area for citations and references Pioneering Tumor - Activated Immuno - Oncology Therapies to Pursue Positive Outcomes for More Patients Mission Design and deliver tumor - activated immuno - oncology therapies that provide effective, tolerable and durable therapeutic options for patien
Slide 7: Leveraging Our Deep Expertise to Build a Transformational IO Company
7 Placeholder area for citations and references Leveraging Our Deep Expertise to Build a Transformational Immuno - Oncology Company • Intentionally built team with significant breadth and depth of biotech and big pharma experience including cytokines such as IL - 12 • Team has collectively contribut
Slide 8: Xilio's Tumor-Activated Precision Immuno-Oncology
8 Placeholder area for citations and references Xilio’s Tumor - Activated Precision Immuno - Oncology • We are passionate about harnessing and focusing the power of the immune system to treat cancer • We have developed a novel approach designed to outsmart tumors by using the tumor’s growth activiti
Slide 9: Building a Transformative Immuno-Oncology Pipeline
9 Placeholder area for citations and references Building a Transformative Immuno - Oncology Pipeline (1) Plan to initially evaluate XTX202 as a monotherapy and as a combination therapy for the treatment of renal cell carcinoma (R CC) and melanoma prior to potential expansion into additional cancer i
Slide 10: Xilio Designed, Tumor Activated
10 Placeholder area for citations and references Xilio Designed, Tumor Activated Seeking to Develop a Transformational IO Approach
Slide 11: Tumor-Activated Design Components – XTX202 (IL-2)
11 Placeholder area for citations and references Xilio’s Tumor - Activated Design Components – XTX202 (IL - 2) Inactive State Cleavage Site Half - Life Extension Domain Effector Domain Masking Domain Active State Half - Life Extension Domain Effector Domain MMP activation MMP: matrix metalloprotease
Slide 12: Molecules are Activated by Dysregulated Tumor Proteases (MMPs)
12 Placeholder area for citations and references Xilio’s Molecules are Activated by Dysregulated Tumor Proteases (MMPs) Xilio’s optimized substrate sequences enable efficient activation of the molecule by MMPs Xilio molecules are readily activated by human tumors ex vivo Xilio molecules demonstrated
Slide 13: First Demonstration of XTX202 Activation in a Patient Tumor
13 Placeholder area for citations and references Xilio’s First Demonstration of XTX202 Activation in a Patient Tumor Patient had an optional on - treatment tumor biopsy and was the first patient for whom a tumor biopsy analysis was available as of November 7, 2022 TREG: Regulatory T cell; TIL: Tumor
Slide 14: Executing on Our Vision to Deliver Tumor-Activated Therapies
14 Placeholder area for citations and references Executing on Our Vision to Deliver Tumor - Activated Immuno - Oncology Therapies Created through our Unique & Efficient Design Process Xilio is positioned to demonstrate clinical platform validation in 2023 NHP: non - human primate ✓ Complete Validate
Slide 15: XTX202 Tumor-Activated IL-2
15 Placeholder area for citations and references XTX202 Tumor - Activated IL - 2
Slide 16: XTX202 (IL-2) Phase 1/2 Trial Design
16 Placeholder area for citations and references XTX202 (IL - 2) Phase 1/2 Trial Design Provides Efficient Path to Potential Monotherapy Proof - of - Concept As of November 7, 2022 : • Dosing patients at 1 mg/kg dose level, the target dose range for XTX202 • No signs of VLS or decreases in albumin (
Slide 17: Enhancement of In Vivo Activity and Memory Response for XTX202 with Anti-PD1
17 Placeholder area for citations and references Enhancement of In Vivo Activity and Evidence of Memory Response for XTX202 (IL - 2) in Combination with Anti - PD1 Anti - tumor activity of XTX202 as a single agent and in combination with anti - mPD - 1 was evaluated in hFcRn Tg32 transgenic mice bea
Slide 18: Multiple Combination Opportunities Enabled by XTX202 (IL-2)
18 Placeholder area for citations and references Multiple Combination Opportunities Enabled by XTX202 (IL - 2) Properties: Tumor - Activated, Well - Tolerated Preclinically, Clinically - Validated Target 5. 1. Xilio data presented at SITC 2022; 2. Gola et al., Haematologica 2003; 3. Wigginton et al.
Slide 19: XTX202 (IL-2) Key Takeaways
19 Placeholder area for citations and references XTX202 (IL - 2) Key Takeaways • IL - 2 has significant therapeutic potential both as monotherapy and in combination - Monotherapy tumor types include: RCC, melanoma, lung cancer - Attractive combination partners include: mAbs (e.g., anti - PD - 1), cy
Slide 20: XTX301 Tumor-Activated IL-12
20 Placeholder area for citations and references XTX301 Tumor - Activated IL - 12
Slide 21: The Potential of IL-12 as a Therapeutic Agent
21 Placeholder area for citations and references The Potential of IL - 12 as a Therapeutic Agent • IL - 12 has ground - breaking potential as a potent IO therapeutic agent • Poor tolerability has limited its clinical progress for decades • No currently approved IL - 12 agents INF γ : i nterferon gam
Slide 22: IL-12 Can Remodel Cold Tumor Microenvironment Towards a Hot State
22 Placeholder area for citations and references IL - 12 Can Remodel Cold Tumor Microenvironment Towards a Pro - Inflammatory (Hot) State that Favors Anti - Tumor Immunity • CD8 T and NK cells are abundant in tumor • Pro - inflammatory microenvironment • Improved prognosis and effective killing of t
Slide 23: XTX301 – Tumor-Activated IL-12 Designed to Outsmart Tumors
23 Placeholder area for citations and references XTX301 – Tumor - Activated IL - 12 Designed to Outsmart Tumors XTX301 custom mask designed to address unique challenges presented by the complex heterodimer structure of IL - 12 Masking Domain Half - Life Extension Domain Cleavage Site Effector Domain
Slide 24: mXTX301 Demonstrated Dose-Dependent Anti-Tumor Activity Without Body Weight Loss
24 Placeholder area for citations and references mXTX301 (Murine Surrogate) Demonstrated Dose - Dependent Anti - Tumor Activity Without Body Weight Loss In Vivo Tumor Growth Body Weight TGI: tumor growth inhibition. MC38 model: s.c. 0.5x10 6 cells; single IV dose of mXTX301 and mXTX302 on Day 0. Tum
Slide 25: mXTX301 Preferentially Activated in Tumors vs. Plasma In Vivo
25 Placeholder area for citations and references mXTX301 (Murine Surrogate) was Preferentially Activated in Tumors vs. Plasma In Vivo mXTX301 demonstrated tumor - specific activation in vivo mXTX301 treatment resulted in cleavage - dependent enhancement in activity vs. non - activatable control Left
Slide 26: mXTX301 Induced Memory Responses Enabling Tumor Rejection Upon Rechallenge
26 Placeholder area for citations and references mXTX301 Induced Memory Responses in Murine Model Enabling Tumor Rejection Upon Rechallenge of Complete Responders mXTX301 treatment resulted in complete regressions in 9 out of 12 mice Majority of mXTX301 complete responders rejected tumors upon recha
Slide 27: XTX301 (IL-12) Preclinical Data Support Broad Therapeutic Index
27 Placeholder area for citations and references XTX301 (IL - 12) Preclinical Data Support Potential for Broad Therapeutic Index • XTX301 was tolerated at doses up to 2.0 mg/kg Q1W x4 in NHP (HNSTD) • mXTX301 induced tumor regressions in murine model following a single dose of 0.13 mg/kg HNSTD: high
Slide 28: XTX301 (IL-12) Trial Designed for Monotherapy and Combination Opportunities
28 Placeholder area for citations and references XTX301 (IL - 12) Trial Designed to Enable Multiple Monotherapy and Combination Opportunities for Expansion in Both Hot and Cold Solid Tumors As of November 7, 2022 : • IND cleared in November 2022 • Anticipate initiating enrollment in monotherapy dose
Slide 29: XTX301 (IL-12) Key Takeaways
29 Placeholder area for citations and references XTX301 (IL - 12) Key Takeaways • IL - 12 has significant therapeutic potential across both “hot” and “cold” tumor types - “Hot” tumors include: lung, bladder, head & neck, kidney, liver, melanoma, MSI high CRC - “Cold” tumors include: prostate, ovaria
Slide 30: XTX101 Tumor-Activated aCTLA-4
30 Placeholder area for citations and references XTX101 Tumor - Activated aCTLA - 4
Slide 31: XTX101 (aCTLA4) Phase 1 Trial
31 Placeholder area for citations and references XTX101 (aCTLA4) Phase 1 Trial As of November 7, 2022 : • Announced encouraging preliminary Part 1A data in August 2022 • Preliminary PK analyses demonstrated dose - proportional drug exposure, with limited active (unmasked) XTX101 in peripheral circul
Slide 32: XTX101 Anti-CTLA-4 Key Takeaways
32 Placeholder area for citations and references XTX101 Anti - CTLA - 4 Key Takeaways • Next generation anti - CTLA - 4 molecules seek to improve upon the efficacy and tolerability of existing molecules, such as ipilimumab • XTX101 is an FC - enhanced, tumor - activated, anti - CTLA - 4 currently be
Slide 33: Looking Ahead: Xilio's Tumor-Activated Platform Opportunities are Broad
33 Placeholder area for citations and references Looking Ahead Xilio’s Tumor - Activated Platform Opportunities are Broad
Slide 34: Potential to Deliver Locally-Activated Immunotherapies Beyond Cancer
34 Placeholder area for citations and references Looking Ahead: Potential to Deliver Highly Potent, Locally - Activated Immunotherapies Beyond Cancer Masked Cytokines Masked Antibodies Pro - and Anti - Inflammatory Processes Proteases in Diseases of Immune Dysregulation Actively pursuing the next ge
Slide 35: Third Quarter 2022 Financial Results
35 Placeholder area for citations and references Third Quarter 2022 Financial Results Balance Sheet September 30, 2022* December 31, 2021 Cash and Cash Equivalents $139.1M $198.1M Statement of Operations Three Months Ended September 30, 2022* 2021* Research & Development Expenses $13.0M $10.5M Gener
Slide 36: Xilio is Poised for a Dynamic 2023 and Multiple Anticipated Milestones
36 Placeholder area for citations and references Xilio is Poised for a Dynamic 2023 and Multiple Anticipated Milestones RP2D: recommended Phase 2 dose * Plan to evaluate XTX101 as a monotherapy for the treatment of advanced solid tumors and explore opportunities for strategic c ollaborations to adva
Slide 37: Xilio is working to deliver highly potent, localized immunotherapies
37 Placeholder area for citations and references Xilio is working to deliver highly potent, localized immunotherapies in cancer and beyond Xilio Therapeutics is a Differentiated IO Company with a Proprietary Tumor - Activated Platform and the Team to Deliver Patient Portrayal