PILA PHARMA publishes interim report for July 1 - September 30, 2021

PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company's interim report for the period July - September 2021. The report can be found on the Company's website: https://pilapharma.com/investors/finansiell-information/


Nine months (1 January - 30 September 2021)

  • Revenue was SEK 0 (0)
  • Operating loss (EBIT) was SEK - 6 180 (- 1 759) thousand
  • Net loss was SEK - 11 785 (- 1 759) thousand
  • Earnings per share, basic and diluted, were SEK - 0,91 (-0,18)
  • Cashflow was SEK - 31 411 (- 3 726) thousand, whereof from ongoing business was SEK- 7 069 (- 5 210) thousand
  • Cash and cash equivalents were at the end of the period SEK 33 318 (340) thousand
  • Equity amounted to SEK 35 717 (7 182) thousand
  • Solidity was 95% (96%)

Third quarter (1 July - 30 September 2021)

  • Revenue was SEK 0 (0)
  • Operating loss (EBIT) was SEK - 3 174 (-294) thousand
  • Net loss was SEK - 5 577 (-294) thousand
  • Earnings per share, basic and diluted, were SEK - 0,39 (-0,03)
  • Cashflow was SEK 26 926 (250) thousand, whereof from ongoing business was SEK - 3 535 (-203) thousand

Significant events in the third quarter (1 July- 30 September 2021)

  • On July 15, 2021, PILA PHARMA's shares were listed on Nasdaq First North Growth Market in Stockholm. The rights issue was fully booked, and the Company received SEK 31,5 million after costs of the issue that amounted to SEK 3,5 million.
  • The warrant PILA PHARMA TO1 had its trade start on July 22
  • A manufacturing agreement was signed with Almac Sciences for the production of the active pharmaceutical ingredient (API), XEN-D0501, for toxicology studies
  • Kickstart meeting with Almac Sciences and first step to the chemical synthesis
  • GMP-certification of a new batch of placebo tablets to match 4 mg XEN-D0501 for use in upcoming clinical trials

Significant events after the quarter

  • The Nobel prize of 2021 in physiology or medicine was partly given to Dr. David Julius, for his discovery of TRPV1 (the chili receptor) and its role in regulation of pain and temperature. The award is an important scientific acknowledgement of crucial bodily functions, which is especially interesting since PILA PHARMA is developing a treatment of diabetes type 2 through a TRPV1 antagonist.

CEO comment:

"The big event of the first half of 2021 was of course the Nasdaq First North listing on July 15. Moreover, PILA PHARMA has received GMP-certification of a new batch of placebo and 4 mg XEN-D0501 tablets which are to be used in our phase 2 study. I am very pleased with this, as it takes several months to produce tablets. It is a big thing to have this done, since, it is one of two bottlenecks prior to sending in the clinical trial application for the phase 2b study. Now remains to conduct the obligatory toxicology studies, as the final bottleneck. For these studies, several kilos of the XEN-D0501 active substance (API) are required. After an evaluation of potential API manufacturers, we signed an agreement with Almac Sciences Limited, UK, and the cooperation proceeds according to plan. We are also in the final phase of contracting a Contract Research Organization (CRO) for the conduct of the toxicology studies. In parallel to this we are evaluating several clinic CRO's in order to choose the one that in the best way can assist us with the phase 2b study.

Malmö, October 26, 2021
The Board of Directors

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 October 26, 2021, at 08:00 CET.

For more information:
Dorte X. Gram, VD
SMS: +46 (0)73 903 6969
[email protected]


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 maximal 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 milligrams 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 skriver avtal med den prekliniska tjänstleveranören ERBC

PILA PHARMA AB (publ) meddelar att ett avtal har tecknats med företaget ERBC avseende genomförandet av PILA PHARMA:s kommande icke-kliniska toxikologiska studier. ERBC är en certifierad pre-klinisk tjänsteleverantör med säte i Frankrike och Italien.

PILA PHARMA AB, announces ink of agreement with pre-clinical service provider ERBC

PILA PHARMA AB (publ) announces that an agreement has been signed with the company ERBC, regarding the conduct of PILA PHARMA's upcoming preclinical safety assessment studies. ERBC is a certified pre-clinical service provider, based in France and Italy.

VD Dorte X. Gram ökar sitt innehav

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.

CEO Dorte X. Gram increases share holding

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

PILA PHARMA offentliggör delårsrapport för 1 juli - 30 september 2021

PILA PHARMA AB (publ) (FN STO: PILA) publicerar i dag bolagets delårsrapport för perioden juli - september 2021 som finns att ta del av på bolagets hemsida: https://pilapharma.com/investors/finansiell-information/

PILA PHARMA publishes interim report for July 1 - September 30, 2021

PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company's interim report for the period July - September 2021. The report can be found on the Company's website: https://pilapharma.com/investors/finansiell-information/

Nobelpris till upptäckten av PILA PHARMA:s ledande princip

På måndagen den 4 oktober meddelande Nobelförsamlingen vid Karolinska Insitutet att 2021 års Nobelpris i fysiologi eller medicin går till David Julius och Ardem Patapoutian, båda vetenskapsmän aktiva vid universitet i USA.

Nobel prize for the discovery of PILA PHARMA's leading principle

On Monday, October 4, the Nobel Assembly at Karolinska Institutet announced that the 2021 Nobel prize in Physiology or Medicine goes to the scientists David Julius and Ardem Patapoutian, both active at universities in the USA.

PILA PHARMA presents at Aktiespararna

PILA PHARMA was listed on Nasdaq First North on July 15. After just over two months, it is time for CEO Dorte X. Gram to make a status update and present how the company is doing with the exciting development of a new drug for type 2 diabetes.

PILA PHARMA presenterar på Aktiespararna

PILA PHARMA noterades på Nasdaq First North den 15 juli. Efter drygt två månader är det dags för VD Dorte X. Gram att göra en lägesuppdatering och presentera hur bolaget ligger till med den spännande utvecklingen av ett nytt läkemedel mot diabetes typ 2.

PILA PHARMA recieves GMP certification of placebo tablets

PILA PHARMA AB (publ) ("PILA PHARMA" or "the Company") announces that the placebo tablets to be used in coming clinical studies have now been manufactured, and GMP (Good Manufacturing Practice) certified.

PILA PHARMA erhåller GMP-certifiering av placebo-tabletter

PILA PHARMA AB (publ) ("PILA PHARMA" eller "Bolaget") meddelar att de placebo-tabletter som ska användas i kommande kliniska studier är tillverkade och GMP-certifierade (Good Manufacturing Process).

PILA PHARMA AB, announces API manufacturing agreement signed

PILA PHARMA AB (PILA) today announces signing of a manufacturing agreement with Almac Sciences Limited, UK, for the production of XEN-D0501 active pharmaceutical ingredient (API). The availability of new API is key for conducting the planned 3 month toxicology studies, that are in turn a prerequisite for initiating the clinical phase 2b study in type-2 diabetics.

PILA PHARMA AB tecknar tillverkningsavtal om API

PILA PHARMA AB ("PILA") meddelar i dag att ett tillverkningsavtal tecknats med Almac Sciences Limited, UK, om produktion av den aktiva farmaceutiska substansen, (API), XEN-D0501. Tillgången till nytt API är avgörande för att genomföra de planerade tremånaders toxikologiska studier som i sin tur är en förutsättning för att initiera de kliniska fas 2b-studierna av PILA:s typ 2-diabetesbehandling.

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