Regulatoriska pressmeddelanden

Malmö, 24 August 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA), (“Pila Pharma” or the “Company”) announces a correction regarding the press release “PILA PHARMA announces capital infusion via convertible loans” which was published earlier today, 24 August 2023. The correction refers to the fact that the press release lacked significant information on the structure and terms of the convertible loans entered by Pila Pharma.

The following text has now been included in the corrected version of today’s press release on Pila Pharma’s entering of convertible loans to sponsor submission of 2 new XEN-D0501 trial applications:

The convertible loans amount to a total of SEK 1.5 M and shall be payable within 3 business days from today. The lenders are long-term shareholders Vimpu Intressenter AB, AnMi Förvaltning AB, AB Hans Ols Bröd, Magnus Hackman and CO2 Balance AS.

The loans bear an interest rate of 10 per cent per annum and interest shall be capitalized annually on 31 December each year.

The outstanding principal amount of the loans together with accrued interest may, at the request of Pila Pharma, be repaid through conversion into shares in Pila Pharma in connection with a financing round on or before 15 February 2024, and carry the same terms as in the financing round with a conversion price per share corresponding to the subscription price applied and be converted into the same class of shares as issued in the financing.

Further, the loans may be converted at the request of the individual lenders in the case of a Capital Deficiency Risk Situation , or, in the case that no financing has taken place on or before 15 February 2024 and the Company has entered into a partnership with an external entity, where conversion shall be of the loan in full and not partly and be made no later than 31 March 2024 at the individual lender’s requests on or before 15 February 2024 at a pre-money valuation of SEK 2 per share.

In case conversion has not taken place or the lenders have not re-quested conversion, on or before 15 February 2024, then the loan (or remaining loan amount as applicable) and accrued interest shall be repaid in cash no later than 31 March 2024.

The correct press release is given below:

PILA PHARMA announces capital infusion via convertible loans. 

The board of Pila Pharma AB (publ) has decided to immediately secure additional funds via convertible loan agreements to sponsor the next clinical trial applications.

The convertible loans amount to a total of SEK 1.5 M and shall be payable within 3 business days from today. The lenders are long-term shareholders Vimpu Intressenter AB, AnMi Förvaltning AB, AB Hans Ols Bröd, Magnus Hackman and CO2 Balance AS.

The loans bear an interest rate of 10 per cent per annum and interest shall be capitalized annually on 31 December each year.

The outstanding principal amount of the loans together with accrued interest may, at the request of Pila Pharma, be repaid through conversion into shares in Pila Pharma in connection with a financing round on or before 15 February 2024, and carry the same terms as in the financing round with a conversion price per share corresponding to the subscription price applied and be converted into the same class of shares as issued in the financing.

Further, the loans may be converted at the request of the individual lenders in the case of a Capital Deficiency Risk Situation , or, in the case that no financing has taken place on or before 15 February 2024 and the Company has entered into a partnership with an external entity, where conversion shall be of the loan in full and not partly and be made no later than 31 March 2024 at the individual lender’s requests on or before 15 February 2024 at a pre-money valuation of SEK 2 per share.

In case conversion has not taken place or the lenders have not re-quested conversion, on or before 15 February 2024, then the loan (or remaining loan amount as applicable) and accrued interest shall be repaid in cash no later than 31 March 2024.

The tablets made in 2021 have recently been cleared by the manufacturer for use in phase 1 or 2a studies and Pila Pharma, therefore, will use the new capital to immediately continue the clinical development of XEN-D0501 by preparing and submit 2 clinical trial applications for regulatory approval.

In diabetes/ obesity, we plan to conduct a phase 2a dose finding trial of 3-month treatment duration in obese persons with diabetes to explore safety and efficacy of XEN-D0501 on diabetes, obesity and cardiovascular markers in a wider dose-span than previously tested before progressing to a subsequent pivotal confirmatory phase 2b trial. 

In pain/ erythromelalgia, we plan to conduct a phase 2a “proof-of-concept” trial to demonstrate the safety and efficacy of XEN-D0501 on relieving pain during “flare ups” in persons with erythromelalgia before progressing to a subsequent pivotal phase 2/3 registration trial.

CEO comments

I’m really pleased, that some of our long-term investors have decided to again support us by providing these convertible loans so we can progress our clinical plans immediately.
This should allow us to submit the applications during the autumn and hopefully before Christmas get regulatory approval to conduct both trials. In that case, the trials can be initiated after New Year given further funding has been secured by then.

“When in doubt just take the next small step”
(Paulo Coelho)

For more information: 

Dorte X. Gram, CEO
Text: +46 (0)73 903 6969
Mail: 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 24 August 2023 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

The discovery of TRPV1 and its role in pain and neurogenic inflammation was awarded the 2021 Nobel Prize in Medicine or Physiology.

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults.

Malmö, 24 August 2023

Download the press release as PDF here

The board of Pila Pharma AB (publ) has decided to immediately secure additional funds via convertible loan agreements to sponsor the next clinical trial applications.

With the recent news that our tablets manufactured in 2021 are cleared by the manufacturer for use in phase 1 or 2a studies, Pila Pharma is now ready to continue the clinical development of XEN-D0501.

The next step will be to submit 2 clinical trial applications for regulatory approval.

The new capital infusion will fund this work that will be resumed asap.

In diabetes/ obesity, we plan to conduct a phase 2a dose finding trial of 3-month treatment duration in obese persons with diabetes to explore safety and efficacy of XEN-D0501 on diabetes, obesity and cardiovascular markers in a wider dose-span than previously tested before progressing to a subsequent pivotal confirmatory phase 2b trial. 

In pain/ erythromelalgia, we plan to conduct a phase 2a “proof-of-concept” trial to demonstrate the safety and efficacy of XEN-D0501 on relieving pain during “flare ups” in persons with erythromelalgia before progressing to a subsequent pivotal phase 2/3 registration trial. 

The loans with an annual interest rate of 10% p.a. are to be paid out shortly and will be converted to shares at the next new shares issue in Pila Pharma.

CEO comments

I’m really pleased, that some of our long-term investors have decided to again support us by providing these convertible loans so we can progress our clinical plans immediately.

This should allow us to submit the applications during the autumn and hopefully before Christmas get regulatory approval to conduct both trials. In that case, the trials can be initiated after New Year given further funding has been secured by then.

“When in doubt just take the next small step”
(Paulo Coelho)

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 24 August 2023 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

The discovery of TRPV1 and its role in pain and neurogenic inflammation was awarded the 2021 Nobel Prize in Medicine or Physiology.

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults.

Malmö, 23 August, 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company´s interim report for      the period April – June 2023. The report can be found on the Company´s website:
https://pilapharma.com/investors/finansiell-information/

SUMMARY OF INTERIM REPORT

Second quarter (1 April- 30 June 2023)

• Operating income amounted to TSEK 301 (651)
• The operating result (EBIT) totaled to TSEK – 1 757 (- 2 250)
• The result for the period totaled to TSEK – 3 059 (- 6 501)
• Earnings per share, basic and diluted, were SEK – 0.17 (- 0.40)
• Cash flow for the period totaled to TSEK – 2 940 (- 6 949), whereof the cash flow for the operating activities totaled to TSEK – 1 639 (- 2 698)

First half year (1 January – 30 June 2023)

• Operating income amounted to TSEK 1 097 (1 186)
• The operating result (EBIT) totaled to TSEK – 3 601 (- 4 653)
• The result for the period totaled to TSEK – 7 099 (- 16 844)
• Earnings per share, basic and diluted, were SEK – 0.39 (- 1.05)
• Cash flow for the first half year totaled to TSEK – 6 801 (- 17 390), whereof the cash flow for the operating activities totaled to TSEK – 3 304 (- 5 199)
• The Company cash amounted to TSEK 442 (10 819) in the end of the half year period
• Equity amounted to TSEK 2 430 (13 451)
• The Company´s solvency ratio amounted to 70% (92%)

Significant events during the quarter (1 April– 30 June 2023)

• The subsidiary, Pila Pharma Danmark ApS Annual report for the financial year 2022 was approved, and a tax refund of DKK 2.6 M (approximately SEK 4 M) is expected in November 
• Pila Pharma’s capital efficiency plan is proceeding as planned 
• Pila Pharma AB (publ) on 30 May 2023 held its annual general meeting with the following main outcome:
  • the company’s Annual report for the financial year 2022 was approved
  • board members Dorte X. Gram and Fredrik Buch were re-elected, and    Søren Weis Dahl and Richard Busellato were newly elected
  • it was decided to establish a new election committee consisting of former board member Lene Andersen Hansen and Dorte X. Gram

Significant events after the quarter

• The company engaged in XEN-D0501 partnering discussions in both diabetes and erythromelalgia 
• The company firmed up strategy and plans for the phase 2a studies in diabetes/obesity and erythromelalgia
• Tablets manufactured in 2021 have been cleared by the manufacturer for use in phase 2a studies
• The company implemented further plans for maximizing capital efficiency

CEO comments

In the diabetes space, recent announcements by Eli Lilly, Novo Nordisk, and Pfizer have been met with significant media interest and a postive response from the stock market. It clearly shows that the pharma industry has a focus on diabetes and in particular the effects in obesity. Recent acquisitions in the field suggests an increasing appetite from pharma to license new projects with obesity effects. This development is positive for Pila Pharma since we expect an effect of XEN-D0501 on bodyweight and cardiovascular risk in addition to the effect in diabetes. It could potentially open for XEN-D0501 to also be a future obesity drug.

To demonstrate and fully leverage the potential of our lead candidate in both diabetes and obesity, we have decided to conduct a phase 2a study with endpoints related to both indications. This study will provide critical information in preparation for a subsequent phase 2b proof-of-concept study and increase the probability of a partnership deal. In parallel, we aim at demonstrating the effect of XEN-D0501 on reduction of pain during “flare ups” in the orphan disease erythromelalgia.

In response to the current high cost of capital, the previous Board in February approved a plan to increase capital efficiency, which is proceeding to plan. Furthermore, in November a tax-return of approximately SEK 4 M is expected in our Danish subsidiary. Pila Pharma AB is not obliged to release consolidated accounts and has historically opted not to do so for cost reasons but given the importance of this tax payment we are disclosing it here.

I’m excited to share that all project results needed for us to progress are now “in the box”.

We are actively planning the studies in diabetes and erythromelalgia, and the financing of them, and plan to submit both trial applications within the next six months.

I very much look forward to us entering this new chapter of Pila Pharma.

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 23 August 2023 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults.

Malmö, April 26, 2023

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 – March 2023 and it is now available on the Company´s homepage, https://pilapharma.com/investors/finansiell-information/, and as an attachment to this press release.

SUMMARY OF INTERIM REPORT

First quarter (1 January – 31 March 2023)

• Revenue was 796 kSEK (535)
• Operating loss (EBIT) was -1 844 kSEK (-2 403)
• Net loss was -4 040 kSEK (-10 343)
• Earnings per share, basic and diluted, were -0,22 SEK (-0,64) 
• Cashflow was -3 861 kSEK (-10 441), whereof from ongoing business was 
• -1 665 (-2 501)
• Cash and cash equivalents were at the end of the period 3 382 kSEK (17 768)
• Equity amounted to 5 489 kSEK (19 952)
• Solidity was 80% (93%)

Significant events in the first quarter (1 January– 31 March 2023)

• Pila Pharma communicated 29 January 2023 that a 13-week preclinical oral safety studie with the development candidate XEN-D0501 on “non-rodents” have completed without adverse signals during the dosing phase. 
• In the end of March Pila Pharma communicated that 13-week preclinical oral safety studies with the development candidate XEN-D0501 have been completed without adverse signals. 

Significant events after the quarter

• Dorte X. Gram, Founder and CEO and as previously the main shareholder of Pila Pharma, acquired further 29 574 shares in the period 29-31 March 2023 and owns directly and indirectly totally 5 195 086 shares, corresponding to 28,2% of all votes and capital.

CEO comments:

“During the first quarter of the year, we continued our operational activities towards our major goal of being able to conduct a 3-month phase 2b study in diabetes with our development candidate XEN-D0501. We have now successfully completed 13 weeks of preclinical safety studies of XEN-D0501 in two animal species with no adverse events recorded.

At the same time, we have discussed and planned this study in detail as well as a “proof of concept” study in erythromelalgia”, says Dorte X. Gram, founder and CEO of Pila Pharma.

For more information: 

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

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 26 April 2023 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. 

Malmö, 26 april 2023

Läs pressmeddelandet som PDF här

Pila Pharma AB (publ) (FN STO: PILA) publicerar i dag bolagets delårsrapport för perioden januari – mars 2023 som finns tillgänglig på bolagets hemsida: https://pilapharma.com/investors/finansiell-information/,

samt som bilaga till detta pressmeddelande.

SAMMANFATTNING AV DELÅRSRAPPORT

Första kvartalet (1 januari – 31 mars 2023)

• Rörelsens intäkter uppgick till 796 kSEK (535)
• Rörelseresultatet (EBIT) uppgick till – 1 844 kSEK (- 2 403)
• Periodens resultat uppgick till – 4 040 kSEK (- 10 343)
• Resultat per aktie före och efter utspädning – 0,22 SEK (-0,64)
• Kassaflödet för kvartalet uppgick till -3 861 kSEK (- 10 441), varav kassaflödet för den löpande verksamheten uppgick till – 1 665 kSEK (- 2 501)
• Bolagets likvida medel uppgick till 3 382 kSEK (17 768) vid kvartalets utgång
• Eget kapital uppgick till 5 489 kSEK (19 952)
• Bolagets soliditet uppgick till 80% (93%)

Väsentliga händelser under första kvartalet (1 januari – 31 mars 2023)

• Pila meddelade 29 januari 2023 att en 13-veckors oral säkerhetsstudie med utvecklingskandidaten XEN-D501 på ”non-rodents” har avslutats utan registrering av kliniska biverkningar under doseringsfasen.
• I slutet av mars meddelades att 13-veckors prekliniska orala säkerhetsstudier med utvecklingskandidaten XEN-D0501 hade slutförts utan registrering av biverkningar.

Väsentliga händelser efter periodens utgång

• Dorte X. Gram, som är grundare och vd och sedan tidigare huvudägare i Pila Pharma, köpte ytterligare 29 574 aktier i perioden 29-31 mars 2023 och äger och via bolag totalt  5 195 086 aktier, vilket motsvarar drygt 28,2 % av röster och kapital.

Kommentar från VD

”Under årets första kvartal fortsatte vi vår operationella verksamhet mot vårt stora mål att kunna genomföra en 3 månaders fas 2b-studie inom diabetes med vår utvecklingskandidat XEN-D0501. Vi har nu framgångsrikt slutfört 13 veckors prekliniska säkerhetsstudier av XEN-D0501 i två djurslag utan registrering av biverkningar.

Samtidigt har vi diskuterat och detaljplanerat denna studie såväl som en ”proof of concept” studie inom erytromelalgi”, säger Dorte X. Gram, grundare och VD för Pila Pharma. 

För mer information:

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

Denna information är sådan information som PILA PHARMA AB är skyldig att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades för offentliggörande den 26 april 2023 kl 08.00 

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser, 

Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

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

Om XEN-D0501 och TRPV1-antagonister

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

Om diabetes

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

Om erytromelalgi

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

Malmö, 29 mars 2023

Läs pressmeddelandet som PDF här

PILA PHARMA AB (publ) (FN STO: PILA) publicerar idag att 13-veckors prekliniska orala säkerhetsstudier med utvecklingskandidaten XEN-D0501 har slutförts utan registrering av biverkningar.

Tidigare har det kommunicerats att “rodent“-delen har genomförts utan registrering av biverkningar och att “non-rodent” även klarat doseringsfasen utan registrering av biverkningar vid hög exponering. De återstående histopatologiska undersökningarna hos “non-rodents” har även nu slutförts också de utan biverkningar registrerade.

Dessa sista resultat kompletterar XEN-D0501 “13-veckors tox-paketet” och visar att TRPV1-antagonisten var säker och väl tolererad vid höga doser och exponeringar i två djurslag.

Dessa goda säkerhetsresultat kommer därför att tillåta XEN-D0501 att gå vidare till kliniska studier med oral dosering i upp till 3 månaders varaktighet.

Pila Pharma har, som tidigare meddelats, för avsikt att fortsätta utvecklingen av XEN-D0501 i en klinisk fas 2b-studie i typ 2-diabetes men planerar också att utveckla substansen som behandling av den sällsynta smärtfulla sjukdomen erytromelalgi. 

VD kommenterar:

”Jag är mycket glad att XEN-D0501 har kommit ut ”clean” efter slutförandet av ”13-veckors säkerhetspaketet”. Detta resultat underbygger vår uppfattning att XEN-D0501 är en unik TRPV1-antagonist med tanke på den mycket goda säkerhetsprofilen som har uppvisats fram till nu. I tidigare kliniska studier har 300 personer behandlats med substansen i upp till 1 månad utan betydande säkerhetsproblem vid de doser som har administrerats. I vår senaste fas 2a-studie på typ 2-diabetiker visade XEN-D0501 också en liten men signifikant effekt på insulinutsöndringen. Sammantaget stärker det min övertygelse om att just denna substans kan vara den TRPV1-antagonist som är lämplig för oral kronisk behandling”, säger Dorte X. Gram, grundare och VD för Pila Pharma.

För mer information: 

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

Denna information är sådan information som PILA PHARMA AB är skyldig att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades för offentliggörande den 29 mars 2023 kl 16.30 

Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser, 

Kontakt: M: ca@aqurat.se, Tel. 08-684 05 800

Om Pila Pharma (PUBL)

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

Om XEN-D0501 och TRPV1-antagonister

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

Om diabetes

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

Om erytromelalgi

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

Malmö, March 29, 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) today publishes that 13-week preclinical oral safety studies with the development candidate XEN-D0501 have completed without adverse signals. 

Previously, it has been communicated that the “rodent” part had completed without adverse signals and that the “non-rodent” also completed the in-life phase without adverse signals despite high exposure. The remaining histopathology investigations in “non-rodents” have now been completed also without adverse signals.

These last results complete the “13-week tox package” of XEN-D0501 that overall demonstrates that the TRPV1 antagonist was safe and well tolerated at high doses and exposures in two animal species.

These good safety results therefore will permit XEN-D0501 to progress to oral dosing clinical studies of up to 3 months duration. 

Pila Pharma is, as previously announced, intending to progress XEN-D0501 into a clinical phase 2b study in type 2 diabetes but also plans to develop the molecule as treatment of the rare painful disease, erythromelalgia. 

CEO comments:

”I’m very pleased that XEN-D0501 has come out “clean” after the completion of the “13-week safety package”. These result support our belief that XEN-D0501 is a unique TRPV1 antagonist given the very good safety profile that we have recorded until now. In previous clinical studies, the molecule has been exposed to 300 people for up to 1 month without significant safety concerns at the doses administered. In our last phase 2a trial in type 2 diabetics, XEN-D0501 also demonstrated a small but significant effect on insulin secretion. Altogether, it consolidates my belief that this particular molecule may be the TRPV1 antagonist suitable for oral chronic treatment”, says Dorte X. Gram, founder and CEO of Pila Pharma. 

For more information: 

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

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 29 March 2023 at 16:30 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 novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. 

Malmö, 28 February 2023

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 2022. 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 2022)

• Revenue was 413 kSEK (719)
• Operating loss (EBIT) was -1 951 kSEK (-3 080)
• Net loss was -4 015 kSEK (-5 422)
• Earnings per share, basic and diluted, were -0,23 SEK (-0,34) 
• Cashflow was 2 121 kSEK (-5 109), whereof from ongoing business was 
• -1 827 (-2 295)

Twelve months (1 January – 31 December 2022)

• Revenue was 1 881 kSEK (719)
• Operating loss (EBIT) was -8 890 kSEK (-9 260)
• Net loss was -26 777 (-17 207)
• Earnings per share, basic and diluted, were -1,55 SEK (-1,32)
• Cashflow was for twelve months -20 966 kSEK (26 302), whereof from ongoing business was -9 091 kSEK (-9 364)
• Cash and cash equivalents were at the end of the period 7 243 kSEK (28 209)
• Equity amounted to 9 529 kSEK (30 295)
• Solidity was 88% (95%)

Significant events in the fourth quarter (1 October– 31 December 2022)

• On 11 October, Pila Pharma published that a 13-week oral safety study in rats had completed the in-life phase with no adverse signals during the dosing phase. Outstanding investigations still to be completed included the pathology, and the bioanalysis and toxicokinetic analyses which are necessary to determine the safety margin for the coming 3-month clinical phase 2b study in diabetes. A pivotal 13-week study in “non-rodents” had also been initiated. The in-life part of this 2nd part of the “13-week tox package” was due to be completed by the end of 2022 and all results of the “13-week safety package” were expected in early 2023. 
• On 25 October, the Company´s Board of Directors decided, in accordance with the authorization from the Annual Shareholders meeting on June 7, 2022, to carry out a rights issue of maximum 5 366 779 new shares that upon full subscription, could add capital to the company with about 16 MSEK before subscription costs. The subscription period was 3-17 November 2022.
• On 2 November, Pila Pharma published an information memorandum related to the rights issue of new shares with the start of subscription period on 3 November 2022.
• On 10 November, Pila Pharma published that the CEO Dorte X. Gram, during the period of 3-9 November, had sold 5 063 158 subscription rights in the ongoing rights issue. 
• On 22 November, Pila Pharma published the outcome of the Company´s rights issue of new shares (“Rights issue”). The Rights issue, subscribed to about 42,99%, was performed without any guarantor commitments and totally about 6,9 MSEK was added in capital to the Company before subscription costs. The CFO Elna Lembrér Åström and the Board member Milan Zdravkovic subscribed 16 666 new shares each. The CEO Dorte X. Gram, main owner since the start of Pila Pharma”, subscribed 106 670 new shares and owns now indirectly via her companies 5 142 828 shares, that corresponds to 27,94% of both votes and share capital.

Significant events after the quarter

• On 30 January 2023, Pila Pharma published that a 13-week oral safety study with the development candidate XEN-D0501 in non-rodents had completed the in-life phase with no adverse signals during the dosing phase and biological samples had been received for assay. Outstanding investigations still to be completed included the pathology, and the bioanalysis and toxicokinetic analyses which are necessary to determine the safety margin for the coming 3-month clinical phase 2b study in diabetes. It followed our earlier report that a 13-week oral safety study in rodents had also completed its in-life phase without registration adverse signals. That rodent study had now completed its outstanding investigations and the histopathology did not either demonstrate any adverse findings, and the bioanalysis results showed that the exposure of XEN-D0501 was as expected, and in the same range as earlier studies. Final result reports from both studies were expected by early March 2023.

CEO comments:

“During the quarter and shortly after, we could conclude that no clinical side effects had been registered in the 13 week preclinical safety studies – neither in “rodents” nor in “non-rodents” -in parallel to that very high blood levels of XEN-D0501 were detected. No organ changes were noted in “rodents” either, and we expect to get similar and last results for “non-rodents” in March. After that, we hope that the combined results of the preclinical safety studies will mean that we can proceed towards regulatory approval to conduct phase 2b clinical studies of up to 3 months’ duration (in diabetes, erythromelalgia or other indications), which would be a huge milestone to reach.” 

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 2023 at 21:30 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: 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 novel treatments. The company currently develop XEN-D0501, as a new oral antidiabetic agent. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. A use-patent application on the use of XEN-D0501 as treatment of diabetes was filed in October 2021. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of Erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies are expected in March and are needed to advance XEN-D0501 to phase 2b clinical studies of 3 months duration in diabetes (or other indications). Considerations for the best clinical development of XEN-D0501 as a treatment for erythromelalgia are also ongoing.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic erythema, pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults. 

Malmö, 28 februari 2023

Läs pressmeddelandet som PDF här

PILA PHARMA AB (publ) (FN STO: PILA) publicerar i dag bolagets bokslutskommuniké för perioden januari – december 2022 som finns att ta del av på bolagets hemsida: https://pilapharma.com/investors/finansiell-information/

SAMMANFATTNING AV BOKSLUTSKOMMUNIKÉ

Fjärde kvartalet (1 oktober – 31 december 2022)

• Rörelsens intäkter uppgick till 413 kSEK (719)
• Rörelseresultatet (EBIT) uppgick till -1 951 kSEK (-3 080)
• Periodens resultat uppgick till -4 015 kSEK (-5 422)
• Resultat per aktie före och efter utspädning -0,23 SEK (-0,34)
• Kassaflödet för kvartalet uppgick till 2 121 kSEK (-5 109), varav kassaflödet för den löpande verksamheten uppgick till -1 827 kSEK (-2 295)

Tolv månader (1 januari – 31 december 2022)

• Rörelsens intäkter uppgick till 1 881 kSEK (719)
• Rörelseresultatet (EBIT) uppgick till -8 890 kSEK (-9 260)
• Årets resultat uppgick till -26 777 kSEK (-17 207)
• Resultat per aktie före och efter utspädning -1,55 SEK (-1,32)
• Kassaflödet för tolv månader uppgick till -20 966 kSEK (26 302), 

            varav kassaflödet för den löpande verksamheten uppgick till -9 091 kSEK (-9 364)

• Bolagets likvida medel uppgick till 7 243 kSEK (28 209) vid årets utgång
• Eget kapital uppgick till 9 529 kSEK (30 295)
• Bolagets soliditet uppgick till 88% (95%)

Väsentliga händelser under fjärde kvartalet (1 oktober – 31 december 2022)

• Pila Pharma meddelade 11 oktober att en 13-veckors säkerhetsstudie med utvecklingskandidaten XEN-D0501 på råttor har avslutats utan registrering av kliniska biverkningar under doseringsfasen. Utestående undersökningar som återstår att slutföra inkluderar patologi, bioanalys och toxikokinetiska analyser. En avgörande 13 veckorsstudie på “non-rodents” har nu också inletts och doseringsdelen ska vara klar i slutet av 2022. Alla resultat av “13-veckors säkerhetspaketet”, som är en förutsättning för att gå vidare till tre månaders fas 2b kliniska studier, väntas i början av mars 2023.
• Bolagets styrelse beslutade, med stöd av bemyndigande från årsstämman den 7 juni 2022, den 25 oktober om en företrädesemission av högst 5 366 779 aktier som vid full teckning i företrädesemissionen kunde tillföra bolaget ca 16 MSEK före emissionskostnader. Teckningsperioden var 3-17 november 2022.
• Pila Pharma meddelade 2 november 2022 ett informationsmemorandum med anledning av Bolagets företrädesemission av aktier, vars teckningsperiod inleddes torsdagen den 3 november 2022.
• Pila Pharma meddelade att VD Dorte X. Gram under perioden den 3-9 november har sålt 5 063 158 teckningsrätter i pågående företrädesemission.
• Pila Pharma meddelade 22 november 2022 utfallet av Bolagets företrädesemission av aktier som offentliggjordes 25 oktober 2022 (”Företrädesemissionen”). Företrädesemissionen, som tecknades om cirka 42,99 procent, genomfördes utan garantiåtaganden och tillförde Bolaget ca 6,9 MSEK före emissionskostnader. CFO Elna Lembrér Åström och Styrelseledamot Milan Zdravkovic tecknade var för sig 16 666 nya aktier. VD Dorte X. Gram som sedan tidigare är huvudägare i Pila Pharma tecknade 106 670 nya aktier och äger nu via bolag 5 142 828 aktier vilket motsvarar drygt 27,94procent av röster och kapital.

Väsentliga händelser efter periodens utgång

• Pila Pharma meddelade 29 januari 2023 att en 13-veckors säkerhetsstudie med utvecklingskandidaten XEN-D0501 på ”non-rodents” har avslutats utan registrering av kliniska biverkningar under doseringsfasen. Återstående undersökningar inkluderar patologi, bioanalys och toxikokinetiska analyser som är nödvändiga för att fastställa säkerhetsmarginalen för den kommande tre månaders kliniska fas 2b- studien inom diabetes. Resultatet är i linje med den tidigare rapporterade 13-veckors orala säkerhetsstudie på råttor, som även den, avslutade sin doseringsfas utan registrering av biverkningar. Denna råttstudie har nu även avslutat utestående undersökningar och histopatologin påvisade inga biverkningar och bioanalysresultaten visar att exponeringen av XEN-D0501 var som förväntat och i samma intervall som tidigare studier. Slutliga resultatrapporter från båda studierna förväntas vara klara i början av mars 2023.

Kommentar från VD

”Under kvartalet och strax efter kunde vi konkludera att ingen kliniska biverkningar hade registrerades i de prekliniska 13 veckors studier i varken “rodents eller “non-rodent” samtidigt som mycket höga blod halter av XEN-D0501 blev påvist. Inga organförändringar heller noterades i ”rodents” och vi förväntar att få motsvarande och sista resultat för ”non-rodents” i mars. Därefter hoppas vi att det samlade resultat av de prekliniska säkerhetsstudierna blir att vi kan gå emot att söka om regulatorisk tillstånd att utföra kliniska fas 2b studier upp till 3 månaders varaktighet (inom diabetes, erytromelalgi eller andra indikationer), vilket vill vara en enorm milstolpe att nå.” 

säger Dorte X. Gram.

För mer information: 

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

Denna information är sådan information som PILA PHARMA AB är skyldig att offentliggöra enligt EU:s marknadsmissbruksförordning.
Informationen lämnades för offentliggörande den 28 februari 2023 kl. 21.30
Bolagets aktie, med kortnamn PILA, är föremål för handel på Nasdaq First North Growth Market med Aqurat Fondkommission AB som Certified Adviser.

Kontakt: M: info@aqurat.se, T: 08-684 05 800

Om PILA PHARMA AB (Publ)

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

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en TRPV1-antagonist som är en selektiv och potent syntetisk liten molekyl, som inlicensierades 2016 och som tidigare utvecklats av Bayer Healthcare, Tyskland och Xention/Ario Pharma, Storbritannien. TRPV1-receptorn (även kallad “chili-receptorn”) och TRPV1-antagonister som nedreglerar neurogen inflammation, har visat upp tillämpningar för smärta och inflammatoriska sjukdomar och spelar potentiellt en roll även vid diabetes. Före inlicensieringen hade XEN-D0501 visat sig ha en god säkerhetsprofil i andra patientgrupper (icke-diabetes). Pila Pharma har hittills genomfört två kliniska fas 2a-studier inom diabetes (PP-CT01 och PP-CT02), som båda visade att XEN-D0501 tolereras väl av typ 2-diabetespatienter. Vidare visade PP-CT02 att XEN-D0501 (administrerad som 4 mg två gånger dagligen i 28 dagar) – med statistisk signifikans jämfört med placebo – förstärker det endogena insulinsvaret på oral glukos. Slutgiltiga resultat från nyss genomförda prekliniska 13 veckors säkerhetsstudier väntas i mars och behövs för att kunna ta XEN-D0501 vidare till kliniska fas 2b-studier av 3 månaders varaktighet inom diabetes (eller andra indikationer). Överväganden för bästa kliniska utveckling av XEN-D0501 som behandling av erytromelalgi pågår dessutom.

Om diabetes

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

Om erytromelalgi

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

Malmö, January 30, 2023

Download the press release as PDF here

PILA PHARMA AB (publ) (FN STO: PILA) today publishes that a 13-week oral safety study with the development candidate XEN-D0501 in non-rodents has completed the in-life phase with no adverse signals during the dosing phase and biological samples have now been received for assay. 

Outstanding investigations still to be completed include the pathology, and the bioanalysis and toxicokinetic analyses which are necessary to determine the safety margin for the coming 3-month clinical phase 2b study in diabetes. This follows our earlier report that a 13-week oral safety study in rodents had also completed its in-life phase without registration adverse signals. That rodent study has now completed its outstanding investigations and the histopathology did not either demonstrate any adverse findings, and the bioanalysis results show that the exposure of XEN-D0501 was as expected, and in the same range as earlier studies. Final result reports from both studies are due to be completed by early March 2023. 

Pila Pharma is, as previously announced, preparing a clinical phase 2b study of the drug candidate XEN-D0501 for type 2 diabetes. The aim with the phase 2b study is to test XEN-D0501 at higher doses and for a longer duration than the previously completed Phase 2a trial to further evaluate its glucose lowering properties. XEN-D0501 has already been evaluated in both toxicological safety studies and in phase 1 and 2a clinical trials in humans with up to 4 weeks treatment duration with good safety results, indicating that the molecule is well tolerated. The 13-week preclinical toxicological studies aim at confirming the preclinical safety prior to the coming 3 months phase 2b clinical study. 

CEO comments:

”I’m very pleased that XEN-D0501 did not cause any clinical side-effects in the 13-week non-rodent study, and it supports that we may have a lead candidate suitable for chronic treatments. We now look forward to completing the “13-week safety package” that is a prerequisite to progress to the 3 months phase 2b clinical studies in diabetes and possibly other indications.”

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 30 January 2023 at 16:30 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: info@aqurat.se, T: +46 (0)8 684 05 800

About Pila Pharma AB (Publ) 

Pila Pharma is a Swedish biotech company in the diabetes segment based in Malmö, Sweden. The aim of the company is to develop TRPV1 antagonists as novel treatments. The company currently develop XEN-D0501, as a new oral antidiabetic agent. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501 as well as back-up candidates. A use-patent application on the use of XEN-D0501 as treatment of diabetes was filed in October 2021. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of Erythromelalgia. The company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was in-licensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PP-CT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. The preclinical 13-week safety studies about to complete are needed to be able to take XEN-D0501 further into a 3-month phase 2b clinical study in patients with type 2 diabetes. Considerations for the best clinical development of XEN-D0501 as a treatment for erythromelalgia are also ongoing.

About Diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility, and affordability perspective.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic erythema, 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.