Heidelberg Pharma AG: Interim Management Statement on the First Three Months
of 2024

EQS-News: Heidelberg Pharma AG / Key word(s): Quarterly / Interim Statement
Heidelberg Pharma AG: Interim Management Statement on the First Three Months
of 2024

25.04.2024 / 07:21 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Heidelberg Pharma AG: Interim Management Statement on the First Three Months
of 2024

  * First efficacy data from the clinical trial with HDP-101 in multiple
    myeloma

* Professor Andreas Pahl becomes Chief Executive Officer

* Successful financing activities

  * Sale of a portion of future royalties for Zircaix(TM) to HealthCare Royalty
    finances further development of the ADC pipeline

Ladenburg, Germany, 25 April 2024 - Heidelberg Pharma AG (FSE: HPHA) today
reported on the first three months of fiscal year 2024 (1 December 2023 - 29
February 2024) and the Group's financial figures.

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: "We are very
pleased to see the first efficacy data in multiple myeloma in the clinical
trial with our ATAC candidate HDP-101. In three patients from the fifth
cohort, we have observed an objective improvement in the disease ("partial
remission"). We will optimize the dosing regimen for the sixth cohort.
HDP-101 was recently granted orphan drug status by the FDA for the treatment
of multiple myeloma; this underlines the potential of our Amanitin-based ADC
candidate in this indication."

Walter Miller, CFO of Heidelberg Pharma AG, added: "In the first quarter of
the financial year, we also successfully worked on financing the company and
our ADC activities and concluded an attractive, non-equity-dilutive
agreement with HealthCare Royalty in March. The upfront payment received at
the end of March and the expected further payments from the partial sale of
future royalties from the worldwide sale of ZircaixTM provide a very solid
financing basis and will help us to accelerate the expansion of our ADC
pipeline."

Important operational developments and achievements

  * HDP-101 (BCMA ATAC) development program: The ATAC product candidate
    HDP-101 is being evaluated in a Phase I/IIa clinical trial for the
    treatment of relapsed or refractory multiple myeloma. The first four
    patient cohorts and dose levels have been completed and proved to be
    safe and well tolerated. Since September 2023, patients in the fifth
    cohort have been treated with a dose of 100 µg/kg HDP-101. After the
    initial administration of HDP-101, a temporary drop in thrombocyte count
    occurred in all patients. However, this normalized within a few days,
    with counts returning to clinically unremarkable levels.
    In order to mitigate the effect of the initial administration, an
    adjustment and optimization of the medication regimen was developed. The
    corresponding protocol adjustments were implemented and recruitment of
    the sixth cohort was started.
    Encouragingly, the fifth cohort showed biological activity in three out
    of five patients, who continued on 100 µg/kg, and an objective
    improvement in the disease was detected ("partial remission"). In
    addition, one of the study participants from the third cohort has been
    treated with HDP-101 as a monotherapy since January 2023 and showed a
    stabilization of the course of disease ("stable disease").

  * New Chief Executive Officer: Dr. Jan Schmidt-Brand, long-standing CEO of
    Heidelberg Pharma AG and Managing Director of the subsidiary Heidelberg
    Pharma Research GmbH, stepped down from his positions on 31 January 2024
    upon reaching retirement age. The Supervisory Board appointed Professor
    Andreas Pahl as CEO with effect from 1 February 2024. Professor Pahl
    also assumed the role of Managing Director of the subsidiary. Professor
    Pahl has been Head of Research & Development at Heidelberg Pharma since
    2012 and has been a member of the Executive Management Board since 2016.
    He holds a doctorate in chemistry and has more than 25 years of
    experience in the pharmaceutical industry as well as in research and
    teaching.

Events after the reporting period

  * Agreement closed with HealthCare Royalty on the sale of a portion of
    future royalties: In early March 2024, Heidelberg Pharma signed an
    agreement with HealthCare Royalty, Delaware, USA, (HCRx) for the sale of
    a portion of future royalties from global sales of Zircaix(TM). Heidelberg
    Pharma received a non-refundable upfront payment of USD 25 million and
    is also entitled to up to an additional USD 90 million from the sale of
    the royalties, if defined milestones are met. Once HCRx has received a
    maximum cumulative amount, the royalties will revert to Heidelberg
    Pharma and HCRx will receive a low single-digit percentage of royalties.
    ZircaixTM is a radiolabeled form of the antibody girentuximab which
    binds to the tumor-specific antigen CAIX on clear cell renal cell
    carcinomas. Heidelberg Pharma developed the antibody up to a first
    completed Phase III clinical trial prior to licensing it to Telix
    Pharmaceuticals Limited, a company based in Melbourne, Australia, in
    2017. Telix submitted its Biologics License Application (BLA) under a
    rolling review submission with the US Food and Drug Administration (FDA)
    in December 2023 and expects market approval by the end of 2024.
    Recently, Telix announced that the BLA is due for completion by end-May
    2024. Telix has requested a Priority Review as well.

  * Orphan drug designation granted by FDA for HDP-101: At the end of March,
    Heidelberg Pharma announced that the US Food and Drug Administration
    (FDA) has granted Orphan Drug Designation (ODD) for the treatment of
    multiple myeloma to its lead candidate HDP-101. Orphan Drug Designation
    is granted for a drug or biological product that is intended for the
    prevention, diagnosis, or treatment of rare diseases or disorders that
    affect fewer than 200,000 people in the US. The designation provides
    significant incentives to promote the development of the drug including
    tax credits for qualified clinical trials, prescription drug user-fee
    exemptions, and potential seven-year marketing exclusivity upon FDA
    approval.

Results of operations, financial position and net assets

The Heidelberg Pharma Group - as of the reporting date comprising Heidelberg
Pharma AG and its subsidiary Heidelberg Pharma Research GmbH - reports
consolidated figures. The reporting period referred to below concerns the
period from 1 December 2023 to 29 February 2024 (Q1 2024).

In the first three months of fiscal year 2024, the Group generated sales
revenue and income totaling EUR 1.9 million (previous year: EUR 2.2
million). This figure includes sales revenue of EUR 1.3 million (previous
year: EUR 2.1 million), which is made up of a roughly from deferred sales.

Other income amounted to EUR 0.6 million (previous year: EUR 0.1 million)
and primarily consisted of the reversal of unutilized provisions that were
subject to the statute of limitations.

Operating expenses including depreciation and amortization totaled EUR 6.6
million in the reporting period (previous year: EUR 8.7 million). Cost of
sales amounted to just under EUR 30 thousand and was therefore significantly
below the previous year's figure of EUR 1.4 million, which is due to the
high proportion of deferred income in sales. Research and development costs
decreased year-on-year to EUR 5.1 million (previous year: EUR 5.8 million)
and represented the largest cost item at 77%. Both periods were primarily
characterized by the cost-intensive external manufacturing for the ATAC
projects and the ongoing clinical trial with HDP-101. Administrative costs
increased slightly to EUR 1.2 million in the first quarter of fiscal year
2024 compared to the prior-year period (EUR 1.1 million). Among others, this
figure includes holding company costs and costs related to the stock market
listing. Other expenses, comprising the costs incurred for business
development, marketing and commercial market supply, halved from EUR 0.4
million to EUR 0.2 million year-on-year.

The Heidelberg Pharma Group's net loss for the first three months of the
fiscal year decreased to EUR 4.5 million, as planned (previous year: EUR 6.6
million). Basic earnings per share based on the weighted average number of
shares issued during the reporting period improved from
EUR -0.14 in the previous year to EUR -0.10 in the reporting quarter as a
result of the lower loss.

Total assets as of 29 February 2024 amounted to EUR 61.7 million and were
lower compared to the 30 November 2023 reporting date (EUR 70.4 million) as
a result of the loss for the period and reduced liabilities and the
associated lower cash. At EUR 45.1 million, equity was also significantly
lower compared to the end of fiscal year 2023 (EUR 49.3 million). This
corresponds to an equity ratio of 73.2% (30 November 2023: 70.1%). No
corporate actions were implemented during the reporting period. The share
capital of Heidelberg Pharma AG therefore remained steady at EUR 46,604,977,
divided into 46,604,977 no par value bearer shares.

Cash as of the end of the quarter amounted to EUR 32.6 million (30 November
2023: EUR 43.4 million). Heidelberg Pharma thus recorded an average cash
outflow of EUR 3.6 million per month in the first quarter of the fiscal year
(previous year: EUR 3.7 million).

Financial outlook for 2024

The Executive Management Board expects the Heidelberg Pharma Group to
generate between EUR 11.0 million and EUR 15.0 million in sales revenue and
other income (2023: EUR 16.8 million) in the 2024 fiscal year. This does not
yet include the upfront payment of USD 25 million received from HCRx and its
effects on operational planning. This inflow was used to repay the remaining
shareholder loan of EUR 5 million and substantial additional funds from the
partial sale of royalties will be used in the short term to accelerate
further ADC projects. Sales revenue from major new license agreements was
not included in this planning.

Operating expenses in 2024 are expected to be between EUR 36.0 million and
EUR 40.0 million if business develops as planned, and thus roughly at the
level of the 2023 reporting year (EUR 38.0 million). This guidance does not
include any adjustments to the R&D budget due to the cash inflow from HCRx.

An operating result of between EUR -23.5 million and EUR -27.5 million is
expected for 2024 (2023: EUR -21.2 million).

Gross funds used are expected to be between EUR 28.0 million and EUR 32.0
million in the 2024 financial year. This corresponds to an average monthly
use of cash of between EUR 2.3 million and EUR 2.7 million (2023: EUR 3.2
million). Based on current planning, the Group is financed until mid-2025,
but assumes that the cash reach will be extended due to further expected
payments from the agreement with HCRx.

A conference call on this interim management statement will not take place.
The complete figures for the interim financial statements can be downloaded
from http://www.heidelberg-pharma.com/ "Press & Investors > Announcements >
Financial Reports > Interim management statement on the first three months
of 2024".

Key figures for the Heidelberg Pharma Group (unaudited)

                            In EUR thsd.    Q1 20241 EUR    Q1 20231 EUR
                                                   thsd.           thsd.
     Earnings
     Sales revenue                                 1,267           2,075
     Other income                                    592              95
     Operating expenses                          (6,566)         (8,718)
     of which research and development           (5,073)         (5,751)
     costs
     Operating result                            (4,707)         (6,548)
     Earnings before tax                         (4,445)         (6,484)
     Net loss for the period /                   (4,494)         (6,563)
     Comprehensive income
     Earnings per share in EUR (basic)            (0.10)          (0.14)

     Balance sheet as of the end of the
     period
     Total assets                                 61,666          86,476
     Cash                                         32,650          65,011
     Equity                                       45,114          60,165
     Equity ratio2 in %                             73.2            69.6

     Cash flow statement
     Cash flow from operating activities        (10,748)        (10,740)
     Cash flow from investing activities            (42)           (302)
     Cash flow from financing activities            (29)         (5,026)

     Employees (number)
     Employees as of the end of the                  111             109
     period3
     Full-time equivalents as of the end              98             100
     of the period3

1 The reporting period begins on 1 December and ends on 28/29 February.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

About Heidelberg Pharma

Heidelberg Pharma develops novel drugs based on its ADC technologies for the
targeted and highly effective treatment of cancer. ADCs are antibody-drug
conjugates that combine the specificity of antibodies with the efficacy of
toxins to fight cancer. Selected antibodies are loaded with cytotoxic
compounds, the so-called payloads, that are transported into diseased cells.
Inside the cells, the toxins then unleash their effect and kill the diseased
cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in
cancer therapy by exploiting the toxin's biological mechanism of action with
its innovative ATAC technology as a new therapeutic modality. It offers the
opportunity to overcome resistance of cancer cells against therapeutic
agents currently used and to eliminate dormant tumor cells, which typically
survive current therapies and are responsible for tumor relapse and
metastasis. This could lead to significant advances in cancer therapy - even
for patients who no longer respond to any other treatment. The most advanced
product candidate HDP-101 is a BCMA-ATAC for the indication multiple
myeloma, which is currently in clinical development.

In addition to Amanitin, alternative payloads also expand the ADC platform
technologies of Heidelberg Pharma to develop targeted and highly effective
ADCs for the treatment of a variety of malignant hematologic and solid
tumors.

Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg,
Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 /
WKN A11QVV / Symbol HPHA. More information is available at
www.heidelberg-pharma.com.

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

    Contact Heidelberg Pharma AG Sylvia       IR/PR-Support MC Services AG
              Wimmer Director Corporate       Katja Arnold (CIRO) Managing
      Communications Tel.: +49 89 41 31    Director & Partner Tel.: +49 89
                          38-29 E-mail:                 210 228-40 E-mail:
              (1)investors@hdpharma.com     (1)katja.arnold@mc-services.eu
           Gregor-Mendel-Str. 22, 68526                                 1.
                          Ladenburg  1.    mailto:katja.arnold@mc-services
          mailto:investors@hdpharma.com                                .eu
   International IR/PR-Support Optimum
   Strategic Communications Mary Clark,
   Zoe Bolt, Katie Flint Tel: +44 20
   3882 9621 E-mail:
   (1)HeidelbergPharma@optimumcomms.com
   1.
   mailto:HeidelbergPharma@optimumcomms
   .com%0D

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
a general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, achievements, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. 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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   Language:       English
   Company:        Heidelberg Pharma AG
                   Gregor-Mendel-Str. 22
                   68526 Ladenburg
                   Germany
   Phone:          +49 (0)89 41 31 38 - 0
   Fax:            +49 (0)89 41 31 38 - 99
   E-mail:         investors@hdpharma.com
   Internet:       www.heidelberg-pharma.com
   ISIN:           DE000A11QVV0
   WKN:            A11QVV
   Listed:         Regulated Market in Frankfurt (Prime Standard);
                   Regulated Unofficial Market in Berlin, Dusseldorf,
                   Munich, Stuttgart, Tradegate Exchange
   EQS News ID:    1888915

End of News EQS News Service
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1888915 25.04.2024 CET/CEST