Heidelberg Pharma Reports on First Half-Year 2024 and the Course of Business

EQS-News: Heidelberg Pharma AG / Key word(s): Half Year Report
Heidelberg Pharma Reports on First Half-Year 2024 and the Course of Business

11.07.2024 / 07:05 CET/CEST
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE

Heidelberg Pharma Reports on First Half-Year 2024 and the Course of Business

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

  * Presentation of preclinical and clinical data of the proprietary ADC
    technology platforms at the AACR Meeting 2024

* HDP-101 granted Orphan Drug Designation by the FDA

  * Sale of a portion of future royalties for TLX250-CDx to HealthCare
    Royalty

* Professor Andreas Pahl takes over as Chief Executive Officer

Ladenburg, Germany, 11 July 2024 - Heidelberg Pharma AG (FSE: HPHA)
published today its financial report on the first six months of 2024 (1
December 2023 - 31 May 2024).

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: "We are very
pleased with the positive preliminary efficacy data from the Phase I
clinical trial with our ATAC development candidate HDP-101. In three
patients from the fifth cohort, we saw an objective improvement in the
disease ("partial remission"). One of these patients is currently showing
further improvement in the development of the disease.

For the second half of the year, we are focusing on patient recruitment and
testing an optimized dosing regimen with three arms in the sixth cohort. We
are optimistic that our clinical trial will continue to develop positively,
and that the study participants will benefit from the therapy.

In March, we concluded an agreement with HealthCare Royalty on the partial
sale of future royalties. The royalties arise from the portfolio candidate
TLX250-CDx that was out-licensed to Telix. This allows us to benefit now and
in the future from the success of the candidate, which could receive
marketing authorization in the USA by the end of this year."

Key events in the first six months of 2024

  * HDP-101 (BCMA-ATAC) program: The first five patient cohorts and dose
    levels in the Phase I/IIa clinical trial for the treatment of relapsed
    or refractory multiple myeloma have been completed. The first four
    patient cohorts proved to be safe and well tolerated. In the fifth
    cohort, all patients at a dose of 100 µg/kg HDP-101 experienced a drop
    in thrombocyte count, which completely normalized after a few days and
    was clinically unremarkable.
    To mitigate this transient effect, the clinical team adjusted and
    optimized the medication regimen. Cohort 6 will consist of three arms,
    with at least three patients enrolled in each arm. In consultation with
    the clinical investigators, the dose will be 90 µg/kg in order to test
    these three dosing regimens with as little risk to the patients as
    possible. Further cohorts are planned with the most promising dosing
    regimens from cohort 6 and an increase in dose levels.
    The relevant authorities approved the mentioned protocol adjustments,
    and the recruitment of the sixth cohort was prepared. First patients are
    currently being screened.
    Fortunately, in cohort 5, three of the five patients treated with 100
    µg/kg showed biological efficacy and an objective improvement in disease
    was detectable ("partial remission"). One of these patients is currently
    showing further improvement in the development of the disease ("very
    good partial response"; VGPR).

  * New preclinical data from the ATAC technology platform presented at the
    AACR 2024 Annual Meeting: Heidelberg Pharma presented clinical and
    preclinical results of its ADC technologies at the American Association
    for Cancer Research (AACR) Annual Meeting in April. Initial safety and
    preliminary efficacy data from the Phase I clinical trial with the ATAC
    candidate HDP-101 were shown as well as preclinical data on the ATAC
    candidate HDP-102.
    In addition, scientists from Heidelberg Pharma presented the first
    preclinical data from the new HDP-201 project, an exatecan-based ADC.
    Following the conference, Heidelberg Pharma hosted its first R&D webinar
    with key opinion leaders (KOLs) in the ADC field. In addition to
    presentations on the technology platform by the management team,
    preclinical data were presented and interpreted by Rakesh Dixit, CEO of
    Bionavigen, Gaithersburg, USA, and clinical data from the study with
    HDP-101 by Jonathan Kaufman, MD, Associate Professor of Hematology &
    Medical Oncology, Emory University School of Medicine, Atlanta, USA.

  * HDP-101 receives orphan drug designation from the FDA: At the end of
    March, Heidelberg Pharma announced that the US Food and Drug
    Administration (FDA) had granted Orphan Drug Designation (ODD) to the
    ATAC candidate HDP-101. Orphan Drug Designation is granted to a drug or
    biological product intended for the prevention, diagnosis or treatment
    of rare diseases affecting fewer than 200,000 people in the United
    States. The status provides significant incentives to encourage
    development of the drug.

  * Agreement concluded on the partial sale of license fees to HealthCare
    Royalty: 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 TLX250-CDx. Heidelberg Pharma
    received a non-refundable upfront payment of USD 25 million and is also
    entitled to receive up to an additional USD 90 million from the sale of
    royalties if defined milestones are reached. After HCRx has received a
    maximum cumulative amount, the royalties revert to Heidelberg Pharma,
    and HCRx receives a low single-digit percentage of Heidelberg Pharma's
    royalties.
    Partner Telix Pharmaceuticals Limited, a company based in Melbourne,
    Australia, (Telix) completed the submission of the marketing
    authorization application for TLX250-CDx to the FDA in early June 2024
    and expects to obtain marketing authorization for the product by the end
    of 2024. An accelerated review ("priority review") was also applied for
    in parallel.

  * Change in the management: The Supervisory Board appointed Professor
    Andreas Pahl as the new Chief Executive Officer effective 1 February
    2024 after Dr. Jan Schmidt-Brand, long-standing Chief Executive Officer
    of Heidelberg Pharma AG and Managing Director of the subsidiary
    Heidelberg Pharma Research GmbH, had stepped down on 31 January 2024
    upon reaching retirement age.

Events after the reporting period

No significant events occurred after the end of the reporting period.

Financial results for the first six months of fiscal year 2024

The Heidelberg Pharma Group, which previously consisted of Heidelberg Pharma
AG and its subsidiary Heidelberg Pharma Research GmbH as of the reporting
date, reports consolidated figures. Two new companies, HDP G250 AG & Co. KG
and HDP G250 Beteiligungs GmbH, were established as part of the HCRx
agreement. These two companies are affiliated below the parent company
Heidelberg Pharma AG and are not operationally active.

The reporting period referred to below relates to the period from 1 December
2023 to the balance sheet date of 31 May 2024 (H1 2024).

The Heidelberg Pharma Group generated sales revenue and income of EUR 6.3
million in the first six months of the 2024 financial year (previous year:
EUR 4.7 million), an increase of 34%.

Sales revenue amounted to EUR 4.1 million in both comparative periods and
mainly comprised the group-wide cooperation agreements for the ATAC
technology (previous year: EUR 4.4 million).

At EUR 2.2 million, other income was significantly higher than the previous
year's level of EUR 0.3 million and consisted of government grants (EUR 1.1
million), the reversal of unutilized accrued liabilities (EUR 0.8 million)
and other items (EUR 0.3 million).

Operating expenses, including depreciation and amortization, amounted to EUR
15.6 million in the reporting period (previous year: EUR 20.7 million).

The cost of sales was below the previous year's level, amounted to EUR 1.4
million (previous year: EUR 2.9 million) and corresponded to 9% of operating
expenses. Research and development costs of EUR 10.6 million fell in
comparison to the previous year (EUR 14.8 million) due to the less
cost-intensive external production for the ATAC projects and the ongoing
clinical trial with HDP-101 compared to the same period in the previous
year. At 68% of operating expenses, this category continued to represent the
largest cost block. Administrative expenses of EUR 3.0 million (previous
year: EUR 2.3 million) amounted to 19% of operating expenses. At EUR 0.6
million, other expenses for business development, marketing and commercial
market supply activities, which mainly comprise staff and travel costs, were
slightly below the previous year's level (EUR 0.7 million) and accounted for
4% of operating expenses.

The Heidelberg Pharma Group's net loss for the first six months of 2024
amounted to EUR 8.7 million (previous year: EUR 16.0 million). The
significant improvement is due to higher income and lower expenses. Earnings
per share amounted to EUR -0.19 and, taking into account the average number
of shares, developed positively compared to the previous year (EUR -0.34).

At the end of the 2024 reporting period, Heidelberg Pharma had cash of EUR
42.6 million, which was below the year-end figure of EUR 43.4 million and
the previous year's half-year figure as of 31 May 2023 (EUR 57.4 million).
This means an average monthly cash outflow of EUR 0.1 million for the first
half of the 2024 financial year.

If the loan repayment in the amount of EUR 5 million is excluded, Heidelberg
Pharma had an average cash inflow of EUR 0.7 million per month in the first
six months of 2024, compared to an average cash outflow of EUR 3.2 million
per month in the prior-year period.

Total assets as of 31 May 2024 amounted to EUR 72.0 million, up from EUR
70.4 million as of the 30 November 2023 reporting date. Equity at the end of
the reporting period amounted to EUR 41.2 million (30 November 2023: EUR
49.3 million) and corresponded to an equity ratio of 57.2% (30 November
2023: 70.1%).

The full-year financial guidance issued on 25 March 2024 for the Heidelberg
Pharma Group was adjusted on 18 June 2024.

The Heidelberg Pharma Group expects for the financial year 2024 sales and
other income between EUR 9.0 million and EUR 12.0 million (previously: EUR
11.0 million to EUR 15.0 million). The reason for the lower sales is that
expected sales are likely to be delayed due to developments at the license
partners. In accordance with accounting regulations, the upfront payment
received from HCRx is not yet reflected in the sales revenue guidance for
financial year 2024. Heidelberg Pharma will be able to show pro rata sales
revenue in the coming financial years only after the product has been
approved, future sales revenue has been generated and license fees have been
received from Telix. Operating expenses will remain between EUR 36.0 million
and EUR 40.0 million. Based on these adjustments, an operating result (EBIT)
between EUR -25.5 million and EUR -29.5 million is expected (previously: EUR
-23.5 million to EUR -27.5 million).

For 2024, Heidelberg Pharma anticipates cash requirements of EUR 18.0
million to EUR 22.0 million (previously: EUR 28.0 million to EUR 32.0
million). Monthly cash consumption is expected to range between EUR 1.5
million and EUR 1.8 million per month (previously: EUR 2.3 million and EUR
2.7 million).

  Financial outlook           Actual 2023  Updated guidance          2024
                              EUR million  2024 EUR million  guidance EUR
                                                                  million
  Sales revenue and other            16.8        9.0 - 12.0   11.0 - 15.0
  income
  Operating expenses                 38.0       36.0 - 40.0   36.0 - 40.0
  Operating result                 (21.2)     (25.5 - 29.5)      (23.5) -
                                                                   (27.5)
  Total funding requirement          37.9       18.0 - 22.0   28.0 - 32.0
  for operations and capex1
  Funds required per month 1          3.2         1.5 - 1.8     2.3 - 2.7

1 Not including any corporate actions

Key figures for the Heidelberg Pharma Group

   In EUR thsd.                           H1 2024 1 EUR    H1 2023 1 EUR
                                                  thsd.            thsd.
   Earnings
   Sales revenue                                  4,055            4,391
   Other income                                   2,227              277
   Operating expenses                          (15,551)         (20,704)
   of which research and development           (10,583)         (14,772)
   costs
   Operating result                             (9,269)         (16,036)
   Earnings before tax                          (8,665)         (15,774)
   Net loss for the period                      (8,665)         (15,951)
   Earnings per share in EUR                     (0.19)           (0.34)

   Balance sheet as of the end of the
   period
   Total assets                                  71,974           77,965
   Cash and cash equivalents                     42,619           57,379
   Equity                                        41,163           50,891
   Equity ratio2 in %                              57,2             65.3

   Cash flow statement
   Cash flow from operating activities         (16,924)         (18,153)
   Cash flow from investing activities             (84)            (788)
   Cash flow from financing activities           16,144          (5,008)

   Employees (number)
   Employees as of the end of the                   110              113
   period3
   Full-time equivalents as of the end               97              103
   of the period3

1 The reporting period begins on 1 December and ends on 31 May
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

The full half-yearly financial report including the consolidated financial
statements prepared in accordance with International Financial Reporting
Standards (IFRS) was published at
http://heidelberg-pharma.com/en/press-and-investors/announcements/financial-reports.
There will be no conference call on the half-year report.

           Contact Heidelberg Pharma AG       IR/PR support MC Services AG
      Director Corporate Communications       Katja Arnold (CIRO) Managing
   Sylvia Wimmer Gregor-Mendel-Str. 22,    Director & Partner Tel.: +49 89
     68526 Ladenburg Tel.: +49 89 41 31                   210 22840 Email:
                            3829 Email:     (1)katja.arnold@mc-services.eu
          (1)investors@hdpharma.com  1.                                 1.
          mailto:investors@hdpharma.com    mailto:katja.arnold@mc-services
                                                                       .eu

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.

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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11.07.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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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:    1943773

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1943773 11.07.2024 CET/CEST