Heidelberg Pharma : Präsentation Bilanzpressekonferenz 2024

FY 2023 Financial Results & Business Update

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Forward looking statements

This communication contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will" "should" "future", "potential" or similar expressions or by general discussion of strategy, plans or intentions of the Company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Such factors include, among others, the following: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication.

Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

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Heidelberg Pharma at a glance

Differentiated ADC Technologies

• • In Plug & Play mode

• • 2 years from target to IND

Strong IP

• • Several IP families

• • Monopoly in the Amanitin/MoA space

GMP Manufacturing

• • Fully synthetic process for Amanitin

• • 5 GMP batches completed

Partnerships

• • Huadong: China-focused

• • Takeda: ATAC technology

* as per end of November 2023

• • 1 ATAC in ongoing Phase I with biological activity and three partial remissions

  Clinical Stage

• • 2 additional ATAC INDs in preparation

Corporate & Finance

• • Experienced leadership team; ~ 105 employees

• • Cash (runway): €43.4 million* (mid-2025)

Our mission is the development of novel drugs for targeted and highly effective cancer treatment

based on our ADC technologies

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Highlights - Corporate update

Executive Management Board expanded

• • Walter Miller was appointed CFO in May 2023

• • Professor Andreas Pahl followed Dr. Jan Schmidt-Brand as CEO as of February 2024

Emergence Transaction

• • Minority shareholding in Emergence was sold to Eli Lilly for USD 7 million in June 2023

Royalty purchase agreement with HealthCare Royalty

• • Partial sale of future royalties from worldwide sales of Telix Pharmaceuticals' imaging diagnostic agent ZircaixTM to HealthCare Royalty in March 2024

Patent for the use of the Amanitin-based ADC technology platform from EPO

• • Protects site-specific ATAC conjugates including the method for synthesizing such conjugates and their use in the treatment of diseases

Phase I/IIa study with HDP-101

• • Data from HDP-101 dose escalation shows first objective responses and partial remissions

Highlights 2023 - Expanded ADC technologies

Developing an ADC toolbox and clinical product pipeline to overcome tumor resistance across cancer types

Toolbox of proprietary payloads

Growing pipeline of proprietary and partnered programs

TelixTelix RedHill

* People's Republic of China, Hong Kong, Macao, Taiwan, South Korea, Indonesia, Singapore, The Philippines, Thailand, Bangladesh, Bhutan, Brunei, Myanmar, Cambodia, Laos, Malaysia, Maldives, Mongolia, Nepal and Vietnam; excludes Japan, India, Pakistan, Sri Lanka

R&D Update

HDP-101 Phase I/II study in Multiple Myeloma patients

Multiple Myeloma (MM) is a type of blood cancer

• • that develops from plasma cells in the bone marrow and can affect more than one part of the body

• • In myeloma, the bone marrow makes lots of abnormal (cancerous) plasma cells.

• • Worldwide incidence of multiple myeloma is currently 160,000 with a mortality of 106,000.

Phase I part is making good progress

• • Five patient cohorts (20, 30, 60, 80 and 100 µg/kg) completed

  • • 18 patients in total

  • • Treatment was safe and well-tolerated in the first four cohorts

  • • 1 patient in stable disease on monotherapy for > 1 year from cohort 3

• • Cohort 5:

  • • First efficacy: 3 objective responses at dose level 100 µg/kg,

  • • 3 partial remissions out of 5 patients treated continuously with 100µg/kg

  • • Safety Review Committee recommended dose optimization to increase tolerability

  • • Initial reduction of thrombocyte count addressed by planned modification and optimization of the medication regimen (protocol amendment) in Cohort 6

Dose scheme adaptation

Dose escalation continues with amended dosing scheme in Cohort 6

Starting from cohort 6, cohort will have 3 arms:

• • Arm A: single dose of HDP-101 (after premedication) on day 1 of each 21-day cycle

• • Arm B: split dose of HDP-101 on days 1, 8, and 15 of each cycle (weekly dosing)

• • Arm C: split dose of HDP-101 on days 1 and 8 of cycle 1 followed by a single dose on day 1 of each subsequent cycle

At least 3 patients per arm to be included

After Cohort 6, potential next cohorts will be continued with promising regimes only

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Heidelberg Pharma AG published this content on 25 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 March 2024 15:46:03 UTC.