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Pila Pharma AB announces outcome in the rights issue

Malmö, 5 December 2023

Download the press release as PDF here

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) announces today, 5 December 2023, the outcome in the Company’s rights issue of shares announced on 25 October 2023 (the “Rights Issue”). The Rights Issue was subscribed for by approximately 30.80 percent and provides the Company with approximately SEK 8,1 million before issue costs.

On 25 October 2023, Pila Pharma announced that the board of directors of the Company, with authorization from the annual general meeting held on 30 May 2023, had resolved upon the Rights Issue of approximately SEK 26.2 million.  The subscription price was SEK 1.50 per share and the total number of shares offered in the Rights Issue amounted to 17,487,000.

Outcome in the Rights Issue

The subscription period for the Rights Issue ended on 4 December 2023. The final outcome shows that 4,546,434 shares have been subscribed for with the support of subscription rights, corresponding to approximately 84.4 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 839,486 shares without support of subscroiption rights, corresponding to approximately 15.6 percent of the Rights Issue. Consequently, in total 5,385,920 shares were subscribed for the the Rights Issue.

In August 2023, Pila Pharma entered into convertible loan agreements under which the Company raised convertible loans of in total SEK 1.5 million from current shareholders. The convertible loans bore an interest rate of 10 percent per. The outstanding principal amount of the convertible loans of SEK 1,5 million together with accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, were, at the request of the Company, converted to shares within the Rights Issue by way of set-off.

Through the Rights Issue, the Company will receive approximately SEK 8.1 million before deduction of issue costs, which are estimated to amount to a maximum of SEK 1 million.

Comment from Dorte X.Gram, CEO

Although the result of the rights issue is obviously below what we planned to raise, I’m pleased to note that many current shareholders have reinvested (getting to about 31% subscription even though we did not include guarantors in the issue) including Vimpu Intressenter who signed pro rata, suggesting strong support to our new aim of developing an “obesity pill”. The raised amount is enough for us to go ahead with the diabetes/obesity project without compromising the quality of the main outcome. The orphan project within erythromelalgia, however, is put on hold until further notice. I now look forward to get the study in obese persons with diabetes done so we can demonstrate, that higher doses of XEN-D0501 when dosed for 3 months is well tolerated with an expected trend for body weight loss. Positive results should lead to new patents and progressing XEN-D0501 as a future obesity treatment.”, says Dorte X. Gram, CEO of Pila Pharma.

Allocation of shares subscribed for without the support of subscription rights

Allocation of shares subscribed for without the support of subscription rights has taken place in accordance with the principles set out in the memorandum that the Company published on 16 November 2023, due to the Rights Issue (the “Memorandum”). Notification of such allocation is announced separately through settlement notes. Nomineeregistered shareholders receive notification of allotment in accordance with instructions from the respective nominee.

Shares, share calital and dillution

Through the Rights Issue, the total number of shares in the Company increase by 5,385,920 shares, from 18,407,369 shares to 23,793,289 shares, and the share capital increase by SEK 230,281.136091, from SEK 787,028 to SEK 1,017,309.136091, corresponding to a dilution effect of 22.64 percent of the total number of shares in the Company.

Trading in paid subscribed shares (“BTA”)

Trading in BTA takes place until the conversion of BTA into shares after the Rights Issue has been registered with the Swedish Companies Registration Office. Registration with the Swedish Companies Registration Office is expected to take place during week 51, 2023.

Advisors

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

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

For more information: 

Dorte X. Gram, CEO
dxg@pilapharma.com 

This information is such information that PILA PHARMA AB (publ) is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on 5 December 2023 at 19:30 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 thecompany 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 midstage 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 and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

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

About Erythromelalgia

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

About Abdominal Aorta Aneurism

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

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. 

No shares or other securities in Pila Pharma have been registered, and no shares or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the “Securities Act”) or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or the regulations of the Nasdaq First North Growth Market for issuers.

PILA PHARMA ANNOUNCES PRECLINICAL RESEARCH COLLABORATION

Malmö, 26 November 2023

Download the press release as PDF here

Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) has entered a research collaboration with the Research Group of Professor Dick Wågsäter, Uppsala University, Sweden (the “Research Group”) on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

The hypothesis is that XEN-D0501 may reduce the chronic inflammation that leads to cardiovascular disease including aorta dilatation. Thus, XEN-D0501 could potentially prevent the lethal end-stage development of Abdominal Aorta Aneurism.

This collaboration will cover a small study in mice that the Research Group will sponsor whilst Pila Pharma sponsors XEN-D0501. The results will be split in that the Research Group gets the publication right (after patenting) and Dick Wågsäter has agreed to transfer to Pila Pharma the patent rights against that Pila Pharma sponsors any resulting patents.

The aim of this new collaboration is to establish a pre-clinical proof-of-concept of an effect of XEN-D0501 on preventing progression of Abdominal Aorta Dilatation in mice.

Professor Dick Wågsäter comments:
One of my professional goals is to search for a suitable treatment of Abdominal Aorta Aneurism!  It is a deadly cardiovascular disease that accounts for 1% of deaths in men over 65 years of age and where no drugs are currently available for prevention or treatment.
So, I’m really pleased that this collaboration with Pila Pharma can finally start. 
If the results of this mouse study will be positive, further clinical development plans for the assessment of XEN-D0501 in humans with Abdominal Aorta Aneurism have already been discussed to further pave the way for XEN-D0501 as the missing preventive treatment. 

CEO Dorte X. Gram comments:                                                       
We’re currently developing XEN-D0501 as an affordable treatment of diabetes and obesity with multiple beneficial effects including the reduction of cardiovascular disease risk.
Our own clinical results on the latter will not be available for long, so I welcome this mouse study as it might provide data on a cardiovascular function effect of XEN-D0501. 

More-over, I have recently experienced the disease of Abdominal Aorta Aneurism in my close family, and I know how frustrating it is to know that stent surgery is the only option for short term survival. In my part of the world, such surgery is available but not without risks. In other parts of the world, it’s not available due to high cost. 
Therefore, contributing to an affordable prevention also of this serious disease has become a personal motivation to me. Hopefully it can save more lives and further increase wellbeing and longevity in man.

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 26 November 2023 at 21:45 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 and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

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

About Erythromelalgia

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

About Abdominal Aorta Aneurism

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

PILA PHARMA PUBLISHES INTERIM REPORT (1 July – 30 September 2023)

Malmö, 25 October, 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 July – September 2023. The report can be found on the Company´s website: https://pilapharma.com/investors/finansiell-information/.

SUMMARY OF INTERIM REPORT

THIRD QUARTER (1 JULY – 30 SEPTEMBER 2023)

  • Operating income amounted to TSEK 0 (281)
  • The operating result (EBIT) totaled to TSEK – 1 518 (- 2 286)
  • The result for the period totaled to TSEK – 1 530 (- 5 917)
  • Earnings per share, basic and diluted, were SEK – 0.08 (- 0.37)
  • Cash flow for the period totaled to TSEK 705 (- 5 697), whereof 
  • the cash flow for the operating activities totaled to TSEK – 795 (- 2 066)

NINE MONTH PERIOD (1 JANUARY – 30 SEPTEMBER 2023)

  • Operating income amounted to TSEK 1 097 (1 468)
  • The operating result (EBIT) totaled to TSEK – 5 119 (- 6 937)
  • The result for the period totaled to TSEK – 8 629 (- 22 760)
  • Earnings per share, basic and diluted, were SEK – 0.47 (- 1.41)
  • Cash flow for the period January – September totaled to TSEK – 6 096 (- 23 087), whereof the cash flow for the operating activities totaled to TSEK – 4 099 (- 7 264)
  • The Company cash amounted to TSEK 1 147 (5 122) in the end of 30 September 2023
  • Equity amounted to TSEK 900 (7 535)
  • The Company´s solvency ratio amounted to 22% (87%)

SIGNIFICANT EVENTS DURING THE QUARTER (1 JULY– 30 SEPTEMBER 2023) 

  • The raising of short-term convertible loans of in total SEK 1.5 M
    In order to finance the Company’s business activities, Pila Pharma entered into convertible loan agreements as per 23 August 2023. Under the loan agreements, the Company raised convertible loans of in total SEK 1.5 M from the long-term shareholders Vimpu Intressenter AB, AnMi Förvaltning AB, AB Hans Ols Bröd, Magnus Hackman and CO2 Balance AS. The convertible loans bear an interest rate of 10 per cent per annum, which shall be capitalized annually on 31 December each year and added to the outstanding principal amount of each convertible loan. The interest shall only be payable upon final repayment or conversion of the convertible loans. The outstanding principal amount of the convertible loans together with accrued interest may, at the request of the Company, be repaid through conversion into shares in the Company in connection with a financing round. If the Company, on or before 15 February 2024, raises the financing, conversion will be at a conversion price per share corresponding to the subscription price applied in the financing round. On 25 October 2023, the Board of Directors resolved on a rights issue of shares (see ”Significant events after the quarter”) and to request that the convertible loans of SEK 1.5 million including accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, are converted to shares in connection thereto by way of set-off to the conversion price in the rights issue, i.e. SEK 1.50 per share in the Company.

SIGNIFICANT EVENTS AFTER THE QUARTER

  • New issue of shares with pre-emption rights for the shareholders
    On 25 October 2023, the Board of Directors of Pila Pharma has, with authorization from the annual general meeting held on 30 May 2023, resolved to carry out a new issue of up to 17,487,000 shares with pre-emption rights for existing shareholders at a subscription price of SEK 1.50 per share. In the event the rights issue is fully subscribed, the Company will be provided with approximately SEK 26.2 million before transaction costs. The convertible loans of SEK 1.5 million including accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, will be converted to shares in the rights issue. 

CEO COMMENTS

We are now ready to continue with the clinical development of XEN-D0501 and the Pila team and our clinical investigators and development partners are gearing up to start these studies. In order to ‘keep moving’ the Board of Directors has decided on a new shares issue to enable us to initiate the clinical trials as soon as they have been approved. It’s truly exciting times and I really look forward to resuming our clinical development of XEN-D0501 now with an increased focus on obesity in addition to diabetes, and on pain in erythromelalgia – results that can pave the way for a pharma partnership!” comments, CEO Dorte X. Gram

For more information: 

Dorte X. Gram, CEO                                                                                     
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 25 October 2023 at 08:15 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.

PILA PHARMA’S BOARD OF DIRECTORS HAS RESOLVED TO CARRY OUT A RIGHTS ISSUE OF SHARES OF APPROXIMATELY SEK 26.2 MILLION

Malmö, 25 October, 2023

Download the press release as PDF here

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

The Board of Directors of Pila Pharma AB (FN STO: PILA) has, with authorization from the annual general meeting held on 30 May 2023, resolved to carry out a new issue of up to 17,487,000 shares with pre-emption rights for existing shareholders at a subscription price of SEK 1.50 per share (the “Rights Issue”). The subscription period will take place from 20 November 2023 until and including 4 December 2023. In the event the Rights Issue is fully subscribed, the Company will be provided with approximately SEK 26.2 million before transaction costs. The transaction costs are estimated to amount to approximately SEK 1 million.

The right to receive subscription rights is granted to those who on the record date 16 November 2023 are registered as shareholders in the Company. Subscription with subscription rights shall be made by cash payment or by set-off of convertible loans during the period from and including 20 November 2023 until and including 4 December 2023. Through the Rights Issue, upon full subscription, the share capital will increase by a maximum of approximately SEK 747,676.576484 and the number of shares by a maximum of 17,487,000. For existing shareholders who do not participate in the Rights Issue, this means, upon full subscription, a dilution effect of approximately 48.72 percent of the capital and votes in the Company. 

The shareholders in Pila Pharma and the general public are hereby invited to subscribe for shares in the Company, with or without pre-emption rights, in the Rights Issue. 

Summary

  • In the event of full subscription in the Rights Issue, the Company is provided approximately SEK 26.2 million before transaction costs, which are estimated to amount to approximately SEK 1 million.
  • Anyone who is registered as a shareholder in Pila Pharma in the shareholders’ register on the record date 16 November 2023 will receive one (1) subscription right for each share owned in the Company and 20 subscription rights entitle the holder to subscribe for 19 new shares.
  • The subscription price is SEK 1.50 per share.
  • The subscription period for subscription of shares will take place from and including 20 November 2023 until and including 4 December 2023. After the end of the subscription period, unexercised subscription rights become invalid and lose their value. Unexercised subscription rights will be deleted from each shareholder’s securities account without special notification from Euroclear. 
  • The Board of Directors of the Company reserves the right to extend the subscription period. A possible extension will be announced by the Company through a press release no later than 4 December 2023.
  • Received subscription rights must either be used for subscription no later than 4 December 2023 or be sold no later than 29 November 2023 in order not to expire worthless. 

Background and motive to the Rights Issue

The issue funds from the Rights Issue of maximum approximately SEK 26.2 million should provide working capital to Pila Pharma for conducting the next two pivotal trials with XEN-D0501. Pila Pharma develops XEN-D0501 as novel treatment of diabetes that may also have effect on obesity, cardiovascular disease and pain. 

The bigger milestone within diabetes is to demonstrate a significant anti-diabetic and -obesity effect in a larger phase 2b trial in up to 300 persons with diabetes. To assure that the three needed dose-levels are adequate with regard to safety and efficacy, an exploratory phase 2a dosing study in fewer individuals will be undertaken first. 

In the rare disease erythromelalgia project, the biggest milestone is to demonstrate efficacy in a handful of subjects with the condition.

We plan to submit clinical trial applications for both phase 2a studies in diabetes/obesity and erythromelalgia soon and the current offer seeks to finance the excution of the studies. The results from both studies are expected within a year from first patient in, after which we see good potential to partner with a specialized pharma companies for each indication.

“We are now ready to continue with the clinical development of XEN-D0501 and the Pila team and our clinical investigators and development partners are gearing up to start these studies. In order to ‘keep moving’ the Board of Directors has decided on a new shares issue to enable us to initiate the clinical trials as soon as they have been approved. It’s truly exciting times and I really look forward to resuming our clinical development of XEN-D0501 now with an increased focus on obesity in addition to diabetes, and on pain in erythromelalgia – results that can pave the way for a pharma partnership!” comments, CEO Dorte X. Gram.

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

In the event of full subscription in the Rights Issue, the amount of shares in the Company may increase by 17,487,000, from 18,407,369 to not more than 35,894,369 and the share capital may increase by not more than SEK 747,676.576484, from SEK 787 028 SEK to not more than SEK 1,534,704.576484, corresponding to a maximum dilution effect of 48.72 percent of the number of shares and votes in the Company.

Memorandum and application forms

The Rights Issue is exempt from the obligation to publish a prospectus as the total contribution for the securities offered by Pila Pharma to investors within the EEA during a twelve-month period corresponds to not more than EUR 2.5 million. A prospectus is defined in accordance with the provisions of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (the “Prospectus Regulation”). Consequently, the memorandum will not have been reviewed, approved, or registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) in accordance with the Prospectus Regulation. 

The memorandum with the complete terms and conditions of the Rights Issue will be published on 16 November 2023 on Pila Pharma’s website, www.pilapharma.com, and Nordic Issuing AB’s website, https://nordic-issuing.se/. The application form for subscription without subscription rights is available on Nordic Issuing’s website and must be received by Nordic Issuing AB no later than 3 pm on 4 December 2023. 

Undertaking to convert convertible loans

In August 2023, Pila Pharma entered into convertible loan agreements under which the Company raised convertible loans of in total SEK 1.5 million from current shareholders. The convertible loans bear an interest rate of 10 per cent per annum, which shall be capitalized annually on 31 December each year and added to the outstanding principal amount of each convertible loan. The interest shall only be payable upon final repayment or conversion of the convertible loans. The outstanding principal amount of the convertible loans together with accrued interest may, at the request of the Company, be repaid through conversion into shares in the Company in connection with a financing round. If the Company, on or before 15 February 2024, raises the financing, conversion will be at a conversion price per share corresponding to the subscription price applied in the financing round. 

On 25 October 2023, the Board resolved to request that the convertible loans of SEK 1.5 million including accrued interest of SEK 39,698.63, i.e. in total SEK 1,539,698.63, are to be converted to shares in the Company in connection with the Rights Issue by way of set-off to the conversion price in the Rights Issue, i.e. SEK 1.50 per share in the Company. 

Indicative timetable for the Rights Issue

Last day of trading in the Company’s shares including the right to receive subscription rights14 November 2023
First day of trading in the Company’s shares excluding the right to receive subscription rights15 November 2023
Record date for participation in the Rights Issue16 November 2023
Estimated date for publication of memorandum16 November 2023
Subscription period for the Rights Issue20 November – 4 December 2023
Trading with subscription rights20 – 29 November 2023
Settlement date for subscription with support of subscription rights4 December 2023
Settlement date for subscription without the support of subscription rightsPlanned to 12 December 2023
Trading with BTA20 November – about 21 December 2023
Estimated date for publication of Rights Issue results5-6 December 2023 

Advisors

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

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

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

For more information: 

Dorte X. Gram, CEO                                                                                              
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 25 October 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.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. 

No shares or other securities in Pila Pharma have been registered, and no shares or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the “Securities Act”) or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or the regulations of the Nasdaq First North Growth Market for issuers.

CORRECTION: Clarification and extended information on previous press release regarding convertible loans and their structure.

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.

PILA PHARMA announces capital infusion via convertible loans

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.

PILA PHARMA publishes interim report (1 April – 30 June 2023)

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.

Pila Pharma AB publishes interim report (1 January – 31 March 2023)

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. 

Pila Pharma AB publicerar publicerar delårsrapport (1 januari – 31 mars 2023)

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.seTel. 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.

XEN-D0501 kan gå vidare till kliniska prövningar upp till 3 månaders varaktighet efter att ha visats säker i 13-veckors prekliniska orala säkerhetsstudier

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.seTel. 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.

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