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Pentixapharm : Financial document (Q3 Prasentation Earnings Call Pentixapharm Holding AG 37hw)

Pentixapharm : Financial document (Q3 Prasentation Earnings Call Pentixapharm Holding AG

Pentixapharm Holding AgNovember 14, 20255
Pentixapharm : Financial document (Q3 Prasentation Earnings Call Pentixapharm Holding AG 37hw)

About this update from Pentixapharm Holding Ag

Third Quarter and First Nine Months 2025 Financial Results and Business Update Expanding the Boundaries of Radiopharmaceuticals November 12, 2025 Expanding the Boundaries of Radiopharmaceuticals Advanced clinical-stage Biotech Headquartered in Berlin, Germany More than 20 dedicated employees Pioneering Programs in Cardiology and Oncology Business Model: R&D Model: Expertise and resources Novel radiopharmaceuticals Strong clinical development expertise Solid global regulatory strategy High-quality CMC Stock Market Listed Since 2024 - PTP Frankfurt Prime Standard Focused clinical development through major value inflection points up to Phase 3 and commercialization November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 3 Radiodiagnostics: High-resolution PET-CT imaging Imaging Stratify patients for tailored treatment Map disease distribution at baseline Track tumor burden with precision Radiotheranostics Seamlessly combining imaging and therapy to improve patient outcomes Radiotherapeutics: precision therapy Therapy Deliver targeted radioactive payload to tumor cells Destroys cancer cells through targeted radiation delivery Optimize tumor penetration / accessibility / lethality through choice of isotope Radiotheranostics: A New Paradigm in Precision Medicine November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 4 Positioned to Unlock New Opportunities in Rapidly Growing G lobal Radiopharmaceutical Market Global Radiopharmaceutical Market Size 1) Radiopharmaceutical Market By Region ~7-10% CAGR Latin America Middle East and Africa $6.7 - 7.5 bn 2024-2025 Exp. $14 - 16 bn 1,92% 0,99% Asia Pacific 25.4% North America 44.0% 2024 Expected to grow to ~ $3.4 bn in 2028 Europe 2033-2034 Adoption driven by need : Increasing cancer prevalence, limited options in late-stage disease, ability to pair high-resolution imaging with precision therapy Addressing major diagnostic and therapeutic gaps , targeting high-need, low-competition indications not yet served by radiopharmaceuticals 27.8% 1) https://www.precedenceresearch.com/radiopharmaceuticals-market as of November 7, 2025 November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 5 A Sharper, More Focused Pentixapharm Following Completed Streamlining Q1 Q2 Q3 Q4 Myelo001 Program discontinued following portfolio prioritization CXCR4 and CD24 Strategic re-orientation of non-clinical and clinical development Focus on clinical development in high-value Indications September 2025: PENTILULA Study Progress CXCR4-targeting therapeutic lead candidate [ 177 Lu]Lu-PentixaTher has advanced to the fourth dose level in the investigator-initiated Phase 1/2 study in acute myeloid leukemia October 2025: Data at EANM Conference Presentation of extensive clinical data from independent investigator-initiated studies assessing CXCR4-targeting diagnostic lead candidate, [ 68 Ga]Ga-PentixaFor November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 6 Transforming Personalized Medicine: Investment Highlights Driving Value as Advanced Clinical-Stage Company Broadening impact of radiopharmaceuticals with advanced pipeline addressing high value biology targets in oncology and beyond Pioneering New High-Value Indications Combining new indications and new targets : generating solutions for high unmet need in cardiology and oncology Seizing High-Growth Market Opportunities Radiopharmaceutical market valued at 6.7-7.5 bn in 2024-2025 projected to be $14-16bn by 2033 Flagship Pipeline Drives Near- and Long-Term Impact PentixaFor/Ther: Phase 3-ready diagnostic in hypertension with and precise imaging agent in blood cancers, alongside first-in-class CD24 antibody platform Leveraging Strategic Supply Advantage Secured isotope access through Eckert&Ziegler ensuring reliable scaling of diagnostic and therapeutic programs November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 7 Focused Competencies at the Core of the Development Value chain Pentixapharm Core Expertise and Value Drivers Value Inflection Discovery Pre-clinical IND/ CTIS Clinical Phase 1 Clinical Phase 2 Diagnostic Clinical Phase 3 In-license Manufacturing Radionuclide Supply Including Regulatory strategy CMC radiopharmaceuticals Theranostic Clinical Phase 3 Approval Commercialization Inlicence & Outsource Development of proprietary assets Strategic Partnerships and Co-Development Outlicense November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 8 Targeting CXCR4: A Biologically Validated Target From Oncology to Cardiology - CXCR4 Anchors Next-Generation Radiopharmaceuticals CXCR4 : One of the most thoroughly researched biological targets of the last decade with a central role in the bone marrow CXCR4 Theranostic in Oncology: Key role in tumor growth and metastasis Highly present in multiple aggressive blood cancers Clinically validated in ~100 patients selected with ⁶⁸Ga-PentixaFor and treated with ⁹⁰Y- and 177 Lu-PentixaTher CXCR4 Diagnostics in Hypertension: Increased presence in adrenal tumors overproducing aldosterone Diagnostic marker to determine lateralization of aldosterone overproduction Emerging clinical evidence in ~1.600 patients diagnosed with ⁶⁸Ga-PentixaFor November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 9 Targeting CD24: Highly Specific Cancer Therapy From Checkpoint Modulation to Targeted Radiotherapy - CD24 Antibody-Based Radioconjugates CD24: A growing body of translational and early clinical work positions CD24 as a new therapeutic gateway in oncology and immunology Therapeutic Role in Oncology: Highly glycosylated cell surface protein and immune checkpoint, contributing to cancer progression Correlates with aggressiveness, metastasis and poor prognosis Expressed on many solid tumors, but also, on healthy tissues Targeting CD24 for payload delivery: Pentixapharm Solution: GT-008 monoclonal antibody targets a tumor-associated glycoform of CD24 Combines CD24 targeting with recognition of tumor-specific carbohydrate patterns, achieving superior tumor selectivity and enabling highly precise payload delivery Promising preclinical radioconjugate efficacy data for aggressive female cancers November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 10 Building Pipeline Momentum Across Oncology and Cardiology Lead Pre- IND/ Candidate Target Indication Optimization clinical CTIS Phase I Phase II Phase III Sponsor Radiodiagnostics PentixaFor PT-001 ⁶⁸Ga PTF302 CXCR4 Cardiovascular Endocrine & Oncology Hypertension - Primary Aldosteronism Ph3 ready IITs Hypertension -Primary Aldorsteronism IIT Morbus Cushing PT-003 ¹⁸F CXCR4 (2 nd -Gen) PT003 Radiotheranostics CNS Lymphoma Ph1/2 IITs MM, NHL Myeloma IITs ALL/AML Solid Tumors (female cancers) CD24 GT-008 (IgG1 mAb Radioligand) TechnicalUniversity of Munich Centre Hospitalier Universitaire de Nantes emia and Multiple Leuk PTT101 Hematologic cancers CXCR4 PentixaTher PT-002 90 Y, 177 Lu Multi Modal Antibody Pipeline CD44 Solid Tumors AML = Acute Myeloid Leukemia ALL = Acute Lymphoid Leukemia CNSL = Central Nervous System Lymphoma MM = Multiple Myeloma NHL = Non-Hodgkin Lymphoma RAC = Radioimmunoconjugates/Radiopharmaceutical Antibody Conjugates PT = Peptide based portfolio GT = Glyco-Antibody based portfolio November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 11 Upcoming Clinical Milestones Poised to Drive Significant Value 2025 2026 2027 2028 PTF302 FDA Scientific Advice Meeting expt. Q4 2025 PTF302 Open IND expt. H1 2026 PTF302 First 50 patients dosed in U.S./EU expt. H1 2027 PTF302 Topline data expt. H2 2028 PT003: Results Ph0 expt. H2 2028 Start PhI/II expt. H2 2028 PTT Hem-Onc: Open IND expt. H1 2026 IIT AML Therapy: Topline results expt. H1 2027 IIT MM Theranostic: Results expt. H2 2028 IIT MM Diagnostic : Topline results expt. H2 2027 IIT AMLTheranostic: Results expt. H2 2028 Oncology PTT101 and Investigator Initiated Studies (IIT) Cardiology PTF302 Primary Aldosteronism Programs in italics contingent on future funding PTF = PentixaFor (radiodiagnostic) PTT = PentixaTher (radiotherapeutic) AML = Acute Myeloid Leukemia MM = Multiple Myeloma IND = Investigational New Drug November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 12 Pentixapharm Radiodiagnostics Cardiology - Hypertension - Primary Aldosteronism November 2025 Pentixapharm ・ Investor Presentation 13 Transforming the Diagnostic Pathway in Primary Aldosteronism Subtyping Subtyping Results Therapy Adrenal CT/ Adrenal Venous Sampling (AVS) Standard of Care Nonlateralizing PA (mostly BAH) 65% of the cases Mineralpocorticoid receptor antagonist (Lifelong medication) Patient with hypertension Our approach [⁶⁸Ga]GaPentixaFor PET/CT Lateralizing PA (mostly unilateral) 35% of the cases Unilateral Adrenalectomy (Surgery) November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 14 Advancing Toward Phase III: Redefining Diagnosis in Primary Aldosteronism with PentixaFor Blinded independent central review Adrenal Venous Sampling (AVS) Local subtyping for unilateral disease Confirmed Primary Aldosteronism 68 [Ga]Ga-PentixaFor PET/CT Local subtyping for unilateral disease Screening Blinded Diagnostics Treatment Adrenal Venous Sampling (AVS) Biochemical Outcomes Primary Endpoint Unilateral adrenalectomy Patient follow-up + vs. Follow-up November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 15 PTF302: Pioneering CXCR4 in Primary Aldosteronism Registrational Phase 3 ready 2026 2027 2028 2029 Type C FDA Advice EMA Prime Designation ⁶⁸Ga-PentixaFor Phase 1/2 IIT Program completed Registrational Phase 3 ready NDA / Market Authorization ¹⁸F-2 nd Gen Phase 0 and IIT Phase 1/2 Go / no-go criteria Biodistribution Efficacy PoC comparison Phase 3 readiness CXCR4 Radio-diagnostic in Cardiovascular Endocrinology ⁶⁸Ga-PentixaFor Frontline therapy-enabling diagnostic for CXCR4 PA imaging Favorable entry point based on generator availability, robust labeling, and strong clinical validation ¹⁸F-CXCR4 Accelerated ¹⁸F clinical development in case of strong ⁶⁸Ga diagnostic performance Bridging studies to leverage ¹⁸F centralized production and complete geographic IP November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 16 Pentixapharm Radiotheranostics Blood Cancers November 2025 Pentixapharm ・ EIB Presentation 17 PentixaFor / PentixaTher CXCR4-directed Radiotheranostics Transforming Bone Marrow Conditioning in Blood Cancers State-of-the-art bone marrow conditioning Before stem cell transplantation (SCT) Precision CXCR4-directed radiotheranostics Transform bone marrow conditioning PentixaFor radiodiagnostic : Map CXCR4 tumor cells expression High-dose chemotherapy and / or full-body irradiation Stem cell transplantation CXCR4 as potent predictive marker for efficacy of subsequent radiotherapy PentixaTher radiotherapeutic : Destroy CXCR4-expressing tumor cells Reducing tumor burden and freeing the bone marrow niche Highly aggressive, strong system toxicity Eradicate cancer cells and suppress patient's immune system Targeting reduced conditioning toxicity Radiotheranostics could precede or reduce aggressive chemo/radiation conditioning while providing highly targeted efficacy November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 18 Where the Need Is Greatest: Global Incidence of Blood Cancers Requiring Bone Marrow Conditioning Bone Marrow Conditioning & Treatment Global Incidence cases per year November 2025 Central Nervous System Lymphoma ~10,000-12,000 Acute Myeloid Leukemia ~145,000 Multiple Myeloma ~185,000 Pentixapharm ・ Third Quarter and First Nine Months 2025 19 Pentilula IIT Phase 1/2 Study of PentixaTher in Relapsed/Refractory Acute Myeloid Leukemia Phase I/II study assessing radioligand therapy with [ 177 Lu]Lu-PentixaTher (PT-002) for relapsed/refractory CXCR4 + acute leukemia Primary Objective: To determine the MTD/DLT of Lu177-PentixaTher (PT-002) Population: n = 6-21 Relapsed or refractory CXCR4 + acute leukemia Methodology: 3+3 Design Imaging: 68 Ga-PentixaFor (PT-001) Therapy: Stand-alone [ 177 Lu]Lu-PentixaTher Sites: Clinic in France Timeline: Enrollment: 24m, Follow-up: 12m FPFV: Q424 LPLV: Q426 Data readout: Q427 CT Number: NCT06356922 Secondary endpoints: Overall Rate of Response Complete Response Rate Overall Survival Leukemia-Free survival Primary endpoint: Number of participants with treatment-related adverse events Recommended Phase 2 Dose Escalation phase n ≈ 6-21 Expansion phase Cohort 4 10 GBq n = 3-6 / 2.5 mCi x 4 Cohort 5 12.5 GBq n = 3-6 / 2.5 mCi x 4 Cohort 2 5 GBq n = 3-6 / 2.5 mCi x 4 Cohort 1 2.5 GBq n = 3-6 / 2.5 mCi x 4 Completed Cohort 3 7.5 GBq n = 3-6 / 2.5 mCi x 4 Completed In Progress Completed IIT: Investigator initiated study; ALL: Acute Lymphocytic Leukemia; AML: Acute Myeloid Leukemia; DLT: dose limiting toxicities November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 20 Pentixapharm Radiotheranostics Antibody Platform November 2025 Pentixapharm ・ EIB Presentation 21 Monoclonal Antibodies Drive Innovation in Radiopharma Pipelines at Every Stage of Development Peptide / Ligand Antibody Small Molecule Mini Proteins UDC ¹⁷⁷Lu ²²⁷Ac ²¹²Pb ¹³¹ ¹²³ I ⁶⁷Cu ⁹⁰Y ²¹¹At ¹⁶¹Tb ¹⁸⁵ ¹⁸⁶ Re ¹⁵³Sm UDC Preclinical /Discover Phase 1 Phase 2 Phase 3 Commercialization GT-008 https://www.linkedin.com/posts/nucleus-radiopharma_nucleus-radiopharma-radiopharmaceutical-pipeline-activity-7323404446149808129-4AEv November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 22 Preclinical Proof-of-Concept Study Demonstrating CD24-Targeting GT-008 Tumor Selectivity and Anti-Tumor Activity GT-008 antibody + Radioisotope 177 Lu or 225 Ac GT-008 radioisotope Vehicle 225 Ac-GT-008 10 kBq 225 Ac-GT-008 3 kBq Injection 1500 Tumor volume [mm 3 ] 1000 500 225 Ac-labeled GT-008 Tumor cell death 5 or 4 single strand break double strand DNA Breast cancer mouse model DNA break 1 1 2 2 3 3 Tumor cell Binding to cancer cell Internalization Radioactive decay 0 Tumor volume [mm 3 ] 1500 1000 500 0 7/8 CR Treatment Unlabelled GT-008 225 Ac-GT-008 10 kBq 225 Ac-GT-008 3 kBq Complete response 7 out of 8 animals 0 10 20 30 40 50 60 70 80 Days after randomization Vehicle 177 Lu-GT-008 10 MBq 177 Lu-GT-008 3 MBq Treatment Unlabelled GT-008 177 Lu-GT-008 10 MBq 177 Lu-GT-008 3 MBq Complete response 2 out of 8 animals 177 Lu-labeled GT-008 2/8 CR 0 10 20 30 40 50 60 70 80 Days after randomization November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 23 Targeting CD24: Closing the Gap for Female Cancers Asset for strategic partnering for co-development or out-licensing Great Investment and Partnering Opportunities [Market size (CAGR)] Breast Cancer: $38.0 billion (9%) Endometrial Cancer: $27.1 billion (6%) Ovarian Cancer: $2.5 billion (2-14%) Still high unmet medical need: Limited treatment options : Despite advances with PARP inhibitors, immunotherapies and antibody-drug conjugates, still many patients with recurrences and resistance Early diagnosis remains a challenge : Many gynecological tumors, especially ovarian cancer, are often only discovered at a late stage. Heterogeneity of tumors : Gynecological tumors have a high degree of molecular variability, which leads to different response rates to existing therapies. November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 24 Pentixapharm Financials Current Financial Position 25 Balance Sheet Third Quarter 2025 30.09.2025 30.09.2025 in € thousands 31.12.2024 in € thousands 31.12.2024 Assets Liabilities and Equity Other intangible assets 35.354 33.194 Property, plant and equipment 269 240 Financial assets 484 484 Total non-current assets 36.107 33.918 Current assets Cash and cash equivalents 23.232 6.974 Trade receivables 6.805 15 Income tax receivables 134 187 Other current assets 1.110 1.866 Total current assets 31.281 9.042 Total assets 67.388 42.960 Non-current assets Equity November 2025 Subscribed capital 24.795 24.795 Capital reserves 37.475 37.475 Retained earnings/Accumulated deficit 0 -12.843 Income/ Loss of the period -12.843 -12.694 Treasury shares -12 -12 Equity attributable to shareholders of the parent company 49.415 36.721 Total equity 49.415 36.721 Non-current liabilities Deferred tax liabilities 3.930 3.635 Non-current provisions 2 2 Total non-current liabilities 3.932 3.637 Current liabilities Trade payables 8.943 1.520 Other current liabilities 5.098 1.082 Total current liabilities 14.041 2.602 Total liabilities and equity 67.388 42.960 Pentixapharm ・ Third Quarter and First Nine Months 2025 26 Profit & Loss Third Quarter 2025 in € thousands 01-09/2024 01-09/2025 Revenue 0 117 Income from the sale of rights/patents 0 0 Other operating income 0 482 Cost of materials and external services for research and development 0 -4.723 Personnel expenses 0 -4,072 Other operating expenses -171 -2.22 8 Earnings before interest, taxes, depreciation, and amortization (EBITDA) -171 -10.424 Depreciation and amortization of non-current assets Earnings before interest and taxes (EBIT) 0 -171 -2.803 -13.227 Financial result 0 246 Earnings before taxes (EBT) -171 -12.981 Income tax expense 0 287 Profit or loss/ Consolidated comprehensive income attributable to the shareholders of the parent company Earnings per share -171 -12.694 Diluted/ Basic (€ per share) -3,42 -0,51 Weighted average number of shares outstanding (diluted/ basic) - in thousands. 50 24.783 November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 27 Cash Flow Statement Third Quarter 2025 01-09/2025 in € thousands 01-09/2024 Cash flow from operating activities Profit/loss -171 -12.694 Adjustments for: Depreciation, amortization and impairment losses 0 2.803 Change in deferred taxes 0 -295 Income taxes paid 0 -53 Other non-cash expenses/income 0 -45 Change in trade receivables and other assets not attributable to investing or f inancing activities 0 6.084 Change in trade payables and other liabilities not attributable to investing or financing activities 125 -11.439 Net cash used in operating activities -46 -15.639 Cash flow from investing activities: Payments for investments in intangible assets and property, plant and equipment 0 -613 Net cash used in investing activities 0 -613 Cash flow from financing activities: Proceeds from capital contributions 50 0 Net cash from financing activities 50 0 Effect of exchange rate changes on cash and cash equivalents 0 -6 Net increase/decrease in cash and cash equivalents 4 -16.258 Cash and cash equivalents at the beginning of the period 0 23.232 Cash and cash equivalents at the end of the period 4 6.974 November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 28 Financial Guidance Full-Year 2025 FY 2025 Total Loss: €18 million R&D Expenses: €7 million Personnel & Other OPEX: €8 million Depreciation: €3.7 million Grants: €0.6 million November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 29 Events After the Reporting Date After the reporting date of September 30, 2025, the Management Board of Pentixapharm Holding AG resolved in October 2025 to implement measures aimed at optimizing the organizational and cost structure. These measures are intended to further increase operational efficiency and are expected to extend the company's financial runway into the first quarter of 2027. Implementation will proceed in stages and will take effect starting in the fourth quarter of 2025. November 2025 Pentixapharm ・ Third Quarter and First Nine Months 2025 30 Attention : This is an excerpt of the original content. To continue reading it, access the original document here .

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