Board Change • May 20
High number of new directors Independent Director Anna Torner was the last director to join the board, commencing their role in 2026. Announcement • Apr 21
Alligator Bioscience Presents New Data from Investigator-Initiated Study Evaluating Mitazalimab At AACR Annual Meeting Alligator 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. Announcement • Mar 27
Alligator Bioscience AB (Publ) Announces Eva Sjökvist Saers Declines Re-Election as Board Members Alligator Bioscience AB (publ) at the AGM to be held on May 6, 2026, Eva Sjökvist Saers has declined re-election as Board members. Announcement • Jan 09
Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers Symposium Alligator 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. Breakeven Date Change • Dec 30
Forecast to breakeven in 2026 The analyst covering Alligator Bioscience expects the company to break even for the first time. New forecast suggests losses will reduce by 51% to 2025. The company is expected to make a profit of kr9.60m in 2026. Average annual earnings growth of 33% is required to achieve expected profit on schedule. Announcement • Dec 20
Alligator 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 Announcement • Nov 04
Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026 Alligator Bioscience AB (publ), Annual General Meeting, May 06, 2026. Announcement • Oct 13
Alligator Bioscience Announces Upcoming Presentation of Data from the Phase 1 Trial At the ESMO Congress 2025 Alligator 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. Announcement • Jul 02
Alligator to Present 24-Month Optimize-1 Data At ESMO GI 2025 Alligator 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. Announcement • Jun 03
Alligator Bioscience Announces Biomarker Data from Its Optimize-1 Trial Presented At Asco 2025 Annual Meeting Alligator 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. Announcement • May 23
Alligator Bioscience Announces Presentation of Biomarker Data from its OPTIMIZE-1 Clinical Trial at 2025 American Society of Clinical Oncology Annual Meeting Alligator 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. Announcement • May 07
Alligator Bioscience AB (Publ) Approves Board Changes Alligator 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. Announcement • Apr 23
Alligator Bioscience AB Initiates Phase 2 Clinical Trial with HLX22 Alligator 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. Announcement • Mar 22
Alligator Bioscience AB (Publ) Announces Executive Changes Alligator 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. Announcement • Feb 14
Alligator 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 Announcement • Jan 27
Alligator Bioscience AB (publ) Announces Positive Outcomes from adjusted Indirect Treatment Comparations Studies Alligator 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. Announcement • Jan 16
Alligator Bioscience Announces Positive Outcome of Regulatory Interactions on Phase 3 Cmc Activities Alligator 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. Announcement • Nov 12
Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB Announce Preliminary Data from Its Phase 1 Trial Evaluating the First-In-Class Bispecific Antibody, ALG.APV-527 Aptevo 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. Announcement • Nov 01
Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025 Alligator Bioscience AB (publ), Annual General Meeting, May 07, 2025. Announcement • Oct 31
Alligator Bioscience AB (Publ) Appoints Nomination Committee in Respect of AGM 2025 Alligator 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 25
Third 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 21% growth forecast for the Biotechs industry in Europe. Announcement • Sep 16
Alligator 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 Study Alligator 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). Announcement • Sep 14
Alligator 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 2024 Alligator 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 12
Second quarter 2024 earnings released: kr0.07 loss per share (vs kr0.19 loss in 2Q 2023) Second quarter 2024 results: kr0.07 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 19% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 44% per year, which means it is significantly lagging earnings. Announcement • Jul 11
Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024 On 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. Announcement • Jul 10
Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 Study Alligator 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. Announcement • Jun 26
Alligator Bioscience Announces Results from the Ongoing Optimize-1 Trial Alligator 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. Announcement • Jun 21
Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024 Alligator 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. Announcement • May 24
Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual Meeting Alligator 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. Announcement • May 15
Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic Cancer Alligator 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. Board Change • May 08
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Employee Representative Director Anette Sundstedt 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. Announcement • Apr 05
Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on Board Alligator 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. Announcement • Mar 07
Alligator 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 5T4 Alligator 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. Announcement • Jan 29
Alligator 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 Cancer Alligator 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. Breakeven Date Change • Nov 22
No longer forecast to breakeven The 3 analysts covering Alligator Bioscience no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr109.5m in 2024. New consensus forecast suggests the company will make a loss of kr205.5m in 2025. Announcement • Nov 07
Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination Committee Alligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee. New Risk • Oct 30
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr232m Forecast net loss in 2 years: kr149m 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 (-kr181m free cash flow). Share price has been highly volatile over the past 3 months (35% average weekly change). Shareholders have been substantially diluted in the past year (198% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr149m net loss in 2 years). Market cap is less than US$100m (€21.1m market cap, or US$22.3m). Reported Earnings • Oct 28
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: kr19.9m (up 290% from 3Q 2022). Net loss: kr52.5m (loss widened 2.2% from 3Q 2022). Revenue is forecast to grow 51% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Announcement • Oct 13
Alligator Bioscience Grants New Composition of Matter Patent in Europe for Mitazalimab Alligator 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. Announcement • Aug 18
Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of October Alligator 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 14
Second 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 13% growth forecast for the Biotechs industry in Germany. Breakeven Date Change • Jul 14 The 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.
Announcement • Jul 06
Alligator Bioscience AB (Publ) Announces Executive Changes Alligator 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. Announcement • Jul 01
Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 Agonist Alligator 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. Announcement • Jun 27
Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic Cancer Alligator 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. Announcement • Jun 06
Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023 Alligator 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. Breakeven Date Change • Apr 26 The 2 analysts covering Alligator Bioscience previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of kr214.1m in 2024.
Reported Earnings • Mar 29
Full year 2022 earnings released Full year 2022 results: kr0.88 loss per share. Revenue: kr36.0m (up 170% from FY 2021). Net loss: kr193.4m (loss widened 37% from FY 2021). Products in clinical trials Phase I: 2 Phase II: 2 Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 49% per year, which means it is significantly lagging earnings. Breakeven Date Change • Feb 26
No longer forecast to breakeven The 2 analysts covering Alligator Bioscience no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr50.6m in 2024. New consensus forecast suggests the company will make a loss of kr44.8m in 2024. Announcement • Feb 14
Alligator Bioscience Promotes Laura Von Schantz to Chief Technology Officer Alligator 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 12
Full 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 22% growth forecast for the Biotechs industry in Europe. 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 44% per year, which means it is significantly lagging earnings. Breakeven Date Change • Jan 03
Forecast to breakeven in 2024 The 3 analysts covering Alligator Bioscience expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr50.6m in 2024. Average annual earnings growth of 78% is required to achieve expected profit on schedule. Announcement • Jan 03
Alligator Bioscience Announces Positive Interim Results from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response Rate Alligator 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. Announcement • Dec 24
Alligator Bioscience Announces Publication Highlighting Phase 1 Mitazalimab Data in Solid Tumors in Peer-Reviewed Journal Alligator Bioscience announced the publication of a peer-reviewed article highlighting data from a Phase 1 dose-escalation study evaluating the safety, dose-limiting toxicities (DLTs), pharmacokinetic (PK) and pharmacodynamic (PD) profile of its lead clinical asset mitazalimab in patients with advanced solid malignancies (NCT02829099). Mitazalimab displayed clinical anti-tumor activity in this study with a partial response observed in a patient with renal cell carcinoma and stable disease (SD) reported in 36.8% of patients with varied tumor types, which lasted for more than six months in 9 patients (thymoma [n=3], sarcoma, adamantinoma, melanoma, cholangiocarcinoma, salivary gland carcinoma, and pancreatic adenocarcinoma [n=1 each]). Alligator is evaluating mitazalimab in combination with mFOLFIRINOX in OPTIMIZE-1, a Phase 1b/2 trial in first-line metastatic pancreatic cancer (NCT04888312). Data from the Phase 1b dose escalation phase of the trial showed mitazalimab in combination with mFOLFIRINOX is safe and well tolerated at the recommended dose of 900 g/kg. Interim data from the study is expected the first weeks of January, and top-line data in first quarter of 2024. Board Change • Nov 17
High number of new directors There 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. Reported Earnings • Oct 21
Third quarter 2022 earnings released: kr0.23 loss per share (vs kr0.43 loss in 3Q 2021) Third quarter 2022 results: kr0.23 loss per share. Revenue: kr5.24m (up 58% from 3Q 2021). Net loss: kr51.4m (loss widened 38% from 3Q 2021). Revenue is forecast to grow 107% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Announcement • Oct 01
Alligator Bioscience Announces Positive Safety Data from 900 mg Dose Cohort in ATOR-1017 Phase 1 Dose Escalation Study in Patients with Advanced Solid Malignancies Alligator Bioscience announced positive safety data from the 900 mg dose cohort in its Phase 1, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer. The Phase 1 open-label dose-escalation study of ATOR-1017 in patients with histologically confirmed, advanced, and/or refractory solid cancer (NCT04144842) has completed enrollment. The primary objective of the study to investigate the safety and tolerability of ATOR-1017 at therapeutic doses has been successfully met. Two patients remain on the study benefitting from ATOR-1017 treatment. Announcement • Sep 20
Alligator Bioscience and Aptevo Therapeutics Announce that FDA has Issued a "May Proceed" Notification for the ALG.APV-527 IND Alligator Bioscience AB and Aptevo Therapeutics announced that the US Food and Drug Administration (FDA) has issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND), allowing the companies to initiate clinical trials evaluating the compound for the treatment of 5T4-expressing tumor antigens in multiple solid tumor types. The companies are moving rapidly to initiate a multi-center Phase 1 trial in the US. ALG.APV-527 is an antibody with dual function: tumor-binding and 4-1BB immunomodulatory agonist effects. This has the potential to be clinically important because 4-1BB has the ability to stimulate the immune cells (antitumor-specific T cells) involved in tumor control, making immune cell stimulation through 4-1BB a particularly compelling target for cancer immunotherapy. Preclinical results, presented at the Society of Immunotherapy Cancer's 2021 Annual Meeting, highlighted the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in vitro models. The tumor-binding function of ALG.APV-527 targets the 5T4 tumor-associated antigen. 5T4 is a protein expression in multiple solid tumor types and limited expression in normal tissues, making 5T4 a compelling target molecule for cancer therapy. Announcement • Sep 15
Alligator Bioscience Presents Additional Data from Mitazalimab OPTIMIZE-1 Phase 1B/2 Trial at AACR Special Conference on Pancreatic Cancer 2022 Alligator Bioscience announced a poster presentation on the OPTIMIZE-1 Phase 1b/2 trial of mitazalimab in combination with modified FOLFIRINOX in first-line metastatic pancreatic cancer with the company's lead asset mitazalimab (CD40 mAb) at the 2022 AACR (American Association for Cancer Research) Special Conference on Pancreatic Cancer, being held in Boston September 13-16. The results presented at AACR, demonstrate that mitazalimab is safe and tolerable at 900 µg/kg, the higher dose tested in OPTIMIZE-1. Most of the mitazalimab related AEs at both dose levels (fever, muscle pain, loss of apetite and fatigue) were mild to moderate (grade 1 or 2) severity and manageable. Only one patient out of the 6 patients in the 900 µg/kg cohort experienced a grade 3 treatment-related adverse event (TRAE) of headache. There were no grade 4 TRAEs or treatment related death reported. Pharmacodynamic markers in peripheral blood confirmed immune activation, in accordance with mitazalimab’s mode of action. Overall, the data showed that mitazalimab combined with mFOLFIRINOX is safe and well tolerated. The 900 µg/kg dose of mitazalimab was selected as the recommended dose for the Phase 2 study. Enrollment for the Phase 2 is ongoing at sites in Europe with an interim efficacy and safety read-out expected in Fourth Quarter 2022. Reported Earnings • Jul 13
Second quarter 2022 earnings released: EPS: kr0.21 (vs kr0.41 loss in 2Q 2021) Second quarter 2022 results: EPS: kr0.21. Revenue: kr5.44m (up 44% from 2Q 2021). Net loss: kr45.7m (loss widened 31% from 2Q 2021). Over the next year, revenue is forecast to grow 162%, compared to a 30% growth forecast for the industry in Germany. Announcement • Jul 08
Alligator Bioscience AB (publ) Appoints Sumeet Ambarkhane as Its Chief Medical Officer Alligator Bioscience AB (publ) appointed Dr. Sumeet Ambarkhane as its Chief Medical Officer earlier 2022. BioStock reached out to Dr. Ambarkhane to learn more about his impressions and expectations in his new position. Announcement • May 31
Alligator Bioscience to Present Additional data of ATOR-1017 First-in-Human Study via poster presentation at ASCO Annual Meeting 2022 Alligator Bioscience AB (publ) announced it will present a poster on the 4-1BB conditional agonist antibody ATOR-1017 at the 2022 ASCO (American Society of Clinical Oncology) Annual Meeting, being held in Chicago June 3-7. The poster, entitled "Initial findings from a first-in-human, multicenter, open-label study of ATOR-1017, a 4-1BB antibody, in patients with advanced solid malignancies", outlines results from Alligator's first-in-human clinical trial with ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic solid cancers. The results, to be presented at ASCO, demonstrate an excellent safety profile. Five (22.7%) of the 22 patients treated with ATOR-1017 experienced grade 3-4 treatment-related adverse events (TRAEs). None of the TRAEs resulted in treatment discontinuation. No dose-limiting toxicity was observed, and thus the maximum tolerated dose (MTD) of ATOR-1017 has not been reached. ATOR-1017 exhibits a dose dependent and favorable pharmacokinetic profile. Activation of peripheral T cells and increased levels of soluble 4-1BB was observed across active dose levels of ATOR-1017, demonstrating biological activity and proof of mechanism. Stable disease was achieved as best objective response in 10 (45%) of patients, with the longest treatment duration being 16 months. Overall, the data showed that ATOR-1017 is safe and well-tolerated at doses up to 600 mg and has shown signs of clinical benefit. Dose escalation continues at the 900 mg dose and data from this cohort is expected to be reported in 2022. Announcement • May 10
Alligator Bioscience Expands Its Board of Directors with the Appointment of Staffan Encrantz and Denise Goode Alligator Bioscience announced the appointment of Staffan Encrantz and Denise Goode as members of the company's Board of Directors. Mr. Encrantz is the founder and Chairman of Allegro Investment Fund, a $750 million fund which has been investing in companies across a number of industries for 30 years and is also a major shareholder in Alligator Bioscience. Ms. Goode has more than 25 years of experience in business leadership and innovation, having held a number of senior executive and board-level positions in the pharmaceutical and life science industries, including at AstraZeneca. The new appointees will bring the number of Board members at Alligator Bioscience to eight, including the Chairman. Staffan is a hugely experienced investor having led the growth and development of numerous companies, including start-ups and established businesses, over the last 30 years. Since 2015, he has taken a great interest in Alligator Bioscience, and the company is delighted to have him assume a formal leadership role in the company. Denise brings with her a huge amount of insight and experience with a deep understanding of the pharmaceutical industry as well as financing, fundraising and business development. Their appointments will further strengthen the leadership of the company and underline commitment to mission of developing antibody-based treatments for cancer while creating outstanding value for shareholders. Board Change • Apr 29
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 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. Announcement • Apr 03
Alligator Bioscience AB (publ) Announces Completion of 600 Mg Dose Cohort for ATOR-1017, Dose-Escalation and Enrollment for 900 Mg Dose Cohort Commences Alligator Bioscience AB (publ) announced completion of the patient enrollment for the 600 mg dose cohort from alligator's phase I, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer. The phase I study with ATOR-1017 is an open-label, dose escalation study in patients with histologically confirmed, advanced and/or refractory solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent phase II studies. The data indicate that for doses up to 600 mg, there were no significant safety concerns with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced. Reported Earnings • Feb 12
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: kr0.64 loss per share (up from kr2.01 loss in FY 2020). Net loss: kr141.7m (loss narrowed 1.1% from FY 2020). Revenue exceeded analyst estimates by 42%. Over the next year, revenue is expected to shrink by 40% compared to a 60% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. Announcement • Feb 01
Alligator Bioscience Appoints Sumeet Ambarkhane as Chief Medical Officer Alligator Bioscience announced the appointment of Sumeet Ambarkhane, MD, as its Chief Medical Officer. In this role, Sumeet will provide medical leadership and direction in the development of Alligator's best-in-class preclinical and clinical pipeline, including Alligator's lead assets mitazalimab, a CD40 agonist currently in Phase II clinical development, and ATOR-1017, a 4-1BB agonist in Phase I. Sumeet is a seasoned professional with over 20 years of drug development experience in academia and in the biotechnology and pharmaceutical industries. Sumeet has a proven track record of advancing investigational medicines including immunotherapy-biologics, from early phases of development through regulatory approvals and adoption into clinical practice. Announcement • Jan 18
Alligator Bioscience Announces Optimize-1 Trial Update Alligator Bioscience AB (publ) announced an update on the on-going OPTIMIZE-1 clinical Phase Ib/II trial with the company's lead asset, mitazalimab. All patients in the 450 µg/kg cohort have been dosed and there have been no adverse effects related to study medication has been reported. Dosing of the 900 µg/kg cohort has been initiated. The Phase 1b part of the study is expected to be completed during first quarter of 2022. OPTIMIZE-1, an open-label, multi-center phase Ib/II study is assessing the safety and efficacy of mitazalimab in combination with chemotherapy, mFOLFIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma. The study is designed to take full advantage of mitazalimab efficacy and tolerability profile administering higher and more frequent doses than competing molecules. This increases the likelihood of demonstrating clinical benefit to patients as a potential first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. Patient recruitment is ongoing in sites France and Belgium. The study aims to enroll 67 patients with metastatic pancreatic cancer. Reported Earnings • Oct 22
Third quarter 2021 earnings released: kr0.43 loss per share (vs kr0.43 loss in 3Q 2020) Third quarter 2021 results: Net loss: kr37.2m (loss widened 21% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Announcement • Jul 02
Alligator Bioscience AB (Publ) Initiates A Phase II Trial with Mitazalimab, and Drug Candidate Ator-1017 Is Soon to Follow Alligator Bioscience AB (publ) announced that the company is about to initiate a phase II trial with mitazalimab, and drug candidate ATOR-1017 is soon to follow. Other projects are also advancing, and BioStock had the opportunity to talk to Bregenholt about his first impressions and what he expects to achieve as CEO of Alligator. Announcement • Jun 30
Alligator Bioscience AB and Scandion Oncology A/S Present Promising Preclinical Data Alligator Bioscience and Scandion Oncology announces promising preclinical data from their ongoing collaboration exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology's drug candidate SCO-101 and Alligator Bioscience's candidate drug mitazalimab. The collaboration explores the anti-tumor efficacy of the CD40 antibody mitazalimab in combination with SCO-101 as an addition to chemotherapy (FOLFIRINOX) in chemotherapy-resistant preclinical tumor models. The hypothesis is that SCO-101 will revert chemotherapy resistance and thereby facilitate a strengthening of the anti-tumor effects of mitazalimab. The combination of mitazalimab and FOLFIRINOX demonstrates a strong anti-tumor response in FOLFIRINOX resistant cancer cells. Importantly, the current data indicate that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. The studies are still ongoing and further monitored for anti-tumor effects and survival. The data further validate the potential of mitazalimab in combination with standard of care chemotherapy such as FOLFIRINOX The data support the basic concept that SCO-101 in combination with chemotherapy and immuno-oncology is well tolerated and has a very potent anti-tumor effect in vivo on drug resistant cancer cells. Executive Departure • Jun 08
Independent Director Kenth Petersson has left the company On the 1st of June, Kenth Petersson's tenure as Independent Director ended. As of March 2021, Kenth still personally held 408.00k shares (€231k worth at the time). A total of 6 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Executive Departure • Jun 08
Independent Director Kirsten Drejer has left the company On the 1st of June, Kirsten Drejer's tenure as Independent Director ended after 2.1 years in the role. We don't have any record of a personal shareholding under Kirsten's name. A total of 6 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Executive Departure • Jun 08
Independent Director Jonas Sjögren has left the company On the 1st of June, Jonas Sjögren's tenure as Independent Director ended. As of March 2021, Jonas still personally held 5.04m shares (€2.9m worth at the time). A total of 6 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Executive Departure • Jun 08
Independent Director Ulrika Danielsson has left the company On the 1st of June, Ulrika Danielsson's tenure as Independent Director ended. We don't have any record of a personal shareholding under Ulrika's name. A total of 6 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Executive Departure • Jun 08
Independent Chairman Peter Benson has left the company On the 1st of June, Peter Benson's tenure as Independent Chairman ended. We don't have any record of a personal shareholding under Peter's name. A total of 6 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Announcement • Jun 04
Alligator Bioscience Presents Positive Phase I Data At ASCO for Its 4-1BB Agonist Drug Candidate ATOR-1017 Alligator Bioscience presents novel supportive data from the ongoing Phase I clinical trial with the 4-1BB (CD137) drug candidate ATOR-1017 developed as tumor-directed therapy for metastatic cancer. The results, presented in a poster presentation at the 2021 ASCO Annual Meeting, validate the therapeutic potential of ATOR-1017 demonstrating a very favorable safety profile combined with clear signs of proof of mechanism, as activation of T cells in the circulation was observed across active dose levels of ATOR-1017. The Phase I study with ATOR-1017 is a dose escalation study in patients with advanced solid cancer (NCT04144842). The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1017 and to determine the recommended dose for subsequent Phase II studies. The first patient was dosed in December 2019. As of data cut-off March 31, 2021, a total of 13 patients with varying advanced solid malignancies had been included. 4 patients (31%) remained on treatment, 3 (23%) of whom had confirmed stable disease for a period of 3.5-12.5 months. The results from the evaluation of doses up to and including 200 mg demonstrate that ATOR-1017 has an encouraging safety profile as the drug related adverse events in the study have generally been mild and transient. No dose-limiting toxicity or severe immune-related adverse events have been reported. The results further demonstrate that ATOR-1017 exhibits a favorable pharmacokinetic profile with linear elimination and no accumulation. Activation of T cells in the circulation was observed across therapeutic dose levels of ATOR-1017 demonstrating biological activity and proof of mechanism. Recent Insider Transactions • May 01
Independent Director recently bought €104k worth of stock On the 27th of April, Jonas Sjögren bought around 200k shares on-market at roughly €0.52 per share. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold €10k more in shares than they bought in the last 12 months.