Annuncio • Apr 29
Aptahem AB (publ) to Report Q1, 2026 Results on May 28, 2026 Aptahem AB (publ) announced that they will report Q1, 2026 results on May 28, 2026 Annuncio • Mar 27
Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 13.841627 million. Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 13.841627 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 20,972,162
Price\Range: SEK 0.66
Transaction Features: Rights Offering Reported Earnings • Nov 29
Third quarter 2025 earnings released Third quarter 2025 results: Net loss: kr1.39m (loss widened 17% from 3Q 2024). Annuncio • Oct 23
Aptahem AB (publ) to Report Q3, 2025 Results on Nov 28, 2025 Aptahem AB (publ) announced that they will report Q3, 2025 results on Nov 28, 2025 Annuncio • Sep 02
Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 24.861 million. Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 24.861 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 15,346,296
Price\Range: SEK 1.62
Transaction Features: Rights Offering New Risk • Aug 31
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: -kr12m 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 (-kr12m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Shareholders have been substantially diluted in the past year (205% increase in shares outstanding). Revenue is less than US$1m (kr3.7m revenue, or US$388k). Market cap is less than US$10m (kr30.2m market cap, or US$3.19m). Annuncio • Aug 28
Aptahem AB (publ) Announces Submission of Application for FDA's Commissioner's National Priority Voucher Pilot Program Aptahem AB (publ) announced that the company has submitted an application for participation in the U.S. Food and Drug Administration's (FDA) Commissioner's National Priority Voucher (CNPV) Pilot Program - "Accelerated Drug Review for Companies Supporting U.S. National Interests." The application is made as a next step after Aptahem's previous application to FDA PreCheck on August 13, 2025. It complements the company's application to FDA PreCheck and strengthens the U.S.-focused regulatory strategy. CNPV is a new pilot program where the FDA, for a limited number of companies, can award a "voucher" that provides significantly shortened regulatory review processing times - from normally around 10-12 months to around 1-2 months - while maintaining applicable safety and efficacy requirements. The selection is directed at development programs that are in line with US national health priorities (e.g., high unmet medical needs, innovation level, crisis management, onshoring, and supply chain robustness). In the first round of the pilot year, a maximum of five participants are intended to be selected. To qualify, it is required, among other things, that the manufacturing part and proposed labeling are submitted at least 60 days before the final application and that the company can maintain a close dialogue with the FDA's cross-functional review team. Annuncio • Aug 21
Aptahem Files Provisional Patent Application in Usa for New Indications for Apta-1 Aptahem AB (publ) announced that the company has received patent pending status through a provisional patent application in the USA. The application aims to protect the company's lead RNA aptamer Apta-1 in new indication areas, based on detailed evaluation of data generated from previous studies with Apta-1. These new insights are based on the detailed evaluation of data generated from Apta-1 by the Company's Co-Founder and CSO Dr. Luiza Jedlina. Dr. Jedlina has identified entirely new indications for the Company's lead RNA aptamer, Apta-1. These discoveries are now protected by a provisional patent application in the United States, further strengthening Apta-1's position as a first-in-class, innovative therapy option. Some of the identified indications include: Neurodegenerative diseases: Apta-1 blocks interactions of Amyloid-b and tau, with the potential to slow progression in Alzheimer's, Parkinson's, frontotemporal dementia, and Huntington's disease. Viral infections: Effective against HSV, CMV, Dengue, Zika, SARS-CoV-2, MERS, HIV, and HPV by preventing viral cell entry. Cancer and metastasis: Inhibits growth factors, slowing angiogenesis and tumor cell spread in aggressive cancers such as breast cancer, melanoma, and glioblastoma. Fibrotic diseases and infectious conditions: interesting indications for idiopathic pulmonary fibrosis, liver and kidney fibrosis, as well as in certain infectious diseases. Dr. Jedlina's evaluation of the study results shows that Apta-1 has the potential to stop disease-driving mechanisms at multiple levels - from protein aggregation and pathogen entry to tissue damage and fibrosis - making Apta-1 a potential game-changer in these indication areas. Annuncio • Aug 16
Aptahem AB (publ) Applies to FDA Precheck Program - Strategic Step Toward Faster, Higher-Quality Drug Manufacturing Aptahem AB (publ) is strengthening its position as a leader in RNA-based therapeutics by applying to the FDA PreCheck Program, the agency's new initiative to accelerate and streamline inspections of drug manufacturing. The program is reserved for companies with a proven track record of high-quality, GMP-compliant operations, offering prioritized inspections and regulatory transparency. For Aptahem, participation means:Faster regulatory pathway for production of Apta-1, its breakthrough RNA aptamer for severe inflammatory conditions. Enhanced confidence from partners and investors, demonstrating the company's commitment to top-tier quality and innovation. Clear quality milestone reducing risks and timelines, supporting future clinical and commercial expansion. Annuncio • Jul 29
Aptahem AB (publ) to Report Q2, 2025 Results on Aug 28, 2025 Aptahem AB (publ) announced that they will report Q2, 2025 results on Aug 28, 2025 Reported Earnings • May 23
First quarter 2025 earnings released First quarter 2025 results: Net loss: kr2.01m (loss narrowed 26% from 1Q 2024). Annuncio • May 08
Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 9.7 million. Aptahem AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 9.7 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: Rights Offering Annuncio • Mar 14
Aptahem AB (publ) Presents Plan for Upcoming Patient Study Aptahem AB (publ) announced a summary for the upcoming clinical phase 2 study of the drug candidate Apta-1. The study will be performed as an open, single arm phase 2 study to evaluate the efficacy and safety of Apta-1, an innovative immunomodulatory and antithrombotic drug candidate, in patients with acute urogenital andrenal conditions. The study will be perform as a Proof-of-Concept study in adult patients diagnosed with various types of acute urogenital disorders including acute kidney disorders. Within these disorders, there are several indications with orphan status, an area where Aptahem sees great potential for Apta-1 based on its unique therapeutic profile. To maximize the opportunities to create value from Apta-1's broad treatment potential, the study is planned to be conducted as a "basket trial", where several acute medical conditions within the relevant patient group are investigated in parallel. The study's primary objectives include biomarkers for hematology, organ function, inflammation, tissue degradation, and reduction of pathogens such as viruses and bacteria. The goal is to demonstrate both therapeutic efficacy and safety. More detailed information about the study will be published in the near future. Reported Earnings • Feb 20
Full year 2024 earnings released: kr0.69 loss per share (vs kr5.79 loss in FY 2023) Full year 2024 results: kr0.69 loss per share (improved from kr5.79 loss in FY 2023). Net loss: kr8.57m (loss narrowed 23% from FY 2023). Annuncio • Jan 16
Aptahem AB (publ) to Report Fiscal Year 2024 Results on Feb 14, 2025 Aptahem AB (publ) announced that they will report fiscal year 2024 results on Feb 14, 2025 Reported Earnings • Dec 01
Third quarter 2024 earnings released Third quarter 2024 results: Net loss: kr1.18m (loss narrowed 26% from 3Q 2023). Annuncio • Oct 31
Aptahem AB (publ) to Report Q3, 2024 Results on Nov 29, 2024 Aptahem AB (publ) announced that they will report Q3, 2024 results on Nov 29, 2024 Annuncio • Sep 02
Aptahem AB (Publ) Announces Completion of Double-Blind Randomised Placebo-Controlled Phase 1 Study Aptahem AB (publ) announced that the completed double-blind randomised placebo-controlled phase 1 study in healthy volunteers also showed indications of drug efficacy. Aptahem has summarised and concluded all additional analyses taking into account the recently completed phase 1 study. At dosing, interesting immunological marker responses were noted in the subjects, prompting further analyses and evaluation of safety and mechanism of action. The analyses revealed that one individual had elevated inflammatory values prior to dosing. In this case, Apta-1 dosing was associated with rapid reduction of inflammatory parameters, with the first signs of normalisation seen already within 4 hours of dosing and further reduction at 6 hours to be completely reduced at the next measurement point at 24 hours. This suggests that Apta-1 could counteract inflammatory responses in individuals with ongoing inflammation. The latter observations are consistent with preclinical data and the proposed mechanism of action showing that Apta-1 protects against acute inflammation. This has been replicated in several independent models and reinforces the belief that Apta-1 can be developed into an effective drug against life-threatening inflammatory disease. Strengthened by these findings, a confirmatory Phase 2 clinical trial in patients with acute inflammatory disease is now being planned in consultation with the company's expert advisors. Reported Earnings • Sep 01
Second quarter 2024 earnings released Second quarter 2024 results: Net loss: kr2.63m (loss narrowed 3.7% from 2Q 2023). Annuncio • Aug 01
Aptahem AB (publ) to Report Q2, 2024 Results on Aug 30, 2024 Aptahem AB (publ) announced that they will report Q2, 2024 results on Aug 30, 2024 Annuncio • Jun 28
Aptahem AB (publ) Reports the FIH Study on Apta-1 Has Been Finalized Aptahem AB (publ) announced that the report on the First in Human (FIH) study has been finalized. The final study report confirms the previous top line results. The study is now closed and reported to the authorities. The top line results previously communicated from the study shows that Apta-1 has been well tolerated in the given doses. No serious side effects were seen and all participants fulfilled the study. In the additional analyzes that were performed during the study of Apta-1 highlighted some clinical markers which are important for understanding the mechanism of action and to support upcoming patient studies. The significance of these findings are being further investigated aided by pre-clinical studies. Reported Earnings • Jun 04
First quarter 2024 earnings released First quarter 2024 results: Net loss: kr2.73m (loss widened 8.4% from 1Q 2023). Annuncio • May 23
Aptahem AB (publ) to Report Q3, 2024 Results on Jun 19, 2024 Aptahem AB (publ) announced that they will report Q3, 2024 results on Jun 19, 2024 Annuncio • Apr 19
Aptahem Plans to Perform A Proof-Of-Concept Phase 2 Study in Patients with Its Lead Candidate Apta-1 Aptahem AB (publ) announced that the company has decided to revise its clinical development strategy by performing a Proof-of-Concept (PoC) study in patients as the next step in the clinical development of the drug candidate Apta-1. The aim with the planned study is to evaluate effect of Apta-1 in patients with acute and serious inflammatory diseases. The final study design is now under evaluation. After analyzing the results from the performed Phase 1a study, including the additional studies, and having discussions with leading Key Opinion Leaders within relevant areas, the company has taken the decision to change the strategy for the clinical development program for Apta-1. The next step will be to perform a Phase 2 study in patients unlike the previously communicated plan which was to perform a study in healthy volunteers (a Phase 1b study). Annuncio • Mar 27
Aptahem Reports Top Line Results from the Fih Study with Apta-1 Aptahem AB (publ) announces top line results from the First in Human (FIH) study. The aim of the study was to evaluate safety and tolerability with the company's lead candidate Apta-1 which was performed as a dose escalating study in healthy volunteers. The unblinded data from the study shows that Apta-1 has been well tolerated in the given doses. No serious side effects were seen and all participants fulfilled the study. In the additional analyzes that were performed during the study Apta-1 showed signs of having effect on some markers which are important for understanding its mechanism of action. The significance of these findings will be evaluated in the continued preclinical and future clinical studies. New Risk • Mar 08
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 170% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr13m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Shareholders have been substantially diluted in the past year (170% increase in shares outstanding). Revenue is less than US$1m (kr2.6m revenue, or US$257k). Market cap is less than US$10m (kr23.9m market cap, or US$2.34m). Reported Earnings • Mar 03
Full year 2023 earnings released: kr0.058 loss per share (vs kr0.053 loss in FY 2022) Full year 2023 results: kr0.058 loss per share (further deteriorated from kr0.053 loss in FY 2022). Net loss: kr11.1m (loss widened 25% from FY 2022). Annuncio • Sep 16
Aptahem AB (publ) Reports Promising Outcome from the Additional Analyses on the Mechanism on Lead Candidate Apta-1 in the FIH Study Aptahem AB (publ) announced that the results from the additional analyses performed in cohorts 1 to 4 in the First in Human (FIH) study, have contributed to the clarification of Apta-1's impact on clinical biomarkers. Next step is to apply for approval to continue the study. Aptahem has now finalized the analyses recommended by the Data Review Committee. The data showed promising results regarding the effect of Apta-1 on clinical biomarkers. Aptahem will swiftly compile the data and aim to submit to the Ethics Committee and Competent Authority as soon as possible after the data review meeting. The continued clinical program will benefit from these new data and be of great help optimizing the clinical development of Apta-1. The objectives with the phase 1a study is to evaluate the safety and tolerability of Apta-1 in multiple doses. Reported Earnings • Sep 03
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: kr2.74m (loss widened 53% from 2Q 2022). Annuncio • Jul 17
Aptahem AB (publ) Announces in Aptahem's FIH Study Further Analytic Studies Will Be Performed Aptahem AB (publ) announces that in the double-blinded randomized placebo controlled first-in-human (FIH) clinical trial further analytic studies on the mechanism of Apta-1 are recommended which will result in a temporary hold of the study. During the course of the study, additional analyses have been performed, which indicated interesting findings. After reviewing the data, the Data Review Committee concluded that further assays would be recommended. Aptahem are using this opportunity to gain more insight into as well as obtain a more robust understanding of the underlying mechanism of Apta-1. These analyses are deemed crucial and important for the further clinical development of Apta-1. The temporary hold will be reported to regulatory authorities in accordance with regulatory requirements. The objectives with the phase 1a study is to evaluate the safety and tolerability of Apta-1 in multiple doses. Annuncio • Jun 01
Aptahem AB (Publ) Announces the Completion of an Additional Cohort in the Ongoing Double-Blinded Randomized Placebo Controlled Clinical First in Human Study Aptahem AB (publ) announced the completion of an additional cohort in the ongoing double-blinded randomized placebo controlled clinical First in Human (FIH) study. During the course of the study, there have been signs of interesting effects on clinical markers. Therefore, before starting the next cohort, extended analyses will be performed to gain a greater understanding of Apta-1's clinical significance. These analyses will form an important basis for the further clinical development of Apta-1. The objectives with the phase 1a study is to evaluate safety and tolerability of Apta-1 in multiple doses. Annuncio • Feb 11
Dutch Ethics Committee Approves Aptahem AB (Publ)'s Second Dose Cohort in the Clinical First in Human Study in Healthy Volunteers Aptahem AB (publ), announced that the second dose cohort in the clinical First in Human (FIH) study in healthy volunteers has been performed and approved by the Dutch ethics committee. The purpose of the study is to evaluate safety and tolerability of Apta-1 in various doses. As previously communicated, the second dose cohort was initiated in early January 2023 and has now been finalized and approved by the authority. Apta-1 seems to continue to be safe and well tolerated also in this dose group. The study is progressing according to plan as the Dutch ethics committee has approved to continue with the next dose cohort. According to the regulations, the ethics committee must approve each cohort before the subsequent cohort can be initiated. Of note, there is a slight difference in that after every second cohort, in addition to safety data, results from the pharmacokinetics (PK), i.e. the amount of Apta-1 at different time points, will be included and submitted for approval. Annuncio • Dec 30
Aptahem AB (publ) Announces First Cohort Dosed in Aptahem's FIH Study Aptahem AB (publ) announces that the first cohort of healthy volunteers (HV) have been dosed in the clinical First in Human (FIH) study. The first HV subjects have now successfully been dosed and the first cohort is completed in the randomized, placebo-controlled Phase 1 study evaluating the safety and tolerability of intravenous Apta-1. After the follow-up visits of this first cohort, Apta-1 seems safe and well tolerated. Annuncio • Dec 16
Aptahem AB (Publ), Announces First Subjects Dosed in Fih Study Aptahem AB (publ), announced that the first healthy volunteers (HV) have been dosed in the clinical First in Human (FIH) study. The first HV subjects have now successfully been dosed in the randomized, placebo-controlled Phase 1 study which will evaluate the safety and tolerability of intravenous Apta-1 in healthy volunteers. Annuncio • Dec 06
Aptahem AB (publ) Announces First Subjects Screened in Aptahem's FIH Study with Apta-1 Aptahem AB (publ) announced that the first healthy volunteers have been screened for inclusion in the clinical First in Human (FIH) study with the drug candidate Apta-1. The randomized, placebo-controlled Phase 1 study will evaluate the safety and tolerability of intravenous Apta-1 in healthy volunteers (HV). The first HV subjects have now been screened and are ready for the first dosing later in December. Annuncio • Dec 02
Aptahem Reports Added Positive and Significant Biological Effect in an Extended Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1 Aptahem can announce that the Toronto team, in extended studies in addition to previously reported positive preliminary data, has concluded significant positive effects in a severe Corona virus induced Acute Lung Injury model with Apta-1 treatment. The preliminary results show that Apta-1 significantly reduces hemmoraghes (bleeding) in the lung tissue, suppress hemolysis and inflammatory response including keeping vital organs in good health. Results are now being prepared in a manuscript for scientific publication. Research commissioned by Aptahem has further confirmed Apta-1's positive effect on a severe viral lung model and added statistical significant data with these additional results. This shows the potential of Apta-1 and its broadness to handle pathogen driven severe inflammatory situations. Aptahem will now conclude and finalize the results in preparing a manuscript comprising this and previous data into a potential publication. Further collaboration is being discussed to see how it could support Aptahem's continued growth as a clinical company. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Jan Nilsson was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Nov 11
Aptahem AB (publ) Receives Full Regulatory Approval to Start the FIH Study with Apta-1 Aptahem AB (publ) received approval from the central ethics committee and the competent authorities in the Netherlands to start a clinical First in Human (FIH) study with its drug candidate Apta-1. The planned randomized, placebo-controlled Phase 1 study will evaluate the safety, tolerability and pharmacodynamic effects of intravenous Apta-1 in healthy volunteers. The results will support the design for the upcoming Phase 2 study to evaluate Apta-1 in patients with sepsis. The planned FIH study will be conducted in collaboration with the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. CHDR is an independent clinical contract research organization (CRO) specialising in innovative early-stage clinical drug research. CHDR has a considerable expertise in advanced inflammation models that makes them well-suited for early clinical development work with Apta-1. With this, Aptahem becomes a company in clinical phase with its lead candidate Apta-1. Years of top forefront development breaking new grounds of unique mode of action and effect with Apta-1 now makes it possible to take yet another step towards the market. Those stakeholders that would greatly benefit from the solution now can increase their hopes, specially those victims of sepsis and life threatening inflammatory conditions. Annuncio • Sep 20
Aptahem AB (publ) Submit Regulatory Approval to Initiate Clinical Phase 1 Study Aptahem AB (publ) announced that applications to the regulatory authority and the central ethics committee in The Netherlands have been submitted for approval to initiate a clinical phase 1 study with its drug candidate Apta-1. Aptahem develop Apta-1 to offer an emergency treatment to prevent the emergence of organ and tissue damage in patients suffering from sepsis or other critical inflammatory conditions. The applications to the regulatory authority, Centrale Commissie Mensgebonden Onderzoek (CCMO, and the responsible ethical committee in The Netherlands for approval to initiate a first-in-human study in healthy volunteers with Aptahem's drug candidate Apta-1 have now been submitted. The study consists of 2 parts. The purpose of part A is to evaluate the safety and tolerability of Apta-1, while part B is to evaluate the response on systemic inflammation of Apta-1 in the participants who have been challenged with LPS (the bacterial toxin lipopolysaccharide). LPS is a well-established provocation model used to induce measurable symptoms for characterizing the early stages of septic inflammation. Annuncio • Jun 23
Aptahem AB (publ) Confirms Lead Candidate Apta-1 Shows Very Good Tolerability in GLP Tox Studies Aptahem AB (publ) announced that the final study report from the GLP (Good Laboratory Practice) toxicology and safety studies has been finalized. The report confirms the previously communicated preliminary results regarding positive safety profile for Apta-1. The GLP tox studies are mandatory parts of the preclinical program to enable approval from the authorities to go into clinic. After performing a thorough analytical work on the data, Aptahem confirms that the lead candidate Apta-1 was well tolerated within the dose window. Aptahem has now finalized the parts of the preclinical program required to meet the safety and toxicological requirements of Apta-1 before moving into clinic. The study protocol has followed the previous non-GLP toxicology studies where the company looked at various dose levels during 5 and 7 days, respectively, treatment in two species. With the finalization of the report from the GLP tox studies all parts of the preclinical program have been fulfilled, including a manufactured and delivered GMP (Good Manufacturing Practice) drug substance batch. The company is now fully focused on compiling the documentation needed to file an application to the authorities for starting the clinical study. Annuncio • Jun 01
Aptahem (Publ) Announces Executive Changes Aptahem (publ) announced that Ingela Hallberg has been appointed new Chief Medical Officer (CMO) in the company as of 1 June 2022. Ingela has long and solid experience from the pharmaceutical industry where she has held senior management positions within clinical research and development and medical affairs in a number of companies, both in regional and global roles, and within several different therapy areas. Four years ago she started her own company to support start-ups within life science to develop their products. Ingela is a medical doctor and previously worked within the area of cardiology, Sahlgrenska University Hospital, Gothenburg. Ingela replaces Anders Bylock, who due to time limitations, can't cover the increased activities required when Aptahem becomes a clinical company. Anders has been the company's CMO since 2018 and is also, since 2017, chairman of the scientific advisory board. In connection with Ingela being appointed new CMO, Aptahem initiates the process in reviewing the scientific advisory board. The purpose is to broaden the advisory board to include more than scientific areas. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Co-Founder & Chairman of the Board Bert Junno was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Feb 22
Aptahem AB (publ) Reports Additional Positive Biological Effect in A Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1 Aptahem AB (publ) announced that in addition to previously reported positive preliminary data, the Toronto team has, from further studies, found essential positive effects in a Corona virus challenge induced Acute Lung Injury model with Apta-1 treatment. Studies show that Apta-1 preliminary protects and recovers the lung tissue, significantly reduce the virus count and hemolysis, plus improves the clinical markers for the liver and kidneys. Previous studies show that Apta-1 supports and maintains systemic circulation, which is crucial to keeping the organism vital. Research commissioned by Aptahem has, with these new results, added yet another level in understanding to the multifunctional properties of Apta-1 and its broadness to handle pathogen driven inflammatory situations. The results resonate very well with the findings from Aptahem's own studies and the collaboration with Örebro University. The research is a continuance of the ongoing studies to map Apta-1's behaviour in a Corona viral lung injury model. Aptahem's third-party research partners have validated Aptahem's own LPS studies in their acute lung injury model. The new data further confirm Aptahem's results, hence essential evidence for Aptahem's claims on Apta-1 in severe inflammatory driven sicknesses like sepsis. Aptahem has now commissioned additional research to continue to analyze other samples and plan the next steps for a preliminary extended collaboration that will bring further clarity on Apta-1 benefits and support Aptahem's continued growth and journey into becoming a clinical biotech company. Annuncio • Feb 05
Aptahem Appoints Karin Aschan as New Regulatory Affairs Director Aptahem has recently recruited to fill key positions ahead of the phase I studies planned with sepsis candidate Apta- Karin Aschan is the company's new Regulatory Affairs Director. Annuncio • Feb 01
Aptahem AB (Publ) Appoints Thomas Rupp as CMC Director Aptahem (publ) announced that Thomas Rupp has been appointed CMC Director in the company. Thomas has worked with Aptahem for several year in the role as aptamer expert, but he will now also take on the role as CMC Director. He has long and solid experience from working with aptamers and regulatory aspects, and he is considered one of the leading experts in the area in the world. In the role as CMC Director, Thomas Rupp is responsible for the manufacturing of Apta-1 and the regulatory aspects of the manufacturing to ensure that Aptahem fulfills the regulations needed to start clinical studies. He will work in close collaboration with COO Maria Ekblad, the manufacturer LGC Biotechnologies, analytical developer AxoLabs and Recipharm, the manufacturer of the formulation. Annuncio • Jul 07
Aptahem AB (publ) Receives Intention to Grant from the European Patent Office for the Protection of Patent Family 2 Aptahem AB (publ) announced that the company has received information that the European Patent Office (EPO) has issued an Intention to Grant of the EU patent application EP 18783424.7 entitled A nucleic acid molecule with anti-inflammatory and anti-coagulant and organ-protective properties. The application covers the therapeutic protection of the company’s aptamer Apta-1 which is being developed as treatment for disease syndroms caused by inflammation, coagulation and/or organ failure. This application is part of the patent family 2 with Aptahem’s CSO Dr. Luiza Jedlina as the inventor. Aptahem has now received an Intention to Grant for this application. Before the patent application can be finally granted, it will be translated to French and German, the other two official languages in Europe. After approval, the so called validation phase starts when the company will decide in which specific European countries to apply for patent protection. When the patents officially have been approved they will be valid until 2037. Annuncio • Jul 01
Aptahem AB (Publ) Receives Notice of Allowance from the US Patent Office Aptahem AB (publ) announces that the company has received information that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance fo the US patent application 16/652,926 entitled A nucleic acid molecule with anti-inflammatory and anti-coagulant and organ-protective properties. The application covers the therapeutic protection of the company's aptamer Apta-1 which is being developed as treatment for disease syndroms caused by inflammation, coagulation and/or organ failure. This application is part of the patent family 2 with Aptahem's CSO Dr Luiza Jedlina as the inventor. Aptahem has now received a Notice of Allowance for this application. The company has informed the authority that the fee will be paid to receive the approval and to have an Issue Notification and the official patent number for the approved patent. When the patent will be officially approved it will be valid until 2037. Annuncio • Mar 10
Aptahem Signs A Non Binding Term Sheet for Development, Manufacturing and Distribution of Apta-1 for Sepsis in Europe Aptahem AB (publ) announce that the company has signed an non binding Term Sheet with a mid-sized pharmaceutical company with head quarters in Europe. The NBTS relates to license terms for exclusive development, manufacturing and distribution of Apta-1 for treatment of sepsis in Europe. The company has decided to publish the information about the NBTS as the signing allows the other party a period to negotiate exclusively with Aptahem. More specific information will be made public if the transaction will take place with the other party. The signed NBTS includes license terms for the therapeutic area, geographical territory, sub-licensing rights, areas of responsibilities, cost allocation, development plan, pricing and financial terms between the parties for Apta-1. Overall, the terms offers the company's counterpart an exclusive right to develop, manufacture and distribute Apta-1 in European countries for the treatment of sepsis. The above mentioned information is based on the ongoing discussions between the company and the counterpart. The company has decided to publicly announce the NBTS as the signing allows the counterpart a period, from the signing of the NBTS, to negotiate exclusively with the company. The company does not guarantee that a final agreement will be signed with the counterpart within the set time frame, or at all. Further, the company does not guarantee that a transaction will take place based on the current terms in the NBTS. Annuncio • Feb 25
Aptahem AB (publ) Signs Agreement with Collaboration Partner LGC Group to Initiate the GMP Manufacturing of Apta-1 Aptahem AB (publ) announced that the company has signed an agreement with their collaboration partner LGC Group to initiate the GMP (good manufacturing practice) manufacturing of Apta-1. By signing this agreement, the GMP campaign starts already in March/April with various preparations running up until the GMP manufacturing process will be initiated in September/October 2021. Delivery of the GMP batch is expected to early 2022. This is an important step in the intense preparations that the company currently are working with to take the lead candidate Apta-1 to clinic in 2022. Is New 90 Day High Low • Feb 19
New 90-day low: kr1.30 The company is down 13% from its price of kr1.50 on 20 November 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 4.0% over the same period. Is New 90 Day High Low • Jan 27
New 90-day low: kr1.33 The company is down 17% from its price of kr1.61 on 29 October 2020. The Swedish market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. Is New 90 Day High Low • Jan 07
New 90-day low: kr1.38 The company is down 27% from its price of kr1.88 on 09 October 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. Is New 90 Day High Low • Dec 22
New 90-day low: kr1.39 The company is down 37% from its price of kr2.19 on 22 September 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period. Is New 90 Day High Low • Nov 13
New 90-day low: kr1.61 The company is down 51% from its price of kr3.28 on 14 August 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 7.0% over the same period. Is New 90 Day High Low • Oct 16
New 90-day low: kr1.76 The company is down 27% from its price of kr2.42 on 17 July 2020. The Swedish market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Annuncio • Oct 06
Aptahem AB (publ) to Report Q3, 2020 Results on Nov 30, 2020 Aptahem AB (publ) announced that they will report Q3, 2020 results on Nov 30, 2020 Is New 90 Day High Low • Sep 30
New 90-day low: kr2.07 The company is down 23% from its price of kr2.68 on 02 July 2020. The Swedish market is up 14% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 15% over the same period.