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PILA PHARMA INVITES TO INVESTOR MEETING IN KOLDING, DENMARK

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 HbA1c, 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.

PILA PHARMA INVITES TO ONLINE INVESTOR MEETING & EARNINGS CALL

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 28th, 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 HbA1c, 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.

PILA PHARMA PUBLISHES YEAR-END REPORT (1 January – 31 December 2023)

Malmö, 28 February, 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company´s year-end report for the period January – December 2023. The report can be found on the Company´s website: https://pilapharma.com/investors/finansiell-information/

SUMMARY OF YEAR-END REPORT 

Fourth quarter (1 October – 31 December 2023)

  • Revenue was 366 kSEK (413)
  • Operating loss (EBIT) was -1,274 kSEK (-1,951)
  • Net loss was -1,301 kSEK (-4,015)
  • Earnings per share, basic and diluted, were -0.06 SEK (-0.23)
  • Cashflow was 4,807 kSEK (2,121), whereof from ongoing business was -2,255 (- 1,827) 

Twelve months (1 January – 31 December 2023)

  • Revenue was 1,463 kSEK (1,881)
  • Operating loss (EBIT) was -6,393 kSEK (-8,890)
  • Net loss was -9,930 (-26,777)
  • Earnings per share, basic and diluted, were -0.47 SEK (-1.55)
  • Cashflow was -1,289 kSEK (-20,966), whereof from ongoing business was -4,854 kSEK (-9,091)
  • Cash and cash equivalents were at the end of the period 5,954 kSEK (7,243)
  • Equity amounted to 6,661 kSEK (9,529)
  • Solvency ratio was 79% (88%)

Significant events in the fourth quarter (1 October- 31 December 2023)

  • On 25 October 2023, the Board of Directors of Pila Pharma resolved, with authorization from the annual general meeting held on 30 May 2023, to carry out a new issue of up to 17,487,000 shares with pre-emption rights for existing shareholders at a subscription price of SEK 1.50 per share, which, in the event the Rights Issue was fully subscribed, would provide the Company with approximately SEK 26.2 million before transaction costs (the “Rights Issue“). In connection thereto, it was also resolved to request that the convertible loans of SEK 1.5 million, raised in August 2023, including accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, were to be converted to shares in the Rights Issue by way of set-off.
  • On 16 November 2023, Pila Pharma published an information memorandum regarding the Rights Issue.
  • On 26 November, Pila Pharma announced it had entered a research collaboration with the Research Group of Professor Dick Wågsäter, Uppsala University, Sweden on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.
  • On 5 December 2023, Pila Pharma announced the outcome in the Rights Issue. The Rights Issue was subscribed for by approximately 30.80 percent and provided the Company with approximately SEK 8,1 million before issue costs, including the conversion of the convertible loans and accrued interest of SEK 1,539,698.63 which were converted to shares in the Rights Issue by way of set-off.

Significant events after the quarter

  • On 16 January 2024, Pila Pharma announced that Pila Pharma and its CEO, Dorte X. Gram, was selected to participate cost-free in a scale-up program “10 X Health” partially sponsored by the European Regional Development Fund and organised by the SmiLe Incubator and Medicon Village in Lund, Sweden.

CEO comments:
“In 2023, our main operational achievement was to demonstrate a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species. The good results were fundamental for us to further progress XEN-D0501 into longer clinical trials. However, the most significant results we shared in 2023, were the late-incoming results from our last 4-week trial in overweight and obese persons with diabetes (PP-CT02).
This showed that XEN-D0501 with highly statistical significance reduced the heart failure biomarker ANP, suggesting that XEN-D0501 may reduce the risk of premature cardiovascular death. The cardiovascular disease Heart Failure is a major cause of death in diabetes.

In early December the Board announced the outcome of a rights issue of approximately SEK 8.1 million that was below what we planned to raise, but enough to finance the initialisation of the next diabetes trial. I really look forward to the coming period where we will step further down the clinical development path. After New Year we have adjusted the trial design to a more cost-effective version whilst still answering certain key questions: 1) is there a good 3-month safety and tolerability of XEN-D0501 and 2) is there then a trend for reductions of blood glucose and body weight?” says Dorte X. Gram.

For more information:

Dorte X. Gram, CEO                                                                                             
Text: +46 (0)73 903 6969                                                                
M: dxg@pilapharma.com                                                                

This information is such information that PILA PHARMA AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on 28 February 2024 at 08:00 CET.

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 HbA1c, 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.

PILA PHARMA HAS BEEN SELECTED TO PARTICIPATE IN THE REGIONAL SCALE-UP PROGRAM “10 X HEALTH”

Malmö, 16 January 2024

Download the press release as PDF here

Pila Pharma and its CEO, Dorte X. Gram, has been selected to participate cost-free in a scale-up program “10 X Health” partially sponsored by the European Regional Development Fund and organised by the SmiLe Incubator and Medicon Village in Lund, Sweden.

Medicon Village and the SmiLe Incubator in Southern Sweden have – with the support of the European Regional Development Fund – initiated a scale-up program (“10 X Health”) for established, smaller life science companies to help accelerate their growth. 

We’re strategically working on supporting the life-science sector in our region to support future regional economic growth. The new “10 X Health” is completely focused on our regional life science companies that have successfully passed the start-up phases and the hope is to consolidate their skills required for them to accelerate their growth further“, says Ulrika Ringdahl, Deputy CEO of Smile Incubator

The program extends over 11 months and will cover several key topics for growth: 1) Self-assessment for scale-up, 2) Strategy, 3) People, 4) Market, 5) Digitalisation and new technologies, 6) Capital and finance, 7) Sustainability, 8) Regulatory Acceleration and 9) Ready to grow 10 X more.

CEO Dorte X. Gram comments: “I’m pleased, that Pila Pharma has been selected to be one out of seven regional life-science companies to enjoy this financial and regional support of the “10 x Health” program and the timing is really perfect. We’re currently heading towards the last small clinical trial with XEN-D0501 in obese persons with diabetes, before we will enter a phase with bigger clinical studies with a need to scale-up our business”.

Malmö, 16 January 2024

For more information:

Dorte X. Gram, CEO
Text: +46 (0)73 903 6969
Mail: 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021. 

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/ Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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. 

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.

About “10 X Health”

The scale-up program “10 X Health” is a new program initiated by Medicon Village and SmiLe Incubator in Lund, Sweden. Seven life science companies have been selected to participate with the aim of strengthen the skills of these established companies to accelerate their growth. In the scale-up phase, there are many challenges and the program is adapted to specific needs in this phase, which include business acumen, financing, technology, internationalization, organization and effective leadership. The program is part-financed over three years by the European Regional Development Fund.

Pila Pharma AB announces outcome in the rights issue

Malmö, 5 December 2023

Download the press release as PDF here

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) announces today, 5 December 2023, the outcome in the Company’s rights issue of shares announced on 25 October 2023 (the “Rights Issue”). The Rights Issue was subscribed for by approximately 30.80 percent and provides the Company with approximately SEK 8,1 million before issue costs.

On 25 October 2023, Pila Pharma announced that the board of directors of the Company, with authorization from the annual general meeting held on 30 May 2023, had resolved upon the Rights Issue of approximately SEK 26.2 million.  The subscription price was SEK 1.50 per share and the total number of shares offered in the Rights Issue amounted to 17,487,000.

Outcome in the Rights Issue

The subscription period for the Rights Issue ended on 4 December 2023. The final outcome shows that 4,546,434 shares have been subscribed for with the support of subscription rights, corresponding to approximately 84.4 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 839,486 shares without support of subscroiption rights, corresponding to approximately 15.6 percent of the Rights Issue. Consequently, in total 5,385,920 shares were subscribed for the the Rights Issue.

In August 2023, Pila Pharma entered into convertible loan agreements under which the Company raised convertible loans of in total SEK 1.5 million from current shareholders. The convertible loans bore an interest rate of 10 percent per. The outstanding principal amount of the convertible loans of SEK 1,5 million together with accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, were, at the request of the Company, converted to shares within the Rights Issue by way of set-off.

Through the Rights Issue, the Company will receive approximately SEK 8.1 million before deduction of issue costs, which are estimated to amount to a maximum of SEK 1 million.

Comment from Dorte X.Gram, CEO

Although the result of the rights issue is obviously below what we planned to raise, I’m pleased to note that many current shareholders have reinvested (getting to about 31% subscription even though we did not include guarantors in the issue) including Vimpu Intressenter who signed pro rata, suggesting strong support to our new aim of developing an “obesity pill”. The raised amount is enough for us to go ahead with the diabetes/obesity project without compromising the quality of the main outcome. The orphan project within erythromelalgia, however, is put on hold until further notice. I now look forward to get the study in obese persons with diabetes done so we can demonstrate, that higher doses of XEN-D0501 when dosed for 3 months is well tolerated with an expected trend for body weight loss. Positive results should lead to new patents and progressing XEN-D0501 as a future obesity treatment.”, says Dorte X. Gram, CEO of Pila Pharma.

Allocation of shares subscribed for without the support of subscription rights

Allocation of shares subscribed for without the support of subscription rights has taken place in accordance with the principles set out in the memorandum that the Company published on 16 November 2023, due to the Rights Issue (the “Memorandum”). Notification of such allocation is announced separately through settlement notes. Nomineeregistered shareholders receive notification of allotment in accordance with instructions from the respective nominee.

Shares, share calital and dillution

Through the Rights Issue, the total number of shares in the Company increase by 5,385,920 shares, from 18,407,369 shares to 23,793,289 shares, and the share capital increase by SEK 230,281.136091, from SEK 787,028 to SEK 1,017,309.136091, corresponding to a dilution effect of 22.64 percent of the total number of shares in the Company.

Trading in paid subscribed shares (“BTA”)

Trading in BTA takes place until the conversion of BTA into shares after the Rights Issue has been registered with the Swedish Companies Registration Office. Registration with the Swedish Companies Registration Office is expected to take place during week 51, 2023.

Advisors

MAQS Advokatbyrå KB, reg. no. 916539-0692 (“MAQS Advokatbyrå”) is the legal advisor to the Company in connection with the Rights Issue. 

Nordic Issuing AB, reg. no. 559338-2509 (“Nordic Issuing”) is the issuing agent in connection with the Rights Issue. 

For more information: 

Dorte X. Gram, CEO
dxg@pilapharma.com 

This information is such information that PILA PHARMA AB (publ) is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on 5 December 2023 at 19:30 CET.

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 thecompany is to develop TRPV1 antagonists as novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the midstage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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.

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.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. 

No shares or other securities in Pila Pharma have been registered, and no shares or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the “Securities Act”) or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or the regulations of the Nasdaq First North Growth Market for issuers.

THE ONGOING RIGHTS ISSUE IN PILA PHARMA HAS ENTERED ITS LAST SUBSCRIPTION WEEK AND WILL END MONDAY 4 DECEMBER. THE LAST DAY OF TRADING SUBSCRIPTION RIGHTS IS WEDNESDAY 29 NOVEMBER

Malmö, 29 November 2023

Download the press release as PDF here

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) hereby informs that the subscription period in Company’s rights issue of shares that was initiated on 20 November 2023 has entered its second subscription week and and will run until Monday 4 December 2023. The last day of trading subscription rights is today, Wednesday 29 November 2023. The rights issue seeks to raise approximately SEK 26.2 million before transaction costs (the “Rights Issue”) to sponsor 2 clinical phase 2a trials within pain, diabetes and obesity.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Pila Pharma on 16 November 2023 published an information memorandum regarding the Company’s ongoing Rights Issue and it available on the Company’s website (https://pilapharma.com/rights-issue-2023/) and on Nordic Issuing’s website (https://nordic-issuing.se/en/ongoing-transactions/pila-pharma-ab-2/) wherefrom online subscription is now also possible until and including 4 December 2023.

Summary of the terms and conditions for the Rights Issue

  • In the event of full subscription in the Rights Issue, the Company is provided approximately SEK 26.2 million before transaction costs, which are estimated to amount to approximately SEK 1 million.
  • Anyone who is registered as a shareholder in Pila Pharma in the shareholders’ register on the record date 16 November 2023 will receive one (1) subscription right for each share owned in the Company and twenty (20) subscription rights entitle the holder to subscribe for nineteen (19) new shares.
  • The subscription price is SEK 1.50 per share.
  • The subscription period for subscription of shares will take place from and including 20 November 2023 until and including 4 December 2023. After the end of the subscription period, unexercised subscription rights become invalid and lose their value. Unexercised subscription rights will be deleted from each shareholder’s securities account without special notification from Euroclear. 
  • The Board of Directors of the Company reserves the right to extend the subscription period. A possible extension will be announced by the Company through a press release no later than 4 December 2023.
  • Received subscription rights must either be used for subscription no later than 4 December 2023 or be sold no later than 29 November 2023 in order not to expire worthless. 
  • For the full terms and conditions and instructions for the Rights Issue, please refer to the information memorandum.

Advisors

MAQS Advokatbyrå KB is the legal advisor to the Company in connection with the Rights Issue. Nordic Issuing AB is the issuing agent in connection with the Rights Issue. 

For more information: 

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 novel treatments of e.g. type 2 diabetes or ofthe painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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.

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.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. 

No shares or other securities in Pila Pharma have been registered, and no shares or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the “Securities Act”) or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or the regulations of the Nasdaq First North Growth Market for issuers.

PILA PHARMA WILL PRESENT AT “STORA AKTIEDAGARNA” IN STOCKHOLM TOMORROW, 27 NOVEMBER 2023 AT 8:00 CET

Malmö, 26 November 2023

Download the press release as PDF here

On Monday 27 November 2023 at 8:00 CET, the CEO of Pila Pharma will present the company’s business and ongoing rights issue at the event “Stora Aktiedagarna” in Stockholm. The presentation can be viewed onsite or via live stream.

Adress:  Birger Jarlsgatan 61 A, Stockholm

Live stream: https://invitepeople.com/public/events/af87c9f59a/pages/aa3d4312cf

No registration is needed for the digital live stream and the video of the presentation will be available after the event at Aktiespararnas Youtube-kanal as well as on Pila Pharmas homepage.

Questions can be send via text to 0046 (0)79-347 98 45.

For more information:

Dorte X. Gram, CEO                                                                                             
Text: +46 (0)73 903 6969                                                                
Mail: 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The Company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The Company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/ Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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.

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.

PILA PHARMA ANNOUNCES PRECLINICAL RESEARCH COLLABORATION

Malmö, 26 November 2023

Download the press release as PDF here

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) has entered a research collaboration with the Research Group of Professor Dick Wågsäter, Uppsala University, Sweden (the “Research Group”) on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

The hypothesis is that XEN-D0501 may reduce the chronic inflammation that leads to cardiovascular disease including aorta dilatation. Thus, XEN-D0501 could potentially prevent the lethal end-stage development of Abdominal Aorta Aneurism.

This collaboration will cover a small study in mice that the Research Group will sponsor whilst Pila Pharma sponsors XEN-D0501. The results will be split in that the Research Group gets the publication right (after patenting) and Dick Wågsäter has agreed to transfer to Pila Pharma the patent rights against that Pila Pharma sponsors any resulting patents.

The aim of this new collaboration is to establish a pre-clinical proof-of-concept of an effect of XEN-D0501 on preventing progression of Abdominal Aorta Dilatation in mice.

Professor Dick Wågsäter comments:
One of my professional goals is to search for a suitable treatment of Abdominal Aorta Aneurism!  It is a deadly cardiovascular disease that accounts for 1% of deaths in men over 65 years of age and where no drugs are currently available for prevention or treatment.
So, I’m really pleased that this collaboration with Pila Pharma can finally start. 
If the results of this mouse study will be positive, further clinical development plans for the assessment of XEN-D0501 in humans with Abdominal Aorta Aneurism have already been discussed to further pave the way for XEN-D0501 as the missing preventive treatment. 

CEO Dorte X. Gram comments:                                                       
We’re currently developing XEN-D0501 as an affordable treatment of diabetes and obesity with multiple beneficial effects including the reduction of cardiovascular disease risk.
Our own clinical results on the latter will not be available for long, so I welcome this mouse study as it might provide data on a cardiovascular function effect of XEN-D0501. 

More-over, I have recently experienced the disease of Abdominal Aorta Aneurism in my close family, and I know how frustrating it is to know that stent surgery is the only option for short term survival. In my part of the world, such surgery is available but not without risks. In other parts of the world, it’s not available due to high cost. 
Therefore, contributing to an affordable prevention also of this serious disease has become a personal motivation to me. Hopefully it can save more lives and further increase wellbeing and longevity in man.

For more information:

Dorte X. Gram, CEO                                                                                             
Text: +46 (0)73 903 6969                                                                
Mail: dxg@pilapharma.com

This information is such information that PILA PHARMA AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on 26 November 2023 at 21:45 CET.

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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The Company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The Company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/ Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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.

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.

PILA PHARMA PUBLISHES INFORMATION MEMORANDUM

Malmö, 17 November 2023

Download the press release as PDF here

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE SUBJECT TO LEGAL RESTRICTIONS. SEE ALSO THE SECTION “IMPORTANT INFORMATION” BELOW.

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) hereby informs that an information memorandum regarding the Company’s forthcoming rights issue of shares of not more than approximately SEK 26.2 million before transaction costs (the “Rights Issue”) was published yesterday night, 16 November 2023.

Pila Pharma hereby informs that an information memorandum regarding the Company’s forthcoming Rights Issue was published yesterday night, 16 November 2023. The information memorandum is available on the Company’s website (https://pilapharma.com/rights-issue-2023/) and on Nordic Issuing’s website (https://nordic-issuing.se/en/ongoing-transactions/pila-pharma-ab-2/) wherefrom online subscription is possible from 20 November to 4 December 2023, both days included.

Summary of the terms and conditions for the Rights Issue

  • In the event of full subscription in the Rights Issue, the Company is provided approximately SEK 26.2 million before transaction costs, which are estimated to amount to approximately SEK 1 million.
  • Anyone who is registered as a shareholder in Pila Pharma in the shareholders’ register on the record date 16 November 2023 will receive one (1) subscription right for each share owned in the Company and twenty (20) subscription rights entitle the holder to subscribe for nineteen (19) new shares.
  • The subscription price is SEK 1.50 per share.
  • The subscription period for subscription of shares will take place from and including 20 November 2023 until and including 4 December 2023. After the end of the subscription period, unexercised subscription rights become invalid and lose their value. Unexercised subscription rights will be deleted from each shareholder’s securities account without special notification from Euroclear. 
  • The Board of Directors of the Company reserves the right to extend the subscription period. A possible extension will be announced by the Company through a press release no later than 4 December 2023.
  • Received subscription rights must either be used for subscription no later than 4 December 2023 or be sold no later than 29 November 2023 in order not to expire worthless. 
  • For the full terms and conditions and instructions for the Rights Issue, please refer to the information memorandum.

Advisors

MAQS Advokatbyrå KB is the legal advisor to the Company in connection with the Rights Issue. Nordic Issuing AB is the issuing agent in connection with the Rights Issue. 

For more information: 

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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

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.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. 

No shares or other securities in Pila Pharma have been registered, and no shares or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the “Securities Act”) or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or the regulations of the Nasdaq First North Growth Market for issuers.

Pila Pharma invites to After-Work investor meetings

Malmö, 7 November 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) hereby invites you to an exciting evening of conversation when we host an after-work investor event near you!

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

In the Q&A we’ll address the market for obesity & weight loss drugs, Pila’s position going forward, our on-going upcoming rights issue and any other questions you may have!

Pila Pharma will sponsor a few drinks per attendee.

DateTimePlace/ Registration
Wed, Nov 8, 20236:00 – 8:00 PM CETStockholm
Wed, Nov 15, 20235:00 – 7:00 PM CETCopenhagen
Thu, Nov 16, 20235:00 – 7:00 PM CETGöteborg
Mon, Nov 20, 20235:00 – 7:00 PM CETMalmö
Tue, Nov 21, 20235:00 – 7:00 PM CETAalborg
Wed, Nov 22, 20235:00 – 7:00 PM CETAarhus
Thu, Nov 23, 20235:00 – 7:00 PM CETStockholm
Tue, Nov 28, 20235:00 – 7:00 PM CETCopenhagen
Thu, Nov 30, 20235:00 – 7:00 PM CETHelsingborg

Full overview of meetings can be found at the Company’s website: https://pilapharma.com/investor-events/

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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes 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. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

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. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

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.

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