Announcement • Jun 12
Cantargia AB (publ) Announces Start Of New Investigator-Initiated Lung Cancer Prevention Study Cantargia AB (publ) reported that the first patient has been dosed in a Phase 2 clinical trial investigating nadunolimab in up to 59 current or previous smokers with multifocal high-risk lung nodules, and therefore at risk of developing lung cancer. The study is an investigator-led initiative in collaboration with Drs. Robert Samstein, Thomas Marron and Miriam Merad at Mount Sinai Tisch Cancer Center, New York. Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have performed preclinical work strongly implicating IL-1 signaling in tumor initiation and the development of early lung cancer. The new phase 2 investigator-initiated trial will be conducted at Mount Sinai Tisch Cancer Center, New York. The study, led by principal investigator Dr. Robert Samstein, is designed to investigate nadunolimab monotherapy in the high-risk population for 3 months. The study participants will then be screened repeatedly for 12 months, measuring the response of the lung nodules to treatment. In addition to investigating anticancer effects, the study will include comprehensive correlative studies to understand the effect IL1RAP targeting on inflammation contributing to cancer and other diseases. Announcement • May 30
Cantargia AB Reports Early Clinical Data And Expands Nadunolimab Development In MDS And AML Cantargia AB has reported promising early clinical data from an ongoing investigator-initiated Phase 1b/2a study at MD Anderson Cancer Center in MDS and AML, where IL1RAP is overexpressed. In the high-risk MDS cohort, all five evaluable patients achieved complete remission in Phase 1b, based on early but notable data. The study is now advancing into Phase 2a, expected to enroll approximately 40 patients. Preclinical data indicate that IL1RAP targeting with nadunolimab complements RAS inhibition and may enhance anti-tumor activity, supporting planned combination study. Continued development in combination with gemcitabine and nab-paclitaxel is supported by encouraging efficacy and manageable safety. These results expand nadunolimab’s clinical potential into hematology and, supported by the strengthened financial position, enable further development planning in MDS as a significant long-term opportunity for the Company. Price Target Changed • May 29
Price target decreased by 11% to kr10.00 Down from kr11.25, the current price target is an average from 2 analysts. New target price is 359% above last closing price of kr2.18. Stock is up 57% over the past year. The company is forecast to post a net loss per share of kr0.65 compared to earnings per share of kr0.59 last year. Announcement • May 29
Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 124.305827 million. Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 124.305827 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 32,266,667
Price\Range: SEK 2.25
Discount Per Security: SEK 0.18
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 22,980,368
Price\Range: SEK 2.25
Transaction Features: Rights Offering Valuation Update With 7 Day Price Move • May 27
Investor sentiment deteriorates as stock falls 16% After last week's 16% share price decline to kr2.92, the stock trades at a trailing P/E ratio of 4.5x. Average trailing P/E is 24x in the Biotechs industry in Sweden. Total loss to shareholders of 37% over the past three years. New Risk • May 04
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr896.0m (US$96.5m) This is considered a minor 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 Risk Earnings are forecast to decline by an average of 70% per year for the foreseeable future. Minor Risk Market cap is less than US$100m (kr896.0m market cap, or US$96.5m). Major Estimate Revision • Mar 02
Consensus revenue estimates decrease by 50% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from kr8.80m to kr4.40m. EPS estimate unchanged from -kr0.63 per share at last update. Biotechs industry in Sweden expected to see average net income growth of 9.0% next year. Consensus price target up from kr10.50 to kr11.25. Share price rose 9.4% to kr4.74 over the past week. Announcement • Feb 20
Cantargia AB (publ) to Report Fiscal Year 2026 Results on Feb 24, 2027 Cantargia AB (publ) announced that they will report fiscal year 2026 results on Feb 24, 2027 Valuation Update With 7 Day Price Move • Jan 23
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to kr6.20, the stock trades at a trailing P/E ratio of 11x. Average trailing P/E is 39x in the Biotechs industry in Sweden. Total loss to shareholders of 7.7% over the past three years. Announcement • Jan 23
Cantargia AB (Publ) Reports First Patient Dosed in New US Investor-Initiated Colorectal Cancer Study Cantargia AB (Publ) reported that the first patient has been dosed in a Phase 1b/2 clinical trial investigating nadunolimab in combination with checkpoint inhibitor therapy in up to 24 patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer (CRC). The study is an investigator-led initiative in collaboration with Dr. Dan Fang at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have a long-standing interest in developing new therapies for the treatment of CRC and have performed preclinical work strongly implicating IL-1 signaling in immune suppressive and treatment resistant pathways in this disease. The new phase 1b/2a investigator-initiated trial will be conducted at Tisch Cancer Institute,Iisch School of Medicine at Mount Sinai., New York. The study, led by principal NCT07281716 investigator Dr. Dan Feng, is designed to investigate nadunolIMab in combination with an anti-PD-1 inhibitor in up to 24 patients with MSS CRC. In addition to investigating anticancer effects, the study will include a comprehensive biomarker assessment package. Valuation Update With 7 Day Price Move • Jan 09
Investor sentiment improves as stock rises 21% After last week's 21% share price gain to kr4.98, the stock trades at a trailing P/E ratio of 8.8x. Average trailing P/E is 35x in the Biotechs industry in Sweden. Total loss to shareholders of 45% over the past three years. Valuation Update With 7 Day Price Move • Dec 12
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to kr4.41, the stock trades at a trailing P/E ratio of 7.8x. Average trailing P/E is 31x in the Biotechs industry in Sweden. Total returns to shareholders of 37% over the past three years. Valuation Update With 7 Day Price Move • Nov 28
Investor sentiment improves as stock rises 30% After last week's 30% share price gain to kr4.11, the stock trades at a trailing P/E ratio of 7.3x. Average trailing P/E is 32x in the Biotechs industry in Sweden. Total returns to shareholders of 20% over the past three years. Major Estimate Revision • Nov 26
Consensus revenue estimates increase by 108% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from kr148.2m to kr308.7m. Now expected to report a profit of kr0.44 instead of losses of -kr0.58 per share. Biotechs industry in Sweden expected to see average net income growth of 24% next year. Consensus price target of kr8.67 unchanged from last update. Share price rose 12% to kr3.56 over the past week. New Risk • Nov 20
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 75% 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 (13% average weekly change). Earnings are forecast to decline by an average of 75% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (35% increase in shares outstanding). Minor Risk Market cap is less than US$100m (kr788.1m market cap, or US$82.5m). Announcement • Nov 12
Cantargia AB (publ), Annual General Meeting, May 21, 2026 Cantargia AB (publ), Annual General Meeting, May 21, 2026. Location: at ideon gateway, scheelevagen 27, lund Sweden New Risk • Oct 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr149m free cash flow). Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (35% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr142m net loss in 3 years). Market cap is less than US$100m (kr592.9m market cap, or US$63.1m). Announcement • Oct 03
Cantargia AB Announces Executive Changes Cantargia AB announced the appointment of Wolfram Dempke, MD, PhD, MBA as Chief Medical Officer, effective 02 October 2025. Dr. Wolfram Dempke is an internationally recognized expert in hematology and oncology with over 30 years of experience in academia, clinical research, and the pharmaceutical industry. Dr. Dempke holds an MD, PhD, and MBA from the Universities of Essen, London, Aachen and Halle/Saale. He is Professor of Haematology &Oncology at the University of Munich and the Cambridge (UK) University Medical School. Dr. Dempke has held leadership roles at several pharmaceutical companies such as Bristol-Myers Squibb, Merck Serono and AstraZeneca, and he oversaw numerous new drug applications (NDAs), including dasatinib, ipilimumab, gefitinib, mogamulizumab and others. His expertise ranges from early clinical development &translational medicine to managing late-stage clinical programs, regulatory strategy and execution. Dr. Morten Lind Jensen, who has served as CMO since March 2025, will leave Cantargia to pursue other opportunities. Announcement • Sep 03
Cantargia AB (publ) to Report Q1, 2026 Results on May 19, 2026 Cantargia AB (publ) announced that they will report Q1, 2026 results on May 19, 2026 Breakeven Date Change • Aug 26
Forecast to breakeven in 2027 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr379.3m in 2027. Average annual earnings growth of 55% is required to achieve expected profit on schedule. Price Target Changed • Jul 15
Price target increased by 22% to kr7.00 Up from kr5.75, the current price target is an average from 2 analysts. New target price is 74% above last closing price of kr4.02. Stock is down 4.7% over the past year. The company is forecast to post a net loss per share of kr1.22 next year compared to a net loss per share of kr0.88 last year. Announcement • May 16
Cantargia AB (publ) Appoints Jenny Sundqvist as Board Member Cantargia AB (publ) announced that at the AGM held on May 15, 2025 approved election of Jenny Sundqvist as board member. New Risk • May 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 58% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr142m free cash flow). Earnings are forecast to decline by an average of 58% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (35% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr508m net loss in 2 years). Market cap is less than US$100m (kr383.4m market cap, or US$39.4m). Announcement • May 13
Cantargia Announces Successful Phase 1 Results: PK/PD Data of Subcutaneous Administered CAN10 Confirms Every 4-Week Dosing Choice in Phase 2 Pharmacokinetic Model Cantargia AB (publ) announced the results of the first CAN10 PK model with SC multiple dose PK data. The model indicates a high bioavailability of CAN10 and confirms every 4-week dosing choice for phase 2 studies. In addition, CAN10 shows potent and long-lasting inhibitory effects on several key inflammatory biomarkers, further strengthening the potential benefit of CAN10 in inflammatory diseases such as hidradenitis suppurativa (HS) and atopic dermatitis (AD). CAN10 is an antibody against IL1RAP designed to potently inhibit the activity of the pro- inflammatory and disease promoting cytokines of the IL-1-super family: IL-1, IL-33 and IL-36. CAN10 is currently being evaluated in a phase 1 clinical trial. The first multiple SC dose cohort in healthy volunteers has now been completed and determined safe, consequently the last multiple dose cohort in healthy volunteers has been started. The cohort of subjects with psoriasis continues recruitment and data will be analyzed and announced at the appropriate time. These data are not required to be able to start phase 2 studies. PK data from the completed single ascending dose (SAD) cohorts and the first multiple SC dose cohort has been used to generate the PK model to be able to determine dose and dosing regimen for future studies. The PK model confirms the predicted dose and dosing regimen for Ph2, including potential for SC dosing every 4-we weeks. The data also demonstrate high bioavailability and a dose proportional PK profile. In addition, new biomarker results show long-lasting effects of CAN10 with complete inhibition of IL-36 and IL-1 beta stimulation 14 days after SC dosing of CAN10. The effects of CAN10 are broad, with inhibition of several key inflammatory biomarkers known to play disease promoting roles in inflammatory diseases such as HS and AD. With the promising new results, Cantargia continues to plan for the start of two phase 2 studies towards the end of 2025; the first will be a randomized, placebo-controlled, dose and regimen ranging study in HS and the second will be a small pilot study in AD patients not responding to dupilumab treatment. New Risk • Apr 08
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: kr162m Forecast net loss in 3 years: kr22m 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 (-kr163m free cash flow). Shareholders have been substantially diluted in the past year (35% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr22m net loss in 3 years). Market cap is less than US$100m (kr310.3m market cap, or US$30.8m). Breakeven Date Change • Apr 07
Forecast to breakeven in 2026 The analyst covering Cantargia expects the company to break even for the first time. New forecast suggests losses will reduce by 2.5% to 2025. The company is expected to make a profit of kr218.8m in 2026. Average annual earnings growth of 57% is required to achieve expected profit on schedule. Announcement • Apr 02
Cantargia AB (publ) Announces Chief Medical Officer Changes Cantargia AB (publ) announced the appointment of Morten Lind Jensen, MD, PhD, as Chief Medical Officer, effective immediately. Morten Lind Jensen has an MD and PhD from Copenhagen University and a Diploma in Pharmaceutical Medicine from the Royal College of Physicians in the UK. He joins Cantargia with extensive leadership in autoimmune and inflammatory diseases. He has led clinical development programs in psoriasis, atopic dermatitis, and hidradenitis suppurativa, which directly aligns with Cantargia's CAN10 program targeting inflammatory and autoimmune conditions. Dr. Lind Jensen's expertise ranges from early clinical development & translational medicine through to late-stage clinical programs and regulatory strategy and execution. Following a short transition, Dominique Tersago, who has served as CMO since 2022, will leave Cantargia to pursue other opportunities. Announcement • Mar 05
Cantargia AB (publ) to Report Fiscal Year 2025 Results on Feb 20, 2026 Cantargia AB (publ) announced that they will report fiscal year 2025 results on Feb 20, 2026 New Risk • Feb 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 35% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (35% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr219m net loss in 2 years). Market cap is less than US$100m (kr372.4m market cap, or US$35.0m). New Risk • Feb 23
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: -kr163m 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 (-kr163m free cash flow). Earnings are forecast to decline by an average of 24% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr229m net loss in 2 years). Market cap is less than US$100m (kr275.2m market cap, or US$25.8m). Announcement • Feb 07
Cantargia AB (publ) Announces CEO Changes Cantargia AB (publ) announced changes to its management. The Board of Directors, in discussion with CEO, Göran Forsberg, has decided to initiate a
search for a new CEO to lead Cantargia into the next phase of development and value creation. Göran Forsberg will be stepping down with immediate effect and will assist with the transition. During the recruitment process, Board Director, Damian Marron, a veteran four-time CEO, will assume the role of Interim CEO, supported by Chairman, Magnus Persson and the Board. Damian Marron is an accomplished Board Chair, Non-Executive Director and former serial CEO with a successful track record of leadership and value creation in public and private biotech companies, including two companies acquired and one IPO. Damian has a strong track record of public and VC financing (EUR 250 million raised), deal making, strategic and portfolio planning and company development. He possesses an extensive network of contacts globally from big pharma through to biotech companies and with investors, banks and analysts. Damian has a BSc Hons in Pharmacology and spent the first ten years of his career in big pharma clinical development. He is Chair of the Board of Circio Holdings ASA and Nicox SA and independent non-executive Board member of Onya Therapeutics Ltd. and Head of Biopharma for Treehill Partners. Announcement • Dec 19
Cantargia AB (publ) Publishes Preclinical Effects and Clinical Monotherapy Results on Nadunolimab in Pancreatic Cancer in Journal for Immunotherapy of Cancer Cantargia AB (publ) announced the publication of preclinical and clinical results using the IL1RAP targeted antibody nadunolimab (CAN04) in pancreatic cancer. Nadunolimab had pronounced effects on PDAC associated fibroblasts and inhibited recruitment of tumor promoting immune cells. These results were linked to monotherapy data in late- stage metastatic PDAC patients showing both clinically meaningful progression free survival and survival in patients with high IL1RAP levels. The studies were performed as a collaboration between Cantargia, Lund University and PanCAN. PDAC is one of the cancer forms with the highest medical need. The incidence is increasing, and the survival is poor. A major clinical challenge in PDAC is its distinct and protective tumor microenvironment, which shields the tumor from the immune system and facilitates tumor growth, metastasis, and resistance to therapy. The crosstalk between cancer cells and cancer- associated fibroblasts plays a pivotal role in shaping this TME. The IL-1 family, through IL1RAP, helps activate CAFs, which attract myeloid immune cells like monocytes and neutrophils into the tumor. This study reveals that nadunolimab blocks this process by inhibiting IL1RAP, reducing the number of immune cells recruited, which weakens the tumor's defenses. Through its other mechanism of action, nadunolimab enhances tumor destruction. The relevance of these preclinical results could be linked to clinical results using nadunolimab monotherapy in the CANFOUR study. In late stage metastatic PDAC patients, high tumor baseline levels of IL1RAP strongly correlate with increased progression free survival (IL1RAP high vs low: 3.5 vs 1.2 months; p=0.0023) and a trend for survival advantage (5.0 vs 2.2 months) with a follow up of 11.5 months. This is in line with previous published results examining nadunolimab with chemotherapies, gemcitabine and nab-paclitaxel, which showed promising efficacy in first line IL1RAP-high PDAC patients. These findings strongly signify the clinical relevance of targeting IL1RAP in PDAC using nadunolimab. This is particularly noteworthy since IL1RAP is considered as a prognostic marker where high IL1RAP expression is linked to shorter survival in PDAC patients. This study used data from the Pancreatic Cancer Action Network's Know Your Tumor precision medicine program as a validation dataset, accessed through the PanCAN SPARK health data platform. This dataset was used to study the impact of IL1RAP expression in PDAC and revealed IL1RAP as a prognostic marker. Announcement • Nov 29
Cantargia AB (publ) Expands CAN10 Phase 1 Clinical Program Building on Positive Results Cantargia AB (publ) reported initiation of an expanded part of CAN10's phase 1 clinical study to investigate higher dose levels of the antibody. The purpose of this expansion is to build on the good safety, potent effects on biomarkers and pharmacokinetic properties of CAN10. Current data indicate durable effects and potential for treatment every 4th week, which will be a competitive advantage. The first participant in this program has now been dosed. CAN10 is an antibody against IL1RAP, designed to potently inhibit the activity of the pro- inflammatory and disease promoting cytokines IL-1, IL-33 and IL-36. CAN10 is currently examined in a phase 1 clinical trial with the primary goal to investigate safety. So far, healthy participants have been treated in 9 single ascending dose (SAD) cohorts and the first multiple ascending dose (MAD) cohort in participants with mild to moderate plaque psoriasis is ongoing. No safety concerns have been reported and biomarker studies confirm binding to immune cells like neutrophils and monocytes as well as complete inhibition of IL-1 and IL-36 stimulation. The results obtained indicate that CAN10 has long-lasting effects that would allow dosing every 4th week, while several other antibodies use more frequent dosing. To further document this potential competitive advantage e.g. leading to improved patient convenience, the clinical protocol has been amended to allow up to two additional SAD cohorts as well as up to two additional MAD cohorts in healthy participants. The first participant in this new part of the trial has been dosed. The plan is to perform these activities during the upcoming months in line with the plan to start phase 2 during second half of 2025. Price Target Changed • Nov 17
Price target decreased by 24% to kr9.67 Down from kr12.67, the current price target is an average from 3 analysts. New target price is 409% above last closing price of kr1.90. Stock is down 50% over the past year. The company is forecast to post a net loss per share of kr0.94 next year compared to a net loss per share of kr1.65 last year. New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.6% 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 (13% average weekly change). Earnings are forecast to decline by an average of 5.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr185m net loss in 2 years). Market cap is less than US$100m (kr348.8m market cap, or US$31.7m). Announcement • Nov 14
Cantargia AB (publ), Annual General Meeting, May 15, 2025 Cantargia AB (publ), Annual General Meeting, May 15, 2025. Location: at ideon gateway, scheelevagen 27, lund Sweden New Risk • Nov 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr113m net loss in 2 years). Market cap is less than US$100m (kr353.2m market cap, or US$33.0m). Announcement • Nov 07
Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 169.910183 million. Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 169.910183 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 91,843,342
Price\Range: SEK 1.85
Transaction Features: Rights Offering Announcement • Nov 06
Cantargia Presents Promising Preclinical Results on Nadunolimab with Antibody-Drug Conjugates At Major Immuno-Oncology Conference Cantargia reported preclinical results on potential synergism between nadunolimab and antibody-drug conjugate (ADC) therapies. The new findings show that ADCs, just like chemotherapy, induce both tumor promoting as well as neuropathy inducing signals that can be counteracted by nadunolimab. Results will be presented in a poster session at the upcoming Society for Immunotherapy of Cancer (SITC), 2024 annual meeting. Traditional chemotherapy can induce the release of inflammatory factors (IL-1a and IL-1b), which act as " dangerous signals" and promote tumor growth, chemotherapy resistance, and immune suppression. In addition, these factors also stimulate inflammation-related damage to the nervous system, contributing to chemotherapy-induced peripheral neuropathy. ADCs, a form of guided missile delivering cytotoxic drugs ("payloads") precisely into the cancer cells via the antibody part of the molecule, is a approach in cancer therapy and the next generation of chemotherapy. ADCs have an edge over traditional chemotherapies as they are widely recognized for their improved tolerance levels and precise target recognition, sparing the healthy cells around the tumor. However, as for traditional chemotherapy, ADCs can also induce treatment resistance and side effects such as neuropathy. Cantargia's new preclinical data shows that ADCs (or payloads) increase the expression of IL-1a and IL- 1b when interacting with cancer cells, cancer-associated fibroblasts, or immune cells. In addition, the data also demonstrates potent inhibition of IL-1 signaling in these ADCs-treated cell culture systems when combined with a nadunolimab surrogate antibody. Furthermore, experiments reveal pronounced payload-driven neuropathic effects in a mouse model of neuropathy. Neuropathy is a common and serious side effect of several chemotherapies or ADCs. Neuropathy often leads to the drop out of patients from an otherwise effective cancer therapy. Announcement • Oct 29
Cantargia Reports New Results from Clinical Studies Investigating Nadunolimab in Several Forms of Cancer; Supporting Ongoing Strategies Cantargia announced new clinical results from two nadunolimab combination therapy trials in 54 patients. Positive signals of efficacy were documented in the key areas of nadunolimab development, non-small cell lung cancer and gastrointestinal cancers. In addition to the efficacy signals, nadunolimab appeared to counteract oxaliplatin induced peripheral neuropathy. No unexpected safety findings were observed. The clinical trials are CESTAFOUR and CAPAFOUR. CESTAFOUR investigated nadunolimab in combination with three different chemotherapies. The CAPAFOUR trial investigated nadunolimib combination therapy with FOLFIRINOX in first line pancreatic cancer, PDAC. Nadunolimab dose levels starting at 0.5 mg/kg, followed by escalation up to 2.5 mg/kg were planned in the two trials. The first arm in CESTAFOUR investigated combination with gemcitabine/cisplatin in 14 patients and generated the strongest signal of efficacy. In the five heavily pretreated (2-11 lines of previous therapy) patients with non-small cell lung cancer, NSCLC, the response rate was 40% according to RECIST 1.1 and PFS 10.2 months. The eight patients, predominantly second line, with biliary tract cancer also showed promising results with a response rate of 13% and PFS of 6.4 months. The second arm in CESTAFOUR investigate combination therapy with FOLFOX in 14 patients with 8 different cancer forms and varying treatment history. Interestingly, three patients had a confirmed partial response, one 4th line colorectal cancer, one first line gastric cancer and one receiving third line treatment of testicular cancer. The PFS in this heterogenous group of patients was 4.6 months. The third arm in CESTAFOUR investigation with docetaxel included eight second- or third-line patients with NSCLC. The protocol was designed to allow frequent dose reductions during the dose finding phase and the efficacy results are therefore not conclusive. The CAPAFOUR study included 18 PDAC patients receiving first line nadunolimab and FOLFIRINOX. The initial safety part at different dose levels is successfully concluded, allowing for start of a future phase 2 trial. The first part of the CAPAFOUR trial allowed frequent dose reductions which limits efficacy conclusions. Future studies in a larger number of patients will be designed to evaluate efficacy. Neuropathy is a major and serious side effect of several chemotherapies like taxanes and oxaliplatin. Adding nadunolimab to nab-paclitaxel in the previously reported CANFOUR trial correlated with a lower incidence and a slower onset of chemotherapy induced neuropathy. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab. addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Announcement • Oct 12
Cantargia Reports New Positive Results on Biomarkers and Safety in CAN10 Phase 1 Clinical Study Cantargia announced new results from the CAN10 phase 1 clinical study. All nine groups, including 68 participants receiving a single dose of CAN10 or placebo, show good safety and promising biomarker results. Importantly, even 1 week after the infusion, a single dose of CAN10 can completely block IL-1 signaling in the blood of the participants. Thereby, combined with the previous confirmation of complete blockade of IL-36 stimulation, key endpoints have been reached. Thus, the phase 1 single dose study strongly validates the potential and the unique mode of action of CAN10. The second part of the trial investigating multiple dosing is ongoing. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of several autoimmune/inflammatory diseases stimulated by IL-1, IL-33 and/or IL-36. The ongoing phase 1 clinical trial initially investigates increasing levels of CAN10 as single intravenous administration in healthy subjects followed by studies of subcutaneous multiple dosing in participants with psoriasis. The primary endpoint relates to safety. The first phase 2 clinical study is planned to start in H2 2025 to investigate CAN10 therapy in e.g. hidradenitis suppurativa or systemic sclerosis. All nine dose groups investigating a single infusion in healthy subjects have passed the protocol stipulated safety review after 2 weeks follow up. No safety concerns were reported and the next part of the trial, multiple dosing in participants with psoriasis, is ongoing. As previously communicated, biomarker samples taken during the study show a potent dose dependent blockade of IL1RAP function, which was measured as inhibition of IL-36 signaling in immune cells. The study also investigates blockade of IL-1 signaling in immune cells. Those analyses have now been finalized and as predicted, CAN10 completely blocks IL-1 signaling in immune cells even a week after a single dose of CAN10. The ability to block both IL-1 and IL-36 signaling is a unique feature of IL1RAP-blockade that is not recapitulated by drugs targeting the individual pathways. Announcement • Oct 10
Cantargia Announces the Publication of the Results Using Nadunolimab Combination Therapy in Advanced/Metastatic Pancreatic Cancer (PDAC) in the Scientific Journal Clinical Cancer Research Cantargia announced the publication of the results using nadunolimab (CAN04) combination therapy in advanced/metastatic pancreatic cancer (PDAC) in the scientific journal Clinical Cancer Research, a journal of the American Association for Cancer Research. Efficacy in the 73 patients treated was better than expected for chemotherapy only based on historical data. Strongest efficacy was observed in patients with high tumor levels of IL1RAP, the target of nadunolimab, with median overall survival (OS) of 14.2 months. The safety was acceptable and notably the level of neuropathy was much lower than expected from chemotherapy alone, suggesting a protective effect of nadunolIMab. Patients with metastatic PDAC have a poor prognosis, and survival probability is <5% at 5 years. The fibro-inflammatory microenvironment which characterizes pancreatic cancer has a stroma infiltrated by cancer-associated fibroblasts and immune cells, creating an environment which involves upregulation of IL1RAP and tumor promoting IL-1 signaling with associated downstream pro-tumor cytokines. Nadunolimab combines blockade of the IL-1 signaling pathway through IL1RAP inhibition with a pronounced ADCC activity. In the CANFOUR trial, 73 first line pancreatic cancer patients were treated with nadunolimab and gemcitabine/nab-paclitaxel (GN). The median OS of 13.2 months is longer than OS reported in Phase 3 trials for GN alone (8.5-9.2 months), FOLFIRINOX (11.1 months), or NALIRIFOX (11.1 months). Cantargia's oncology program, the antibody nadunolimab ("CAN04"), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab. The antibody nadunolimib binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimib can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolim AB is investigated in multiple clinical trials; the phase I /IIa trial CANFOUR, evaluates nadunolimab in combination with standard NCT03267316. chemotherapies in patients with PDAC (gemcitabine/nab -paclitaxel) or NSCLC (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 years. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels ofIL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, also NCT05181462 shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolim ab combined with carboplatin/gemcitabine. Announcement • Sep 09
Cantargia Announces New Data from Two Clinical Studies Strongly Support Nadunolimab Efficacy After Relapse on PD1-Inhibitors Cantargia reported data from two clinical trials including nadunolimab combination therapy in 55 cancer patients. Both trials show strong antitumor effects as well as very encouraging median survival times in patients previously treated with pembrolizumab. These clinical data combined with baseline biopsy analyses suggest a unique role of nadunolimab acting on immunosuppressive cells in the tumor microenvironment. The data will be presented September 14 at the ESMO Congress 2024 in Barcelona. The immunotherapy pembrolizumab is one of the most important cancer treatments with sales around USD 25 billion 2023. New data from two clinical trials in 55 patients highlight a unique opportunity using nadunolimab in patients after they have progressed on pembrolizumab treatment. The first trial, CANFOUR, investigated nadunolimab in combination with platinum doublet chemotherapy in 40 first- or second-line non-small cell lung cancer, NSCLC, patients. Stronger efficacy was seen in 2L pts (n=18 in total; n=17 post-pembrolizumab) compared to 1L pts (n=22) (ORR 72% vs 41%; PFS 7.6 mo vs 6.7 mo, p = 0.038; OS 15.7 mo vs 11.5 mo). Biopsy analyses showed that 2L pts had a higher number of IL1RAP-positive immune cells, CD163+ macrophages, CD56+ NK cells and CD8+ T cells in the tumor at baseline. Efficacy results were most pronounced in second line non-squamous pts (n=12; ORR 92%, OS 28.9 mo; PFS 13.0 mo) including two complete responders. The data suggest that nadunolimab may mediate its anti-tumor activity by blocking tumor promoting cells within the TME. The safety results of the combination have been presented previously and show an acceptable side effect profile. The second trial, CIRIFOUR, investigated nadunolimab combination therapy with pembrolizumab in 15 heavily pretreated patients who had previously progressed on pembrolizumab monotherapy or combination treatments. Nine patients had head and neck cancer, 5 NSCLC and 1 melanoma. In this trial, the median survival was 19.7 months and the disease control rate was 60%. Similar to the CANFOUR data, the strongest benefits were observed in the group of patients with a specific profile of immune and immunosuppressive cells in the tumor microenvironment. The combination therapy was well tolerated. The two posters will be presented at the ESMO Congress 2024 in Barcelona on Saturday, September 14th by Dr Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain and Dr Roger Cohen, University of Pennsylvania, Philadelphia, PA, US, respectively. Announcement • Aug 27
Cantargia AB (publ) Reports Timelines for Nadunolimab Clinical Trials in Leukemia and Triple Negative Breast Cancer Cantargia reported currently expected timelines for nadunolimab clinical trials. The US FDA has granted MD Andersson Cancer Center the IND for nadunolimab related to the upcoming phase 1b/2a clinical trial of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an estimate for trial initiation during fourth quarter 2024. The first results on safety and short-term efficacy in the ongoing phase 2 clinical trial in triple negative breast cancer (TNBC), in collaboration with GEICAM, is expected during first half 2025. The new phase 1b/2a clinical trial is designed to investigate nadunolimab in up to 20 patients with AML and 20 with MDS. The trial is sponsored by a grant from the US Department of Defense, DOD, to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial. More details on the trial, including estimated timelines will be disclosed once the trial has received full IRB approval, which is expected during third quarter 2024, followed by initiation during fourth quarter 2024. Based on the positive phase 1 clinical data previously presented for nadunolimab combination therapy in TNBC, the randomized, controlled phase 2 clinical trial in approximately 100 patients with TNBC is advancing even though recruitment temporarily slowed down during summer. The first results of the trial, including safety and short-term efficacy, are therefore expected during first half 2025. Announcement • Jul 22
Cantargia Announces Resignation of Liselotte Larsson as Chief Operating Officer Cantargia announced that its Chief Operating Officer (COO), Liselotte Larsson has resigned and will continue her career outside Cantargia. She will depart her role by mid-October, 2024. Liselotte Larsson joined Cantargia in 2014 and during her time at the company, she has played an important role in building the company. The process to recruit a replacement has begun. Announcement • Jun 15
Cantargia AB (Publ) Reports Further Progress in Ongoing Phase 1 Clinical Trial with CAN10 Cantargia AB (publ) reported progress in the ongoing phase 1 clinical trial of the CAN10 antibody. Seven dose groups have now been concluded without any safety concerns. Furthermore, additional receptor occupancy studies confirm that CAN10 saturates its target molecule, IL1RAP, on immune cells from the study participants. The study follows timelines with the next dose group starting immediately, followed by the first group investigating multiple dosing, planned to start during third quarter. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases and has "pipeline in a pill" potential with several possible target indications. The phase 1 clinical trial investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in participants with mild to moderate psoriasis. The primary endpoint relates to safety. The first seven dose groups in healthy volunteers have now concluded the treatment period. No safety concerns have been observed and the eighth dose group is about to start in accordance with the protocol. In addition, the important receptor occupancy study continues to follow predictions from preclinical studies and complete target saturation has now been documented on both monocytes and neutrophils. Biomarker samples taken during the study are being analyzed to document a dose dependent inhibition of IL-1 and IL-36 stimulated release of biomarkers from immune cells. Additional biomarker results based on the first seven dose groups are expected mid-2024. Dosing in participants with psoriasis are expected to start Third Quarter 2024 ahead of phase 2 in 2025. Announcement • Jun 13
Cantargia AB (Publ) Announces Appointment of Ton Berkien as Chief Business Officer, Effective October 1, 2024 Cantargia AB (publ) announced appointment of Ton Berkien as Chief Business Officer. At Cantargia, he will be responsible for business development efforts and continue to maintain and foster relationships with leading pharmaceutical and biotechnology companies. Ton has a solid background through approximately 30 years in pharma, biotech, investment and consulting with significant experience in business development. He will commence his role October 1, 2024. Ton Berkien previously held senior business development positions at Amgen, Nuevolution, Takeda and Nycomed. Before that he held positions at Ferring, PWC, Rijnconsult, KPMG and Gilde Investment Management. He joins from the position as Chief Business Officer at Ultimovacs. Ton Berkien has a BA degree in economics from Saxion University of Applied Sciences in the Netherlands, as well as an LSid from PwC/Harvard Business School/IMD. Ton is a Dutch and Swedish citizen and lives in Sweden. Board Change • Jun 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Director Damian Marron was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 24
Cantargia Presents New Positive Clinical Data on Nadunolimab Counteracting Chemotherapy Induced Neuropathy Cantargia disclosed new clinical data indicating that nadunolimab counteract the serious problem of chemotherapy induced neuropathy, in addition to previously reported promising antitumor effects. The new data in 73 pancreatic cancer patients receiving nadunolimab and chemotherapy show a statistically significant correlation between nadunolimab dose level and incidence of neuropathy as well as a low level of grade 3 neuropathy, supporting the protective effect of nadunolimab. This positive effect is further strengthened by preclinical in vivo studies on chemotherapy induced neuropathy. The new results will be presented at ASCO Annual Meeting May 31- June 4, 2024. Neuropathy is a serious medical condition and a side effect of several classes of chemotherapies. The main symptoms are weakness, pain and numbness in hands and feet. Neuropathy often leads to discontinuation of therapy in patients despite effective antitumor activity. The mechanisms behind chemotherapy induced neuropathy relate to damaged nerve cells and neuroinflammation, where the IL-1 pathway has been indicated as a key driver. With nadunolimab blocking IL-1 activity through its binding to IL1RAP, nadunolimab has the potential to counteract neuropathy during treatment with chemotherapies, such as paclitaxel. In the CANFOUR trial, 73 first line pancreatic cancer patients were treated with nadunolimab and gemcitabine/nab-paclitaxel. The median survival of 13.2 months and iPFS of 7.2 months are longer than expected from historical control data for the chemotherapy alone (1). The incidence of neuropathy was notably lower than expected from chemotherapy treatment. Only one grade 3 event was observed and a statistically significant (p=0.042) relationship between dose level and any grade neuropathy was observed. At 1 mg/kg nadunolimab, 60% of patients had any grade neuropathy with a median time to onset of 112 days. At 2.5 mg/kg or higher, only 36% had any grade neuropathy and median time to onset was not reached. Studies in mouse models show that several aspects of chemotherapy induced neuropathy, such as sensitivity to mechanical pressure, temperature and decreased grip strength, all were prevented by concomitant treatment with the nadunolimab surrogate antibody. Combination studies were performed with either paclitaxel or vincristine. Breakeven Date Change • May 22
Forecast to breakeven in 2026 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 41% per year to 2025. The company is expected to make a profit of kr46.3m in 2026. Average annual earnings growth of 62% is required to achieve expected profit on schedule. New Risk • May 21
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr287m free cash flow). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr61m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr664.9m market cap, or US$62.2m). Announcement • Apr 18
Cantargia Publishes New Data on the Can10 Antibody, Detailing Its Interaction with IL1RAP and Functional Inhibition Cantargia AB (publ) reported publication of new preclinical data in the highly reputable scientific journal Cell Reports on the clinical stage antibody CAN10, specifying the precise interactions between CAN10 and its target IL1RAP and highlighting its functional capabilities to block multiple signaling pathways. These analyses explain the unique properties that makes CAN10 a potent blocker of the disease-promoting inflammatory cytokines IL-1, IL-33 and IL-36. This mechanism could be of high value in the treatment of a large number of diseases. CAN10 is an IL1RAP-binding antibody in Phase I clinical development for treatment of autoimmune and inflammatory diseases. It has unique properties as it simultaneously blocks three inflammatory pathways important in several diseases. The data, now published in the journal Cell Reports, show in detail how CAN10, by binding to a specific part of IL1RAP, can efficiently block the IL-1 a/ß, IL-33, and IL-36 a/ß/? signaling pathways. The publication also details biophysical and structural properties of the interaction between CAN10 and IL1RAP and shows that IL1RAP blockade has functional impact in counteracting inflammation beyond blocking only the IL-1 signaling pathway. In addition, the now published data also details the binding and function of a second Cantargia anti-IL1RAP antibody, 3G5, which also efficiently blocks IL-1 a/b, IL-33, and IL-36 a/b/g signaling but does this via a molecular mechanism distinct from the one employed by CAN10. Thus, the new results combined with the knowledge in the Cantargia IL1RAP innovation platform add sophisticated understanding to the structure/function properties of targeting IL1RAP and thereby allows for continued strategic development of new therapeutic antibodies, tailored for specific medical needs. Announcement • Apr 11
Cantargia AB (publ) Publishes Preclinical Data on the Potential of CAN10 in Systemic Sclerosis in A Leading Scientific Journal Cantargia AB (publ) reported publication of preclinical results obtained with CAN10 in systemic sclerosis in one of the leading rheumatology journals, ‘Annals of the Rheumatic Diseases'. CAN10 reduces both lung and skin fibrosis in multiple preclinical models of systemic sclerosis. The results are strengthened by the target of CAN10, IL1RAP and its signaling systems (IL-1, IL-33, and IL-36) being upregulated and disease-promoting in systemic sclerosis patient skin. CAN10 is an antibody in phase I clinical development. Systemic sclerosis is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Patients often have a severely impacted quality of life and there are no effective treatments today. Systemic sclerosis is one of the lead indications in the CAN10 development program. The published data demonstrate that the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients and that IL-1, IL-33 and IL-36 have profibrotic effects on skin fibroblasts from systemic sclerosis patients, which can be reduced by CAN10. Moreover, therapeutic treatment with a surrogate of CAN10 (mCAN10) in three different preclinical models of systemic sclerosis potently reduced both skin and lung fibrosis. Gene expression analysis indicated a broad mode of action of mCAN10, which normalized the expression of a majority of the genes commonly dysregulated in systemic sclerosis. In summary, the published data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides a novel and promising opportunity to treat this disease. The publication in this high-impact journal (impact factor 27.4) reflects the scientific significance of the data. This work was performed in collaboration with a world-leading research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany. Key data from these studies were recently presented as a poster at the Systemic Sclerosis World Congress March 14-16, 2024. New Risk • Apr 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.4% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr287m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr762.3m market cap, or US$71.6m). Announcement • Apr 03
Cantargia Publishes Data Highlighting the Potential of CAN10 in Atherosclerosis Cantargia AB (publ) reported publication of promising preclinical data supporting the potential of the anti-IL1RAP antibody CAN10 as treatment of atherosclerosis. The data, published in the journal 'Cardiovascular Research', shows that IL1RAP-blockade reduced the development of atherosclerotic plaques as well as reduced the plaque inflammation. Atherosclerosis is a huge future opportunity within the CAN10 project. Atherosclerosis is the main underlying cause of cardiovascular disease, including heart attack and stroke, and the leading cause of death in western societies. It is a chronic inflammatory vascular disease characterized by atherosclerotic plaque formation in the arterial wall. A high degree of inflammation in the atherosclerotic plaque is associated with an increased risk of heart attack and stroke, and molecules involved in plaque inflammation are therefore considered important therapeutic targets. The published data demonstrate that IL1RAP may be one such promising target that is expressed on various inflammatory cells in the atherosclerotic plaques. Therapeutic treatment with a CAN10 surrogate antibody resulted in a significant reduction in plaque burden and a reduced plaque inflammation, through both attenuated accumulation of inflammatory cells as well as a reduced expression of inflammatory mediators in the plaques of mCAN10 treated mice. Collectively, this strongly suggests that CAN10 treatment can have a positive effect on atherosclerosis and plaque inflammation, supporting the notion that IL1RAP represents a novel therapeutic target in this disease. These data were generated in collaboration with Dr. Daniel Engelbertsen's research group at Lund University. Key data from these studies have previously been presented as a poster at the European Atherosclerosis Society Congress in 2022. The article, titled "IL1RAP blockade limits development of atherosclerosis and reduces plaque inflammation", is published by Mulholland et al. and is available via the following link. Announcement • Mar 27
Cantargia AB (publ) Reports Progress Towards Start of DOT-Sponsored Clinical Trial of Nadunolimab in Leukemia Cantargia reported on the progress in the upcoming phase Ib/IIa clinical trial investigating nadunolimab in up to 40 patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This trial is financedthrough a grant from the US Department of Defense (DOD). With the upcoming submission to the US FDA, the current plan is to commence the trial during the summer of 2024, pending regulatory approval. In the context of cancer, IL1RAP was initially discovered as a therapeutic target in leukemia. Preclinical and translational results on IL-1 biology in various forms of leukemia as well as an overexpression of IL1RAP on both leukemia cells and leukemic stem cells indicate that nadunolimab has the potential to be used in the treatment of several different forms of the disease. The new phase Ib/IIa clinical trial is designed to investigate nadunolimab monotherapy as well as combination therapy, in up to 20 patients with AML and 20 with MDS. In addition to investigating anticancer effects, the study will include an extensive package of biomarker assessments using blood and bone marrow samples, including single cell multimodal analysis. The trial is sponsored by a grant from the DOD to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial, with Dr Gautam Borthakur as principal investigator. More details on the trial will be disclosed once the trial has received regulatory approval from the US FDA and relevant IRB. Announcement • Mar 15
Cantargia Reports New Data Highlighting Potential of CAN10 Antibody, Currently in Phase I Clinical Development, as Therapy in Systemic Sclerosis Cantargia reported new data highlighting the potential of the CAN10 antibody, currently in phase I clinical development, as therapy in systemic sclerosis. All signaling systems targeted by CAN10 (IL-1, IL-33 and IL-36) were found to be highly upregulated in patient skin biopsies. These cytokines induce fibrosis in skin fibroblasts isolated from patients, and this manifestation of disease was blocked by CAN10. In mouse models, CAN10 reversed the aberrant expression of several genes involved in the systemic sclerosis pathogenesis in humans. The data is presented at the Systemic Sclerosis World Congress in Prague 14-16 March 2024. CAN10 is currently in phase I clinical development with transition from healthy volunteers to patients planned for Q3, 2024. One of the lead indications, systemic sclerosis, is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Current treatments focus on symptomatic treatment rather than addressing underlying disease mechanisms. It is estimated that in the US, approximately 100,000 patients suffer from the disease. CAN10 has orphan drug status in the US for treatment of systemic sclerosis. The new results demonstrate that both the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients. This disease develops as fibroblasts promote the formation of an excessive buildup of connective tissue in skin and internal organs, so-called fibrosis. The results show that IL-1, IL-33 and IL-36 collagen production on skin fibroblasts from systemic sclerosis patients, leading to fibrosis. These disease-associated mechanisms can be reduced by CAN10. These new data strengthen previously reported beneficial effects of IL1RAP-blockade in three mouse models of systemic sclerosis, where treatment with a mouse surrogate of CAN10 reduced both skin and lung fibrosis. Additional gene expression analysis of mouse systemic sclerosis skin showed decreased expression of several key disease-related profibrotic factors in the skin by CAN10. In summary, the data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides an opportunity to treat underserved systemic sclerosis patients. These data were generated in collaboration with a research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany and will be presented as a poster at the 8th Systemic Sclerosis World CongressMarch 14-16, 2024 in Prague, Czech Republic. Announcement • Mar 08
Cantargia Reports New Preclinical Data on Antitumor Effects of nadunolimab in Pancreatic Cancer Cantargia reported new preclinical data highlighting how nadunolimab, an IL1RAP-targeting antibody currently in phase II clinical development, may induce antitumor activity in pancreatic cancer by blocking fibrosis. The data will be presented as a poster at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego and were generated in a collaboration with Nordic Bioscience A/S and the group of Dr. Marcus Järås at Lund University. Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease with poor survival prognosis. Nadunolimab is currently in phase II clinical development in first line PDAC and has shown pronounced effects including a much longer survival than expected from historical controls. One factor that significantly contributes to the poor treatment response in PDAC is the high abundance of tumor-supporting stroma, driven by the excessive activity of cancer-associated fibroblasts (CAFs). The new data now show that in pancreatic cancer-associated fibroblasts, interleukin-1alpha (IL-1alpha) and IL-1beta both induce formation of type III collagen (as measured by PRO-C3), a biomarker which has been found to correlate with poor survival in PDAC. Similarly, formation of type III collagen could also be induced by pancreatic cancer cells when co-cultured with pancreatic CAFs. Notably, addition of nadunolimab to the in vitro co-cultures potently blocked the induction of type III collagen formation. Thus, the new data strengthen the role of IL-1alpha and IL-1beta in pancreatic tumor fibrosis and highlight the potential for nadunolimab to counter the detrimental, fibrotic microenvironment in PDAC tumors. Price Target Changed • Feb 25
Price target decreased by 7.3% to kr12.67 Down from kr13.67, the current price target is an average from 3 analysts. New target price is 293% above last closing price of kr3.22. Stock is down 53% over the past year. The company is forecast to post a net loss per share of kr1.61 next year compared to a net loss per share of kr1.65 last year. Breakeven Date Change • Feb 25
Forecast to breakeven in 2026 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr46.3m in 2026. Average annual earnings growth of 31% is required to achieve expected profit on schedule. New Risk • Feb 23
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: -kr287m 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 (-kr287m free cash flow). Earnings are forecast to decline by an average of 51% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr720m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr574.9m market cap, or US$55.8m). Announcement • Feb 22
Cantargia AB (publ) to Report Fiscal Year 2024 Results on Feb 21, 2025 Cantargia AB (publ) announced that they will report fiscal year 2024 results on Feb 21, 2025 Announcement • Feb 21
Cantargia Reports US Regulatory Approval to Start Pancreatic Cancer Phase IIB Trial with Nadunolimab Cantargia reported that after both FDA and IRB review, regulatory approval has been granted to start recruiting patients in a controlled phase IIb trial in metastatic pancreatic cancer investigating nadunolimab as first line combination therapy. The trial is planned to start mid-2024 with initial results 2025. The planned phase IIb trial (PANFOUR) in metastatic PDAC will investigate first line treatment of nadunolimab in combination with standard of care chemotherapy (gemcitabine/nab-paclitaxel). Two different dose levels of nadunolimab will be investigated and the study will include a control arm with chemotherapy only. Each arm will consist of approximately 50 patients, totaling 150 patients in the trial, with a data review after approximately 60 patients. Patients will be enrolled in the US and in a number of European countries where regulatory approval is awaited. The current plan is to start the trial during mid-2024 although the exact time point is pending ongoing financing discussions. Announcement • Feb 13
Cantargia Reports New Data Reinforcing Nadunolimab as Cancer Combination Therapy Cantargia AB reported new clinical and preclinical results from the nadunolimab (CAN04) program, providing a promising starting point for additional future opportunities. The data show that nadunolimab, currently in phase II clinical development for cancer treatment, has additional effects that could be of high value when combined with either standard chemotherapies or antibody drug conjugates (ADC). These effects relate to alleviation of neuropathy and counteraction of tumor promoting signals. Consequently, nadunolimab treatment has the potential to improve efficacy of such treatments as well as to reduce serious side effects such as neuropathy. Nadunolimab has been investigated as cancer therapy in about 300 patients. The most promising results reported are in combination with chemotherapy in pancreatic cancer (PDAC), non-small cell lung cancer and triple negative breast cancer with higher response rates followed by longer progression free survival and overall survival compared to historical data with chemotherapy alone. Neuropathy is a serious side effect of several cancer therapies, including traditional chemotherapies and ADCs, which effectively are a type of tumor-targeting chemotherapies. Neuropathy often leads to discontinuation of an otherwise effective therapy. Previously, top line data from clinical studies using nadunolimab in combination with gemcitabine/nab-paclitaxel in PDAC, have indicated lower incidence of grade 3 and 4 neuropathy than expected from historical data using this chemotherapy regimen alone. Further detailed evaluation of the clinical results has provided additional support for a neuroprotective effect of nadunolimab. Mechanistically, several chemotherapies can stimulate IL-1 driven neuroinflammation, which is linked to neuropathy and may be counteracted by nadunolimab. In line with this, a pronounced protective effect on chemotherapy-induced neuropathy has been documented in two different animal models. A number of ADC-s have recently been approved as cancer treatment which has generated significant commercial interest in this approach. The new data show that several cytotoxic payloads used in ADCs act like traditional chemotherapy by inducing both forms of IL-1 on tumor cells, known to act as a danger signal that can lead to tumor progression and potentially resistance. IL-1 mediated inflammatory processes can thus be induced by both chemotherapy and ADCs and may induce resistance to therapy as well as onset of neuropathy. The new results suggest that these can effectively be blocked by nadunolimab. The new results are planned to be presented at upcoming scientific conferences during 2024. Recent Insider Transactions • Jan 22
Chief Executive Officer recently bought kr104k worth of stock On the 19th of January, Goran Forsberg bought around 31k shares on-market at roughly kr3.34 per share. This transaction amounted to 11% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Goran has been a buyer over the last 12 months, purchasing a net total of kr207k worth in shares. Announcement • Jan 10
Cantargia Reports Phase I Clinical Progress in the CAN10 Project Cantargia reported encouraging progress in the ongoing phase I clinical trial of the CAN10 antibody. The study proceeds according to plan, with the four initial dose groups concluded without any safety concerns. In addition, as predicted from preclinical models, CAN10 binds to its target, IL1RAP, on immune cells from the study subjects in a dose dependent manner. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases with lead indications being systemic sclerosis and myocarditis. The phase I clinical trial initially investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in patients with psoriasis. The primary endpoint relates to safety. The first four dose groups in healthy subjects have now concluded the treatment period. No safety concerns have been observed and the fifth dose group has started in accordance with the protocol. In addition, a receptor occupancy study shows that already at initial dose levels, the majority of IL1RAP molecules on immune cells are binding CAN10 in a dose dependent manner. This is in line with predictions from preclinical studies. Furthermore, biomarker samples taken during the study are currently analyzed to document blocking of IL-1 and IL-36 stimulation of immune cells. The first results from such studies are expected during second quarter 2024. Studies in patients with psoriasis are expected to start second quarter 2024. Announcement • Nov 25
Cantargia Reports New Preclinical Data Confirming the Potential of Nadunolimab and Can10 Cantargia reported new preclinical data providing further support for its lead assets, the IL1RAP-binding antibodies nadunolimab (CAN04) and CAN10, in both cancer and cardiovascular disease. The data shows that IL1RAP blockade results in reduced vascular inflammation and that levels of IL1RAP correlate with various inflammatory markers in inflamed tissue. Vascular inflammation is considered integral for both cardiovascular disease and tumor growth. The findings demonstrate that antibody blockade of IL1RAP in a cell-based system results in decreased levels of multipleinflammatory markers, including interleukin-6 (IL-6), produced by vascular cells. The data further indicates that these effects may lead to reduced recruitment of inflammatory immune cells. Notably, analyses of human atherosclerotic plaques show that the level of IL1RAP correlated with several of the inflammatory markers reduced by IL1RAP blockade, including IL-6. Recent Insider Transactions • Nov 23
Chief Executive Officer recently bought kr103k worth of stock On the 20th of November, Goran Forsberg bought around 27k shares on-market at roughly kr3.82 per share. This transaction amounted to 11% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Goran has been a buyer over the last 12 months, purchasing a net total of kr243k worth in shares. New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 53% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr299m free cash flow). Earnings are forecast to decline by an average of 53% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr730m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr653.6m market cap, or US$61.9m). New Risk • Nov 12
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: -kr299m 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 (-kr299m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr253m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr663.1m market cap, or US$60.8m). Announcement • Nov 04
Cantargia AB (publ), Annual General Meeting, May 23, 2024 Cantargia AB (publ), Annual General Meeting, May 23, 2024. Location: Ideon Gateway, Scheelevägen 27 Lund, Lund Sweden New Risk • Nov 01
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 10.0% 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 Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr295m). Currently unprofitable and not forecast to become profitable over next 2 years (kr257m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (kr656.5m market cap, or US$58.5m). Announcement • Sep 28
Cantargia Presents New Clinical Data Further Supporting Nadunolimab's Antitumor Activity and A Key Role of Its Target IL1RAP in Pancreatic Cancer Cantargia reported new clinical and biomarker data in further support of nadunolimab (CAN04) for treatment of pancreatic cancer (PDAC). Updated results in first-line combination with chemotherapy, as well as new results in late-stage monotherapy, show the strongest efficacy in patients with high levels of IL1RAP, the target of nadunolimab. Biomarker data consolidate these observations as levels of IL1RAP increase during PDAC development and appear to be linked to specific KRAS mutations associated with aggressive disease. These data will be presented at the AACR Special Conference: Pancreatic Cancer 2023, 27-30 September. In the clinical phase I/IIa trial CANFOUR, a total of 23 late-stage PDAC patients received nadunolimab monotherapy, typically after failure on at least two previous chemotherapy regimens. Of these, IL1RAP levels were assessed in tumor biopsies taken before treatment from 17 patients, categorized as either IL1RAP high or IL1RAP low. Notably, IL1RAP high patients had stronger clinical benefit compared to IL1RAP low patients, including prolonged median overall survival (5.8 vs 2.6 months; p=0.078) and progression-free survival (iPFS 3.6 vs 1.6 months; p=0.0073), indicating target engagement by nadunolimab leading to antitumor activity. Similar observations were made for the 73 first-line patients treated with a combination of nadunolimab and gemcitabine/nab-paclitaxel in CANFOUR, although as expected the median survival was generally longer compared to the late-stage patients. Significantly prolonged median overall survival was observed in IL1RAP high compared to IL1RAP low patients (14.2 vs 10.6 months; p=0.026), with a trend for higher response rates, with deeper and more durable responses. These results are complemented by biomarker data obtained from publicly available gene databases, in collaboration with experts in PDAC, as well as molecular profiling data from pancreatic cancer patients included in the Know Your Tumor programme by Pancreatic Cancer Action Network (PanCAN). Collectively, the biomarker data show that levels of IL1RAP, as well as IL-1alpha and IL-1beta which signal via IL1RAP, are increased in PDAC tumors compared to healthy pancreas. Further, the highest levels of IL1RAP were observed in late-stage PDAC tumors, and patients with high IL1RAP levels had shorter overall survival. Notably, high IL1RAP levels also correlated with the presence of KRAS mutations, in particular G12D, which is the most common KRAS mutation in PDAC. This is a key finding as KRAS mutations are considered a crucial component for disease progression in PDAC, and few effective therapies for targeting such mutations have been developed. Announcement • Sep 21
Cantargia Reports New Preclinical Data on nadunolimab Potential to Enhance Anti-Tumor Effect of Immunotherapy Presented at CRI-ENCI-AACR Cantargia reported new preclinical data highlighting how nadunolimab, an IL1RAP-targeting antibody currently in phase II clinical development, can be used to block the activity of cancer-promoting immune cells and increase the anti-tumor efficacy of immunotherapy i.e. a cancer vaccine. The data were generated by Professor Douglas Hanahan's research group at the Lausanne Branch of the Ludwig Institute for Cancer Research and the Swiss Institute for Experimental Cancer Research (EPFL) and are presented in a poster session at the CRI-ENCI-AACR International Cancer Immunotherapy Conference 2023. Tumors possess a wide variety of strategies by which they can gain resistance to anti-tumor therapies. One such strategy is the expansion of immune cell populations known as myeloid-derived suppressor cells (MDSC). MDSC have immunosuppressive properties and can mediate resistance to immunotherapy, as well as chemotherapy and cancer vaccines. The new data demonstrate that IL-1 signaling molecules, including IL-1alpha, drive the in vivo expansion of MDSC which have high levels of IL1RAP, the target of nadunolimab. Nadunolimab can potently block signaling via IL-1alpha and IL-1beta. In a model of cervical cancer, shown to produce IL- 1 signaling molecules and trigger MDSC expansion, a nadunolimab surrogate was able to dampen the MDSC expansion and reduce tumor growth. Notably, the nadunolimab surrogate also improved the anti-tumor efficacy of a cancer vaccine, in parallel with increasing the number of tumor-reactive T cells generated in response to the vaccine. Thus, nadunolimab can alleviate immunosuppressive mechanisms used by tumors to provide resistance against anti-tumor therapies. These preclinical data are presented in detail in a poster session at the CRI-ENCI-AACR International Cancer Immunotherapy Conference 2023. Announcement • Sep 19
Cantargia AB (publ) Announces New Nadunolimab Clinical Trial in Leukemia Financed by External US Grant Cantargia AB (publ) announced award of a $1.1 million grant from the US Department of Defense for investigation of Cantargia's lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in a phase Ib/IIa clinical trial in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The grant is awarded to Professor Gautam Borthakur at The University of Texas MD Anderson Cancer Center who will lead the trial. The trial will investigate nadunolimab alone or in combination with the chemotherapy azacytidine in patients with intermediate or high-risk MDS. Nadunolimab will also be evaluated with azacytidine and the targeted therapy drug venetoclax in patients with relapsed/refractory AML. The primary objective of this investigator-initiated trial is to assess the safety of different dose levels of nadunolimab; early efficacy and various biomarkers will be evaluated as secondary objectives. The trial may include a total of 40 patients. The trial will be managed by MD Anderson who will submit a clinical trial application. IL1RAP (Interleukin-1 Receptor Accessory Protein), the target of nadunolimab, was originally discovered as a promising therapeutic target on leukemia stem cells by Dr. Marcus Järås and Dr. Thoas Fioretos and at Lund University, Sweden. The group has published strong therapeutic effects of IL1RAP-targeting antibodies in several advanced preclinical models of leukemia. Nadunolimab has also shown signals of clinical activity in combination with chemotherapy in pancreatic cancer, triple-negative breast cancer and non-small cell lung cancer, and clinical trials are ongoing in these diseases. Announcement • Sep 06
Cantargia AB (publ)Expands Clinical Pipeline and Starts Treatment in Second Program, CAN10, for Autoimmune Diseases Cantargia AB (publ) announced that the first subject has been treated with the IL1RAP-binding antibody CAN10, developed for treatment of autoimmune/inflammatory diseases. The phase I clinical trial, conducted in Germany, investigates the safety, pharmacokinetics and biomarkers of CAN10 in healthy volunteers and psoriasis patients. A total of 80 subjects may be included in the trial. Initial data from the trial are expected in 2024. The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10. Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to up to 64 healthy volunteers. A subsequent part of the trial is designed to also generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis, who will receive multiple injections of CAN10 subcutaneously at two dose levels. Additional trial details will be disclosed on clinicaltrials.gov. The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. CAN10 has previously shown promising effects in several models of such diseases, including the lead indications systemic sclerosis and myocarditis. Pronounced effects have also been observed in models of psoriasis and these findings will form the basis for studying the effects of CAN10 in psoriasis patients in the phase I trial. Subsequent trials intend to focus on patients with systemic sclerosis or myocarditis. Breakeven Date Change • Aug 24
No longer forecast to breakeven The 3 analysts covering Cantargia no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr520.0m in 2024. New consensus forecast suggests the company will make a loss of kr249.6m in 2025. New Risk • Aug 23
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: -kr295m 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 (-kr295m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr709.0m market cap, or US$64.9m). Announcement • Aug 22
Cantargia AB (publ) to Report Q1, 2024 Results on May 21, 2024 Cantargia AB (publ) announced that they will report Q1, 2024 results on May 21, 2024 Announcement • Aug 11
Cantargia AB (publ) Receives Regulatory Approval to Start Phase I Clinical Trial for CAN10 Cantargia announced that the application for a phase I clinical trial with the IL1RAP-binding antibody CAN10 has been approved. The trial will investigate the safety of various single and multiple dose levels of CAN10 given intravenously to healthy volunteers or subcutaneously to psoriasis patients. Up to 80 subjects may be included in the trial, which is expected to start in September 2023. Following the approval by both the regulatory authority as well as the ethics committee in Germany, the phase I trial will now be initiated. The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, two diseases with a high medical need. CAN10 has shown promising effects in several models of these diseases. The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10 using a standard design involving single ascending doses (SAD), followed by evaluation of multiple ascending doses (MAD). Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to healthy volunteers. A subsequent part of the trial is designed to generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis who will receive CAN10 subcutaneously at two dose levels. Indication of clinically relevant effects on biomarkers will also be evaluated throughout the study. Treatment is expected to start in September2023. New Risk • Jul 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (67% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr885.9m market cap, or US$84.2m). Announcement • Jun 05
Cantargia Publishes ASCO 2023 Poster on Promising Nadunolimab Efficacy in Non-Small Cell Lung Cancer Cantargia presented interim efficacy data for 39 non-small cell lung cancer (NSCLC) patients treated with nadunolimab (CAN04) and platinum-based chemotherapy as a poster at the ASCO Annual Meeting 2023 (ASCO 2023), and on the Cantargia webpage. Efficacy of the combination therapy was well above historical data for chemotherapy alone, including two patients with complete response. The data presented at ASCO 2023 were communicated at the time of abstract release on May 25, 2023. In summary, the results show strong efficacy of nadunolimab combined with platinum-based chemotherapy in 39 NSCLC patients. Efficacy for the total 30 first- or second-line NSCLC patients treated with this combination in the CANFOUR trial is summarized below, as reported May 25, 2023: Efficacy parameter, All (n=30), Historical control, Non-squamous (n=16), Non-squamous, historical control, Median OS, 13.7 mo, 10.3 mo, 15.9 mo, 11.3 mo, Median PFS, 7.0 mo, 5.1 mo, 7.3 mo, 4.9 mo, ORR, 53%, 22-28%, 56%, 19%, Complete response, 6.7% (n=2), <1%. Consistently high response rates to nadunolimab Combined with platinum doublets in different lines of therapy were also reported. This includes a preliminary ORR of 60% in five first- or second-lineNSCLC patients with carboplatin/pemetrexed, and a preliminary ORR of 50% in four third-line or beyond NSCLC patients with cisplatin/gemcitabine. Announcement • Jun 02
Cantargia AB (publ) Promotes David Liberg to Chief Scientific Officer Cantargia announced that Dr. David Liberg, member of Cantargia's management team, has been promoted to Chief Scientific Officer (CSO). Dr. Liberg joined Cantargia in 2015 and has since been part of Cantargia's management team and held the role of VP Research. He has over 25 years of experience in immunology and tumor biology research with a background from Active Biotech and Imperial College in London. Dr. Liberg has played a key role in advancing the preclinical and translational development of Cantargia's lead asset nadunolimab (CAN04), as well as its second development project CAN10. 