Press release

Malmö, 26 June 2024

Download the press release as PDF here

PILA PHARMA today announces it’s participation in and co-sponsorship of the 41st International Symposium on Diabetes and Nutrition, organized by the Diabetes and Nutrition Study Group (DNSG).

The conference is taking place in Uppsala, Sweden from June 27-30. 

PILA PHARMA has been invited to participate by the chairman of the DNSG organizing committee, Professor Ulf Risérus, Uppsala University, Sweden who is a renowned expert in diabetes, nutrition and obesity science.

The conference gathers several hundred international experts on diabetes, nutrition and body-weight regulation. 

The sponsorship amounts to SEK 50.000 as unrestricted funding, i.e. partially covering running costs for the symposium. The aim of PILA PHARMA is to spread awareness among clinical experts on the theory behind using TRPV-1 antagonists to treat diabetes and potentially other metabolic conditions such as obesity and cardiovascular disease.

PILA PHARMA will be represented by CSO and Founder Dr. Dorte X. Gram who will present the hypothesis of targeting the “chili-receptor”, TRPV1 in metabolic disorders. 

For more information:   

Gustav H. Gram, CEO
ghg@pilapharma.com

To stay up to date on news, events & where to meet us, please see our website:
https://www.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 antagonists 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 Type-2 Diabetes, Erythromelalgia, and Abdominal Aorta Aneurism.

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. 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 type 2 diabetic patients. 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 heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. 
Recently, finances to sponsor a slim phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes. In addition to this, it’s aimed to further identify (trends for) a reduction of HbA1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 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.
Obesity is most often preceding the development of type 2 diabetes and 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.

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”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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 on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 11 June 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) announces that it will present tomorrow at the Aktiespararna’s “Store Aktiedagarna” event.

We hereby invite interested parties and investors to follow the event.

It will take place tomorrow, Wednesday 12 June 2024 at 08:00 CET.

The presentation is held physically in Stockholm, Sweden and is also livestreamed. 

You can follow the event, ask questions and sign up at this link:

https://www.aktiespararna.se/aktiviteter/aktiedagarna-i-stockholm-42149

CEO Gustav H. Gram will elaborate on Pila Pharma’s latest developments and how its innovative oral treatment could play a future role in treating diabetes and possibly associated metabolic disorders. It will be conducted in English. 

There will be a Q&A where questions will be addressed.  

For more information:   

Gustav H. Gram, CEO
ghg@pilapharma.com

To stay up to date on news, events & where to meet us, please see our website:
https://www.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 antagonists 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 Type-2 Diabetes, Erythromelalgia, and Abdominal Aorta Aneurism.

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. 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 type 2 diabetic patients. 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 heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. 
Recently, finances to sponsor a slim phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes. In addition to this, it’s aimed to further identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 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.
Obesity is most often preceding the development of type 2 diabetes and 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.

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”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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 on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 23 May 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) announces that it will present today at the Redeye Theme: Diabetes.

We hereby invite interested parties and investors to follow the event.

It will take place today, Thursday 23 May 2024 at 09:30 CEST.

The presentation is held physically in Redeye’s studio in Stockholm, Sweden and is also livestreamed.

You can follow the event, ask questions and sign up at this link:

https://www.redeye.se/events/992747/redeye-theme-diabetes-2

CEO Gustav H. Gram will elaborate on Pila Pharma’s positioning in the diabetes space and how its innovative oral treatment could play a future role in treating diabetes and its associated disorders.

There will be a Q&A where we’ll address questions from Redeye analyst Filip Einarsson!

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

To stay up to date on news, events & where to meet us, please see our website:
https://www.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 antagonists 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 Type-2 Diabetes, Erythromelalgia, and Abdominal Aorta Aneurism.

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. 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 type 2 diabetic patients. 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 heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. 
Recently, finances to sponsor a slim phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes. In addition to this, it’s aimed to further identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 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.
Obesity is most often preceding the development of type 2 diabetes and 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.

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”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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 on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 7 May 2024

Download the press release as PDF here

Pila Pharma AB (publ) (FN STO: PILA) hereby informs that it has been awarded an innovation grant corresponding to a value of SEK 100.000 to sponsor a further developed IP strategy.

The innovation grant is sponsored by the Swedish Innovation Agency, Vinnova, and has been handled via the local Incubator at Medeon Science Park in Malmö, Sweden wherefrom Pila Pharma AB started it’s journey.

Engaged IP partner to develop Pila Pharma AB’s updated IP strategy is the Scandinavian IP boutique firm HØIBERG that has been working with Pila Pharma AB’s founder Dorte X. Gram since 2010. Their first assignment was to help getting the first use-patents issued on using TRPV1 antagonists as treatment of obesity and obesity related diseases and disorders. The issued use-patents to treat obesity and diabetes with antagonists of TRPV1 were the basis for founding Pila Pharma AB in 2014 and still valid. In 2016, Pila Pharma in-licensed a TRPV1 antagonist asset including the clinical development candidate, XEN-D0501. Given that the original chemistry patents have expired, it is essential for Pila Pharma AB to file new patents to protect Pila Pharma AB’s future business. Any new patents filed will be publicly available 18 months after filing.

Jens Viktor Nørgaard, European Patent Attorney, Partner at HØIBERG and member of Pila Pharma AB’s Scientific Advisory Board, comments: “The specific work to be done now during the next maximum 6 months is divided into three segments:  1) Overview of Pila Pharma’s own current IP, 2) Competitor- and freedom-to-operate analyses and 3) Development of updated IP strategy to support the business strategy. We’ve done this kind of work many times and we have a deep understanding of Pila’s status and potential so we look forward to contribute to this important key strategic document“.

Chairman & Chief Scientific Officer in Pila Pharma AB, Dorte X. Gram complements: “We’re very happy to receive this support from Vinnova via Medeon and I’m looking forward to having some extra funds to double check and further develop our IP strategy in Pila Pharma AB. We will be dependent on smart IP for our future commercialization. In late 2023 we decided to move from late to earlier patenting strategy, and we’re thus already in the process of mapping what we can and need to target to IP protect. The timing is spot-on and with the new development of the obesity market as well as our recently shared positive results on a biomarker for heart failure, ANP, we obviously need to update our strategy to cover these two important potential additional markets as well. The new updated IP strategy will hopefully be serving as a future red thread showing a clear and meaningful path forward in our continued development of XEN-D0501“.

For more information:   

Gustav H. Gram, CEO        

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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 22-Apr-2024

Download the press release as PDF here

Pila Pharma AB (publ) (FN STO: PILA) hereby reminds, that the Company has transferred to half-year financial reporting and, thus, the Company’s next financial report is due on 27 August 2024 as previously reported in the Financial Year-End Report 2023.

Please, be reminded that Pila Pharma AB in February released the Financial Year-End Report for 2023 and here, in the CEO word on page 3 communicated that “to reduce internal administrative costs, the Board had resolved to transfer from quarterly to half-year financial interim reporting“. Further, on page 7 under “Upcoming financial information”, the date for the next financial report, “Interim Report, 1 January-30 June 2024” was shown to be 27 August 2024.

 Please, therefore, update your internal records on Pila Pharma AB’s financial reporting dates accordingly.

For more information, please contact:

Gustav H. Gram, CEO
M: ghg@pilapharma.com
T: +45 2860 6383

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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 11 March 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) hereby invites investors to participate in the below scheduled events in the next weeks:

Redeye Online Investor Event (ONLINE / Stockholm, Sweden)
Thursday, 11 April 2024 from 14:00 CET

Dansk Aktionærforening Fyn [INVESTOR DAGEN] (Odense, Denmark)
Tuesday, 16 April 2024 from 15:00 CET

Aktiespararna Online Lifescience Day (ONLINE / Stockholm, Sweden)
Wednesday, 17 April  2024 from 15:00 CET

PILA PHARMA will present the story & investment case around its potentially innovative pill treatment for diabetes, obesity, and obesity related diseases & disorders. Presentations online will be carried out in English.

We hope to see you there!  

Please follow and sign up at the links below:

Redeye Online:https://www.redeye.se/events/972689/investor-forum-online-27
DAF Fyn: https://www.shareholders.dk/lokalforeningsarrangement/investordagen-i-odense
Aktiespararna: https://www.aktiespararna.se/aktiviteter/digital-temadag—life-science-47005

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

For more information:  

Gustav H. Gram, Head of Investor Relations        
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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 21 March 2024

Download the press release as PDF here

Founder and CEO, Dorte X. Gram of PILA PHARMA AB (publ) (FN STO: PILA) comments on recent Company news that she is nominated to become the next Chairman of the Board.

PILA PHARMA earlier today released the call for the company’s Annual General Meeting taking place on 18. April 2024 including the disclosure of nominees to be elected to the Board of Directors during 2024-2025. Founder, CEO and current Director of the Board, Dorte X. Gram is now nominated to become the next Chairman of the Board. 

Dorte X. Gram comments: 

“Given the path lying ahead of PILA PHARMA, I have recently evaluated that I will best serve the Shareholders of PILA PHARMA by becoming the Company’s next Chairman of the Board. At the General Meeting on 18 April 2024, I hope to get the shareholders support for this move and the underlying plan of recalibrating PILA PHARMA for future success. Should I get the support from our shareholders and become the next Chairman of the Board in PILA PHARMA, I will immediately step down as CEO and the company will work to find a new CEO who can secure the company’s future success. Some have told me that I’m the identity of PILA PHARMA and I believe that’s true. But for me PILA PHARMA is also my identity! So, there should be no doubt that I will keep working relentlessly for our Company’s success – and from April hopefully as working Chairman in a strong partnership with a new CEO.“

For more information about Dorte X. Gram, see:
https://pilapharma.com/people/dorte-x-gram

For information on coming investor meetings, see:
https://pilapharma.com/pila-pharma-invites-you-to-investor-meetings/

For other questions, please contact:

Dorte X. Gram, CEO                                                                                              
dxg@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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists
XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity
Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism
Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 19 March 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) hereby invites you to participate in these upcoming investor events:

___________

AktieInfo Investor Evening (Scandic Sydhavnen, Copenhagen, Denmark)
Thursday, 21 March 2024 from 17:30 CET

Dansk Aktionærforening Vestegnen (Café Svanen, Vallensbæk, Denmark)
Tuesday, 26 March 2024 from 17:30 CET

Redeye Online Investor Event (ONLINE / Stockholm, Sweden)
Thursday, 11 April 2024 from 14:00 CET

Dansk Aktionærforening Fyn [INVESTOR DAGEN] (Odense, Denmark)
Tuesday, 16 April 2024 from 15:00 CET

Aktiespararna Online Lifescience Day (ONLINE / Stockholm, Sweden)
Wednesday, 18 April  2024 from 15:00 CET
___________

CEO & Founder Dorte X. Gram will elaborate on the story and motivation of Pila Pharma and its potentially innovative pill treatment for diabetes, obesity, and obesity related diseases & disorders. 

We hope to see you there! 

Please follow and sign up at the links below:

AKTIEINFO:	https://www.aktieinfo.net/investorarangementer/
DAF Vestegnen:	https://www.shareholders.dk/lokalforeningsarrangement/generalforsamling-med-indlaeg-fra-pila-pharma
Redeye Online:	https://www.redeye.se/events/972689/investor-forum-online-27
DAF Fyn:	https://www.shareholders.dk/lokalfo
Aktiespararna:	https://www.aktiespararna.se/aktiviteter/kalender

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

For more information: 

Gustav H. Gram, Head of Investor Relations
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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 01 March 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) hereby invites local Danish investors to participate in the event we organize together with the regional office of Danish Shareholders Association (Dansk Aktionærforening).

It will take place on Monday, 04 March 2024 from 17:30 CET

CEO & Founder Dorte X. Gram will elaborate on the story of Pila Pharma’s and how its potentially innovative pill treatment for diabetes, obesity and other related disorders came to be.

There will be time for questions and answers followed by a small networking session sponsored by Pila Pharma.  

Please follow and sign up at the link below:
https://www.shareholders.dk/lokalforeningsarrangement/moed-pila-pharma-og-formue-nord-og-generalforsamling-daf-trekant

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

Malmö, 01 March 2024

For more information: 

Gustav H. Gram, Head of Investor Relations
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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 28 February, 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) hereby invites you to an online session to discuss and comment the year-end report.

It will take place today February 28^th, 2024 at 2PM CET.

CEO & Founder Dorte X. Gram will elaborate on Pila Pharma’s progress and its innovative pill treatment for diabetes, obesity and other related disorders. 

There will be a Q&A where we’ll address the questions you may have!

Please submit your questions and follow the event at the link:
https://www.stokk.io/app/event/128/q4-and-fy-2023-presentation-and-qa/

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

For more information:   
Gustav H. Gram, Head of Investor Relations        
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 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. 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 has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed 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 obesity as well. 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 PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a 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. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons 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 with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

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. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ 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, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.