ATACs: Unique new mode of action to fight cancer

Safe Harbor

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.

This material is not intended as an offer or solicitation for the purchase or sale of shares of Heidelberg Pharma AG. This material may not be distributed within countries where it may violate applicable law.

© Heidelberg Pharma AG

2

Key achievements

Differentiated ADC Technologies

Strong IP

•

In Plug & Play mode

•

Several IP families

•

2 years from target to IND

•

Monopoly in the Amanitin/MoA space

GMP Manufacturing

Strategic partnerships

•

Fully synthetic process for Amanitin

•

Huadong: China-focused partnership

•

5 GMP batches completed

•

Takeda: ATAC technology partnership

Clinical Stage

Corporate & Finance

•

1 ATAC in ongoing Phase I

•

Experienced leadership team

•

2 additional ATAC INDs within the next year

•

Cash (runway): EUR 50.7m* (mid-2025)

* as per end of August 2023

© Heidelberg Pharma AG

3

Strong in-house R&D capabilities and expertise

Synthetic chemistry

Antibody generation

Preclinical testing

& bioconjugation

CMC

Bioanalytical sciences

Clinical Development

Best ADC candidate in the shortest time

© Heidelberg Pharma AG

4

Value creation through development of best-in-class ADC assets

Discovery & development engine

Scouting

Partnering

In-licensing

We are NOT a Target ID Company We are NOT Ab Discovery Company

Toolbox

of proprietary

payloads

Multiple targets

Development

AntibodiesExpertise

Partnering at IND-ready, First clinical data, EOP1, Clinical POC

Co-Development

Upside : Retain territorial rights for potential commercialization

© Heidelberg Pharma AG

5

Payload Toolbox - Multiple MOAs

Toolbox

of proprietary

payloads

ATAC-Technology

RNA-Polymerase II Inhibitor

Amanitin-based

© Heidelberg Pharma AG

TOPO1-Technology

Topoisomerase I Inhibitor

Exatecan-based

IM-Technology

TLR7 agonist

6

Growing pipeline of proprietary and partnered programs

Product

Target

Indication

Research Preclinic Phase I Phase II

Phase III Partner

HDP-101

BCMA

Multiple Myeloma

Huadong (China+)

ATAC pipeline

HDP-102

CD37

NHL (DLBCL/CLL)

HDP-103

PSMA

Prostate cancer

HDP-104

GCC

Gastrointestinal (e.g., CRC)

Huadong (option China+)

Huadong (China+)

Huadong (option China+)

TOPO

HDP-201

n/a

Solid tumors

Proprietary

ATAC partners

TAK-ATAC

n/a

Oncology

Takeda

assets

TLX250-CDxCA-IX

Renal Carcinoma

Telix

Urothelial Carcinoma, TNBC

Legacy

TLX250

CA-IX

Renal carcinoma

Telix

RHB-107

Oncology/GI, Covid-19

RedHill

© Heidelberg Pharma AG

7

Resistance is one of the biggest challenges in oncology

1 in 2

> 90%

people will be diagnosed

of cancer deaths

with cancer in their

are caused by drug

lifetime

resistance

© Heidelberg Pharma AG

8

The journey of many cancer patients

Before Treatment

Treatment

Resistance & Relapse

Wagke, N.et al, J Clin Oncol. 2011; 29(22): 3085-3096

We need new drugs with new mode-of-action to overcome resistance

© Heidelberg Pharma AG

9

The payload MOA is what makes the difference!

12-month PFS

75.8%

34.1%

Enhertu®

Payload: deruxtecan (Topo 1 inhibitor)

Kadcyla®

Payload: emtansine (Tubulin inhibitor)

Cortés, J. et al, N Engl J Med 2022; 386:1143-1154

Same target (Her2), same antibody (Trastuzumab), same patient population

© Heidelberg Pharma AG

10

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Heidelberg Pharma AG published this content on 20 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 March 2024 11:14:28 UTC.