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CEO Gustav H. Gram increases holding in Pila Pharma AB

 Malmö, 15 May 2024

Download the press release as PDF here

Pila Pharma AB (publ) (FN STO: PILA) announces that newly appointed CEO Gustav H. Gram has purchased additional shares. 

The purchases occurred in two tranches: 

Friday May 10th, where 13.756 shares in the company were acquired. 
The shares were purchased at an average price of SEK 2,4615.
___

Monday May 13th, where 8.453 shares in the company were acquired. 
The shares were purchased at an average price of SEK 2,5976.

Mr. Gram’s direct holdings in Pila Pharma AB now amounts to 45.441 shares.

CEO Gustav H. Gram comments: 
“We feel we have a great clinical-stage drug candidate for type 2 diabetes with further possible benefits on cardiovascular disease and potentially obesity. The market has developed immensely around this therapeutic area in recent years and we have a candidate that could potentially disrupt the way cardiometabolic conditions are treated. At a time with globally exploding numbers in patients with lifestyle disease it has never been more important to drive innovation, and the team and myself are adamant to show that we can succeed with bringing forward the first TRPV1-antagonist to proof-of-concept. On this basis I feel it’s important, both as investor and as CEO, to increase my commitment and keep re-investing in the company.”

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

For more information:   

Gustav H. Gram, CEO
ghg@pilapharma.com

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

About PILA PHARMA AB (Publ)

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

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016. TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes and potentially other metabolic disorders like obesity. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg bi-daily for 28 days) – with statistical significance versus placebo – enhanced the endogenous insulin response to oral glucose. 
Furthermore, ANP, a heart failure biomarker, was highly statistically significantly reduced. During 2023 we could report a very good tolerability of XEN-D0501 following 13 weeks administration of very high doses in 2 animal species, and XEN-D0501 can thus progress into longer clinical trials. 
Recently, finances to sponsor a slim phase 2a dose-escalation study was secured and the study is being prepared with the objective of identifying the maximal tolerable dose of XEN-D0501 in overweight or obese people with type 2 diabetes. In addition to this, it’s aimed to further identify (trends for) a reduction of HbA1c, body weight and ANP, a relevant marker of cardiovascular disease.

About Diabetes and Obesity

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

About Erythromelalgia

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

About Abdominal Aorta Aneurism

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

PHARMA AB – CEO Dorte X. Gram increases share holding

Malmö, Sweden, November 16, 2021

Download the press release as PDF here

PILA PHARMA AB (publ) announces that CEO Dorte X. Gram on Monday, November 15, bought 31,570 shares in the company, after placing a bid for 45,000 shares. The shares was purchased at a price of SEK 6.50. The transaction took place through the company Gram Equity Invest, which she owns together with her son Gustav Hanghøj Gram.

Dorte X. Gram is the main owner of PILA PHARMA and after Monday’s acquisition, she owns via companies a total of 5,031,580 shares, which corresponds to 31.25 percent of the votes and capital.

“I am doing this acquisition because I have cash to manage, and at the current price of PILA PHARMA’s share, I see no better investment than this one. I am completely convinced that we at PILA PHARMA have a very potent drug candidate for type 2 diabetes and our development is going according to the plan we have communicated to the stock market “, says Dorte X. Gram.

PILA PHARMA was listed on the Nasdaq First North Growth Market on July 15 this year. The company then offered a unit consisting of one share for SEK 9 and a warrant with the right to buy a new share in May 2022 for SEK 10.

For more information: 

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

About PILA PHARMA

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). The maximum tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and well-tolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective.

PILA PHARMA AB – VD Dorte X. Gram ökar sitt innehav

Malmö, 16 november, 2021

Läs pressmeddelandet som PDF här

PILA PHARMA AB (publ) meddelar att VD Dorte X. Gram under måndagen den 15 november köpt 31 570 aktier i bolaget, efter att ha lagt ett köpbud på 45 000 aktier. Posten köptes till en kurs om 6,50 SEK. Affären har skett genom bolaget Gram Equity Invest som hon äger tillsammans med sin son Gustav Hanghøj Gram.

Dorte X. Gram är sedan tidigare huvudägare i PILA PHARMA och efter måndagens förvärv äger hon via bolag totalt 5 031 580 aktier vilket motsvarar 31,25 procent av röster och kapital.

”Jag gör den här affären eftersom jag har likvida medel att förvalta, och vid nuvarande kurs i PILA PHARMA:s aktie ser jag ingen bättre placering än denna. Jag är helt övertygad om att vi i PILA PHARMA har en mycket potent läkemedelskandidat för typ 2-diabetes och vår utveckling går enligt den plan som vi kommunicerat till aktiemarknaden”, säger Dorte X. Gram.

PILA PHARMA noterades på Nasdaq First North Growth Market den 15 juli i år. Bolaget erbjöd då en unit bestående av en aktie för 9 kronor och en teckningsoption med rätt att köpa en ny aktie i maj 2022 för 10 kronor.

För mer information: 

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

Om PILA PHARMA

PILA PHARMA är ett svenskt bioteknik-företag inom diabetesforskning med säte i Malmö. Bolagets mål är att utveckla en överlägsen ny medicin i tablettform mot typ 2-diabetes. Bolaget äger användarpatent för behandling av diabetes och fetma med TRPV1-antagonister samt immateriella rättigheter för utvcekling av  produktkandidaten XEN-D0501.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en mycket selektiv och potent liten molekyl, en TRPV1-antagonist, som  tidigare utvecklades av Bayer Healthcare och Xention/Ario Pharma.TRPV1-receptorn (även kallad chilireceptorn) har visat sig ha en roll vid smärta och inflammatoriska sjukdomar och tros även spela en roll vid diabetes. PILA PHARMA förvärvade XEN-D0501 i mars 2016 eftersom molekylen i tester visat upp mycket god säkerhet jämfört med andra TRPV1-antagonister i klinisk fas.

TRPV1-antagonister som läkemedelsklass har tidigare förknippats med allvarliga biverkningar som till exempel hypertermi (feber). Den maximala dosen av XEN-D0501 för icke-diabetiska individer har tidigare satts till 4 milligram två gånger dagligen där man noterade god säkerhet men ingen effekt i inte-diabetiska patienter med överaktiv urinblåsa och kronisk hosta. 

I november 2018 kunde PILA PHARMA presentera den första kliniska studien (PP-CT01) där typ 2-diabetespatienter fått XEN-D0501. Studien visade upp god säkerhet upp till 8 milligram vid en enda dos. Det senaste studieresultatet presenterades i september 2020. Studien (PP-CT02) visade att multipla doser av XEN-D0501 (4 mg två gånger dagligen i 28 dagar) också tolererades väl av patienter med typ 2-diabetes. Därutöver visade studien, med statistisk signifikans jämfört med placebo, att XEN-D0501 stimulerar kroppens insulinrespons vid ett oralt intag av glukos (socker). Detta var ett bevis för att den här mekanismen för insulinreglering fungerar (proof of principle).

Om diabetes

Diabetes är en global pandemi. Cirka 463 miljoner människor lider av sjukdomen, vilket motsvarar 8-10 procent av jordens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

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