Press release

Malmö, 27 January 2026

PILA PHARMA AB (publ) (FN STO: PILA) (“PILA PHARMA” or the “Company”), an innovative biotech company developing a novel oral, small molecule TRPV1 inhibitor, today hosts an online Q&A (questions and answers) in relation to its concluded preclinical studies and upcoming clinical activities.

The Company invites for a live online Q&A, today 27 January at 14:30 CET, with Direkt Studios.

The Company will be represented by CEO Gustav H. Gram together with Founder, Chairman and CSO Dorte X. Gram

Link to the event: https://www.youtube.com/live/_8TF8lYefh8

Questions can be submitted live at the link or prior to the broadcast to investor@pilapharma.com.

Malmö, 27 January 2026

For more information:  
CEO, Gustav H. Gram       

Email: ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“ODD”) for XEN-D0501 as a treatment for a painful rare disease erythromelalgia. PILA PHARMA currently focuses on obesity and type-2 diabetes whilst focusing on licensing opportunities for erythromelalgia and abdominal aorta aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. The next step is now to submit a clinical trial application for a dose-finding study in people living with obesity. The clinical trial application should be submitted around the end of Q1 2026. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About obesity and diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is preparing to submit clinical trial applications in people living with obesity alone as well as with type 2 diabetes.

About erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. 
PILA PHARMA has made a draft clinical development plan for this project and the project is available for outlicensing.

Download the press release as PDF here

Malmö, 16 January 2026

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing a novel oral drug based on TRPV1 inhibition for treatment of obesity and diabetes, is delighted to inform that the company’s CEO Gustav Hanghøj Gram participated in Swedish investment podcast Market Makers, with the episode released yesterday, January 15, 2026.

In the podcast, PILA PHARMA is introduced, the history behind the company is elaborated, and what fuels the aspirations to investigate the company’s oral, potential first-in-class TRPV1 inhibitor, in pure obesity studies – a market estimated to more than 1 billion people globally. They also discuss the timelines with which investors can expect news.

Furthermore, they discuss the obesity market as a theme and megatrend, and how a company like PILA PHARMA’s and its simple oral solution could play a part in a future fragmenting market with strong emphasis on tablets to address the market volume.

The new podcast segment is recorded in English and can be found here:
___________

Market Makers Podcast (Online Recording from San Francisco) 
Recorded Wednesday, January 14, 15:00 CET (06:00 PT) (Segment starts at 48:20)

Spotify: https://open.spotify.com/episode/1M4rLQhGWVGY1IdFrdF9Kb?si=t2TQUZWCR22LlhwuxXPbqg


Apple: https://podcasts.apple.com/sv/podcast/market-makers/id1287619526

___________

Malmö, 16 January 2026

For more information:

Gustav H. Gram, CEO
ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800 

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now assessing the drug candidate in preclinical obesity studies with Gubra. The results are expected in start of 2026 with effect on bodyweight vs placebo the primary endpoint. The subsequent plan is for the company to initiate two tracks assessing the drug candidate in individuals living with obesity as well as obesity with type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. PILA PHARMA has made a draft clinical development plan for this project and are assessing the next steps 

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 16 January 2026

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing a novel oral drug based on TRPV1 inhibition for treatment of obesity and diabetes, is deepening its efforts in Investor Relations by commencing a new research coverage with Analyst Group.

The coverage includes equity research with quarterly updates as well as analyst comments on financial reports and press releases. Analyst Group’s initiation equity research report was released Wednesday, January 14, 2026. The research will be published in English & Swedish.

Analyst Group’s dedicated page for PILA PHARMA can be found here: https://www.analystgroup.se/analyser/pila-pharma/

PILA PHARMA CEO Gustav H. Gram comments: 

“As the obesity market from the start of 2026 increasingly pivots towards novel, scalable and oral solutions, with differentiated safety and tolerability profiles, and especially also simpler manufacture / superior scalability, PILA PHARMA’s unique, oral, small molecule TRPV1 inhibitor XEN-D0501 stands out clearly in the landscape of clinical development candidates.

Currently in development for treatment of obesity and diabetes, its presumed to have a significantly different side-effect profile, and a simpler chemical synthesis, to the commonly known gut-hormone therapies in development and on the market. 

We believe there is strong value in increasing our visibility further in the Nordic capital markets, through our many ongoing collaborations like the one now with Analyst Group, that highlights our strategy, and gives a concrete judgement on our short and long-term potential”

Malmö, 16 January 2026

For more information:

Gustav H. Gram, CEO
ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now assessing the drug candidate in preclinical obesity studies with Gubra. The results are expected in start of 2026 with effect on bodyweight vs placebo the primary endpoint. The subsequent plan is for the company to initiate two tracks assessing the drug candidate in individuals living with obesity as well as obesity with type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. PILA PHARMA has made a draft clinical development plan for this project and are assessing the next steps 

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

About Analyst Group

Analyst Group is a research firm focused on small- and micro-cap companies in Scandinavia. 
Since its founding in 2014, the company has developed deep expertise and experience in analysing and providing equity research, financial marketing and assisting companies improve their investor relations to increase understanding and transparency.

Download the press release as PDF here

Malmö, 05 January 2026

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing a novel oral drug based on TRPV1 inhibition for treatment of obesity and diabetes, today shares that it’s been invited to a corporate presentation slot at the Biotech Showcase™ during the 2026 J.P Morgan Healthcare week in San Francisco, United States. 

The company’s CEO Gustav H. Gram will present the company and its highly differentiated approach to existing treatments for obesity, to American investors. 

With an obesity market that pivots towards novel scalable oral solutions, with differentiated safety and tolerability profiles, and especially also simpler manufacture, PILA PHARMA’s oral small molecule TRPV1 inhibitor XEN-D0501 stands out in the landscape as clinical development candidate. Currently in development for treatment of obesity and diabetes, its presumed to have a different side-effect profile and a simpler chemical synthesis, to gut-hormone therapies in development and on the market. 

CEO of Demy-Colton (organizer of Biotech Showcase™) Sara Demy, comments: 
“We are delighted that PILA PHARMA will be joining us in San Francisco and presenting at Biotech Showcase this year. Biotech Showcase is a prime opportunity for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of human health.”

CEO of PILA PHARMA Gustav H. Gram comments:

I’m honored that we’ve been invited to J.P Morgan’s Healthcare week and Biotech Showcase™, to present our highly differentiated oral drug candidate for obesity, at the most high-profile investor and partnering week of the year in biotech and pharma. 

I look forward to engaging with American investors in San Francisco and share our story and how we envision that our that our clinical stage oral small-molecule TRPV1 inhibitor, which is currently being assessed in pre-clinical obesity studies, can play a role in the growing market for weight management and its associated comorbidities. A market that will likely encompass many solutions to improve tolerability, patient adherence, accessibility and address both medical and cosmetic weight-loss and weight maintenance.

The presentation is set for Tuesday, January 13 at 11:30 PT (20:30 CET). 
A recording will possibly be made available afterwards. 

For more information:

Gustav H. Gram, CEO
ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

Malmö, 05 January 2026

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies. 
This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing.

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 02 January 2026

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing a novel oral drug based on TRPV1 inhibition for treatment of obesity and diabetes, today announces that CEO Gustav H. Gram has increased his shareholding in the company.

Mr. Gram acquired a total of 40,188 shares in PILA PHARMA AB on 29 and 30 December 2025 through market purchases at an average price of approximately SEK 2.15 per share. Following the transactions, Mr. Gram holds 207,484 shares in the company.

The transaction has been reported to the Swedish Financial Supervisory Authority (Finansinspektionen) in accordance with applicable regulations.
_______

To stay up to date on news, events & where to meet us, please see our website:
https://www.pilapharma.com/

Malmö, 02 January 2026

For more information:

Gustav H. Gram, CEO

ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800 

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies. 
This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing.

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 04 December 2025

PILA PHARMA AB (publ) (FN STO: PILA) informs that Professor Thomas Lutz DVM, PhD, University of Zurich, Switzerland is now joining PILA PHARMA’s Scientific Advisory Board.  

Professor Thomas Lutz MD, PhD is a leading pre-clinical researcher in obesity and metabolic diseases that since the 1990’ies has been working in the field of research on the regulation of food intake with a special focus on the pancreatic hormone amylin in the control of metabolism and also on the role of aggregating amylin in the pathophysiology of type 2 diabetes mellitus. 

Prof. Lutz’ research contributed substantially to the current knowledge of the biology of amylin and its effects on energy metabolism. This research also examined the interactions between amylin and other controls of metabolism, such as leptin, GLP-1 and sex hormones, and it forms the basis of various efforts to target the amylin system in the treatment of obesity, diabetes mellitus and other metabolic diseases.  

CSO & Founder Dorte X. Gram comments:

“I’m very pleased that Professor Lutz is now joining our Scientific Advisory Board bringing substantial knowledge and know-how within pre-clinical studies of obesity. I first met Thomas more than 25 years ago when we both annually attended “The Winter Conference on Brain Research”, an international scientific meeting for basic scientists within “the regulation of food intake”. We already then were working on our favourite topics: Thomas on amylin’s biology and I on the role of the capsaicin receptor (TRPV1) in obesity and its comorbidities.
I now really look forward to join forces with Thomas to unravel how XEN-D0501 may affect obesity in man, and in particular interpreting the results of PILA’s upcoming two pre-clinical obesity studies in DIO and Zucker rats.” 

_______ 

For more information: 

Gustav H. Gram, CEO 

ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ) 

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm. 

About XEN-D0501 and TRPV1 antagonists 

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation.  

TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups.  

PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bidaily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced.  

During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in pre-clinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential firstin-class drug candidate. 

About Obesity and Diabetes 

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 

It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand.  

Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints.  

Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now, from autumn 2025, preparing to assess the drug candidate in pre-clinical obesity studies.  

This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential firstin-class drug candidate.

About Erythromelalgia 

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable.  

PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing.

About Abdominal Aorta Aneurysm 

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing pre-clinical proofof-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 27 October 2025

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing a novel oral drug based on TRPV1 inhibition for treatment of obesity and diabetes, informs of its participation in two upcoming scientific conferences in the United States.

04-07 November: ObesityWeek® by The Obesity Society (TOS)
Atlanta, United States
https://obesityweek.org/

07-10 November: American Heart Association® Convention (AHA) 
New Orleans, United States
https://professional.heart.org/en/meetings/scientific-sessions

The company looks forward to engaging with researchers and key stakeholders in the obesity and cardiovascular space and to discuss PILA PHARMA’s unique approach targeting TRPV1 and our proprietary oral TRPV1 inhibitor XEN-D0501.

To stay up to date on news, events & where to meet us, please see our website:
https://www.pilapharma.com/

Malmö, 27 October 2025

For more information:

Gustav H. Gram, CEO
ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies. 
This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing.                                                           

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 07 October 2025

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing novel oral drugs based on TRPV1 inhibition for treatment of obesity and diabetes, informs investors and others with interest in the space that CEO Gustav H. Gram has increased his shareholding in the company.

Mr. Gram acquired a total of 36,677 shares in PILA PHARMA AB on 3 and 6 October 2025 through market purchases at an average price of approximately SEK 2.26 per share. Following the transactions, Mr. Gram holds 167,296 shares in the company.

The transaction has been reported to the Swedish Financial Supervisory Authority (Finansinspektionen) in accordance with applicable regulations.

To stay up to date on news, events & where to meet us, please see our website:
https://www.pilapharma.com/

For more information:

Gustav H. Gram, CEO

ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 
Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800 

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of obesity, type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists for treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for a painful rare disease Erythromelalgia. PILA PHARMA currently focuses on Obesity & Type-2 Diabetes whilst focusing on licensing opportunities for Erythromelalgia and Abdominal Aorta Aneurysm.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 inhibitor that was in-licensed in 2016. The drug candidate is a small molecule currently formulated in a simple and stable tablet formulation. 
TRPV1 inhibitors that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. PILA PHARMA’s founder and current CSO Dorte X. Gram, is the inventor of the principle of treating diabetes and obesity with TRPV1 inhibitors – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. Here she discovered that TRPV1 inhibitors would prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. 
PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, in PP-CT02, it was demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. ANP, a cardiovascular biomarker for heart failure, was also highly statistically significantly reduced. 
During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, a new clinical phase 2a trial, PP-CT03, is being prepared. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. The Company is now, from autumn 2025, also preparing to assess the drug candidate in preclinical obesity studies. This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Obesity and Diabetes

Obesity (BMI >30) is pandemic in its essence with estimates of more than 1 billion people living with it in 2025. Overweight (BMI >27) is also at staggeringly high levels with estimates of 4 billion people globally. 
It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances and the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate enormous and growing demand. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
Having previously completed two clinical trials in people living with overweight and diabetes, the Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies. 
This could enable the company to have two tracks assessing the drug candidate in individuals living with overweight as well as with and without type-2 diabetes. The ambition is to create a comprehensive and meaningful data package that supports XEN-D0501 as an oral, potential first-in-class drug candidate.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. There are no current treatments available to patients, but it is widely believed by doctors that an oral solution with systemic effects would be highly preferable. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available both continuous studies as well as for out-licensing.

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In December 2024, in collaboration with Uppsala University, PILA PHARMA’s TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept and further establishing it potentially beneficial cardiovascular properties. The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing for the right partner.

Download the press release as PDF here

Malmö, 08 September 2025

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing novel oral drugs based on TRPV1 inhibition for treatment of obesity and diabetes, informs investors and others with interest in the space, of the participation at the 2025 annual congress, hosted by the European Association for Studies of Diabetes (EASD).

PILA PHARMA CEO Gustav H. Gram together with Chief Scientific Officer Dorte X. Gram will travel to Vienna from 16-19 September to attend the annual congress. Here, the objective is to obtain the newest understanding of diabetes and obesity research, care, as well as meet with scientific partners in the space.

As obesity research and care becomes an ever-larger topic in the field of diabetes research, it is of importance to the team to stay up to date and keep close contacts with key stakeholders in the scientific community. The PILA PHARMA team, with its proprietary and uniquely diversified oral TRPV1-inhibitor, expects to engage with potential partners it has previously met with, to update them on the recent successful rights issue and the upcoming in-vivo studies in obesity.

More information about the congress can be found here:
https://www.easd.org/annual-meeting/easd-2025/

More events are subject to being announced! To always stay up to date on events and where to meet us, please see our website: https://www.pilapharma.com/

For more information:  
CEO, Gustav H. Gram
Email: ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia. PILA PHARMA currently focuses on 3 projects within Obesity & Type-2 Diabetes, Erythromelalgia, and Abdominal Aorta Aneurysm. 

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. TRPV1 antagonists have been shown to prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. Furthermore, ANP, a cardiovascular biomarker for heart failure, was highly statistically significantly reduced. During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, clinical phase 2a trial, PP-CT03, is being prepared and will be followed by a clinical trial application submission in the UK. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. 
The Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies as well as clinical studies in humans living with obesity and diabetes.

About Obesity and Diabetes

Obesity is pandemic with estimates of more than 1 billion people suffering from it in 2025. It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate growing demand, and several acquisitions have been done in the obesity segment recently. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
The Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies as well as clinical studies in humans living with obesity and diabetes.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Pila Pharma aims to conduct a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”. There are no current treatments available to patients. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available for out-licensing.                            

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered with Uppsala University. In December 2024, PILA PHARMAs TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept. 
The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing.

Download the press release as PDF here

Malmö, 08 September 2025

PILA PHARMA AB (publ) (FN STO: PILA), an innovative biotech company developing novel oral drugs based on TRPV1 inhibition for treatment of obesity and diabetes, informs investors and others with interest in the space, of the recordings from the last few weeks activities and presentations.

10X Podcast (Recording – Stockholm, Sweden)
Recorded Wednesday 27 August 11:00 CET (ENGLISH)
CEO Gustav H. Gram visit Swedish investment podcast 10X, talking about PILA PHARMA, their significantly oversubscribed rights issue, the plans to develop a new type of obesity drug and diseases like obesity’s role in Longevity. (Segment starts 29:40)

H1 Review – Infront Direkt Studios (Live Broadcast Recording – Stockholm, Sweden)
Recorded Wednesday 27 August 13:30 CET (ENGLISH)
CEO Gustav H. Gram visits Direkt Studios to discuss the company’s report for the first half year of 2025 and the significantly oversubscribed rights issue, and the next steps and plans to develop a new type of obesity drug.

H1 Sitdown Interview – Finwire (Recording – Stockholm, Sweden)
Recorded Thursday 28 August 15:00 CET (ENGLISH)
CEO Gustav H. Gram sits down with Finwire, to comment on the significantly oversubscribed rights issue, and the next steps develop a new type of obesity drug based on the company’s oral TRPV1-inhibitior.

ProInvestor with Helge Larsen (ProInvestor Studio – Denmark)
Recorded Thursday 04 September 11:30 CET (DANISH)
CEO Gustav H. Gram sits down with Helge Larsen from Danish biotech and pharma investment community ProInvestor, to comment on the significantly oversubscribed rights issue, and the future steps to develop a new type of obesity drug based on the company’s oral TRPV1-inhibitior.

More events are subject to being announced! To always stay up to date on events and where to meet us, please see our website: https://www.pilapharma.com/

For more information:  
CEO, Gustav H. Gram
Email: ghg@pilapharma.com

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

PILA PHARMA is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 inhibitors as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation, or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia. PILA PHARMA currently focuses on 3 projects within Obesity & Type-2 Diabetes, Erythromelalgia, and Abdominal Aorta Aneurysm. 

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. TRPV1 antagonists have been shown to prevent glucose intolerance and body weight gain in spontaneously obese pre-diabetic rats. These results pointed to a new and previously undiscovered role of TRPV1 in regulating both blood glucose and body weight. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by in people living with obesity and type 2 diabetes. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. Furthermore, ANP, a cardiovascular biomarker for heart failure, was highly statistically significantly reduced. During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Currently, clinical phase 2a trial, PP-CT03, is being prepared and will be followed by a clinical trial application submission in the UK. The objective of the study is to identify the maximal tolerable dose of XEN-D0501 in people living with obesity and type 2 diabetes and to evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants that should allow for efficacy readouts on reduction of body weight. 
The Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies as well as clinical studies in humans living with obesity and diabetes.

About Obesity and Diabetes

Obesity is pandemic with estimates of more than 1 billion people suffering from it in 2025. It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate growing demand, and several acquisitions have been done in the obesity segment recently. 
Diabetes is a similar spanning pandemic with strong ties to obesity, and with a staggering estimated prevalence of more than 828 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints. 
The Company is now, from autumn 2025, preparing to assess the drug candidate in preclinical obesity studies as well as clinical studies in humans living with obesity and diabetes.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Pila Pharma aims to conduct a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”. There are no current treatments available to patients. 
PILA PHARMA has made a draft clinical development plan for this project, and it is available for out-licensing.

About Abdominal Aorta Aneurysm

Abdominal aorta aneurysm is a cardiovascular disease with ‘ballooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered with Uppsala University. In December 2024, PILA PHARMAs TRPV1 inhibitor, XEN-D0501, was shown to significantly reduce abdominal aorta aneurysm growth in mice, establishing preclinical proof-of-concept. 
The project should be able to progress to proof-of-concept clinical trials and is available for out-licensing.

Download the press release as PDF here