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SynAct Pharma Interim / Quarterly Report 2026
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Interim / Quarterly Report
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SYNACT PHARMA
INTERIM REPORT
January - March 2026
Research and development in inflammatory diseases
This English version of SynAct Pharma's Interim Report for the first quarter of 2026 has been prepared by the Company as a service to its non-Swedish stakeholders. In case of differences, the original Swedish report prevails
www.synactpharma.com
SYNACT PHARMA
SynAct Pharma is a clinical stage biotechnology company focused on resolving inflammation with melanocortin biology
Significant events in the first quarter
s. 4
CEO Jeppe Øvlesen comments on the first quarter
s. 5
CONTENT
Summary of the interim report 3
Significant events in the quarter 4
CEO comments 5
SynAct Pharma in brief 6
Q&A with Chief Business Officer Mads Bjerregaard 7
Research and Development 8
SynAct Pharma share 17
Financial development 18
Income statement 19
Report on financial position 20
Report on changes in equity 21
Report on cash flow 22
The parent company's income statement 23
The parent company's balance sheet 24
Notes and disclosures 25
Alternative performance measures 28
The CEO declaration 29
Dictionary 30
Other company information 33
SynAct Pharma AB
Visiting address: Scheelevägen 2
223 63 Lund, Sweden
Postal: Scheelevägen 2
223 63 Lund, Sweden
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+46 10 300 10 23
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[email protected]
Interim report for the first quarter 2026
First quarter
January – March
- The Group's net sales amounted to SEK 0 (0) thousand.
- Operating expenses amounted to SEK 30,558 (28.098) thousand, an increase of 9%.
- The Group's loss after tax amounted to SEK 25,487 (24.684) thousand.
- The Group's earnings per share before and after dilution amounted to -0.48 (-0.51) SEK.
- Cash flow from operating activities amounted to SEK -32,952 (-28.826) thousand.
- Cash flow from financing activities amounted to SEK 45,308 (19.703) thousand.
- Cash flow for the period amounted to SEK 12,356 (-9.123) thousand.
- Cash and cash equivalents at the end of the period amounted to SEK 65,782 (51.161) thousand.
The Group's financial performance per quarter
| (SEK thousand) | 2026 Q1 | 2025 Q4 | 2025 Q3 | 2025 Q2 | 2025 Q1 | 2024 Q4 | 2024 Q3 | 2024 Q2 |
|---|---|---|---|---|---|---|---|---|
| Net sales | - | - | - | - | - | - | - | - |
| Operating income | -30,558 | -22,720 | -35,377 | -30,345 | -28,098 | -20,797 | -24,309 | -19,167 |
| Profit before tax | -30,544 | -22,902 | -35,706 | -30,057 | -30,326 | -20,318 | -24,687 | -19,771 |
| Profit for the period | -25,487 | -22,929 | -35,690 | -27,522 | -24,684 | -18,379 | -20,489 | -18,628 |
| Total assets | 237,880 | 220,518 | 253,583 | 243,595 | 219,171 | 270,520 | 217,131 | 241,053 |
| Equity / asset ratio (%)1 | 81% | 77% | 77% | 81% | 83% | 70% | 78% | 78% |
| Earnings per share (SEK) | -0.48 | -0.43 | -0.67 | -0.56 | -0.51 | -0.44 | -0.50 | -0.47 |
| Research & development cost / operating expenses (%)1 | 75% | 54% | 79% | 78% | 76% | 70% | 80% | 38% |
1) Alternative performance measures - APM, ref. p. 28 for definitions
SynAct Pharma AB - Interim Report - January - March 2026
Significant events during the first quarter of 2026 and after the end of the reporting period
Q1
Q2
| ☐—☐
JAN 9 | The Board of Directors of SynAct Pharma AB (publ) has resolved on the repurchase of own shares |
| --- | --- |
| ☐—☐
JAN 30 | SynAct Pharma initiates Phase 2 study in respiratory insufficiency |
| ☐—☐
FEB 6 | SynAct Pharma successfully reached recruitment goal in Ph2b ADVANCE study |
| ☐—☐
FEB 24 | SynAct Pharma appoints Ann Kristin Led as Chief Financial Officer |
| ☐—☐
MAR 2 | SynAct Pharma has carried out a directed issue of new shares of approximately £1.9 MSEK |
| --- | --- |
| ☐—☐
MAR 26 | SynAct Pharma doses first patients in the Phase 2 RESOVIR-2 study with resomelagon |
| ☐—☐
MAR 31 | Change in number of shares and voting rights in Synact Pharma AB |
| ☐—☐
APR 23 | SynAct Pharma's Nomination Committee ahead of the 2026 Annual General Meeting |
| --- | --- |
| ☐—☐
MAY 6 | SynAct Pharma completes dosing for last patient in Phase 2b ADVANCE study |
| ☐—☐
MAY 7 | Notice of annual general meeting in SynAct Pharma AB |
SynAct Pharma AB - Interim Report, January - March 2026
The CEO, Jeppe Øvlesen comments on the first quarter 2026
Advancing toward the most important data readout in SynAct's history
As we close the first quarter of 2026, SynAct Pharma is in a stronger position than at any previous point in the company's history: clinically, operationally and financially. The defining moment of this year is close. Following the end of the quarter, on May 6, we announced that the last patient had completed dosing in our Phase 2b ADVANCE study. Topline data are expected in June, and significant momentum is built toward this readout.
The ADVANCE study is a prospective, double-blind, placebo-controlled study in 246 newly diagnosed RA patients with high disease activity and active systemic inflammation, the target population where resomelagon has consistently shown its strongest signal. The study tests three doses of resomelagon in combination with Methotrexate, with DAS-28-CRP reduction at week 12 as the primary endpoint. It is designed to identify doses for Phase 3 and to give us and potential partners a clear and definitive read on
resomelagon's efficacy and safety profile in this setting. We have prepared carefully. We are ready.
Interest from potential strategic partners is real, and it is growing as we approach the data. Resomelagon's differentiated profile, a non-suppressive mechanism that works with the immune system rather than against it, is increasingly well understood in the pharmaceutical industry. Positive ADVANCE data is the key event that will move partnering conversations forward. We are well prepared.
The quarter itself was active on multiple fronts. In March, we hosted our Capital Markets Day in Stockholm, where we provided a comprehensive update on resomelagon's clinical strategy in RA and our host-directed therapy program in viral infections. The event strengthened our dialogue with key investors and analysts at a critical juncture. During the first quarter, we increased our partnering outreach at the J.P. Morgan Healthcare Conference, Bio-China, and BIO-Europe Spring. In the second quarter, we are further building momentum at regional and global meetings culminating
at the BIO International in San Diego in June being one of biggest partnering events of the year.
On the pipeline we are currently recruiting patients to the RESOVIR-2 study in Dengue fever in Brazil. We have since the first recruitment in late March had a steady increase in number of inclusions and will continue in June as Mosquito season at site seems to continue. To secure progress in the RESPIRE study site on the southern hemisphere has been identified with the aim benefit of the upcoming season. These programs are not merely optionality. They reflect a growing body of clinical evidence supporting resomelagon as a platform asset across multiple inflammatory settings.
Financially, we completed a directed share issue of approximately SEK 51.9 million in early March, strengthening our balance sheet and extending our cash runway. This secures the company through the ADVANCE data readout and into the period that follows it, including the business development process that positive results would unlock. Shareholders should note this financing as a deliberate positioning ahead of a value inflection point, not a reactive move.
On the leadership side, we welcomed Ann Kristin Led as our permanent Chief Financial Officer in February. With our team now complete and our clinical program finalizing proof-of-concept in RA, we are well placed to manage what comes next, including, if results warrant, the rapid transition into Phase 3 readiness and commercial partnering discussions.
Jeppe Øvlesen
Chief Executive Officer
SynAct Pharma AB - Interim Report, January - March 2026
SynAct Pharma in Brief
About SynAct Pharma AB
SynAct Pharma AB is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity in autoimmune and inflammatory diseases to help patients achieve immune balance and overcome their inflammation.
Business model
SynAct's business strategy is to drive projects into clinical development in order to secure proof-of-concept, i.e. support for clinical relevance. The company's ambition is to conduct Phase 2 clinical studies, and then to sign commercial agreements with one or more major pharmaceutical companies.
Group relationship and shareholding
SynAct Pharma AB (with corporate registration number 559058-4826) is the parent company of a group that includes the wholly owned subsidiaries SynAct Pharma ApS and TXP Pharma AG. The "Company" or "SynAct" means the Group i.e., SynAct Pharma AB and its wholly owned subsidiaries. In addition to the above, SynAct has no additional shareholdings.
Review by the Company's Auditor
This interim report has not been reviewed by the Company's Auditor.
Forward looking statements
This financial report contains statements that are forward-looking. Such forward looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Business Development
Business development is central to SynAct Pharma's strategy and embedded in the company's mission. SynAct's business model is structured around advancing its proprietary pipeline through Phase 2 clinical proof-of-concept before entering into commercial agreements with one or more major pharmaceutical companies for Phase 3 development and beyond. This approach directs SynAct's resources towards clinical validation while ensuring that Phase 3 execution and global commercialisation are managed by partners with the required scale, infrastructure, and therapeutic area expertise.
A Phase 3 programme in rheumatology or other inflammatory indications requires operational capabilities, regulatory expertise, and market presence that are best provided by an established pharmaceutical partner. SynAct's role is to generate robust, well-designed clinical data that positions resomelagon as a compelling and differentiated asset in a competitive partnering environment. A potential licensing agreement would typically include an upfront payment at signing, milestone payments tied to clinical and regulatory progress, and royalties on future net sales - representing multiple value inflection points for shareholders over the development timeline.
SynAct Pharma AB - Interim Report, January - March 2026
Q&A with Chief Business Officer Mads Bjerregaard
Major Value Inflection Points Ahead
June 2026 is shaping up to be a defining moment for SynAct Pharma. With dosing of the last patient in the Phase 2b ADVANCE study now complete, topline data from 246 patients across more than 30 sites is expected within weeks. The question on every investor's mind: what happens next?
For Mads Bjerregaard, SynAct's Chief Business Officer, the commercial thesis is already well established, and it rests on a mechanism that does something the $20 billion+ rheumatoid arthritis market has never truly delivered meaningful disease control without immunosuppression. Below, Mads outlines the business development opportunity, what the data needs to show, and who SynAct wants at the table for Phase 3.
Why would a pharma partner find resomelagon genuinely interesting, not just scientifically, but commercially?
Resomelagon modulates immune cell activity without suppressing the immune system. That is fundamentally different from every existing treatment in the inflammatory disease space. If the efficacy data are positive and the safety picture is clean, that combination makes it a genuinely interesting asset to pharmaceutical companies across a broad range of inflammatory diseases.
The market context supports that case. Globally, more than 18 million people are living with RA. Every year, more than 300,000 newly diagnosed patients with elevated CRP levels and moderate-to-severe disease enter the system. The US market alone is valued at more than $20 billion, driven by novel biological and synthetic DMARDs, all associated with immunosuppressant side effects and limitations of use. Resomelagon represents the opportunity to expand the market of novel mechanisms earlier in disease and address the unmet medical need for patients who require safe alternatives to biologic DMARDs and glucocorticoids for early and sustainable disease control.
From a BD perspective, what does the ADVANCE data need to show?
Positive Phase 2b ADVANCE data validates the concept in RA and sets the direction for the competitiveness of the profile. The focus for us is on avoiding or delaying treatment escalation in patients with increased risk of disease progression due to high inflammatory response. To demonstrate that credibly, patients need to achieve clinical benefit and stay on therapy without progressing to more aggressive immunosuppressant options.
If the ADVANCE study can substantial that, based on the overall read clinical picture evaluated by DAS28-CRP, CDAI, the ACR scores and the HAQ-scores, together with the full safety picture across the active group, then partners will get the clinical blueprint they need to move forward.
Who is on your radar as a potential partner, and what does the ideal profile look like?
We are focused on global and regional pharma companies with a strong presence in immunology. Our initial priority is to engage with partners that can address the opportunities in the US, the major markets in Europe, and in China, Japan, and South Korea – collectively or individually. Whoever we partner with will need to demonstrate a proven track record in Phase 3 development, successful market entry, and the ability to expand opportunities across multiple indications.
How does positive data change the BD dynamic immediately?
Positive data in the Phase 2b ADVANCE study would immediately strengthen our position in moving partnering discussions forward. It converts a dialogue into a negotiation. The deal structure we would potentially work toward reflects that value step-up: an upfront payment at signing, development milestones tied to Phase 3 and regulatory progress, and royalties on commercialized sales. The June readout is not just a clinical event. It is the single most important business development catalyst the company has faced.
SynAct Pharma AB - Interim Report, January - March 2026
Research and development
INFLAMMATORY DISEASE
Inflammation is the immune system's way of responding to infections or injuries. Normally an inflammatory response is self-limiting. The immune system will 'deactivate' itself and the inflammation will be resolved after the invading pathogen has been removed or the injury has begun to heal.
However, in many cases, the inflammation can be excessive or chronic and it can overwhelm the immune system's ability to resolve the inflammation. This can lead to pain, destruction of tissue, and loss of function.
Autoimmune or chronic inflammatory diseases, like rheumatoid arthritis (RA) are associated with an inappropriate inflammatory response that is not resolved through endogenous mechanisms and therefore becomes chronic.
Other examples of diseases with uncontrolled inflammatory responses are virus infections such as respiratory virus including Influenza and Covid-19 and a number of mosquito borne diseases such as Dengue fever associated with an exacerbated inflammatory response that brings the patient into a hyperinflammatory state with high risk for organ dysfunction where patients need hospitalization.
Currently, these inflammatory diseases are treated with various drugs including drugs that target the inflammatory response with the risk of suppressing the immune system to a degree that unwanted side effects develop.
INFLAMMATION RESOLUTION
Recent research has shown that resolution of inflammation is not a passive process, but it can be promoted by activating certain biological pathways, and thereby inflammatory response may be treated without immune suppression.
Activation of the melanocortin receptors (MCR) is believed to lead to inflammation resolution, specifically the receptor subtypes MC1R and MC3R, are believed to be key receptors involved in direct effects on the immune system.
MC1R and MC3R are located on many cell types and are spread throughout most of the body, including immune cells and associated structural and supportive cells. MC4R is primary found in the central nervous system and plays a pivotal role in central regulation of metabolism including food intake. MC5R is found in exocrine glands, expressed by some subtypes of immune-active cells in the eye among others. MC2R is primary expressed in the adrenal glands where stimulation is directly associated with the release of cortisol, a steroid.
Activation of the MCRs is causing the immune cells to produce fewer pro-inflammatory molecules, resulting in relief of symptoms. At the same time, the stimulation also resets the homeostasis of the immune system, which is out of balance. Anti-inflammatory drugs that cause pro-resolution effects, such as switching cells to perform inflammation "cleanup" or to regulatory functions, add to the treatment options for inflammatory diseases and provide an alternative to immunosuppressive anti-inflammatory drugs.
CURRENT TREATMENT GUIDELINES FOR RHEUMATOID ARTHRITIS (RA)
Today, inflammatory joint diseases like RA are treated with many different drugs. From classical nonsteroid anti-inflammatory drugs (NSAID) to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and biologics (bDMARDs) given as injections. Even if the drugs are effective, they may also carry a risk, as they suppress the immune system and can lead to adverse events for the patient.
RA patients are today treated according to international treatment guidelines. These treatment guidelines build on specific criteria to obtain the best treatment for the specific patient. Treatment decisions are based on disease activity, safety issues and other patient factors, such as comorbidities
REUMATOID ARTHRITIS (RA) IS AN AUTOIMMUNE DISEASE
RA is an autoimmune disorder, a disease where the immune system mistakenly attacks your body's own tissues. The disease affects the lining of the joints, causing painful swelling that can result in cartilage and bone erosion and joint deformity, but it is often associated with symptoms also involving other parts of the body including skin, eyes, lungs, heart, and blood vessels.
While new types of medications have improved treatment options, significant unmet needs still exist.
For most patients, RA still progresses, and damage accumulates. Patients cycle through therapies and classes of therapies and must deal with periods of acute disease activity called flares, which can occur several times per year and drive the need to adjust the dose of current drugs or to change to a new therapy to maintain control of the disease.
SynAct Pharma AB - Interim Report, January - March 2026
(other disorders that the patient might have) and progression of structural damage in the joints. The guidelines also emphasize the importance of patients requiring access to multiple drugs with different modes of action to address the heterogeneity of RA; and that patients may require multiple successive therapies throughout life.
According to the treatment guidelines, treatment with DMARDs should be started as soon as the diagnosis of RA is made (so called first line treatment). Treatment with DMARDs inhibits the inflammatory process so that the joint pain, swelling, and stiffness are relieved or disappear.
Early and effective treatment is emphasized as being very important in the treatment guidelines, as this will have an impact on the long-term outcome of the disease and therefore also a profound impact on patient's everyday life.
The treatment guidelines also emphasize that Methotrexate should be part of the first treatment for the RA-patient. However, the challenge is, many patients treated with Methotrexate do not reach sufficient dose due to adverse events and therefore do not reach what is called sustained remission or low disease activity.
Therefore, there is a clear unmet medical need for these early diagnosed RA patients. There is a need for a new medicine, which can be combined with Methotrexate, so that a larger proportion of early diagnosed RA patients can have a positive impact on their disease. However, this new medicine should have a positive adverse event profile.
According to the treatment guidelines the early RA patient may also be treated short-term with glucocorticoids (GC), that is steroids. GCs can be given orally or as joint injections either alone or together with Methotrexate. The reason why GCs is
The melanocortin system and its role in inflammation
considered is to obtain a clinical meaningful disease reduction within 3 to 6 months. However, GCs has significant adverse events and therefore should be tapered and discontinued as rapidly as clinically feasible according to treatment guidelines. Also, the use of GCs even though intended to be temporary often results in more chronic use, which is unwanted due to the side effects profile.
Overall, up to 50% of the early diagnosed RA patients do not respond adequately to recommended first line treatment. If the treatment target is not achieved (the patients is not sufficiently treated) with the first line treatments the rheumatologist should consider biological disease-modifying antirheumatic drugs (bDMARD) according to the treatment guidelines.
The bDMARD are potent medicine decreasing the inflammation. However, the bDMARD also implies the risk of suppression of the immune system, which could lead to unwanted infections. Typically, the patient is treated with a TNF-blocker as an add-on to the first line treatment.
JAK-inhibitors may also be considered, but pertinent risk factors must be taken into account. The risk factors include both cardiovascular risks and the risk for malignancies, and these risks should be evaluated before the patient can receive JAK-inhibitors. As many RA patients are elderly and therefore might have cardiovascular disorders and increased risk of malignancy, the JAK-inhibitors are often considered third-line treatment.
SynAct Pharma AB - Interim Report, January - March 2026
Resomelagon – Lead drug candidate
SynAct Pharma’s drug candidate, resomelagon (AP1189), is a once-daily oral selective melanocortin agonist.
Resomelagon selectively stimulates the MC1R and MC3R on target cells in the immune system that are directly involved in inflammation and its resolution. It is a clear advantage that the compound does not stimulate MC2R, and hence the anti-inflammatory and immune resolution effects (restoring the balance of the immune system) are not mediated by increase in the cortisol level, as seen with adrenocorticotropic hormone (ACTH) based therapies. Induction of cortisol levels will induce side effects as also seen following GC treatment. Further as resomelagon is a biased agonist, it does not stimulate melanocortin pathways that are responsible for off target activity such as skin hyperpigmentation, which is therefore avoided. Resomelagon has so far demonstrated an advantageous safety and tolerability profile.
The main focus in inflammatory and autoimmune diseases is treatment of rheumatoid arthritis (RA). In the phase 2b clinical study, ADVANCE the compound has been given to treatment naive newly diagnosed RA patients, with high disease activity including signs of systemic inflammation in combination with the first line DMARD Methotrexate (MTX). The study has recruited all the planned patients, and the last patient has completed the study. Currently, the data is being collected, and results are planned to be released in June.
The patient population targeted in ADVANCE are characterized not only by having high disease activity but also being in risk for early development of morphological and irreversible joint affections and with increased risk for lack of effect of MTX. The patients are therefore often co-treated with glucocorticoids and second line treatment as bDMARDs is often introduced early. The potential benefit of giving resomelagon as first line treatment is to avoid introduction to glucocorticoids and postpone introduction of bDMARDs.
The current clinical development path for resomelagon in RA has therefore been designed to address the huge unmet medical need within RA-treatment with initial focus on newly diagnosed patients with high disease activity including signs of systemic inflammation, i.e. patients is high risk for early development of poor prognosis factor as they are less likely to response to current treatment option and are in risk for early development of loss of joint functionality. Previous phase 2 studies have been conducted in RA to gain knowledge about resomelagon in these patients. In addition, with reference to mode of action development of resomelagon as a new treatment option for acute exacerbations, what is called flares, in the disease would be a logic parallel development track. The possibility to setup development of the compound in RA patients with flares is currently evaluated.
The development of resomelagon is focused on two development paths:
Inflammatory and autoimmune diseases where the lead compound resomelagon (AP1189) currently is in phase 2b clinical development in rheumatoid arthritis (RA) where data from the ADVANCE study, being collected and evaluated, prior to expected release in June.
Additional activities include phase 2a development in patients with polymyalgia rheumatica (PMR) where the compounds unique profile as a glucocorticoid sparing compound will be examined.
Host-directed therapy in viral infections where resomelagon has the potential to interact with a viral-induced hyper inflammatory responses as demonstrated in Covid-19 when administration of the compound facilitated faster respiratory recovery.
A phase 2 proof of concept study, the RESPIRE study, in patients hospitalized with respiratory virus infections has been initiated. Sites in the southern hemisphere will be added to take advantage of the upcoming winter season.
Further, a phase 2 study in Dengue patients, the RESOVIR-2 study, is ongoing and recruiting.
SynAct Pharma AB - Interim Report, January - March 2026
Development of resomelagon
Inflammatory and autoimmune diseases
Completed Ongoing
SynAct Pharma AB - Interim Report, January - March 2020
BEGIN
- Phase 2a in early severe RA together with MTX
The BEGIN study in early severe RA was completed in 2021. The study was a randomized, double-blind, placebo controlled multicenter study in previous treatment naive RA patients where either 50 mg or 100 mg of resomelagon or placebo were given in addition to MTX treatment.
Resomelagon given once daily for four weeks was safe and well tolerated. Based on the primary read out, changes in clinical disease activity index (CDAI), the data showed a clear dose response for 50 and 100 mg resomelagon relative to placebo, with 100 mg of resomelagon demonstrating a statistically significant 65% higher mean reduction in CDAI during the treatment period compared to placebo-treated control group (mean reduction in CDAI: resomelagon 100 mg (n=33): 15.5 points compared with placebo (n=30): 9.3 points, p=0.0394). The 100 mg resomelagon group also demonstrated a significantly higher fraction of patients achieving ACR20 than placebo treated patients (ACR20: resomelagon (n=33) 100 mg: 60.6%; Placebo (n=30): 33.3%, p=0.0437) within the 4 weeks treatment period.
EXPAND
- Phase 2b in MTX-naive RA patients with severe disease activity
In continuation of the BEGIN study, the EXPAND study was designed to investigate the safety and disease activity (measured by the ACR20 response rate and other RA disease measures) following 12-weeks of treatment with a once daily 100 mg resomelagon tablet plus MTX compared to placebo plus MTX.
Resomelagon was safe and well tolerated. Similar incidence rates of treatment-emergent adverse events (TEAEs) were seen across treatment groups (44.4% and 42.2%). TEAEs were seen in 11.1% and 6.3% in the resomelagon vs placebo groups, respectively and included upper respiratory tract infections (6.3% vs 6.3%), abdominal pain upper (6.3% vs 3.1%), nausea (6.3% vs 3.1%), and headache (0% vs 9.4%), resomelagon vs placebo respectively. Two serious TEAEs were reported; one in the resomelagon group and one in the placebo group but both were unrelated to study drug. Six subjects reported TEAEs leading to discontinuation; five in the resomelagon group (3 of these subjects with drug related gastrointestinal disorders); and one in the placebo group (unrelated to study drug).
No statistically significant difference was obtained between resomelagon and placebo in the ACR20 response rate at week 12 (54.7% and 55.7% in the resomelagon and placebo groups, respectively) - meaning that the primary endpoint of the study was not met.
However, of the patient population in the EXPAND study, 39% did not show signs of systemic inflammation, as high sensitive C-reactive protein (hsCRP) were in the normal range (i.e. hsCRP<3 mg/L). Further, a fraction of the patients was not considered newly diagnosed with some being without adequate treatment for years before entering into the study. Therefore, these patients should probably not have been included in the study.
When focusing of the segment of patients, that were considered newly diagnosed (defined as having been diagnosed with RA within 6 months of inclusion into the study) and who showed signs of systemic inflammation (hsCRP>3 mg/L at introduction to the study), ACR20 actually reached 82% in the resomelagon group (n=28) vs 52% in the placebo group (n=27), p<0.05 using Fisher's exact test.
The treatment effect in this very relevant patient segment, mimicking the patients in the BEGIN study, i.e. to be considered the target population for resomelagon in RA was further supported by significantly larger reduction in disease activity measures: CDAI: resomelagon (n=28): 24.6 points vs placebo (n=27): 14.7 points, p<0.01; DAS28-CRP: resomelagon (n=28): 1.9 points vs placebo (n=27): 1.2 points, p<0.01. Also, the improvement in health assessment questionnaire HAQI, a measure of the patient's ability to handle daily living was significantly larger in the resomelagon group: change in HAQ: resomelagon (n=28): 0.69 points vs placebo (n=27): 0.31 points, p<0.05.
Together these above post-hoc analyses strongly support further development of resomelagon in newly diagnosed RA patients with high disease activity including signs of systemic inflammation treated together with MTX.
RESOLVE
- Phase 2b in RA patients with an inadequate response to MTX
Only the first part of the study was conducted, providing results with respect to the efficacy and safety of multiple doses of resomelagon combined with MTX over 4 weeks. Also, in this study resomelagon was safe and well tolerated. Similar incidence rates of TEAEs were observed across treatment groups (range: 21.4% to 34.4% across treatment groups). Treatment related TEAEs were reported in 10%, 10.7%, 12.5%, and 5.7% in the resomelagon 60 mg, 80 mg, and 100 mg vs placebo groups, respectively. Gastrointestinal disorders were the most common treatment-related SOC category (3.3%, 7.1%, 9.4%, and 5.7% in the resomelagon 60 mg, 80 mg, and 100 mg vs placebo groups, respectively). No statistically significant difference was observed between resomelagon and placebo in the primary efficacy endpoint (ACR20 response rate at week 4) and most secondary variable analyses.
ADVANCE
- Phase 2b 12-week study in early DMARD naïve RA-patients with high disease activity and active inflammation in combination with MTX
Based on the above knowledge of resomelagon in RA, the ADVANCE study is a phase 2B proof of concept study in the target population for resomelagon. That is newly diagnosed RA patients with high disease activity including signs of systemic inflammation.
The ADVANCE study is a randomized, double blind, placebo controlled, dose response, phase 2b, multicentre trial to evaluate the efficacy and safety of once daily oral resomelagon (AP1189) administered at the doses of 40, 70 or 100 mg for 12 weeks in combination with MTX, in DMARD-naïve newly diagnosed RA patients with high disease activity and signs of systemic inflammation.
The recruitment of total of 246 patients has been completed and the last patient has completed the study. The aim of the study is to identify the dose regiment for Phase 3 development based in the compound's ability to reduce disease activity relative to placebo treatment based on reduction in DAS28-CRP (primary readout) ACR20 (Key-secondary readout), ACR 50, ACR70, CDAI, HAQ-DI and other relevant clinical readouts. The study is conducted at sites in Europe and US under the current US-IND (FDA) for development of resomelagon (AP1189) in RA.
SyrAct Pharma AB - Interim Report, January - March 2020
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SynAct Pharma AB - Interim Report, January - March 2020
START
- Resomelagon in Polymyalgia Rheumatica (PMR)
Polymyalgia rheumatica, an inflammatory condition characterized by severe bilateral pain and morning stiffness of the shoulder, neck and pelvic girdle. PMR typically affects people that are middle aged to older and ranks at the second most common rheumatic disease after RA in Northern Europe and North America. The current first line treatment in PMR is GCs given orally.
To reduce the risk for GC induced side effects the recommendation in the current treatment guideline is to tamper GCs over a few weeks. GC discontinuation is associated with high risk for relapses. Consequently, early intervention with resomelagon could be a treatment option to reduce the use of GC, reduce the risk for relapses, and provide better disease control.
SynAct has therefore decided to enter into a clinical collaboration with leading Nordic rheumatologists with the aim to test the compound's potential to reduce the use of GC in PMR. The study will be conducted as a standard sponsor initiated clinical trial at sites in Denmark to test resomelagon versus placebo given orally once daily to patients for 3 months after initial tampering of GCs. The study is currently under review in the centralized European CTIS system for an exploratory Phase 2 protocol aimed to dose 60 PMR patients 100 mg resomelagon or placebo once daily (1:1 randomisation) for 12 weeks. The study called START (STeroid spARing Treatment in patients with PMR) will examine the potential of resomelagon to secure that PMR patients will be kept free of glucocorticoid treatment following GC tapering.
RESOMELAGON IN IDIOPATHIC MEMBRANOUS NEPHROPATHY
- Nephrotic Syndrome (NS)
Nephrotic Syndrome (NS) is a condition associated with increased loss of protein into the urine resulting in tissue swelling and eventually development of edemas.
Untreated or insufficiently treated NS will in many cases be associated with hypercholesterolemia, increased risk for blood clots, increased risk for infections and can develop into chronic kidney disease that is associated with increased risk of development of cardiovascular disease and risk of development of end stage kidney disease and thereby need for renal replacement therapy (dialysis or transplant).
Resomelagon is currently tested in Idiopathic Membranous Nephropathy (iMN), one of more common causes of primary NS, in an exploratory, randomized, double-blind,
multicenter, placebo controlled Phase 2a study with repeated once-daily 100 mg dosing to assess the safety, tolerability, pharmacokinetics, and efficacy of resomelagon.
The study population consists of patients with iMN, who are on an ACE inhibitor or angiotensin II receptor blocker treatment. The main efficacy read-out is the effect on urinary protein excretion. The recruitment has been lower than expected due to a lack of eligible patients and even though there have been some improvements in recruitment during 2025, the overall recruitment rate has been disappointing. Therefore, only by adding substantial resources to the study, that everything else equal has lower priority compared to the programs in RA, PMR and host-directed therapy in viral infections, would secure complement of recruitment of all patients in a timely manner.
13
Development of resomelagon
Host-directed therapy in viral infections
Resomelagon in host-directed therapy in viral infections
Host-directed therapies target the effects of the viral infection, in our case induced inflammatory diseases, independently of which virus type or virus strain, is causing the disease. Thus, applying resomelagon as host-directed therapy offers a treatment opportunity in a wide range of virus infections causing inflammatory diseases.
Viral induced hyperinflammation is associated with respiratory insufficiency, as seen in viral infections such as Influenza and Covid-19, where infected patients evolve hyperinflammation in the lungs, but also in other viral infections, including arboviral infections, where the inflammation relates to more systemic effects and more organs.
Arboviral infections are caused by a group of viruses spread to people by the bite of infected arthropods (insects) such as mosquitoes and ticks. Arboviral infections are no longer exclusive to the Global South but are going to become more common also in the Global North.
SynAct Pharma has set up a strategic collaboration with the William Harvey Research Institute (WHRI) at Queen Mary University of London, UK and Department of Biochemistry and Immunology at the Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Brazil, called RESOVIR (resolution in viral infection) collaboration, with world leading scientists and clinicians in resolution biology, including Professor, Mauro Perretti PhD (WHRI) and Professor Mauro Teixeira, MD, PhD (UFMG).
The research has generated preclinical proof of concept in disease models of Covid-19, Influenza, Dengue fever and Chikungunya infection (Arbo virus associated with development of severe joint inflammation including severe pain). Based on the pharmacology program and the initial clinical RESOVIR-1 study additional clinical studies, the RESOVIR-2 and the RESPIRE study has been setup and initiated.
RESOVIR 1
- Severe Covid-19 infection
Resomelagon was tested in the RESOVIR-1 study, a 60-patient placebo-controlled Phase 2A clinical trial of treatment of hospitalized Covid-19 infected patients who required supplemental oxygen. 100 mg resomelagon or placebo was administered orally once daily for 2 weeks.
All resomelagon treated patients (including the first 6 open-label safety patients) achieved respiratory recovery on average 4.0 days (40%) quicker than placebo treated patients (5.9 days and 9.9 days on average respectively). Resomelagon patients were discharged on average 3.3 days earlier than placebo and by day 4, 41% of resomelagon patients had been discharged vs 0% for placebo.
SynAct Pharma AB - Interim Report, January - March 2020
PEPTIDE AGONISTS
TXP-11
The lead peptide agonist is TXP-11. This peptide also shows high potency at MC1R and MC3R. However, TXP-11 is taken as an intravenous administration and expected to be used in complicated medical conditions where patients are hospitalized with the risk of developing organ/life threatening hyperinflammation. The development potential of TXP-11 is to prevent organ failure following major surgery, traumas, and infections.
RESPIRE
- Resomelagon for treatment of inflammation caused by respiratory viruses
The RESPIRE study is a randomized, double-blind, multicenter, placebo-controlled study enrolling 96 patients. The study population will consist of hospitalized patients with respiratory insufficiency expected to be caused by respiratory viral infection.
Respiratory viral infections include Influenza, Covid-19, and RSV, which are the most common respiratory viral infections leading to an estimated two million people hospitalized annually in Europe and the U.S. Respiratory viral infections may worsen to a condition involving hyperinflammation in the respiratory system that renders the patient unable to provide enough oxygen to the body. Consequently, the patient would need to go to a hospital to get adequate treatment including oxygen therapy. If symptoms worsen, the patient may experience acute respiratory distress syndrome (ARDS) and require escalating oxygen support or mechanical ventilation.
The study will include male and female participants, 18 years and older, with expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV on bedside LAF test. Symptomatic participants needing respiratory support, as defined by saturation of O2 ≤ 93% at ambient air or requiring significantly greater FiO2 to maintain SpO2 > 93% (i.e., need for supplementary oxygen supply by a nasal catheter or facial mask), and who agrees to participate in the study. Resomelagon or Placebo treated given once daily as a tablet will be maintained for 14 days during the hospital stay. If participants are discharged before day 14, they should continue with the treatment at home.
The treatment effects of resomelagon versus placebo will be evaluated from baseline to day 28 on the composite endpoint: Occurrence of any one of the following: Death; Invasive mechanical ventilation; Extracorporeal Membrane Oxygenation (ECMO); Cardiovascular organ support (balloon pump or inotropes/vasopressors); or Renal failure (Cockcroft-Gault estimated creatinine clearance <15 mL/min), hemofiltration or dialysis.
RESOVIR 2
- Resomelagon for treatment of dengue fever
RESOVIR-2 is a randomized placebo-controlled, phase 2 study testing once daily oral dosing of resomelagon (AP1189) vs placebo (1:1 randomization, n=120) as add-on to standard treatment in patients with symptomatic Dengue. The potential treatment effect of resomelagon will be evaluated by time to disease resolution though a composite clinical end point. Secondary clinical end points include the ability to reduce the incidence of warning signs of and/or the development of severe dengue. The study is initiated and led by Professor Mauro Teixeira, MD, PhD Universidade Federal de Minas Gerais (UFMG), Belo Horizonte at clinical sites in Brazil. It is expected that the patients will be included at the next epidemic at sites that most likely will develop during Q2 2026. However, it has to be emphasized that recruitment to and completion of the study depends on the severity of this year's Dengue epidemic at sites.
The RESOVIR collaboration setup evaluate the potential of resomelagon and potential other pro-resolving compounds as host-directed therapy for treatment of severe viral infections. Following on to RESOVIR-1 that showed clinical proof-of concept in Covid-19 patients RESOVIR-2 as well as RESPIRE could add additional clinical proof-of-concept for the effect of resomelagon for resolving inflammation in patients with severe viral infections.
SynAct Pharma AB - Interim Report, January - March 2026
Pipeline overview
| ASSET | INDICATION | PRECLINICAL | PHASE 1 | PHASE 2A | PHASE 2B | PHASE 3 | STATUS |
|---|---|---|---|---|---|---|---|
| Resomelagon (AP1189) | Rheumatoid arthritis (RA) | ||||||
| - 1st line treatment together with Methotrexate | • ADVANCE - Ph2b - recruitment completed | ||||||
| Host-Directed Therapy in Viral Infections | Respiratory infections | • RESPIRE - Ph2 - hyperflammation due to respiratory infections (Influenza, Covid-19, RSV) ongoing | |||||
| Dengue virus | • RESOVIR-2 - Ph2a - Proof of Concept study | ||||||
| PoC in Arboviral infection (Dengue fever) ongoing | |||||||
| Polymyalgia Rheumatica (PMR) | • START - Ph2a - study ongoing | ||||||
| Idiopathic Membranous Nephropathy (iMN) | • Ph2a study ongoing (rare disease potential) | ||||||
| TXP-11 | Prevent organ failure in surgery | • Preclinical pharmacology to support Ph1 CTA ongoing - aim to be Ph1 ready in 2026 | |||||
| Next generation molecules | Autoimmune & inflammatory diseases | • Discovery phase |
SynAct Pharma AB - Interim Report - January - March 2026
The SynAct Pharma Share
Share information
SynAct Pharma's share has been listed on Nasdaq Stockholm since July 12, 2022. The stock is traded with the ticker or short name SYNACT. From the initial public offering in 2016 until July 11, 2022, the company's stock was traded on Spotlight.
The closing price of the SynAct share on the last trading day in March 2026 was SEK 18.28.
In March 2026, the Board of Directors resolved, based on the authorization granted by the Annual General Meeting on May 27, 2025, on a directed share issue of SEK 51.9 million before issue costs. Through the directed share issue, the number of shares increased by 2,883,725 to 56,213,968.
Ownership (March 31, 2026)
| Shareholder | Capital and votes(%) |
|---|---|
| Avanza Pension | 11.26% |
| NBCD A/S | 10.63% |
| Thomas Ringberg | 4.78% |
| Thomas Jonassen | 4.53% |
| Nordnet Pensionsförsäkring | 4.22% |
| Oliver Aleksov | 1.96% |
| Handelsbanken fonder | 1.62% |
| Kenneth Bjerg-Nielsen | 1.60% |
| Hunter capital | 0.94% |
| Johannes Schildt | 0.92% |
| Total (top-10) | 42.5% |
| Others (-15,100) | 57.5% |
Compiled and processed data from the share register of SynAct Pharma AB kept by Euroclear AB. Share of capital and votes is based on the number of shares outstanding at the time, 56,213,968.
Repurchase of own shares
During the period Januari 12 to February 28, SynAct has repurchased a total of 215,698 own shares. The buy-backs are part of the buy-back program decided on 9 January 2026 where the total acquisition amount is a maximum of SEK 5 million.
Share-based incentive programs
The company has two employee option programs, Employee Option Program 2024, ESOP (for employees) and BSOP (for the Board of Directors) as well as the recently introduced Employee Option Program 2025.
For further information, please refer to Note 5 of the financial statements.
Lock-up agreement
On December 23, 2025, SynAct announced a lock-up agreement for its Board of Directors and executive management regarding their respective holdings of shares. The lock-up agreement means that no sale of existing shares for a member of the board of directors or executive management except what is reasonable for the management of tax effects on said holdings until June 30, 2026.
Financial calendar
SynAct prepares and publishes a quarterly financial report. Upcoming reports and general meetings are planned as follows:
| Report: | Date: |
|---|---|
| Annual general meeting | 2026-06-11 |
| Interim Report Q2 2026 | 2026-08-20 |
| Interim Report Q3 2026 | 2026-11-03 |
SynAct Pharma AB - Interim Report, January - March 2026
Comments on the development for the first quarter of 2026
Net sales
Net sales for the first quarter amounted to SEK 0 (0) thousand. The company is not expected to generate any revenue until after the completion of Phase 2 program involving the drug candidate resomelagon (AP1189), at the earliest in 2026.
Research and development (R&D) costs
Total costs for R&D in the first quarter amounted to SEK 22,870 (21,464) thousand and includes the ongoing studies ADVANCE and RESPIRE.
Administration costs
Administrative expenses amounted to SEK 7,711 (6,632) thousand in the first quarter.
Financial items
Net financial items amounted to SEK 13 (-2,228) thousand in the first quarter and is attributable to exchange rate adjustments.
Tax for the period
Tax revenues in the first quarter amounted to SEK 5,057 (5,641) thousand. See Note 8 - Tax receivables.
Loss for the period
The Group's loss for the first quarter amounted to SEK 25,487 (24,684) thousand.
Cash flow, financial position and going concern
Total assets amounted to SEK 237,880 (219,171) thousand. Equity increased as a result of the directed share issues carried out in March.
Receivables from the Danish tax authorities that follow from the so-called "Tax Credit Scheme" (see Tax on profit for the period above and Note 8 - Tax receivables) amounted to SEK 13,233 (13,450) thousand.
Cash flow from operating activities amounted to SEK -32,952 (-28,826) thousand in the quarter. Cash flow from financing activities amounted to SEK 45,308 (19,703) thousand in the first quarter and includes the outcome of the directed share issue that was carried out in March.
Cash flow for the period amounted to SEK 12,356 (-9,123) thousand.
The Group's cash and cash equivalents as of March 31, 2026, amounted to SEK 65,782 (51,161) thousand.
The Board of Directors continuously assesses the Company's financial position and has determined that its current cash and cash equivalents is sufficient to fund the development plan and other communicated activities 12 months forward.
Employees
The number of employees was 8 (6) of which seven employees (4) were employed by the affiliate SynAct Pharma ApS.
Parent Company
The parent company's sales are from services delivered to the Danish subsidiary and amounted to SEK 1,606 (1,644) thousand in the first quarter.
In the Parent Company, net financial items amounted to SEK -21,846 (-24,472) thousand in the quarter. The group reports no proprietary intangible assets because the criteria according to IAS 38 are not met. To be able to continue the development activities in Denmark, the Swedish parent company provides ongoing capital contributions to the company that conducts the development activities. Under normal circumstances, the parent company would capitalize the contribution as shares in subsidiaries, but since no part of these funds is capitalized in the balance sheet, the contribution is a cost to the parent company and this cost is reported as a financial cost.
General meetings
Annual general Meeting
The Annual General Meeting will be held in Stockholm on Thursday, June 11 at 11.00 a.m.
SynAct Pharma AB - Interim Report, January - March 2026
Consolidated income statement
| SEK (thousand) | Note | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| Net sales | - | - | - | |
| Gross profit | - | - | - | |
| Research and development costs | -22.870 | -21.464 | -85.614 | |
| General and administration costs | 4.5 | -7.711 | -6.632 | -31.536 |
| Other operating income/expenses | 23 | -1 | 611 | |
| Total operating expenses | -30.558 | -28,098 | -116.540 | |
| Operating income | -30.558 | -28,098 | -116.540 | |
| Net financial items | 13 | -2.228 | -2.451 | |
| Profit after financial items | -30.544 | -30,326 | -118.991 | |
| Tax on profit/loss for the period | 7 | 5.057 | 5.641 | 8.165 |
| Profit for the period | -25.487 | -24,684 | -110.826 | |
| Earnings per share (SEK) | -0.48 | -0.51 | -2.17 | |
| Diluted earnings per share (SEK) | -0.48 | -0.51 | -2.17 | |
| Average number of shares outstanding (000) | 6 | 53.522 | 48.617 | 51.082 |
The result for the period is attributable in its entirety to the owners of the parent company
Consolidated statement of comprehensive Income
| SEK (thousand) | Note | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| Profit for the period | -25.487 | -24.684 | -110.826 | |
| Items reclassifiable to profit or loss | ||||
| Translation differences from foreign operation | 2.886 | -9.093 | -6.128 | |
| Comprehensive income after tax for the period | -22.602 | -33.778 | -116.955 | |
| Comprehensive income for the period | -22.602 | -33.778 | -116.955 |
The total comprehensive income for the period is attributable in its entirety to the owners of the parent company
SynAct Pharma AB - Interim Report, January - March 2026
Consolidated statement of financial position
| SEK (thousand) | Note | 03/31/2026 | 03/31/2025 | 12/31/2025 |
|---|---|---|---|---|
| Assets | ||||
| Non-current assets | ||||
| Intangible assets | 151.139 | 144.542 | 147.821 | |
| Right-of-use assets | 1.072 | 1.681 | 1.214 | |
| Financial assets | 9 | 137 | 136 | 135 |
| Total non-current assets | 152.348 | 146.359 | 149.170 | |
| Current assets | ||||
| Tax credit | 8 | 13.233 | 13.450 | 7.966 |
| Other current receivables | 4.692 | 1.961 | 5.415 | |
| Prepaid expenses | 1.824 | 6.240 | 4.562 | |
| Cash and cash equivalents | 9 | 65.782 | 51.161 | 53.406 |
| Total current assets | 85.532 | 72.812 | 71.348 | |
| Total assets | 237.880 | 219.171 | 220.518 | |
| SEK (thousand) | Note | 03/31/2026 | 03/31/2025 | 12/31/2025 |
| --- | --- | --- | --- | --- |
| Equity and liabilities | ||||
| Share capital | 7.027 | 6.126 | 6.666 | |
| Other paid-in capital | 5 | 881.035 | 763.547 | 835.340 |
| Reserves | 14.999 | 9.148 | 12.113 | |
| Retained earnings/losses including net profit | -709.315 | -597.686 | -683.828 | |
| Total equity | 193.745 | 181.135 | 170.291 | |
| Non-current liabilities | ||||
| Deferred tax liability | 17.895 | 17.114 | 17.502 | |
| Leasing liability | 435 | 1.066 | 595 | |
| Contingent earnout | 8.230 | 8.165 | 8.036 | |
| Other provision | 5 | 2.660 | 420 | 2.569 |
| Total non-current liabilities | 29.220 | 26.765 | 28.703 | |
| Current liabilities | ||||
| Accounts payable | 9 | 6.559 | 2.068 | 9.486 |
| Leasing liability | 636 | 577 | 616 | |
| Other current liabilities | 171 | 420 | 279 | |
| Accrued expenses | 9 | 7.548 | 8.206 | 11.143 |
| Total current liabilities | 14.914 | 11.271 | 21.524 | |
| Total equity and liabilities | 237.880 | 219.171 | 220.518 |
SynAct Pharma AB - Interim Report, January - March 2026
Consolidated statement of changes in equity
| 01/01/2025 - 12/31/2025
SEA (thousand) | Share capital | Ongoing new share issue | Other paid-in capital | Reserves | Retained earnings, including profit for the period | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Opening equity | 5,811 | 315 | 762,803 | 18,241 | -573,002 | 214,169 |
| Profit for the period | - | - | - | - | -110,826 | -110,826 |
| Other comprehensive income | - | - | - | -6,128 | - | -6128 |
| Comprehensive income for the period | - | - | - | -6,128 | -110,826 | -116,955 |
| Transactions with owners | | | | | | |
| Rights issue (reg 14/01/2025) | 315 | -315 | | | | - |
| Directed share issue | 108 | | 36,721 | | | 36,826 |
| Directed share issue (reg 08/07/2025) | 181 | | | | | 181 |
| Conversion warrants | 251 | | 35,104 | | | 35,355 |
| Issue expenses | | | -1,176 | | | -1,176 |
| Employee option program | | | 1,888 | | | 1,888 |
| Total transaction with owners | 855 | -315 | 72,536 | - | - | 73,077 |
| Closing equity | 6,666 | - | 835,340 | 12,113 | -683,828 | 170,291 |
| 01/01/2026 - 1/31/2026
SEA (thousand) | Share capital | Ongoing new share issue | Other paid-in capital | Reserves | Retained earnings, including profit for the period | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Opening equity | 6,666 | - | 835,340 | 12,113 | -683,828 | 170,291 |
| Profit for the period | - | | - | - | -25,487 | -25,487 |
| Other comprehensive income | - | | - | 2,886 | - | 2,886 |
| Comprehensive income for the period | - | - | - | 2,886 | -25,487 | -22,602 |
| Transactions with owners | | | | | | |
| Directed share issue | 360 | | 51,547 | | | 51,907 |
| Issue expenses | | | -1,451 | | | -1,451 |
| Employee option program | | | 600 | | | 600 |
| Share buy back | | | -5,000 | | | -5,000 |
| Total transaction with owners | 360 | - | 45,696 | - | - | 46,056 |
| Closing equity | 7,027 | - | 881,035 | 14,999 | -709,315 | 193,745 |
SynAct Pharma AB - Interim Report, January - March 2026
Condensed consolidated statement of cash flows
| SEK (thousand) | Note | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| Cash flow from operations | ||||
| Operating income | -30,558 | -28,098 | -116,540 | |
| Adjustment for non-cash items | 904 | 1,829 | 5,507 | |
| Interest received | - | 134 | 440 | |
| Interest paid | -68 | -1,582 | -2,381 | |
| Corporate income tax received/paid | - | - | 8,156 | |
| Cash flow from operations before change in working capital | -29,722 | -27,716 | -104,818 | |
| Change in working capital | -3,230 | -1,110 | 7,488 | |
| Cash flow from operating activities | -32,952 | -28,826 | -97,330 | |
| Cash flow from financing activities | 45,308 | 19,703 | 90,458 | |
| Cash flow for the period | 12,356 | -9,123 | -6,872 | |
| Cash and cash equivalents at beginning of period | 53,405 | 61,209 | 61,209 | |
| Decrease/increase in cash and cash equivalents | 12,356 | -9,123 | -6,872 | |
| Exchange rate difference in cash and cash equivalents | 21 | -925 | -932 | |
| Cash and cash equivalents at end of period | 65,782 | 51,161 | 53,405 |
SynAct Pharma AB - Interim Report, January - March 2026
Parent company's condensed income statement
| SEK (thousand) | Note | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| Net sales | 1,606 | 1,644 | 6,839 | |
| Gross profit | 1,606 | 1,644 | 6,839 | |
| General and administration costs | 5.6 | -4,613 | -4,023 | -19,856 |
| Other operating expenses | -21 | -74 | -97 | |
| Total operating expenses | -4,634 | -4,097 | -19,953 | |
| Operating income | -3,028 | -2,453 | -13,115 | |
| Net financial items | -21,846 | -24,472 | -85,029 | |
| Profit after financial items | -24,875 | -26,924 | -98,144 | |
| Tax on profit for the period | - | - | - | |
| Profit for the period | -24,875 | -26,924 | -98,144 |
Parent company's statement of comprehensive income
| SEK (thousand) | Note | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| Profit for the period | -24,875 | -26,924 | -98,144 | |
| Other comprehensive income | - | - | - | |
| Total comprehensive income | -24,875 | -26,924 | -98,144 |
SynAct Pharma AB - Interim Report, January - March 2026
Parent company's condensed balance sheet
| SEK (thousand) | Note | 03/31/2026 | 03/31/2025 | 12/31/2025 |
|---|---|---|---|---|
| Assets | ||||
| Non-current assets | ||||
| Financial assets | 180.473 | 181.207 | 180.473 | |
| Total non-current assets | 180.473 | 181.207 | 180.473 | |
| Current assets | ||||
| Receivables in group companies | 12.653 | 10.226 | 11.318 | |
| Other receivables | 544 | 903 | 216 | |
| Prepaid expenses | 1.485 | 492 | 1.789 | |
| Cash and cash equivalents | 56.013 | 34.215 | 36.419 | |
| Total current assets | 70.694 | 45.836 | 49.743 | |
| Total assets | 251.168 | 227.043 | 230.217 | |
| SEK (thousand) | Note | 03/31/2026 | 03/31/2025 | 12/31/2025 |
| --- | --- | --- | --- | --- |
| Equity and liabilities | ||||
| Restricted equity | ||||
| Share capital | 7.027 | 6.126 | 6.666 | |
| Non-restricted equity | ||||
| Other paid-in capital | 5 | 857.820 | 740.332 | 812.125 |
| Retained earnings/losses | -602.498 | -504.354 | -504.354 | |
| Profit for the period | -24.875 | -26.924 | -98.144 | |
| Total equity | 237.474 | 215.180 | 216.293 | |
| Non-current liabilities | ||||
| Contingent earnout | 8.230 | 8.165 | 8.036 | |
| Other provisions | 5 | 2.660 | 420 | 2.569 |
| Total non-current liabilities | 10.890 | 8.585 | 10.606 | |
| Current liabilities | ||||
| Accounts payable | 796 | 310 | 365 | |
| Other liabilities | 156 | 249 | 264 | |
| Accrued expenses | 1.852 | 2.720 | 2.689 | |
| Total current liabilities | 2.804 | 3.279 | 3.318 | |
| Total equity and liabilities | 251.168 | 227.043 | 230.217 |
SynAct Pharma AB - Interim Report, January - March 2026
SynAct Pharma AB - Interim Report, January - March 2026
Notes and disclosures
Note 1 - General information
This interim report covers the Swedish parent company SynAct Pharma AB (publ) ("SynAct" or the "Parent Company"), corporate identity number 559058-4826 and its subsidiaries (collectively, the "Group"). The Group's main business is to conduct the development of pharmaceuticals. The parent company is listed on Nasdaq Stockholm, with ticker SYNACT. The Parent Company is a limited liability company registered with its registered office in Lund, Sweden. The address of the head office is Scheelevägen 2, 223 63 Lund, Sweden. This interim report was approved for publishing on May 27, 2026.
Note 2 - Accounting principles
The interim report has been prepared in accordance with IAS 34 Interim Reporting. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB) with interpretations from the IFRS Interpretation Committee, approved by and implemented in the European Union.
The accounting principles applied in this interim report are aligned with the ones used for the Annual Report 2025, note 2 pages 39 to 42. No new or changed standards implemented on or after January 1, 2026 have had any significant impact on the company's financial reporting.
Note 3 - Significant risks and uncertainties
The risks and uncertainties to which SynAct's operations are exposed are, in summary, related to, among other things, drug development, competition, technology development, patents, regulatory requirements, capital requirements, currencies and interest rates.
The Group's overall risk management focuses on identifying, analyzing and evaluating risks that could affect the business and the Company's overall goals with the intention of minimizing potential adverse effects. The most significant risks and uncertainties are described below. See the Annual Report for 2025, pages 24-29 for further information on the Group's general risk management.
As the company does not have approved products on the market that can generate positive cash flow, the business requires additional capital. The Company's operations require new capital injections in the medium term, which is why this refinancing risk cannot be considered negligible.
The macroeconomic situation with concerning inflation and interest rates did not have a significant impact on SynAct's operations in the first quarter. Our suppliers and partners have been able to produce and deliver according to the plans we work with and without any significant cost increases. However, it cannot be ruled out that increased inflation and rising interest rates may lead to price increases for goods and services that could have a negative impact on the Company's future financial results and position.
The Group's operation is exposed to currency risks with its financing in SEK and main operations in DKK and EUR. SynAct took mitigating steps to reduce the risk through placement of liquidity in EUR and DKK accounts.
SynAct Pharma conducts clinical trials at clinics in Eastern Europe in the vicinity of the conflict in Ukraine, including in neighboring Moldova. The risks of this have been considered and action plans in the scenario where the conflict spreads and further affects the neighboring countries have been developed. To-date, SynAct and its collaborating partners have not encountered any difficulties that have not been overcome with only minor cost increases but without delays in the execution of the studies. Minor delays and/or minor impact on the Company's operating costs cannot be completely ruled out.
Note 4 - Assessments and estimates
Intangible assets in the Company are attributable to development projects. They have arisen in connection with the acquisition of the company TXP Pharma AG and its associated product portfolio. In the acquisition analysis, TXP Pharma's lead candidate TXP-11 was identified as a separately identifiable asset. The value in the accounting was based on a valuation made by an external valuation specialist. There is a significant risk of impairment of the intangible asset TXP-11 in the coming financial year in the event of negative changes in the material assumptions underlying the fair value measurement minus costs to sell for the cash-generating unit that includes TXP-11. The development timeline is one of the important assumptions underlying the value. To be able to complete the development as planned, the project requires necessary financial resources. The ability to allocate such financial resources to the project is dependent on the Company being able to acquire future financing and the value of the intangible asset is based on and dependent on the going concern assumptions.
The other significant assessments that are of greatest importance to Synact Pharma are described in Note 3 on page 42 of the Annual Report for 2025.
.25
Notes and disclosures (continued)
Note 5 - Share-based payments
The purpose of the employee option programs is to secure a long-term commitment for the employees in the Company through a compensation system which is linked to the Company's future value growth. Through the implementation of a share-based incentive program, the future value growth in the Company is encouraged, which implies common interests and goals for the shareholders of the Company and employees. Such share-based incentive programs are also expected to increase the Company's possibilities to retain competent persons.
Employee Option Program 2024
At the Annual General Meeting on May 31, 2024, it was resolved to introduce an employee option program, ESOP (for employees) and BSOP (for the Board of Directors).
These employee option programs shall comprise a maximum of 3,097,228 employee options, 2,271,301 for ESOP and 825,927 for BSOP. The allotted employee options vest with 1/3 from the date that is 12, 24 and 36 months after the date of allotment. Previous option holders, who have waived the rights to the earlier options programs, will vest 25% directly as a compensation for the waiver. The option holders shall be able to exercise granted and vested employee options during the period starting on the day that falls 3 years after the date of allotment and ending on 30 June 2029. Each employee option entitles the holder to acquire one new share in the company. Exercise price amounting to SEK 12.25, corresponding to 175 percent of the volume-weighted average share price of the company's share on Nasdaq Stockholm during 10 trading days immediately prior to the day on which a participant is granted options. The employee options shall be granted free of charge, shall not constitute securities and shall not be transferable or pledged. The allotment of 3,097,228 of the options included in the program took place on June 1, 2024.
Employee Option Program 2025
At the Extraordinary General Meeting held on 27 November 2025, it was resolved to introduce a new employee option program, ESOP2025.
This employee option program shall comprise a maximum of 1,250,000 employee options. The allotted employee stock options vest at the rate of 1/3 from the date that falls 12, 24 and 36 months after the date of allotment. The warrant holders shall be able to exercise allotted and vested employee options during the period starting on the date that falls 3 years after the date of allotment and ending on 1 January 2030. Each employee option entitles the holder to acquire one new share in the company. Exercise price of SEK 38.26, corresponding to 175 percent of the volume-weighted average share price of the company's share on Nasdaq Stockholm during the 10 trading days immediately prior to the day on which a participant is granted options. The employee stock options shall be allotted free of charge, shall not constitute securities and shall not be transferable or pledged.
As of March 31, 2026, SynAct had 53,213,968 shares outstanding. If the outstanding options (2,271,301) for the ESOP 2024 are vested and exercised in full, it would result in a dilution of 4.3%. If the outstanding options (825,927) for the BSOP 2024 are vested and exercised in full, it would result in a dilution of 1.6%. If the outstanding options (xx) for the ESOP 2025 are vested and exercised in full, it would result in a dilution of 1.4%.
The costs for the programs are estimated at SEK 12 125 thousand and refer to both the estimated cost of the value of the employees' services during the entire vesting period, valued at the market value at the time of allocation, and the estimated earned social security contributions related to Swedish participants. In the first quarter of 2026, the costs for the employee option programs amounted to SEK 690 thousand (832).
| Change in outstanding incentive programs (number of options) | 2026 | 2025 | Total |
|---|---|---|---|
| Jan-Mar | Jan-Mar | ||
| Allotted instruments | |||
| ESOP 2024 | - | - | 2,271,301 |
| BSOP 2024 | - | - | 825,927 |
| ESOP 2025 | 733,011 | - | 733,011 |
| Instruments decided, not allocated | |||
| ESOP 2025 | 516,989 | - | 516,989 |
| Recalled/voided instruments | |||
| ESOP 2024 | - | - | -326,930 |
| Maximum number of shares to which allocated options can entitle | 03/31/2026 | ||
| --- | --- | ||
| ESOP 2024 | 1,944,371 | ||
| BSOP 2024 | 825,927 | ||
| ESOP 2025 | 733,011 | ||
| Total Employee Option | 3,503,309 |
SynAct Pharma AB - Interim Report, January - March 2026
Notes and disclosures (continued)
Note 6 - Transactions and agreements with related parties
In addition to salaries and other remuneration (including invoiced) to the Company's management, board remuneration, according to the resolution of the Annual General Meeting, to the board, and intra-group transactions no transactions have taken place with related parties in the reporting period.
Related transactions have been made with NBCD A/S (CRO) of approximately SEK 11.3 million and ResoTher Pharma of approximately SEK 160 thousand
The Company has entered into an agreement with Boesen Biotech ApS regarding the transfer of intellectual property rights. The agreement did not involve any financial transactions in reported periods. See Note 10, Contingent liabilities for more information.
Note 7 - Number of registered shares
| Thousand | 2025 | 2025 | 2025 |
|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | |
| Number of shares at the beginning of the period | 53,330 | 46,487 | 46,487 |
| Number of shares at the end of the period | 56,214 | 49,009 | 53,330 |
| Average number of shares outstanding in the period | 53,522 | 48,617 | 51,082 |
All shares are freely traded and the Company holds 215,698 of its own shares.
Note 8 - Tax receivables
According to Danish tax law (the tax credit scheme), the subsidiary SynAct Pharma ApS is entitled to receive a current tax income for some of the expenses that are directly attributable to the company's research and development (R&D). Settled expenses for R&D that result in tax revenue received reduce the company's tax loss carryforwards with the corresponding amount. SynAct Pharma ApS can settle a maximum of tax deficits attributable to research and development up to DKK 25 million per year. This corresponds to DKK 5.5 million as possible tax revenue, as the tax rate in Denmark is 22%.
The claim on the Danish tax authorities that follows from this scheme amounted to SEK 13,233 thousand (13,450). The balance related to fiscal year 2025 with an amount of SEK 7,966 thousand is expected to be received in November 2026.
Note 9 - Financial assets and liabilities
| SEK (thousand) | 03/31/2026 | 03/31/2025 | 12/31/2025 |
|---|---|---|---|
| Financial assets | |||
| Non-current financial assets | 137 | 136 | 135 |
| Cash and cash equivalents | 65,782 | 51,161 | 53,406 |
| Total financial assets | 65,919 | 51,297 | 53,541 |
| Financial liabilities | |||
| Accounts payable | 6,559 | 2,068 | 9,486 |
| Accrued expenses | 7,548 | 8,206 | 11,143 |
| Total financial liabilities | 14,107 | 10,274 | 20,629 |
SynAct Pharma does not hold any financial instruments that are valued at fair value. For all financial assets and liabilities, the reported value above is deemed to be an approximation of fair value. No change in classification of financial instruments has occurred over the reported periods.
Note 10 - Contingent liabilities
In March 2021, the subsidiary SynAct Pharma ApS acquired the rights to a number of innovative chemical molecules from Boesen Biotech ApS, a company controlled by COO Thomas Boesen. The transfer took place free of charge, but according to the agreement, Boesen Biotech ApS is entitled to receive milestone payments and royalties in the future related to any progress in the Company's development and commercialization of products based on these rights. Upon successful achievement of defined milestones, Boesen Biotech ApS may receive up to a maximum of DKK 4.5 million in payment. In the event of any future commercialization of a product where these IP rights are used, Boesen Biotech ApS is entitled to royalties amounting to 3% of net sales for 10 years from launch and with a maximum amount of DKK 500 million.
As the remunerations that may be paid to Boesen Biotech is not considered to be secure or probable commitment for SynAct, they are not reported as a liability (accrual or provision). Based on current plans, a first milestone payment may be charged to the income statement and balance sheet at the earliest in 2026 and have a cash flow effect no earlier than 2027.
SynAct Pharma AB - Interim Report, January - March 2026
Alternative performance measures - APM
The use of Alternative Performance Measures in financial reports is regulated by the European Securities and Markets Authority (ESMA) in guidelines issued in 2015. According to these guidelines, an alternative key ratio refers to a financial measure of historical or future earnings development, financial position, financial result or cash flows. It is not such a financial measure that is defined or specified in the applicable rules for financial reporting.
SynAct Pharma uses alternative key figures to increase the understanding of the information provided in financial reports, both for external analysis, comparison and internal evaluation. The company has chosen equity / assets ratio and research and development costs / operating expenses as alternative key figures in its reporting. Definitions and tables for deriving these are shown below.
Equity / asset ratio
The equity ratio is a financial ratio indicating the relative proportion of equity used to finance a company's assets. The two components are taken from the SynAct Pharma's balance sheet or statement of financial position (so-called book value). Equity divided by total assets.
| # | SEK (thousand) | 03/31/2026 | 03/31/2025 | 12/31/2025 |
|---|---|---|---|---|
| Assets | ||||
| Total non-current assets | 152,348 | 146,359 | 149,170 | |
| Total current assets | 85,532 | 72,812 | 71,348 | |
| [1] | Total assets | 237,880 | 219,171 | 220,518 |
| Equity and liabilities | ||||
| [2] | Total equity | 193,745 | 181,135 | 170,291 |
| Total non-current liabilities | 29,220 | 26,765 | 28,703 | |
| Total current liabilities | 14,914 | 11,271 | 21,524 | |
| Total liabilities | 44,134 | 38,036 | 50,227 | |
| Total equity and liabilities | 237,880 | 219,171 | 220,518 | |
| [2]/[1] | Equity / asset ratio (%) | 81% | 83% | 77% |
Research and development costs / operating expenses
Total cost of Research and Development as a percentage of total operating expenses. Indicates the share of total investment allocated to R&D. Subsequently, the residual (1 - R&D/Operating Expenses), indicates share of total invested into General & Administration activities.
| # | SEK (thousand) | 2026 | 2025 | 2025 |
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Jan-Dec | ||
| [1] | Research and development costs | -22,870 | -21,464 | -85,614 |
| General and administration costs | -7,711 | -6,632 | -31,536 | |
| Other operating income / expense | 23 | -1 | 611 | |
| [2] | Total operating expenses | -30,558 | -28,098 | -116,540 |
| [1]/[2] | Research and development costs / operating expenses (%) | 75% | 76% | 73% |
SynAct Pharma AB - Interim Report, January - March 2026
The CEO declaration
The CEO assures that this interim report provides a true and fair view of the development and the Group's and the Parent Company's operations, position and results, and describes significant risks and uncertainties that the Parent Company and the companies included in the Group face.
The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) adopted by the EU and the interim report has been prepared in accordance with IAS 34 - Interim Financial Reporting. The interim report has been reviewed by the company's auditors.
Lund, May 27, 2026
Jeppe Øvlesen
Chief Executive Officer (CEO)
SynAct Pharma AB - Interim Report, January - March 2026
Dictionary
ACE inhibitor
A group of drugs that lower blood pressure by inhibiting the angiotensin-converting enzyme (ACE).
ADVANCE
Ongoing clinical Phase 2b study in newly diagnosed treatment naive rheumatoid arthritis patients characterized by high disease activity including signs of systemic inflammation who are eligible for Methotrexate (MTX) treatment. In the study 3 doses of resomelagon (AP1189) vs placebo (n=240) given once daily for 12 weeks are tested in combination with standardized MTX treatment. The aim is to identify clinically active doses of resomelagon to be taken into Phase 3 clinical development. The primary efficacy readout, set in accordance with US-FDA recommendation for phase 2 dose range studies is changed in the clinical score DAS28-CRP relative to placebo treatment. The study is conducted at more than 30 sites in Europe and US with the aim to have last patient dosed in Q4 2025.
Agonist
An agonist is a chemical that activates a receptor to produce a biological response. Receptors are cellular proteins whose activation causes the cell to modify what it is currently doing. In contrast, an antagonist blocks the action of the agonist, while an inverse agonist causes an action opposite to that of the agonist.
Angiotensin
Angiotensin is a peptide hormone important for the regulation of blood pressure.
Arboviral Infections
Infections due virus infection following mosquito bites. Examples of arbo-virus are Dengue virus, Chikungunya virus, Zica virus and West Nile virus. Arboviral infections are more common in tropical and subtropical climates but has spread in recent years also to Europe and the US where the mosquitoes have become endemic. A major reason to the spreading of the virus is most likely global warming.
Autoimmune disease
An autoimmune disease is a condition arising from an abnormal immune response to a functioning body part.
BAP
Branched Amino Acid Probes (BAP) is a proprietary technology improving the properties of peptides, developed by TXP Pharma for the modification of therapeutic peptides.
BEGIN
The BEGIN study was a multi-center, two-part, double-blind, placebo-controlled study, in which two doses of resomelagon (50 mg and 100 mg orally administered once daily) were evaluated against placebo as adjunctive therapy to methotrexate in newly diagnosed patients with acute, active RA. The study's primary endpoint is a reduction in disease activity from high (defined as clinical disease activity>22) to moderate or low activity during the four-week treatment period. Key data from the study were presented on November 30, 2021.
cAMP
cAMP, or cyclic adenosine monophosphate, is an adenine-based (nitrogen-based), cyclic nucleotide (molecular building block) that participates in the formation of DNA and RNA, by acting as a secondary messenger for several signaling substances and hormones and their receptors, inside the cells.
Clinical study
Clinical studies are conducted to test the efficacy and safety of new drugs, diagnostic tests, products, or treatments. Before human studies begin tests have already been done in several different ways in laboratory experiments and in animal studies. Clinical studies or trials are carried out both with healthy volunteers and individuals with the disease being studied.
CMC
CMC is an acronym for Chemistry, Manufacturing and Controls which are critical activities in the development of new drug products. In addition to the processes themselves, CMC also refers to practices and specifications that must be followed and met to ensure product safety and batch-to-batch consistency.
Contract Research Organization (CRO)
Within the life science industry, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology and medical technology industry in the form of research services outsourced on contract. A CRO can provide such services as biopharmaceutical development, development of biological assays, commercialization, clinical development, management of clinical studies, safety monitoring, outcome research and so-called real world evidence studies.
DMARD
Disease-modifying anti-rheumatic drugs (DMARD) are a category of otherwise unrelated drugs defined by their use in rheumatoid arthritis and other rheumatic diseases. The term often finds its meaning in contrast to non-steroidal anti-inflammatory drugs and steroids (NSAIDs). The term overlaps with antirheumatics, but the two terms are not synonymous.
EXPAND
The EXPAND (SynAct-CS007) study was a multi-center, randomized, double-blind, placebo-controlled, 12-week study in MTX naive patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22). In EXPAND, 120 RA patients with high disease activity (CDAI > 22) was randomized to treatment with resomelagon 100 mg once daily or placebo for 12 weeks in combination with MTX treatment. The overall conclusion from the study was that resomelagon was well tolerated, but no treatment effects compared to placebo treatment was observed. However, in the fraction of patients (approx. 50 of the recruited pts) who were newly diagnosed and with signs of systemic inflammation, ie patients presenting with poor prognosis parameters, the response rate to treatment was significantly increased in the resomelagon treated when compared to placebo treatment. This finding, together with comparable finding in the BEGIN study, the first study of resomelagon in RA, support the further development of resomelagon in the ADVANCE study.
SynAct Pharma AB - Interim Report, January - March 2026
SynAct Pharma AB - Interim Report, January - March 2020
FDA
The United States Food and Drug Administration (FDA or USFDA) is the US food and drug authority responsible for food (for humans and animals), dietary supplements, drugs (for humans and animals), cosmetics, medical devices (for humans and animals), radioactive equipment and blood products.
Hypercholesterolemia
Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood.
Hyperinflammation
Exacerbated inflammatory response in the body and or in organs/tissues. Hyperinflammatory responses are seen secondary to infections or in response to major surgery, severe bleeding or traumas. When present hyperinflammation can develop into tissue and/or organ dysfunction and in the most severe cases in systemic inflammatory response syndrome (SIRS) with multi-organ failure. No current treatment are available to control hyperinflammatory responses in controlled fashion.
iMN
Idiopathic membranous nephropathy is an autoimmune disease in which the membranes of the glomerulus are attacked by generated autoantibodies, resulting in progressive deterioration of kidney function.
IND (Investigational New Drug) Application
An application to the FDA that must be submitted and approved before a drug can be tested on humans, so-called permit application for drug testing.
Melanocortin
Melanocortin is a body-specific hormone that acts by activating specific melanocortin receptors on the cell surface of certain white blood cells.
Melanocortin receptors
When these receptors are activated, processes start in the body that lead to reduced release of pro-inflammatory mediators (slowed down inflammation) and stimulation of healing processes (dead cells and cell debris are cleaned away and the tissue heals).
Methotrexate (MTX)
Methotrexate is a folic acid antagonist that belongs to the group of cytostatics. Today it is used in rheumatoid arthritis, psoriasis and Crohn's disease as a disease-modifying drug but can also be used as a cancer treatment.
Nephrotic syndrome (NS)
Nephrotic syndrome is a syndrome (a collection of symptoms) resulting from a change in the kidneys.
Organ dysfunction/Organ failure
Organ dysfunction is a condition where an organ does not perform its expected function. Organ failure is organ dysfunction to such a degree that normal homeostasis cannot be maintained without external clinical intervention.
Peptide
A peptide is a molecule that consists of a chain of amino acids (also called monopeptides) joined together by peptide bonds to form a short chain. Peptides differ from proteins only in that they are smaller. Peptides occur naturally in the body but can also be produced synthetically.
pERK pathway
The pERK pathway (also known as the MAPK/ERK or RasRaf-MEK-ERK pathway) is a chain of proteins in the cell that communicates a signal from a receptor on the surface of the cell to the DNA in the nucleus of the cell.
Pharmacokinetics
Pharmacokinetics (PK) is the study of drug metabolism in the body, i.e. how the levels of a drug in the body change through absorption, distribution (distribution), metabolism and excretion.
RA
Rheumatoid arthritis is an autoimmune disease characterized by chronic inflammation (arthritis) and pain (arthralgia) in the body's joints. Inflammation has a strong ability to break down cartilage, adjacent bones, tendons and arteries.
RESOLVE
The RESOLVE study (SynAct-CS006) was set up under a USIND to evaluate the potential of resomelagon in so-called DMARD-IR patients, i.e. RA patients who had inadequate response to first line treatment defined as MTX including co-administration of glucocorticoids. The study was set up in two-parts, as randomized, double-blind, multi-center, placebo-controlled studies. Part A was a 4-week dose range study testing 3 doses of resomelagon vs placebo. The primary aim for part A was to identify feasible doses for part B of the study. Part B was planned as Phase 2b randomized, double-blind, multi-center, placebo-controlled studies testing up to three doses of resomelagon vs placebo in DMARD-IR patients. As the outcome of Part A was inconclusive as regard to dose response and efficacy relative to placebo treatment it was decided not to initiate part B. The reason for the inconclusive results in part A could most likely be attribute to the short treatment period (4 weeks) and the fact the only a fraction, less than 105 of the patients had been treated with MTX for less than 12 months with a fraction not been optimally titrated with MTX. SynAct Pharma has decided to postpone further development in RA DMARD-IR patients to a later timepoint.
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SynAct Pharma AB - Interim Report, January - March 2026
Resomelagon (AP1189)
The mechanism of action of SynAct Pharma's lead drug candidate resomelagon is the promotion of inflammation resolution through the selective activation of melanocortin receptors 1 and 3. These receptors are found on all immune cells, including macrophages and neutrophils. Activation of these receptors leads to two direct anti-inflammatory effects: it influences these cells to produce fewer inflammation-driving molecules and also alters them to initiate clearance of the inflammation, also known as efferocytosis (J Immun 2015, 194:3381-3388). This process has been shown to be effective in models of inflammatory and auto-immune diseases and the clinical potential is being tested in clinical programs in patients with rheumatoid arthritis (RA), nephrotic syndrome (NS) and COVID-19. The safety and efficacy of resomelagon have not been reviewed by any regulatory authority globally.
RESOVIR
RESOVIR (Resolution Therapy for Viral Inflammation Research) is a scientific and clinical collaboration between Professor Mauro Teixeira, MD, PhD, Universidade Federal de Minas, Belo Horizonte, Brazil, Professor Mauro Perretti, PhD William Heavy Research Institute, Barts and London School of Medicine, Queen Mary University, London, UK, and SynAct. The aim of the RESOVIR collaboration is to investigate the utility of resolution therapy to resolve the cytokine storm inflammation associated with significant viral infections.
Respiratory insufficiency
Means that breathing does not work as it should, which leads to a lack of oxygen.
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Other company information
| SynAct Pharma AB – parent company | ||
|---|---|---|
| Company name | SynAct Pharma AB | |
| Trade name/Ticker | SynAct Pharma/SYNACT. Shares are traded at Nasdaq Stockholm. | |
| ISIN-kod | The ISIN-code of the share is SE000B341491 | |
| LEI-kod | 549300RRYIEFEQ72N546 | |
| Registered office and domicile | Skåne County, Lund Municipality, Sweden | |
| Corporate registration number | 559058-4826 | |
| Date of incorporation | 2016-04-12 | |
| Date of operation | 2016-04-12 | |
| Jurisdiction | Sweden | |
| Association form | Public limited liability company | |
| Legislation | Swedish law and Swedish Companies Act | |
| Company address | Scheelevägen 2, 223 63 Lund, Sweden | |
| Phone number | +46 10 300 10 23 | |
| Homepage | www.synactpharma.com | |
| Auditor | KPMG AB (Box 227, 201 22 Malmö), auditor in charge Linda Bengtsson. | |
| SynAct Pharma ApS – affiliate | ||
| --- | --- | --- |
| Country of establishment | Denmark | |
| Country of operations | Denmark | |
| CVR-number (Company registration id) | 34459975 | |
| Holding | 100 percent | |
| TXP Pharma AG – affiliate | ||
| Country of establishment | Switzerland | |
| Country of operations | Switzerland | |
| Firmenummer (Company registration id) | CHE-271.053.235 | |
| Holding | 100 percent |
SynAct Pharma AB - Interim Report, January - March 2026
SYNACT PHARMA
SynAct Pharma AB
Visiting address: Scheelevägen 2, 223 63 Lund, Sweden
Postal address: Scheelevägen 2, 223 63 Lund, Sweden
Phone: +46 10 300 10 23
E-mail: [email protected]
www.synactpharma.com
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