Alligator Bioscience（0RK9）株式概要アリゲーター・バイオサイエンス社（Alligator Bioscience AB）は研究開発型のバイオテクノロジー企業で、ベルギーでがん治療用の抗体医薬を開発している。 詳細0RK9 ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長1/6過去の実績0/6財務の健全性4/6配当金0/6報酬収益は年間7.12%増加すると予測されています 過去5年間の収益は年間3.6%増加しました。 リスク分析キャッシュランウェイが1年未満である 今後3年間の収益は年平均34.7%減少すると予測されている。 収益が 100 万ドル未満 ( SEK520K )UK市場と比較して、過去 3 か月間の株価の変動が非常に大きい+3 さらなるリスクすべてのリスクチェックを見る0RK9 Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueSEK Current PriceSEK 0.2219.8k% 割高 内在価値ディスカウントEst. Revenue$PastFuture-249m213m2016201920222025202620282031Revenue SEK 733.6kEarnings SEK 133.3kAdvancedSet Fair ValueView all narrativesAlligator Bioscience AB (publ) 競合他社Aptamer GroupSymbol: AIM:APTAMarket cap: UK£19.9mCardiogeniSymbol: OFEX:CGNIMarket cap: UK£6.7mTheracryfSymbol: AIM:TCFMarket cap: UK£4.9mOptiBiotix HealthSymbol: AIM:OPTIMarket cap: UK£5.9m価格と性能株価の高値、安値、推移の概要Alligator Bioscience過去の株価現在の株価SEK 0.2252週高値SEK 6.7752週安値SEK 0.16ベータ1.241ヶ月の変化-6.12%3ヶ月変化15.01%1年変化-94.87%3年間の変化-99.90%5年間の変化n/aIPOからの変化-99.90%最新ニュースReported Earnings • May 07First quarter 2026 earnings releasedFirst quarter 2026 results: Net income: kr1.44m (up kr9.79m from 1Q 2025). Revenue is forecast to grow 12% p.a. on average during the next 2 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom.お知らせ • Apr 21Alligator Bioscience Presents New Data from Investigator-Initiated Study Evaluating Mitazalimab At AACR Annual MeetingAlligator Bioscience announced that new data from a Phase 1 investigator-initiated trial evaluating intratumoral mitazalimab administered in conjunction with irreversible electroporation (IRE) in locally advanced pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. The abstract reports updated immunological findings from the ongoing Phase 1 dose-escalation study (NCT06205849). The study assesses mitazalimab when injected directly into the tumor at the time of surgical IRE in patients with locally advanced PDAC after standard-of-care chemotherapy. The abstract highlights that all six patients with completed pre- and post-treatment analyses demonstrated T-cell reactivity to patient-specific neoantigens. Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells.Reported Earnings • Apr 01Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is forecast to grow 4.2% p.a. on average during the next 2 years, compared to a 5.0% decline forecast for the Biotechs industry in the United Kingdom.お知らせ • Mar 27Alligator Bioscience AB (Publ) Announces Eva Sjökvist Saers Declines Re-Election as Board MembersAlligator Bioscience AB (publ) at the AGM to be held on May 6, 2026, Eva Sjökvist Saers has declined re-election as Board members.New Risk • Feb 17New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr51m Forecast net loss in 2 years: kr66m 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 (-kr157m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 32x increase in shares outstanding). Revenue is less than US$1m (kr4.4m revenue, or US$495k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr66m net loss in 2 years). Market cap is less than US$100m (kr94.1m market cap, or US$10.5m).Reported Earnings • Feb 15Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is expected to fall by 4.5% p.a. on average during the next 2 years compared to a 3.1% decline forecast for the Biotechs industry in the United Kingdom.最新情報をもっと見るRecent updatesReported Earnings • May 07First quarter 2026 earnings releasedFirst quarter 2026 results: Net income: kr1.44m (up kr9.79m from 1Q 2025). Revenue is forecast to grow 12% p.a. on average during the next 2 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom.お知らせ • Apr 21Alligator Bioscience Presents New Data from Investigator-Initiated Study Evaluating Mitazalimab At AACR Annual MeetingAlligator Bioscience announced that new data from a Phase 1 investigator-initiated trial evaluating intratumoral mitazalimab administered in conjunction with irreversible electroporation (IRE) in locally advanced pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. The abstract reports updated immunological findings from the ongoing Phase 1 dose-escalation study (NCT06205849). The study assesses mitazalimab when injected directly into the tumor at the time of surgical IRE in patients with locally advanced PDAC after standard-of-care chemotherapy. The abstract highlights that all six patients with completed pre- and post-treatment analyses demonstrated T-cell reactivity to patient-specific neoantigens. Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells.Reported Earnings • Apr 01Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is forecast to grow 4.2% p.a. on average during the next 2 years, compared to a 5.0% decline forecast for the Biotechs industry in the United Kingdom.お知らせ • Mar 27Alligator Bioscience AB (Publ) Announces Eva Sjökvist Saers Declines Re-Election as Board MembersAlligator Bioscience AB (publ) at the AGM to be held on May 6, 2026, Eva Sjökvist Saers has declined re-election as Board members.New Risk • Feb 17New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr51m Forecast net loss in 2 years: kr66m 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 (-kr157m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 32x increase in shares outstanding). Revenue is less than US$1m (kr4.4m revenue, or US$495k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr66m net loss in 2 years). Market cap is less than US$100m (kr94.1m market cap, or US$10.5m).Reported Earnings • Feb 15Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is expected to fall by 4.5% p.a. on average during the next 2 years compared to a 3.1% decline forecast for the Biotechs industry in the United Kingdom.Board Change • Feb 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Employee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offeringお知らせ • Dec 03+ 3 more updatesAlligator Bioscience AB (publ) to Report First Half, 2026 Results on Aug 27, 2026Alligator Bioscience AB (publ) announced that they will report first half, 2026 results on Aug 27, 2026New Risk • Nov 07New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr78m Forecast net loss in 2 years: kr47m 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 (-kr165m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Negative equity (-kr9.2m). Shareholders have been substantially diluted in the past year (over 56x increase in shares outstanding). Market cap is less than US$10m (kr84.1m market cap, or US$8.79m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr47m net loss in 2 years). Revenue is less than US$5m (kr46m revenue, or US$4.8m).お知らせ • Nov 04Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026.Breakeven Date Change • Oct 24Forecast to breakeven in 2026The analyst covering Alligator Bioscience expects the company to break even for the first time. New forecast suggests losses will reduce by 49% to 2025. The company is expected to make a profit of kr139.0m in 2026. Average annual earnings growth of 53% is required to achieve expected profit on schedule.New Risk • Oct 23New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: kr62.2m (US$6.62m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr163m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Negative equity (-kr35m). Shareholders have been substantially diluted in the past year (over 56x increase in shares outstanding). Market cap is less than US$10m (kr62.2m market cap, or US$6.62m). Minor Risk Revenue is less than US$5m (kr44m revenue, or US$4.7m).お知らせ • Oct 13Alligator Bioscience Announces Upcoming Presentation of Data from the Phase 1 Trial At the ESMO Congress 2025Alligator Bioscience announced the upcoming presentation of data from the Phase 1 REACtiVe-2 trial (NCT05650918) at the ESMO Congress 2025, showcasing the immunologic and clinical effects of mitazalimab in combination with dendritic cell therapy in patients with metastatic pancreatic cancer. The investigator-sponsored trial, conducted at Erasmus MC Cancer Institute, demonstrated that the combination of mitazalimab and Amphera's dendritic cell vaccine MesoPher was safe and well-tolerated, with enhanced systemic and local immune responses. Half of the patients achieved stable disease after three administrations, with post-treatment biopsies revealing increased tumor-infiltrating T cells and reduced collagen deposition.New Risk • Jul 14New minor risk - Revenue sizeThe company makes less than US$5m in revenue. Total revenue: kr48m (US$5.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr163m free cash flow). Shares are highly illiquid. Negative equity (-kr35m). Shareholders have been substantially diluted in the past year (over 44x increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr48m revenue, or US$5.0m). Market cap is less than US$100m (kr190.3m market cap, or US$19.9m).Reported Earnings • Jul 12Second quarter 2025 earnings released: kr0.08 loss per share (vs kr66.36 loss in 2Q 2024)Second quarter 2025 results: kr0.08 loss per share (improved from kr66.36 loss in 2Q 2024). Revenue: kr345.0k (down 95% from 2Q 2024). Net loss: kr1.69m (loss narrowed 97% from 2Q 2024). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 9.7% growth forecast for the Biotechs industry in the United Kingdom.お知らせ • Jul 02Alligator to Present 24-Month Optimize-1 Data At ESMO GI 2025Alligator Bioscience announced that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2- 5 July. The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1, a Phase 1b/2 trial in patients with previously untreated NCT04888312 metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 ug/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone. A comparison between the 900 ug/kg and 450 ug/kg cohorts revealed a higher response rate for 900 ug/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab's contribution to the positive clinical, reinforcing the candidate's favorable response data observed in OPTIMIZE-1. safety profile and supporting 900 ug/kg as the recommended Phase 3 dose - a decision recently endorsed by the FDA.お知らせ • Jun 03Alligator Bioscience Announces Biomarker Data from Its Optimize-1 Trial Presented At Asco 2025 Annual MeetingAlligator Bioscience announced that biomarker data from its OPTIMIZE-1 clinical trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. OPTIMIZE-1 is a Phase 1b/2 trial evaluating mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The study has demonstrated strong clinical outcomes to date, including a 30% survival rate at 24 and a median overall survival of 14.9 months. The biomarker analyses highlighted mitazalimab's immunological mechanism of action, with immune activation in responding patients and gene signatures associated with clinical benefit and improved survival. These results support continued development of mitazalimab, including a planned confirmatory trial in mPDAC.お知らせ • May 23Alligator Bioscience Announces Presentation of Biomarker Data from its OPTIMIZE-1 Clinical Trial at 2025 American Society of Clinical Oncology Annual MeetingAlligator Bioscience announced the presentation of biomarker data from its OPTIMIZE-1 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a 30% survival rate at 24-months follow up. Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes. These translational data strengthen the rationale for mitazalimab's mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab In mPDAC, including the planned randomized confirmatory trial. Alligator's participation at ASCO reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab's potential and engage in strategic partnering discussions.お知らせ • May 07Alligator Bioscience AB (Publ) Approves Board ChangesAlligator Bioscience AB (publ) held its AGM on 7 May 2025, Hans-Peter Ostler was elected as new Chairman of the board. The previous board members Anders Ekblom and Staffan Encrantz were not available re-election.お知らせ • Apr 23Alligator Bioscience AB Initiates Phase 2 Clinical Trial with HLX22Alligator Bioscience AB announced that Shanghai Henlius Biotech Inc. has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator's subsidiary, Atlas Therapeutics. HLX22 is being developed by Henlius under a sublicense from AbClon Inc., which had previously licensed the antibody from Alligator. The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy. Under the terms of the license agreement, Alligator is entitled to 35% of AbClon's revenue from its sublicense agreement with Henlius.New Risk • Apr 04New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: kr93.0m (US$9.26m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 24x increase in shares outstanding). Market cap is less than US$10m (kr93.0m market cap, or US$9.26m).Reported Earnings • Apr 02Full year 2024 earnings released: kr0.32 loss per share (vs kr0.55 loss in FY 2023)Full year 2024 results: kr0.32 loss per share (improved from kr0.55 loss in FY 2023). Revenue: kr57.7m (down 2.6% from FY 2023). Net loss: kr233.9m (loss narrowed 5.9% from FY 2023).お知らせ • Mar 22Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Dr. Sumeet Ambarkhane MD, Chief Medical Officer, will be leaving Alligator by end of March 2025. Dr. Ambarkhane has played a key role in advancing Alligator's immune-oncology pipeline and establishing its clinical development organization over the past years. In particular, he led the clinical development of mitazalimab and OPTIMIZE-1, Alligator's Phase 2 trial in metastatic pancreatic cancer towards its readiness for a Phase 3 confirmatory development. Having worked with the company for an extended period, enabling a smooth transition, Dr. Tom Moore will assume the role as Chief Medical Officer. Dr. Moore is a seasoned oncology drug developer bringing industry experience from over a decade with Roche and subsequent work as a consultant, with deep experience in immuno-oncology and a strong commitment to advancing innovative treatments. His decision to step into the new role underscores his confidence in mitazalimab's potential and Alligator's mission to bring new therapeutic options to patients with high unmet medical needs. Dr. Moore will assume his role from the start of April ensuring a smooth transition in Alligator's clinical development leadership.New Risk • Mar 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Over 24x increase in shares outstanding. 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 Less than 1 year of cash runway based on free cash flow trend (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 24x increase in shares outstanding). Minor Risk Market cap is less than US$100m (kr777.7m market cap, or US$73.9m).お知らせ • Feb 14Alligator Bioscience AB (publ) has completed a Composite Units Offering in the amount of SEK 152.964693 million.Alligator Bioscience AB (publ) has completed a Composite Units Offering in the amount of SEK 152.964693 million. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 1,529,646,926 Price\Range: SEK 0.1 Transaction Features: Rights OfferingNew Risk • Feb 03New major risk - Revenue and earnings growthEarnings have declined by 9.0% 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 (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Market cap is less than US$10m (kr30.6m market cap, or US$2.73m). Minor Risk Shareholders have been diluted in the past year (15% increase in shares outstanding).お知らせ • Jan 27Alligator Bioscience AB (publ) Announces Positive Outcomes from adjusted Indirect Treatment Comparations StudiesAlligator Bioscience AB (publ) announced positive outcomes from adjusted indirect treatment comparison studies, demonstrating that mitazalimab + mFOLFIRINOX shows significantly better Overall Survival (OS) compared to FOLFIRINOX-based and NALIRIFOX treatment regimens for the frontline treatment of metastatic pancreatic adenocarcinoma cancer (mPDAC). As the OPTIMIZE-1 trial for mitazalimab did not include a control group, these indirect treatment comparisons are a means to establish the relative efficacy of mitazalimab in combination with mFOLFIRINOX compared to existing treatment regimens. A robust comparison was achieved using published literature from randomized Phase 2/3 studies in frontline mPDAC with mitazalimab +mFOLFIRINOX (18-month follow-up analysis), FOLFIRINOX, mFOLFIRINOX and NALIRIFOX regimens, after applying the ITC methodologies. The results demonstrated a significantly better Overall Survival (OS) potential for mitazalimab in collaboration with expert pancreatic cancer clinicians and results were presented on January 24 at the 2025 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, California by Professor Eileen O'Reilly in a presentation titled Evaluating the relative treatment efficacy of CD40 agonist mitazalimab in combined with mFOLFIRINO X in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) using unanchored indirect treatment comparisons (ITCs). The encouraging survival benefits demonstrated through this analysis contribute to the growing body of evidence supporting mitazalimab's potential in treating metastatic pancreatic cancer. These findings provide further momentum as Alligator works toward refining standards of care and improving outcomes for patients facing this devastating disease. These methods, commonly referred to as indirect treatment comparison (ITC), are standard in the context of health outcomes research, and pricing & reimbursement considerations.お知らせ • Jan 16Alligator Bioscience Announces Positive Outcome of Regulatory Interactions on Phase 3 Cmc ActivitiesAlligator Bioscience announced the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. A recent Type CMC interaction with the FDA in December 2024 reinforced feedback received from the PEI in July 2024, confirming that the completed and planned CMC work through early 2025 enables the Phase 3 development of mitazalim AB. With this feedback, Alligator initiated manufacturing of mitazalimab to be used in the Phase 3 study, and thus remains on track for initiation of Phase 3 clinical activities during 2025.お知らせ • Dec 04+ 4 more updatesAlligator Bioscience AB (publ) to Report Fiscal Year 2024 Results on Jan 22, 2025Alligator Bioscience AB (publ) announced that they will report fiscal year 2024 results on Jan 22, 2025お知らせ • Nov 12Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB Announce Preliminary Data from Its Phase 1 Trial Evaluating the First-In-Class Bispecific Antibody, ALG.APV-527Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB (Alligator) (ATORX) announced preliminary data from the companies' Phase 1 trial evaluating the first-in-class bispecific antibody, ALG.APV-527, as monotherapy for the treatment of multiple solid tumor types likely to express tumor antigen 5T4. These data indicate that trial endpoints of adequate exposure, safety, tolerability and biological activity were met. Outcomes were presented at a poster session on Friday November 8, 2024, at the Society for Immunotherapy of Cancer Conference in Houston, Texas. Clinical Highlights: Safety and Tolerability: ALG.APV-527 demonstrated positive safety and tolerability across all cohorts; No serious liver toxicity, a common side effect of other 4-1BB targeting treatments that can cause patients to discontinue dosing, was observed; A maximum tolerated dose has not been identified, highlighting the tolerability of the drug at high dose levels. Clinical Activity/Efficacy: Nine of 16 efficacy evaluable patients (56%) achieved stable disease (SD); One colon cancer patient achieved SD for more than six months; The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice. Evidence of biological activity of ALG.APV-527: ALG.APV-527 could be measured in all patients. Serum concentrations of ALG.APV-527 were proportional to the administered dose; Analysis of biomarkers in the serum of treated patients including soluble 4-1BB (surface protein found on certain immune cells) confirm biological activity of ALG.APV-527; Analysis of biomarkers in biopsies (including the 5T4 target cells and CD8 T cancer killer cells are consistent with immune activation in the tumor microenvironment). This observation consistent with ALG.APV-527 expected MOA.お知らせ • Nov 01Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025.お知らせ • Oct 31Alligator Bioscience AB (Publ) Appoints Nomination Committee in Respect of AGM 2025Alligator Bioscience announced that the Nomination Committee in preparation for the Annual General Meeting (AGM) on May 7, 2025, has been appointed. Pursuant to the instruction for the Nomination Committee adopted by the AGM in 2019, the Nomination Committee for the Alligator Bioscience AGM 2025 shall consist of four members, representing the three largest shareholders at the last weekday of June, together with the Chairman of the Board. If a shareholder does not exercise its right to appoint a member, entitlement to appoint a member of the Nomination Committee transfers to the shareholder who is the next largest shareholder in terms of voting rights. Based on the above, the Nomination Committee for the AGM 2025 has been established to consist of the following persons, together representing approximately 44.6 percent of the shares and votes in the company as per the end of June 2024: Bertil Brinck, representing Koncentra Holding AB; Lars Bergkvist, representing Roxette Photo SA; Magnus Pettersson, representing his own shareholding; and Anders Ekblom, Chairman of the Board. Bertil Brinck has been appointed Chairman of the Nomination Committee. The task of the Nomination Committee's prior to AGM is to prepare and submit proposals regarding the Chairman of the AGM, the number of Board members elected by the AGM, the Chairman and other Board members elected by the AGM, the fees and other remuneration for each of the Board members elected by the AGM and for members of Board committees, the number of auditors, the auditors, the fee for auditors and election of a Nomination Committee, or alternatively a decision on principles for appointing a Nomination Committee, as well as instructions for the Nomination Committee.Reported Earnings • Oct 25Third quarter 2024 earnings released: kr0.08 loss per share (vs kr0.083 loss in 3Q 2023)Third quarter 2024 results: kr0.08 loss per share. Revenue: kr2.27m (down 89% from 3Q 2023). Net loss: kr66.5m (loss widened 27% from 3Q 2023). Revenue is forecast to stay flat during the next 3 years compared to a 16% growth forecast for the Biotechs industry in the United Kingdom.お知らせ • Sep 16Alligator Bioscience and Aptevo Therapeutics Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor StudyAlligator Bioscience and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The results, which include clinical activity, safety, tolerability outcomes, pharmacokinetics and pharmacodynamics were presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain. ALG.APV-527 is a first-in-class bispecific antibody that targets 4-1BB and the tumor antigen 5T4. The compound is being evaluated in a multi-center, dose escalation trial that has 18 patients included in the safety analysis. These patients received multiple prior rounds of therapy for the treatment of solid tumor types. The trial is approaching full enrollment and interim results include: Nine of 15 efficacy evaluable patients (60%) have a best overall response to date of stable disease (SD). The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice. One colon cancer patient with sustained SD remains on study for more than four months. ALG.APV-527 demonstrated positive safety and tolerability across all cohorts. A maximum tolerated dose has not been identified. ALG.APV-527 could be measured in all patients with serum concentration of ALG.APV-527 consistent with the administered dose and preclinical predictions. Biomarker analyses confirm biological activity of ALG.APV-527. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that includes administration of ALG.APV-527 in up to six escalating dose levels in a 3+3 design. The trial is enrolling adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial is assessing the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities (DLTs) at that dose level. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR).お知らせ • Sep 14Alligator Bioscience AB (publ) and Aptevo Therapeutics to Present Positive Interim Phase 1 Data Evaluating ALG.APV- 527 Monotherapy in Multiple Solid Tumor Types At ESMO Congress 2024Alligator Bioscience AB and Aptevo Therapeutics announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024, taking place September 13th - 17th, 2024 in Barcelona, Spain. The ALG.APV- 527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that will include administration of ALG.APV-727 up to six escalating dose levels in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. and will enroll adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG. APV-527 will be given intravenously once every two weeks. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR).Reported Earnings • Jul 12Second quarter 2024 earnings released: kr0.066 loss per share (vs kr0.19 loss in 2Q 2023)Second quarter 2024 results: kr0.066 loss per share (improved from kr0.19 loss in 2Q 2023). Revenue: kr7.34m (down 59% from 2Q 2023). Net loss: kr49.2m (loss narrowed 23% from 2Q 2023). Revenue is forecast to grow 3.0% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom.New Risk • Jul 12New minor risk - Revenue sizeThe company makes less than US$5m in revenue. Total revenue: kr46m (US$4.4m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr222m free cash flow). Shares are highly illiquid. Negative equity (-kr9.5m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr79m net loss in 2 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Revenue is less than US$5m (kr46m revenue, or US$4.4m). Market cap is less than US$100m (kr908.1m market cap, or US$86.1m).お知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.Board Change • Jun 19High number of new directorsEmployee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023.Board Change • Jun 18High number of new directorsEmployee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023.お知らせ • May 24Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual MeetingAlligator Bioscience AB (publ) announced that two clinical abstracts on its lead drug candidate mitazalimab, a best- in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4. Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1. OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve. The open-label, multi-center OPTIMIZE-1 study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve patients. More details can be found with the clinicaltrials.gov identifier NCT04888312.お知らせ • May 15Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic CancerAlligator Bioscience announced the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.お知らせ • May 12+ 1 more updateAlligator Bioscience AB (publ) to Report Nine Months, 2024 Results on Oct 24, 2024Alligator Bioscience AB (publ) announced that they will report nine months, 2024 results on Oct 24, 2024お知らせ • Apr 05Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on BoardAlligator Bioscience AB (publ) at the annual general meeting to be held on 7 May 2024, Graham Dixon and Veronica Wallin are not proposed for re-election on the board.お知らせ • Mar 07Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose, Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.お知らせ • Feb 09+ 1 more updateAlligator Bioscience Plans to Adjust Size of Organization with Reduction of Approximately 20% to 25% of Current WorkforceAlligator Bioscience announced that it plans to adjust the size of its organization to reflect the end of the resource-intensive OPTIMIZE-1 Phase 2 clinical trial with its lead asset mitazalimab, and the need for the company to prioritize its preclinical and early-stage assets. The planned restructuring remains subject to negotiation with the relevant trade unions but would result in a reduction of approximately 20% to 25% of the current workforce, which once implemented is expected to reduce operational cash burn with SEK 20 million annually. Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding employee reductions will take place after the change consultations have been concluded according to local regulations.お知らせ • Jan 29Alligator Bioscience Announces Positive Top-Line Results from the Optimize-1 Phase 2 Study of the Company's Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients. The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated: Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial. An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX and 45.6% for NALIRIFOX Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX. Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed. As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up. Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.Board Change • Jan 05High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.Board Change • Nov 23High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Nov 07Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination CommitteeAlligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee.Board Change • Oct 30High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Oct 13Alligator Bioscience Grants New Composition of Matter Patent in Europe for MitazalimabAlligator Bioscience announced that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate= mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer. Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early first quarter of 2024.お知らせ • Aug 18Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of OctoberAlligator Bioscience AB (publ) announced the resignation of Malin Carlsson as the company's Chief Operating Officer (COO). Dr Carlsson will leave her role at the end of October to assume an executive role in a global pharma company. Dr Carlsson’s responsibilities will be transferred to other members of the Management team.Reported Earnings • Jul 14Second quarter 2023 earnings released: kr0.19 loss per share (vs kr0.21 loss in 2Q 2022)Second quarter 2023 results: kr0.19 loss per share. Revenue: kr17.9m (up 234% from 2Q 2022). Net loss: kr63.7m (loss widened 39% from 2Q 2022). Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in the United Kingdom.Breakeven Date Change • Jul 14The 3 analysts covering Alligator Bioscience previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 17% to 2023. The company is expected to make a profit of kr142.5m in 2024.お知らせ • Jul 06Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Anette Sundstedt, PhD, Principal Scientist at Alligator, has been appointed as employee representative, and Karin Nordbladh, Director Clinical Operations at Alligator, as deputy employee representative at the Alligator Bioscience AB's Board of Directors, effective July 5, 2023. Anette Sundstedt, who joined Alligator in 2021, replaces Tova Landström, who resigned on May 26, 2023, for personals reasons.お知らせ • Jul 01Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 AgonistAlligator Bioscience AB (publ) has presented a second round of interim results from a phase II trial with mitazalimab in pancreatic cancer patients. The follow-up evaluation on the first 23 patients shows an objective response rate of 57% - up from 52% at the first evaluation reported in January. The evaluation on the full set of 57 patients reveals an objective response rate of 44% - also susceptible to an increase as the study progresses. More data points indicate that mitazalimab provides a durable response in combination with standard of care chemotherapy.Board Change • Jun 27High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jun 27Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023. demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%. Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone. Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.お知らせ • Jun 06Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023Alligator Bioscience announces that data from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, June 2-6. The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab. When administered at 900 µg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed: 8 patients achieved stable disease resulting in a 91% disease control rate (DCR), 6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.Board Change • May 31High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Employee Representative Director Tova Landstrom was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Reported Earnings • Apr 28First quarter 2023 earnings released: kr0.28 loss per share (vs kr0.20 loss in 1Q 2022)First quarter 2023 results: kr0.28 loss per share (further deteriorated from kr0.20 loss in 1Q 2022). Revenue: kr10.4m (up 94% from 1Q 2022). Net loss: kr62.5m (loss widened 45% from 1Q 2022). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom.Board Change • Apr 28High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Employee Representative Director Tova Landstrom was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Board Change • Mar 01High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Feb 15+ 1 more updateAlligator Bioscience AB (Publ) Announces Management ChangesLaura von Schantz, employee representative, has resigned from the Alligator Bioscience AB Board of Directors, effective February 14, 2023, following her promotion to CTO and member of the Executive Management Team.お知らせ • Feb 14Alligator Bioscience Promotes Laura Von Schantz to Chief Technology OfficerAlligator Bioscience announced the promotion of Laura von Schantz to Chief Technology Officer, and her joining the executive management team. In this role, Laura will oversee all technical aspects in the development of Alligator's best-in-class preclinical and clinical pipeline, including lead assets mitazalimab, a CD40 agonist currently in Phase 2 clinical development, and ATOR-1017, a Phase 2-ready 4-1BB agonist. Laura joined Alligator in 2014 and was most recently Vice President, Discovery, a position she held since January 2021 and in which she played a key role in securing Alligator's research agreements most recently with Orion Corporation, as well as restructuring and invigorating the company's Discovery function. Prior to that, Laura was Director, Antibody Engineering where she was responsible for Alligator's technology platform.Reported Earnings • Feb 12Full year 2022 earnings released: kr0.88 loss per share (vs kr0.64 loss in FY 2021)Full year 2022 results: kr0.88 loss per share (further deteriorated from kr0.64 loss in FY 2021). Revenue: kr36.0m (up 170% from FY 2021). Net loss: kr193.4m (loss widened 37% from FY 2021). Products in clinical trials Phase I: 1 Phase II: 2 Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 55% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings.Board Change • Feb 08High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jan 03Alligator Bioscience Announces Positive Interim Results from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response RateAlligator Bioscience announces strong interim results from the ongoing OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. This open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Within this pre-planned interim analysis for futility, data were assessed by the participating investigators and independent experts for the probability of a positive study at primary completion. The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Disease control rate, the proportion of patients with objective response or stabilization of disease, was more than 90%. These data are noteworthy, especially in the light of an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population. Safety data confirm results from the Phase 1b dose escalation phase of the trial, which showed that mitazalimab in combination with mFOLFIRINOX was safe and well tolerated at the recommended dose of 900 µg/kg. Based on these positive results, Alligator plans to initiate discussions with regulators in the US and Europe on potential accelerated development and approval pathway for mitazalimab in pancreatic cancer, while continuing patient enrolment in this ongoing trial. Top-line data from this trial are expected in First Quarter 2024.Board Change • Oct 05High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jul 13Alligator Bioscience AB (publ) to Report Fiscal Year 2022 Results on Feb 10, 2023Alligator Bioscience AB (publ) announced that they will report fiscal year 2022 results on Feb 10, 2023Board Change • Mar 29Less than half of directors are independentFollowing 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. 4 non-independent directors. Independent Director Graham Dixon was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.株主還元0RK9GB BiotechsGB 市場7D-3.2%2.3%1.5%1Y-94.9%26.9%19.4%株主還元を見る業界別リターン: 0RK9過去 1 年間で26.9 % の収益を上げたUK Biotechs業界を下回りました。リターン対市場: 0RK9は、過去 1 年間で19.4 % のリターンを上げたUK市場を下回りました。価格変動Is 0RK9's price volatile compared to industry and market?0RK9 volatility0RK9 Average Weekly Movement28.6%Biotechs Industry Average Movement9.4%Market Average Movement5.7%10% most volatile stocks in GB Market12.0%10% least volatile stocks in GB Market3.1%安定した株価: 0RK9の株価は、 UK市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 0RK9の weekly volatility ( 29% ) は過去 1 年間安定していますが、依然としてUKの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト200011Søren Bregenholtwww.alligatorbioscience.seアリゲーター・バイオサイエンス社（Alligator Bioscience AB）は研究開発型のバイオテクノロジー企業で、ベルギーでがん治療用の抗体医薬を開発している。同社はCD40を標的とする刺激性抗体Mitazalimabを開発しており、膵臓癌を含む固形転移性腫瘍の治療薬として第3相臨床試験を実施中である。また、免疫療法のためのNeo-X-Prime技術プラットフォームを用いて開発された腫瘍指向性二重特異性抗体ATOR-4066を開発しており、固形転移性腫瘍の治療薬として前臨床段階にある。また、4-1BBと5T4分子を標的とする二重特異性抗体ALG APV-527は、固形転移性腫瘍の治療薬として臨床第2相試験中であり、腫瘍内のT細胞とNK細胞上の4-1BB受容体を刺激するモノクローナル抗体ATOR-1017は、固形転移性癌の治療薬として臨床第1相試験中であり、転移性癌、胃癌、乳癌の治療薬として臨床第3相試験中の抗体HLX22も提供している。さらに、独自のヒト抗体ライブラリーであるALLIGATOR-GOLD、創薬に最適な特性を持つ複数の足場を構築し、生成される抗体の構造の多様性をさらに高めるALLIGATOR-FAB、抗体やその他のタンパク質の最適化のための分子進化技術であるFIND、二重特異性抗体フォーマットであるRUBYなどの技術プラットフォームを用いた製品開発も行っている。さらに、アプテボ・セラピューティクス社、オリオン社、バイオアークティック社、ヘンリウス・バイオテック社、アブクロン社との共同研究契約および導出契約を結んでいる。同社は2000年に設立され、スウェーデンのルンドに本社を置いている。もっと見るAlligator Bioscience AB (publ) 基礎のまとめAlligator Bioscience の収益と売上を時価総額と比較するとどうか。0RK9 基礎統計学時価総額SEK 132.84m収益（TTM）-SEK 41.56m売上高(TTM)SEK 520.00k254.3xP/Sレシオ-3.2xPER（株価収益率0RK9 は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計0RK9 損益計算書（TTM）収益SEK 520.00k売上原価SEK 60.61m売上総利益-SEK 60.09mその他の費用-SEK 18.52m収益-SEK 41.56m直近の収益報告Mar 31, 2026次回決算日Aug 27, 2026一株当たり利益（EPS）-0.066グロス・マージン-11,555.19%純利益率-7,993.08%有利子負債／自己資本比率0%0RK9 の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/25 19:45終値2026/05/25 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Alligator Bioscience AB (publ) 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Carl RamaniusRedeyeFilip LindkvistRedeye
Reported Earnings • May 07First quarter 2026 earnings releasedFirst quarter 2026 results: Net income: kr1.44m (up kr9.79m from 1Q 2025). Revenue is forecast to grow 12% p.a. on average during the next 2 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom.
お知らせ • Apr 21Alligator Bioscience Presents New Data from Investigator-Initiated Study Evaluating Mitazalimab At AACR Annual MeetingAlligator Bioscience announced that new data from a Phase 1 investigator-initiated trial evaluating intratumoral mitazalimab administered in conjunction with irreversible electroporation (IRE) in locally advanced pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. The abstract reports updated immunological findings from the ongoing Phase 1 dose-escalation study (NCT06205849). The study assesses mitazalimab when injected directly into the tumor at the time of surgical IRE in patients with locally advanced PDAC after standard-of-care chemotherapy. The abstract highlights that all six patients with completed pre- and post-treatment analyses demonstrated T-cell reactivity to patient-specific neoantigens. Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells.
Reported Earnings • Apr 01Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is forecast to grow 4.2% p.a. on average during the next 2 years, compared to a 5.0% decline forecast for the Biotechs industry in the United Kingdom.
お知らせ • Mar 27Alligator Bioscience AB (Publ) Announces Eva Sjökvist Saers Declines Re-Election as Board MembersAlligator Bioscience AB (publ) at the AGM to be held on May 6, 2026, Eva Sjökvist Saers has declined re-election as Board members.
New Risk • Feb 17New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr51m Forecast net loss in 2 years: kr66m 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 (-kr157m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 32x increase in shares outstanding). Revenue is less than US$1m (kr4.4m revenue, or US$495k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr66m net loss in 2 years). Market cap is less than US$100m (kr94.1m market cap, or US$10.5m).
Reported Earnings • Feb 15Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is expected to fall by 4.5% p.a. on average during the next 2 years compared to a 3.1% decline forecast for the Biotechs industry in the United Kingdom.
Reported Earnings • May 07First quarter 2026 earnings releasedFirst quarter 2026 results: Net income: kr1.44m (up kr9.79m from 1Q 2025). Revenue is forecast to grow 12% p.a. on average during the next 2 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom.
お知らせ • Apr 21Alligator Bioscience Presents New Data from Investigator-Initiated Study Evaluating Mitazalimab At AACR Annual MeetingAlligator Bioscience announced that new data from a Phase 1 investigator-initiated trial evaluating intratumoral mitazalimab administered in conjunction with irreversible electroporation (IRE) in locally advanced pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. The abstract reports updated immunological findings from the ongoing Phase 1 dose-escalation study (NCT06205849). The study assesses mitazalimab when injected directly into the tumor at the time of surgical IRE in patients with locally advanced PDAC after standard-of-care chemotherapy. The abstract highlights that all six patients with completed pre- and post-treatment analyses demonstrated T-cell reactivity to patient-specific neoantigens. Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells.
Reported Earnings • Apr 01Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is forecast to grow 4.2% p.a. on average during the next 2 years, compared to a 5.0% decline forecast for the Biotechs industry in the United Kingdom.
お知らせ • Mar 27Alligator Bioscience AB (Publ) Announces Eva Sjökvist Saers Declines Re-Election as Board MembersAlligator Bioscience AB (publ) at the AGM to be held on May 6, 2026, Eva Sjökvist Saers has declined re-election as Board members.
New Risk • Feb 17New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr51m Forecast net loss in 2 years: kr66m 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 (-kr157m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 32x increase in shares outstanding). Revenue is less than US$1m (kr4.4m revenue, or US$495k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr66m net loss in 2 years). Market cap is less than US$100m (kr94.1m market cap, or US$10.5m).
Reported Earnings • Feb 15Full year 2025 earnings released: kr1.87 loss per share (vs kr319 loss in FY 2024)Full year 2025 results: kr1.87 loss per share (improved from kr319 loss in FY 2024). Net loss: kr51.4m (loss narrowed 78% from FY 2024). Revenue is expected to fall by 4.5% p.a. on average during the next 2 years compared to a 3.1% decline forecast for the Biotechs industry in the United Kingdom.
Board Change • Feb 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Employee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.
お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offering
お知らせ • Dec 03+ 3 more updatesAlligator Bioscience AB (publ) to Report First Half, 2026 Results on Aug 27, 2026Alligator Bioscience AB (publ) announced that they will report first half, 2026 results on Aug 27, 2026
New Risk • Nov 07New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr78m Forecast net loss in 2 years: kr47m 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 (-kr165m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Negative equity (-kr9.2m). Shareholders have been substantially diluted in the past year (over 56x increase in shares outstanding). Market cap is less than US$10m (kr84.1m market cap, or US$8.79m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr47m net loss in 2 years). Revenue is less than US$5m (kr46m revenue, or US$4.8m).
お知らせ • Nov 04Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026.
Breakeven Date Change • Oct 24Forecast to breakeven in 2026The analyst covering Alligator Bioscience expects the company to break even for the first time. New forecast suggests losses will reduce by 49% to 2025. The company is expected to make a profit of kr139.0m in 2026. Average annual earnings growth of 53% is required to achieve expected profit on schedule.
New Risk • Oct 23New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: kr62.2m (US$6.62m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr163m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Negative equity (-kr35m). Shareholders have been substantially diluted in the past year (over 56x increase in shares outstanding). Market cap is less than US$10m (kr62.2m market cap, or US$6.62m). Minor Risk Revenue is less than US$5m (kr44m revenue, or US$4.7m).
お知らせ • Oct 13Alligator Bioscience Announces Upcoming Presentation of Data from the Phase 1 Trial At the ESMO Congress 2025Alligator Bioscience announced the upcoming presentation of data from the Phase 1 REACtiVe-2 trial (NCT05650918) at the ESMO Congress 2025, showcasing the immunologic and clinical effects of mitazalimab in combination with dendritic cell therapy in patients with metastatic pancreatic cancer. The investigator-sponsored trial, conducted at Erasmus MC Cancer Institute, demonstrated that the combination of mitazalimab and Amphera's dendritic cell vaccine MesoPher was safe and well-tolerated, with enhanced systemic and local immune responses. Half of the patients achieved stable disease after three administrations, with post-treatment biopsies revealing increased tumor-infiltrating T cells and reduced collagen deposition.
New Risk • Jul 14New minor risk - Revenue sizeThe company makes less than US$5m in revenue. Total revenue: kr48m (US$5.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr163m free cash flow). Shares are highly illiquid. Negative equity (-kr35m). Shareholders have been substantially diluted in the past year (over 44x increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr48m revenue, or US$5.0m). Market cap is less than US$100m (kr190.3m market cap, or US$19.9m).
Reported Earnings • Jul 12Second quarter 2025 earnings released: kr0.08 loss per share (vs kr66.36 loss in 2Q 2024)Second quarter 2025 results: kr0.08 loss per share (improved from kr66.36 loss in 2Q 2024). Revenue: kr345.0k (down 95% from 2Q 2024). Net loss: kr1.69m (loss narrowed 97% from 2Q 2024). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 9.7% growth forecast for the Biotechs industry in the United Kingdom.
お知らせ • Jul 02Alligator to Present 24-Month Optimize-1 Data At ESMO GI 2025Alligator Bioscience announced that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2- 5 July. The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1, a Phase 1b/2 trial in patients with previously untreated NCT04888312 metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 ug/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone. A comparison between the 900 ug/kg and 450 ug/kg cohorts revealed a higher response rate for 900 ug/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab's contribution to the positive clinical, reinforcing the candidate's favorable response data observed in OPTIMIZE-1. safety profile and supporting 900 ug/kg as the recommended Phase 3 dose - a decision recently endorsed by the FDA.
お知らせ • Jun 03Alligator Bioscience Announces Biomarker Data from Its Optimize-1 Trial Presented At Asco 2025 Annual MeetingAlligator Bioscience announced that biomarker data from its OPTIMIZE-1 clinical trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. OPTIMIZE-1 is a Phase 1b/2 trial evaluating mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The study has demonstrated strong clinical outcomes to date, including a 30% survival rate at 24 and a median overall survival of 14.9 months. The biomarker analyses highlighted mitazalimab's immunological mechanism of action, with immune activation in responding patients and gene signatures associated with clinical benefit and improved survival. These results support continued development of mitazalimab, including a planned confirmatory trial in mPDAC.
お知らせ • May 23Alligator Bioscience Announces Presentation of Biomarker Data from its OPTIMIZE-1 Clinical Trial at 2025 American Society of Clinical Oncology Annual MeetingAlligator Bioscience announced the presentation of biomarker data from its OPTIMIZE-1 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a 30% survival rate at 24-months follow up. Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes. These translational data strengthen the rationale for mitazalimab's mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab In mPDAC, including the planned randomized confirmatory trial. Alligator's participation at ASCO reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab's potential and engage in strategic partnering discussions.
お知らせ • May 07Alligator Bioscience AB (Publ) Approves Board ChangesAlligator Bioscience AB (publ) held its AGM on 7 May 2025, Hans-Peter Ostler was elected as new Chairman of the board. The previous board members Anders Ekblom and Staffan Encrantz were not available re-election.
お知らせ • Apr 23Alligator Bioscience AB Initiates Phase 2 Clinical Trial with HLX22Alligator Bioscience AB announced that Shanghai Henlius Biotech Inc. has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator's subsidiary, Atlas Therapeutics. HLX22 is being developed by Henlius under a sublicense from AbClon Inc., which had previously licensed the antibody from Alligator. The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy. Under the terms of the license agreement, Alligator is entitled to 35% of AbClon's revenue from its sublicense agreement with Henlius.
New Risk • Apr 04New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: kr93.0m (US$9.26m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 24x increase in shares outstanding). Market cap is less than US$10m (kr93.0m market cap, or US$9.26m).
Reported Earnings • Apr 02Full year 2024 earnings released: kr0.32 loss per share (vs kr0.55 loss in FY 2023)Full year 2024 results: kr0.32 loss per share (improved from kr0.55 loss in FY 2023). Revenue: kr57.7m (down 2.6% from FY 2023). Net loss: kr233.9m (loss narrowed 5.9% from FY 2023).
お知らせ • Mar 22Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Dr. Sumeet Ambarkhane MD, Chief Medical Officer, will be leaving Alligator by end of March 2025. Dr. Ambarkhane has played a key role in advancing Alligator's immune-oncology pipeline and establishing its clinical development organization over the past years. In particular, he led the clinical development of mitazalimab and OPTIMIZE-1, Alligator's Phase 2 trial in metastatic pancreatic cancer towards its readiness for a Phase 3 confirmatory development. Having worked with the company for an extended period, enabling a smooth transition, Dr. Tom Moore will assume the role as Chief Medical Officer. Dr. Moore is a seasoned oncology drug developer bringing industry experience from over a decade with Roche and subsequent work as a consultant, with deep experience in immuno-oncology and a strong commitment to advancing innovative treatments. His decision to step into the new role underscores his confidence in mitazalimab's potential and Alligator's mission to bring new therapeutic options to patients with high unmet medical needs. Dr. Moore will assume his role from the start of April ensuring a smooth transition in Alligator's clinical development leadership.
New Risk • Mar 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Over 24x increase in shares outstanding. 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 Less than 1 year of cash runway based on free cash flow trend (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 24x increase in shares outstanding). Minor Risk Market cap is less than US$100m (kr777.7m market cap, or US$73.9m).
お知らせ • Feb 14Alligator Bioscience AB (publ) has completed a Composite Units Offering in the amount of SEK 152.964693 million.Alligator Bioscience AB (publ) has completed a Composite Units Offering in the amount of SEK 152.964693 million. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 1,529,646,926 Price\Range: SEK 0.1 Transaction Features: Rights Offering
New Risk • Feb 03New major risk - Revenue and earnings growthEarnings have declined by 9.0% 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 (-kr212m free cash flow). Shares are highly illiquid. Negative equity (-kr131m). Earnings have declined by 9.0% per year over the past 5 years. Market cap is less than US$10m (kr30.6m market cap, or US$2.73m). Minor Risk Shareholders have been diluted in the past year (15% increase in shares outstanding).
お知らせ • Jan 27Alligator Bioscience AB (publ) Announces Positive Outcomes from adjusted Indirect Treatment Comparations StudiesAlligator Bioscience AB (publ) announced positive outcomes from adjusted indirect treatment comparison studies, demonstrating that mitazalimab + mFOLFIRINOX shows significantly better Overall Survival (OS) compared to FOLFIRINOX-based and NALIRIFOX treatment regimens for the frontline treatment of metastatic pancreatic adenocarcinoma cancer (mPDAC). As the OPTIMIZE-1 trial for mitazalimab did not include a control group, these indirect treatment comparisons are a means to establish the relative efficacy of mitazalimab in combination with mFOLFIRINOX compared to existing treatment regimens. A robust comparison was achieved using published literature from randomized Phase 2/3 studies in frontline mPDAC with mitazalimab +mFOLFIRINOX (18-month follow-up analysis), FOLFIRINOX, mFOLFIRINOX and NALIRIFOX regimens, after applying the ITC methodologies. The results demonstrated a significantly better Overall Survival (OS) potential for mitazalimab in collaboration with expert pancreatic cancer clinicians and results were presented on January 24 at the 2025 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, California by Professor Eileen O'Reilly in a presentation titled Evaluating the relative treatment efficacy of CD40 agonist mitazalimab in combined with mFOLFIRINO X in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) using unanchored indirect treatment comparisons (ITCs). The encouraging survival benefits demonstrated through this analysis contribute to the growing body of evidence supporting mitazalimab's potential in treating metastatic pancreatic cancer. These findings provide further momentum as Alligator works toward refining standards of care and improving outcomes for patients facing this devastating disease. These methods, commonly referred to as indirect treatment comparison (ITC), are standard in the context of health outcomes research, and pricing & reimbursement considerations.
お知らせ • Jan 16Alligator Bioscience Announces Positive Outcome of Regulatory Interactions on Phase 3 Cmc ActivitiesAlligator Bioscience announced the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. A recent Type CMC interaction with the FDA in December 2024 reinforced feedback received from the PEI in July 2024, confirming that the completed and planned CMC work through early 2025 enables the Phase 3 development of mitazalim AB. With this feedback, Alligator initiated manufacturing of mitazalimab to be used in the Phase 3 study, and thus remains on track for initiation of Phase 3 clinical activities during 2025.
お知らせ • Dec 04+ 4 more updatesAlligator Bioscience AB (publ) to Report Fiscal Year 2024 Results on Jan 22, 2025Alligator Bioscience AB (publ) announced that they will report fiscal year 2024 results on Jan 22, 2025
お知らせ • Nov 12Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB Announce Preliminary Data from Its Phase 1 Trial Evaluating the First-In-Class Bispecific Antibody, ALG.APV-527Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB (Alligator) (ATORX) announced preliminary data from the companies' Phase 1 trial evaluating the first-in-class bispecific antibody, ALG.APV-527, as monotherapy for the treatment of multiple solid tumor types likely to express tumor antigen 5T4. These data indicate that trial endpoints of adequate exposure, safety, tolerability and biological activity were met. Outcomes were presented at a poster session on Friday November 8, 2024, at the Society for Immunotherapy of Cancer Conference in Houston, Texas. Clinical Highlights: Safety and Tolerability: ALG.APV-527 demonstrated positive safety and tolerability across all cohorts; No serious liver toxicity, a common side effect of other 4-1BB targeting treatments that can cause patients to discontinue dosing, was observed; A maximum tolerated dose has not been identified, highlighting the tolerability of the drug at high dose levels. Clinical Activity/Efficacy: Nine of 16 efficacy evaluable patients (56%) achieved stable disease (SD); One colon cancer patient achieved SD for more than six months; The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice. Evidence of biological activity of ALG.APV-527: ALG.APV-527 could be measured in all patients. Serum concentrations of ALG.APV-527 were proportional to the administered dose; Analysis of biomarkers in the serum of treated patients including soluble 4-1BB (surface protein found on certain immune cells) confirm biological activity of ALG.APV-527; Analysis of biomarkers in biopsies (including the 5T4 target cells and CD8 T cancer killer cells are consistent with immune activation in the tumor microenvironment). This observation consistent with ALG.APV-527 expected MOA.
お知らせ • Nov 01Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025.
お知らせ • Oct 31Alligator Bioscience AB (Publ) Appoints Nomination Committee in Respect of AGM 2025Alligator Bioscience announced that the Nomination Committee in preparation for the Annual General Meeting (AGM) on May 7, 2025, has been appointed. Pursuant to the instruction for the Nomination Committee adopted by the AGM in 2019, the Nomination Committee for the Alligator Bioscience AGM 2025 shall consist of four members, representing the three largest shareholders at the last weekday of June, together with the Chairman of the Board. If a shareholder does not exercise its right to appoint a member, entitlement to appoint a member of the Nomination Committee transfers to the shareholder who is the next largest shareholder in terms of voting rights. Based on the above, the Nomination Committee for the AGM 2025 has been established to consist of the following persons, together representing approximately 44.6 percent of the shares and votes in the company as per the end of June 2024: Bertil Brinck, representing Koncentra Holding AB; Lars Bergkvist, representing Roxette Photo SA; Magnus Pettersson, representing his own shareholding; and Anders Ekblom, Chairman of the Board. Bertil Brinck has been appointed Chairman of the Nomination Committee. The task of the Nomination Committee's prior to AGM is to prepare and submit proposals regarding the Chairman of the AGM, the number of Board members elected by the AGM, the Chairman and other Board members elected by the AGM, the fees and other remuneration for each of the Board members elected by the AGM and for members of Board committees, the number of auditors, the auditors, the fee for auditors and election of a Nomination Committee, or alternatively a decision on principles for appointing a Nomination Committee, as well as instructions for the Nomination Committee.
Reported Earnings • Oct 25Third quarter 2024 earnings released: kr0.08 loss per share (vs kr0.083 loss in 3Q 2023)Third quarter 2024 results: kr0.08 loss per share. Revenue: kr2.27m (down 89% from 3Q 2023). Net loss: kr66.5m (loss widened 27% from 3Q 2023). Revenue is forecast to stay flat during the next 3 years compared to a 16% growth forecast for the Biotechs industry in the United Kingdom.
お知らせ • Sep 16Alligator Bioscience and Aptevo Therapeutics Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor StudyAlligator Bioscience and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The results, which include clinical activity, safety, tolerability outcomes, pharmacokinetics and pharmacodynamics were presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain. ALG.APV-527 is a first-in-class bispecific antibody that targets 4-1BB and the tumor antigen 5T4. The compound is being evaluated in a multi-center, dose escalation trial that has 18 patients included in the safety analysis. These patients received multiple prior rounds of therapy for the treatment of solid tumor types. The trial is approaching full enrollment and interim results include: Nine of 15 efficacy evaluable patients (60%) have a best overall response to date of stable disease (SD). The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice. One colon cancer patient with sustained SD remains on study for more than four months. ALG.APV-527 demonstrated positive safety and tolerability across all cohorts. A maximum tolerated dose has not been identified. ALG.APV-527 could be measured in all patients with serum concentration of ALG.APV-527 consistent with the administered dose and preclinical predictions. Biomarker analyses confirm biological activity of ALG.APV-527. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that includes administration of ALG.APV-527 in up to six escalating dose levels in a 3+3 design. The trial is enrolling adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial is assessing the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities (DLTs) at that dose level. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR).
お知らせ • Sep 14Alligator Bioscience AB (publ) and Aptevo Therapeutics to Present Positive Interim Phase 1 Data Evaluating ALG.APV- 527 Monotherapy in Multiple Solid Tumor Types At ESMO Congress 2024Alligator Bioscience AB and Aptevo Therapeutics announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024, taking place September 13th - 17th, 2024 in Barcelona, Spain. The ALG.APV- 527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that will include administration of ALG.APV-727 up to six escalating dose levels in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. and will enroll adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG. APV-527 will be given intravenously once every two weeks. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR).
Reported Earnings • Jul 12Second quarter 2024 earnings released: kr0.066 loss per share (vs kr0.19 loss in 2Q 2023)Second quarter 2024 results: kr0.066 loss per share (improved from kr0.19 loss in 2Q 2023). Revenue: kr7.34m (down 59% from 2Q 2023). Net loss: kr49.2m (loss narrowed 23% from 2Q 2023). Revenue is forecast to grow 3.0% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom.
New Risk • Jul 12New minor risk - Revenue sizeThe company makes less than US$5m in revenue. Total revenue: kr46m (US$4.4m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr222m free cash flow). Shares are highly illiquid. Negative equity (-kr9.5m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr79m net loss in 2 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Revenue is less than US$5m (kr46m revenue, or US$4.4m). Market cap is less than US$100m (kr908.1m market cap, or US$86.1m).
お知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.
お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.
お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.
お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.
Board Change • Jun 19High number of new directorsEmployee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023.
Board Change • Jun 18High number of new directorsEmployee Representative Director Karin Nordbladh was the last director to join the board, commencing their role in 2023.
お知らせ • May 24Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual MeetingAlligator Bioscience AB (publ) announced that two clinical abstracts on its lead drug candidate mitazalimab, a best- in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4. Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1. OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve. The open-label, multi-center OPTIMIZE-1 study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve patients. More details can be found with the clinicaltrials.gov identifier NCT04888312.
お知らせ • May 15Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic CancerAlligator Bioscience announced the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.
お知らせ • May 12+ 1 more updateAlligator Bioscience AB (publ) to Report Nine Months, 2024 Results on Oct 24, 2024Alligator Bioscience AB (publ) announced that they will report nine months, 2024 results on Oct 24, 2024
お知らせ • Apr 05Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on BoardAlligator Bioscience AB (publ) at the annual general meeting to be held on 7 May 2024, Graham Dixon and Veronica Wallin are not proposed for re-election on the board.
お知らせ • Mar 07Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose, Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.
お知らせ • Feb 09+ 1 more updateAlligator Bioscience Plans to Adjust Size of Organization with Reduction of Approximately 20% to 25% of Current WorkforceAlligator Bioscience announced that it plans to adjust the size of its organization to reflect the end of the resource-intensive OPTIMIZE-1 Phase 2 clinical trial with its lead asset mitazalimab, and the need for the company to prioritize its preclinical and early-stage assets. The planned restructuring remains subject to negotiation with the relevant trade unions but would result in a reduction of approximately 20% to 25% of the current workforce, which once implemented is expected to reduce operational cash burn with SEK 20 million annually. Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding employee reductions will take place after the change consultations have been concluded according to local regulations.
お知らせ • Jan 29Alligator Bioscience Announces Positive Top-Line Results from the Optimize-1 Phase 2 Study of the Company's Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients. The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated: Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial. An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX and 45.6% for NALIRIFOX Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX. Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed. As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up. Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.
Board Change • Jan 05High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
Board Change • Nov 23High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Nov 07Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination CommitteeAlligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee.
Board Change • Oct 30High number of new and inexperienced directorsThere are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Chairman of the Board Anders Ekblom is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Oct 13Alligator Bioscience Grants New Composition of Matter Patent in Europe for MitazalimabAlligator Bioscience announced that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate= mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer. Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early first quarter of 2024.
お知らせ • Aug 18Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of OctoberAlligator Bioscience AB (publ) announced the resignation of Malin Carlsson as the company's Chief Operating Officer (COO). Dr Carlsson will leave her role at the end of October to assume an executive role in a global pharma company. Dr Carlsson’s responsibilities will be transferred to other members of the Management team.
Reported Earnings • Jul 14Second quarter 2023 earnings released: kr0.19 loss per share (vs kr0.21 loss in 2Q 2022)Second quarter 2023 results: kr0.19 loss per share. Revenue: kr17.9m (up 234% from 2Q 2022). Net loss: kr63.7m (loss widened 39% from 2Q 2022). Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in the United Kingdom.
Breakeven Date Change • Jul 14The 3 analysts covering Alligator Bioscience previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 17% to 2023. The company is expected to make a profit of kr142.5m in 2024.
お知らせ • Jul 06Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Anette Sundstedt, PhD, Principal Scientist at Alligator, has been appointed as employee representative, and Karin Nordbladh, Director Clinical Operations at Alligator, as deputy employee representative at the Alligator Bioscience AB's Board of Directors, effective July 5, 2023. Anette Sundstedt, who joined Alligator in 2021, replaces Tova Landström, who resigned on May 26, 2023, for personals reasons.
お知らせ • Jul 01Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 AgonistAlligator Bioscience AB (publ) has presented a second round of interim results from a phase II trial with mitazalimab in pancreatic cancer patients. The follow-up evaluation on the first 23 patients shows an objective response rate of 57% - up from 52% at the first evaluation reported in January. The evaluation on the full set of 57 patients reveals an objective response rate of 44% - also susceptible to an increase as the study progresses. More data points indicate that mitazalimab provides a durable response in combination with standard of care chemotherapy.
Board Change • Jun 27High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jun 27Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023. demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%. Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone. Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.
お知らせ • Jun 06Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023Alligator Bioscience announces that data from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, June 2-6. The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab. When administered at 900 µg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed: 8 patients achieved stable disease resulting in a 91% disease control rate (DCR), 6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.
Board Change • May 31High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Employee Representative Director Tova Landstrom was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Reported Earnings • Apr 28First quarter 2023 earnings released: kr0.28 loss per share (vs kr0.20 loss in 1Q 2022)First quarter 2023 results: kr0.28 loss per share (further deteriorated from kr0.20 loss in 1Q 2022). Revenue: kr10.4m (up 94% from 1Q 2022). Net loss: kr62.5m (loss widened 45% from 1Q 2022). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom.
Board Change • Apr 28High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Employee Representative Director Tova Landstrom was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Board Change • Mar 01High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 15+ 1 more updateAlligator Bioscience AB (Publ) Announces Management ChangesLaura von Schantz, employee representative, has resigned from the Alligator Bioscience AB Board of Directors, effective February 14, 2023, following her promotion to CTO and member of the Executive Management Team.
お知らせ • Feb 14Alligator Bioscience Promotes Laura Von Schantz to Chief Technology OfficerAlligator Bioscience announced the promotion of Laura von Schantz to Chief Technology Officer, and her joining the executive management team. In this role, Laura will oversee all technical aspects in the development of Alligator's best-in-class preclinical and clinical pipeline, including lead assets mitazalimab, a CD40 agonist currently in Phase 2 clinical development, and ATOR-1017, a Phase 2-ready 4-1BB agonist. Laura joined Alligator in 2014 and was most recently Vice President, Discovery, a position she held since January 2021 and in which she played a key role in securing Alligator's research agreements most recently with Orion Corporation, as well as restructuring and invigorating the company's Discovery function. Prior to that, Laura was Director, Antibody Engineering where she was responsible for Alligator's technology platform.
Reported Earnings • Feb 12Full year 2022 earnings released: kr0.88 loss per share (vs kr0.64 loss in FY 2021)Full year 2022 results: kr0.88 loss per share (further deteriorated from kr0.64 loss in FY 2021). Revenue: kr36.0m (up 170% from FY 2021). Net loss: kr193.4m (loss widened 37% from FY 2021). Products in clinical trials Phase I: 1 Phase II: 2 Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 55% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings.
Board Change • Feb 08High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jan 03Alligator Bioscience Announces Positive Interim Results from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response RateAlligator Bioscience announces strong interim results from the ongoing OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. This open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Within this pre-planned interim analysis for futility, data were assessed by the participating investigators and independent experts for the probability of a positive study at primary completion. The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Disease control rate, the proportion of patients with objective response or stabilization of disease, was more than 90%. These data are noteworthy, especially in the light of an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population. Safety data confirm results from the Phase 1b dose escalation phase of the trial, which showed that mitazalimab in combination with mFOLFIRINOX was safe and well tolerated at the recommended dose of 900 µg/kg. Based on these positive results, Alligator plans to initiate discussions with regulators in the US and Europe on potential accelerated development and approval pathway for mitazalimab in pancreatic cancer, while continuing patient enrolment in this ongoing trial. Top-line data from this trial are expected in First Quarter 2024.
Board Change • Oct 05High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Director Staffan Encrantz was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jul 13Alligator Bioscience AB (publ) to Report Fiscal Year 2022 Results on Feb 10, 2023Alligator Bioscience AB (publ) announced that they will report fiscal year 2022 results on Feb 10, 2023
Board Change • Mar 29Less than half of directors are independentFollowing 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. 4 non-independent directors. Independent Director Graham Dixon was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
