HALF-YEAR REPORT
AS OF 30 3UN E 2025
Philogen
innovating targBt
Index
Group data and information for shareholders 1
Corporate Governance 2
Philogen: introduction to the Group 3
History 3
The Group Strategy 3
The Group Pipeline 3
Intellettual property 4
Macroeconomic context 6
Philogen stock performance 7
Interim management report as of June 30, 2025 9
Introduction 10
Information on the Group 10
Research and development activities 11
Scientific developments during the first half of 2025 11
Summary of development and GMP activities carried out in the period ended June 30, 2025 11
Significant events during the first half of 2025 14
License agreement between subsidiary Philochem AG and RayzeBio 14
Update on the marketing authorization application for Nidlegy™ 14
Internal Dealing Transactions 15
Purchase of treasury shares 15
Remuneration policy 16
Appointment of the Board of Directors and Board Committees 17
Relations with the Revenue Agency 18
Group economic and financial results 18
Income statement 18
Balance sheet 20
Alternative Performance Indicators 21
Procedure and relations with related parties 23
Organization, management, and control model pursuant to Legislative Decree 231/2001 and Whistleblowing Procedure 23
Information on corporate governance and ownership structure 24
Main risks and uncertainties 24
Strategic and operational risks 24
Information on the environment and occupational safety 26
Responsibility towards the environment and climate change 26
Personnel Information 27
Significant events after the end of the period 29
License agreement between subsidiary Philochem AG and RayzeBio 29
Purchase of treasury shares 29
Forecast business outlook 30
Condensed consolidated half-year financial statements as of June 30, 2025 33
Consolidated income statement 34
Consolidated statement of comprehensive income 35
Consolidated statement of financial position 36
Statement of changes in consolidated shareholders' equity 37
Consolidated cash flow statement 38
Notes to the condensed consolidated interim financial statements 39
Preparation criteria 39
Introduction 39
Entity preparing the condensed consolidated half-yearly financial statements ( ) 39
Criteria for preparation 39
Segment reporting 40
Income statement 41
Revenues and income 41
Operating costs 42
Financial income and expenses 45
Taxes 45
Earnings/(loss) per share 47
Assets 48
Property, plant, and equipment 48
Intangible assets 49
Right-of-use assets and lease liabilities 49
Inventories 50
Contract assets and liabilities 51
Trade receivables 51
Tax receivables and payables 52
Other current financial assets 53
Other current assets 54
Cash 54
Shareholders' equity and liabilities 54
Employee benefits 57
Current and non-current financial liabilities 58
Trade payables 59
Other current liabilities and non-current 59
Other information 60
Share-based payment incentive plan 60
Financial risk disclosure 62
Information on financial instruments 65
Related parties 66
Accounting principles 68
Valuation criteria 68
Main accounting principles 68
Certification of the condensed consolidated half-year financial statements pursuant to Article 81-ter of Consob Regulation No. 11971 of May 14, 1999, as amended and supplemented by Legislative Decree No. 58 of February 24, 1998 84
Group data and information for shareholdersPhilogen S.p.A
Registered office: Piazza La Lizza no. 7, 53100 Siena Secondary offices:
Local unit no. SI/2 Via Montarioso n.11, Loc. Monteriggioni, 53035 Siena
Local unit no. SI/5 Loc. Bellaria n.35, Sovicille, 53018 Siena Arezzo-Siena Companies Register:
VAT number/Tax code 00893990523
REA SI-98772
Share capital: €5,731,226.64 fully paid up
Italian Stock Exchange Symbol: PHIL
ISIN ordinary shares: IT0005373789
Multiple voting ISIN: IT0005373821
LEI code: 81560009EA1577917768
Shares: 40,611,111
Philochem AG
Registered office: Libernstrasse 3, 8112 Otelfingen, Switzerland
Commercial Register: No. CH-020.3.030.226-7
VAT number: MWST-Nr/VAT-REG: CHE-113181.443
Share capital: CHF 5,051,000
Investor relations
Email: IR@philogen.com - Dr. Emanuele Puca, PhD
Website
https://www.philogen.com
Corporate GovernanceBoard of Directors
The Board of Directors, appointed by the Shareholders' Meeting on April 29, 2025, will remain in office for the three-year period 2025-2027, until the approval of the financial statements for the year ending December 31, 2027.
Executive Chairman (*) Dr. Duccio Neri
Chief Executive Officer (*) Prof. Dario Neri
Managing Director (*) Dr. Giovanni Neri
Director Sergio Gianfranco Dompé
Director Dr. Nathalie Dompé
Director Dr. Leopoldo Zambeletti
Director (**)/(***) Marta Bavasso
Director (**) Dr. Chiara Falciani
Director Patrizia Sacchi
Director (**) Flavia Scarpellini
(*)Executive Director.
(**)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(***)Lead Independent Director.
Board of Auditors
Chairman of the Board of Auditors Maurizio Di Marcotullio
Statutory Auditor Pierluigi Matteoni
Statutory Auditor Alessandra Pinzuti
Alternate Statutory Auditor Roberto Bonini
Alternate Statutory Auditor Nadia Fontana
Auditing Firm
KPMG S.p.A.
Manager responsible for preparing the company's financial reports
Dr. Laura Baldi, Chief Financial Officer, Chartered Accountant and Statutory Auditor.
Supervisory Body Legislative Decree 231/2001
The single-member Supervisory Body (SB), appointed by resolution of the Board of Directors on April 29, 2025, for the three-year period 2025-2027, is composed of Marco Tanini. The SB will remain in office until the end of the current Board of Directors term and will be appointed by the new incoming Board.
Control, Risk and Sustainability Committee (*)
Marta Bavasso (Chair) (**) /(***)
Chiara Falciani (**)
Patrizia Sacchi
(*)This Committee also acts as the Related Party Transactions Committee.
(**)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(***)Lead Independent Director.
Appointments and Remuneration Committee
Marta Bavasso (Chair) (*) / (**)
Chiara Falciani (*)
Patrizia Sacchi
(*)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(***)Lead Independent Director
Philogen: introduction to the Group-
History
Philogen, listed on the Mercato Telematico Azionario (EXM) since March 3, 2021, is an Italian Swiss company founded in 1996, specializing in the research and development of drugs for the treatment of highly lethal diseases. The company is a leader in the identification of high-affinity ligands for tumor antigens, used to selectively deliver active ingredients to the diseased area. The focus is on the development of oncology drugs, but the company also has products for the treatment of chronic inflammatory diseases. In recent years, Philogen has expanded its pipeline, bringing new drugs into the clinic and initiating experimental studies in new indications. Currently, the group has a diversified pipeline with numerous Phase II and III studies, including Nidlegy™ and Fibromun in Phase III. The company has increased its investment in small organic molecules with high affinity for tumor targets, leading to the discovery of drugs such as OncoFAP and OncoACP3, currently in clinical trials.
Philogen has a research and development facility in Zurich, where new experimental drugs are discovered. The most promising prototypes are transferred to Siena for production at the company's GMP facilities. The company has a GMP facility in Montarioso (Siena) approved by AIFA to produce experimental drugs. A second GMP production facility has been built in Rosia (Siena) to produce commercial drugs and for clinical trials, certified by AIFA in 2023 and valid in various countries.
The figure below illustrates the three phases of Philogen's history from 1996 to June 30, 2025, with their respective industrial achievements.
Note: 1L first-line treatment (i.e., newly diagnosed patients); 3L third-line treatment (i.e., patients who have failed two lines of therapy); Oligomet. NSCLC: oligometastatic non-small cell lung cancer; NMSC: non-melanoma skin cancer; MAA: Marketing Authorization Application; EMA: European Medicines Agency; BMS: Bristol Myers Squibb
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The Group Strategy
Philogen is a biotechnology company with strong vertical integration, covering all stages of drug development, including research, GMP manufacturing, and clinical development. In addition to its research site in Zurich and its GMP site in Montarioso (Siena), the Group has expanded its production capacity by building a new GMP facility in Rosia (Siena) to serve the future commercialization of its products. The new facility received certification from the AIFA GMP MED office in 2023.
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The Group Pipeline
Philogen The Group's product portfolio consists of (i) antibody-based products and small organic molecules that are in various stages of clinical development, and (ii) various preclinical programs that are fundamental to the Group's continued innovation in the future.
Nidlegy™ (for the treatment of skin cancer in Europe, Australia, and New Zealand), Fibromun, Dekavil, OncoFAP-diagnostic, and OncoACP3 are currently subject to licensing agreements with other pharmaceutical companies. The other products are wholly owned by the Philogen Group.
- Intellettual property
The Group protects the results of its research and development activities by using a broad international portfolio of patents for industrial inventions and patent applications currently being registered, consolidating its patent position in the field of vascular targeting.
The Group protects the results of its research and development activities by using a broad international portfolio of patents for industrial inventions and patent applications currently being registered, consolidating its patent position in the field of vascular targeting.
Patents and patent applications serve to protect market exclusivity for candidate products, the technical processes necessary for their production, or the related medical treatment protocols.
The duration of individual patents depends on the legal duration of patents in the countries in which they were obtained. In most countries, including Italy, the duration of a patent is 20 years from the first claimed filing date of a non-provisional patent application or its foreign equivalent in the country in question.
The Group owns or has exclusive licenses for more than one hundred national patents filed in various countries.
The Group's patents mainly include: (i) "technology" patents relating to the fundamental enabling technologies used in the Group's activities; (ii) "product" patents, i.e., patents relating to preclinical and clinical development candidates and their constituent elements; and (iii) "combination" patents relating to the combination of patented product candidates with other therapeutic agents not covered by patents.
Patent portfolio
For a better understanding of the intellectual property held by the Group, below is a summary of patents or patent applications registered in the name of the Parent Company and its subsidiary as of June 30, 2025.
Philogen S.p.A.:
Country | Patents Granted/Applications Accepted | Patent applications |
Algeria | 1 | - |
Australia | 13 | 4 |
Brazil | 1 | 2 |
Canada | 11 | 4 |
China | 3 | 6 |
Colombia | 1 | - |
Eurasia | 1 | - |
Europe | 14 | 9 |
Hong Kong | 4 | 5 |
India | 3 | 2 |
Indonesia | 1 | - |
Iraq | 1 | - |
Israel | 1 | - |
Japan | 11 | 3 |
Lebanon | 1 | - |
Malaysia | 1 | - |
Mexico | 7 | 2 |
New Zealand | 5 | 2 |
Gulf Cooperation Council (GCC) countries | - | 1 |
Pakistan | 1 | - |
Peru | 1 | - |
Russia | 4 | |
Singapore | 1 | 1 |
South Africa | 4 | - |
South Korea | 7 | 2 |
Taiwan | 2 | - |
United States | 23 | 9 |
Vietnam | 1 | - |
Patent Cooperation Treaty (PCT) (*) | - | 3 |
(*)PCT (Patent Cooperation Treaty): treaty on cooperation in patent matters - 158 states participating in the treaty to date. The owner of an international PCT patent application may continue the application in specific states in which they wish to obtain the patent, completing the actual filing of the international application in each of these states within 30 months of the filing date (or priority date) of the application.
Philochem AG:
Country | Patents Granted/Applications Accepted | Patent Applications |
Australia | 1 | 4 |
Brazil | 1 | 3 |
Canada | 1 | 5 |
China | 1 | 4 |
Europe | 5 | 7 |
Hong Kong | 1 | 3 |
India | - | 3 |
Israel | 1 | 2 |
Japan | - | 5 |
Macau | 1 | - |
Mexico | 1 | 3 |
Singapore | - | 3 |
South Korea | - | 3 |
United States of America | 4 | 7 |
Patent Cooperation Treaty (PCT)(() | - | 2 |
(*)PCT (Patent Cooperation Treaty): treaty on cooperation in the field of patents - 158 states participating in the treaty to date. The owner of an international PCT patent application may continue the application in the specific states in which they wish to obtain the patent, finalizing the actual filing of the international application in each of these states within 30 months of the filing date (or priority date) of the application.
Macroeconomic contextIn the first half of 2025, financial markets were dominated by Donald Trump's executive orders. On April 2, he announced a maxi tariff package with "reciprocal" duties on over 180 countries, effective from August 1. Agreements already in place with the United Kingdom and Vietnam, partial détente with China, negotiations open with the EU and Japan.
Despite the initial impact, the markets closed positively, supported by tech (AI), rate cuts in the Eurozone, and Germany's plan for tax reforms and green investments (€500 billion over 12 years). In Asia, domestic stimulus measures benefited China, while Japan suffered from weak growth and an unstable yen.
The ECB made four 25 bp cuts, bringing the deposit rate to 2.00%, with a further cut likely before the end of the year. The Fed kept rates steady, postponing possible reductions until October.
Manufacturing in the Eurozone remained in contraction but showed a slight recovery, while services supported employment and growth. In the US, manufacturing reached its highest level in three years, despite risks from tariffs and inflation; services showed moderate growth.
Attention remains focused on the Middle East, due to the Israel-Hamas and Israel-Iran conflicts and the possible effects on energy and raw materials.
Philogen stock performancePhilogen shares (Ticker: PHIL) closed the first half of 2025 with a share price of €21.50, giving the company a market capitalization of €873.14 million.
Philogen | |
Price June 30, 2025 (Eu) | 21.50 |
No. of shares (mn) | 40.61 |
Market cap (€ million) | 873.14 |
IPO price March 3, 2021 (Eu) | 17 |
Price change (EUR) | 4.50 |
Price change (%) | 26.47 |
The minimum closing price in the first half of 2025, recorded on January 31, was €17.50, while the maximum closing price
in the reference period, recorded on June 16, was €27.40.
During the first six months of 2025, trading in Philogen shares on the market managed by Borsa Italiana S.p.A. reached
an average daily value of €336,154.95, equivalent to an average daily volume of 14,752.64 shares.
Since its listing, the Company has not distributed dividends, but has initiated and executed several share buyback programs, holding 346,892 treasury shares as of June 30, 2025, equal to 0.8542% of the share capital.
Period | Average volumes Italian Stock Exchange | Average value Italian Stock Exchange | Days on Italian Stock Exchange |
1H2025 average | 14,753 | 336,155 | 125 |
Average 2024 | 8,704 | 165,952 | 253 |
Average 2023 | 11,187 | 186,591 | 254 |
Average 2022 | 6,530 | 91,374 | 252 |
Average 2021 | 24,050 | 362,383 | 214 |
Average from IPO to 06/30/25 | 12,459 | 211,271 | 1,098 |
Closing price | 1 month | 3 months | 6 months | 12 months | |
Simple average (EU) | 24.57 | 22.51 | 20.56 | 20.42 | |
Volume-weighted average (EU) | 24.65 | 22.50 | 20.52 | 20.37 | |
Max (EU) | 27.40 | 27.40 | 27.40 | 27.40 | |
Min (EU) | 17.00 | 17 | 17 | 17 | |
In the first six months of 2025, the FTSE MIB index recorded a positive performance of 16.40%, while the SPDR S&P
Biotech suffered some losses, falling by 7.92%.
In a positive market environment, focused on companies with greater capitalization, which guarantee better liquidity, and oriented mainly towards sectors with positive sector-specific dynamics, such as the defense sector, Philogen shares recorded a solid overall performance (+10.26%) in the first six months of 2025, despite the volatility that characterized May and June following significant news flow.
In particular, among the company-specific news flow that influenced the performance of Philogen shares, we note (i) the decision to voluntarily withdraw the marketing authorization application to the European Medicines Agency (EMA) for the product Nidlegy™, which had been submitted in June 2024 (for further information, please refer to paragraph 4.2 of the interim management report), and (ii) the licensing agreement between the subsidiary Philochem AG and RayzeBio (Bristol-Myers Squibb group) signed on June 10, 2025, which grants RayzeBio worldwide rights to OncoACP3, a therapeutic and diagnostic agent for prostate cancer (see paragraphs 4.1 and 13.1 of the interim management report).
Following the announcement of the agreement, Philogen's share price rose sharply, gaining approximately +20.9% and closing at €27.2, with price fluctuations between €26.6 and €27.8, showing a positive market reaction to the news, with a surge in the stock price reflecting investor confidence in the potential growth resulting from the contract, significantly outperforming the biotechnology market and positioning itself slightly below the Italian market.
The stock's performance is shown in the graph below.
Comparison of Philogen's performance with the main benchmark indices
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Comparison of Philogen's performance with the main benchmark indices
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As shown in the chart, Philogen's stock experienced an initial post-listing decline, followed by a gradual recovery and a very sharp acceleration in early 2025, supported by exceptional volumes and corporate drivers.
Today, it is trading at its highest level for the period, showing relative strength compared to the international biotech sector and more in line with the performance of the Italian market.
Interim management report as of June 30, 2025
Introduction
Dear Shareholders,
The Interim Report on Operations of Philogen S.p.A. (hereinafter also referred to as the "Company" or the "Parent Company" and, together with its Swiss subsidiary Philochem, the "Group") is presented together with the condensed consolidated financial statements for the six months ended June 30, 2025.
This Interim Report on Operations is intended to provide information on the income, assets, financial position, and operations of the Company and the Group, accompanied, where possible, by historical data and/or alternative performance evaluation indicators, and has been prepared in accordance with the provisions of Article 2428 of the Italian Civil Code and Legislative Decree No. 58 of February 24, 1998 ("Consolidated Law on Finance" or "TUF").
The condensed consolidated half-year financial statements at June 30, 2025, have been prepared in accordance with the international accounting standard on interim reporting (IAS 34 - Interim Financial Reporting).
Please refer to the explanatory notes for all information relating to the presentation of the condensed consolidated half-year financial statements as at June 30, 2025.
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Information on the Group
The Group focuses its activities on the development of drugs based primarily on antibody conjugates, capable of selectively accumulating at sites where the disease is present.
This is possible thanks to a scientific approach known as tumor targeting, in which the Group is one of the recognized scientific leaders worldwide. In this context, the Group carries out all stages of its production cycle in-house, which consists of the discovery and production of new drugs and the coordination of preclinical and clinical studies at its facilities in Siena (Italy) and at the research center in Zurich (Switzerland), where its subsidiary Philochem AG is based.
Since 2019, the Group has focused its development activities primarily on two of the most advanced products in its pipeline, Fibromun and Nidlegy(TM), embarking on a path of regulatory testing for the two drugs. At the same time, it has redesigned a competitive and diversified pipeline in order to opportunistically evaluate licensing agreements for its products or platforms under development. In parallel, the Group has invested in the field of small molecules with high affinity for tumor targets, leading to the discovery of OncoFAP and OncoACP3, currently in the experimental phase.
The Group has a research and development facility in Zurich (through its subsidiary Philochem), where new experimental drugs are discovered. The most promising prototypes (in terms of biochemical characteristics, safety, and efficacy based on preclinical tumor models) are then transferred to Siena, where they are produced at the company's GMP (Good Manufacturing Practice) facilities. Philogen has a GMP facility in Montarioso (Siena) approved by the Italian Medicines Agency (AIFA) for the production of experimental drugs and antibodies in mammalian cells. A second GMP production facility has also been built at the Rosia (Siena) site for the production of both commercial drugs and drugs for clinical trials. This new facility received certification from the AIFA GMP MED office in 2023. The certification is valid in Europe, the United States, Switzerland, England, Canada, Japan, Australia, New Zealand, and Israel (see Mutual Recognition Agreements of the European Medicines Agency).
It should be noted that the Parent Company is considered an "SME" pursuant to Article 1, paragraph 1, letter w)-quater 1 of the Consolidated Law on Finance, which defines small and medium-sized enterprises as issuers of listed shares with a market capitalization of less than €1,000 million. Issuers of listed shares that have exceeded this limit for three consecutive financial years are not considered SMEs. (Consob publishes the list of companies on its website). It should be noted that category B shares (multiple voting shares) are excluded from the Italian Stock Exchange capitalization. Philogen's average capitalization, net of category B shares, from the start date of trading (March 3, 2021) to December 30, 2025, is €629 million.
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Research and development activities
The Group's activities cover all stages of the drug development process, including discovery, basic research, preclinical and clinical development, and manufacturing.
The Group operates through:
Philogen S.p.A., based in Siena, which manages GLP-authorized laboratories, GMP-authorized production facilities (at the Montarioso and Rosia sites), and numerous international clinical trial centers through its internal Contract Research Organization (CRO) and collaboration with several external CROs;
Philochem AG, based in Switzerland, 99.998% owned by Philogen S.p.A., which carries out research and development in the fields of selective discovery and therapeutic antibodies at its laboratories in Zurich, as well as the development of technologies such as antibody libraries and DNA-encoded chemical libraries.
Research and development is currently the Group's main activity.
However, the Group is also expanding its manufacturing activities at GMP-approved facilities for both its proprietary products and contract manufacturing.
The following table shows the research and development costs recognized in the income statement for the years ended June 30, 2025, and June 30, 2024, and their impact on total revenues from contracts with customers and total operating costs of the Group.
Data in thousands of euros and as a percentage
Period ended June 30
2025
2024
Research and development costs
14,325
11,241
Percentage of total contract revenue
260.3
1,443.6
Percentage of total operating costs
63.4
66.3
It should be noted that research and development costs include all direct costs related to discovery, basic research, preclinical and clinical development, and production activities, including the cost of personnel employed in these activities.
For further details on the Group's research and development activities, please refer to the introductory section "History," while for operating costs, please refer to note 6 of the condensed consolidated half-year financial statements.
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Scientific developments during the first half of 2025
The main scientific events for the period ended June 30, 2025, are reported below.
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Summary of development and GMP activities carried out in the period ended June 30, 2025
The Group reports the following main industrial milestones achieved during the period:
Proprietary products
Antibody-based products
Nidlegy™
Composed of two active ingredients: L19-IL2 and L19-TNF.
The L19 antibody is specific to the B domain of fibronectin, a protein expressed in tumors and absent in most healthy tissues.
The cytokines IL2 and TNF have antitumor activity.
Currently in clinical development (Phase II and III).
Product agreements:
Sun Pharma (June 2023): license and commercialization in Europe, Australia, and New Zealand;
Merck Sharp & Dohme (June 2023): clinical collaboration (Phase II in unresectable melanoma).
Summary table - Clinical studies on Nidlegy™
Study / Area
Phase
Indication
Status / Key notes
EU locally advanced melanoma
III
III II
II
Melanoma
Primary objective achieved (October 2023). EMA application submitted (June 2024) and withdrawn (June 2025) due to need for additional data.
US locally advanced melanoma
Melanoma
129/186 patients enrolled. Ongoing in the US, Spain, Switzerland, expansion to other countries.
Duncan (NMSC: BCC, cSCC)
Non-melanoma skin cancers
Enrollment completed in CH, DE, PL. Data expected at ESMO October 2025.
Intrinsic (various NMSCs)
Kaposi's sarcoma, cutaneous T-cell lymphoma, Merkel cell carcinoma, BCC, cSCC, etc.
Ongoing in Italy and France, target 70 patients
New registration studies (US)
II
BCC and cSCC
Application submitted to FDA for three new studies.
Collaboration with Merck (USA)
II
Stage III/IV unresectable melanoma
Study in patients refractory to checkpoint inhibitors.
Fibromun
L19 antibody fused with TNF.
Active clinical trials in STS (soft tissue sarcomas), leiomyosarcoma, and glioblastoma (Phases I-III).
Agreement with Sun Pharma (October 2024) for global commercialization.
Summary table - Clinical studies on FIbromun
Study / Area
Phase
Indication
Status / Key notes
EU soft tissue sarcoma (STS), 1st line
III
STS in combination with doxorubicin
Enrollment completed. Final results expected in the coming months.
US leiomyosarcoma, 1st line
IIb
Leiomyosarcoma in combination with doxorubicin
Ongoing in 7 US centers; expansion with new centers opening.
EU soft tissue sarcoma (STS), 3rd line
II
STS in combination with dacarbazine
Enrollment completed. Final results expected in the coming months.
Glioblastoma, 1st line (EU)
I/II/IIb
In combination with radiotherapy + temozolomide
Phase I completed. Phase II to start in 2026.
Glioblastoma, 2nd line (EU)
I / II
In combination with lomustine
Enrollment completed. Results expected in the first half of 2026.
Pre-treated glioblastoma (US)
II
In combination with lomustine
Study approved by the FDA. 70/90 patients enrolled. Ongoing.
Small molecule products
OncoFAP
Molecule with high affinity for FAP (fibroblast activation protein), expressed in over 90% of epithelial tumors.
Diagnostic applications (imaging with 68Ga-OncoFAP, Phase I completed) and therapeutic applications (OncoFAP-23 in Phase I).
Licensing agreement with Blue Earth Diagnostics (Bracco) for imaging.
OncoACP3
Molecule with affinity for prostatic acid phosphatase (PAP).
Diagnostic and therapeutic applications for prostate cancer.
Phase I study underway in Italy.
License agreement with RayzeBio (BMS) (June 2025).
Summary table - OncoFAP and OncoACP3 clinical trials
Study / Area
Phase
Indication
Status / Key notes
OncoFAP (diagnostic, 68Ga-OncoFAP)
I
Imaging of solid tumors (breast, colorectal, lung, prostate, pancreas, sarcomas, etc.)
Phase I clinical trial completed in Germany. Product development according to the license agreement signed with Blue Earth Diagnostics (Bracco).
OncoFAP-23 (therapeutic)
I
Solid tumors
Phase I clinical trial approved by AIFA; first patient expected shortly.
OncoFAP-GlyPro-MMAE (therapeutic)
Preclinical (in vivo on dogs)
Solid tumors
Preclinical study completed with objective responses. GMP production planned and human clinical trials to begin.
OncoACP3 (diagnostic, 68Ga-OncoACP3)
I
Prostate cancer
Imaging already performed in Germany. Phase I clinical study underway in Italy.
OncoACP3 (therapeutic)
Phase I preparation
Prostate cancer
Preparatory activities underway. Compassionate use in Germany has shown excellent tumor targeting (persistence in the tumor ≥ 7 days).
OncoACP3 (RayzeBio license)
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Prostate cancer
Global license agreement signed with RayzeBio (BMS) on June 10, 2025.
Products in partnership
OncoACP3 → RayzeBio (BMS).
Nidlegy™ → Sun Pharma (EU, AU, NZ);
Fibromun → Sun Pharma
Dekavil → Pfizer.
Small molecules → Janssen.
OncoFAP (Imaging) → Bracco.
GMP (production)
Rosia plant (Siena): fully operational since 2023, AIFA GMP certifications (clinical and commercial production).
Montarioso plant (Siena): production of experimental drugs and contract manufacturing since 2004. The Montarioso plant is undergoing revamping in 2025. The plant is expected to return to operation towards the end of 2025.
Both sites are GMP-authorized and subject to periodic inspections by the competent authorities.
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Summary of development and GMP activities carried out in the period ended June 30, 2025
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Significant events during the first half of 2025
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License agreement between subsidiary Philochem AG and RayzeBio
On June 10, 2025, Philogen S.p.A. announced to the market, in a press release published on the company's website (https://www.philogen.com/investors/press-releases/), that its subsidiary Philochem AG and RayzeBio Inc. (a wholly owned subsidiary of Bristol-Myers Squibb) had signed a license agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize OncoACP3 (a therapeutic and diagnostic agent in clinical development for the treatment of prostate cancer).
Under the agreement, Philochem will receive an initial payment of $350 million (upfront payment) and RayzeBio will be responsible for the development and subsequent commercialization of OncoACP3.
The license agreement also provides for payments of up to $1 billion based on milestones for development, regulatory, and commercialization activities, as well as mid-single to low double-digit royalties payable on global net sales.
The effectiveness of the agreement is subject to antitrust review (waiting period pursuant to the Hart-Scott-Rodino Antitrust Improvements Act), which postponed the effectiveness of the agreement from June 10, the date of signing, to August 18, the effective closing date.
, on August 18, Philochem AG and RayzeBio, Inc. announced the successful completion of the antitrust review in the United States and the effective date of the global license agreement for OncoACP3.
For this reason, in accordance with the applicable accounting standards, it was not possible to reflect in the income statement for the first half of 2025 the revenue deriving from the aforementioned upfront payment, which was invoiced in August 2025 and duly collected in September 2025.
If the US Antitrust investigation had been completed by June 30, 2025, the main economic KPIs for the first half of 2025, considering the above-mentioned upfront payment, would have been as follows
Economic KPIs
First half of 2025 Adjusted(**)
Figures in thousands of euros
Revenues (*)
307,422
Operating costs
(22,589)
EBITDA
284,853
Depreciation
(1,963)
EBIT
282,890
Financial income
Financial expenses
2,670
(2,194)
PROFIT BEFORE TAXES
283,366
(*)The exchange rate used is the average exchange rate at June 30, 2025, for the consolidated half-year financial statements, equal to 0.9414.
(**)Non-accounting measures estimated by management.
For further details, please refer to paragraph 13.1 of the interim report on operations.
-
Update on the marketing authorization application for Nidlegy™
On June 24, 2025, Philogen S.p.A. announced to the market, in a press release published on the company's website (https://www.philogen.com/investors/press-releases/), of its decision to voluntarily withdraw its marketing authorization application to the European Medicines Agency (EMA) for the product Nidlegy™, which had been submitted in June 2024.
The company explained that the decision to withdraw the application was due to the time needed to collect additional data relating to Chemistry Manufacturing and Controls (CMC) (production) and clinical data.
The Company plans to resubmit the updated Marketing Authorization Application (MAA) as soon as possible, consistent with the time required to obtain the above-mentioned data.
-
Internal Dealing Transactions
Starting in July 2021, director Sergio Dompé, through Dompè Holding S.r.l., based on his confidence in the Group's potential and capabilities, purchased 622,284 ordinary shares of Philogen S.p.A. on the market, of which 19,994 were purchased during the first half of 2025.
Starting in November 2024, director Dr. Maria Giovanna Calloni, based on her confidence in the Group's potential and capabilities, purchased 18,000 ordinary shares of Philogen S.p.A. on the market, of which 13,100 were purchased during the first half of 2025.
Communications pursuant to Internal Dealing regulations are available on the Company's website (https://www.philogen.com/).
-
Purchase of treasury shares
On April 29, 2025, following the revocation of the authorization to purchase and dispose of treasury shares adopted on April 29, 2024, the Ordinary Shareholders' Meeting authorized the Company to purchase treasury shares, giving the Board of Directors the power to delegate to the Chairman of the Board of Directors and/or the Chief Executive Officer the authority to proceed, including through specially appointed intermediaries, with the purchase of Philogen S.p.A. shares, establishing the relevant terms and conditions and the price per share, in compliance with applicable laws and regulations.
This resolution provides the Company with a strategic flexibility tool that can be used to:
fulfill obligations arising from incentive plans, whether paid or free of charge, in favor of company representatives, employees, or collaborators of the Group;
establish a securities warehouse to dispose of treasury shares as part of agreements with strategic partners and/or extraordinary corporate/financial transactions, including, by way of example and without limitation, acquisitions, mergers, capital transactions, exchanges, contributions, swaps, financing transactions, or other transactions, in relation to which the allocation or other disposal of treasury shares is necessary or appropriate
support the liquidity of Philogen S.p.A. shares in order to facilitate regular trading and avoid price movements that are not in line with market trends, as well as to regularize trading and price trends in the face of temporary distortions linked to excessive volatility or low trading liquidity, also pursuant to and for the purposes of the market practice permitted by Consob in accordance with the provisions of Article 13 of EU Regulation No. 596/2014;
operate with a medium- and long-term investment perspective, intervening on the market, both on over-the-counter markets and outside the market, through accelerated book building or block trades, at any time, in whole or in part, on one or more occasions, provided that market conditions allow.
The Company may purchase (i) up to a maximum of 250,000 ordinary shares (ii) for eighteen months from the date of the shareholders' meeting resolution authorizing the purchase, within the limits established by Article 2357, paragraph 2, of the Italian Civil Code, and without time limits with regard to the disposal; (iii) at a purchase or disposal price, as the case may be, to be determined from time to time by the Board of Directors, also taking into account the method chosen for carrying out the transaction and in compliance with any applicable regulatory requirements; and (iv) for a total expenditure for the purchase transactions not exceeding €5,750,000 in any case.
On May 6, 2025, the Board of Directors approved the launch of the share buyback program, in implementation of the authorization granted by the Shareholders' Meeting on April 29, 2025, and appointed Mediobanca (Banca di Credito Finanziario S.p.A.) to carry out the purchases.
As of June 30, 2025, the Company holds 346,892 treasury shares in its portfolio, equal to 0.8542% of the share capital.
All communication relating to the purchase of treasury shares are available and can be consulted on the Company's website at (https://http://www.philogen.com/).
As of June 30, 2025, the Company's shareholding structure was as follows:
Shareholder Shareholding structure as of June 30, 2025
Type of shares
Shares
% of share capital
% of voting rights
B shares
8,565,018
21.09
40.56
Nerbio S.r.l.
Ordinary Shares
8,098,251
19.94
12.78
Subtotal
16,663,269
41.03
53.35
Shares B 2,803,232 6.90 13.28
Dompé Holdings S.r.l. Ordinary Shares
10,076,538
24.81
15.91
Subtotal
12,879,770
31.71
29.18
Philogen S.p.A Ordinary shares
346,892
0.85
0.55
Subtotal
346,892
0.85
0.55
Shares B
-
-
-
Market Ordinary Shares
10,721,180
26.40%
16.92%
Subtotal
10,721,180
26.40
16.92
Total
40,611,111
100
100
-
Remuneration policy
In accordance with the regulations applicable to listed companies, the Group adopted a remuneration policy starting in 2021, the year of its listing.
On April 29, 2025, pursuant to Article 123-ter of the Consolidated Law on Finance, the Shareholders' Meeting, having taken note of the Report on the remuneration policy and compensation paid in the 2024 financial year, approved by the Board of Directors on March 27, 2025, approved Section I of the Report on Remuneration Policy and Compensation Paid, and voted in favor of Section II of the Report on Remuneration Policy and Compensation Paid.
The Report on Remuneration Policy and Compensation Paid is available and can be consulted on the Company's website at (https://http://www.philogen.com/) in the Governance/Shareholder's Meetings section.
Monetary incentive plan ("MBO")
From June 1, 2025, until May 31, 2026, the executive directors (Dario Neri, Duccio Neri, and Giovanni Neri) and the Company's executives are beneficiaries of an incentive plan, known as management by objectives ("MBO"), under which they may be entitled to receive an annual incentive, the amount of which is commensurate with the achievement of corporate performance objectives.
The maximum impact of the MBO on the annual remuneration of the Executive Directors is 75%, while for Executives it ranges from 10% to 22% of annual remuneration.
Without prejudice to the maximum impact of MBO described above, on May 27, 2025, the Company's Board of Directors, upon the recommendation of the Appointments and Remuneration Committee, assigned performance objectives and defined the targets associated with the maximum monetary compensation to the aforementioned Executive Directors and Executives of the Company for the period from June 1, 2025, to May 31, 2026.
It should be noted that, in line with the provisions of the Remuneration Policy for the year 2024, the Executive Directors were paid the MBO for the period April 1, 2024 - March 31, 2025 in May 2025.
With reference to the 2024-2025 MBO assigned to a manager, it should be noted that one of the objectives assigned to the aforementioned manager includes a performance period ending on September 30, 2025. Therefore, the Company will verify the achievement of this objective at a Board of Directors' meeting after September 30, 2025.
Medium- to long-term incentive plan
At the Company's Ordinary Shareholders' Meeting on April 29, 2025, amendments were made to the Information Documents of the following incentive plans: the "2027-2029 Stock Grant Plan" (reserved for employees and consultants of the Philogen Group) and the "2024-2027 Share Ownership Plan for Directors" (originally called the "2024-2026 Share Ownership Plan for Directors," reserved for executive directors of the Philogen Group).
The Board of Directors, meeting on May 27, 2025, following the favorable opinion of the Nomination and Remuneration Committee, approved the updated regulations for both Plans and identified the beneficiaries of the "2024-2027 Shareholding Plan for Directors" and defined the performance objectives and related targets for the second cycle of the aforementioned Shareholding Plan. The characteristics of the 2027-2029 Stock Grant Plan and the 2024-2027 Share Ownership Plan for Directors, as amended by the Shareholders' Meeting, are illustrated in the respective Information Documents and related Regulations available and consultable on the Company's website at (https://http://www.philogen.com/).
-
Appointment of the Board of Directors and Board Committees
Board of Directors
On April 29, 2025, the Shareholders' Meeting, in accordance with current laws and regulations, the provisions of the Articles of Association (Article 16 of the Articles of Association) and the Corporate Governance Code, for the purposes of submitting lists for the appointment of the Board of Directors and the information contained in the "Explanatory Report of the Board of Directors" relating to the appointment of the Board of Directors, drawn up in accordance with Article 125-ter of Legislative Decree No. 58 of February 24, 1998 ("TUF"), appointed the Board of Directors, which, in the composition set out below, will remain in office until the approval of the financial statements for the year ending December 31, 2027.
Executive Chairman (*) Duccio Neri
Chief Executive Officer (*) Prof. Dario Neri
Managing Director (*) Dr. Giovanni Neri
Director Sergio Gianfranco Dompé
Director Dr. Nathalie Dompé
Director Dr. Leopoldo Zambeletti
Director (**) /(***) Marta Bavasso,
Director (**) Dr. Chiara Falciani
Director Patrizia Sacchi
Director (**) Flavia Scarpellini
(*)Executive Director.
(**)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(***)Lead Independent Director.
Board committees
On May 6, 2025, the Company's Board of Directors, in compliance with the recommendations of the Corporate Governance Code, established and appointed the following internal committees: the "Control, Risks and Sustainability Committee," with the functions set forth in recommendations 33 and 35 of the Corporate Governance Code, and the "Appointments and Remuneration Committee," with the functions set forth in recommendations 19 (on appointments) and 25 (on remuneration). In particular, the Control, Risk and Sustainability Committee has also been assigned the functions relating to transactions with Related Parties provided for in the Consob Regulation adopted by resolution no. 17221 of March 12, 2010.
Control, Risk and Sustainability Committee (*)
Marta Bavasso (Chair) (**) /(***)
Chiara Falciani (**)
Patrizia Sacchi
(*)This Committee also acts as the Related Party Transactions Committee.
(**)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(***)Lead Independent Director.
Appointments and Remuneration Committee
Marta Bavasso (Chair) (*) /(**)
Chiara Falciani (*)
Patrizia Sacchi
(*)Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance and Article 2 of the Corporate Governance Code.
(**)Lead Independent Director.
-
Relations with the Revenue Agency
In March 2025, the Siena Revenue Agency launched a tax audit for direct taxes for the tax years 2019 to 2023. The audit mainly concerned operating grants and capital grants received by the Company in reference periods for a total of €10,243 thousand and their non-contribution to the taxable base for IRES and IRAP direct taxes, as the Company recorded operating losses in the reference years.
In May 2025, the Company received notification of the initiation of the formal assessment procedure, which the Company contests in its entirety. Discussions are ongoing with the Revenue Agency to clarify the interpretation of the relevant regulatory framework.
To date, the Agency has not issued any draft assessment.
Given the current stage of discussions and considering the assessment of the assessment process by the external consultant it has engaged, the Company has deemed the degree of risk to be "possible."
It should be noted that, in the event of an unfavorable rule, previous tax losses in the years in question would be reduced by the above amount, resulting in a reduction in deferred tax assets recorded in the financial statements of approximately
€3 million, from approximately €10 million to approximately €7 million, without any cash outlay. Please refer to note 8 of the condensed consolidated half-year financial statements.
-
License agreement between subsidiary Philochem AG and RayzeBio
-
Group economic and financial results
-
Income statement
The following table shows the Group's consolidated financial results for the periods ended June 30, 2025, and June 30, 2024:
Figures in thousands of euros and as a percentage As at June 30 Changes
2025
%
2024
%
2025 vs
2024
%
Revenue from contracts with customers
5,502
100.0
779
100.0
4,724
606.7%
Others income
3,218
58.5
931
119.6
2,287
245.7%
Total Revenue
8,721
158.5
1,710
219.6
7,011
410.1
Operating costs (*)
(22,589)
(410.5)
(16,958)
(2,178.0)
%
(5,631)
33.2
EBITDA (**)
(13,869)
(252.0)
(15,249)
(1,958.4)
%
1,380
(9.1)
Depreciation
(1,963)
(35.7)
(1,798)
(230.9)
(166)
9.2
EBIT
(15,832)
(287.7)
(17,046)
(2,189.3)
%
1,215
(7.1)
Financial income
2,670
48.5%
3,571
458.6%
(900)
(25.2)
Financial expenses
(2,194)
(39.9)
(2,033)
(261.1)
(161)
7.9
Profit before taxes
(15,355)
(279.1)
(15,509)
(1,991.8)
154
(1.0)
Taxes
461
8.4
(8)
(1.0) %
468
(6047.2)
Profit (Loss) for the period
(14,894)
(270.7)
(15,516)
(1,992.8)
622
(4.0)
(*)Operating costs are given by the sum of the following items in the condensed consolidated half-year financial statements: purchases of raw materials and consumables, costs for services, costs for use of third-party assets, personnel costs, and other operating costs.
(**)EBITDA is represented by operating profit before depreciation and amortization. EBITDA is a measure defined and used by the Group to monitor and evaluate the Group's operating performance, but it is not defined under IFRS; therefore, it should not be considered an alternative measure for evaluating the Group's operating performance. The Company believes that EBITDA is an important parameter for measuring the Group's performance as it allows for the analysis of its margins by eliminating the effects of non-recurring economic factors. Since EBITDA is not a measure whose determination is regulated by the accounting standards of reference for the preparation of the Group's consolidated financial statements, the criteria applied to determine EBITDA may not be consistent with those adopted by other groups and may therefore not be comparable.
Below is a commentary on the income statement table above.
The Group's total revenues as of June 30, 2025, amounted to €8,721 thousand, an increase of approximately €7,011
thousand compared to the period ended June 30, 2024. Total revenues consist of:
Revenues from contracts with customers amounting to €5,502 thousand (€779 thousand as of June 30, 2024) relate to : (i) the contribution from the SUN contract signed in 2024 for the Fibromun product, represented on the basis of the progress of clinical trials (ii) the progress of GMP manufacturing contracts signed with third parties during 2024, in addition to the continuation of existing contracts, and (iii) sales of the Nidlegy™ product to SUN to support pre-commercialization plans.
Other income amounting to €3,218 thousand at June 30, 2025 (€931 thousand at June 30, 2024) mainly relates to credits that the Group benefits from on an ongoing basis by virtue of its research and development activities, including the research and development credit of €2,342 thousand as of June 30, 2025, compared to €724 thousand in the same period of the previous year. The increase is due to the higher research costs incurred by the Group during the first half of 2025. In addition, the item Other income also includes the Industry 4.0 credit, which was granted following investments made in 2022 for the equipment and interconnection of the new GMP facility at the Rosia (Siena) site, in accordance with Law 160/2019 (the 2020 Budget Law) and Law 178/2020 (the 2021 Budget Law). The Industry 4.0 credit realized totals €2,586 thousand (it should be noted that this contribution is recognized in revenues over the useful life of the GMP facility to which the contribution refers).
Operating costs of €22,589 thousand mainly include costs for production materials, clinical and preclinical services, personnel, and other operating costs and show an increase of approximately 33.2% compared to the previous period. This change is mainly due to:
the increase in costs for services related to the Group's core business activities, which rose from €7,427 thousand at June 30, 2024, to €12,329 thousand at June 30, 2025. In particular, there were significant increases in cost items related to the clinical trial phase of the drug and the valuation of incentive plans for directors.
an increase in personnel costs from €7,466 thousand at June 30, 2024, to €8,118 thousand on June 30, 2025, due to new qualified hires and the implementation of incentive plans for employees.
For further details, please refer to note 6 and note 25 of the condensed consolidated half-year financial statements.
EBITDA improved by approximately 9.1%, going from a negative value of €15,249 thousand at June 30, 2024, to a negative value of €13,869 thousand at June 30, 2025, because of increased operating costs against a growth in revenues.
Depreciation and amortization were in line with the previous period, showing a slight increase of approximately 9.2% compared to the period ending June 30, 2024.
EBIT, calculated as the difference between EBITDA and depreciation and amortization, shows a negative balance of
€15,832 thousand for the period ended June 30, 2025.
Net financial management for the period ending June 30, 2025 shows a net positive result of €477 thousand, down by
approximately €1,061 thousand compared to June 30, 2024. This result is the difference between financial income of
€2,670 thousand and financial expenses of €2,194 thousand and can be mainly attributed to (i) net income on the securities portfolio , amounting to €1,314 thousand, consisting of net capital gains on disposals, coupon and dividend receipts; (ii) net valuation losses of €13 thousand relating to changes in the fair value of the securities portfolio; (iii) interest income of
€72 thousand, of which €53 thousand related to time deposits that matured during the half-year; (iv) interest expense and other financial expenses of €187 thousand; (v) net foreign exchange losses of €709 thousand.
For further details on financial management, please refer to note 7 of the condensed consolidated half-year financial statements.
Taxes of €461 thousand represent the net balance between current taxes and deferred taxes. For further details, please refer to note 8 of the condensed consolidated half-year financial statements.
As a result of the above, the Group closed the period ending June 30, 2025, with a net loss of €14,894 thousand.
-
Balance sheet
The following table shows the reclassified statement of financial position for the Group for the periods ending June 30, 2025, and December 31, 2024:
Figures in thousands of euros and as a percentage
As of June 30 2025 As of December
31 2024
Changes 2025 vs 2024
%
Assets
Property, plant, and equipment
15,821
15,473
347
2.2
Intangible assets
1,230
1,159
71
6.1
Assets for right of use
9,369
9,401
(32)
(0.3)
Other non-current assets
1,626
1,626
-
-
Deferred tax assets
10,883
8,468
2,415
28.5
Employee benefits
(1,360)
(1,293)
(67)
5.2
Deferred tax liabilities
(405)
(283)
(123)
43.4
Other non-current liabilities
(1,107)
(1,107)
-
-
Net fixed capital (*)
36,056
33,444
2,612
7.8
Inventories
4,301
3,260
1,040
31.9
Contract assets
5,156
3,261
1,895
58.1
Trade receivables
969
760
209
27.5
Tax receivables
8,598
10,253
(1,655)
(16.1)
Other current assets
1,373
1,062
311
29.2
Trade payables
(13,471)
(9,550)
(3,921)
41.1
Contractual liabilities
(2,533)
(643)
(1,890)
293.8
Tax liabilities
(188)
(2,135)
1,948
(91.2)
Other current liabilities
(2,976)
(3,239)
263
(8.1)
Net working capital (*)
1,229
3,029
(1,800)
(59.4)
Net invested capital (*)
37,285
36,473
812
2.2
Sources
Net equity
125,810
138,657
(12,847)
(9.3)
Net financial Position (*)
(88,525)
(102,184)
13,659
(13.4)
Total sources
37,285
36,473
812
2.2
(*)Net fixed capital, net working capital, net invested capital, and net financial debt are alternative performance indicators that are not identified as accounting measures under IFRS and, therefore, should not be considered alternative measures provided in the Group's financial statements for assessing the Group's financial position and results of operations.
An analysis of the financial position shows that the Group has a positive net financial position of €88,525 thousand, the change in which is detailed in the following paragraph on the Net Financial Debt table.
Net Financial Debt
The details of Net Financial Debt as of June 30, 2025, and December 31, 2024, are prepared in accordance with ESMA Guideline 32-382-1138 of March 4, 2021, and Consob through Attention Notice No. 5/21:
Figures in thousands of euros
Net financial debt
June 30, 2025
December 31,
2024
(A) Cash and cash equivalents
11,182
25,574
(B) Cash equivalents
-
5,000
(C) Other current financial assets
88,839
83,154
(D) Cash and cash equivalents (A+B+C)
100,021
113,728
(E) Current financial debt
40
37
(F) Current portion of non-current financial debt
1,157
1,034
(G) Net current financial debt (E+F)
1,197
1,070
(H) NET CURRENT FINANCIAL DEBT (G-D)
(98,824)
(112,658)
(I) Non-current financial debt
10,299
10,473
(J) Debt instruments
-
-
(K) Trade payables and other current liabilities
-
-
(L) Non-current financial debt (I+J+K)
10,299
10,473
(M) NET FINANCIAL DEBT (H+L)
(88,525)
(102,184
For clarity, the reconciliation between the items reported in the Net Financial Debt table and the Balance Sheet of the condensed consolidated half-year financial statements is shown below:
"Cash and cash equivalents" (A) are classified under "Cash and cash equivalents";
"Cash equivalents" (B) are classified under "Cash and cash equivalents";
"Other current financial assets" (C) are classified under "Other current financial assets";
"Current financial debt" (E) is classified under "Current financial liabilities";
"Current portion of non-current financial debt" (F) is classified under "Current financial liabilities" and "Current lease liabilities";
"Non-current financial debt" (I) is classified under "Non-current financial liabilities" and "Non-current lease liabilities."
Net financial debt at June 30, 2025 shows a financial surplus of €88,525 thousand, which broke down as follows:
Cash and cash equivalents (D) amounted to €100,021 thousand, down by approximately 4.4% compared to the period ending December 31, 2025. This change is attributable to the net balance between: (i) receipts for revenues from contracts with customers of approximately €5,251 thousand, (ii) operating expenses of approximately
€16,773 thousand, (iii) investment expenses of €1,639 thousand mainly relating to the renovation of the production site in Montarioso (Siena) and the construction of a private-company car park covered with photovoltaic panels at the Rosia site (Siena); (iv) net income from financial operations of €808 thousand, consisting of €556 thousand relating to the net decrease in the fair value of the securities portfolio held and €1,364 thousand relating to coupon payments and interest received on the maturity of restricted current accounts; (v) €1,354 thousand relating to the purchase of treasury shares.
Current and non-current financial debt (G+L) amounted to €11,496 thousand, of which approximately €11,456 thousand related to the right-of-use liability for properties (IFRS 16) and €40 thousand to the balance of credit cards as of June 30, 2025. For further information on liabilities for right of use and financial payables, please refer to note 12 and note 22 of the condensed consolidated half-year financial statements.
-
Alternative Performance Indicators
In order to assess the Group's performance, management monitors, among other things, Alternative Performance
Indicators ("APIs") relating to assets and financials.
For a correct interpretation of these APIs, please note the following:
APIs are constructed from historical data and are not indicative of the Group's future performance.
APIs are not measuring whose determination is regulated by international accounting standards (IFRS);
APIs should not be considered a substitute for the indicators provided for by the relevant accounting standards (IFRS);
These IAPs should be read in conjunction with the Group's financial information taken from the condensed consolidated half-year financial statements at June 30, 2025.
the definitions of the APIs used by the Group, as they do not derive from the relevant accounting standards, may not be consistent with those adopted by other groups and therefore may not be comparable with them.
The following are the alternative economic performance indicators identified by the Group:
Data in thousands of euros and as a percentage
Period ended June 30
2025
2024
Revenue from contracts with customers
5,502
779
EBITDA (*)
(13,869)
(15,249)
EBITDA Margin
(252.0)
(1,958.4)
EBIT
(15,832)
(17,046)
(*)EBITDA represents operating profit before depreciation and amortization. EBITDA is a measure defined and used by the Group to monitor and evaluate the Group's operating performance, but it is not defined under IFRS; therefore, it should not be considered an alternative measure for evaluating the Group's operating performance. Since EBITDA is not a measure whose determination is regulated by the accounting standards used to prepare the Group's consolidated financial statements, the criteria applied to determine EBITDA may not be consistent with those adopted by other groups and may therefore not be comparable.
Data in thousands of euros and as a percentage
As of June 30
As of December 31
2025
2024
Net fixed capital
36,056
33,444
Net working capital
1,229
3,029
Net invested capital
37,285
36,473
Net financial debt
(88,525)
(102,184)
Financial independence ratio
79.0
82.3
Structure margin
323.2
383.8
Liquidity ratio
591.3
784.1
Debt ratio
9.1
8.3
The table below shows the reconciliation of EBIT and EBITDA with profit (loss) for the period.
Figures in thousands of euros
Period ended June 30
2025
2024
Profit (loss) for the period
(14,894)
(15,516)
Income taxes
461
(8)
Financial income and expenses
477
1,538
EBIT
(15,832)
(17,046)
Depreciation and amortization
(1,963)
(1,798)
EBITDA
(13,869)
(15,249)
The EBITDA margin is calculated as shown in the table below:
Data in thousands of euros and as a percentage
Period ended June 30
2025
2024
Revenue from contracts with customers (A)
5,502
779
EBITDA (B)
(13,869)
(15,249)
EBITDA Margin (B/A)
(252.0)
(1,958.4)
The following are the Alternative Performance Indicators identified by the Group:
The following table shows the details of the Financial Independence Ratio:
Data in thousands of euros and as a percentage
As of June 30
As of December 31
2025
2024
Net equity (A)
125,810
138,657
Total assets (B)
159,436
168,452
Financial independence ratio (A/B)
79.0
82.3
The following table shows the details of the structural margin:
Data in thousands of euros and as a percentage
At June 30
As of December 31
2025
2024
Net equity (A)
120,418
138,657
Non-current assets (B)
20,365
36,127
Structural margin (A/B)
591.3
383.8
The following table shows the details of the liquidity index:
Data in thousands of euros and as a percentage
At June 30
As of December 31
2025
2024
Current assets (A)
120,418
132,325
Current liabilities (B)
20,365
16,639
Liquidity ratio (A/B)
591.3
795.3
The following table shows the details of the Debt Ratio:
Data in thousands of euros and as a percentage
As of June 30
As of December 31
2025
2024
Financial debt (*)(A)
11,496
11,544
Net equity (B)
125,810
138,657
Debt ratio (A/B)
9.1
8.3
(*)Financial debt was calculated as the algebraic sum of the following balance sheet items: "Current financial liabilities," "Non-current financial liabilities," "Current lease liabilities," and "non-current lease liabilities."
The indicators shown in the tables above highlight the Group's solid and liquid financial position.
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Income statement
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Procedure and relations with related parties
In accordance with the current "Procedure for Transactions with Related Parties," the OPC Committee (composed of the Chief Financial Officer and the Head of Legal Affairs) sent the OPC Committee the necessary communications relating to the transactions carried out by the Company, which were subsequently recorded in the relevant register of Transactions with Related Parties.
During the first half of 2025, transactions were carried out with related parties under normal market conditions, generating profitability in line with the company's income parameters. Related party transactions are disclosed in the financial statements and described in detail in note 30 of the condensed consolidated half-year financial statements, to which reference should be made, and are not classified as atypical or unusual.
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Organization, management, and control model pursuant to Legislative Decree 231/2001 and Whistleblowing Procedure.
In order to clearly and transparently define the set of values that inspire it to achieve its institutional objectives, Philogen
S.p.A. adopted, starting in 2020, an Organization, Management, and Control Model pursuant to Legislative Decree 231/2001, which has been updated over time to reflect changes in applicable regulations ("Model").
In particular, during the first half of 2025, the Company continued to monitor any legislative changes and amendments to the corporate governance structure adopted by the Company following its listing, in order to be able to incorporate them into the Model in a timely manner.
The current versions of the Organizational Model ("General Section") and the Code of Ethics are available on the Company's website (https://http://www.philogen.com/) in the Governance section (code-of-ethics-and-model-231).
The Company has implemented a process to review its Organizational Model, with the support and under the supervision of the Supervisory Body, in order to verify its adequacy following recent regulatory updates.
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Information on corporate governance and ownership structure
Philogen S.p.A. adheres to the Corporate Governance Code for Italian listed companies, adapting it to its own characteristics.
In order to meet the transparency requirements of the sector regulations, the "Report on corporate governance and ownership structure" required by Article 123-bis of the Consolidated Law on Finance has been drawn up, providing a general description of the governance system adopted by Philogen S.p.A. in addition to information on the ownership structure, the organizational model adopted pursuant to Legislative Decree No. 231 of 2001, and the degree of compliance with the Corporate Governance Code, including the main governance practices applied and the characteristics of the risk management and internal control system in relation to the financial reporting process.
In particular, the aforementioned "Report on Corporate Governance and Ownership Structure" indicates the most significant events that characterized corporate management during 2024, including the resignation of executives with strategic responsibilities Dr. Duccio Neri, Prof. Dario Neri, and Dr. Giovanni Neri, respectively Chairman of the Board of Directors, Chief Executive Officer and Managing Director, respectively, and the consequent revision of the powers delegated to the aforementioned executive directors and the assessments made by the Board of Directors on the "Recommendations of the Committee for 2024" contained in the letter sent to the Company by the Chairman of the Corporate Governance Committee at the Board of Directors' meeting on January 30, 2025.
This document is available on the Company's website at https://www.philogen.com.
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Main risks and uncertainties
The information specifically required by Article 2428 of the Italian Civil Code is analyzed in greater detail below.
The mapping and management of business risks is an activity carried out constantly by the Group in order to assess, in terms of probability and impact, all aspects that may in some way hinder the achievement of business objectives. Business risks are divided into operational risks, if related to business processes and activities, and financial risks, if related to the financial area.
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Strategic and operational risks
Risks related to dependence on senior management, key personnel, and specialized personnel
Due to the specialized nature of its activities, the Group is significantly dependent on qualified management and other key scientific personnel, for whom it faces intense competition and which it will need to expand in order to grow, such as, in particular, the Chairman of the Scientific Committee and CEO, who has gained extensive scientific research experience at some of Europe's leading research centers, including the Medical Research Council and ETH Zurich. The loss of key personnel or the inability to attract and retain additional qualified personnel could have a negative impact on the development and commercialization of product candidates. The occurrence of such risks could have a serious negative impact on the Group's economic, financial, and equity position.
Risks associated with conducting research, clinical and preclinical studies, and manufacturing
The Group's strategy is aimed at marketing pharmaceutical products that are still in the experimental phase, only two of which are in the more advanced stages of study. There are significant uncertainties associated with the success of the experimental phase and obtaining authorizations from the competent authorities for the marketing of pharmaceutical products. Furthermore, the products may not meet market expectations in terms of efficacy and safety and, therefore, no significant revenue may be generated from their marketing. If the Group is unable to market its products and license its
product candidates, or if other competing products are preferred by the market over those of the Group, this will have a serious negative impact on the Group's economic, financial, and equity position.
Risks related to the protection of intellectual property rights and dependence on trade secrets
The Group's commercial success will also depend on its ability to protect its intellectual or industrial property rights, including potential rights (covering processes and the use of the products themselves), in the European Union, the United States of America, Japan, and other countries. If the Group's efforts to protect its exclusive and intellectual property rights are insufficient, competitors could exploit the Group's technologies to create competing products, erode its competitive advantage, and take over all or part of its market share. The occurrence of such risks could have a material adverse effect on the Group's economic, financial, and equity position.
Risks related to changes and non-compliance with industry regulations
In conducting clinical trials of compounds, the Group must comply with applicable national and international regulations, including, in particular, Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines. Any changes to the current regulatory framework could lead to longer production times and/or clinical trials for compounds and increased costs, with a consequent negative impact on the Group's economic, equity and financial situation.
Risks related to IT systems
IT systems are exposed to the risk of IT network failures and/or malfunctions, data security breaches, viruses, unauthorized access, and natural events that could result in data loss or the disclosure/communication of confidential and/or proprietary information, with potential negative effects on the Group's activities and growth and development prospects. Philogen guarantees the security of sensitive data and information and intellectual property, managing the entire cycle, which includes threat detection and the definition of countermeasures in response to attacks. The Group's IT defense system provides for specific organizational safeguards - in compliance with regulations and reference standards, which involve the adoption of specific requirements and timelines for the communication of incidents and/or data breaches - as well as the continuous training of operators and operational tools.
Financial risks and risks related to the fair value of the securities portfolio
Financial risks are risks arising from the ownership or trading of financial instruments. The Company invests diligently in accordance with a financial investment policy approved by the Board of Directors, which is constantly monitored and updated. The Group is subject to the risk of changes in the fair value of the financial instruments held in its portfolio, the value of which at June 30, 2025, was €88,839 thousand. The occurrence of this risk could have a significant negative impact on the Group's economic, financial, and equity position. Detailed tables of financial risks are provided in note 28 to the condensed consolidated half-year financial statements.
Exchange rate risk
The Group is exposed to exchange rate risk in the case of sales, purchases, receivables, and loans denominated in a currency other than the Group's functional currency. Production activities are limited to Italy and Switzerland and therefore the Group is exposed to fluctuations between the euro and the Swiss franc, while receipts are mainly in dollars and euros. The reference currency is the euro. Philogen is subject to exchange rate risk arising from the conversion of the financial statements of its Swiss subsidiary Philochem AG, with an effect on consolidated net income and consolidated shareholders' equity (translation risk). For further details on financial risks, please refer to note 26 of the condensed consolidated half-year financial statements.
Risks associated with existing lease agreements
As part of the management of leased properties, the Company constantly monitors rental risk, i.e., the risk arising from the possibility that leased properties may be subject to changes in rent or in the duration of leases as originally agreed in the contract (renewal may take place on less favorable terms than in previous years) or in the costs associated with the management of leased spaces or difficulties, in the event of non-renewal of lease agreements, in finding additional spaces and/or properties in which to carry out its business.
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Strategic and operational risks
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Information on the environment and occupational safety
The location where the Company operates and its production activities are subject to stringent environmental and occupational safety regulations.
The Company adopts safety procedures for the management of work activities in accordance with Legislative Decree 81/2008 and Legislative Decree 206/2001 on the handling of genetically modified microorganisms (MOGM). Staff undergo specific training in this area and operate according to procedures designed to minimize the risks of contamination, not only biological. Special waste is disposed of in accordance with current regulations (Legislative Decree 152/06), following dedicated procedures, with the support of a specialized and authorized company.
In accordance with the obligations of Article 37 of Legislative Decree 81/2008 and the procedures defined by the State -Regions Agreement of December 21, 2011, periodic training and refresher courses on safety are provided for all employees, divided into general and specific training courses, which employees attend according to a program specified by the applicable industry regulations.
In carrying out its activities, the Company uses chemical and biological agents for which specific risk assessments are carried out in accordance with Legislative Decree 81/2008. Personnel also use personal protective equipment (PPE) in line with regulations.
The Company believes that it conducts its business in compliance with environmental regulations and the authorizations required by applicable laws and is constantly committed to operating in an environmentally responsible manner.
Group personnel are constantly updated and trained with reference to applicable industry regulations. In particular, in the first half of 2025, training courses were again held to update and increase the number of employees trained in first aid, in line with the increase in staff numbers. This course was enhanced with an optional module on the use of defibrillators, a life-saving device that is increasingly recommended in companies. In addition, refresher courses were held for RLS (Workers' Safety Representatives) and training and refresher courses for managers and supervisors, and training courses were completed for work at height, confined spaces, work on electrical systems (PES-PAV-PEI) and 3rd degree boiler operators.
Finally, it should be noted that no definitive sanctions or penalties have ever been imposed on the company for environmental crimes or damage.
- Responsibility towards the environment and climate change
The European Securities and Markets Authority (ESMA) highlight the importance for the Company to consider the main climate risks and impacts when preparing its financial statements.
In this regard, ESMA notes that investors are increasingly interested in information regarding the impact that climate-related issues may have on companies, especially considering international and European commitments such as the 2015 Paris Agreement and the European Climate Law (EEC/EU Regulation No. 1119 of June 30, 2021).
Considering international and European commitments, such as the 2015 Paris Agreement and the European Climate Law, as well as numerous regulatory interventions in recent years, the Company recognizes the importance of combating climate change and is committed to contributing positively to environmental protection through the development of strategies and initiatives aimed at minimizing the environmental impact of its business activities.
