PPadmin

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.