New Risk • May 31
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: zł27m Forecast net loss in 3 years: zł93m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-zł32m free cash flow). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł93m net loss in 3 years). Share price has been volatile over the past 3 months (9.0% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (zł111.8m market cap, or US$30.8m). New Risk • May 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 27% This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-zł32m free cash flow). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł93m net loss in 3 years). Share price has been volatile over the past 3 months (9.1% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (zł118.0m market cap, or US$32.3m). Announcement • May 22
Poltreg S.A., Annual General Meeting, Jun 17, 2026 Poltreg S.A., Annual General Meeting, Jun 17, 2026, at 12:00 Central European Standard Time. New Risk • May 19
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: zł27m Forecast net loss in 3 years: zł93m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-zł32m free cash flow). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł93m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Market cap is less than US$100m (zł92.8m market cap, or US$25.3m). New Risk • Mar 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Polish stocks, typically moving 8.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-zł28m free cash flow). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (8.5% average weekly change). Market cap is less than US$100m (zł76.9m market cap, or US$20.7m). New Risk • Mar 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 22% per year for the foreseeable future. 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 expected to decline, then in most cases the share price will decline over time as well. 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 Less than 1 year of cash runway based on free cash flow trend (-zł28m free cash flow). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (zł114.3m market cap, or US$30.9m). Announcement • Mar 11
PolTREG SA Moves Forward With European Registration Process For TREG Therapy In Type 1 Diabetes PolTREG SA announced that a significant milestone has been achieved in the process of registration of cell therapy for the treatment of symptomatic type 1 diabetes in the European Union. The European Medicines Agency (EMA) has officially confirmed that the Committee for Medicinal Products for Human Use (CHMP), based on the studies and documentation presented by the Company, has qualified the TREGs cells preparation product – PolTREG-T1D (PTG-007) for submission of an application for marketing authorization under the centralized procedure in the European Union. The Committee for Medicinal Products for Human Use (CHMP) made the decision after analyzing the clinical trial results presented by PolTREG to date. The Committee highly valued the substantive content of the documentation, which allows the Company to apply for marketing authorization for a pediatric indication. PolTREG submitted globally unique data from 7–12 years of patient follow-up (clinical trials conducted by PolTREG) in support of the application for registration. These data confirmed that TREG therapy not only has an unprecedented safety profile but, above all, inhibits disease progression and maintains long-term endogenous insulin secretion. The EMA initially expected 5-year data, but PolTREG provided scientific evidence spanning over a decade, placing the PTG-007 project in a best-in-class position. The EMA registration process concerns the treatment of type 1 diabetes in the early symptomatic phase (stage 3). In the pre-symptomatic phase of type 1 diabetes (stages 1 and 2), clinical trials are being conducted in children in Poland and are also planned in the US. The EMA's positive assessment of PolTREG's application places the company at the center of attention in the global pharmaceutical industry. The history of the biotechnology market shows that the registration of an innovative therapy for type 1 diabetes is a direct factor in concluding multi-billion dollar deals. Confirmation of eligibility triggers the formal registration timeline: designation at the EMA, at the Company’s request, of a dedicated administrative and substantive team dealing with the registration process; Submission of the full Dossier (MAA): The Company is finalizing the preparation of the full technical and clinical documentation; After submitting the application, there is a substantive assessment phase (usually lasting approximately 210 days of pure assessment time, not including the so-called clock-stops for agency questions); After obtaining a positive opinion from the CHMP, the European Commission issues a central marketing authorization valid in all EU and EEA countries. PolTREG estimates that the full schedule of meetings and assessments (the so-called EMA calendar) will be finalised within the next two months. New Risk • Feb 01
New major risk - Revenue and earnings growth Earnings have declined by 56% 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 Less than 1 year of cash runway based on free cash flow trend (-zł28m free cash flow). Earnings have declined by 56% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (zł120.3m market cap, or US$33.9m). Announcement • Nov 15
Poltreg S.A. to Report Q3, 2025 Results on Nov 19, 2025 Poltreg S.A. announced that they will report Q3, 2025 results on Nov 19, 2025 Announcement • Nov 08
Immuthera and Its Wholly Owned Subsidiary of Poltreg S.A Appoints Adrian Bot to Its Board of Directors Poltreg S.A. announced that Dr. Adrian Bot, a renowned biopharmaceutical founder and scientist, has joined Immuthera’s Board of Directors to strengthen its pipeline development and commercialization efforts. Immuthera, operating in the United States, is a wholly owned subsidiary of PolTREG S.A. a leader in innovative immune therapies with focus on regulatory T cell technologies. In addition, Dr. Bot will serve as Scientific Advisor of PolTREG S.A., leveraging his experience in development and commercialization of novel cell and gene therapies. Dr. Bot brings 27 years of experience in the U.S. biopharmaceutical industry, spanning discovery, preclinical and clinical development, translational medicine and product life cycle management in commercial setting. He spent over half of his professional career developing first-in-class or best-in-class CAR T cell products. Dr. Bot was the founding CSO and EVP of R&D for Capstan Therapeutics, a company developing in vivo mRNA-based CAR-T therapies. He helped secure $165 million in financing for Capstan and then participated in the company's sale to AbbVie for $2.1 billion in 2025. Dr. Bot held leadership positions at Kite Pharma, where he contributed to the success of Yescarta and Tecartus, CAR-T cell therapies for Oncology. The company was acquired by Gilead for $11.9 billion in 2017. Dr. Adrian Bot, M.D., Ph.D., was the founding Chief Scientific Officer and EVP of R&D for Capstan Therapeutics, a company focused on the development of in vivo CAR-T therapies. Prior to this, he held leadership positions at Kite Pharma, before and after the acquisition by Gilead Sciences, where he contributed to the development and approvals of Yescarta® and Tecartus®, the first autologous CAR-T cell therapies for Non-Hodgkin’s lymphoma and other indications. He obtained his M.D. from the University of Medicine and Pharmacy, Timisoara in Romania in 1993 and his Ph.D. in Biomedical Sciences at Mount Sinai School of Medicine in New York in 1998. He was also a Guest Scientist at Scripps Research Institute in La Jolla, California andauthored or co-authored over 100 scientific publications. In addition to his expertise and network of scientific collaborators in areas relevant to PolTREG and Immuthera, Dr. Bot possesses unique experience in the development and commercialization of groundbreaking therapies integrating gene medicines and cellular technologies. He participated in numerous financing rounds and two major acquisitions, in companies where he served as Chief Scientific Officer. Under his leadership, Capstan secured $165 million in financing and was subsequently acquired by AbbVie for $2.1 billion in 2025. Capstan's primary assets included its in vivo CAR-T therapy candidate, CPTX2309, and its patented lipid nanoparticle platform technology, used for mRNA delivery and cell engineering. At Kite Pharma, he was instrumental in the scientific leadership and translational development of Yescarta® and Tecartus®, groundbreaking cell gene therapies that target and destroy cancer cells using the patient's own modified CAR-T immune cells. Yescarta® was the second CAR-T therapy approved by the FDA and the first one for Non-Hodgkin’s lymphoma; and shortly before marketing approval, Kite was acquired by Gilead Sciences for $11.9 billion in 2017. New Risk • Sep 12
New major risk - Revenue and earnings growth Earnings have declined by 65% 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 Earnings have declined by 65% per year over the past 5 years. Revenue is less than US$1m (zł250k revenue, or US$69k). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł7.0m net loss next year). Share price has been volatile over the past 3 months (8.1% average weekly change). Market cap is less than US$100m (zł128.2m market cap, or US$35.4m). New Risk • Sep 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Polish stocks, typically moving 6.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (zł250k revenue, or US$69k). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł16m net loss next year). Share price has been volatile over the past 3 months (6.2% average weekly change). Market cap is less than US$100m (zł122.6m market cap, or US$33.7m). Announcement • Aug 21
Poltreg S.A. to Report Q2, 2025 Results on Sep 10, 2025 Poltreg S.A. announced that they will report Q2, 2025 results on Sep 10, 2025 Announcement • Aug 05
PolTREG S.A. Doses First Patient in Phase II Trial for Pre-Symptomatic Type 1 Diabetes with PTG-007 PolTREG S.A. and its U.S. subsidiary Immuthera, announced that they have administered the first dose of PTG-007 to a patient in their Phase II clinical trial for pre-symptomatic type 1 diabetes. The trial, called "Pre-Treg" will enroll up to 150 genetically high-risk children and adolescents (aged 3-18) who have not yet developed clinical symptoms of the disease. If successful, PolTREG aims to develop and register the world's first therapy to prevent the onset of type 1 diabetes symptoms. The company has proposed a parallel study to Pre-Treg to the U.S. Food and Drug Administration (FDA) in a recent Pre-IND meeting. The FDA's response was that the U.S. Trial could potentially be registrational. Further, patients enrolled in Poland at Stage 1 of the disease may, upon completion of enrollment, be included in the U.S. statistical analysis of the study. The Phase II study will include 150 participants in a randomized, placebo-controlled design. Recruitment is ongoing at three academic centers in Poland, with six additional clinical hospitals set to begin enrollment shortly. PolTREG has been awarded a non-dilutive grant of PLN 31.7 million (approx. $11.3 million) from the Polish Medical Research Agency to support the execution of this Phase II trial. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman-- joined the company's Scientific Advisory Board. In late July, PolTREG received the formal outcome of its pre-IND meeting with the FDA and is now preparing its IND submission. The company has partnered with Noble Capital Markets Inc. and Kinexum Services LLC to support its U.S. regulatory strategy, and is collaborating with Swiss-based Antion Biosciences to develop next-generation allogeneic Treg therapies. Announcement • Aug 01
Poltreg and Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial PolTREG S.A. and Immuthera announced that the U.S. Food and Drug Administration (FDA) has issued a formal meeting protocol summarizing the recent pre-Investigational New Drug (pre-IND) meeting on the adaptive Phase 2/3 trial of PTG-007 in children with stage 1 and stage 2 presymptomatic Type 1 diabetes. The protocol confirms that the clinical data submitted by PolTREG and Immuthera are sufficient to support an IND application and outlines several regulatory pathways to accelerate U.S. development. Key Takeaways from the FDA Protocol: The FDA indicated that the general study design (double-blind, four treatment groups, stratification by age and HLA, and quarterly follow-up) is reasonable. FDA agrees that, in the proposed study, the potential benefits of treatment outweigh any risks to patients. FDA confirms that the clinical data submitted by the Company are sufficient to support an IND application for the proposed U.S. study. FDA is open to including Stage 1 patients from Poland in the U.S. trial’s statistical analysis. FDA prefers that technology transfer data to the U.S. be included in the IND submission. FDA will consider treating the Company’s proposed adaptive Phase 2/3 study as a registrational trial. In a next step, PolTREG plans to file its formal IND meeting request with the FDA in the coming weeks. Strengthening U.S. Presence PolTREG has been bolstering its U.S. footprint: In mid-June, PolTREG established Immuthera, a 100%-owned Delaware C Corporation. In early July, acclaimed diabetes and neuroimmunology experts Prof. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman joined the Company’s Scientific Advisory Board. Earlier this year, Noble Capital Markets Inc. and Kinexum Services LLC came on board to support PolTREG’s U.S. registration efforts. PolTREG also initiated a collaboration with Antion Biosciences (Switzerland) to develop next-generation allogeneic TREG therapies. PolTREG is developing Multi-edited and Allogeneic CAR-Tregulatory cell therapies which can be used to treat patients diagnosed with T1D (Stage 3), which, in combination with PTG-007 in Stage 1 and Stage 2, will provide clinical solutions for patients across all Stages of T1D. New Risk • Jun 09
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: zł21m Forecast net loss in 1 year: zł16m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (zł250k revenue, or US$67k). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł16m net loss next year). Market cap is less than US$100m (zł164.6m market cap, or US$44.0m). Breakeven Date Change • May 26
Forecast to breakeven in 2026 The analyst covering Poltreg expects the company to break even for the first time. New forecast suggests the company will make a profit of zł11.6m in 2026. Average annual earnings growth of 82% is required to achieve expected profit on schedule. Announcement • May 15
PolTREG S.A. Announces Positive Ema Opinion on Pediatric Investigation Plan for PolTREG's Treg Therapy in Type 1 Diabetes PolTREG S.A. announced that the Paediatric Committee (PDCO) of the European Medicines Agency has issued a positive opinion on the Pediatric Investigation Plan (PIP) for its investigational somatic cell therapy product, polyclonal Treg lymphocytes (PTG-007), aimed at preventing symptomatic type 1 diabetes in children. "Securing a positive opinion from the PDCO brings PolTREG one step closer to the potential approval of PTG-007 for pediatric use across the European Union and the European Economic Area. Achieving the PIP-defined clinical endpoints may serve as the basis for obtaining marketing authorization. The in vivo murine results obtained a few days ago using CAR-TREG lymphocytes shows the preliminary safety and efficacy of CAR-Treg therapies--data derived from clinical trials and hospital exemptions in Poland. In parallel, PolTREG has achieved a major milestone toward its CAR-TREG program, in collaboration with AZTherapies. In vivo studies in murine models demonstrate encouraging preliminary safety and efficacy for CAR-Treg lymphocytes, supporting an application for a Phase 1 clinical trial in multiple sclerosis and Amyotrophic Lateral Sclerosis in the coming months. This cellular product will be further made allogeneic in the cooperation with Swiss-based company Antion Biosciences. PolTREG manufactures its Treg therapeutics at its own GMP-certified manufacturing facility. Announcement • Apr 17
Poltreg S.A., Annual General Meeting, May 20, 2025 Poltreg S.A., Annual General Meeting, May 20, 2025. Reported Earnings • Nov 22
Third quarter 2024 earnings released: zł1.26 loss per share (vs zł1.06 loss in 3Q 2023) Third quarter 2024 results: zł1.26 loss per share (further deteriorated from zł1.06 loss in 3Q 2023). Net loss: zł5.88m (loss widened 19% from 3Q 2023). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 57 percentage points per year, which is a significant difference in performance. Price Target Changed • Nov 13
Price target decreased by 13% to zł59.65 Down from zł68.20, the current price target is an average from 2 analysts. New target price is 19% above last closing price of zł50.00. Stock is down 13% over the past year. The company is forecast to post a net loss per share of zł5.20 next year compared to a net loss per share of zł2.91 last year. Announcement • Oct 25
PolTREG S.A. Launches Phase 2 Cell Therapy Trial in Children with Presymptomatic Diabetes PolTREG S.A. has launched a placebo-controlled Phase 2 clinical trial with PTG-007 Treg cell therapy in presymptomatic type-1 diabetes (T1D) patients, after receiving approval from the European Medicines Agency. The study will evaluate safety and efficacy in 150 patients, including those aged between 6 and 16 years who are at high genetic risk of developing T1D, but who have not yet shown any symptoms. Clinical sites for the study have started to open, and patient recruitment and randomization will follow later this year. "When patients are diagnosed with diabetes, they typically have already lost the vast majority of pancreatic islets producing insulin, and the rest will follow not much later. When administering PTG-007 at an earlier stage of the disease, the number of viable islets is still sufficient to prevent symptoms from occurring. PolTREG is the only company to hold up to 12 years' worth of proprietary safety and efficacy data in patients with early-onset T1D for PTG-007, a polyclonal autologous Treg cellular therapy. The data showed that a proportion of patients remained insulin-independent up to 18 to 24 months after treatment, while another subset of patients was still in clinical remission - defined as having a low need for external insulin - 7 to 12 years after treatment. The company is planning to launch a pivotal Phase 2/3 trial with PTG-007 in early-onset T 1D, for which it is looking for external funding. PTG-007 is an Advanced Therapy Medicinal Product (ATMP), which serves as a platform to develop therapies for a wide range of autoimmune diseases. The company has completed a total of five clinical trials in T1D, multiple sclerosis (MS) and graft vs host disease. PolTREG is the first company to develop all available Treg modalities in house, including CAR-Treg and other engineered Treg cells. Its lengthy safety and efficacy track record with PTG-007 in patients of more than a decade puts it ahead of its competitors, as the new products it is adding to its pipeline show a large degree of bioequivalence with PTG-007, leading the company to expect it will be able to develop new therapies and bring them to market quicker than others. Announcement • Jun 25
PolTREG’s Type-1 Diabetes Treg Cell Therapy PTG-007 Demonstrates Long-Term Safety and Efficacy for Up to 12 Years PolTREG S.A. announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care, in a long-term clinical study into the safety and efficacy of lead asset PTG-007. The study monitored pediatric patients who received the autologous treatment over a period of 7 to 12 years. The main findings were: Patients who received PTG-007 continued to secrete insulin, while untreated patients in the control group did not, Safety measures showed no significant difference in the health status of patients who received Treg therapy compared to the control group, The duration of disease remission - the period of disease characterized by moderate severity of disease symptoms with low insulin requirement or insulin independence - was significantly longer in patients who received PTG-007 compared to the control group. A preliminary estimate is that the difference was between 3 and 4 years, however, that number still needs to be confirmed in final results. With the study, PolTREG has fulfilled a requirement by the European Medicines Agency to confirm the safety of Treg therapies at least 5 years after their administration. To the best of PolTREG’s knowledge, no other company currently can show similar long-term safety results of Treg therapy in T1D. This is a significant competitive advantage, and paves the way for the company to launch a pivotal Phase 2/3 study of PTG-007 to treat T1D. PolTREG is currently seeking partnership funding for this pivotal trial, the final step required before seeking regulatory authorization for commercialisation. The company will submit the data for a peer-reviewed scientific publication in the near future. PolTREG holds one of the largest and most advanced pipelines for Treg therapies for autoimmune disease, developing both polyclonal and engineered therapies. Its lead candidate, PTG-007, an autologous polyclonal Treg treatment, is in mid-stage clinical studies for T1D and multiple sclerosis (MS). Next year, PolTREG expects to start a first-in-human trial of its engineered CAR-Tregs for treatment of two neurodegenerative diseases, MS and amyotrophic lateral sclerosis (ALS). The company also is in preclinical development with two further types of engineered Treg cells. PolTREG manufactures all its Treg therapeutics at its own GMP-certified manufacturing facility. It is the first company in the world to administer Treg therapies to patients, and, under a hospital exemption valid in Poland, the first to start receiving revenues from a Treg therapeutic for autoimmune disease. Its GMP manufacturing facility is one of Europe’s largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies. It can ship its wide range of cellular therapy products across Europe within 24 hours. Announcement • May 31
Poltreg S.A., Annual General Meeting, Jun 25, 2024 Poltreg S.A., Annual General Meeting, Jun 25, 2024. New Risk • May 26
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: zł16m Forecast net loss in 1 year: zł699k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (zł900k revenue, or US$230k). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł699k net loss next year). Market cap is less than US$100m (zł228.0m market cap, or US$58.2m). Reported Earnings • Apr 22
Full year 2023 earnings released Full year 2023 results: Net loss: zł13.6m (loss widened zł11.6m from FY 2022). Revenue is forecast to grow 33% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Announcement • Mar 13
Poltreg S.A. Receives CGMP Certification to Produce Cell Therapies At Its State-Of-The-Art Manufacturing Site in Poland PolTREG S.A. announced it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS). PolTREG was the first company in the world to administer T-reg therapies to patients, and the first to start receiving revenues from its lead product under a hospital exemption valid in Poland. Its manufacturing facility is one of Europe’s largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies from future partners. The company now has more than 17 years of experience treating patients, having administered Treg cells to more than 100 people over that period, either in hospital exemption procedures or in clinical trials. PolTREG has developed one of the most advanced pipeline for Treg therapies for autoimmune disease, with both polyclonal and engineered cells. Its lead candidate, PTG-007, is in mid-stage clinical studies for two indications in T1D and two in MS. For CAR-Tregs, it expects to start a First-in-Human trial for two neurodegenerative diseases - MS and Amyotrophic Lateral Sclerosis (ALS) – in early 2025. It is also in preclinical tests with two further types of engineered cells. Reported Earnings • Nov 26
Third quarter 2023 earnings released Third quarter 2023 results: Net loss: zł4.93m (loss widened zł4.40m from 3Q 2022). Reported Earnings • Sep 12
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: zł3.17m (down zł3.25m from profit in 2Q 2022). Announcement • May 31
Poltreg S.A., Annual General Meeting, Jun 26, 2023 Poltreg S.A., Annual General Meeting, Jun 26, 2023, at 12:00 Central European Standard Time. Reported Earnings • Apr 25
Full year 2022 earnings released Full year 2022 results: Net loss: zł1.97m (loss narrowed 47% from FY 2021). Reported Earnings • Nov 27
Third quarter 2022 earnings released Third quarter 2022 results: Net loss: zł530.0k (loss narrowed 43% from 3Q 2021). Announcement • May 31
Poltreg S.A., Annual General Meeting, Jun 24, 2022 Poltreg S.A., Annual General Meeting, Jun 24, 2022, at 10:00 Central European Standard Time. Reported Earnings • Dec 02
Third quarter 2021 earnings: Revenues and EPS in line with analyst expectations Third quarter 2021 results: zł0.28 loss per share. Net loss: zł923.0k (flat on 3Q 2020). Revenue was in line with analyst estimates.