HALF YEAR
REPORT
AS OF JUNE 2026
Philogen
eci
Table of Contents (Courtesy English translation)
Group Data and Information for Shareholders 1
Corporate Bodies 2
Philogen: Introduction to the Group 3
Group's History 3
The Group's Strategy 4
The Group's Pipeline 4
Intellectual Property 6
Macroeconomic Context 8
Philogen Stock Performance 9
Interim Management Report as of June 30, 2026 13
Introduction 14
Information on the Group 14
Research and Development Activities 15
Scientific Developments During the First Half of 2026 15
Summary of development and GMP activities carried out during the period ended June 30, 2026 15
Significant events that occurred during the first half of 2026 18
Dividend Distribution 18
Internal Dealing Transactions 18
Purchase of Treasury Stock 18
Remuneration Policy 20
Relations with the Tax Authority 20
Compliance with Directive (EU) 2022/2555 (NIS2) and Legislative Decree No. 138 of September 4, 2024 -Appointment of the Data Protection Officer 21
Other Significant Events Occurring During the First Half of 2026 21
Group Financial Results 21
Income Statement 21
Balance Sheet 23
Alternative Performance Measures 24
Procedure and Transactions with Related Parties 26
Organizational, Management, and Control Model pursuant to Legislative Decree No. 231/2001 "Organizational Decree" ( ) and Whistleblowing Procedure 27
Information on Corporate Governance and Ownership Structure 27
Key Risks and Uncertainties 27
Strategic and Operational Risks 27
Environmental and Occupational Safety Disclosure 29
Environmental Responsibility and Climate Change 30
Personnel Information 31
Significant Events Subsequent to the End of the Period 33
Purchase of Treasury Stock 33
Update on the Marketing Authorization Application for Nidlegy™ 34
Business Outlook 34
Condensed Consolidated Half-Year Financial Statements as of June 30, 2026 39
Consolidated Income Statement 40
Consolidated Statement of Comprehensive Income 41
Consolidated Statement of Financial Position 42
Statement of Changes in Consolidated Shareholders' Equity 43
Consolidated Cash Flow Statement 44
Notes to the condensed consolidated interim financial statements 45
Basis of Preparation 45
Introduction 45
Entity Preparing the condensed consolidated semiannual financial statements 45
Preparation Criteria 45
Segment Reporting 46
Income Statement 47
Revenues and Income 47
Operating Expenses 48
Financial Income and Expenses 51
Taxes 51
Earnings/(Loss) per Share 53
Assets 53
Property, Plant, and Equipment 53
Intangible Assets 54
Right-of-use assets and lease liabilities 55
Inventories 56
Contract Assets and Liabilities 57
Trade receivables 57
Tax receivables and payables 58
Other Current Financial Assets 59
Other current assets 60
Cash and Cash Equivalents 60
Net Equity and Liabilities 60
Shareholders' Equity 60
Employee Benefits 63
Current and Non-Current Financial Liabilities 64
Trade payables 65
Other current and non-current liabilities 65
Other Information 66
Stock-Based Compensation Plan 66
Financial Risk Disclosure 69
Disclosures on Financial Instruments 72
Related Parties 73
Accounting Principles 75
Valuation Criteria 75
Principal Accounting Principles 75
Certification of the condensed consolidated semiannual 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
91
Group Data and Information for ShareholdersPhilogen S.p.A.
Registered office: Piazza L a Lizza No. 7, 53100 Siena Branch offices:
Local Unit No. SI/2 Via Montarioso No. 11, Loc. Monteriggioni, 53035 Siena
Local Unit No. SI/5 35 Bellaria, Sovicille, 53018 Siena
Local Unit No. MI/1 7 Via Privata Maria Teresa, Milan, 20123 Milan Arezzo-Siena Business Registry:
VAT ID/Tax ID 00893990523
REA SI-98772
Share Capital: 5,731,226.64 euros, fully paid-in
Borsa Italiana Ticker Symbol: PHIL
ISIN for common shares: IT0005373789
ISIN for multiple-voting shares: 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 ID: VAT No.: CHE-113181.443
Share Capital: CHF 5,051,000
Investor RelationsEmail: IR@philogen.com - Dr. Emanuele Puca, PhD
Websitehttps://www.philogen.com
Corporate Bodies Board of DirectorsThe Board of Directors, appointed by the Shareholders' Meeting on April 29, 2025, will remain in office for the three-year term 2025-2027, until the approval of the financial statements as of December 31, 2027.
• | Executive Chairman (*) | Dr. Duccio Neri |
• | Chief Executive Officer(*) | Prof. Dario Neri |
• | Managing Director (*) | Dr. Giovanni Neri |
• | Director | Dr. Sergio Gianfranco Dompé |
• | Director | Dr. Nathalie Dompé |
• | Director | Dr. Leopoldo Zambeletti |
• | Director(**) | Dr. Chiara Falciani |
• | Director | Avv. Patrizia Sacchi |
• | Director(**) | Avv. Flavia Scarpellini |
Director (**)/(***) Avv. Marta Bavasso
(*) Executive Director.
(**) Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance (TUF) and Article 2 of the Corporate Governance Code.
(***) Lead Independent Director.
Board of Statutory AuditorsAudit Firm•
Chairman
Dr. Maurizio Di Marcotullio
•
Standing Auditor:
Dr. Pierluigi Matteoni
•
Standing Auditor:
Dr. Alessandra Pinzuti
•
Alternate Auditor:
Roberto Bonini, Ph.D.
•
Alternate Auditor:
Dr. Nadia Fontana
KPMG S.p.A.
Officer Responsible for Preparing the Company's Financial StatementsDr. Laura Baldi, Chief Financial Officer, Certified Public Accountant, and Statutory Auditor.
Supervisory BodyThe single-member Supervisory Body (OdV), appointed by resolution of the Board of Directors on April 29, 2025, for the three-year period 2025-2027, consists of Dr. Marco Tanini. The OdV will remain in office until the end of the current Board of Directors' term.
Control, Risk, and Sustainability Committee (*)Marta Bavasso (Chair) (**)/(***)
Chiara Falciani (**)
Patrizia Sacchi
(*) This Committee also serves as the Related-Party Transactions Committee.
(**) Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance (TUF) and Article 2 of the Corporate Governance Code.
(***) Lead Independent Director.
Nominating and Compensation CommitteeMarta Bavasso (Chair) (*)
Chiara Falciani (*)
Patrizia Sacchi
(*) Independent director pursuant to Article 147-ter, paragraph 4, of the Consolidated Law on Finance (TUF) and Article 2 of the Corporate Governance Code.
Philogen: Introduction to the Group-
Group's History
Philogen ("the Group" or "the Company"), listed on the Mercato Telematico Azionario ("EXM") operated by Borsa Italiana (Reuters: PHIL) as of March 3, 2021, is an Italian-Swiss company founded in 1996 that operates in the biotechnology sector and specializes in the research and development of drugs for the treatment of highly lethal diseases. In particular, the Group is a leader in the identification of high-affinity ligands (human monoclonal antibodies and small organic molecules) for tumor antigens (i.e., proteins expressed in tumors but not in healthy tissues). These ligands are primarily used to selectively deliver an active ingredient (e.g., cytokines, radionuclides, cytotoxic agents) to the affected area. The Group's focus is primarily on the development of oncology drugs, although the company has also advanced products for the treatment of chronic inflammatory diseases into clinical trials.
In recent years, Philogen has consolidated and expanded its pipeline, both by advancing new drugs into clinical trials and by initiating experimental studies in new indications with products already in development. As of the date of this Report, the Group maintains a diversified pipeline thanks to the conduct of numerous Phase II and III registration studies.
The Group operates a research and development facility in Zurich through its subsidiary, where new experimental drugs are discovered. The most promising candidates (in terms of biochemical characteristics, safety, and efficacy based on preclinical tumor models) are subsequently transferred to Siena, where they are manufactured at the Company's two GMP (Good Manufacturing Practice) facilities.
As of today, the Philogen Group operates two GMP manufacturing facilities located in the province of Siena, both authorized by the Italian Medicines Agency (AIFA).
The Montarioso site is authorized to manufacture investigational medicinal products and also holds GMP compliance certification and authorization to manufacture and import active pharmaceutical ingredients. The Rosia site is authorized to manufacture sterile products for clinical and commercial use and holds authorization to manufacture and import active pharmaceutical ingredients for the same purposes. Additionally, the Rosia site was recently authorized by AIFA to manufacture small-volume injectable drugs under aseptic conditions, not limited to biotechnology products.
This structure enables the Group to operate through a manufacturing infrastructure capable of supporting both clinical and commercial activities.
Specifically:
Montarioso: AIFA (MED) authorization dated April 21, 2026, No. aM-52/2026, and GMP certificate No. IT/68/H/2026, for the production of monoclonal antibodies in small-volume liquids prepared under aseptic conditions for clinical use
Montarioso: AIFA (API) authorization dated August 31, 2026, No. GMP-API/208/2026, and GMP certificate No. IT-API/115/H/2026, for the production of biotechnological active substances (monoclonal antibodies) for clinical use.
Rosia: AIFA (MED) authorization dated July 3, 2026, No. aM 99/2026, and GMP certificate No. IT/132/H/2026, for the aseptic production of small-volume medicinal products, both investigational and commercial, including biotechnological drugs.
Rosia: AIFA (API) authorization dated September 1, 2025, No. GMP.API/175/2025, and GMP certificate IT-API/84/H/2025, for the production of biotechnological active substances (monoclonal antibodies) for clinical and commercial use.
The figure below illustrates the three phases of Philogen's history from 1996 to June 30, 2026, along with the respective industrial milestones.
Note: 3L third-line treatment (i.e., patients who have failed two lines of therapy); NMSC: non-melanoma skin cancer; EMA: European Medicines Agency; BMS: Bristol Myers Squibb
- The Group's Strategy
Philogen is a biotechnology company with strong vertical integration, as it covers all phases of drug development, including research, GMP manufacturing, and clinical development. In addition to its research facility in Zurich, Switzerland, the Company has two GMP-certified manufacturing sites: one in Montarioso (Siena), where the Company produces drugs for clinical trials, and one in Rosia (Siena), dedicated to the production of drugs for both clinical trials and commercial use. Furthermore, the Rosia site was recently authorized by AIFA to produce small-volume injectable drugs under aseptic conditions, not limited to biotechnology products.
- The Group's Pipeline
The Group's product portfolio consists of (i) antibody-based products and small organic molecules at various stages of clinical development, and (ii) various preclinical programs that are fundamental to the Group's continued innovation in the future.
The Group's Pipeline is outlined below:
In particular,
Nidlegy™: In May 2023, the Company entered into a licensing agreement with Sun Pharma for the commercialization, licensing, and supply of Nidlegy™ in Europe, Australia, and New Zealand for the treatment of skin cancers. Philogen retains the rights to all other territories and therapeutic indications.
The Company has resubmitted its Marketing Authorization Application to the European Medicines Agency (EMA) for the treatment of melanoma. The U.S. Phase III trial aimed at obtaining approval in the United States is ongoing. In addition, Phase 2 clinical trials for non-melanoma skin cancers have been completed, and new registration studies have begun for locally advanced basal cell carcinoma (BCC) and squamous cell carcinoma (cSCC) in the last-line setting. These new studies are currently underway in Europe and the United States.
Fibromun: On October 1, 2024, the Philogen Group announced an additional licensing agreement with Sun Pharma, this time for the commercialization of Fibromun (L19TNF), an innovative anti-tumor immunotherapy currently being tested in clinical trials by Philogen for the treatment of soft tissue sarcoma and glioblastoma. Sun Pharma will have exclusive worldwide commercialization rights for Fibromun. Philogen will complete the clinical trials, pursue marketing authorization with regulatory authorities, and manufacture the commercial batches. Sun Pharma will be responsible for commercialization activities.
Philochem AG, a subsidiary of the Philogen Group, has isolated high-affinity small-molecule organic ligands from DNA-encoded chemical libraries targeting various tumor-associated antigens. By conjugating these ligands to potent payloads such as cytotoxic drugs or radionuclides, it has developed a series of promising small-molecule diagnostic and therapeutic compounds.
It is also worth noting the progress in the field of small organic molecules that characterize the pipeline of the subsidiary Philochem.
OncoFAP: The OncoFAP ligand is the subject of several clinical trials, both as a radioactive and non-radioactive derivative. 68 Ga-OncoFAP is the subject of an industrial collaboration with Blue Earth Diagnostic for imaging applications, for which Phase 2 has begun. 177 Lu-OncoFAP-23 is a proprietary drug being studied in Phase I for therapeutic applications. OncoFAP-GlyPro-MMAE will enter clinical development in patients in the near future.
⁶⁸Ga-OncoCAIX: The Group is developing this investigational drug for imaging applications. Phase I has been completed, and preparations are underway for the launch of Phase III.
OncoACP3: On June 10, 2025, a licensing agreement was announced with RayzeBio for a total value of up to 1.35 billion USD plus royalties.
The Group also engages in collaboration, licensing, and service provision (including GMP activities) for pharmaceutical and biotechnology companies, as well as organizations and institutions operating in the biotechnology research sector. It has established partnerships with numerous renowned entities.
- Intellectual Property
The Group protects the results of its research and development activities through a broad international portfolio of patents for industrial inventions and pending patent applications, thereby 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 protocols for medical treatment.
The term of individual patents depends on the statutory term of patents in the countries where they were granted. In most countries, including Italy, the patent term is 20 years from the earliest claimed filing date of a non-provisional patent application or its foreign equivalent in the country in question.
The Group owns or holds exclusive licenses to more than one hundred national patents filed in various countries.
The Group's patents primarily include: (i) "technology" patents relating to the fundamental enabling technologies used in the Group's activities; (ii) "product" patents, i.e., patents relating to product candidates in preclinical and clinical development 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 PortfolioTo provide a better understanding of the intellectual property held by the Group, the following table lists the patents and patent applications held by the Parent Company and its subsidiary as of June 30, 2026.
Philogen S.p.A.:
Country
Granted Patents / Accepted Applications
Patent Applications
Australia
13
4
Brazil
1
1
Canada
12
3
China
3
6
Europe
15
7
Hong Kong
3
1
India
3
2
Indonesia
1
-
Israel
1
-
Japan
11
2
Malaysia
1
-
Mexico
6
2
New Zealand
5
2
Singapore
1
-
South Africa
3
-
South Korea
7
2
Taiwan
1
-
United States of America
22
7
Vietnam
1
-
Patent Cooperation Treaty (PCT) (*)
-
4
(*) PCT (Patent Cooperation Treaty): a treaty on patent cooperation-158 member states to date. The owner of a PCT international patent application may pursue that application in the specific countries where they wish to obtain a patent by completing the actual filing of the international application in each of those countries within 30 months of the filing date (or priority date) of the application.
Philochem AG:
Country
Granted Patents / Accepted Applications
Patent Applications
Algeria
-
1
Saudi Arabia
-
1
Australia
1
4
Brazil
1
4
Canada
1
6
China
1
6
Colombia
-
1
United Arab Emirates
-
1
Eurasia
-
1
Europe
3
9
Germany
1
-
Hong Kong
1
2
India
-
4
Israel
1
3
Japan
2
5
Macau
1
-
Malaysia
-
1
Mexico
1
4
New Zealand
-
1
Singapore
2
2
South Africa
1
1
South Korea
-
4
United States of America
4
8
Thailand
-
1
Patent Cooperation Treaty (PCT)(*)
-
2
(*) PCT (Patent Cooperation Treaty): a treaty on patent cooperation-158 member states to date. The owner of a PCT international patent application may pursue that application in the specific countries where they wish to obtain a patent, by completing the actual filing of the international application in each of those countries within 30 months of the filing date (or priority date) of the application.
Macroeconomic ContextThe first half of 2026 was marked by a complex macroeconomic environment, influenced by escalating geopolitical tensions in the Middle East and the ongoing conflict between Russia and Ukraine. These factors fueled volatility in energy markets, driving upward pressure on oil and natural gas prices and contributing to a deterioration in global growth prospects and greater uncertainty regarding inflation trends.
In Europe, rising energy costs and the worsening geopolitical landscape led to a downward revision of the Eurozone's growth outlook, despite support from investment programs in infrastructure, defense, and energy security. In this context, the European Central Bank adopted a more cautious and restrictive stance, halting its rate-cutting cycle and taking action during the half-year to counter the resurgence of inflationary pressures.
In the United States, the economy showed greater resilience than Europe's, supported by strong consumer spending, investment, and a robust labor market. Faced with persistent price pressures, the Federal Reserve kept interest rates unchanged, reaffirming a cautious approach focused on containing inflation. In Asia, China continued to benefit from global demand in the technology sectors, though it was weighed down by weakness in the real estate sector and moderate domestic consumption growth.
Artificial intelligence remained one of the key structural factors supporting the markets, driving substantial investment in digital infrastructure, data centers, semiconductors, and computing power. Despite high geopolitical uncertainty, the economic slowdown, and the restrictive stance of monetary policies, the major European and U.S. stock markets closed the half-year with generally positive performance, supported, respectively, by investments in infrastructure, defense, and energy, and by the continued strength of the technology sector.
Philogen Stock PerformancePhilogen stock (Ticker: PHIL) posted a slightly negative performance (-0.43%) during the first half of 206, closing the period at a price of 23.20 euros per share.
By comparison, the stock underperformed both the Italian market and its sector. The FTSE MIB Index, which represents the leading domestic companies, posted a positive return of 14.99%; the FTSE Italia Mid Cap Index, which represents companies with a market capitalization similar to Philogen's, also managed to close the half-year with a gain of 5.96%. At the sector level, the benchmark index, the SPDR S&P Biotech, rose by 29.79%.
As noted, the first half of 2026 unfolded against a market backdrop characterized by persistent macroeconomic and geopolitical uncertainty, which continued to influence investors' decisions. Investors' attention focused in particular on the evolution of monetary policies, inflationary trends, and developments in the international landscape-factors that contributed to fueling volatility in the financial markets. In this scenario, company-specific news and updates continued to be a key factor driving differences in stock performance. As for Philogen, market interest during the half-year was driven by the steady progress of clinical development activities aimed at achieving several significant milestones, which were reached over the summer.
As of June 30, 2026, the market capitalization was 942.18 million euros. This market capitalization includes both the common shares, listed on the MTA, and the Class B preferred shares, which are excluded from the market capitalization calculated by Borsa Italiana, as it includes only common shares in its calculation. Specifically, it should be noted that the market capitalization, net of Class B shares, as of the end of June 2026 amounted to 678.43 million euros.
Philogen
Prezzo 30 giugno 2026 (Eu)*
23.20
N. azioni (n. mn)
40.61
Mkt Cap (Eu mn)
942.18
Prezzo 30 dicembre 2025 (Eu)
23.30
Variazione di prezzo (Eu) 1H 2026
-0.10
Variazione di prezzo (%) 1H 2026
-0.43%
* The price refers to June 30, 2026, the last trading day of the half-year, and December 30, 2025, the last trading day of the year 2025
The chart below shows the stock's performance.
Comparison of Philogen's performance against the main benchmark indicesSPDR S&P Biotech
FTSE MIB Index
Philogen
Volumes
0
giu-26
mag-26
apr-26
mar-26
feb-26
gen-26
€ 18,00
dic-25
10
€ 20,00
20
€ 22,00
50
40
30
€ 26,00
€ 24,00
60
€ 28,00
70
€ 30,00
80
€ 32,00
1,000 shares
(December 30, 2025 - June 30, 2026)
During the first half of 2026, the lowest closing price, recorded on April 13, was 19.86 euros, while the highest closing price during the reference period, recorded on May 26, 2026, was 23.50 euros. During 2025, trading in Philogen shares on the market operated by Borsa Italiana S.p.A. reached an average daily value of 404,000 euros, equivalent to an average daily volume of 18,487 shares.
In the first half of 2026, the Company distributed dividends totaling 28.1 million euros, and on April 29, 2026, it authorized a share buyback program, which was initially launched on May 12, 2026, up to a maximum of 300,000 common shares with a total expenditure not exceeding 6,900,000.00 euros. As of June 30, 2026, Philogen held 362,799 common shares (equal to 0.8933% of the share capital). For further details regarding the share buyback program, please refer to paragraph
of the management report.
The table below shows the monthly trading volumes and values from the listing date through June 30, 2026.
Period
Average Volumes
Borsa Italiana
Average Value
Borsa Italiana
Days on
Borsa Italiana
Mar-21
84,044
1,365,674
21
Apr-21
19,241
297,186
20
May 21
19,614
290,014
21
Jun-21
15,192
221,401
22
Jul-21
25,044
345,163
22
Aug-21
13,709
200,180
22
Sep-21
19,977
287,286
22
Oct 21
15,817
221,544
21
Nov-21
18,917
270,596
22
Dec-21
10,021
144,890
21
Jan-22
13,895
196,643
21
Feb-22
8,614
125,241
20
Mar-22
9,514
128,921
23
Apr-22
8,011
108,927
19
May 22
9,797
136,871
22
Jun-22
5,546
80,172
22
Jul-22
10,346
144,427
21
Aug-22
1,373
19,549
22
Sep-22
3,145
43,578
22
Oct 22
1,705
23,081
19
Nov-22
2,145
29,441
21
Dec-22
3,942
55,178
20
Jan-23
6,386
91,591
22
Feb-23
14,262
227,525
20
Mar-23
5,537
86,887
23
Apr-23
11,524
177,364
18
May 23
11,463
173,504
22
Jun-23
9,058
143,884
22
Jul-23
3,783
59,473
21
Aug-23
9,191
149,760
22
Sep-23
7,422
121,184
21
Oct-23
17,199
307,438
22
Nov-23
18,843
344,664
22
Dec-23
21,005
380,015
19
Jan. 24
8,096
141,256
22
Feb-24
8,632
148,214
21
Mar-24
10,955
194,043
20
Apr-24
16,583
299,075
21
May 24
13,013
254,749
22
Jun-24
7,699
158,734
20
Jul-24
5,257
108,061
23
Aug-24
4,180
88,990
21
Sep-24
5,811
116,319
21
Oct-24
12,528
254,669
23
Nov-24
5,569
109,609
21
Dec-24
5,523
103,833
18
Jan. 25
5,131
93,943
22
Feb-25
6,462
116,401
20
Mar-25
10,434
198,861
21
Apr-25
8,618
174,934
20
May 25
9,394
209,285
21
Jun-25
48,248
1,216,897
21
Jul-25
17,204
369,638
23
Aug. 25
13,490
307,825
20
Sep-25
17,321
399,238
22
Oct-25
31,114
733,705
23
Nov-25
18,531
440,861
20
Dec-25
33,050
764,842
19
Jan-26
24,222
531,709
21
Feb-26
11,165
238,827
20
Mar-26
20,294
450,081
22
Apr-26
24,453
509,661
20
May 26
17,166
385,828
20
Jun-26
13,641
308,133
22
1H 2026 Average
18,487
404,263
125
Average 2025
18,273
419,386
252
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 since IPO as of June 30, 2026
13,890
256,425
1,350
Comparison of Philogen's Performance Against Key BenchmarksClosing price
1 month
3 months
6 months
12 months
Simple Average (EU)
22.75
22.07
21.95
21.96
Volume-Weighted Average (EU)
22.70
22.02
21.93
21.94
Max (EU)
23.30
23.50
23.50
24.80
Min (EU)
21.75
19.86
19.86
19.86
SPDR S&P Biotech
FTSE MIB Index
Philogen
Volumes
8-set-26
25-ago-26
11-ago-26
14-lug-26 28-lug-26
0
€ 20,00
30-giu-26
20
€ 21,00
40
€ 22,00
60
€ 23,00
80
€ 24,00
100
€ 25,00
120
€ 26,00
140
€ 27,00
1,000 shares
(June 30, 2026 - September 15, 2026)
In the third quarter of 2026, Philogen's stock posted a performance slightly above break-even (+0.22%), despite volatility driven by company-specific news: Philogen took a significant step forward in the regulatory process for Nidlegy™ by resubmitting its application to the EMA, supported by updated clinical data from the Phase III PIVOTAL study, which was subsequently published in the Journal of Clinical Oncology.
The market as a whole also remained largely unchanged, with the biotechnology sector benchmark index (SPDR S&P Biotech -2.67%) slightly underperforming the Italian index (FTSE MIB -0.25%). On September 15, 2026, Philogen stock closed at a price of 23.25 euros per share.
Comparison of Philogen's Performance Against Key Benchmark Indices€ 45,00
€ 40,00
900
800
€ 35,00
€ 30,00
700
600
500
€ 25,00
€ 20,00
€ 15,00
400
300
200
€ 10,00
100
€ 5,00 0
Volumes
Philogen
FTSE MIB Index
SPDR S&P Biotech
1,000 shares
(from IPO on March 3, 2021 - June 30, 2026)
From its IPO through the end of the first half of 2026, Philogen's stock performed well (+36.47% as of June 30, 2026), underperforming the Italian market (FTSE MIB +123.89%), but remaining firmly above the biotechnology sector benchmark index, which returned to positive territory in June following the decline that began in 2021 (SPDR S&P Biotech +7.76%).
Interim Management Report as of June 30, 2026 IntroductionDear Shareholders,
This Interim Management Report 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 in conjunction with the condensed consolidated half-year financial statements as of June 30, 2026.
This Interim Management Report is intended to provide information on the Company's and the Group's income, equity, financial position, and operations, supplemented, where possible, by historical data and/or alternative performance metrics, and is 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 semiannual financial statements as of June 30, 2026, have been prepared in accordance with the international accounting standard regarding interim financial reporting (IAS 34 - Interim Financial Reporting).
Please refer to the notes to the financial statements for all information pertaining to the presentation of the condensed consolidated semiannual financial statements as of June 30, 2026.
- 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 made possible by a scientific approach known as tumor targeting, in which the Group is one of the world's recognized scientific leaders. In this context, the Group carries out all phases of its production cycle in-house, which includes the discovery and production of new drugs as well as 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 headquartered.
Since 2019, the Group has continued to invest both in the development of advanced products in its pipeline-with the goal of bringing them to market, such as Nidlegy™-and in the discovery of new therapeutic candidates, such as OncoACP3. At the same time, it has continued the clinical development of products such as OncoCAIX, whose promising results support the launch of new clinical trials aimed at regulatory approval.
The Group operates a research and development facility in Zurich (through its subsidiary "Philochem"), where new experimental drugs are discovered. The most promising candidates (in terms of biochemical characteristics, safety, and efficacy based on preclinical tumor models) are subsequently transferred to Siena, where they are manufactured at the Company's GMP (Good Manufacturing Practice) facilities. Philogen operates a GMP facility in Montarioso (Siena) approved by the Italian Medicines Agency (AIFA) for the production of experimental drugs, including antibodies produced in mammalian cells, and a second GMP production facility at its Rosia (Siena) site dedicated to the production of both commercial drugs and those for clinical trials. The Rosia site has also recently been authorized by AIFA to produce small-volume injectable drugs under aseptic conditions, not limited to biotechnology products.
For details regarding the certifications obtained, please refer to Section 1, "History."
Please note that the Parent Company is considered an "SME" pursuant to Article 1, paragraph 1, letter w)-quater 1 of the TUF, which defines small and medium-sized enterprises as issuers of listed shares with a market capitalization of less than 1,000 million euros; issuers of listed shares that have exceeded this limit for three consecutive fiscal years are not considered SMEs, (CONSOB publishes the list of companies on its website). It should be noted that Class B shares (shares with multiple voting rights) are excluded from the market capitalization calculated by Borsa Italiana. Philogen's average market capitalization, net of Class B shares, from the start of trading (March 3, 2021) through June 30, 2026, amounts to 538 million euros.
- Research and Development Activities
The Group's activities encompass all phases of the drug development process, including discovery, basic research, preclinical and clinical development, and manufacturing.
The Group operates through:
Philogen S.p.A., headquartered in Siena, which manages GLP-certified laboratories, GMP-certified manufacturing facilities (at the Montarioso and Rosia sites), and numerous international clinical trial centers through its in-house Contract Research Organization (CRO) and collaborations with several external CROs;
Philochem AG, headquartered in Switzerland and 99.998% owned by Philogen S.p.A., conducts research and development at its Zurich laboratories in the areas of selective discovery and therapeutic antibodies, as well as in the development of technologies such as antibody libraries and DNA-encoded chemical libraries.
Research and development currently represents the Group's primary activity.
The following table shows the research and development costs recognized in the income statement for the fiscal years ended June 30, 2026, and June 30, 2025, and their respective percentage of the Group's total operating costs.
Figures in thousands of euros and as a percentage
Period ended June 30
2026
2025
Research and development expenses
13,139
14,325
Percentage of total operating costs
51.8%
63.4
It should be noted that research and development costs include all direct costs related to discovery, basic research, preclinical and clinical development, and manufacturing activities, including the cost of personnel engaged in these activities.
For more details on the Group's research and development activities, please refer to the introductory section "History," and for operating costs, please refer to Note 6 of the condensed consolidated semiannual financial statements.
- Scientific Developments During the First Half of 2026
The following are the main scientific developments for the period ended June 30, 2026.
- Summary of development and GMP activities carried out during the period ended June 30, 2026
The Group reports the following key industrial milestones achieved during the period:
Products developed by Group companies
Antibody-based products
Nidlegy™ (Philogen)
Composed of two active ingredients: L19-IL2 and L19-TNF.
The L19 antibody is specific for the B domain of fibronectin, a protein expressed in tumors and absent in most healthy tissues.
The cytokines IL-2 and TNF have antitumor activity.
Currently in clinical development (Phases II and III).
Product agreements:
Sun Pharma (June 2023): licensing and commercialization in Europe, Australia, and New Zealand;
Merck Sharp & Dohme (June 2023): clinical collaboration (Phase II in unresectable melanoma).
Summary Table - Clinical Trials on Nidlegy™
Study / Area
Phase
Indication
Status / Key Notes
EU Locally Advanced Melanoma
III
Melanoma
Primary endpoint achieved (October 2023). EMA application submitted (June 2024) and withdrawn (June 2025) due to the need for additional data. EMA application resubmitted (July 2026).
US locally advanced melanoma
III
Melanoma
178/240 patients enrolled. Ongoing in the U.S., Spain, and Switzerland; expansion to other countries. A regulatory strategy alignment meeting was held with the FDA in late March 2026 to obtain authorization in the United States.
Duncan (NMSC: BCC, cSCC)
II
Non-melanoma skin cancers
Study completed in Switzerland, Germany, and Poland.
Intrinsic (various NMSCs)
II
II
Kaposi's sarcoma, cutaneous T-cell lymphoma, Merkel cell carcinoma, BCC, cSCC, etc.
Study completed in Italy and France.
New registration studies (USA)
BCC and cSCC
Three new clinical trials have been initiated in the United States and Europe, two of which are registration trials (i.e., third-line BCC and second-line cSCC).
Collaboration with Merck (USA)
II
Unresectable Stage III/IV Melanoma
Ongoing study in patients refractory to checkpoint inhibitors.
-
Fibromun (Philogen)
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 Trials on FIbromun
Study / Area
Phase
Indication
Status / Key Notes
EU soft tissue sarcoma (STS), 1st-line
III
IIb
STS in combination with doxorubicin
Study completed. Evidence of activity in terms of overall survival observed in the "Liposarcoma + others" subgroup. A new registration study in this subpopulation is being planned.
US leiomyosarcoma, 1st-line
Leiomyosarcoma in combination with doxorubicin
Ongoing at 7 centers in the U.S.; expansion with new centers is underway.
EU soft tissue sarcoma (STS), 3rd-line
II
STS in combination with dacarbazine
Study completed. Primary endpoint not met.
Glioblastoma, 1st-line (EU)
I / II / IIb
In combination with radiation therapy + temozolomide
Phase I completed. Phase II of the study has begun, with results expected in 2027. The results of Phase II will be decisive for the final, registration-seeking phase of the study.
Glioblastoma, 2nd-line (EU)
I / II
In combination with lomustine
Study completed. Primary endpoint not met.
Study / Area
Phase
Indication
Status / Key Notes
Pre-treated glioblastoma (U.S.)
II
In combination with lomustine
Enrollment completed. Study results expected in Q3 2026.
Small-molecule products
- OncoFAP (Philochem)
A molecule with high affinity for FAP (fibroblast activation protein), which is expressed in over 90% of epithelial tumors.
Diagnostic applications (imaging with 68Ga-OncoFAP; Phase II has begun) and therapeutic applications (OncoFAP-23 in Phase I).
Licensing agreement with Blue Earth Diagnostics (Bracco) for imaging.
The OncoFAP-GlyPro-MMAE product showed strong signs of antitumor activity in a clinical study in dogs with spontaneous tumors. A reduction in disease was observed in six out of seven treated patients. GMP production of the drug is underway, and the Phase I clinical trial is scheduled to begin in 2027.
- OncoACP3 (Philochem)
A molecule with affinity for prostatic acid phosphatase (PAP).
Diagnostic and therapeutic applications for prostate cancer.
Phase I imaging study completed.
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. Product development in accordance with the licensing agreement signed with Blue Earth Diagnostics (Bracco). Phase II trial initiated.
OncoFAP-23 (therapeutic)
I
Solid tumors
Phase I clinical trial in progress.
OncoFAP-GlyPro-MMAE (therapeutic)
Preclinical (in vivo in dogs)
Solid tumors
Preclinical study completed with objective responses. GMP production underway, and human clinical trials scheduled to begin in early 2027.
OncoACP3 (diagnostic, 68Ga-OncoACP3)
I
Prostate cancer
Phase I clinical trial completed.
OncoACP3 (therapeutic)
Phase I Trial
Prostate cancer
Preparatory work is underway. Compassionate use in Germany has demonstrated excellent tumor targeting (persistence in the tumor ≥ 7 days).
OncoACP3 (licensed by RayzeBio)
-
Prostate cancer
Global licensing agreement signed with RayzeBio (BMS) on June 10, 2025.
-
OncoCAIX (Philochem)
Molecule with affinity for carbonic anhydrase IX (CAIX).
Diagnostic applications for kidney cancer (clear cell renal cell carcinoma).
Phase I imaging study completed.
Development of a GMP kit and GMP production of the precursor are underway.
Phase III registration trial to begin in 2027.
Products in partnership
OncoACP3 → RayzeBio (BMS).
Nidlegy™ → Sun Pharma (EU, AU, NZ);
Fibromun → Sun Pharma
Dekavil → Pfizer.
OncoFAP (Imaging) → Bracco.
GMP (manufacturing)
Rosia Plant (Siena): fully operational since 2023, AIFA GMP certifications (clinical and commercial manufacturing).
Montarioso Plant (Siena): production of investigational drugs and contract manufacturing since 2004.
Both sites are GMP-certified and undergo periodic inspections by the relevant authorities.
- OncoFAP (Philochem)
- Summary of development and GMP activities carried out during the period ended June 30, 2026
- Significant events that occurred during the first half of 2026
-
Dividend Distribution
In May 2026, the Company distributed to shareholders a dividend of 0.70 euros per share, gross of statutory withholding taxes, for each Philogen Class B common and special share entitled to dividends as of the ex-dividend date, for a total amount of 28,173,807 euros. The dividend was paid out of the "Retained Earnings/(Losses)" reserve.
- Internal Dealing Transactions
Internal dealing transactions are subject to specific monitoring and are managed in accordance with applicable regulations and internal procedures. The related disclosures are made available on the Company's website, in the section dedicated to Internal Dealing (https://www.philogen.com/).
- Purchase of Treasury Stock
On April 29, 2026, following the revocation of the authorization to purchase and dispose of treasury shares adopted on April 29, 2025, the Ordinary Shareholders' Meeting authorized the Company to purchase treasury shares, granting the Board of Directors-with the authority to delegate to the Chairman of the Board of Directors and/or the Chief Executive Officer-the power to proceed, including through specially appointed specialized intermediaries, to purchase shares of Philogen S.p.A., establishing the relevant terms and the price per share, in compliance with applicable laws and regulations.
This resolution provides the Company with a strategic flexibility tool to be used for the purpose of:
establish a share reserve, to use the treasury shares in connection with agreements with strategic partners and/or extraordinary corporate/financial transactions, including, by way of example and without limitation, acquisitions, mergers, capital transactions, barter, contributions, exchanges, " " transactions, financing, or other transactions in connection with which the allocation or other disposition of treasury shares is necessary or appropriate
to fulfill obligations arising from incentive plans, whether for consideration or free of charge, in favor of corporate officers, employees, or collaborators of the Group
to support the liquidity of Philogen S.p.A. shares in order to facilitate the smooth conduct of trading and avoid price movements inconsistent with market trends, as well as to stabilize trading and price trends in the face of temporary distortions caused by excessive volatility or low trading liquidity, including in accordance with and for the purposes of the market practice permitted by Consob pursuant to the provisions of Article 13 of EU Regulation No. 596/2014;
to operate with a medium- and long-term investment perspective, trading on the market-whether on over-the-counter markets or off-market-through Accelerated Book Building or block trades, at any time, in whole or in part, on one or more occasions, provided that such transactions are conducted on market terms.
The Company may purchase (i) up to a maximum of 300,000 common shares (ii) for a period of eighteen months from the date of the shareholders' meeting resolution authorizing such purchases, subject to the limits set forth in Article 2357, paragraph 2, of the Italian Civil Code, and without any time limits with respect to dispositions; (iii) at a purchase or sale price, as applicable, to be determined on a case-by-case basis by the Board of Directors, 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 on purchases not exceeding €6,900,000 in any case.
On May 12, 2026, the Board of Directors approved the launch of the share buyback program, in accordance with the authorization granted by the Shareholders' Meeting on April 29, 2026, and appointed Mediobanca (Banca di Credito Finanziario S.p.A.) to carry out the share buybacks.
As of June 30, 2026, the Company held 362,799 treasury shares in its portfolio, representing 0.8933% of the share capital.
All disclosures regarding treasury stock purchases are available and can be viewed on the Company's website at (http://www.philogen.com/).
As of June 30, 2026, the Company's shareholder structure is as follows:
Shareholder Shareholder Structure as of June 30, 2026
Type of Shares
Shares
% of share capital
% of Voting Rights
Class B Shares
8,565,018
21.09%
40.56%
Nerbio S.r.l.
Common Stock
8,098,251
19.94%
12.78%
Subtotal
16,663,269
41.03%
53.35%
Dompé Holdings S.r.l. Common Stock
10,076,538
24.81%
15.91%
Subtotal
12,879,770
31.71%
29.18%
Philogen S.p.A. Common stock
362,799
0.89%
0.57%
Subtotal
362,799
0.89%
0.57%
Class B Shares
-
-
-
Market Common Stock
10,705,273
26.36%
16.90%
Subtotal
10,705,273
26.36%
16.90%
Total
40,611,111
100%
100%
Class B Shares 2,803,232 6.90% 13.28%
-
Remuneration Policy
In accordance with the regulations applicable to publicly traded companies, the Group adopted a compensation policy effective in 2021, the year of its listing.
On April 29, 2026, pursuant to Article 123-ter of the Consolidated Law on Finance (TUF), the Shareholders' Meeting, having taken note of the Report on Remuneration Policy and Compensation Paid for the 2025 fiscal year, which had been approved by the Board of Directors on March 27, 2026, approved Section I of the Report on Remuneration Policy and Remuneration Paid, and voted in favor of Section II of the Report on Remuneration Policy and Remuneration Paid.
The Report on Remuneration Policy and Remuneration Paid is available and can be viewed on the Company's website at (http://www.philogen.com/) in the Governance/Shareholders' Meetings section.
Cash Incentive Plan ("MBO")
From June 1, 2026, through May 31, 2027, 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 proportion of the MBO relative to the annual compensation of the Executive Directors is 75%, while for executives it ranges from 10% to 20% of annual compensation.
Subject to the maximum impact of the MBO described above, on May 12, 2026, the Company's Board of Directors, upon the recommendation of the Nominating and Compensation Committee, assigned performance objectives and defined the targets associated with the maximum monetary compensation for the aforementioned executive directors and Company executives for the period from June 1, 2026, to May 31, 2027.
It should be noted that, in accordance with the provisions of the Compensation Policy for the year 2025, the Executive Directors were paid, together with their compensation for the month of July 2026, the MBO incentive for the period June 1, 2025 - May 31, 2026.
Medium- to Long-Term Incentive Plan
The incentive plans approved by the Company's Shareholders' Meeting are as follows: the "2027-2029 Stock Grant Plan" (reserved for employees and consultants of the Philogen Group), the "2024-2027 Share Ownership Plan for Directors" (originally named the "2024-2026 Share Ownership Plan for Directors," reserved for executive directors of the Philogen Group), and the "2024-2026 Stock Grant Plan" (reserved for employees of the Philogen Group).
For more information regarding the characteristics of the incentive plans listed above, please refer to the respective Information Documents and related Regulations, which are available and can be consulted on the Company's website at (http://www.philogen.com/).
- Relations with the Tax Authority
In March 2025, the Siena Revenue Agency initiated a tax audit regarding direct taxes for the tax years 2019 through 2023. The audit primarily focused on the operating grants and capital grants received by the Company during the relevant periods, totaling 10,243 thousand euros, and their exclusion from the taxable base for IRES and IRAP direct taxes, as the Company reported operating losses during the relevant years.
In May 2025, the Company received notice of the initiation of the assessment report, which the Company contested in its entirety.
We hereby report that, as of the date of this report, the proceedings have been closed by the Italian Revenue Agency. Consequently, there are no remaining claims against the Company regarding the matters subject to the audit, and no economic, equity, or financial effects related to this matter have occurred or are expected to occur.
- Compliance with Directive (EU) 2022/2555 (NIS2) and Legislative Decree No. 138 of September 4, 2024 - Appointment of the Data Protection Officer
The National Cybersecurity Authority (ACN) has designated Philogen S.p.A. as a "Significant" entity for the year 2026 as well.
As a result of this designation, the Company has adopted and implemented the organizational, technical, and procedural measures required by current legislation. In particular, during its meetings in the 2025-2026 reporting period, the Board of Directors approved internal procedures designed to regulate the use of IT systems by the Company's various departments in order to ensure an adequate level of security as required by applicable regulations.
In addition to the above, it should be noted that Flavio Corsinovi, Esq., was appointed as the Company's Data Protection Officer, with the responsibility of overseeing compliance with applicable regulations regarding the protection of personal data and providing support and advice to the Company regarding related obligations.
- Other Significant Events Occurring During the First Half of 2026
During the first half of 2026, the Company continued to develop and consolidate its operational, organizational, and research activities, with particular focus on the following areas:
During the first few months of 2026, the new Milan office became operational, where project activities-including those in the field of artificial intelligence-were launched. The opening of the new office also aligns with the Group's objective of strengthening its ability to attract new talent and professional expertise, particularly in the clinical and regulatory areas;
Activities related to third-party GMP contracts continued, as did those pertaining to the services required as part of the collaboration with RayzeBio. At the same time, the Company participated in competitive bidding processes and public tenders aimed at securing resources to support research and development and GMP production activities;
During the half-year, preparatory activities were also initiated to obtain certain ISO certifications, as part of the process of further structuring and formalizing business processes;
The Group continued to strengthen its organizational structure, with a significant increase in the number of employees compared to the previous fiscal year, in line with the expansion of its operational and development activities.
-
Dividend Distribution
- Group Financial Results
-
Income Statement
The table below presents the Group's consolidated financial results for the periods ended June 30, 2026, and June 30, 2025:
Figures in thousands of euros and as a percentage As of June 30 Changes
2026
%
2025
%
2026 vs.
2025
%
Revenue from customer contracts
2,052
100.0%
5,502
100.0%
(3,451)
(62.7)%
Other income
2,205
107.5%
3,218
58.5%
(1,013)
(31.5)%
Total Revenue
4,257
207.5%
8,721
158.5%
(4,463)
(51.2)%
Operating expenses (*)
(25,368)
(1,236.4)%
(22,589)
(410.5)%
(2,779)
12.3%
EBITDA (**)
(21,111)
(1,028.9)%
(13,869)
(252.0)%
(7,242)
52.2%
Depreciation and Amortization
(2,204)
(107.4)%
(1,963)
(35.7)%
(241)
12.3%
EBIT
(23,315)
(1,136.3)%
(15,832)
(287.7)%
(7,483) 47.3%
Financial income
11,320
551.7%
2,670
48.5%
8,650
323.9%
Financial expenses
(8,484)
(413.5)%
(2,194)
(39.9)%
(6,290) 286.8%
Income before taxes
(20,479)
(998.1)%
(15,355)
(279.1)%
(5,124) 33.4%
Taxes
887
43.2%
461
8.4%
426 92.6%
Net Income (Loss) for the Period
(19,592)
(954.9)%
(14,894)
(270.7)%
(4,697) 31.5%
(*) Operating expenses consist of the sum of the following items from the condensed consolidated half-year financial statements: purchases of raw materials and supplies, costs for services, costs for use of third-party assets, personnel costs, and other operating expenses.
(**) EBITDA represents operating income 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 metric for measuring the Group's performance, as it allows for an analysis of the Group's profitability by eliminating the effects of non-recurring economic items. Since the calculation of EBITDA is not regulated by the accounting standards applicable to the preparation of the Group's consolidated financial statements, the method used to calculate EBITDA may not be consistent with that adopted by other groups and, therefore, may not be comparable.
Below is a discussion of the income statement table shown above.
The Group's total revenue as of June 30, 2026, amounted to 4,257 thousand euros, a decrease of 4,463 thousand euros compared to the period ended June 30, 2025.
The "Total Revenues" line item consists of:
Revenue from contracts with customers totaling 2,052 thousand euros (5,502 thousand euros as of June 30, 2025) relates to the progress of GMP contract manufacturing for third parties, as well as the continuation of certain activities related to partnership agreements. To date, the Group has no recurring revenue, as it has not yet brought any products to market.
Other income totaling 2,205 thousand euros as of June 30, 2026 (3,218 thousand euros as of June 30, 2025) is primarily related to operating grants that the Group receives on an ongoing basis in connection with its research and development activities, including the research and development tax credit and the Group's share of the Industry 4.0 tax credit.
Operating expenses totaled 25,368 thousand euros (22,589 thousand euros as of June 30, 2025), with more than half attributable to R&D costs. Specifically, they include costs for production materials, costs for clinical and preclinical services, personnel costs, and other operating costs, and show an increase of 2,779 thousand euros compared to the previous period. This variance is primarily attributable to:
an increase in personnel costs, which rose from 8,118 thousand euros as of June 30, 2025, to 9,838 thousand euros as of June 30, 2026, due to the hiring of new qualified staff and the implementation of incentive plans for employees and strategic executives.
an increase in the cost of raw materials, which rose from 1,765 thousand euros as of June 30, 2025, to 2,423 thousand euros as of June 30, 2026.
For further details, please refer to Note 6 and Note 25 of the condensed consolidated semiannual financial statements.
EBITDA shows a deterioration of approximately 52.2%, falling from a negative figure of 13,869 thousand euros as of June 30, 2025, to a negative figure of 21,111 thousand euros as of June 30, 2026, as a result of higher operating costs and a decline in revenue.
Depreciation and amortization increased slightly compared to the previous period, rising by approximately 12.3% compared to the period ended June 30, 2025.
EBIT, calculated as the difference between EBITDA and depreciation and amortization, showed a net loss of 23,315 thousand euros for the period ended June 30, 2026.
Net cash flow from financing activities for the period ended June 30, 2026, shows a positive result of 2,837 thousand euros, an improvement of approximately 2,360 thousand euros compared to the corresponding period in 2025. This result, determined by the difference between financial income of 11,320 thousand euros and financial expenses of 8,484 thousand euros, also includes realized and valuation effects related to the management of cash and cash equivalents and transactions denominated in foreign currencies. In particular, valuation effects also include the adjustment of the balances of foreign-currency current accounts used by the Company in its operations to the exchange rates at the end of the period.
Specifically, the result from financial operations is primarily attributable to: i) net income from realizations of 3,207 thousand euros; ii) net income from valuation of 421 thousand euros; iii) net income from realizations related to foreign currency management of 33 thousand euros; and iv) net expenses from valuation related to foreign currency management of 824 thousand euros.
For further details regarding financial management, please refer to Note 7 of the condensed consolidated semiannual financial statements.
Taxes, which were positive in the amount of 887 thousand euros, primarily reflect the reversal of part of the provision set aside in the prior fiscal year by Philochem. Specifically, the taxes estimated as of December 31, 2025, were higher than those subsequently determined on a case-by-case basis during 2026; the resulting difference was therefore recognized in the income statement for the current fiscal year, contributing to the reduction of the loss for the period.
As a result of the above, the Group closed the period ended June 30, 2026, with a net loss of 19,592 thousand euros.
- Balance Sheet
The following table presents the reclassified "Sources and Uses" statement of the Group's financial position for the periods ended June 30, 2026, and December 31, 2025:
Figures in thousands of euros and as a percentage
As of June 30
As of December
31
Changes
2026
2025
2026 vs. 2025
%
Loans
Property, plant, and equipment
14,848
16,029
(1,181)
(7.4)%
Intangible assets
1,076
1,107
(31)
(2.8)%
Right-of-use assets
9,407
8,820
587
6.7%
Other non-current assets
5,719
4,442
1,277
28.7%
Deferred tax assets
9,394
9,052
342
3.8%
Employee benefits
(1,370)
(1,330)
(41)
3.1%
Deferred tax liabilities
(814)
(407)
(408)
100.3%
Other non-current liabilities
(717)
(717)
-
-
Net fixed assets (*)
37,543
36,998
545
1.5%
Inventories
2,922
2,961
(39)
(1.3)%
Contract assets
4,622
2,937
1,685
57.4%
Trade receivables
842
1,269
(427)
(33.6)%
Tax receivables
8,197
10,395
(2,198)
(21.1)%
Other current assets
1,337
1,093
244
22.3%
Trade payables
(11,606)
(13,031)
1,425
(10.9)%
Contractual liabilities
(2,399)
(1,834)
(565)
30.8%
Tax liabilities
(30,672)
(31,295)
623
(2.0)%
Other current liabilities
(4,795)
(3,921)
(874)
22.3%
Net working capital (*)
(31,552)
(31,427)
(125)
0.4%
Net invested capital (*)
5,991
5,571
420
7.5%
Sources
Shareholders' Equity
331,691
373,867
(42,175)
(11.3)%
Net financial debt (*)
(325,700)
(368,295)
42,595
(11.6)%
Total sources
5,991
5,571
420
7.5%
(*) Net fixed assets, net working capital, net invested capital, and net financial debt are alternative performance indicators that are not recognized as accounting measures under IFRS and, therefore, should not be considered alternatives to the 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 325,700 thousand euros; the change in this figure is detailed in the following paragraph through the Net Financial Debt schedule.
Net Financial Debt
The breakdown of Net Financial Debt as of June 30, 2026, and December 31, 2025, is presented in accordance with the format set forth in ESMA Guidance 32-382-1138 dated March 4, 2021, and by Consob through Advisory Notice No. 5/21:
Figures in thousands of euros
Net financial debt
June 30, 2026
December 31,
2025
(A) Cash and cash equivalents
5,131
54,784
(B) Cash equivalents
-
72,416
(C) Other current financial assets
332,013
252,023
(D) Cash and cash equivalents (A+B+C)
337,144
379,223
(E) Current financial debt
16
44
(F) Current portion of non-current financial debt
1,330
1,164
(G) Net current financial debt (E+F)
1,346
1,208
(H) NET CURRENT FINANCIAL DEBT (G-D)
(335,798)
(378,015)
(I) Non-current financial debt
10,097
9,719
(J) Debt instruments
-
-
(K) Trade payables and other current liabilities
-
-
(L) Non-current financial debt (I+J+K)
10,097
9,719
(M) NET FINANCIAL DEBT (H+L)
(325,700)
(368,295)
For clarity, the following is a reconciliation of the items shown in the Net Financial Debt table with the Statement of Financial Position in the condensed consolidated semiannual financial statements:
"Cash" (A) is classified under the item "Cash and Cash Equivalents";
"Cash equivalents" (B) are classified under the item "Cash and cash equivalents";
"Other current financial assets" (C) are classified under the line item "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 the line items "Current financial liabilities" and "Current lease liabilities";
"Non-current financial debt" (I) is classified under "Non-current lease liabilities."
Net financial debt as of June 30, 2026, shows a net cash position of 325,700 thousand euros, composed as follows:
Cash and cash equivalents (D) of 337,144 thousand euros, a decrease of approximately 11.1% compared to the period ended December 31, 2025. This change is attributable to the net balance between: (i) cash inflows from revenue on contracts with customers of approximately 1,698 thousand euros, (ii) cash outflows related to the payment of dividends of 28,167 thousand euros, (iii) cash outflows for operating activities of approximately 19,206 thousand euros, and (iv) cash outflows for investments totaling 541 thousand euros; (v) a net gain from financial operations of 4,833 thousand euros, consisting of 526 thousand euros related to the net increase in the fair value of the securities portfolio held, and 4,307 thousand euros related to coupon payments and interest received upon maturity of restricted checking accounts; (vi) 696 thousand euros related to the purchase of treasury stock.
Current and non-current financial debt (G+L) totaled 11,444 thousand euros, of which approximately 11,428 thousand euros consisted of debt related to the right-of-use of properties (IFRS 16) and 16 thousand euros consisted of the balance on credit cards as of June 30, 2026. For further information on liabilities related to the right-of-use model and financial liabilities, please refer to Note 12 and Note 22 of the condensed consolidated semiannual financial statements.
- Alternative Performance Measures
In order to assess the Group's performance, management monitors, among other things, Alternative Performance Indicators (APIs) related to equity and financial performance.
For a proper interpretation of these APIs, please note the following:
APIs are derived from historical data and are not indicative of the Group's future performance;
APIs are not measures whose calculation is regulated by International Financial Reporting Standards (IFRS);
APIs should not be considered a substitute for the indicators required by the applicable accounting standards (IFRS);
these APIs should be read in conjunction with the Group's financial information taken from the condensed consolidated semiannual financial statements as of June 30, 2026;
the definitions of the APIs used by the Group, as they are not derived from the applicable accounting standards, may not be consistent with those adopted by other groups and therefore may not be comparable to them.
The following are the Alternative Economic Performance Indicators identified by the Group:
Figures in thousands of euros and as percentages
Period ended June 30
2026
2025
Revenue from contracts with customers
2,052
5,502
EBITDA (*)
(21,111)
(13,869)
EBITDA Margin
(1,028.9)%
(252.0)%
EBIT
(23,315)
(15,832)
(*) EBITDA represents operating income 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 calculation is regulated by the accounting standards applicable to the preparation of the Group's consolidated financial statements, the method used to calculate EBITDA may not be consistent with that adopted by other groups and, therefore, may not be comparable.
The table below shows the reconciliation of EBIT and EBITDA to net income (loss) for the period.
Figures in thousands of euros
Period ended June 30
2026
2025
Net Income (Loss) for the Period
(19,592)
(14,894)
Income taxes
887
461
Financial income and expenses
2,837
477
EBIT
(23,315)
(15,832)
Depreciation and Amortization
(2,204)
(1,963)
EBITDA
(21,111)
(13,869)
The EBITDA margin is calculated as shown in the table below:
Figures in thousands of euros and as a percentage
Period ended June 30
2026
2025
Revenue from contracts with customers (A)
2,052
5,502
EBITDA (B)
(21,111)
(13,869)
EBITDA Margin (B/A)
(1,028.9)%
(252.0)%
The following are the Alternative Financial Performance Measures identified by the Group:
Figures in thousands of euros and as percentages As of June 30 As of December 31
2026
2025
Net fixed assets
37,543
36,998
Net working capital
(31,552)
(31,427)
Net invested capital
5,991
5,571
Net financial debt
(325,700)
(368,295)
Financial independence ratio
83.9%
85.5%
Structural margin
820.1%
947.7%
Liquidity ratio
698.7%
775.7%
Debt ratio
3.5%
2.9%
The following table provides a breakdown of the financial independence ratio:
Figures in thousands of euros and as percentages
As of June 30
As of December 31
2026
2025
Shareholders' equity (A)
331,691
373,862
Total assets (B)
395,508
437,328
Financial Independence Ratio (A/B)
83.9%
85.5%
The following table provides a breakdown of the operating margin:
Figures in thousands of euros and as percentages
As of June 30
As of December 31
2026
2025
Shareholders' equity (A)
331,691
373,862
Non-current assets (B)
40,444
39,451
Structural Margin (A/B)
820.1%
947.7%
The following table provides a breakdown of the liquidity ratio:
Figures in thousands of euros and as percentages
As of June 30
As of December 31
2026
2025
Current assets (A)
355,064
397,877
Current liabilities (B)
50,818
51,289
Liquidity ratio (A/B)
698.7%
775.7%
The following table provides a breakdown of the Debt Ratio:
Figures in thousands of euros and as percentages
As of June 30
As of December 31
2026
2025
Financial debt (*) (A)
11,444
10,927
Shareholders' equity (B)
331,691
373,862
Debt-to-equity ratio (A/B)
3.5%
2.9%
(*) 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.
-
Income Statement
- Procedure and Transactions with Related Parties
In accordance with the current "Procedure for Related-Party Transactions," the OPC Oversight Committee (comprising the Chief Financial Officer and the Head of Legal Affairs) submitted the necessary disclosures to the OPC Committee regarding transactions carried out by the Company, which were subsequently recorded in the relevant Related-Party Transactions Register.
During the first half of 2026, transactions were carried out with related parties under normal market conditions, generating profitability in line with the Company's earnings parameters. Related-party transactions are disclosed in the financial statements and described in detail in Note 30 of the condensed consolidated interim financial statements, to which reference is made; they are not classified as either atypical or unusual.
- Organizational, Management, and Control Model pursuant to Legislative Decree No. 231/2001 "Organizational Decree" ( ) and Whistleblowing Procedure.
Philogen S.p.A., in order to clearly and transparently define the set of values that guide it in achieving its institutional objectives, has adopted, effective 2020, an Organizational, Management, and Control Model pursuant to Legislative Decree 231/2001, which has been updated over time to reflect changes in applicable legislation ("Model").
In particular, during the first half of 2026, the Company continued to monitor any new legislation as well as changes to the corporate governance structure adopted by the Company following its listing, in order to promptly incorporate them into the Model.
The current versions of the Organizational Model ("General Section") and the Code of Ethics are available on the Company's website (http://www.philogen.com/) in the Governance section (codice-etico-e-modello-231).
- Information on Corporate Governance and Ownership Structure
Philogen S.p.A. adheres to the Corporate Governance Code for Listed Italian Companies, adapting it to its specific characteristics.
In order to meet the transparency obligations set forth by sector-specific regulations, the "Report on Corporate Governance and Ownership Structure" required by Article 123-bis of the Consolidated Law on Finance has been prepared, providing a general description of the governance system adopted by Philogen S.p.A. In addition to information on ownership structures, 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-are also provided.
In particular, the aforementioned "Report on Corporate Governance and Ownership Structure" was approved by the Ordinary Shareholders' Meeting of Philogen S.p.A. on April 29, 2026, and details the most significant events that characterized the company's management during 2025, including the renewal of the Board of Directors, the establishment of the Board committees (see the section "Appointment of the Board of Directors and Board Committees"), and the subsequent appointment of Mr. Duccio Neri, Prof. Dario Neri, and Mr. Giovanni Neri as Chairman of the Board of Directors, Chief Executive Officer, and Managing Director, respectively, along with the resulting revision of the powers delegated to the aforementioned executive directors and the assessments made by the Board of Directors regarding the "Committee's Recommendations for 2026" contained in the letter sent to the Company on December 18, 2025, by the Chair of the Corporate Governance Committee on the occasion of the Board of Directors' meeting held on January 29, 2026.
This document is available on the Company's website at https://www.philogen.com.
- Key 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 ongoing activity carried out by the Group to assess, in terms of probability and impact, all aspects that could in any way hinder the achievement of corporate objectives. Business risks are categorized as operational-if related to business processes and activities-and financial-if related to the financial area.
- Strategic and Operational Risks
Risks Related to Dependence on Senior Executives, Key Personnel, and Specialized Staff
Given the specialized nature of its operations, the Group relies heavily on qualified management and other key scientific personnel, for whom it faces intense competition and whom it must recruit in order to grow. This includes, in particular, the Chair of the Scientific Committee and CEO, who has extensive scientific research experience at some of Europe's leading research centers, including the Medical Research Council and ETH Zurich. The potential loss of key personnel or the inability to attract and retain additional qualified personnel could have negative effects on the development and commercialization of product candidates. The occurrence of such risks could have serious negative effects on the Group's economic, financial, and equity position.
In order to expand the pool of potential candidates and strengthen the Group's ability to attract qualified personnel, a new corporate office was opened in Milan in January 2026, providing access to a broader labor market and enabling the Group to recruit a greater number of specialized professionals.
Risks Related to Research, Clinical and Preclinical Studies, and Production
The Group's strategy is focused on marketing pharmaceutical products that are still in the experimental phase, only two of which are in a more advanced stage of development. There are significant uncertainties regarding the success of the experimental phase and the Group's ability to obtain marketing authorizations from the relevant regulatory authorities for these pharmaceutical products. Furthermore, the products may fail to meet market expectations in terms of efficacy and safety; consequently, no revenue may be generated from their commercialization. Should the Group be unable to commercialize its products or license its product candidates, or should other competing products be preferred by the market over those of the Group, this would have serious negative effects on the Group's economic, financial, and equity position.
Risks Related to the Protection of Intellectual Property Rights and Reliance 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 (such as 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 rights and intellectual property rights prove insufficient, competitors could exploit the Group's technologies to create competing products, erode its competitive advantage, and capture all or part of its market share. The occurrence of such risks could have significant adverse effects on the Group's economic, financial, and equity position.
Risks Related to Changes in 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, the guidelines for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Any changes to the current regulatory framework could result in delays in the production of the compounds and/or their clinical trials, as well as increased costs, with consequent negative effects on the Group's economic, financial, and equity position.
Risks Related to Information Technology Systems
IT systems are exposed to the risk of failures and/or malfunctions in the IT network, data security breaches, viruses, unauthorized access, as well as natural events that could result in data loss or the disclosure of confidential and/or proprietary information, with potential negative effects on the Group's operations and its growth and development prospects. Philogen ensures the security of data, sensitive information, and intellectual property by managing the entire cycle, which includes threat detection and the implementation of countermeasures in response to attacks. The Group's cybersecurity system includes specific organizational controls-in compliance with applicable regulations and industry standards-which entail the adoption of specific requirements and timelines regarding the reporting of incidents and/or data breaches, as well as the ongoing training of personnel and the use of operational tools. For the sake of completeness, it should be noted that on April 14, 2026, the Company received notification from the National Cybersecurity Agency (ACN) regarding its continued inclusion on the list of "important entities" pursuant to Article 7, paragraph 3, letter B) of the NIS Decree (Legislative Decree 138/2024).
Financial Risks and Risks Related to Changes in the Fair Value of the Securities Portfolio
Financial risks refer to risks arising from the holding or trading of financial instruments. The Company invests by diligently following a financial investment policy approved by the Board of Directors, which is constantly monitored and updated. The
policy is based on selecting financial investments that are readily marketable and predominantly have a low-risk profile. The Group is exposed to the risk of changes in the fair value of the financial instruments held in its portfolio, whose value as of June 30, 2026, amounts to 332,013 thousand euros. The occurrence of this risk could have significant adverse effects on the Group's economic, financial, and equity position. Detailed tables on financial risks are presented in Note 28 of the condensed consolidated semiannual financial statements.
Foreign Exchange Risk
The Group is exposed to foreign exchange risk in connection with sales, purchases, receivables, and loans denominated in a currency other than the Group's functional currency. Production activities are limited to Italy and Switzerland; therefore, the Group is exposed to fluctuations between the euro and the Swiss franc. The reference currency for the Group's consolidation is the euro. Philogen is subject to foreign exchange risk arising from the translation of the financial statements of its Swiss subsidiary, Philochem AG, which affects consolidated net income and consolidated shareholders' equity (translation risk). Finally, starting in 2025, following the signing of the agreement with RayzeBio, the Group is exposed to exchange rate risk between the euro and the U.S. dollar, arising from the receipt of the upfront payment and subsequent contractually stipulated milestone payments in U.S. dollars. For further details on financial risks, please refer to Note 26 of the condensed consolidated semiannual financial statements.
Risks Related to Existing Lease Agreements
As part of its management of leased properties, the Company constantly monitors rental risk-that is, the risk arising from the possibility that leased properties may experience changes in rent or in the duration of leases as originally agreed upon in the contracts (renewal could occur under less favorable terms than in previous years) or in the costs associated with managing the leased spaces, or the difficulty-in the event of non-renewal of lease agreements-of securing additional spaces and/or properties in which to conduct its business.
- Strategic and Operational Risks
- Environmental and Occupational Safety Disclosure
The locations where the Company operates and its production activities are subject to stringent environmental and workplace safety regulations.
The Company implements safety procedures for managing work activities in accordance with Legislative Decree 81/2008 and Legislative Decree 206/2001 regarding the handling of genetically modified microorganisms (GMMs). Staff undergo specific training on this subject and operate according to procedures designed to minimize the risks of contamination, not only biological.
Special waste is disposed of in accordance with applicable regulations (Legislative Decree 152/06), following dedicated procedures, with the support of a specialized and authorized company.
In accordance with the requirements of Article 37 of Legislative Decree 81/2008 and the procedures defined by the State-Regions Agreement of December 21, 2011, periodic safety training and refresher courses are provided for all employees, divided into general and specific training courses, which employees attend according to a schedule specified by the applicable industry regulations.
In the course of its operations, the Company uses chemical and biological agents for which specific risk assessments are conducted in accordance with Legislative Decree 81/2008. Personnel also use equipment and personal protective equipment (PPE) in compliance with applicable regulations.
The Company believes 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.
The Group's staff receives ongoing updates and training regarding applicable industry regulations. Specifically, in the first half of 2026, training courses were once again conducted to update and increase the number of employees trained in first aid, in response to the growth in the workforce. This course was enhanced with an optional module providing specific training on the use of a defibrillator, a life-saving device increasingly recommended in companies. In addition, a refresher
course was conducted for the Health and Safety Representative (RSL), a training course for the new RSL at the Milan office, refresher courses for supervisors, and safety training and refresher courses for all Philogen staff.
Furthermore, the Company has further strengthened its occupational health and safety measures by training additional fire safety and evacuation personnel for the new Milan office, in accordance with current regulations and the company's emergency management plan. This initiative has increased the number of qualified and formally designated personnel, ensuring greater organizational coverage across the various sites and shifts, as well as more effective management of any potential risk situations. The training covered both theoretical aspects (relevant regulations, internal procedures, roles, and responsibilities) and practical exercises, with particular emphasis on how to activate the alarm, coordinate evacuation operations, and use firefighting equipment.
This initiative is part of the Company's broader program of continuous training and prevention, aimed at strengthening a culture of safety and reducing exposure to operational risks, thereby helping to maintain high standards of compliance and the protection of people.
Finally, it should be noted that the company has never been subject to any definitive sanctions or penalties for environmental crimes or damage.
- Environmental Responsibility and Climate Change
The European Securities and Markets Authority (ESMA) emphasizes the importance for the Company to consider key climate risks and impacts when preparing its financial statements.
In this regard, ESMA notes that investors are increasingly interested in information regarding the impacts that climate-related issues may have on companies, especially in light of international and European commitments such as the 2015 Paris Agreement and the European Climate Law (Regulation (EEC/EU) No. 1119 of June 30, 2021).
In light of international and European commitments, such as the 2015 Paris Agreement and the European Climate Law, as well as the regulator's numerous 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 impacts associated with its business operations.
In this context, the Group's production facilities operate in compliance with applicable environmental regulations and the authorizations to which they are subject, specifically:
the Montarioso (Siena) site holds an AUA (Single Environmental Authorization) discharge permit issued by the Municipality of Monteriggioni (Siena), which is set to expire in 2032;
The Rosia (Siena) site holds an AUA (Single Environmental Authorization) discharge permit issued by the Municipality of Sovicille (Siena), which is set to expire in 2030;
With regard to its laboratories in Switzerland, Philochem ensures compliance with the "CFSL Directive," which governs the design, construction, operation, and maintenance of laboratories that use chemicals or flammable and hazardous substances to ensure they are efficient and safe. The company ensures the uniform, appropriate, and technically up-to-date application of relevant legal provisions, including the "Federal Environmental Protection Act."
These regulations, applied at both sites (Montarioso and Rosia), govern, among other things, air emissions and the storage and disposal of hazardous waste.
The Group is committed to protecting and preserving the environment through continuous improvement in energy efficiency and by promoting the use of renewable energy sources. The first step toward reducing energy consumption from non-renewable sources is undoubtedly reducing electricity consumption.
At the GMP plant in Rosia, two new photovoltaic systems have become operational, helping to increase the supply of energy from renewable sources. This initiative is part of a broader commitment to environmental sustainability, which also
includes the adoption of innovative and responsible practices within the supply chain, with the goal of reducing the overall environmental impact and promoting a more efficient production model that respects the local area.
As evidence of this commitment, among the measures aimed at improving the energy efficiency of its processes, the Group has focused on replacing obsolete machinery with more modern equipment at numerous facilities, thereby contributing to a reduction in overall energy consumption. In recent years, Philogen has invested in advanced technologies and innovative practices to optimize energy consumption across its three facilities. Of particular note is the recent project, completed in August at the Montarioso site, which involved replacing the boiler that serves the entire plant, including operations within the GMP production department. This project is part of a broader program for the maintenance and modernization of the company's facilities, aimed at ensuring operational continuity, efficiency, and alignment with the needs of production activities.
With regard to water resources, the production of injectable solutions requires the use of equipment to treat water drawn from the municipal water supply to make it suitable for medical use. During operations at the Rosia plant, the Group has installed only state-of-the-art treatment systems, which ensure significantly lower energy consumption compared to older systems.
For an organization like the Group, which operates in the biopharmaceutical research sector and produces experimental drugs, attention to and proper management of the waste generated are also of fundamental importance. Philogen produces both ordinary municipal waste, which is disposed of through separate collection, and special waste, which is collected by specialized companies. For the former, the separate collection system at the Montarioso site-operated by a specialized company-ensures the proper disposal of all municipal waste. The Rosia plant is also equipped with a separate collection system for ordinary waste. Special waste generated by the laboratories is stored in a dedicated warehouse, collected in containers approved for medical waste, and disposed of by a specialized company in accordance with legal requirements.
Philogen relies on a company certified under ISO 14001 for the activities of "Collection and Transport of Special Waste, Brokerage, Disposal and Asbestos Remediation, and Environmental Consulting," and listed among the organizations registered under EC Regulation No. 1221/2009. Liquid waste generated by the production process, on the other hand, is channeled through a wastewater collection system and then collected in a dedicated storage tank. It is subsequently disposed of by a specialized company in accordance with current regulations.
- Personnel Information
As of June 30, 2026, the Group's workforce consisted of 230 employees, of whom 181 were employed by Philogen S.p.A., at the Siena (Rosia and Montarioso) and Milan locations, and 49 by Philochem AG at the Zurich site, marking an overall increase of approximately 7.98% compared to December 31, 2025.
The increase, shown in the table below, is attributable to: (i) Philochem: 6 new hires and 7 terminations; (ii) Philogen: 33 new hires and 15 terminations.
Group Headcount as of the Reporting Date
As of June 30
As of
December 31
Changes
2026
2025
2026 vs. 2025
%
Employees
230
213
17
7.98%
The Group is committed to pursuing a human resources policy aimed at recruiting professionals in the field of research and development of new technologies, products, and processes, while promoting training and the exchange of know-how on an international level.
The Group's workforce is highly qualified and specialized, a factor that contributes to the company's competitiveness. Information on New Hires:
Position Philochem AG Philogen S.p.A. Group
Men
Wome
n
Total
Men
Wome
n
Total
Men
Wome
n
Total
Ph.D.
1
-
1
-
8
8
1
8
9
Bachelor's Degree
-
5
5
9
12
21
9
17
26
High School Diploma
-
-
-
2
2
4
2
2
4
No title
-
-
-
-
-
-
-
-
-
Grand Total
1
5
6
11
22
33
12
27
39
In order to keep staff constantly up to date on specific topics and industry regulations, various training and refresher courses were held during the first half of 2026. The most significant courses are listed below:
A 64-hour training course for Quality Assurance and Auditors, organized by SIMeF ETS (RICMA and GIQAR Working Groups) and GIDM, covering quality in clinical research, GCP regulations, risk management, clinical trial monitoring, pharmacovigilance, quality systems, and Quality Assurance/Quality Control, audit methodologies and plans, deviation management, and CAPA, attended by an employee from the Clinical Quality Assurance department.
Course titled "Vendor Qualification in Clinical Research-In-Depth Analysis, Examples, and Practical Aspects," organized by Life Science Academy, lasting 4 hours, covering vendor qualification and supervision in clinical research, the outsourcing process, risk analysis, vendor qualification and audit methodologies, performance monitoring, Quality Oversight Agreements, and Quality Key Performance Indicators (KPIs), attended by an employee from the Clinical Quality Assurance department.
Course titled "Advanced Safety Management in Clinical Trials under CTR 536/2014," organized by Life Science Academy, lasting 4 hours, covering safety management in clinical trials pursuant to Regulation (EU) No. 536/2014, product classification, management and reporting of adverse events and SUSARs, Reference Safety Information (RSI), risk mitigation strategies, safety reporting, the Annual Safety Report (ASR), DSUR, and management of related workflows via CTIS, attended by an employee from the Pharmacovigilance department.
Advanced training course "Authorized Economic Operator (AEO)," delivered by KPMG with organizational support from SEAC CeFor and accredited by the Customs Agency, consisting of 200 hours of training, 10 hours of practical exercises, and 4 hours of exam simulations, aimed at obtaining the qualification of customs affairs manager and acquiring the necessary skills to manage the company's customs obligations, procedures, and risks, in which the Warehouse & Shipping Manager participated.
The 33rd GIQAR National Congress, organized by SIMeF ETS, was held in Cagliari from May 20 to 22, 2026. It was dedicated to the professional development of the Quality & Regulatory community in the GxP field, with in-depth discussions on key regulatory and technological developments, including Artificial Intelligence, Audit Trail Review, Supplier Management, GVP, GLP, and ICH GCP R3, aimed at fostering discussion and providing updates on issues related to quality, compliance, audits, and inspections in the pharmaceutical and clinical research sectors
The "Sterility Assurance Principles" course, organized by PQE, consisted of two modules, each lasting 4 hours, for a total of 8 hours of training. The course was designed to provide an in-depth understanding of the principles and requirements for ensuring sterility and contamination control in production processes. Several employees from the Quality Control, Quality Assurance, Production, and Logistics departments participated in the course.
The Group reaffirms its ongoing commitment to the principles of gender equality and inclusion. Currently, approximately 55-60% of employees are women, and the workforce represents over 15 different nationalities, reflecting a multicultural and inclusive work environment.
The composition of the top management reflects a gender balance that has characterized the Group since before its initial public offering. Some notable examples include:
the appointment of the CFO in 2007,
the Head of Human Resources in 2008,
the Company Legal Counsel in 2016,
the Head of Project Management & Strategy in 2020,
the Qualified Person at the Rosia site in 2023
the Head of Clinical Operations in 2025
Starting in 2016, Philogen has progressively increased the representation of women on its Board of Directors, initially with the appointment of Dr. Nathalie Dompé. Following the IPO, the composition of the Board was further enriched by the addition of Attorney Marta Bavasso, consolidating greater diversification in the skills, professional experiences, and perspectives represented within it.
This trend continued during the most recent renewal of the Board of Directors, which took place in April 2025, with the appointment of Flavia Scarpellini, Esq., Prof. Chiara Falciani, and Patrizia Sacchi, Esq. The evolution of the Board's composition reflects the Company's growing focus on gender diversity and the promotion of qualified professionals-elements that foster more nuanced discussions, a greater diversity of perspectives, and a balanced and effective decision-making process.
In the field of research as well, top leadership roles have been and continue to be held by women. Professor Cornelia Halin is a member of the Scientific Advisory Committee, and the antibody research area has been led by a female scientist for years.
In accordance with Italian law, Philogen also employs six individuals from protected categories.
The Group does not identify any specific risks related to diversity and inclusion, but recognizes that careful and mindful management of these aspects presents an opportunity to foster a stimulating, creative, and open work environment.
As of the date of this Report, the Company does not consider it necessary to adopt specific diversity policies, as the composition of its workforce, gender balance, and training and career paths are already consistent with the principles of inclusion and the promotion of diversity.
- Significant Events Subsequent to the End of the Period
-
Purchase of Treasury Stock
The Group is continuing the treasury stock repurchase program approved on April 29, 2026, by the Company's Shareholders' Meeting and launched on May 12, 2026, by the Board of Directors, with a duration of 18 months from the date of approval (see paragraph 4.4 of the interim management report).
Since the start of the program, Philogen has purchased 7,942 common shares (equal to 0.0196% of the share capital), for a total value of €182,193.20. As of September 23, 2026, Philogen holds a total of 370,741 common shares (equal to 0.9129% of the share capital). Disclosures pursuant to the regulations governing share buybacks are available on the company's website (https://www.philogen.com).
Update on the Marketing Authorization Application for Nidlegy™
As announced to the market in a press release published on the company's website (https://www.philogen.com/investors/press-releases/) on July 27, 2026, Philogen submitted an application for marketing authorization for the product Nidlegy™ to the European Medicines Agency (EMA), based on new clinical data published in the Journal of Clinical Oncology (Hauschild et al., J. Clin. Oncol., 44, 23; doi: 10.1200/JCO-26-00852).
-
Purchase of Treasury Stock
- Business Outlook
- Information on the Group
The Group reports the following major industrial milestones achieved during the period: Proprietary Products
Antibody-based products:
Nidlegy™-a biopharmaceutical product designed for the treatment of skin cancers
Following the withdrawal in 2025 of the Marketing Authorization Application (MAA) previously submitted to the EMA for the melanoma indication, in July 2026 the Company submitted a new application in Europe, supported by updated clinical data and a revised Chemistry, Manufacturing, and Controls (CMC) dossier.
In the United States, a Phase III clinical trial for locally advanced melanoma is currently underway in both the U.S. and Europe. In March 2026, a Type C meeting was held with the U.S. Food and Drug Administration (FDA), during which data from the European study were presented and an agreement was reached on the regulatory pathway aimed at obtaining approval for the treatment of melanoma in the United States, subject to the completion and positive outcome of the ongoing study. As of the date of this half-year report, 184 patients had been enrolled (out of the 240 planned in the protocol).
In the non-melanoma skin cancer (NMSC) program, the Phase II "Duncan" and "Intrinsic" studies, conducted in patients with basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), have been completed. The excellent results were recently accepted for publication in the prestigious Journal of Clinical Oncology.
The very positive results observed in the "Duncan" and "Intrinsic" trials provided a solid rationale for launching three new registration studies in these indications in Europe and the United States for BCC and cSCC. These studies have begun, in line with the company's timeline.
Finally, an additional Scientific Advice session with the FDA was completed to define a fourth registration study in first-line BCC, in which the performance of Nidlegy™ will be compared with that of Hedgehog pathway inhibitors (HHIs); the study has been submitted, and the first patient enrollments are expected in the second half of 2026.
- Fibromun - STS and Glioblastoma
Following the results of the FIBROSARC study in first-line soft tissue sarcoma, which showed encouraging signs in terms of survival in patients with liposarcoma and other types of sarcoma, discussions are underway with the FDA and EMA to define the design of a potential new Phase III registration study (FIBROSARC-2).
The GLIOSUN clinical trial, conducted in treatment-naïve (i.e., first-line) glioblastoma patients who had not previously been exposed to alkylating agents, has completed the dose-escalation phase and has begun the subsequent dose-expansion phase.
Finally, the GLIOSTELLA study, underway in patients with last-line glioblastoma, has completed patient enrollment in the United States and expects to report survival data in Q3 2026.
Small-molecule products:
- OncoFAP - FAP Platform
This is a small molecule with extremely high affinity for fibroblast activation protein. The product is suitable for diagnostic and therapeutic applications for various solid tumors.
The diagnostic study 68Ga-OncoFAP has completed Phase I (solid tumors), and Blue Earth Diagnostic has initiated Phase II.
The Phase I therapeutic study 177Lu-OncoFAP-23 (solid tumors) is continuing with encouraging results.
The OncoFAP-GlyPro-MMAE conjugate has demonstrated marked antitumor activity in both preclinical studies and a Phase I veterinary clinical trial conducted at the University of Milan. A substantial reduction in disease was reported in six out of seven treated animal patients. Preparations for the start of clinical trials in 2027 are underway. In addition, a new immunotherapy candidate based on the OncoFAP ligand is showing promising signs of efficacy in a veterinary Phase I study. These results lay the groundwork for the expansion of the future pipeline based on small-molecule drug conjugates.
- OncoACP3 - PAP target (prostate)
This is a small molecule with extremely high affinity for the Prostatic Acid Phosphatase protein. The product is suitable for diagnostic and therapeutic applications for prostate cancer.
On the diagnostic front, the Phase I trial with 68Ga-OncoACP3 has been completed in Italy.
On the therapeutic front, preparatory activities are underway with RayzeBio for Phase I (the first patient has already been treated in Germany under a compassionate use program [AMG 13.2b], with tumor persistence of ≥7 days).
- OncoCAIX - CAIX target (kidney cancer and hypoxic tumors)
On the diagnostic front, the Phase I trial with 68Ga-OncoCAIX has been completed in Italy (20 out of 20 patients enrolled) with excellent results that have already been presented at international scientific conferences.
Preparatory work is underway to launch a Phase III registration study directly in 2027. A Scientific Advice meeting with the FDA is planned to align on the product's regulatory development.
Discovery and Development of New CompoundsThe Group's DNA-encoded chemical libraries, containing billions of compounds, are generating highly specific ligands against targets of pharmaceutical interest, with significant biomedical and commercial potential.
- Strengthening Artificial Intelligence Activities
Following its collaboration with Google-which was the subject of a dedicated scientific publication-the Philogen Group has expanded its artificial intelligence team to support and optimize the activities of its clinical and manufacturing departments. These efforts promise to accelerate the discovery and development of new drugs, helping to improve the Company's operational efficiency and competitive positioning in the medium to long term.
Products Developed Through Partnerships
Collaborations continue on:
Dekavil (Pfizer),
Nidlegy™ (Sun Pharma and MSD),
Fibromun (Sun Pharma),
OncoFAP (Bracco),
OncoACP3 (RayzeBio).
- OncoFAP - FAP Platform
Program | Indication / Study | Phase | Status / Enrollment | Countries / Sites | Next Steps / Timeline |
Nidlegy™ | Locally Advanced Melanoma (Phase III, U.S.) | III | 178/240 enrolled; study ongoing | U.S., EU, Switzerland (+ expansion) | Geographic expansion; new EMA MAA submitted. FDA meeting scheduled for Q1 2026 |
Nidlegy™ | NMSC - Duncan (advanced BCC, cSCC) | II | Completed | Switzerland, EU | - |
Nidlegy™ | NMSC - Intrinsic (various NMSCs: Kaposi's sarcoma, CTCL, adnexal tumors, keratoacanthoma, MCC, cSCC, BCC) | II | Completed | EU | Enrollment ongoing |
Nidlegy™ | Registration studies (2× BCC, 1× cSCC) | - | Enrollment has begun | U.S. + EU | Study results |
Fibromun | First-line STS + doxorubicin (EU) | III | Study completed. | EU | Planning for a confirmatory registration study in the liposarcoma + others subgroup |
Fibromun | First-line leiomyosarcoma + doxorubicin (USA) | IIb | Ongoing study | USA | - |
Fibromun | STS 3rd-line + dacarbazine (EU) | II | Primary endpoint not met | EU | - |
Fibromun | Second-line glioblastoma + lomustine | I/II | Primary endpoint not met | EU | - |
Fibromun | First-line glioblastoma + RT + temozolomide | I/II/IIb | Phase I completed Dose-expansion phase initiated | EU, Switzerland | Dose expansion completed |
OncoFAP | 68Ga-OncoFAP (diagnostic) | I | Phase I completed (solid tumors) Phase II initiated | - | Phase II Readout |
