PENTIXAPHARM

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Frühjahrskonferenz Frankfurt, 14. Mai 2024

Dr. Andreas Eckert

1

Important Disclaimer

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2

Pentixapharm Overview

Pentixapharm AG (PTX) is a stand-alone, radiopharmaceutical development company founded in 2019

  • PTX is currently a 100% subsidiary of Eckert & Ziegler (hereafter "EZAG", seewww.ezag.de) and located in Würzburg, Bavaria and Berlin, Germany. PTX currently employs a staff of 40, mostly PhDs involved in clinical development
  • Main asset of PTX are the global rights to the use of the CXCR4 receptor in the development of radiopharmaceuticals, invented by Prof. Hans-Jürgen Wester and his group, in- licensed from Technical University of Munich
  • EZAG total investment in Pentixapharm AG through 2024 1H will total c. €74m

PTX is bound to be spun-off

  • With encouraging clinical data pouring in, PTX started potentially to compete with EZAG's pharmaceutical customers who purchase the isotopes it produces and distributes.
  • As a clinical stage biotech, PTX also follows a different business model compared to the EBIT/ cash flow focussed parent company. Existing EZAG investors are looking for a cash dividend whereas Pentixapharm AG is a cash-burning,clinical-stage biotech.
  • EZAG management therefore in 2023 decided to spin off PTX and prepare a listing on the Frankfurt Stock Exchange. For details, see the press release of 20/10/2023 atthis link.

Clear commercialisation pathway

  • First objective for PTX is to explore the diagnostic superiority of the CXCR4 receptor through a first-in-class, medical break-through in a cardiovascular disease
  • Second objective is taking substantial market share from industry workhorse FDG through line extensions. Investment hypothesis, hardened by clinical evidence, is that CXCR4 is substantially more specific and sensitive than FDG in a broad area of indications
  • Third objective is to leverage the therapeutic potential of the CXCR4 receptor in a basket of haemato-oncological indications

Long term goal remains migration to U.S. capital markets / dual listing

  • The Frankfurt listing at the Prime Standard is primarily seen as a stepping stone. It will enable major EZAG stakeholders, including founder and shareholder Andreas Eckert, to become anchor shareholders for Pentixapharm AG

3

Past Milestones of Pentixapharm

Q2/2024

Ga68-CXCR4 in PA: FDA Type-C Meeting Feedback

EZAG Shareholder

meeting on 26 June to decide about secession

Q2/2025

Ga68-CXCR4 in PA: IND

approval for Phase III

Q2/2025

Q4/2025

Ga68-CXCR4 in MZL:

Ga68-CXCR4 in MZL:

Last Patient Phase III

Phase III Data Read-Out

2024

Q2/2024

Ga68-CXCR4 in MIBC:

First Patient Scanned in

IIS

Q4/2024

Ga68-CXCR4 in

MIBC: IIS completed

Likely start of

Q1/2025

F18-CXCR4: Pre-

Clinical Data Set

Completed

2025

Q3/2025

F18-CXCR4: IND Approval for First Clinical Study*

listing in Frankfurt

Prime Standard

Q2/2025

Q4/2025

Y90-CXCR4 in T-Cell

Y90-CXCR4 in CNS-

Lymphoma: First Patient

Lymphoma: Phase I/II

in Phase I/II

Read-Out

*IND requires complete CMC process and tox study

4

Targeted Radiopharmaceuticals:

Going for CXCR4

Established and validated mode of action

  • A radioactive isotope, or payload, is linked to a biologically active molecule called a ligand
  • This compound can be injected intravenously and targets all affected cells in the body, including small metastases
  • The selection of radioisotope determines its function: high-energy isotopes kill targeted cells, while low-energy ones are used for imaging

What is special about CXCR4?

  • The C-X-C chemokine receptor type 4 (CXCR4) is overexpressed on a variety of malignant diseases, such as solid and hematological cancer as well as cardiovascular endocrinological diseases
  • It is one of the most thoroughly researched targets of the last decade:
    • 9 Reviews, 2 method articles, >100 Publications1 on [68Ga]Ga-PentixaFor
    • More than 2,500 Patients1 have already been imaged with [68Ga]Ga-PentixaFor without any safety issues
    • Since 2024, 474 patients were diagnosed for Primary Aldosteronism (PA) with [68Ga]Ga-PentixaFor1
  • PTX sponsors more than 20 investigator initiated clinical studies (IIS)

Strong data base to build on a clinical development plan to obtain market authorization

1 see Backup for full list

5

The Value Building Blocks

Get Marketing Authorization for Ga68-CXCR4 in Europe and the U.S.

1

Phase-III-Study ongoing for marginal zone lymphoma in Europe. Phase-III-Study application pending for hypertension in US. Time to registration 2 to 4 years.

Statistical risk of failure in imaging diagnostics significantly lower than normal.

2

3

Move to larger F-18 fluorodeoxyglucose (FDG) after Ga68-CXCR4 is validated

  • Line extension of Ga68-CXCR4 from PA and MZL into basket of haemato-oncologicalspecialties.
  • Line extension of Ga68-CXCR4 into quality of life enhancing diagnostic for muscle invasive bladder cancer.
  • Thereafter: Migrate validated CXCR4 indications into fluorine-18 tracers and cash in on higher specificity and sensitivity of CXCR4 in comparison to industry workhorse FDG.

Develop Companion Therapeutics and Pipeline Outside of PSMA/ NET

  • Branch out from the ongoing Phase I/IIa Y90-CXCR4 dose finding study into spectrum of high value haemato-oncological therapeutics for range of myelomas and leukemia.
  • Develop Y90-based CXCR4 as a therapeutic for high value applications of radiosynoviorthesis (RSO), targeting chronic synovitis in indications such as rheumatoid arthritis.

1 PSMA / NET: Prostate-specific membrane antigen / Neuroendocrine tumour

Three Campaigns to Harvest the

Potential of CXCR4:

Primary Endpoints

Marginal Zone Lymphoma (MZL)

Ga-68

Primary Aldosteronism (PA)

Bladder cancer (MIBC)

F-18

Primary Aldost. (PA)

Y-90

CNS Lymphoma

Pre-Clinical

Phase I

Phase II

Phase III

Specialty diagnostic for PA, MIBC, MZL and basket of hemato-oncological indications

Roll out into F-18 based broad substitute for FDG

Line extension into basket of high value lymphoma, melanoma, and niche therapeutics

Note: CNSL: Central Nervous System Lymphoma; MIBC: Muscle Invasive Bladder Cancer;

*IND requires complete CMC process and tox study

POC: proof of concept; PA: Primary Aldosteronism; MZL: Marginal Zone Lymphoma;

FDA: Food and Drug Administration; EMA: European Medicines Agency

Clinical trials ongoing/pending

The way to go

7

Initial Budget: €80m - Secondary Later

Likely Once Objectives are Reached

Project

Therapy

Indication

Phase

Funding (€m)

Subtotal (€m)

Total (€m)

PTF-301

Gallium-68 CXCR4

Marginal Zone Lymphoma

Phase III

10.0

15.0

(Non-HodgkinB-cell Lymphoma)

Market Access

5.0

PTF-302

Gallium-68 CXCR4

Primary Aldosteronism

Phase III (US)

25.0

40.0

(Hypertension)

Market Access

15.0

80.0

CNS-Lymphoma

Dose finding

PTT-101

Yttrium-90 CXCR4

(data can be further used for multiple

10.0

10.0

• Phase I / IIa

myeloma indications)

PTT-101

Fluorine-18 CXCR4

Primary Aldosteronism

• Phase I / IIa

15.0

15.0

8

First-Class Clinical Team, Corona- Hardened. Experienced Entrepreneurs.

9

Radiopharmaceuticals Have Become a Hot M&A Space

May 2024

March 2024

January 2024

December 2023

Description:

Description:

Description:

Description:

  • A preclinical-stage biotechnology company focused on developing novel radioligand therapies (RLTs) to treat cancers with high unmet need
  • A clinical-stage biopharmaceutical company developing next-generation radioconjugates
  • Fusion's lead program is FPI-2265, an
  • A clinical-stage radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies for cancer
  • A clinical-stage radiopharmaceutical therapeutics (RPT) company with an innovation-leading position in actinium- based RPTs
  • Mariana's acquisition encompasses a portfolio of RLT programs across a range of solid tumor indications, including development candidate MC-339, an actinium-based RLT being investigated in small cell lung cancer

Deal metrics:

actinium-225 based prostate-specific membrane antigen (PSMA) - targeting radioconjugates for metastatic castration- resistant prostate cancer (mCRPC), currently in a Phase II trial

Deal metrics:

  • 126% premium to Fusion's closing market
  • POINT's lead program is PNT2002, a
    PSMA - targeted radioligand therapy in development for patients with mCRPC, currently in a Phase III trial

Deal metrics:

  • 87% premium to POINT's closing market price before announcement
  • RayzeBio's lead program is RYZ101, in Phase III development for treatment of gastroenteropancreatic neuroendocrine tumors and early-stage development for treatment of small cell lung cancer

Deal metrics:

104% premium to RayzeBio's closing

Upfront payment of $1bn + $750m

price before announcement

Stake: 100%

market price before announcement

milestones payments

Stake: 100%

Stake: 100%

Stake: 100%

$3.6bn

$2.4bn

$1.0bn

$1.4bn

Transaction value

Transaction value

Transaction value

Transaction value

10

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Eckert & Ziegler AG published this content on 15 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 May 2024 11:28:20 UTC.