Board Change • May 20
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Chairman of the Board Sophie Lapointe was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Apr 30
Poxel S.A. to Report Fiscal Year 2025 Results on Jun 15, 2026 Poxel S.A. announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Jun 15, 2026 Board Change • Dec 30
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Chairman of the Board Sophie Lapointe was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Nov 27
Poxel S.A., Annual General Meeting, Dec 11, 2025 Poxel S.A., Annual General Meeting, Dec 11, 2025. Location: 12 cours de verdun rambaud esplanade de la gare, lyon France Annuncio • May 28
Poxel SA Announces New Clinical and Scientific Data on TWYMEEG® to Be Presented at the 68th Annual Meeting of the Japan Diabetes Society POXEL SA announced that new clinical and scientific data on TWYMEEG will be presented at the 68th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan. A total of 15 presentations, including results from 7 clinical trials, 3 post-hoc analyses and 5 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. These findings further confirm TWYMEEG's efficacy in monotherapy and combination therapies, safety, dual mechanism of action and potential benefits in specific patient populations. Main topics include: TWINKLE (TWYMEEG®? in diabetic patients with renal impairment: A post-marketing long-term study) study (Phase 4 study): confirmation of TWYMEEG®? efficacy and safety in diabetic patients with renal impairment; FAMILIAR Study: confirmation of TWYMEE G®? efficacy and safety in combination with DPP-4 inhibitors; PARADIME Clamp: confirmation of TWYMeeG®? dual mechanism of action in diabetic patients - clinical data showing effects on insulin sensitivity (clamp part) and glucose stimulated insulin secretion (OGTT part); PARADIME TIR: confirmation of TWYMCEG®? effects on glucose variability; PET/MRI Study: confirmation of TWY MEEG®? effect on glucose excretion in the gut. Annuncio • Apr 08
Poxel SA Announces Regulatory Approval by Japanese Authorities to Expand TWYMEEG®? Package Insert to Include Type 2 Diabetes Patients with Renal Impairment POXEL SA announced that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved the revision of TWYMEEG®? package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2. This approval follows positive topline results from the post-marketing clinical study TWINKLE (TWYMEEG®? in diabetic patients with renal impairment: A post-marketing long-term study) in Japanese type 2 diabetic patients with renal impairment, which confirmed TWYMEEG®®?'s safety and tolerability profile, as announced last August1. Based on these results, discussions with the Japanese regulatory authorities were initiated by Sumitomo Pharma, resulting in the approval that will be officially implemented by Sumitomo Pharma as of April 8, 2025. Annuncio • Nov 08
Poxel S.A. Provides Revenue Guidance for the Full Year 2024 Poxel S.A. provided revenue guidance for the full year 2024. The company to see the good sales trajectory for TWYMEEG in Japan, which should lead to the achievement of JPY 5 billion net sales in the coming months, at which point, Poxel will be entitled to 10% royalties on all TWYMEEG net sales and a sales-based payment of JPY 500 million (EUR 3.1 million).These amounts, based on recent royalty monetization agreement, will serve to start repayment of bonds to OrbiMed. Additionally, Poxel will benefit from the residual amount of the reserve deposit made under the terms of the agreement with OrbiMed, in addition to the USD 42.5 million proceeds received upon closing. Annuncio • Oct 24
Poxel S.A., Annual General Meeting, Nov 28, 2024 Poxel S.A., Annual General Meeting, Nov 28, 2024. Location: hotel mercure lyon, centre chateau perrache, 12 cours de verdun rambaud esplanade de la gare, lyon France Reported Earnings • Oct 04
Full year 2023 earnings released Full year 2023 results: Revenue: €1.98m (up 194% from FY 2022). Net loss: €35.1m (loss widened 12% from FY 2022). New Risk • Sep 30
New major risk - Financial data availability The company's latest financial reports are more than a year old. Last reported fiscal period ended June 2023. This is considered a major risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. In the worst case scenario, it may be facing other major going concern issues jeopardizing its viability as a listed company. Currently, the following risks have been identified for the company: Major Risks Latest financial reports are more than 1 year old (reported June 2023 fiscal period end). Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-€42m). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Minor Risks Revenue is less than US$5m (€1.5m revenue, or US$1.7m). Market cap is less than US$100m (€29.1m market cap, or US$32.4m). New Risk • Sep 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 50% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€42m). Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Revenue is less than US$5m (€1.5m revenue, or US$1.7m). Market cap is less than US$100m (€29.2m market cap, or US$32.4m). New Risk • Aug 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€42m). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Revenue is less than US$5m (€1.5m revenue, or US$1.7m). Market cap is less than US$100m (€35.1m market cap, or US$38.7m). Annuncio • Aug 07
Sumitomo Pharma and Poxel Announce Topline Results from Post-Marketing Clinical Study on TWYMEEG for the Treatment of Type 2 Diabetes in Japan Sumitomo Pharma Co., Ltd. and POXEL SA announced topline results obtained from a post-marketing clinical study, TWINKLE (TWYMEEG in diabetic patients with renal impairment: A post-marketing long-term study) (“the Study”), in Japanese type 2 diabetic patients with renal impairment for TWYMEEG Tablets 500 mg (generic name: imeglimin hydrochloride, “the Drug”) being sold in Japan, based on the Risk Management Plan. The Study was an open-label, uncontrolled, long-term study in 60 Japanese type 2 diabetic patients with renal impairment, who had no experience of type 2 diabetes treatment other than diet and exercise therapy or insufficient glycemic management in monotherapy with a hypoglycemic agent excluding insulin formulation. The Drugwas administered at 500 mg twice-daily to patients with moderate and severe renal impairment, characterized by an estimated glomerular filtration rate (eGFR) between 15 mL/min/1.73 m2 or higher to less than 45 mL/min/1.73 m2, or at 500 mg once-daily to patients with end-stage renal disease, characterized by an eGFR less than 15 mL/min/1.73m2, in monotherapy or in combination therapy with a hypoglycemic agent excluding insulin formulation, to evaluate safety and tolerability when administered orally for 52 weeks. The Drug was observed to be safe and well tolerated in Japanese type 2 diabetic patients with renal impairment and no significant differences were found in the incidence of adverse events, their types and severities in this study from previous clinical studies. Specifically, most of the adverse events were mild or moderate in severity. The incidence of serious adverse events was 16.7% (10 of 60 subjects) and causality with the Drug could be ruled out in all cases. Incidence of adverse events leading to study treatment discontinuation was also limited (4 of 60 subjects). At present, administration of the Drug is not recommended for patients with renal impairment with eGFR less than 45 mL/min/1.73m2. Based on the results of the Study, Sumitomo Pharma is planning to conduct discussions with the regulatory authorities in Japan, on revising the package insert in fiscal 20241 for patients with renal impairment with eGFR less than 45 mL/min/1.73m2. New Risk • Jun 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 50% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€42m). Earnings have declined by 27% per year over the past 5 years. Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Revenue is less than US$5m (€1.5m revenue, or US$1.7m). Market cap is less than US$100m (€28.8m market cap, or US$30.9m). New Risk • Apr 17
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-€42m). Earnings have declined by 27% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (34% increase in shares outstanding). Revenue is less than US$5m (€1.5m revenue, or US$1.6m). Market cap is less than US$100m (€25.0m market cap, or US$26.6m). New Risk • Apr 08
New major risk - Revenue and earnings growth Earnings have declined by 27% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-€42m). Earnings have declined by 27% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (34% increase in shares outstanding). Revenue is less than US$5m (€1.5m revenue, or US$1.7m). Market cap is less than US$100m (€25.8m market cap, or US$27.9m). Breakeven Date Change • Oct 18
Forecast to breakeven in 2024 The 2 analysts covering Poxel expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 18% to 2023. The company is expected to make a profit of €26.2m in 2024. Average annual earnings growth of 22% is required to achieve expected profit on schedule. Reported Earnings • Sep 28
First half 2023 earnings released First half 2023 results: Net loss: €26.2m (loss widened 96% from 1H 2022). Revenue is forecast to grow 90% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Annuncio • Aug 31
Poxel S.A. to Report Q2, 2023 Results on Sep 26, 2023 Poxel S.A. announced that they will report Q2, 2023 results on Sep 26, 2023 Annuncio • May 16
Poxel S.A., Annual General Meeting, Jun 21, 2023 Poxel S.A., Annual General Meeting, Jun 21, 2023, at 09:00 Central European Standard Time. Location: Mercure Hotel, Lyon Centre Saxe Lafayette, 29 rue de Bonnel, 69003 LYON, France. Lyon France Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Masato Kasuga was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Sep 23
First half 2022 earnings released First half 2022 results: Net loss: €13.4m (loss widened 67% from 1H 2021). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Annuncio • Aug 30
Poxel S.A. Announces Positive Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, A Novel, Proprietary Deuterium-Stabilized R-Stereoisomer of Pioglitazone POXEL SA announced positive top-line results for DESTINY-1 (Deuterium-stabilized R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH), the dose-ranging Phase 2 trial of PXL065 for the treatment of NASH. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which has reduced PPAR? activity but retains non-genomic thiazolidinedione (TZD) actions. Summary of Phase 2 NASH (DESTINY-1) PXL065 Study Results: DESTINY-1 is a Phase 2, 36-week, randomized, dose-ranging, double-blind, placebo-controlled, parallel group study designed to assess the efficacy and safety of PXL065 in patients with noncirrhotic biopsy-proven NASH across multiple clinical sites in the US. The primary endpoint of the study measured the relative change in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). The study also assessed the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers. Histology results are expected in September. Top-line results available at present include: 117 subjects were randomized to one of 4 daily (QD) treatment arms (7.5 mg, 15 mg, 22.5 mg, placebo). The primary efficacy endpoint was achieved: a statistically significant (p=0.024 to p=0.008) mean relative decrease vs. placebo of 21% to 25% in liver fat content from baseline to 36 weeks was observed at all PXL065 doses. 40% of patients who received PXL065 at the 22.5 mg dose achieved a >30% relative reduction in liver fat content. Non-invasive biomarker results to-date included: dose-dependent decreases in fibrogenesis markers Pro-C3 (significant vs. placebo at the 22.5 mg dose; p=0.02) and enhanced liver fibrosis (ELF) index. Trends in least-square mean ALT decreases up to 18.4 IU/L vs. baseline were observed. However, this parameter did not reach statistical significance. Further data analysis is ongoing. There was no dose dependent increase in body weight: a minimal least-square mean increase of 0.68 kg was observed at the top dose of 22.5 mg vs. placebo. The incidence of edema did not show an observed treatment or dose relation when compared to placebo. With respect to other safety measures, PXL065 was observed to be generally safe and well tolerated; the number of patients presenting with treatment-emergent serious adverse events (TESAEs) were similar among all groups including placebo without dose effect. As predicted, pharmacokinetic measurements showed dose-proportional drug levels with the desired degree of higher exposure to the pioglitazone R-stereoisomer and reduced exposure to the (PPARg active) S-stereoisomer. Additional data from histology results are expected in September. The full Phase 2 results will be submitted for presentation at an upcoming scientific meeting. Breakeven Date Change • Aug 12
Forecast to breakeven in 2024 The 3 analysts covering Poxel expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €19.5m in 2024. Reported Earnings • May 24
Full year 2021 earnings released: €0.83 loss per share (vs €1.16 loss in FY 2020) Full year 2021 results: €0.83 loss per share (up from €1.16 loss in FY 2020). Revenue: €13.4m (up 97% from FY 2020). Net loss: €23.8m (loss narrowed 25% from FY 2020). Products in clinical trials Phase I: 3 Phase II: 2 Post-clinical trial products Approved (during full year): 1 Launched (during full year): 1 Over the next year, revenue is expected to shrink by 23% compared to a 30% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 29% per year but the company’s share price has fallen by 36% per year, which means it is performing significantly worse than earnings. Annuncio • May 18
Poxel S.A. Announces Pxl065 and Pxl770 Granted Orphan Drug Designation from the U.S. Fda for X Linked Adrenoleukodystrophy Poxel S.A. announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to PXL065 and PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. Both compounds are preparing to enter into Phase 2a clinical Proof-of-Concept (POC) biomarker studies as soon as possible, subject to financing. ODD is granted by the FDA to novel therapeutics for diseases or conditions that affect fewer than 200,000 individuals in the U.S. Orphan Drug Designation1 gives a company a potential seven-year window of exclusive marketing rights following FDA approval, along with a reduction in certain application fees, and tax credits for expenses related to qualified clinical trials conducted after orphan designation is received. Annuncio • May 13
Poxel S.A., Annual General Meeting, Jun 21, 2022 Poxel S.A., Annual General Meeting, Jun 21, 2022, at 09:00 Central European Standard Time. Location: Collège Hôtel, 5 Place Saint-Paul, 69005 Lyon France Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Masato Kasuga was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annuncio • Apr 12
Poxel Announces PXL770 Wins FDA Fast Track Designation for X-Linked Adrenoleukodystrophy POXEL SA announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator that is preparing to enter into a Phase 2a clinical Proof-of-Concept (POC) biomarker study midyear, subject to additional financing. The Phase 2a clinical POC biomarker studies for Poxel’s two products, PXL770 and PXL065, in X-linked ALD are, subject to additional financing, anticipated to begin midyear, with results anticipated early 2023. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Masato Kasuga was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Board Change • Mar 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Masato Kasuga was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annuncio • Feb 17
Poxel Announces PXL065 Granted FDA Fast Track Designation for X-Linked Adrenoleukodystrophy Poxel S.A. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PXL065 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone that is preparing to enter into a Phase 2a clinical Proof-of-Concept (POC) biomarker study midyear. The Phase 2a clinical POC biomarker study for PXL065 in X-linked ALD is anticipated to begin midyear, followed by results in early 2023. Reported Earnings • Sep 25
First half 2021 earnings released The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: €13.3m (up 108% from 1H 2020). Net loss: €8.03m (loss narrowed 33% from 1H 2020). Annuncio • Sep 21
POXEL SA Completes Enrollment in Phase 2 NASH Trial for PXL065 (DESTINY-1) in Biopsy-Proven Patients POXEL SA announced the completion of enrollment in DESTINY-1 (Deuterium-stabilized R-pioglitazone (PXL065) Efficacy and Safety Trial In NASH), a dose-ranging Phase 2 trial evaluating PXL065 for the treatment of NASH. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. DESTINY-1 enrolled 123 noncirrhotic biopsy-proven NASH patients across multiple clinical sites in the US in a 36-week, randomized, dose-ranging, double-blind, placebo-controlled, parallel group study designed to assess the efficacy and safety of PXL065. The primary endpoint of the study will measure the relative change in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). The study will also assess the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers. Results from the Phase 2 study are anticipated in Third Quarter 2022. PXL065 DESTINY-1 Trial Design: The single Phase 2 36-week trial in 123 noncirrhotic biopsy-proven NASH patients will assess three doses of PXL065 (7.5, 15, 22.5 mg) compared to placebo. The primary endpoint of this trial will be the relative change in the percentage of liver fat content measured by MRI-PDFF at 36 weeks. The Phase 2 trial will also evaluate the efficacy on histological endpoints assessed by liver biopsy, assessment of other non-invasive tests and assessment of body weight changes. The goal of this trial is to identify the optimal dose or doses of PXL065 to advance into a Phase 3 registration trial for the treatment of noncirrhotic biopsy-proven NASH patients. Annuncio • Sep 11
Poxel and Sumitomo Dainippon Pharma Announce Product Launch in Japan for TWYMEEG® as Treatment for Type 2 Diabetes Poxel S.A. announced with its partner, Sumitomo Dainippon Pharma, that the product launch of TWYMEEG® (Imeglimin hydrochloride), 500mg tablets for the treatment of type 2 diabetes in Japan, is planned for September 16, 2021. TWYMEEG is Poxel’s first product to reach commercialization and Japan is the first country where the product has been approved. Poxel has received a milestone payment of JPY 1.75 billion (EUR 13.2 million, USD 15.8 million) from Sumitomo in July for the approval of TWYMEEG. Additionally, as part of the license agreement with Sumitomo, Poxel is entitled to receive escalating double-digit royalties on net sales (based on Poxel’s current forecast) and sales-based payments of up to JPY 26.5 billion (approximately EUR 200 million, USD 230 million) in accordance with sales goals. TWYMEEG is a drug with a unique dual mechanism of action for the treatment of type 2 diabetes across the continuum of the current treatment paradigm. It has been approved as a monotherapy and as an add-on treatment to other glucose lowering therapy regimens. The product launch follows the approval by the Japanese regulatory agency in June of this year, which was based on positive results from various preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by Poxel and Sumitomo. The program included three pivotal trials to evaluate TWYMEEG’s efficacy and safety in over 1,100 patients. TWYMEEG met its primary endpoints and objectives, exhibiting a favorable safety and tolerability profile. Annuncio • Jul 14
Poxel S.A. Announces New Strategic Direction with Increasing Focus on Rare Metabolic Diseases POXEL SA announced a new strategic direction to focus its pipeline on high value, rare metabolic indications and NASH, with the goal of creating pipeline synergies, maximizing resources, and driving shareholder value. Based on results from the ongoing PXL065 DESTINY Phase 2 NASH trial and the planned Phase 2a POC biomarker studies for PXL065 and PXL770 in ALD, the Company intends to select one program, either PXL065 or PXL770, to advance in NASH and one program to advance in ALD. In parallel with the Company’s efforts in ALD, another important goal is to launch an additional rare disease development program in 2022. The Company believes that this strategy will expand the addressable market opportunity for its development programs and offers stakeholders a more diversified clinical pipeline. As a result of the review process and portfolio prioritization, the Company is announcing the following clinical development program updates: In ALD, Phase 2a clinical POC biomarker studies of PXL065 and PXL770 are planned to initiate in early 2022, with data expected by year end 2022. The initial focus will be on patients with adrenomyeloneuropathy (AMN), the large subtype of ALD. Two identical studies will enroll adult male AMN patients and assess the effect of PXL065 and PXL770 over 12 weeks of treatment on pharmacokinetics, safety, and efficacy using relevant biomarkers, including the impact on elevated very long-chain fatty acids (VLCFA), the hallmark plasma marker of disease. In NASH, PXL065, deuterium-stabilized R-pioglitazone, is in a streamlined Phase 2 trial (DESTINY). Patient screening is finished and enrollment is now expected to complete in Third Quarter 2021, with topline data anticipated approximately one year later. This Phase 2 36-week trial in noncirrhotic biopsy-proven NASH patients will assess three doses of PXL065 compared to placebo in at least 120 patients. The results of this trial will be used to help identify the dose or doses for a Phase 3 registration trial. Initiation of the NASH Phase 2b trial for PXL770, a first-in-class, oral direct AMPK activator, will be postponed, pending results from the ongoing PXL065 Phase 2 trial in NASH and both Phase 2a POC biomarker studies in AMN. In the STAMP-NAFLD Phase 2a trial, completed at the end of 2020, PXL770 was observed to produce significant improvements in liver fat content and liver enzymes with a greater response in patients with co-existing Type 2 diabetes mellitus (T2DM); in these patients, additional improvements in glycemia were observed. PXL770 was observed to be safe and well tolerated. Annuncio • Jun 26
Poxel Presents Results of Two Clinical Studies on Its Direct Amp Kinase Activator, the Pxl770 Poxel S.A. presented the results of the 12-week, randomized, controlled Phase 2a trial in 120 presumed NASH patients, with or without T2DM, which evaluated three dosing regimens of PXL770, Poxel’s lead direct AMP kinase activator, versus placebo. The results showed that treatment with PXL770 at 500 mg QD resulted in significant reductions in mean liver fat content and alanine transaminase (ALT) levels (vs. baseline). Greater effects were observed in patients with coexisting Type 2 diabetes (T2D, 41-47% of each group): -27% reduction in liver fat content at 500 mg QD vs. baseline; an increase in the proportion of responders (>30% reduction in liver fat); dose-responsive and significant mean decreases in ALT and aspartate transaminase (AST) levels vs. placebo. In the T2D patients, significant placebo-adjusted decreases were observed in fasting plasma glucose and HbA1c (-0.64%) despite well-controlled baseline fasting levels (121-144 mg/dL and 6.6-7.1%, respectively), along with improvements in commonly used fasting indices of insulin sensitivity (HOMA-IR and QUICKI scores). PXL770 was well tolerated with an acceptable safety profile. Annuncio • Jun 24
Poxel SA and Sumitomo Dainippon Pharma Co., Ltd. Announces Approval of TWYMEEG for Treatment of Type 2 Diabetes in Japan POXEL SA and Sumitomo Dainippon Pharma Co., Ltd. announced that a new drug application for TWYMEEG® Tablets 500mg3 (International Nonproprietary Name (INN): Imeglimin hydrochloride), for the treatment of type 2 diabetes, was approved in Japan on June 23. The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by Poxel and Sumitomo Dainippon Pharma, which included three pivotal trials to evaluate TWYMEEG’s efficacy and safety in over 1,100 patients. In all three trials, TWYMEEG met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile. The Phase 3 TIMES program was a joint development effort between Poxel and Sumitomo Dainippon Pharma. The companies entered into a strategic partnership in October 2017 for the development and commercialization of TWYMEEG in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries4. The approval triggers a JPY 1.75 billion (approximately EUR 13.3 million, USD 15.9 million)5 milestone payment to Poxel. Furthermore, after product launch, Poxel is entitled to receive escalating double-digit royalties on net sales and sales-based payments of up to JPY 26.5 billion (approximately EUR 200 million, USD 230 million) in accordance with sales goals. TWYMEEG® is a first-in-class drug with a unique dual mechanism of action for the treatment of Type 2 Diabetes across the continuum of the current treatment paradigm, both as a monotherapy or as an add-on to other glucose lowering therapies. The approval in Japan triggers a JPY 1.75 billion (approximately EUR 13.3 million, USD 15.9 million)1 milestone payment to Poxel from Sumitomo Dainippon Pharma. TWYMEEG’s target product launch is anticipated in fiscal year 2021. The Japanese approval for TWYMEEG is supported by positive results from the Phase 3 TIMES program in over 1,100 patients in Japan. Annuncio • May 21
Poxel S.A. Presents New Results of Imeglimin Phase 2 and 3 Clinical Studies in Japan at the 64th Annual Meeting of the Japan Diabetes Society (JDS) POXEL SA announced presentations of new results from Imeglimin Phase 2 and 3 clinical studies at the 64th Annual Meeting of the Japan Diabetes Society, which is being held virtually (May 20-22, 2021). Imeglimin is a novel agent that acts on both key defects in type 2 diabetes (T2DM) by improving insulin secretion in response to glucose and insulin sensitivity through a unique mode of action. These new results (summarized below) were obtained and presented by company’s clinical development team in collaboration with its partner, Sumitomo Dainippon Pharma and leading diabetologists in Japan. TIMES 2: Long-term efficacy and safety in Phase 3 study with Imeglimin as a mono- and add-on therapies in Japanese T2DM: results from TIMES 2 trial: Open-label, non-placebo controlled, multicenter study to assess the long-term safety/efficacy of Imeglimin for 52 weeks as a mono- and add-on to other available individual antidiabetic therapies in Japanese T2DM patients. Adverse events were generally mild and consistent with known safety/tolerability profile; there was no severe hypoglycemia. Changes from baseline in HbA1c ranged from -0.56 ± 0.08 to -0.92 ± 0.11% in patients receiving Imeglimin added to other oral antidiabetics. Post hoc analysis of Phase 2 and 3 studies of Imeglimin – efficacy and safety in patients with different backgrounds, including elderly patients and those with renal impairment: Further analysis of data derived from key subgroups - based on age, renal function or body mass index (BMI) - from the completed Japanese Phase 2b and TIMES1 Phase 3 trial. Imeglimin treatment produced similar efficacy (HbA1c reduction) regardless of age, renal function, and BMI; the safety profile was also consistent in each subgroup and in comparison with the broader population. Post hoc analyses of Phase 2 and 3 studies of Imeglimin – efficacy in patients with impaired insulin secretion or impaired insulin sensitivity: Further analysis of data derived from the completed Japanese Phase 2b, TIMES 1 and TIMES 2 Phase 3 trials. Subpopulations of patients with greater or lesser degrees of insulin resistance and impaired insulin secretion were identified using standard indices (the value of HOMA-IR, QUICKI and HOMA-ß at baseline, respectively or combination of these indices). The effect of Imeglimin to decrease HbA1c was similar in patient subgroups with predominant insulin resistance or impaired insulin secretion. Reported Earnings • Mar 26
Full year 2020 earnings released The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €6.81m (down 74% from FY 2019). Net loss: €31.9m (loss widened 24% from FY 2019). Is New 90 Day High Low • Jan 19
New 90-day high: €7.54 The company is up 22% from its price of €6.16 on 21 October 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 4.0% over the same period. Annuncio • Jan 15
Poxel S.A. Terminates Partnership Agreement with Metavant Poxel S.A. announced that, as part of the previously communicated decision by Metavant not to advance Imeglimin into a Phase 3 program for strategic reasons, its partnership agreement with Metavant will be terminated, effective January 31, 2021. Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program. Annuncio • Dec 15
Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH POXEL SA announced an update on results from the PXL770 Phase 2a STAMP-NAFLD trial in NASH. The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. The STAMP-NAFLD study was a 12-week, randomized, controlled trial in 120 presumed NASH patients, with or without T2DM, which evaluated three dosing regimens of PXL770 versus placebo. Primary enrollment criteria were hepatic steatosis (NAFLD) based on a controlled attenuation parameter (CAP) score of >300 db/m measured by MRI-PDFF. In patients with T2DM (41-47% of each group), the results observed showed treatment with PXL770 resulted in a -27% mean relative reduction in liver fat content at 500 mg QD (p=0.004) versus baseline. In a new analysis of the T2DM subpopulation patients, findings included: a significant increase in the proportion of responders (>30% reduction in liver fat); dose-responsive and significant mean decreases in alanine transaminase (ALT) and aspartate transaminase (AST) levels were achieved despite only slightly elevated mean baseline ALT levels (36-47 IU/L; normal range <41 IU/L). In the T2DM patients, baseline fasting glucose (121-144 mg/dL) and HbA1c (6.6-7.1%) levels were well controlled, and in this context, significant placebo-adjusted decreases were observed in both glycemic parameters along with improvements in commonly used fasting indexes of insulin sensitivity (HOMA-IR and QUICKI scores). In the T2DM subpopulation, PXL770 was generally safe and well tolerated and was similar to the whole trial population. Annuncio • Nov 20
Poxel Provides Update on Metavant Partnership with Imeglimin Poxel S.A. announced that Metavant has conducted a strategic review and has decided not to move forward with the development of Imeglimin. This decision was not based on any efficacy, safety or other data generated through the partnership. Metavant will not be entitled to any payment from Poxel in the event that rights to Imeglimin are returned to Poxel. Poxel anticipates no impact to its projected cash runway and that its cash and cash equivalents will continue to be sufficient to fund operations through 2022 based on its current business plan. Annuncio • Nov 18
Poxel Presents Phase 1b Clinical Results for PXL065 and New Preclinical Data for PXL770 at AASLD The Liver Meeting 2020 POXEL SA announced the presentation of clinical data from the company’s Phase 1b study of PXL065, which established a dose-proportional pharmacokinetic profile with a substantially altered ratio of R- and S-pioglitazone stereoisomers as predicted from preclinical and Phase 1a results. Additionally, several preclinical studies supporting the efficacy of PXL770 in NASH and other metabolic diseases were presented. The data were illustrated in four poster presentations at The Liver Meeting® Digital Experience 2020, held virtually from November 13-16, 2020, in association with the American Association for the Study of Liver Diseases (AASLD). PXL065, the novel, proprietary deuterium-stabilized R-pioglitazone stereoisomer is currently being evaluated in DESTINY-I, a Phase 2 study in biopsy-proven NASH patients, which seeks to identify the optimal dose or doses for a Phase 3 registration trial. PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, will be advancing into a Phase 2b study for the treatment of noncirrhotic, biopsy-proven NASH. STAMP-NAFLD, the company’s Phase 2a proof-of-concept trial in nonalcoholic fatty liver disease (NAFLD) patients, recently met its primary endpoint and study objectives, demonstrating that PXL770 was observed to be safe, well-tolerated and that it achieved a statistically significant improvement in the relative decrease in liver fat mass as measured by MRI-PDFF at 12 weeks. Additionally, across several clinical parameters and preclinical studies, PXL770 has demonstrated broader potential in other chronic metabolic indications. Poxel is also evaluating earlier stage molecules from its AMPK activator and deuterated thiazolidinedione (TZD) platforms targeting other chronic and rare metabolic diseases. The double-blind, randomized, placebo-controlled Phase 1b study in healthy subjects evaluated PXL065 dosed at 7.5, 15 or 30 mg as compared to 45 mg of Actos over seven days, with a food effect assessment at 15 mg. Objectives of the study included assessing PXL065’s pharmacokinetic and pharmacodynamic (PK/PD) profile, specifically comparing relative exposures to R- and S-stereoisomers. The study also assessed intra-individual variability and exposure to the major metabolites of pioglitazone, M-III and M-IV. The Phase 1b study met its endpoints and demonstrated a favorable safety and tolerability profile. Dose-proportionality was established at all doses. The 15 mg PXL065 dose resulted in plasma exposure to R-pioglitazone that was similar to Actos 45 mg. In contrast, exposure to S-pioglitazone (previously shown to be the only stereoisomer with PPAR? agonist activity) was five times lower after dosing PXL065 versus Actos. Together, these data indicate that deuterium at the chiral center of PXL065 results in consistent stabilization which delays interconversion to S-pioglitazone. Furthermore, analysis of metabolites showed that there is no change in the metabolism of PXL065 versus pioglitazone. Based on preclinical data and these Phase 1 human PK results, approximately 15 mg of PXL065 is predicted to yield similar chronic exposure to the desired stereoisomer, R-pioglitazone, and NASH efficacy as compared with 45 mg Actos, while reducing or eliminating PPAR?-related side effects such as weight gain. Is New 90 Day High Low • Nov 14
New 90-day high: €7.04 The company is up 5.0% from its price of €6.68 on 14 August 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 29
New 90-day low: €5.98 The company is down 7.0% from its price of €6.42 on 30 July 2020. The German market is down 5.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Oct 02
Poxel Announces Positive Results From Phase 2a NASH Trial With PXL770, an Oral First-in-Class Direct AMPK Activator Poxel S.A. announced positive top-line results for STAMP-NAFLD, the PXL770 Phase 2a trial. The Phase 2a trial was a 12-week, randomized, parallel group study, in 120 presumed NASH patients with or without diabetes. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and a range of other chronic and rare metabolic diseases. STAMP-NAFLD was a 12-week randomized, placebo-controlled, parallel group trial in 120 presumed NASH patients, with or without diabetes, which evaluated three dosing regimens of PXL770 versus placebo. Primary enrollment criteria were evidence of hepatic steatosis (NAFLD) based on a controlled attenuation parameter (CAP) score of >300 db/m measured by MRI-PDFF. Patients were randomized into four groups: PXL770 at 250 mg once-daily (QD); 250 mg twice-daily (BID); 500 mg once-daily (QD) versus patients who received placebo. The Phase 2a trial met its primary efficacy endpoint; PXL770 was observed to produce a statistically significant mean relative decrease of 18% in liver fat mass from baseline at 12-weeks in the 500 mg QD dose group as measured by MRI-PDFF (p=0.0036 vs. -0.7% change in placebo). A greater proportion of patients who received PXL770 also achieved a >30% relative reduction in liver fat content compared to placebo; greater liver fat content reduction (up to -85%) was also observed in more responsive patients. Although mean baseline ALT values (37-41 U/L) were near the upper range of normal, a statistically significant reduction in mean ALT was also observed in the 500 mg dose group. In patients with type 2 diabetes (41-47% of each group), PXL770 treatment resulted in a greater mean relative reduction in liver fat content (-27% at 500 mg QD; p=0.004 versus baseline). The effects of PXL770 in this key subpopulation will be further evaluated within each treatment group. Despite nearly normal mean baseline HbA1c values (6.03-6.30%) across all groups (patients with and without diabetes), a significant reduction in mean HbA1c was also observed. A similar trend was also observed on fasting plasma glucose. Annuncio • Sep 24
Poxel S.A. Presents Imeglimin Phase 3 TIMES Results and PXL770 Preclinical Cardio-Renal Results at the 56th European Association for the Study of Diabetes Annual Meeting Poxel S.A. announced that it presented Imeglimin Phase 3 results for TIMES 2 and TIMES 3 and new preclinical results for PXL770 in a cardio-renal disease model at the 56thEuropean Association for the Study of Diabetes (EASD) Annual Meeting, which is being held virtually. In two presentations, Phase 3 results from the Imeglimin TIMES 2 and TIMES 3 (Trials of IMeglimin for Efficacy and Safety) trials were presented. The TIMES program in Japan was a joint development effort between Poxel and Sumitomo Dainippon Pharma Co. Ltd. and it included three pivotal trials in over 1,100 patients. In all three trials, Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile. In July 2020, a New Drug Application (NDA) was submitted by Sumitomo Dainippon Pharma in Japan and is currently under review by the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes. In a poster session focusing on PXL770, a direct AMPK activator, results from a cardio-renal syndrome preclinical model demonstrated observed improvements in diabetic nephropathy and in diastolic cardiac dysfunction that are consistent with the prevention of disease progression in both the kidney and heart. These results demonstrate that PXL770 and direct AMPK activation may lead to broader utility for organ diseases mediated by metabolic pathway dysfunction. 
