Ascelia Pharma

Quarterly Report • Nov 5, 2025

Interim Report Q3 2025

January – September 2025

Orviglance® NDA Submitted to the FDA

KEY EVENTS IN Q3 2025

• New Drug Application (NDA) for Orviglance submitted to the US Food and Drug Administration (FDA)
• Directed share issue of approximately SEK 30 million completed
• Fenja Capital II A/S converted all outstanding convertibles of SEK 7.5 million
• Updated timeline for submission of the Orviglance NDA to take place early September 2025

KEY EVENTS AFTER THE PERIOD

Management changes to support future growth

Submitting the Orviglance NDA to the FDA is a major achievement for us. We now look forward to advancing Orviglance through the FDA review process." "

KEY RATIOS GROUP

Q3 (Jul-Sep)			9M (Jan-Sep)
2025	2024	2025	2024
OPERATING RESULT (SEKm)
-15.3	-17.8	-58.6	-45.8
EARNINGS PER SHARE (SEK)
-0.13	-0.42	-0.55	-1.30
CASH FLOW FROM OPERATIONS (SEKm)
-15.7	-17.0	-50.6	-44.1
LIQUID ASSETS (SEKm)
72.3	95.7	72.3	95.7

CEO STATEMENT

We submitted the NDA for Orviglance to the FDA in early September. This is a major achievement for us. Our focus is now on advancing Orviglance through the FDA review to obtain marketing authorization for Orviglance as a liver MRI contrast agent for patients with severe kidney impairment. We expect a standard 10 months review timeline with the FDA.

The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. In our Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance for all three readers (<0.001).

This quarter, we considerably strengthened our balance sheet. In September 2025, Fenja converted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue raising SEK 30 million before costs. With this fundraise, based on the inbound interest expressed by investors, we also broaden and anchor our investor base. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance.

We are excited about our continued progress with Orviglance and the ongoing FDA review process. Partnership discussions for the commercialization of Orviglance continue and we look forward realizing the potential of Orviglance and provide better access to diagnosis and care for cancer patients with impaired kidney function.

Orviglance NDA submitted. The NDA for Orviglance has been submitted to the FDA. Ascelia Pharma seeks marketing approval for Orviglance as liver magnetic resonance imaging (MRI) contrast agent for patients with severe kidney impairment. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the gadolinium-based contrast agents normally used today. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population and Orviglance has been granted an Orphan Drug Designation by the FDA.

The standard FDA review timeline of the NDA file is 10 months. Mid November, 74 days after submission, the FDA will share the expected date for their review completion, i.e. the PDUFA date.

Completion of Orviglance clinical development. The NDA submission is based on a successfully completed development program, including nine clinical studies with consistent positive efficacy and safety results. The program includes nine clinical studies with a total of 286 patients and healthy volunteers. 85 patients with known or suspected focal liver lesions and severely impaired kidney function were included in the global multi-center pivotal Phase 3 study, SPARKLE.

As announced in 2024, the SPARKLE study successfully met the primary endpoint and demonstrated that our contrast agent Orviglance, significantly improved visualization of focal liver lesions compared to unenhanced MRI. The positive results had an acceptable level of variability and high statistical significance (P values <0.001) for all three independent readers, who scored study images according to the FDA agreed methodology.

Common adverse events in the vulnerable patient population were in line with previous studies, such as mild- to moderate nausea. No serious adverse drug reactions were observed.

Orviglance aims to give patients with impaired kidney function access to safe and effective liver imaging and the strong results from the clinical studies reinforce our confidence in the market potential and path to market for Orviglance. We are now focused on bringing Orviglance through the FDA review process.

"With our directed share issue of SEK 30 million before costs, we broaden our investor base and strengthen our balance sheet. We now have a cash runway into Q4 2026".

Recognition in the scientific community. We are pleased to see the acceptances of Orviglance data for presentation at major scientific conferences. In total four oral presentations and five abstract presentations have been accepted since the announcement of our Phase 3 results, underscoring the interest in the medical and scientific community for an alternative to gadolinium-based contrast agents.

SPARKLE results have been presented as Cutting-Edge Research at the Radiological Society of North America conference (RSNA) in November 2024. Other key conferences have also welcomed SPARKLE data, such as the American Society of Nephrology Kidney Week, Society of Abdominal Radiology (SAR), and European Society of Gastrointestinal and Abdominal Radiology (ESGAR). In addition, a burden of illness real-world data analysis was presented at the Professional Society for Health Economics and Outcomes Research (ISPOR) Conference. In April 2025, an article in Investigative Radiology was published featuring Orviglance in a Phase 2 comparison study to unenhanced MRI and to gadolinium. The publication presents data utilizing the same independent reader methodology and approach as used in SPARKLE.

Strategy to commercialize with partners. Orviglance addresses a well-defined unmet medical need representing an annual global addressable market of USD 800 million, with 100,000 annual procedures in the target patient population in the US alone. Our commercialization strategy is to launch Orviglance with commercialization partners. This strategy enables us to leverage established commercialization capabilities of a partner with a low investment from Ascelia Pharma required for launch. A focused, ambitious launch plan, built on advanced market insights, is in place.

We continue to advance the dialogues with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without the safety risks associated with gadolinium.

Strengthened financial position. This quarter, we considerably strengthened our balance sheet. In September 2025, Fenja converted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue raising SEK 30 million before costs. With this fundraise, based on the inbound interest expressed by investors, we also broaden and anchor our investor base. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance.

Opportunities ahead into 2026 and beyond. With the NDA submission to the FDA, we are excited to advance Orviglance through the FDA review process and to advance the partnering process for the US launch of Orviglance. We look forward to continuing our journey with opportunities for growing Ascelia Pharma into 2026 and beyond.

Magnus Corfitzen

CEO

ADVANCING ORPHAN ONCOLOGY

OUR VALUES OUR VISION OUR BASE

FOCUS

We are devoted to improving the lives of patients and creating values for our stakeholders.

COURAGE

We work tirelessly and follow our convictions even when it means changing status quo.

INTEGRITY

We build powerful relationship with mutual respect and adhere to the high ethical standards of our industry.

Building Ascelia Pharma and building value

To be a leader in identifying, developing and commercializing novel drugs that address unmet needs of people with rare cancer conditions.

Our headquarter is in Malmö, Sweden, and our US base is in New Jersey.

The shares in the company are listed on NASDAQ Stockholm (ticker: ACE).

ADVANCING PIPELINE AND COMMERCIAL CAPABILITIES

• Orviglance in
• Oncoral Phase 2 ready

PRODUCT LAUNCH AND EXPANDING PIPELINE

• Orviglance revenue
• Oncoral Phase 2
• Pipeline expansion

ESTABLISHED MARKET POSITION IN ORPHAN ONCOLOGY

• Orviglance market leader
• Oncoral Phase 3
• Pipeline development
• Pipeline further expanded

OUR PIPELINE

ORVIGLANCE

Diagnostic drug for liver MRI in registration phase

Orviglance is our first-in-class non-gadolinium diagnostic drug (contrast agent) to be used for magnetic resonance imaging (MRI) of the liver. Orviglance is developed to improve the visualization of focal liver lesions (liver metastases and primary liver cancer) in patients with impaired kidney function at risk of severe side-effects from the gadolinium contrast agents currently on the market.

• First-in-class manganese-based diagnostic drug with FDA Orphan Drug Designation
• USD 800 million global annual addressable market
• Clinical development completed, incl. pivotal Phase 3, with consistent positive efficacy and safety data from nine clinical studies with 286 patients and healthy volunteers
• NDA submitted to the FDA

ONCORAL

Daily tablet chemotherapy ready for Phase 2

Oncoral is our novel oral irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. The potential anti-tumor effect of irinotecan is well established.

• Oral daily dosing of irinotecan chemotherapy
• Potential for better efficacy and safety by frequent low dosing
• Ready for Phase 2 in gastric cancer; potential to expand into other cancers

ORVIGLANCE ADDRESSES UNMET NEED FOR LIVER MRI IN PATIENTS WITH KIDNEY IMPAIRMENT

Orviglance aims to be the standard of care liver MRI contrast agent for patients also suffering from severe kidney impairment. These patients are at risk of severe side-effects from using gadolinium-based contrast agents.

USD 800 million global annual addressable market

The target group for Orviglance is patients who need liver imaging and have severely impaired kidney function. This patient group is at risk of serious, and potentially fatal, side effects from using the currently available gadolinium based contrast agents. These contrast agents, carry black box warnings for patients with severely reduced kidney function.

The completed clinical studies show that Orviglance improves the diagnostic performance of MRI and offers a significantly better alternative than unenhanced MRI (i.e., MRI without contrast agent). Consequently, Orviglance fills a significant unmet medical need to improve the diagnosis, and subsequently, the treatment of liver metastases and primary liver cancer for these patients.

The immediate addressable market for Orviglance is estimated at USD 800 million yearly and Orviglance is expected to be the only gadolinium-free product on the market for this patient segment.

Orphan Drug Designation

Orviglance has received Orphan Drug Designation from the FDA. One major advantage of orphan drug status is, among other things, that orphan drugs can obtain longer market exclusivity after regulatory approval.

Early detection of liver metastases is key

Orviglance is a contrast agent used in MRIs to improve the detection and visualization of focal liver lesions (liver metastases and primary tumors). The liver is the second most common organ for metastasis after the lymph nodes. Detecting liver metastases at an early stage is crucial for determining the right treatment method and for the patient's chances of survival. Studies show that the five-year survival rate can increase from 6 percent to 46 percent if liver metastases can be removed surgically. An accurate MR scan using contrast agents is therefore critical to evaluate the possibilityfor surgical resection, but also for monitoring of treatment effect and surveillance for recurrence of the disease.

Suspected cancer in the liver Test kidney function MRI contrast agent decision Liver MRI scan

ORVIGLANCE CLINICAL DEVELOPMENT COMPLETED

Orphan liver MRI contrast agent in registration phase

How Orviglance works

Orviglance is an orally administrated contrast agent developed for use with MRI of the liver. It is based on the chemical element manganese, which is a natural trace element in the body. Orviglance also contains L-alanine and vitamin D3 to enhance the function of manganese as a contrast agent. After having been absorbed from the small intestine, the manganese is transported to the liver where it is taken up by and retained in the normal liver cells. The high manganese uptake causes the normal liver tissue to appear bright on MR images. Metastases and tumor cells do not take up manganese to the same extent as normal liver tissue and therefore appear dark on MR images. Liver metastases are easier to identify due to this contrast effect by Orviglance.

Successful clinical development

Clinical development of Orviglance has been completed with consistent positive efficacy and safety data from nine studies with 286 patients and healthy volunteers. The pivotal Phase 3 study for Orviglance, SPARKLE successfully met the primary endpoint and demonstrated that Orviglance significantly improved visualization of focal liver lesions compared to unenhanced MRI. The positive results were strong and conclusive and had both an acceptable level of variability and high statistical significance (P values <0.001) for all three readers. Common adverse events in this vulnerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were observed.

Advanced to registration phase

The NDA for Orviglance has been submitted to the FDA early September 2025. To reach this milestone, the Full Clinical Study Report from SPARKLE Phase 3 was completed in Q4 2024 and a pre-NDA meeting with the FDA was held in Q1 2025. The meeting provided clear and concrete guidance from the FDA for the finalization and submission of the NDA.

The standard FDA review timeline of the NDA file is 10 months. Mid November, 74 days after submission, the FDA will share the expected date for their review completion, i.e. the PDUFA date.

Improved visualization of focal liver lesions with Orviglance

PHASE 3 SUCCESSFULLY COMPLETED

Phase 3 primary endpoint met

The pivotal Phase 3 study, SPARKLE, successfully met the primary endpoint and demonstrated that Orviglance significantly improved the visualization of focal liver lesions compared to MRI without contrast, unenhanced MRI. The results for all three readers were highly statistically significant (P values <0.001).

Common adverse events in this vulnerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were observed.

Designed to support regulatory approval

The pivotal Phase 3 study (SPARKLE) is a global multicentre study, which was completed with 85 enrolled patients with suspected or known focal liver lesions and severely impaired kidney function.

The evaluation of the primary endpoint was carried out by three blinded, independent radiologists (readers), in accordance with regulatory guidance to the industry. The readers assessed the changes in visualization of liver lesions with and without Orviglance, as well as other secondary efficacy endpoints.

Following an unacceptably high intra-reader variability in the first image scoring by readers mid-2023, a new evaluation of the images with new readers was successfully completed with the announced positive headline results and acceptable variability in May 2024, in line with the planned timeline.

The full Phase 3 program was designed in accordance with industry standards, regulatory guidance for imaging agent development and based on discussions with regulatory agencies. The program aims to support a regulatory filing and approval for use of Orviglance for liver imaging in patients where the use of gadolinium may be medically inadvisable.

Strong positive Phase 3 results

to unenhanced MRI, e.g. with at least one additional lesion detected in 40-52% of patients with

*Visualization assessed by 3 independent readers as the improvement of Lesion border delineation (LBD) and Lesion contrast (LC) on combined Orviglance-enhanced + unenhanced (CMRI) images compared to unenhanced (UMRI) images for all matched lesions, using a 4-point scale (from 1 ("poor") to 4 ("excellent")). Data presented as mean paired differences for matched lesions per patient for CMRI and UMRI with 95% Confidence Intervals. One-sided paired t-test (α=0.025).Total N=85, n=number of patients with matched lesions (per reader).

ANNUAL ADDRESSABLE MARKET OF USD 800 MILLION

Clear and attractive addressable market

Orviglance addresses a well-defined unmet medical need representing an attractive commercial potential with an annual global addressable market of USD 800 million. This estimate is based on:

• Patients with primary liver cancer or liver metastases and severe kidney impairment (~4 percent)
• Actual imaging procedures (real-world data)¹
• Payer and expert input (+75 stakeholders)²

Unique opportunity to address an unmet need

Orviglance addresses an attractive market opportunity by offering contrast enhanced liver imaging for cancer patients with poor kidney function

• not associated with gadolinium safety risks for patients with poor kidney function
• addressing the increasing demand for alternatives to toxic gadolinium

90 percent of health care professionals are concerned by safety issues related to gadolinium contrast agents including NSF. In fact, according to market research, 16 percent of healthcare providers have experienced gadolinium-induced NSF³.

In the US alone real-world data shows that 100,000 abdominal imaging procedures are performed every year in 50,000 patients that fall under the black-box warning for gadolinium contrast agents, which is about 4 percent of the cancer patient population undergoing abdominal imaging.

Partnering strategy

The go-to-market strategy for Orviglance is to launch with commercialization partners. This approach enables Ascelia Pharma to leverage established commercialization capabilities and maintain a low investment requirement for launch.

The focus of Ascelia Pharma is to create value by ensuring launch readiness and collaboration with a partner by preparing for optimal adoption by key stakeholders at launch.

UNIQUE OPPORTUNITY

Give people with cancer in the liver and poor kidney function ACCESS TO SAFE AND EFFECTIVE IMAGING to live healthier and longer lives

CLEAR AMBITION

Be the STANDARD OF CARE liver imaging choice for cancer patients with poor kidney function

FOCUSED, AMBITIOUS STRATEGY

Ensure OPTIMAL LABEL, timely SUPPLY and launch READINESS Drive EARLY ADOPTION AND PREFERENCE by decision makers with focused efforts and a strong value proposition

11

Our commercialization strategy is to launch through partners, supporting our ambition to secure the optimal balance between future revenues and investment required. Our focus is therefore to continue the ongoing dialogue with potential partners and to ensure that Orviglance is ready for launch when approved", says Julie Waras Brogren, Deputy CEO

1) Ascelia Pharma market research on real-world volumes with DRG (2020)
2) Market access research and analyses with Charles River Associates (2020). Triangle (2022)

and Trinity (2022), incl. 75 stakeholder and expert interactions. Final pricing and access strategy subject to Phase 3 data and payer evidence

3) Ascelia Pharma market research with Two Labs including 254 US HCPs (2022).

ONCORAL POTENTIAL WITH DAILY DOSING

Oncoral is a novel daily irinotecan chemotherapy in development. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily irinotecan tablet with the potential to offer better efficacy with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital.

Proven anti-cancer effect

The active substance in Oncoral is irinotecan, which has an established and proven effect in killing cancer cells. Irinotecan is a so-called antineoplastic agent that after metabolic activation inhibits the enzyme topoisomerase 1, thereby inducing cancer cell death via the prevention of their DNA replication. Irinotecan is converted by carboxylesterases, primarily in the liver, to the active metabolite SN-38 which is 100–1,000 more potent than irinotecan in killing tumor cells.

Potential to be the first oral version of irinotecan

Oncoral is a new patented oral tablet formulation of irinotecan, which enables a reliable release and efficient absorption of irinotecan from the gastro intestinal tract after oral administration. With oral administration, irinotecan can be given with low daily doses. This is very different from the current standard of giving a high intravenous doses every third week.

All-oral chemo combination

Oncoral has the potential to be combined with other chemotherapies and targeted cancer drugs and enable an all oral combination chemotherapy option with improved clinical outcomes.

ONCORAL – a novel formulation of irinotecan TODAY – Intravenous bolus infusions

Intravenous Oral, daily dosing New cancer indications Approved cancer indications Gastric cancer ONCORAL Colorectal cancer Pancreatic cancer Potential to expand Oncoral into other solid tumor indications

Infrequent high-dose IV irinotecan

• Gastrointestinal and hematological side effects
• Dose limiting toxicity: 30 percent severe or lifethreatening (grade 3 or 4)

TOMORROW – Oncoral oral daily dosing

Potential – Frequent low-dose irinotecan

• Improved efficacy driven by pharmacokinetic profile
• Improved tolerability due to lower peak exposure with less severe side effects and manageable toxicity with flexible dosing

PHASE 2 STUDY DESIGN AND COLLABORATION

Phase 2 study design

Clinical collaboration with Taiho Oncology

• ^Q Clinical Phase 2 collaboration with Taiho Oncology Inc. (part of Otsuka Group)
• ^Q Taiho Oncology Inc. will supply Lonsurf and provide scientific expertise
• ^Q The collaboration may be extended for further development
• ^Q Ascelia Pharma retains full development and commercialization rights

LONSURF® is approved for treatment of metastatic gastric cancer and metastatic colorectal cancer

FINANCIAL OVERVIEW Q3 (JUL-SEP 2025)

EARNINGS AND PROFITABILITY

Net sales and other operating income

The Group's net sales in Q3 (Jul-Sep 2025) amounted to SEK 0 (SEK 0). Other operating income totalled SEK 0 (SEK 6 thousand).

Administrative costs

Administrative costs amounted to SEK 4.3 million (SEK 3.6 million). The cost increase compared to the same period last year is mainly driven by higher recognized costs for employee incentive programs.

Research and development costs (R&D)

R&D costs amounted to SEK 10.9 million (SEK 14.2 million). The cost decrease is related to the finalized NDA submission early September 2025.

Commercial preparation costs

No costs for commercial preparations were reported in the period.

Operating results (EBIT)

The operating result amounted to SEK -15.3 million (SEK -17.8 million). The cost decrease is related to the finalized NDA submission early September 2025.

Net Profit/Loss for the period

The Group's net loss in Q3 2025 amounted to SEK -15.7 million (SEK -21.7 million). A net financial cost of SEK -0.5 million was recognized for convertibles based on accounting priniciples. These costs have no cash flow impact. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.13 (SEK -0.42).

CASH FLOW AND FINANCIAL POSITION

Cash flow from operating activities before changes in working capital amounted to SEK -14.0 million (SEK -19.1 million). Changes in working capital for the quarter showed an outflow of SEK -1.7 million (SEK 2.0 million). The changes in working capital reflects a decrease in current liabilities. Cash flow from investing activities in amounted to SEK 0 (SEK 0) while cash flow from financing activities amounted to an inflow of SEK 27.5 million (inflow of SEK 83.1 million). In September 2025, a directed issue was completed generating proceeds of SEK 30 million before costs.

On the closing date, equity amounted to SEK 114.4 million, compared with SEK 78.9 million per 31 December 2024 and SEK 107.6 million per 30 September 2024. The increase since 31 December 2024 and 30 September 2024 reflects the new share issue related to the warrants TO 1 in April 2025 as well as the directed new share issue carried out in Sepmteber 2025. Liquid assets amounted to SEK 72.3 million on the closing date, compared to SEK 75.3 million per 31 December 2024 and SEK 95.7 million per 30 September 2024.

Financial key ratios for the Group	Q3 (July-September)
	2025	2024
Operating result (SEK 000')	-15,252	-17,790
Net result (SEK 000')	-15,673	-21,732
Earnings per share (SEK)	-0.13	-0.42
Weighted avg. number of shares	117,470,277	51,370,478
R&D costs/operating costs (%)	71%	80%
Cash flow used in operating activities (SEK 000')	-15,658	-17,043
Equity (SEK 000')	114,401	107,582
Liquid assets incl. marketable securities (SEK 000')	72,275	95,718

FINANCIAL OVERVIEW 9M (JAN-SEP 2025)

EARNINGS AND PROFITABILITY

Net sales and other operating income

The Group's net sales during the period (Jan-Sep) amounted to SEK 0 (SEK 0). Other operating income totalled SEK 0.1 million (SEK 0.4 million). The income refers to exchange rate gains.

Administrative costs

Administrative costs in the period amounted to SEK 13.2 million (SEK 14.3 million). The cost decrease compared to the same quarter last year, is mainly driven by lower recognized costs for employee incentive programs.

Research and development costs (R&D)

R&D costs amounted to SEK 45.2 million (SEK 32.5 million). The cost increase of SEK 12.7 million mainly reflects the costs for NDA submission preparations.

Commercial preparation costs

No costs for commercial preparations were reported in the period.

Operating results (EBIT)

The operating result for the Group amounted to SEK -58.6 million (SEK -45.8 million). The increased loss mainly reflects the costs for NDA submission preparations.

Net Profit/Loss for the period

The Group's net loss in he period amounted to SEK -60.4 million (SEK -51.7 million). A net financial loss of SEK -2.2 million was recognized, which mainly reflects interest and arrangement fee expenses related to loans. The net loss corresponds to a loss per share, before and after dilution, of SEK -0.55 (SEK -1.30).

CASH FLOW

Cash flow from operating activities before changes in working capital amounted to SEK -56.4 million (SEK -45.1 million). Changes in working capital for the period showed a positive impact of SEK 5.8 million (SEK 1.0 million). The changes in working capital reflects an increase in accounts payable, repayment of advances from suppliers and a decrease in credits on the tax account.

Cash flow from investing activities amounted to an outflow of SEK -57 thousand (SEK 0). Cash flow from financing activities totalled an inflow of SEK 48.6 million (inflow of SEK 117.2 million). The inflow during the period is attributable to the net effect of proceeds from the warrants series TO 1 and repayment of the loan to Fenja in April, and proceeds from the directed new share issue carried out in September.

FINANCIAL POSITION

The exercise period for warrants series TO 1 in Ascelia Pharma AB ended on 15 April 2025. The outcome shows that a total of 19,919,494 TO 1 were exercised for subscription of 19,919,494 new ordinary shares, corresponding to a subscription rate of

approximately 96 percent. Ascelia Pharma received net proceeds of SEK 41.5 million. In connection to the new share issuance a loan of SEK 20 million was repaid to Fenja.

In September 2025, Fenja converted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue, raising SEK 30 million before costs. With this fundraise, we broaden our investor base and strengthen our balance sheet. On the balance sheet date, liquid assets amounted to SEK 72.3 million.

We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance.

Financial key ratios for the Group	9M (January-September)
	2025	2024
Operating result (SEK 000')	-58,595	-45,837
Net result (SEK 000')	-60,388	-51,697
Earnings per share (SEK)	-0.55	-1.30
Weighted avg. number of shares	108,924,023	39,671,510
R&D costs/operating costs (%)	77%	70%
Cash flow used in operating activities (SEK 000')	-50,560	-44,060
Equity (SEK 000')	114,401	107,582
Liquid assets incl. marketable securities (SEK 000')	72,275	95,718

OTHER INFORMATION

Incentive programs

Ascelia Pharma has has one outstanding employee option program as well as three share saving programs. If the terms of the option program are met at the time for utilization, the employees has the right to purchase shares at a pre-determined price For the share-saving programs, employees are entitled to receive matching and performance shares according to the terms of the program.

The Group recognizes share-based remuneration, which personnel may receive. A personnel cost is recognized, together with a corresponding increase in equity, distributed over the vesting period. Social security costs are revalued at fair value. Further information about the incentive programs can be found in the Annual Report 2024 on pages 67-69.

In case all outstanding incentive programs per 30 September 2025 are exercised in full, a total of 7.5 million common shares will be issued (including hedge for future payment of social security charges). This corresponds to an aggregate maximum dilution of approximately 5.6 percent of Ascelia Pharma's share capital after full dilution (calculated on the number of common shares that will be added upon full exercise of all incentive programs).

Warrants TO 1

The warrants are valued at fair value based on the necessary variables using a Monte Carlo simulation. A first valuation was made after the Rights Issue in September 2024. A new fair value is calculated at each quarterly period. The new valuation generates either a financial income or a financial cost which do not effect the cash flow. In 2025 a financial income of SEK 2.1 million was recognizied related to TO 1.

Information about risks and uncertainties for the Group and the parent company

Ascelia Pharma continuously needs to secure financing to ensure continued development and growth. Market dynamics and financing needs create uncertainties regarding ongoing and future operations. To strengthen the balance sheet and ensure continued operations, the Company carried out a fully subscribed Rights Issue in September 2024 with warrants exercised in April 2025. The balance sheet was further strengthened with a directed new share issue in September 2025.

From an operational perspective, the Company is exposed to a number of risks and uncertainties which impact, or could impact, it's business, operations, financial position, and results. The risks and uncertainties considered to have the highest impact on results are within clinical drug development, regulatory conditions, commercialization and licensing, intellectual property rights and other forms of protection, financing conditions, macroeconomic conditions including impact from pandemics, geopolitical effects, inflation and foreign exchange exposure.

The Group's overall strategy for risk management is to limit undesirable impact on its result and financial position, to the extent it is possible. The Group's risks and uncertainties are described in more detail in the Annual Report 2024 on pages 35–37.

Significant events after the end of the reporting period

On 3 November, Ascelia Pharma announced management changes to support future growth.

Auditor's review

This interim report has not been reviewed by the company's auditor.

This interim report has been prepared in both Swedish and English versions. In the event of any differences between the translations and the Swedish original, the Swedish version shall prevail.

Malmö, 4 November 2025 Ascelia Pharma AB (publ)

Magnus Corfitzen CEO

Consolidated Income Statement

		Q3 (Jul-Sep)		9M (Jan-Sep)
SEK in thousands (unless otherwise stated)*	2025	2024	2025	2024
Net sales	–	–	–	–
Gross profit/loss	–	–	–	–
Administrative costs	-4,308	-3,550	-13,197	-14,313
Research and development costs	-10,887	-14,173	-45,205	-32,470
Commercial preparation costs	–	-31	–	669
Other operating income	–	6	124	376
Other operating costs	-57	-42	-316	-99
Operating result	-15,252	-17,790	-58,595	-45,837
Finance income	427	168	2,974	1,161
Finance costs	-898	-4,136	-5,168	-7,077
Net financial items	-471	-3,968	-2,194	-5,916
Loss before tax	-15,723	-21,758	-60,789	-51,753
Tax	50	26	401	55
Loss for the period	-15,673	-21,732	-60,388	-51,697
Attributable to:
Owners of the Parent Company	-15,673	-21,732	-60,388	-51,697
Non-controlling interest	–	–	–	–
Earnings per share
Before and after dilution (SEK)	-0.13	-0.42	-0.55	-1.30

Consolidated Statement of Comprehensive Income

		Q3 (Jul-Sep)	9M (Jan-Sep)
SEK in thousands (unless otherwise stated)*	2025	2024	2025	2024
Profit/loss for the period	-15,673	-21,732	-60,388	-51,697
Other comprehensive income
Currency translation of subsidiaries**	-1	32	92	-20
Other comprehensive income for the period	-1	32	92	-20
Total comprehensive income for the period	-15,675	-21,700	-60,296	-51,717

^* Some figures are rounded, so amounts might not always appear to match when added up.

^** Will be classified to profit and loss when specific conditions are met

Consolidated Balance Sheet

	30 Sep	30 Sep	31 Dec
SEK in thousands*	2025	2024	2024
ASSETS
Non-current assets
Intangible assets	57,073	57,076	57,078
Tangible assets - Equipment	57	34	15
Right-of-use assets	1,107	325	109
Total non-current assets	58,236	57,434	57,202
Current assets
Advance payments to suppliers	1,755	3,255	1,755
Current receivables
Income tax receivables	1,539	1,688	632
Other receivables	1,572	913	5,054
Prepaid expenses and accrued income	1,038	2,401	1,022
Cash and bank balances	72,275	95,718	75,256
Total current assets	78,179	103,975	83,718
Total assets	136,415	161,409	140,920
EQUITY
Share capital	127,903	97,193	97,193
Other paid-in capital	771,366	721,750	721,750
Reserve of exchange differences on translation	1,065	651	974
Loss brought forward (incl. net profit/loss for the period)	-785,932	-712,012	-740,973
Equity attributable to Parent Company shareholders	114,401	107,582	78,944
Total equity	114,401	107,582	78,944
LIABILITIES
Long-term liabilities
Long-term interest bearing liabilities	–	26,215	–
Lease liabilities	285	–	–
Total long-term liabilities	285	26,215	–
Current liabilities
Accounts payable	7,245	2,596	4,733
Tax payable	–	1	–
Other liabilities	973	13,479	19,113
Interest bearing liabilities	–	–	25,225
Current lease liabilities	890	402	172
Accrued expenses and deferred income	12,621	11,133	12,733
Total current liabilities	21,730	27,612	61,976
Total liabilities	22,014	53,827	61,976
Total equity and liabilities	136,415	161,409	140,920

^* Some figures are rounded, so amounts might not always appear to match when added up.

Consolidated Statements of Changes in Equity

		9M (Jan-Sep)
SEK in thousands*	2025	2024	2024
Equity at start of the period	78,944	74,328	74,328
Comprehensive income
Profit/loss for the period	-60,388	-51,498	-80,029
Other comprehensive income	92	-20	303
Total comprehensive income	-60,296	-51,518	-79,726
Transactions with shareholders
New issue of common shares	80,325	105,324	105,324
Settlement of debt for warrants	16,100	-12,385	-12,385
New issue of C-shares	–	–	–
Common shares: Conversion from C-shares	–	–	-26
C-shares: Resolution of C-shares	–	–	26
Issuance expenses	-3,618	-14,452	-15,207
Call option premium in relation to loan facility	–	2,165	2,165
Share based remuneration to employees	2,946	4,320	4,446
Total transactions with shareholders	95,754	84,973	84,343
Equity at end of the period	114,401	107,782	78,944

^* Some figures are rounded, so amounts might not always appear to match when added up.

Consolidated Cash Flow Statement

	Q3 (Jul-Sep)		9M (Jan-Sep)
SEK in thousands*	2025	2024	2025	2024
Operating activities
Operating result	-15,252	-17,790	-58,595	-45,837
Expensed share based remuneration	1,061	811	3,164	4,289
Adjustment for items not included in cash flow	195	-539	631	-69
Interest received	292	3	625	38
Interest paid	-211	-1,425	-1,703	-3,857
Income tax paid/received	-94	-147	-511	354
Cash flow from operating activities before changes in working capital	-14,008	-19,087	-56,389	-45,084
Cash flow from changes in working capital
Increase (-)/Decrease (+) of advance payments	–	297	–	178
Increase (-)/Decrease (+) of operating receivables	805	-812	3,625	-2,121
Increase (+)/Decrease (-) of accounts payable	2,952	-73	2,516	1,069
Increase (+)/Decrease (-) of other liabilities	-5,407	2,632	-312	1,898
Change in working capital	-1,650	2,044	5,830	1,024
Cash flow used in operating activities	-15,658	-17,043	-50,560	-44,060
Investing activities
Investment in equipment	–	–	-57	–
Divestment of right-of-use assets	–	–	–	–
Cash flow from investing activities	–	–	-57	–
Financing activities
New share issue	29,999	105,324	72,825	105,324
Transaction costs for issuance	-2,295	-14,023	-3,618	-14,452
Conversion from C-shares	–	–	–	–
Resolution of C-shares	–	–	–	–
Convertible bond issue	–	-700	–	733
New loans	–	272	–	33,715
Amortisation of loan	–	-7,500	-20,000	7,500
Amortisation of lease liabilities	-199	-224	-600	-658
Cash flow from financing activities	27,505	83,149	48,607	117,162
Cash flow for the period	11,847	66,106	-2,010	73,103
Cash and cash equivalents at start of period	60,443	29,775	75,256	21,855
Exchange rate differences in cash and cash equivalents	-15	-163	-970	760
Cash and cash equivalents at end of period	72,275	95,718	72,275	95,718

^* Some figures are rounded, so amounts might not always appear to match when added up.

Parent Company – Income Statement

	Q3 (Jul-Sep)		9M (Jan-Sep)
SEK in thousands*	2025	2024	2025	2024
Net sales	96	21	233	159
Gross profit/loss	96	21	233	159
Administrative costs	-4,259	-3,524	-13,074	-14,185
Research and development costs	-10,766	-14,099	-43,573	-32,312
Commercial preparation costs	–	-31	–	669
Other operating income	–	7	63	10
Other operating costs	-31	-2	-85	-30
Operating result	-14,962	-17,628	-56,436	-45,689
Finance income	1,443	167	5,765	1,037
Finance costs	-856	-3,922	-5,066	-6,820
Result from other long-term receivables	-475	773	-5,070	2,570
Net financial costs	112	-2,982	-4,371	-3,213
Loss before tax	-14,849	-20,610	-60,807	-48,901
Tax	–	–	–	–
Loss for the period	-14,849	-20,610	-60,807	-48,901

^* Some figures are rounded, so amounts might not always appear to match when added up.

Parent Company – Balance Sheet

	30 Sep	30 Sep	31 Dec
SEK in thousands*	2025	2024	2024
ASSETS
Non-current assets
Tangible assets
Equipment	57	34	15
Financial assets
Shares in affiliated companies	58,068	58,068	58,068
Other long-term receivables from group companies	39,237	38,076	39,255
Total non-current assets	97,361	96,178	97,338
Current assets
Advance payments to suppliers	1,755	3,255	1,755
Current receivables
Receivables from group companies	2,974	2,469	2,560
Income tax receivables	1,040	1,310	534
Other receivables	1,523	892	5,011
Prepaid expenses and accrued income	1,038	2,352	1,004
Cash and bank balances	70,976	95,223	74,440
Total current assets	79,306	105,501	85,303
Total assets	176,667	201,679	182,641
EQUITY
Restricted equity
Share capital	127,903	97,193	97,193
Non-restricted equity
Other paid-in capital	771,366	721,750	721,750
Loss brought forward	-682,526	-609,108	-622,123
Loss for the period	-60,807	-48,901	-75,831
Total equity	155,936	160,933	120,989
LIABILITIES
Long-term liabilities
Long-term interest bearing liabilities	–	26,215	–
Total long-term liabilities	–	26,215	–
Current liabilities
Accounts payable	7,181	2,587	4,632
Other liabilities	973	894	19,113
Interest bearing liabilities	–	–	25,225
Accrued expenses and deferred income	12,578	11,050	12,683
Total current liabilities	20,731	14,531	61,652
Total equity and liabilities	176,667	201,679	182,641

^* Some figures are rounded, so amounts might not always appear to match when added up.

Notes

General information

This interim report for the Group has been prepared according to IAS 34 Interim Financial Reporting and applicable rules in the Swedish Annual Accounts Act (ÅRL). The interim report for the parent company has been prepared according to the Swedish Annual Accounts Act chapter 9, Interim Reporting. For the Group and the parent company, the same accounting principles and basis for calculations have been applied as in the recent Annual Report.

Fair value of financial instruments

The recognized value for other receivables, cash and cash equivalents, trade payables and other liabilities constitutes a reasonable approximation of fair value. Interest bearing liabilities are recognized at amortized cost which is considered an approximation of the fair value.

Purchases from related parties

No significant transactions with related parties have occurred during the period.

Use of non-international financial reporting standards (IFRS) performance measures

Reference is made in this interim report to alternative performance measures that are not defined according to IFRS. Ascelia Pharma considers these performance measures to be an important complement since they enable a better evaluation of the company´s economic trends. The company believes that these alternative performance measures give a better understanding of the company´s financial development and that such key performance measures contain additional information to the investors to those performance measures already defined by IFRS. Furthermore, the key performance measures are widely used by the management in order to assess the financial development of the company. These financial key performance measures should not be viewed in isolation or be considered to substitute the key performance measures prepared by IFRS. Furthermore, such key performance measures should not be compared to other key performance measures with similar names used by other companies. This is due to the fact that the above-mentioned key performance measures are not always defined identically by other companies. These alternative performance measures are described below.

Important estimations and judgements

Valuation of intangible assets

The recognized research and development project in progress is subject to management's impairment test. The most critical assumption, subject to evaluation by management, is whether the recognized intangible asset will generate future economic benefits that at a minimum correspond to the intangible asset's carrying amount. Management's assessment is that the expected future cash flows will be sufficient to cover the intangible asset's carrying amount and accordingly no impairment loss has been recognized.

Capitalization of development expenses

In 9M 2025, the criteria for classifying R&D costs as an asset according to IAS 38 has not been met (capitalization of development expenses is normally done in connection with final regulatory approval). Hence, all R&D costs related to the development of the product candidates have been expensed.

Share-based incentive programs

Employee option programs

Ascelia Pharma has one onging employee option program which was implemented in February 2025. The parameter, which has the largest impact on the value of the options, is the publicly traded share price.

The total recognized costs for the option program in 9M 2025 including social security charges were SEK 2.2 million.

Share saving programs

Ascelia Pharma has three active long-term incentive programs for employees in the form of performance-based share saving programs. The parameter, which has the largest impact on the value of the programs, is the publicly traded share price.

The total recognized costs for the share saving programs including social security charges in 9M 2025 were SEK 1.0 million.

Notes

Definitions of alternative performance measures

Alternative performance measures	Definition	Aim
Operating results (TSEK)	Profit before financial items and tax.	The performance measure shows the company´s operational performance.
Research and development costs/Operating costs (%)	The research and development expenses in relation to total operating costs (consisting of the sum of administrative expenses, R&D, costs for commercial prepara tions and other operating expenses).	The performance measure is useful in order to understand how much of the operating costs that are related to research and development expenses.

Reconciliation table for alternative performance measures for the Group

	Q3 (July-September)		9M (January-September)
SEK in thousands*	2025	2024	2025	2024
Administrative costs	-4,308	-3,550	-13,197	-14,313
R&D costs	-10,887	-14,173	-45,205	-32,470
Commercial preparation costs	–	-31	–	669
Other operating costs	-57	-42	-316	-99
Total operating costs	-15,252	-17,796	-58,718	-46,213
R&D costs/Operating costs (%)	71%	80%	77%	70%

Financial calendar

Full-year report 2025 (Jan-Dec): 5 February 2026 Annual General Meeting 2026: 4 May 2026 Interim report Q1 2026 (Jan-Mar): 14 May 2026 Half-year report 2026 (Jan-Jun): 20 August 2026 Interim report 9M 2026 (Jan-Sep): 5 November 2026 Full-year report 2026 (Jan-Dec): 11 February 2027

Contact

Magnus Corfitzen, CEO moc@ascelia.com | +46 735 179 118

Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial) jwb@ascelia.com | +46 735 179 116

ASCELIA PHARMA AB (publ)