Regulatoriska pressmeddelanden

Malmö, 27 August, 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company´s interim report for the period January – June 2024. The report can be found on the Company´s website: https://pilapharma.com/investors/finansiell-information/

SUMMARY OF INTERIM REPORT

First Half year (1 January – 30 June 2024)

• Operating income amounted to TSEK 683 (1 097)
• The operating result (EBIT) totalled to TSEK – 4 083 (- 3 601)
• The result for the period totalled to TSEK – 4 086 (- 7 099)
• Earnings per share, basic and diluted, were SEK – 0.17 (- 0.39)
• Cash flow for the first half year totalled to TSEK – 3 411 (- 6 801), whereof the cash flow for the operating activities totalled to TSEK – 3 411 (- 3 304)
• The Company’s cash amounted to TSEK 2 543 (442) in the end of 30 June 2024
• Equity amounted to TSEK 2 575 (2 430)
• The Company’s solvency ratio amounted to 57% (70 %)

Significant events during the Half year (1 January- 30 June 2024)

• On 18 April 2024 the Annual General Meeting were held and the founder, CEO and Director of the Board, Dorte X. Gram was elected new Chairman of the Board and, therefore, with immediate effect, she has stepped down as the Company’s CEO. As working Chairman, she also became new CSO to strengthen Pila Pharma AB’s R&D focus and ensure maximum progress in the development of the company’s product for the treatment of type 2 diabetes and potentially obesity and heart failure which is now in phase 2a. Further, besides reelected Board members Dorte X. Gram and Richard Busellato, two new members were elected to strengthen the Boards financial, strategic and market insight, thus recalibrating the objectives of Pila Pharma AB. Lasse Richter Petersen has been elected Director of the Board due to his extensive background and experience in the international pharmaceutical business including diabetes, and Julie Waras Brogren has been elected Director of the Board due to her extensive experience in developing strategies for advancing pharma assets from development to commercialisation and in finance and investor relations.
• On 19 April 2024 it was announced that new CEO of Pila Pharma AB was Gustav H. Gram, who until then had held the position as Head of Investor Relations. Working within the Life Science Industry and in Pila Pharma AB for more than seven years, Gustav H. Gram has a unique insight and extensive experience into Pila Pharma AB. As such he is already primed for this career advancement and can take over the CEO role immediately. The management team now consists of CEO Gustav H. Gram, CFO Elna Lembrér Åström and CSO Dorte X. Gram.
• On 7 May 2024, the company announced it had been awarded an innovation grant corresponding to a value of SEK 100.000 to sponsor a further developed IP strategy. The innovation grant is sponsored by the Swedish Innovation Agency, Vinnova, and has been handled via the local Incubator at Medeon Science Park in Malmö, Sweden wherefrom the company started its journey.

Significant events after the period

• On 16 July 2024, the Board of Directors of Pila Pharma AB with authorization from the general meeting held on 18 April 2024, resolved to carry out a directed new shares issue with exemption from the preferential rights for existing shareholders at a subscription price of SEK 3,00 per share. At full subscription, the Company was expected to be provided with approximately SEK 10 million before transaction costs.  
• On 24 July 2024, the Company announced it had entered into agreement with a United Kingdom based clinical research organisation, Lindus Health, on supply of  clinical research services to assist with the submission of an clinical trial application for approval for PP-CT03, a phase 2a study in obese people with type-2 diabetes.
• On 25 July 2024, the Company announced a fully subscribed directed issue of approximately SEK 10 million and, that the Board of Directors had resolved to allocate 3.333.334 new shares to the directed shares issue subscribers relative to their payment. The Company was to be provided with approximately SEK 10 million before transaction costs. The transaction costs are estimated to amount to approximately SEK 100.000 (1% of transaction amount).

CEO comments: 

“Now, after almost four months as CEO, I can say with confidence and pride that we have done great progress and good strides forward during the first half of 2024! 
A major highlight is our recent, successful, and fully subscribed directed new shares issue in July! Commitments for a total investment of SEK 10 million were secured. This is extremely positive and confirming of our efforts. It reflects a positive sentiment around PILA PHARMA, but also permits us to rapidly change gears and include obesity as an endpoint in our planned and upcoming Phase 2a trial. We will work relentlessly to increase overall shareholder value. I am very optimistic for our Company due to the way the obesity market has developed, as we see that we can achieve an edge and unique position in the eco system with our unique TRPV1 candidate as a potential novel first-in-class diabetes and obesity treatment. It’s truly very exciting times ahead for PILA PHARMA!” says Gustav H. Gram, CEO

For more information:

Gustav H. Gram, CEO
M: ghg@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 27 August 2024 at 08:00 CEST.

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: info@aqurat.se, T: +46 (0)8 684 05 800 

About PILA PHARMA AB (Publ)

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

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. PILA PHARMA has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. Furthermore, ANP, a cardiovascular biomarker for heart failure, was highly statistically significantly reduced. During 2023 the Company could report very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. 
Currently, the next clinical phase 2a trial, PP-CT03, is being prepared. The objective is identifying the maximal tolerable dose of XEN-D0501 in obese people with type 2 diabetes and evaluate the safety profile following 3 months chronic treatment. In addition to the safety assessment, PP-CT03 will also include sufficient participants  to allow for efficacy readouts on reduction of HbA_1c, body weight and the cardiovascular biomarker ANP.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes. Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints.
Obesity is an even larger pandemic with estimates of more than 1 billion people suffering from it in 2025.  It is most often preceding the development of type 2 diabetes and is a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate growing demand and several acquisitions have been done in the obesity segment recently.

About Erythromelalgia

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

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered with Professor Dick Wågsäter from Uppsala University for investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 24 July 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO:PILA) today announces it has entered into agreement with a United Kingdom based clinical research organisation, Lindus Health, on supply of  clinical research services to assist with the submission of an clinical trial application for approval for PP-CT03, a phase 2a study in obese people with type-2 diabetes.

Lindus Health are experts in metabolic health and proactively seek to reduce clinical trial timelines and increase quality through technology and digital centric approaches to all facets of trial execution. They, furthermore, offer a risk-shared, fixed-price and milestone-based payment model attractive to companies like Pila Pharma.

During the first half of the year, Pila Pharma’s clinical team has prepared the documents needed for regulatory approval and Lindus Health will now compile and submit the clinical trial application.

PP-CT03 is designed to define the maximal tolerable dose of XEN-D0501 as well as assessing the safety and tolerability and to determine any bodyweight effect following 3 months treatment in obese people with type 2 diabetes. Pending approval of the application, the expectation is that recruitment of trial participants to this phase 2a dose-escalation trial can begin in early autumn this year. The trial results are anticipated to pave the way for a phase 2b trial with efficacy endpoints. 

CEO comments:

“We are very pleased to announce our new collaboration with Lindus Health, UK. They have an impressive and smart new model for clinical research work that will both ensure high quality and accelerated timelines. They will now assist us with submission of the clinical trial application in anticipation of our next clinical trial, a trial that could be pivotal for Pila Pharma to define the potential of our novel and potentially “First-in-Class” oral anti-diabetic treatment based on a TRPV1 antagonist with potential effects on cardiovascular disease and obesity” says Gustav H. Gram, CEO of PILA PHARMA.

For more information:

Gustav H. Gram, CEO
Mail: ghg@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 24 July 2024 at 18:00 CEST.

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

About PILA PHARMA AB (Publ)

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

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. 
Furthermore, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. 
Currently, the next clinical phase 2a trial, PP-CT03, is being prepared. The objective is identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes and evaluate the safety profile following 3 months chronic treatment in a smaller subject population before progressing to the pivotal phase 2b trial. In addition to safety assessment, PP-CT03 may identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints.
Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate growing demand and several acquisitions have been done in the obesity segment recently.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Pila Pharma aims to conduct a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

About Lindus Health (by Lindus Health)

Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 30 million Electronic Health Records.

Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management. To date, Lindus Health has delivered more than 90 trials across the US, UK and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

Malmö, 16 July 2024

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.

The Board of Directors of Pila Pharma AB (FN STO: PILA) has, with authorization from the general meeting held on 18 April 2024, resolved to carry out a new issue of up to 3,333,334 shares with excemption from the preferential rights for existing shareholders at a subscription price of SEK 3.00 per share (the “Directed Issue”). In the event the Directed Issue is fully subscribed, the Company will be provided with approximately SEK 10.0 million before transaction costs. The transaction costs are estimated to amount to approximately SEK 100.000.

Shortly, the offer to subscribe will be directed to a limited number of current shareholders and new investors contacted for interest in investing during the previous week 8-10 July 2024. Through the Directed Issue, upon full subscription, the share capital will increase by a maximum of approximately SEK 142,520.48683 and the number of shares by a maximum of 3,333,334. Upon full subscription, a dilution effect of approximately 12.29 percent of the capital and votes in the Company. 

Summary

• In the event of full subscription in the Directed Issue, the Company is provided approximately SEK 10.0 million before transaction costs, which are estimated to amount to approximately SEK 100.000
• The right to subscribe for the new shares shall vest in, with deviation from the shareholders pre-emption rights, a limited number of current shareholders and new investors contacted for interest to invest during 8-10 July 2024 (the “Sounding”) 
• The subscription price is SEK 3.00 per share 
• Subscription through payment for the newly-issued shares shall take place no later than 23 July 2024
• The board of directors shall be entitled to extend the subscription period and the time for payment
• The new shares entitle the holder to a dividend as from the date on which the shares are entered in the share register

Determination of share price in the Directed Issue

• The subscription shareprice was calculated based on the Volume-Weighted Average Price (VWAP) during 15 trading days preceding the Sounding minus a discount of approximately 30% 
• The calculated VWAP during the period 17 June to 5 July was SEK 4,365 per share, see below
• The discount of approximately 30% of the calculated VWAP was calculated and rounded off to be: SEK 1,365 per share
• The maximal dilution will be 12,29% for shareholders not participating in the Directed Issue 

Table 1: Calculated VWAP during 17 June to 5 July 2024 
(Source: Modular Finance Monitor, data from Big XYT)

2024-06-17 -> 2024-07-05 (yyyy-mm-dd)	PILA (SEK)
Average daily turnover	756240
Average daily turnover rel. mcap	0,73%
Average daily shares traded	173248
Number of shares traded	2425471
Average trades per day	161
Number of trades	2256
Average value per trade	4693
High	6,30 SEK.
Low	3,00 SEK.
Volume-Weighted Average Price (VWAP)	4,365 SEK

Background and motive to the Directed Issue

The reason for deviation from the shareholders’ preferential rights are as follows:

There is a need to inject additional capital into the company to finance the company’s continued expansion. During the company’s latest preferential share issue, which took place from November 20, 2023, to December 4, 2023, the share price was 1,50 SEK, and only about 31% of the offering was subscribed, resulting in the raising of fewer funds than desired and several shareholders not exercising their preferential rights. 

Most of the company’s management team was occupied with the share issue for approximately two months, resulting in about SEK 8.1 million with approximately SEK 1 million (about 12.3%) in issue costs. 

The company’s board has therefore determined that the company’s future financing depends on bringing in long-term new owners in addition to the existing shareholders. It is estimated that this share issue can be completed within two weeks’ working time in the management team and that the cost for the new SEK 10 million will be about SEK 100.000 (1%) in issue costs. 

The board therefore believes that a directed share issue is currently the best way to cost-effectively secure financing for the company’s future operations and development in the short and long term. This will benefit all the company’s shareholders. 

Specifically, there is an immediate financing need in connection with the submission of a clinical trial application. There is a need to be able to demonstrate to an ethics committee in the trial country that the company has sufficient funds to conduct the clinical trial. The board has recently approved changes to the design of the upcoming clinical trial, resulting in a greater capital requirement. The change includes an increased number of participants to ensure that any effect on weight reduction in overweight individuals with type 2 diabetes can be demonstrated, rather than just studying the safety of the company’s development substance. A positive outcome from the clinical trial could potentially be extremely value-creating for the company’s shareholders. All shareholders will benefit from the company quickly mobilizing the additional necessary funds now required to avoid delaying the study and the company’s progress unnecessarily.

“Lately, products for regulating body-weight have become major topics of interest globally. Despite not having any confirmatory data yet, our understanding of the scientific literature suggest that a TRPV1 antagonist such as our clinical lead candidate, XEN-D0501, could reduce bodyweight. In order to asses the effect on bodyweight in the coming phase 2a clinical study additional subjects are . We therefore judge that it will be in the interest of all shareholdes, that we can mobilise the needed funding to include more subjects in the trial to be able to approach this significant milestone. 
During the first half of the year, the clinical team in Pila Pharma and it’s many consultants have done a great job in preparing all clinical trial documents to reflect the change of adding additional patients and exploratory endpoints like assessment of bodyweight regulation to the protocol. 
Before regulatory submission, and in order to obtain approval from the Ethics Committee, we have however needed to secure the funds for the larger trial including bodyweight change as an extra exploratory efficacy endpoint. 
I’m pleased, that the Board of Directors has chosen to follow the recommendation of the management team, of aiming at securing the needed SEK 10 million via a quickly carried out directed issue, so that we progress to results as soon as possible .” comments, CEO Gustav H. Gram.

Change in the number of shares and share capital as well as dilution

In the event of full subscription in the Directed Issue, the amount of shares in the Company may increase by 3,333,334, from 23,793,289 to not more than 27,126,623 and the share capital may increase by not more than SEK 142 520,48683, from SEK 1 017 309,14 SEK to not more than SEK 1 159 829,62292, corresponding to a maximum dilution effect of 12.29 percent of the number of shares and votes in the Company.

Advisors

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

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

Authorised auditors elected by the Annual General Meeting are Deloitte AB. 

For more information: 

Gustav H. Gram, CEO                                                                                                
ghg@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 16 July 2024 at 17:00 CEST.

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser. 

Contact: M: ca@aqurat.se – T: +46 (0)8 684 05 800

About PILA PHARMA AB (Publ)

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

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. 
Furthermore, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. 
Currently, the next clinical phase 2a trial, PP-CT03, is being prepared. The objective is identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes and evaluate the safety profile following 3 months chronic treatment in a smaller subject population before progressing to the pivotal phase 2b trial. In addition to safety assessment, PP-CT03 may identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

Diabetes is a globally spanning pandemic with a staggering estimated prevalence of more than 537 million people living with diabetes corresponding to approximately 8-10% of the global adult population. Among these, its estimated that more than approximately 90 % of all diabetics suffer from type-2 diabetes, whilst approximately less than 10% suffers from type-1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from efficacy, safety, and accessibility standpoints.
Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseases. The accumulated effect is a year-long reduction in quality of life for obese people with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people living with obesity. Even long-term, public health costs are expected to be reduced if the clinically negative effects of the obesity pandemic are limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility criteria needed to stimulate growing demand and several acquisitions have been done in the obesity segment recently.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Pila Pharma aims to conduct a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, which is both expensive and with possibility for complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

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, 19 april 2024

Download the press release as PDF here

Following the election yesterday of Dorte X. Gram as new Chairman of the Board of Pila Pharma AB (publ) (FN STO: PILA) she simultaneously has stepped down as CEO. The newly elected Board of Directors has subsequently appointed Gustav H. Gram as new CEO and Dorte X. Gram as Chief Scientific Officer (CSO) of Pila Pharma AB. 

Pila Pharma AB yesterday held its Annual General Meeting where founder, CEO and Director of the Board, Dorte X. Gram was elected new Chairman of the Board and therefore, with immediate effect, she has stepped down as the company’s CEO.

With the purpose of strengthening the market focus and gearing the company as best as possible for growth and to deliver a new development candidate to the industry with a focus on TRPV1, Pila Pharma AB is now appointing a new Chairman of the Board, new members of the Board of Directors and a new CEO and CSO.

New Chairman of the Board is Dorte X. Gram, CEO and founder of Pila Pharma AB. The reorganisation means that Dorte X. Gram now takes over the position as working Chairman of the Board, steps down as CEO and become new CSO to strengthen Pila Pharma AB’s R&D focus and ensure maximum progress in the development of the company’s product for the treatment of type 2 diabetes and potentially obesity and heart failure which is now in phase 2a. 

New CEO of Pila Pharma AB is Gustav H. Gram, who until now has held the position as Head of Investor Relations. Working within the Life Science Industry and in Pila Pharma AB for more than seven years, Gustav H. Gram has a unique insight and extensive experience into Pila Pharma AB. As such he is already primed for this career advancement and can take over the CEO role immediately. The management team now consists of CEO Gustav H. Gram, CFO Elna Lembrér Åström and CSO Dorte X. Gram.

Further, besides reelected Board members Dorte X. Gram and Richard Busellato, two new members have been elected to strengthen the Boards financial, strategic and market insight, thus recalibrating the objectives of Pila Pharma AB. Lasse Richter Petersen has been elected Director of the Board due to his extensive background and experience in the international pharmaceutical business including diabetes, and Julie Waras Brogren has been elected Director of the Board due to her extensive experience in developing strategies for advancing pharma assets from development to commercialisation and in finance and investor relations.

Dorte X. Gram comments:

“To fully leverage the potential of our assets, we need to increase our focus on progressing the coming phase 2a clinical study and in parallel refining our strategy for the place and the path to market of our assets. In this setting, I am confident that I will serve Pila Pharma AB best as Chairman of the Board and in the operations be dedicated to the role of CSO. Gustav has the right internal background from Pila Pharma AB as well as from the industry to ensure continuity of our operations and to define the next strategy for our development portfolio and the company together with the Board and myself. We judge that this new setup is the right one for best securing the success of Pila Pharma AB in the coming phase.“

For more information, please contact:

Dorte X. Gram, Chairman of the Board
M: dxg@pilapharma.com

Or

Gustav H. Gram, CEO
T: +45 2860 6383
Mail: ghg@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 19 April 2024 at 09:45 CEST.

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

About PILA PHARMA AB (Publ)

Pila Pharma is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia.
Pila Pharma currently has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and obesity as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 18 april 2024

Download the press release as PDF here

Pila Pharma AB (publ) höll på torsdagen den 18 april 2024 årsstämma hos MAQS Advokatbyrå, Gibraltargatan 7 i Malmö. Följande huvudsakliga beslut fattades: 

Fastställande av resultat- och balansräkningar
Årsstämman fastställde bolagets resultat- och balansräkning för räkenskapsåret 2023.

Resultatdisposition
Årsstämman beslutade att ingen utdelning ska lämnas för räkenskapsåret 2023.

Beslut om ansvarsfrihet
Årsstämman beviljade styrelsen och verkställande direktören ansvarsfrihet för förvaltningen under räkenskapsåret 2023.

Val och arvodering av styrelse och revisor
Årsstämman beslutade om omval av styrelseledamöterna Dorte Xenia Gram och Richard Busellato samt nyval av Lasse Richter Petersen och Julie Waras Brogren. Till styrelsens ordförande valdes Dorte Xenia Gram.

Årsstämman beslutade att styrelsearvoden per stämmovalda ledamöter ska fördelas enligt följande: styrelsens ordförande 200 000 kronor och ledamot 150 000 kronor. Ledamöter som jobbar för bolaget som konsult med uppgifter som ligger utanför styrelseuppdraget kan fakturera enligt av bolaget godkänd räkning.

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 Niels Raaschou.

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.

Malmö, 18 april 2024

För mer information:

Dorte X. Gram, Styrelsens ordförande
SMS: +46 (0)73 903 6969 
Mail: 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

About PILA PHARMA AB (Publ)

Pila Pharma is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia.
Pila Pharma currently has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and obesity as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö i mars 2024

Download the press release as PDF here

Aktieägarna i PILA PHARMA AB, org.nr 556966-4831 (“PILA PHARMA” eller “Bolaget”), kallas härmed till årsstämma tisdag den 18 april 2024 kl. 15.00 hos MAQS Advokatbyrå, Gibraltargatan 7 i Malmö. Registrering till stämman börjar kl. 14.30.

Anmälan

Aktieägare, som önskar delta vid årsstämman, ska

(i) dels vara införd i den av Euroclear Sweden AB förda aktieboken per onsdagen den 10 april 2024, och, om aktierna är förvaltningsregistrerade, begära att förvaltaren rösträttsregistrerar aktierna senast fredagen den 12 april 2024, samt

(ii) dels ha anmält sitt deltagande antingen via e-post till info@pilapharma.com eller per brev till adressen PILA PHARMA, “Årsstämma 2024”, Norra Vallgatan 72, 211 22 Malmö, senast måndagen den 15 april 202

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 12 april 2024.

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 balans­räkningen,
   (c) ansvarsfrihet för styrelseledamöter och verkställande direktör,
      (i) Dorte Xenia Gram (ledamot, verkställande direktör),
      (ii) Fredrik Buch (ledamot),
      (iii) Lene Andersen Hansen (ledamot),
      (iv) Milan Zdravkovic (ledamot),
      (v) Richard Busellato (ledamot),
      (vi) Søren Weis Dahl (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 bemyndigande för styrelsen att emittera aktier och/eller teckningsoptioner och/eller konvertibler,
16. Beslut om justeringsbemyndigande,
17. 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 2023.

10 Beslut om fastställande av antalet styrelseledamöter och styrelsesuppleanter samt antalet revisorer

Valberedningen föreslår att fem styrelseledamöter, noll styrelsesuppleanter och ett revisionsbolag utses för tiden intill nästa årsstämma.

11 Beslut om fastställande av arvoden till styrelseledamöter och revisorer

Valberedningen föreslår att styrelsearvoden per stämmovalda ledamöter fördelar sig enligt följande: styrelsens ordförande 200 000 kronor och till ledamot 150 000 kronor.

Arvode till revisor föreslås utgå enligt av Bolaget godkänd räkning.

12 Val av styrelse

Valberedningen föreslår omval av styrelseledamöterna Dorte Xenia Gram, Fredrik Buch, Richard Busellato och Søren Weis Dahl samt nyval av Lasse Richter Petersen.

Till styrelsens ordförande föreslås nyval av Dorte Xenia Gram.

Lasse Richter Petersen har över 30 års erfarenhet av läkemedelsbranschen bland annat inom kommersiell utveckling av diabetesprodukter. Han började sin karriär i Eli Lilly där han var regional VD i Norge och sedan “European Marketing Director” inom onkologi. Från och med 2008 hade han olika positioner i Sanofi där han senast var “VP Global Commercial Excellence” och ansvarade för “performance management” (i ett 16B€ bolag) samt “Division Strategic and Planning Process”.

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 Niels Raaschou.

15 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.

16 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 23 793 289. 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 mars 2024

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

Malmö, 20 March 2024

Download the press release as PDF here

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

” The year 2023 was when the global interest in treatments of obesity became a megatrend! This is interesting for us, since I expect that XEN-D0501 will also show effect on body weight reduction and would then, if proven, open up for additional partner opportunities. During 2023, we ourselves shared 2 important results that both supports how unique a molecule XEN-D0501 is. First, we showed very impressive results of the 13-week preclinical safety studies in 2 animal species, where no side-effects were observed even at very high circulating levels of XEN-D0501. Secondly, we shared new results from our latest clinical study in overweight people with type 2 diabetes (PP-CT02) that ANP, a biomarker for heart failure, was highly significantly reduced after just 4 weeks treatment with bidaily doses of 4 mg XEN-D0501. These ANP results could mean that XEN-D0501 may reduce the risk of heart failure in overweight people. Heart failure is one of the causes of premature death in people with diabetes so, if prevented, people could live longer! In the end of 2023, we raised more capital and we’re now actively working on getting all documents ready for the regulatory approval of the next phase 2a trial in overweight persons with type 2 diabetes. says Dorte X. Gram, founder and CEO of Pila Pharma.

For more information, please contact:

Dorte X. Gram, CEO                                                                                              
dxg@pilapharma.com

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

About PILA PHARMA AB (Publ)

Pila Pharma is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia.
Pila Pharma currently has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and obesity as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 20 March 2024

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) has decided to advance the publication of its annual report for the financial year ended 31 December 2023 to the 20 March 2024.

The previous date for the publication of the annual report for the financial year ended 31 December 2023 was the 21 March 2024, but the release is now advanced to the 20 March 2024.

For more information, please contact:

Dorte X. Gram, CEO                                                                                              
dxg@pilapharma.com 

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

About PILA PHARMA AB (Publ)

Pila Pharma is a Swedish biotech company based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as a novel treatment of type 2 diabetes and potentially of other diseases with an inflammatory background, such as the painful rare disease erythromelalgia. The Company owns a TRPV1 asset with data and chemical entities including the development candidate XEN-D0501. Further, the Company owns use-patents covering the use of TRPV1-antagonists as treatment of obesity and diabetes and intends to submit further patents regarding the synthesis, formulation or use of XEN-D0501 or back-up compounds. In July 2022, the Company was awarded orphan drug designation (“Orphan drug designation”) for XEN-D0501 as a treatment for erythromelalgia.
Pila Pharma currently has focus on 3 projects within Diabetes/Obesity (ongoing, next step 3 mo phase 2a trial to assess maximal tolerable dose), Erythromelalgia (on hold pending funding, next step phase 2a PoC on pain during flare ups) and Abdominal Aorta Aneurism (ongoing, preclinical research collaboration).

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and obesity as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Further, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. Recently, finances to sponsor a phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes as well as to identify (trends for) a reduction of HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

Malmö, 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 HbA_1c, body weight and ANP, a relevant marker of CVD.

About Diabetes and Obesity
Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.
Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia
Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. Currently the project is on hold awaiting finances to sponsor a small proof of concept study in persons with erythromelalgia to demonstrate an effect of XEN-D0501 on reducing perceived pain during “flare ups”.

About Abdominal Aorta Aneurism
Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available. In November 2023 a research collaboration was entered on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.