Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Director Aleksandar Danilovski was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • May 20
Forecast breakeven date pushed back to 2027 The analyst covering Active Biotech previously expected the company to break even in 2026. New forecast suggests losses will reduce by 11% to 2026. The company is expected to make a profit of kr18.2m in 2027. Average annual earnings growth of 99% is required to achieve expected profit on schedule. Announcement • May 07
Active Biotech AB (publ) to Report Fiscal Year 2026 Results on Feb 11, 2027 Active Biotech AB (publ) announced that they will report fiscal year 2026 results on Feb 11, 2027 Announcement • Apr 21
Active Biotech AB (publ), Annual General Meeting, May 20, 2026 Active Biotech AB (publ), Annual General Meeting, May 20, 2026, at 17:00 W. Europe Standard Time. Location: in the premises of the company, scheelevagen 22, se-223 63 lund, lund Sweden Announcement • Apr 17
Uli Hacksel and Axel Glasmacher Decline Re-Election as Director of Active Biotech AB (Publ) Active Biotech AB (publ) announced that Uli Hacksel and Axel Glasmacher has declined re-election as director at the upcoming Annual General Meeting. Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Director Aleksandar Danilovski was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 18
Active Biotech AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 70.295124 million. Active Biotech AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 70.295124 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 1,405,902,488
Price\Range: SEK 0.05
Transaction Features: Rights Offering Announcement • Jul 10
Active Biotech Provides Status Update of Its Development Programs Active Biotech AB (publ) provided a status update of its development programs with laquinimod in inflammatory eye disorders and tasquinimod with the core focus in myelofibrosis. The company has communicated progress in the clinical development programs for both drug candidates recently, and a majority of the planned clinical milestones 2025 have been executed. In the laquinimod project, announced topline data from the biodistribution LION study in early May, and most recently an with the principal investigators of the study was published. The interview results from the LION study confidentlyingly demonstrate that laquinimod, at a therapeutic concentration, reaches the back of the eye when administered topically as an eye drop formulation. There is a high unmet need for non-invasive local delivery of therapeutic agents for use in the treatment of inflammatory eye diseases such as non-infectious uveitis and diseases with excessive neovascularisation like wet AMD. The work was carried out in collaboration with Dr. Rachel Caspi's world leading group of at the NEI /NIH and provides the mechanistic basis for the effect of laquinimod in inflammatory Eye disorders. In the myelofibrosis studies with tasquinimod in US and Europe, the first patients were recruited in the beginning of 2025. The protocols for both studies are presently being amended to allow an initial dose-titration regimen with both up- and down-regulation of dosing for increased flexibility in the clinical management of the patients. In the US study the combination of tasquinimod with The newly marketed JAK inhibitor momelotinib is included in the combination cohort. During this process recruitment is paused. Enrollment to the studies will be restarted as soon as have clearance from the Regulatory Authorities and Ethical Committees in the US and Europe. Myelofibrosis is a very rare haematological malignancy with low patient recruitment rate and thus do not foresee major changes to the projected study times lines. Data from the multiple at Abramson Cancer center were reported in early June at myeloma study. ASCO, the world's leading cancer congress. The data from the combination with a standard oral treatment IRd demonstrate the effect of tasquinimod on the tumor microenvironment in the bone marrow and support a role for tasquinimod also in myelofibrosis". The full study data will be submitted for publication in a peer reviewed Journal. Announcement • May 29
Active Biotech AB (Publ) Approves Composition of Election Committee Active Biotech AB (publ) at its AGM held on May 28, 2025, resolved, in accordance with the Election Committee’s proposal, that the Election Committee shall be composed of the Chairman of the Board and one member appointed by each of the three largest shareholders of the Company based on the ownership structure at the end of September 2025. Announcement • May 05
Active Biotech Reports Positive Top-Line Results from the Lion Study on Ocular Absorption and Distribution of Laquinimod in the Eye Active Biotech announced positive top-line results from the clinical phase I LION study. Patients scheduled to undergo pars plana vitrectomy for various elective indications were administered laquinimod daily as eye drops during a 14-day preoperative period. The top-line results from the LION study (Safety, Tolerability, and Distribution of Topical Laquinimod) show that daily dose Eye Drops, an Innovative ImmunomodulatOr Targeting Aryl HydrocarboN Receptor levels of either 0.6, 1.2 and 1.8 mg resulted in dose related intraocular concentrations of laquinimod, which reached a therapeutically relevant level in both the vitreous humor and anterior chamber. Laquinimod administered as eye drops at the chosen daily dose levels was safe and well tolerated for the period of administration studied, and no dose-limiting toxicities were reported in any of the subjects. Importantly, these results demonstrate that laquinimod, when administered topically by patients as an eye drop, can yield intra-ocular concentrations in the posterior parts of the eye, which are known to affect ongoing inflammatory processes. These data support a continued development of laquinimod eye drops for patients with non-infectious inflammatory eye-diseases. Active Biotech currently holds three projects in its portfolio, of which tasquinimod and laquinimod are wholly owned small molecule immunomodulators with a mode of action that includes modulation of myeloid immune cell function. The projects are in clinical development for hematological malignancies and inflammatory eye disorders, respectively. The company's core focus is on the development of tasquinimod in myelofibrosis, a rare blood cancer, where clinical proof-of-concept studies has been initiated. Also ongoing is a clinical Phase Ib/IIa study in multiple myeloma. Laquinimod is in clinical development for the treatment of non-infectious uveitis. A clinical phase I program with a topical ophthalmic formulation is ongoing to support phase II development together with a partner. The third pipeline project is naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, which is in a phase Ib/II clinical program in patients with advanced solid tumors. Announcement • Apr 28
Active Biotech AB (publ), Annual General Meeting, May 28, 2025 Active Biotech AB (publ), Annual General Meeting, May 28, 2025, at 17:00 W. Europe Standard Time. Location: in the premises of the company, at scheelevagen 22, se-223 63 lund Sweden Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Director Axel Glasmacher was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. New Risk • Oct 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr40m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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 (-kr40m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€8.93m market cap, or US$9.66m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr11m net loss in 2 years). Shareholders have been diluted in the past year (36% increase in shares outstanding). New Risk • Sep 27
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.95m (US$9.99m) 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 (-kr42m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€8.95m market cap, or US$9.99m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr21m net loss in 2 years). Shareholders have been diluted in the past year (36% increase in shares outstanding). Announcement • Sep 10
Active Biotech AB (Publ) Reports Intention Inaugural Interocular Concentrations Achieves in A Clinical Bylistribution Study of Laquinimod Eye Drops Active Biotech announced an update to the ongoing clinical phase I biodistribution study of laquinimod eye drops in patients undergoing vitrectomy. A proprietary formulation of laquinimod for corneal application was developed, taking the specific physico-chemical characteristics of this agent into account, to facilitate that a clinically relevant intraocular therapeutic concentration of laquinimod can be obtained. The study, which is being conducted by principal investigator Professor Dr Nguyen at the Byers Eye Institute, Stanford University, Palo Alto, CA, US, aims to evaluate if laquinimod when administered as eye drops reaches the anterior and the posterior chambers of the eye, to support further development in patients with Uveitis. During a 14-day preoperative administration of laquinimod as eye drops, all the three subjects in the first dose group received 0.6mg laquinimod once daily. All subjects, had significant concentrations of laquinimod in vitreous as well as in the anterior chamber fluid when sampled during surgery. This supports distribution of laquinimod from the cornea and sclera into the anterior chamber and onwards to the posterior parts of the eye. These data are also consistent with results previously obtained in rabbits and in an in vitro bovine corneal model of laquinimod penetration into the eye. The bioanalytical results also show that administration of laquinimod eye drops leads to quantities of laquinimod in vitreous humour at therapeutically relevant concentrations, as determined from prior studies in multiple sclerosis patients. Anecdotally, a potent anti-inflammatory ocular effect of laquinimod was noted in the anterior chamber of one patient following 14-days of application as per the protocol, in absence of any concomitant corticosteroid treatment. These initial findings are important to the further development of laquinimod for ocular disorders, as they unequivocally establish trans-corneal-scleral passage of laquinimod. The current study design involves enrolling additional patients at different dose-levels with top-line results expected in late 2024/early 2025. Breakeven Date Change • Aug 25
No longer forecast to breakeven The analyst covering Active Biotech no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr7.80m in 2026. New forecast suggests the company will make a loss of kr280.0k in 2026. Announcement • Jul 15
Active Biotech Provides Update on the Clinical Phase Ib/IIa Study with Tasquinimod in Relapsed Refractory Multiple Myeloma Active Biotech announced an update to a clinical study of tasquinimod in patients with relapsed refractory multiple myeloma (RRMM) being conducted at the Abramson Cancer Center at the University of Pennsylvania in Philadelphia. The study is ongoing in its expansion cohort at the optimal dose of tasquinimod in combination with the standard anti-myeloma regimen of ixazomib, lenalidomide and dexamethasone (IRd). Data from 11 patients so far treated with the combination indicate that adding tasquinimod to IRd shows no unexpected or dose-limiting toxicity and is generally well tolerated. The specific anti-myeloma activity of tasquinimod in this combination is evidenced by three patients with clinical benefit (one partial response and two minimal responses) among the 9 patients who were previously refractory to their most recent combination regimen including a proteasome inhibitor and an immunomodulatory drug. Enrollment in the study continues with a goal of enrolling up to 6 more patients who are refractory to their most recent proteasome inhibitor/immunomodulatory drug combination. Announcement • Jul 01
Active Biotech Enters Agreement for A Clinical Study of Tasquinimod in Myelofibrosis Active Biotech announced it has entered into a clinical study agreement for a Phase II investigator-initiated clinical study investigating the use of tasquinimod in myelofibrosis. The study will be led by Lucia Masarova, M.D., assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center. Active Biotech will support the study with the Investigational Medicinal Product and related costs. The clinical study, entitled Open Label Phase 2 Study of Tasquinimod in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF), will evaluate the efficacy and safety of tasquinimod in patients with myelofibrosis. The primary objective of the study is to determine the anti-tumor activity of tasquinimod as monotherapy and in combination with a stable dose of ruxolitinib based on the measurement of objective response rate (ORR) after six cycles of treatment. Secondary objectives include safety and tolerability, symptom burden, duration of response and bone marrow fibrosis grade. Announcement • Apr 03
Active Biotech AB (publ) Announces Start of Enrollment to the Clinical Phase I Biodistribution Study with Laquinimod Eye Drops Active Biotech announced that the clinical phase I biodistribution study Safety, Tolerability, and Distribution of Laquinimod Eye Drops: The LION Study (clinicaltrials.gov NCT06161415) with laquinimod eye drops is now recruiting patients following the approval from the Food and Drug Administration (FDA) and the Institutional Review Board at Stanford University School of Medicine. The LION study will evaluate whether laquinimod reaches the posterior chamber of the eye to support further development in patients with Non-Anterior-Non-Infectious Uveitis (NA-NIU). Subjects will be dosed with laquinimod eye drops before elective vitrectomy and thereafter samples including vitreous, anterior chamber fluid and plasma will be analysed for laquinimod concentration. Active Biotech supports the study with the Investigational Medicinal Product and related costs. The study is supported by preclinical data where laquinimod was shown to distribute into the posterior segment of the eye following daily instillations of laquinimod eye drops. The recently completed phase I clinical study in healthy subjects showed no safety or tolerability concerns with daily instillations up to 21 days. The biodistribution study consists of a dose-escalation part and an optional masked, randomized dose-comparison part. Results from the study will be reported during 2024. Global Ophthalmic Research Center (GORC), Los Altos, CA, US, is the LION study administrative sponsor, and it will be conducted in collaboration with clinician scientists at the Byers Eye Institute, Stanford University, Palo Alto, CA, led by Principal Investigator Professor Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics, Stanford University School of Medicine. Dr. Nguyen is known for his innovative work in early proof-of-concept, first-in-human clinical trials to evaluate potential pharmacotherapeutic agents for retinal vascular and uveitic diseases. He is a member of various prestigious professional organizations including the Club Jules Gonin, the Macula Society, the Retina Society, the American Ophthalmological Society, and the International Uveitis Study Group, among others. He serves as President of the International Ocular Inflammation Society as well as Executive Vice President of the Foster Ocular Immunology Society. Breakeven Date Change • Feb 13
No longer forecast to breakeven The analyst covering Active Biotech no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr64.0m in 2024. New forecast suggests the company will make a loss of kr43.0m in 2024. New Risk • Feb 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (54% average weekly change). Earnings are forecast to decline by an average of 1.7% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr2.1m net loss in 3 years). Shareholders have been diluted in the past year (37% increase in shares outstanding). Market cap is less than US$100m (€18.8m market cap, or US$20.3m). New Risk • Jan 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 37% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (37% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr6.9m net loss in 2 years). Shareholders have been diluted in the past year (37% increase in shares outstanding). Market cap is less than US$100m (€15.5m market cap, or US$16.9m). Announcement • Dec 22
Active Biotech AB (Publ) Provides Update on the Scheduled Clinical Program for 2024 Active Biotech AB (publ) announced an update to the timelines of its scheduled clinical studies to be initiated in 2024, backed by the company's recently completed successful financing round. Announcement • Dec 01
Active Biotech AB (Publ) Appoints Mats Arnhög and Petter Wingstrand to Nomination Committee Active Biotech AB (publ) in accordance with a decision made by the Annual General Meeting held on May 24, 2023, the Nomination Committee shall comprise the representatives for the three largest shareholders by votes, as per end of September 2023, and the Chairman of the Board. The company appointed Mats Arnhög and Petter Wingstrand to Nomination Committee. The Nomination Committee is composed with participants representing the largest shareholders in Active Biotech as of September 30, 2023, and consists of: Michael Shalmi, chairman; Mats Arnhög, MGA Holding; Peter Thelin, Sjuenda Holding; Petter Wingstrand, T-bolaget. Breakeven Date Change • Nov 12
Forecast breakeven date pushed back to 2025 The analyst covering Active Biotech previously expected the company to break even in 2024. New forecast suggests losses will reduce by 12% per year to 2024. The company is expected to make a profit of kr6.00m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Announcement • Nov 11
Active Biotech AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 51.135046 million. Active Biotech AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 51.135046 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 113,633,436
Price\Range: SEK 0.45
Transaction Features: Rights Offering New Risk • Aug 25
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: kr51m Forecast net loss in 1 year: kr5.7m 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 (-kr50m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr5.7m net loss next year). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (€18.2m market cap, or US$19.6m). Breakeven Date Change • Aug 25
Forecast to breakeven in 2024 The analyst covering Active Biotech expects the company to break even for the first time. New forecast suggests the company will make a profit of kr64.0m in 2024. Average annual earnings growth of 152% is required to achieve expected profit on schedule. Announcement • Aug 01
Active Biotech AB (publ) Enters into Clinical Trial Collaboration Agreement for a Clinical Study with Tasquinimod in Myelofibrosis Active Biotech announced it has entered into a clinical trial collaboration agreement with Stichting Haemato-Oncologie Volwassenen Netherland (HOVON) and Stichting Oncode Institute (Oncode) for the upcoming clinical proof-of-concept trial of tasquinimod in myelofibrosis. HOVON will be the legal sponsor of the trial, Oncode the main financier and Active Biotech will provide tasquinimod study drug to the study. Active Biotech has a global patent license agreement with Oncode Institute, acting on behalf of Erasmus Universiteit Medisch Centrum (Erasmus MC) to develop and commercialize tasquinimod worldwide in myelofibrosis is planned to start in 2023. Myelofibrosis (MF) is a rare blood cancer belonging to a group of disorders called myeloproliferative neoplasms. The underlying cause of MF is unknown. MF is associated with shortened survival and causes of death include bone marrow failure and transformation into acute leukemia. MF can be treated with bone marrow transplantation for eligible individuals, erythropoietin to manage anemia and JAK inhibitors to reduce spleen size. At present there are no approved therapies that would reverse bone marrow fibrosis in MF. Board Change • Jun 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 1 highly experienced director. Independent Director Elaine Sullivan was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 27
Active Biotech Announces Positive Interim Data from an Ongoing Study with Tasquinimod in Relapsed and Refractory Multiple Myeloma Active Biotech AB (publ) announced that tasquinimod, when given as monotherapy or in combination with ixazomib, lenalidomide and dexamethasone (IRd), has a favourable safety profile in heavily pre-treated patients with a median of 8 previous lines. All 15 patients included in this interim readout were previously refractory to IMiDs, Proteasome Inhibitors (PIs) and CD38 mAbs. With single agent tasquinimod three patients with progressive disease at study entry had stabilization of disease while on study. Of 5 patients treated with tasquinimod in combination with IRd, one patient (20%) has a durable partial response ongoing since April 2022, despite being previously refractory to ixazomib-pomalidomide and carfilzomib-pomalidomide combinations. No dose limiting toxicity was seen in the combination with tasquinimod at 1mg daily after a one week run in at 0.5 mg daily. The study (NCT04405167) which is conducted at Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA is ongoing in the dose-escalation cohort investigating the safety, tolerability, and maximum tolerated dose (MTD) of tasquinimod in combination with (IRd). Enrolment into the study continues and an expansion cohort will start once the MTD is established. Announcement • Jan 31
Active Biotech AB (Publ) Confirms Positive Clinical Safety Profile of Laquinimod Eye Drops Active Biotech AB (publ) announced the completion of the phase I clinical study testing the safety and tolerability of the newly developed laquinimod eye drop formulation in healthy subjects. According to the results, the eye drop was safe and well tolerated both at single ascending doses and after repeated doses for up to 21 days. No serious adverse events were reported. Laquinimod is being developed as a new treatment for inflammatory eye disorders, and preclinical data suggest that laquinimod may have a therapeutic effect when given as a capsule or as a topical treatment onto the eye. The company has developed an eye drop formulation of laquinimod with the aim to use it for treatment initially in patients with non-infectious uveitis. The study was a randomized, double-masked, placebo-controlled phase I study to determine the safety and tolerability and establish a safe and tolerable dose for continued development of laquinimod eye drops after single and repeated dosing in healthy subjects. Secondary aims included the assessment of ocular toxicity and pharmacokinetics of laquinimod. The complete data set from the study is currently being analyzed, and the full study results will be reported in first half of 2023. Announcement • Dec 06
Active Biotech's Announces Nomination Committee Active Biotech announced that the Nomination Committee is composed with participants representing the largest shareholders in Active Biotech as of September 30, 2022, and consists of: Michael Shalmi, chairman, Mats Arnhög, MGA Holding, Peter Lundkvist, 3:e AP Fonden, Peter Thelin, Sjuenda Holding. Breakeven Date Change • Nov 16
Forecast to breakeven in 2024 The analyst covering Active Biotech expects the company to break even for the first time. New forecast suggests the company will make a profit of kr94.0m in 2024. Average annual earnings growth of 98% is required to achieve expected profit on schedule. Announcement • Sep 28
Active Biotech AB (publ) to Report Fiscal Year 2022 Results on Feb 09, 2023 Active Biotech AB (publ) announced that they will report fiscal year 2022 results on Feb 09, 2023 Announcement • Jun 02
Active Biotech AB (Publ) Announces Successful Completion of the First Stage of the Phase Iia Clinical Trial of Naptumomab in Combination with Docetaxel and the Study Is Now Enrolling into the Second Stage Active Biotech and its partner NeoTX announce the successful completion of the first stage of a Simon 2 stage phase IIa clinical trial of naptumomab estafenatox (NAP, naptumomab), in combination with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs). In the study, the patients are treated with NAP for 4 consecutive days and with docetaxel at a standard dose on day 5 in 21-day treatment cycles. The first stage of this trial required a minimum of two responses out of ten patients to move to the second stage of the trial, which is now enrolling. Announcement • May 19
Active Biotech AB (publ) announces that Food and Drug Administration has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis Active Biotech AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis. The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that affects fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives. Board Change • Apr 27
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. 1 highly experienced director. Independent Director Peter Thelin is the most experienced director on the board, commencing their role in 2011. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Feb 08
Active Biotech Announces First Patient Dosed in the Combination Part of the Phase Ib/IIa Study of Tasquinimod in Multiple Myeloma Active Biotech announced that the first patient has been dosed in the combination part of the phase Ib/IIa clinical study of tasquinimod in relapsed or refractory multiple myeloma. In this part of the study treatment with tasquinimod will be tested together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd). Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group. As previously communicated, the optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma, was established at 1 mg per day after a one-week run in of 0.5 mg daily. Tasquinimod was generally well tolerated and the established treatment schedule and safety profile of tasquiniomod in myeloma patients resembled that previously demonstrated in solid tumors. The study is conducted in an academic partnership with the Abramson Cancer Center of the University of Pennsylvania, with Dr. Dan Vogl as principal investigator. Detailed information about the study is available on clinicaltrials.gov (NCT04405167). Announcement • Dec 11
Active Biotech AB (publ) Announces First Subject Dosed in Phase I Clinical Study with Eye-Drop Formulation of Laquinimod Active Biotech AB (publ) announced that the first subject has been dosed in the phase I clinical study of the newly developed eye-drop formulation of the company's candidate drug laquinimod. Laquinimod is being developed as a new treatment for non-infectious non-anterior uveitis and has the potential to be used in the first line treatment as an add-on to steroids as well as in the second line treatment for patients that have failed steroid treatment. Preclinical data suggest that laquinimod may influence inflammatory eye diseases when given both as a tablet and directly onto the eye. Active Biotech has developed an eye-drop formulation of laquinimod with the aim to use it for the treatment of inflammatory eye diseases, initially in patients with non-infectious non-anterior uveitis. These are patients who lack sufficiently effective and safe treatments and in addition, there is currently no eye-drop treatment available. A preclinical program shows that the laquinimod eye-drop is safe and well tolerated, and the safety of this new formulation will now be tested in a phase I clinical study in healthy subjects. The primary endpoint of the study is to determine the safety and tolerability of laquinimod eye-drops after single and repeat doses. Secondary endpoints include eye toxicity and pharmacokinetics. Announcement • Jul 06
Active Biotech AB (publ) Provides Status Update of its Clinical Naptumomab Project Active Biotech AB (publ) provided a status update of its leading candidate drug naptumomab, developed together with the company’s partner NeoTX. As previously communicated, they expected to be able to present data from the ongoing clinical phase Ib/II study with naptumomab in combination with checkpoint inhibition in patients with advanced solid tumors during the first half of this year. The study was amended to also include assessment of pre-treatment with obinutuzumab to assess its effect on anti-drug antibodies (ADAs) to naptumomab. The study is still enrolling, and they will update once results are available. Preparations are also ongoing for initiation of the previously communicated phase IIa study in combination with docetaxel in patients with non-small cell lung cancer. Recent Insider Transactions • Jun 05
Independent Chairman of the Board recently bought €26k worth of stock On the 1st of June, Michael Shalmi bought around 175k shares on-market at roughly €0.15 per share. This was the largest purchase by an insider in the last 3 months. This was Michael's only on-market trade for the last 12 months. Is New 90 Day High Low • Dec 22
New 90-day high: €0.25 The company is up 44% from its price of €0.17 on 23 September 2020. The German market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 7.0% over the same period. Announcement • Dec 13
Active Biotech Receive Milestone Payment from Neotx Active Biotech AB (publ) announced a milestone payment of USD 750,000 from the partner NeoTX Therapeutics (NeoTX) under the terms of license agreement on the immunotherapy naptumomab. Based on preclinical data and the previous clinical experience of naptumomab, a phase Ib/II study in patients with advanced solid tumors was initiated by NeoTX, in cooperation with AstraZeneca, in 2019. The study is currently ongoing, and the results from the dose escalation part of the study are expected early next year. NeoTX plans to expand the clinical program in the combination of naptumomab and durvalumab with focus on indications in so-called “cold tumors” with poor response to checkpoint inhibition alone, as well as evalutate further combination strategies such as the combination with docetaxel. About the agreement: In 2016, Active Biotech and NeoTX entered into a partnership for the development and commercialization of naptumomab in cancer indications. Under the terms of the agreement, Active Biotech has granted NeoTX exclusive rights to develop and commercialize naptumomab worldwide in cancer indications. The total deal value amounts to USD 71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech has received so far USD 250 000. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales of naptumomab. 
