Pentixapharm Holding AgXETR: PTP

Financial document (Q3 Prasentation Earnings Call Pentixapharm Holding AG 85dk)

· Issued by 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 Global Radiopharmaceutical Market

Global Radiopharmaceutical Market Size1) 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 [177Lu]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, [68Ga]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 177Lu-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

(2nd-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

90Y, 177Lu



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-2ndGen

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 [177Lu]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: 68Ga-PentixaFor (PT-001)

Therapy: Stand-alone [177Lu]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

177Lu or 225Ac



GT-008

radioisotope

Vehicle

225Ac-GT-008 10 kBq

225Ac-GT-008 3 kBq

Injection

1500

Tumor volume [mm3]

1000

500

225Ac-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 [mm3]

1500

1000

500

0

7/8 CR

Treatment

Unlabelled GT-008

225Ac-GT-008 10 kBq

225Ac-GT-008 3 kBq

Complete response

7 out of 8 animals



0 10 20 30 40 50 60 70 80

Days after randomization

Vehicle

177Lu-GT-008 10 MBq

177Lu-GT-008 3 MBq

Treatment

Unlabelled GT-008

177Lu-GT-008 10 MBq

177Lu-GT-008 3 MBq

Complete response

2 out of 8 animals



177Lu-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

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