Press release

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.

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.

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.

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.

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.

Date	Time	Place/ Registration
Wed, Nov 8, 2023	6:00 – 8:00 PM CET	Stockholm
Wed, Nov 15, 2023	5:00 – 7:00 PM CET	Copenhagen
Thu, Nov 16, 2023	5:00 – 7:00 PM CET	Göteborg
Mon, Nov 20, 2023	5:00 – 7:00 PM CET	Malmö
Tue, Nov 21, 2023	5:00 – 7:00 PM CET	Aalborg
Wed, Nov 22, 2023	5:00 – 7:00 PM CET	Aarhus
Thu, Nov 23, 2023	5:00 – 7:00 PM CET	Stockholm
Tue, Nov 28, 2023	5:00 – 7:00 PM CET	Copenhagen
Thu, Nov 30, 2023	5:00 – 7:00 PM CET	Helsingborg

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.

Malmö, 22 augusti 2023

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Styrelsen för Pila Pharma AB (publ) har beslutat att ändra kommunikationsspråk till engelska till följd av att bolaget har en internationell styrelse där endast 2 av 4 ledamöter har svensk bakgrund. Bolaget upplever även ett ökat intresse från internationella investerare.

Övergången kommer att genomföras i samband med publicering av bolagets kvartals rapport imorgon, vilket innebär att bolaget endast kommer att kommunicera och förbereda finansiella rapporter och pressreleaser på engelska från och med den 23 augusti 2023.  

Bytet sker med omedelbar verkning.  

Historiska pressmeddelanden på svenska kommer att finnas tillgängliga på hemsidan även framöver.

Årsredovisningen kommer fortsatt att vara på svenska.

För mer information:

Dorte X. Gram, VD
SMS: +46 (0)73 903 6969 
dxg@pilapharma.com

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser, 
Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

Pila Pharma är ett svenskt bioteknikföretag baserat i Malmö. Bolagets mål är att utveckla TRPV1-antagonister som nya behandlingar. Bolaget utvecklar för närvarande XEN-D0501 som ett nytt oralt antidiabetiskt läkemedel. Företaget äger både användarpatent för behandling av diabetes och fetma med TRPV1-antagonister, samt de immateriella rättigheterna för den kliniska utvecklingskandidaten XEN-D0501. FDA i USA beviljade juli 2022 ”Orphan Drug Designation” för XEN-D0501 för behandling av erytromelalgi. Bolaget noterades på Nasdaq First North GM i Stockholm under 2021.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en selektiv, syntetisk potent liten molekyl TRPV1-antagonist som inlicensierades 2016 och, tidigare, utvecklad av Bayer Healthcare, Tyskland och Xention/Ario Pharma, Storbritannien. TRPV1-målet (även kallat “chili-receptorn”) och TRPV1-antagonister som nedreglerar neurogen inflammation, har visat tillämpningar över smärta och inflammatoriska sjukdomar och spelar potentiellt en roll även vid diabetes. Före inlicensieringen hade XEN-D0501 visat sig ha en god säkerhetsprofil hos andra (icke-diabetiker) patientgrupper. Pila Pharma har hittills genomfört två kliniska fas 2a-prövningar (PP-CT01 och PP-CT02), som båda visade att XEN-D0501 tolereras väl av typ 2-diabetespatienter. Vidare visade PP-CT02 att XEN-D0501 (administrerad som 4 mg två gånger dagligen i 28 dagar) – med statistisk signifikans jämfört med placebo – förstärker det endogena insulinsvaret på oralt glukos. Slutliga resultat från nyligen avslutade prekliniska 13-veckors säkerhetsstudier visar att XEN-D0501 tolereras väl hos både “gnagare” och “icke-gnagare” och molekylen kan därmed gå vidare till kliniska studier med upp till 3 månaders varaktighet.

Om diabetes

Diabetes är en global pandemi. Cirka 537 miljoner människor lider av sjukdomen vilket motsvarar uppskattningsvis 8 till10 procent av världens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

Om erytromelalgi

Erytromelalgi är en sällsynt sjukdom där neurogen inflammation spelar en roll i utvecklingen av symtom. Sjukdomen kan orsaka nästan konstant eller episodisk smärta (som sträcker sig från lätt stickningar till svåra brännande känsla) och rodnad i extremiteter. Det drabbar oftast fötterna men kan också förekomma i händer, ansikte eller andra delar av kroppen med både nerver och blodkärl inblandade. Symtom hanteras ofta genom att undvika smärttriggers. Störningen kan vara extremt försvagande, med en betydande negativ inverkan på livskvaliteten och med potential att påverka dödligheten bland unga och självmordsfrekvensen bland vuxna.

Malmö, 1 juni 2023

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Pila Pharma AB (publ) höll på tisdagen den 30 maj årsstämma i bolagets lokaler på Norra Vallgatan 72 i Malmö. Följande huvudsakliga beslut fattades: 

Fastställande av resultat- och balansräkningar
Årsstämman fastställde bolagets resultat- och balansräkning för räkenskapsåret 2022.

Resultatdisposition
Årsstämman beslutade att ingen utdelning ska lämnas för räkenskapsåret 2022.

Beslut om ansvarsfrihet
Årsstämman beviljade styrelsen och verkställande direktören ansvarsfrihet för förvaltningen under räkenskapsåret 2022.

Val och arvodering av styrelse och revisor
Årsstämman beslutade i enlighet med nomineringskommitténs förslag om omval av styrelseledamöterna Dorte Xenia Gram och Fredrik Buch samt nyval av Søren Weis Dahl och Richard Busellato.

Årsstämman beslutade att styrelsearvoden per stämmovalda ledamöter ska fördelas enligt följande: styrelsens ordförande 315 000 kronor och ledamot som inte är anställd i bolaget 157 500 kronor. Ledamot som är anställd i bolaget erhåller ingen ersättning för arbete i egenskap av styrelseledamot.

Till revisor omvalde stämman revisionsbolaget Deloitte AB. Deloitte hade före stämman meddelat att vid omval kommer Maria Ekelund fotsättningsvis vara huvudansvarig revisor. Arvode till revisorn ska utgå enligt av bolaget godkänd räkning.

Valberedning
Årsstämman beslutade att valberedningen ska bestå av Dorte Xenia Gram och Lene Andersen Hansen.

Ny Bolagsordning
Årsstämman beslutade i enlighet med styrelsens förslag att ändra bolagsordningen enligt följande.

Den bedrivna verksamheten ska vara: Bolaget ska direkt eller indirekt genom hel- eller delägt bolag bedriva verksamhet inom utveckling, framställning och försäljning av läkemedel och därmed förenlig verksamhet.

Aktiekapitalet kan uppgå till lägst 780 000 kronor och högst 3 120 000 kronor och att antalet aktier lägst kan uppgå till 18 000 000 och högst 72 000 000. Syftet med ändringen är att kunna emittera flera aktier för att finansiera Bolagets verksamhet.

Emissionsbemyndiganden
Årsstämman belsutade att bemyndiga styrelsen att, vid ett eller flera tillfällen under tiden fram till och med nästa årsstämma fatta beslut om nyemission av aktier och/eller teckningsoptioner och/eller konvertibler mot kontant betalning och/eller med bestämmelse om apport eller kvittning eller eljest med villkor och att därvid kunna avvika från aktieägarnas företrädesrätt.
Emissionerna ska ske till marknadsmässig teckningskurs fastställd av styrelsen i samråd med bolagets finansiella rådgivare, med beaktande av marknadsmässig emissionsrabatt i förekommande fall.

För mer information:

Dorte X. Gram, VD
SMS: +46 (0)73 903 6969 
dxg@pilapharma.com

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser, 
Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

Pila Pharma är ett svenskt bioteknikföretag baserat i Malmö. Bolagets mål är att utveckla TRPV1-antagonister som nya behandlingar. Bolaget utvecklar för närvarande XEN-D0501 som ett nytt oralt antidiabetiskt läkemedel. Företaget äger både användarpatent för behandling av diabetes och fetma med TRPV1-antagonister, samt de immateriella rättigheterna för den kliniska utvecklingskandidaten XEN-D0501. FDA i USA beviljade juli 2022 ”Orphan Drug Designation” för XEN-D0501 för behandling av erytromelalgi. Bolaget noterades på Nasdaq First North GM i Stockholm under 2021.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en selektiv, syntetisk potent liten molekyl TRPV1-antagonist som inlicensierades 2016 och, tidigare, utvecklad av Bayer Healthcare, Tyskland och Xention/Ario Pharma, Storbritannien. TRPV1-målet (även kallat “chili-receptorn”) och TRPV1-antagonister som nedreglerar neurogen inflammation, har visat tillämpningar över smärta och inflammatoriska sjukdomar och spelar potentiellt en roll även vid diabetes. Före inlicensieringen hade XEN-D0501 visat sig ha en god säkerhetsprofil hos andra (icke-diabetiker) patientgrupper. Pila Pharma har hittills genomfört två kliniska fas 2a-prövningar (PP-CT01 och PP-CT02), som båda visade att XEN-D0501 tolereras väl av typ 2-diabetespatienter. Vidare visade PP-CT02 att XEN-D0501 (administrerad som 4 mg två gånger dagligen i 28 dagar) – med statistisk signifikans jämfört med placebo – förstärker det endogena insulinsvaret på oralt glukos. Slutliga resultat från nyligen avslutade prekliniska 13-veckors säkerhetsstudier visar att XEN-D0501 tolereras väl hos både “gnagare” och “icke-gnagare” och molekylen kan därmed gå vidare till kliniska studier med upp till 3 månaders varaktighet.

Om diabetes

Diabetes är en global pandemi. Cirka 537 miljoner människor lider av sjukdomen vilket motsvarar uppskattningsvis 8 till10 procent av världens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

Om erytromelalgi

Erytromelalgi är en sällsynt sjukdom där neurogen inflammation spelar en roll i utvecklingen av symtom. Sjukdomen kan orsaka nästan konstant eller episodisk smärta (som sträcker sig från lätt stickningar till svåra brännande känsla) och rodnad i extremiteter. Det drabbar oftast fötterna men kan också förekomma i händer, ansikte eller andra delar av kroppen med både nerver och blodkärl inblandade. Symtom hanteras ofta genom att undvika smärttriggers. Störningen kan vara extremt försvagande, med en betydande negativ inverkan på livskvaliteten och med potential att påverka dödligheten bland unga och självmordsfrekvensen bland vuxna.

Malmö, 28 april 2023

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Aktieägarna i PILA PHARMA AB, org.nr 556966-4831 (”PILA PHARMA” eller ”Bolaget”), kallas härmed till årsstämma tisdagen den 30 maj 2023 kl. 10.00 på Norra Vallgatan 72 i Malmö. Registrering till stämman börjar kl. 09.30.

Anmälan

Aktieägare, som önskar delta vid årsstämman, ska

1. dels vara införd i den av Euroclear Sweden AB förda aktieboken per måndagen den 22 maj 2023, och, om aktierna är förvaltningsregistrerade, begära att förvaltaren rösträttsregistrerar aktierna senast onsdagen den 24 maj 2023, samt
2. dels ha anmält sitt deltagande antingen via e-post till info@pilapharma.com eller per brev till adressen PILA PHARMA, ”Årsstämma 2023”, Norra Vallgatan 72, 211 22 Malmö, senast torsdagen den 25 maj 2023.

Vid anmälan ska uppges namn, adress, telefonnummer, person- eller organisationsnummer samt antal biträden.

Aktieägare som önskar företrädas av ombud ska utfärda daterad fullmakt för ombudet. Fullmakts­formulär kan erhållas genom Bolaget och finns även tillgängligt på Bolagets hemsida, www.pilapharma.com. Fullmakten i original bör om möjligt i god tid före stämman insändas till Bolaget på ovanstående postadress. Den som företräder juridisk person ska bifoga kopia av aktuellt registreringsbevis eller annan tillämplig handling.

Förvaltningsregistrerade aktier

Aktieägare, som låtit förvaltningsregistrera sina aktier, måste, för att ha rätt att delta på årsstämman, begära att tillfälligt föras in som ägare i aktieboken hos Euroclear Sweden AB. Aktieägaren bör under­rätta förvaltaren härom i god tid så att införing i aktieboken har skett den 24 maj 2023.

Ärenden på stämman

Förslag till dagordning:

1. Stämman öppnas,
2. Val av ordförande vid stämman,
3. Upprättande och godkännande av röstlängd,
4. Val av en eller två justeringspersoner;
5. Prövning om stämman blivit behörigen sammankallad,
6. Godkännande av dagordning,
7. Framläggande av årsredovisning och revisionsberättelse,
8. Anförande av verkställande direktören,
9. Beslut om:
   a) fastställande av resultat- och balansräkning för bolaget,
   b) dispositioner beträffande bolagets vinst eller förlust enligt den fastställda balans-räkningen,
   c) ansvarsfrihet för styrelseledamöter och verkställande direktör,
   • Dorte Xenia Gram (ledamot, verkställande direktör),
   • Lene Andersen Hansen (ledamot),
   • Tyge Korsgaard (ledamot),
   • Fredrik Buch (ledamot),
   • Milan Zdravkovic (ledamot)
10. Beslut om fastställande av antalet styrelseledamöter och styrelsesuppleanter samt antalet revisorer,
11. Beslut om fastställande av arvoden till styrelseledamöter och revisorer,
12. Val av styrelse,
13. Val av revisor,
14. Val av valberedning,
15. Beslut om ny Bolagsordning, 
16. Beslut om bemyndigande för styrelsen att emittera aktier och/eller teckningsoptioner och/eller konvertibler,
17. Beslut om justeringsbemyndigande,
18. Stämmans avslutande.

Beslutsförslag

2. Val av ordförande vid stämman
Föreslås att advokat Krister Hjelmstedt väljs till ordförande på stämman.

3. Upprättande och godkännande av röstlängd
Den röstlängd som föreslås godkännas är den röstlängd som upprättats av ordföranden, baserat på bolagsstämmoaktieboken, och som har kontrollerats av justeringspersonerna.

4. Val av en eller två justeringspersoner
Föreslås till person att justera protokollet Gustav Hanghøj Gram, eller, vid förhinder för honom, den eller de som styrelsen i stället anvisar. Justeringspersonens uppdrag innefattar även att kontrollera röstlängden och att inkomna förhandsröster blir rätt återgivna i stämmoprotokollet.

9 b. Beslut om dispositioner beträffande Bolagets resultat enligt den fastställda balansräkningen
Styrelsen föreslår att stämman beslutar att Bolagets resultat disponeras i enlighet med styrelsens förslag i årsredovisningen. Styrelsen föreslår således att ingen utdelning lämnas för räkenskapsåret 2022.

10. Beslut om fastställande av antalet styrelseledamöter och styrelsesuppleanter samt antalet revisorer
Styrelsen föreslår att fyra styrelseledamöter, noll styrelsesuppleanter och ett revisionsbolag utses för tiden intill nästa årsstämma.

11. Beslut om fastställande av arvoden till styrelseledamöter och revisorer
Nomineringskommittén föreslår att styrelsearvoden per stämmovalda ledamöter fördelar sig enligt följande: styrelsens ordförande 315 000 kronor och ledamot som inte är anställd i Bolaget 157 500 kronor. Ledamot som är anställd i bolaget erhåller ingen ersättning för arbete i egenskap av styrelseledamot.

Arvode till revisor föreslås utgå enligt av Bolaget godkänd räkning.

12. Val av styrelse
Nomineringskommittén föreslår omval av styrelseledamöterna Dorte Xenia Gram och Fredrik Buch samt nyval av Søren Weis Dahl och Richard Busellato.

Søren Weis Dahl har över 25 års erfarenhet av läkemedelsbranschen bland annat som VD för Prophylix AS, Norge, där han bland annat ansvarade för försäljningen av bolagets ”Prophylix pipeline” till den amerikanska särläkemedelsspecialisten Rallybio LLC. Han bor i New York, USA,  sedan 2014 och är VD för DeckTherapeutics, Inc., USA, som utvecklar produkter för behandling av sällsynta barnsjukdomar.

Richard Busellato har över 30 års erfarenhet av finansbranschen genom att förvalta stora finansiella portföljer vid världsledande finansinstitut och hedgefonder så som Moore Capital, Bank of America och Tokai Bank. Sedan 2020 verksam som grundare genom ”Rethinking Choises” – en organisation som fokuserar på klimatförändringarnas finansiella konsekvenser.

13. Val av revisor
Till revisor för tiden intill slutet av nästa årsstämma föreslås omval av revisionsbolaget Deloitte AB (”Deloitte”). Deloitte har meddelat att för det fall Deloitte utses till revisionsbolag kommer Maria Ekelund även fortsättningsvis vara huvudansvarig revisor.

14. Val av valberedning
Föreslås att valberedningen ska bestå av Dorte Xenia Gram och Lene Andersen Hansen.

15. Beslut om ny bolagsordning
Styrelsen föreslår att ändra bolagsordningen enligt följande.

Den bedrivna verksamheten ska vara: Bolaget ska direkt eller indirekt genom hel- eller delägt bolag bedriva verksamhet inom utveckling, framställning och försäljning av läkemedel och därmed förenlig verksamhet.

Aktiekapitalet kan uppgå till lägst 780 000 kronor och högst 3 120 000 kronor och att antalet aktier lägst kan uppgå till 18 000 000 och högst 72 000 000. Syftet med ändringen är att kunna emittera flera aktier för att finansiera Bolagets verksamhet.

16. Beslut om bemyndigande för styrelsen att besluta om nyemission av aktier och/eller tecknings­optioner och/eller konvertibler
Styrelsen i Bolaget föreslår att stämman bemyndigar styrelsen att, vid ett eller flera tillfällen under tiden fram till och med nästa årsstämma fatta beslut om nyemission av aktier och/eller tecknings­optioner och/eller konvertibler mot kontant betalning och/eller med bestämmelse om apport eller kvittning eller eljest med villkor och att därvid kunna avvika från aktieägarnas företrädesrätt.

Emissionerna ska ske till marknadsmässig teckningskurs fastställd av styrelsen i samråd med Bolagets finansiella rådgivare, med beaktande av marknadsmässig emissionsrabatt i förekommande fall.

Syftet med bemyndigandet och skälen till eventuell avvikelse från aktieägarnas företrädesrätt är att emissioner ska kunna ske för finansiering av Bolagets verksamhet, kommersialisering och utveckling av Bolagets produkter och marknader och/eller förvärv av verksamheter, bolag eller del av bolag, och/eller att möjliggöra en breddning av ägarbasen i Bolaget.

För beslut enligt ovan krävs biträde av aktieägare som företräder minst 2/3 av såväl de avgivna rösterna som de vid stämman företrädda aktierna.

17. Beslut om justeringsbemyndigande
Styrelsen, den verkställande direktören eller den styrelsen i övrigt förordnar, ska bemyndigas att vidta de smärre justeringar i vid stämman fattade beslut som kan visa sig nödvändiga för registrering av besluten.

Antalet aktier och röster

Per kallelsedagen uppgår det totala antalet aktier och röster i Bolaget till 18 407 369. Bolaget innehar inga egna aktier.

Upplysningar

Styrelsen och verkställande direktören ska, om någon aktieägare begär det och styrelsen anser att det kan ske utan väsentlig skada för bolaget, lämna upplysningar om dels förhållanden som kan inverka på bedömningen av ett ärende på dagordningen, dels förhållanden som kan inverka på bedömningen av bolagets ekonomiska situation.

Årsredovisning och övriga handlingar

Redovisningshandlingar, revisionsberättelse och övriga handlingar att behandlas på stämman kommer att hållas tillgängliga på Bolagets huvudkontor med adress Norra Vallgatan 72, 211 22 i Malmö, samt på dess hemsida, www.pilapharma.com, senast tre veckor före stämman. Handlingarna skickas också utan kostnad till de aktieägare som begär det och som uppger sin postadress.

Behandling av personuppgifter

För information om hur dina personuppgifter behandlas se https://www.euroclear.com/dam/ESw/Legal/Integritetspolicy-bolagsstammor-svenska.pdf.

Malmö i april 2023

PILA PHARMA AB
Styrelsen

För mer information:

Dorte X. Gram, VD
SMS: +46 (0)73 903 6969 
dxg@pilapharma.com

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser, 
Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

Pila Pharma är ett svenskt bioteknikföretag baserat i Malmö. Bolagets mål är att utveckla TRPV1-antagonister som nya behandlingar. Bolaget utvecklar för närvarande XEN-D0501 som ett nytt oralt antidiabetiskt läkemedel. Företaget äger både användarpatent för behandling av diabetes och fetma med TRPV1-antagonister, samt de immateriella rättigheterna för den kliniska utvecklingskandidaten XEN-D0501. FDA i USA beviljade juli 2022 ”Orphan Drug Designation” för XEN-D0501 för behandling av erytromelalgi. Bolaget noterades på Nasdaq First North GM i Stockholm under 2021.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en selektiv, syntetisk potent liten molekyl TRPV1-antagonist som inlicensierades 2016 och, tidigare, utvecklad av Bayer Healthcare, Tyskland och Xention/Ario Pharma, Storbritannien. TRPV1-målet (även kallat “chili-receptorn”) och TRPV1-antagonister som nedreglerar neurogen inflammation, har visat tillämpningar över smärta och inflammatoriska sjukdomar och spelar potentiellt en roll även vid diabetes. Före inlicensieringen hade XEN-D0501 visat sig ha en god säkerhetsprofil hos andra (icke-diabetiker) patientgrupper. Pila Pharma har hittills genomfört två kliniska fas 2a-prövningar (PP-CT01 och PP-CT02), som båda visade att XEN-D0501 tolereras väl av typ 2-diabetespatienter. Vidare visade PP-CT02 att XEN-D0501 (administrerad som 4 mg två gånger dagligen i 28 dagar) – med statistisk signifikans jämfört med placebo – förstärker det endogena insulinsvaret på oralt glukos. Slutliga resultat från nyligen avslutade prekliniska 13-veckors säkerhetsstudier visar att XEN-D0501 tolereras väl hos både “gnagare” och “icke-gnagare” och molekylen kan därmed gå vidare till kliniska studier med upp till 3 månaders varaktighet.

Om diabetes

Diabetes är en global pandemi. Cirka 537 miljoner människor lider av sjukdomen vilket motsvarar uppskattningsvis 8 till10 procent av världens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

Om erytromelalgi

Erytromelalgi är en sällsynt sjukdom där neurogen inflammation spelar en roll i utvecklingen av symtom. Sjukdomen kan orsaka nästan konstant eller episodisk smärta (som sträcker sig från lätt stickningar till svåra brännande känsla) och rodnad i extremiteter. Det drabbar oftast fötterna men kan också förekomma i händer, ansikte eller andra delar av kroppen med både nerver och blodkärl inblandade. Symtom hanteras ofta genom att undvika smärttriggers. Störningen kan vara extremt försvagande, med en betydande negativ inverkan på livskvaliteten och med potential att påverka dödligheten bland unga och självmordsfrekvensen bland vuxna.

Malmö, 26 april 2023

Läs pressmeddelandet som PDF här

Pila Pharma AB (publ) meddelar att årsredovisningen nu finns tillgänglig på bolagets hemsida: https://pilapharma.com/investors/finansiell-information/ samt som bilaga till detta pressmeddelande.

VD kommenterar:

”Året 2022 blev ett år som präglats av två större aktiviteter i Pila Pharma. 
För det första genomförde vi de inledande två stegen i vår tre-stegsplan som presenterades i vår IPO 2021 och lyckades framgångsrikt att tillverka mer API av XEN-D0501 för att sedan genomföra 13-veckors prekliniska säkerhetsstudier. För det andra sökte vi och fick särläkemedelsstatus (”orphan drug designation”) i USA för XEN-D0501 som behandling av den sällsynta sjukdomen erytromelalgi och etablerade därmed fundamentet för ett andra utvecklingsprojekt i bolaget. Vi går nu emot en mycket spännande period där vi vill ta XEN-D0501 vidare till ”proof of concept” inom både erytromelalgi och diabetes. Båda projekten är väl förberedda och kan, med lite tur och erhållande av tillräcklig finansiering, i båda fall leda till partnerskap med ett större farmabolag”, säger Dorte X. Gram, grundare och VD för Pila Pharma.

För mer information: 

Dorte X. Gram, VD
SMS: +46 (0)73 903 6969
E: dxg@pilapharma.com

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser,
Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

Pila Pharma är ett svenskt bioteknikföretag baserat i Malmö. Bolagets mål är att utveckla TRPV1-antagonister som nya behandlingar. Bolaget utvecklar för närvarande XEN-D0501 som ett nytt oralt antidiabetiskt läkemedel. Företaget äger både användarpatent för behandling av diabetes och fetma med TRPV1-antagonister, samt de immateriella rättigheterna för den kliniska utvecklingskandidaten XEN-D0501. FDA i USA beviljade nyligen ”Orphan Drug Designation” för XEN-D0501 för behandling av erytromelalgi. Bolaget noterades på Nasdaq First North GM i Stockholm under 2021.

Om XEN-D0501 och TRPV1-antagonister

Pila Pharma är ett svenskt bioteknikföretag baserat i Malmö, Sverige. Målet med företaget är att utveckla TRPV1-antagonister som nya behandlingar av t.ex. typ 2-diabetes och av den smärtsamma sällsynta sjukdomen erytromelalgi. Företaget äger både användningspatent för behandling av diabetes och fetma med TRPV1-antagonister, och de immateriella rättigheterna för klinisk utvecklingskandidat XEN-D0501 i mitten av stadiet såväl som reservkandidater. FDA i USA i juli 2022 beviljade Orphan Drug Designation för XEN-D0501 som behandling av erytromelalgi. Bolaget noterades på Nasdaq First North GM i Stockholm i juli 2021.

Om diabetes

Diabetes är en global pandemi. Cirka 537 miljoner människor lider av sjukdomen vilket motsvarar uppskattningsvis 8 till10 procent av världens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

Om erytromelalgi

Erytromelalgi är en sällsynt sjukdom där neurogen inflammation spelar en roll i utvecklingen av symtom. Sjukdomen kan orsaka nästan konstant eller episodisk smärta (som sträcker sig från lätt stickningar till svåra brännande känsla) och rodnad i extremiteter. Det drabbar oftast fötterna men kan också förekomma i händer, ansikte eller andra delar av kroppen med både nerver och blodkärl inblandade. Symtom hanteras ofta genom att undvika smärttriggers. Störningen kan vara extremt försvagande, med en betydande negativ inverkan på livskvaliteten och med potential att påverka dödligheten bland unga och självmordsfrekvensen bland vuxna.

Malmö, April 26, 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) announces that the annual report now is available on the Company´s homepage, https://pilapharma.com/investors/finansiell-information/, and as an attachment to this press release.

CEO comments:

”The year 2022 was a year marked by two major activities in Pila Pharma.

First, we completed the initial two steps of our three-step plan presented in our 2021 IPO and successfully manufactured more API of XEN-D0501 to then complete 13-week preclinical safety studies. Secondly, we applied for and received orphan drug designation in the USA for XEN-D0501 as a treatment for the rare disease erythromelalgia, thereby establishing the foundation for a second development project in the company.

We are now facing a very exciting period where we want to take XEN-D0501 forward to “proof of concept” in both erythromelalgia and diabetes. Both projects are well prepared and, with a bit of luck and obtaining sufficient funding, can in both cases lead to a partnership with a major pharma company”, says Dorte X. Gram, founder and CEO of Pila Pharma.

For more information: 

Dorte X. Gram, CEO
Text: +46 (0)73 903 6969
M: 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 in-licensed 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 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 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 diabetics 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.