View ValuationAptahem 将来の成長Future 基準チェック /06現在、 Aptahemの成長と収益を予測するのに十分なアナリストの調査がありません。主要情報n/a収益成長率n/aEPS成長率Biotechs 収益成長25.5%収益成長率n/a将来の株主資本利益率n/aアナリストカバレッジNone最終更新日n/a今後の成長に関する最新情報更新なしすべての更新を表示Recent updatesお知らせ • Apr 29Aptahem AB (publ) to Report Q1, 2026 Results on May 28, 2026Aptahem AB (publ) announced that they will report Q1, 2026 results on May 28, 2026お知らせ • Mar 27Aptahem 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 OfferingReported Earnings • Nov 29Third quarter 2025 earnings releasedThird quarter 2025 results: Net loss: kr1.39m (loss widened 17% from 3Q 2024).お知らせ • Oct 23Aptahem AB (publ) to Report Q3, 2025 Results on Nov 28, 2025Aptahem AB (publ) announced that they will report Q3, 2025 results on Nov 28, 2025お知らせ • Sep 02Aptahem 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 OfferingNew Risk • Aug 31New major risk - Financial positionThe 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).お知らせ • Aug 28Aptahem AB (publ) Announces Submission of Application for FDA's Commissioner's National Priority Voucher Pilot ProgramAptahem 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.お知らせ • Aug 21Aptahem Files Provisional Patent Application in Usa for New Indications for Apta-1Aptahem 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.お知らせ • Aug 16Aptahem AB (publ) Applies to FDA Precheck Program - Strategic Step Toward Faster, Higher-Quality Drug ManufacturingAptahem 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.お知らせ • Jul 29Aptahem AB (publ) to Report Q2, 2025 Results on Aug 28, 2025Aptahem AB (publ) announced that they will report Q2, 2025 results on Aug 28, 2025Reported Earnings • May 23First quarter 2025 earnings releasedFirst quarter 2025 results: Net loss: kr2.01m (loss narrowed 26% from 1Q 2024).お知らせ • May 08Aptahem 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お知らせ • Mar 14Aptahem AB (publ) Presents Plan for Upcoming Patient StudyAptahem 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 20Full 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).お知らせ • Feb 18+ 1 more updateAptahem AB (publ) to Report Q1, 2025 Results on May 28, 2025Aptahem AB (publ) announced that they will report Q1, 2025 results on May 28, 2025お知らせ • Jan 16Aptahem AB (publ) to Report Fiscal Year 2024 Results on Feb 14, 2025Aptahem AB (publ) announced that they will report fiscal year 2024 results on Feb 14, 2025Reported Earnings • Dec 01Third quarter 2024 earnings releasedThird quarter 2024 results: Net loss: kr1.18m (loss narrowed 26% from 3Q 2023).お知らせ • Oct 31Aptahem AB (publ) to Report Q3, 2024 Results on Nov 29, 2024Aptahem AB (publ) announced that they will report Q3, 2024 results on Nov 29, 2024お知らせ • Sep 02Aptahem AB (Publ) Announces Completion of Double-Blind Randomised Placebo-Controlled Phase 1 StudyAptahem 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 01Second quarter 2024 earnings releasedSecond quarter 2024 results: Net loss: kr2.63m (loss narrowed 3.7% from 2Q 2023).お知らせ • Aug 01Aptahem AB (publ) to Report Q2, 2024 Results on Aug 30, 2024Aptahem AB (publ) announced that they will report Q2, 2024 results on Aug 30, 2024お知らせ • Jun 28Aptahem AB (publ) Reports the FIH Study on Apta-1 Has Been FinalizedAptahem 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 04First quarter 2024 earnings releasedFirst quarter 2024 results: Net loss: kr2.73m (loss widened 8.4% from 1Q 2023).お知らせ • May 23Aptahem AB (publ) to Report Q3, 2024 Results on Jun 19, 2024Aptahem AB (publ) announced that they will report Q3, 2024 results on Jun 19, 2024お知らせ • Apr 19Aptahem Plans to Perform A Proof-Of-Concept Phase 2 Study in Patients with Its Lead Candidate Apta-1Aptahem 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).お知らせ • Mar 27Aptahem Reports Top Line Results from the Fih Study with Apta-1Aptahem 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 08New major risk - Shareholder dilutionThe 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).お知らせ • Mar 03+ 2 more updatesAptahem AB (publ), Annual General Meeting, May 15, 2024Aptahem AB (publ), Annual General Meeting, May 15, 2024.Reported Earnings • Mar 03Full 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).お知らせ • Sep 16Aptahem AB (publ) Reports Promising Outcome from the Additional Analyses on the Mechanism on Lead Candidate Apta-1 in the FIH StudyAptahem 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 03Second quarter 2023 earnings releasedSecond quarter 2023 results: Net loss: kr2.74m (loss widened 53% from 2Q 2022).お知らせ • Jul 17Aptahem AB (publ) Announces in Aptahem's FIH Study Further Analytic Studies Will Be PerformedAptahem 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.お知らせ • Jun 10+ 1 more updateAptahem AB (publ) to Report Nine Months, 2023 Results on Oct 26, 2023Aptahem AB (publ) announced that they will report nine months, 2023 results on Oct 26, 2023お知らせ • Jun 01Aptahem AB (Publ) Announces the Completion of an Additional Cohort in the Ongoing Double-Blinded Randomized Placebo Controlled Clinical First in Human StudyAptahem 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.お知らせ • Feb 11Dutch Ethics Committee Approves Aptahem AB (Publ)'s Second Dose Cohort in the Clinical First in Human Study in Healthy VolunteersAptahem 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.お知らせ • Jan 22+ 3 more updatesAptahem AB (publ), Annual General Meeting, Jun 01, 2023Aptahem AB (publ), Annual General Meeting, Jun 01, 2023.お知らせ • Dec 30Aptahem AB (publ) Announces First Cohort Dosed in Aptahem's FIH StudyAptahem 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.お知らせ • Dec 16Aptahem AB (Publ), Announces First Subjects Dosed in Fih StudyAptahem 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.お知らせ • Dec 06Aptahem AB (publ) Announces First Subjects Screened in Aptahem's FIH Study with Apta-1Aptahem 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.お知らせ • Dec 02Aptahem Reports Added Positive and Significant Biological Effect in an Extended Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1Aptahem 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 16No independent directorsFollowing 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.お知らせ • Nov 11Aptahem AB (publ) Receives Full Regulatory Approval to Start the FIH Study with Apta-1Aptahem 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.お知らせ • Sep 20Aptahem AB (publ) Submit Regulatory Approval to Initiate Clinical Phase 1 StudyAptahem 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.お知らせ • Jun 23Aptahem AB (publ) Confirms Lead Candidate Apta-1 Shows Very Good Tolerability in GLP Tox StudiesAptahem 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.お知らせ • Jun 01Aptahem (Publ) Announces Executive ChangesAptahem (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 27No independent directorsFollowing 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.お知らせ • Feb 22Aptahem AB (publ) Reports Additional Positive Biological Effect in A Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1Aptahem 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.お知らせ • Feb 05Aptahem Appoints Karin Aschan as New Regulatory Affairs DirectorAptahem 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.お知らせ • Feb 01Aptahem AB (Publ) Appoints Thomas Rupp as CMC DirectorAptahem (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.お知らせ • Jul 07Aptahem AB (publ) Receives Intention to Grant from the European Patent Office for the Protection of Patent Family 2Aptahem 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.お知らせ • Jul 01Aptahem AB (Publ) Receives Notice of Allowance from the US Patent OfficeAptahem 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.お知らせ • Mar 10Aptahem Signs A Non Binding Term Sheet for Development, Manufacturing and Distribution of Apta-1 for Sepsis in EuropeAptahem 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.お知らせ • Feb 25Aptahem AB (publ) Signs Agreement with Collaboration Partner LGC Group to Initiate the GMP Manufacturing of Apta-1Aptahem 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 19New 90-day low: kr1.30The 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 27New 90-day low: kr1.33The 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.お知らせ • Jan 13+ 2 more updatesAptahem AB (publ) to Report Fiscal Year 2020 Final Results on Apr 08, 2021Aptahem AB (publ) announced that they will report fiscal year 2020 final results on Apr 08, 2021Is New 90 Day High Low • Jan 07New 90-day low: kr1.38The 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 22New 90-day low: kr1.39The 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 13New 90-day low: kr1.61The 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 16New 90-day low: kr1.76The 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.お知らせ • Oct 06Aptahem AB (publ) to Report Q3, 2020 Results on Nov 30, 2020Aptahem AB (publ) announced that they will report Q3, 2020 results on Nov 30, 2020Is New 90 Day High Low • Sep 30New 90-day low: kr2.07The 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. このセクションでは通常、投資家が会社の利益創出能力を理解する一助となるよう、プロのアナリストのコンセンサス予想に基づく収益と利益の成長予測を提示する。しかし、Aptahem は十分な過去のデータを提供しておらず、アナリストの予測もないため、過去のデータを外挿したり、アナリストの予測を使用しても、その将来の収益を確実に算出することはできません。 シンプリー・ウォール・ストリートがカバーする企業の97%は過去の財務データを持っているため、これはかなり稀な状況です。 業績と収益の成長予測NGM:APTA - アナリストの将来予測と過去の財務データ ( )SEK Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20253-6-10-7N/A9/30/20252-8-18-14N/A6/30/20253-7-12-8N/A3/31/20253-8-12-8N/A12/31/20244-9-18-14N/A9/30/202411-10-21-10N/A6/30/202412-11-27-16N/A3/31/202411-11-27-16N/A12/31/202310-11-23-13N/A9/30/20233-10-58-11N/A6/30/20233-10-52-5N/A3/31/20233-9-67-20N/A12/31/20223-9-425N/A9/30/20222-12-5-5N/A6/30/20221-15-9-9N/A3/31/20221-18-3-3N/A12/31/2021N/A-28-38-37N/A9/30/2021N/A-35-42-41N/A6/30/2021N/A-34-41-41N/A3/31/2021N/A-33-33-33N/A12/31/2020N/A-24-20-19N/A9/30/2020N/A-15-14-14N/A6/30/2020N/A-16-13-13N/A3/31/2020N/A-17-12-12N/A12/31/2019N/A-17-19-19N/A9/30/20190-18N/A-13N/A6/30/20190-16N/A-12N/A3/31/20190-21N/A-16N/A12/31/20180-21N/A-16N/A9/30/20180-19N/A-20N/A6/30/20180-17N/A-25N/A3/31/20180-11N/A-20N/A12/31/20170-10N/A-15N/A9/30/20170-10N/A-14N/A6/30/20170-10N/A-8N/A3/31/20170-10N/A-9N/A12/31/20160-10N/A-9N/A9/30/20160-10N/A-9N/A6/30/20160-8N/A-8N/A3/31/2016N/A-6N/A-6N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: APTAの予測収益成長が 貯蓄率 ( 2% ) を上回っているかどうかを判断するにはデータが不十分です。収益対市場: APTAの収益がSwedish市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です高成長収益: APTAの収益が今後 3 年間で 大幅に 増加すると予想されるかどうかを判断するにはデータが不十分です。収益対市場: APTAの収益がSwedish市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。高い収益成長: APTAの収益が年間20%よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。一株当たり利益成長率予想将来の株主資本利益率将来のROE: APTAの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 22:06終値2026/05/21 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Aptahem AB (publ) 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • Apr 29Aptahem AB (publ) to Report Q1, 2026 Results on May 28, 2026Aptahem AB (publ) announced that they will report Q1, 2026 results on May 28, 2026
お知らせ • Mar 27Aptahem 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 29Third quarter 2025 earnings releasedThird quarter 2025 results: Net loss: kr1.39m (loss widened 17% from 3Q 2024).
お知らせ • Oct 23Aptahem AB (publ) to Report Q3, 2025 Results on Nov 28, 2025Aptahem AB (publ) announced that they will report Q3, 2025 results on Nov 28, 2025
お知らせ • Sep 02Aptahem 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 31New major risk - Financial positionThe 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).
お知らせ • Aug 28Aptahem AB (publ) Announces Submission of Application for FDA's Commissioner's National Priority Voucher Pilot ProgramAptahem 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.
お知らせ • Aug 21Aptahem Files Provisional Patent Application in Usa for New Indications for Apta-1Aptahem 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.
お知らせ • Aug 16Aptahem AB (publ) Applies to FDA Precheck Program - Strategic Step Toward Faster, Higher-Quality Drug ManufacturingAptahem 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.
お知らせ • Jul 29Aptahem AB (publ) to Report Q2, 2025 Results on Aug 28, 2025Aptahem AB (publ) announced that they will report Q2, 2025 results on Aug 28, 2025
Reported Earnings • May 23First quarter 2025 earnings releasedFirst quarter 2025 results: Net loss: kr2.01m (loss narrowed 26% from 1Q 2024).
お知らせ • May 08Aptahem 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
お知らせ • Mar 14Aptahem AB (publ) Presents Plan for Upcoming Patient StudyAptahem 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 20Full 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).
お知らせ • Feb 18+ 1 more updateAptahem AB (publ) to Report Q1, 2025 Results on May 28, 2025Aptahem AB (publ) announced that they will report Q1, 2025 results on May 28, 2025
お知らせ • Jan 16Aptahem AB (publ) to Report Fiscal Year 2024 Results on Feb 14, 2025Aptahem AB (publ) announced that they will report fiscal year 2024 results on Feb 14, 2025
Reported Earnings • Dec 01Third quarter 2024 earnings releasedThird quarter 2024 results: Net loss: kr1.18m (loss narrowed 26% from 3Q 2023).
お知らせ • Oct 31Aptahem AB (publ) to Report Q3, 2024 Results on Nov 29, 2024Aptahem AB (publ) announced that they will report Q3, 2024 results on Nov 29, 2024
お知らせ • Sep 02Aptahem AB (Publ) Announces Completion of Double-Blind Randomised Placebo-Controlled Phase 1 StudyAptahem 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 01Second quarter 2024 earnings releasedSecond quarter 2024 results: Net loss: kr2.63m (loss narrowed 3.7% from 2Q 2023).
お知らせ • Aug 01Aptahem AB (publ) to Report Q2, 2024 Results on Aug 30, 2024Aptahem AB (publ) announced that they will report Q2, 2024 results on Aug 30, 2024
お知らせ • Jun 28Aptahem AB (publ) Reports the FIH Study on Apta-1 Has Been FinalizedAptahem 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 04First quarter 2024 earnings releasedFirst quarter 2024 results: Net loss: kr2.73m (loss widened 8.4% from 1Q 2023).
お知らせ • May 23Aptahem AB (publ) to Report Q3, 2024 Results on Jun 19, 2024Aptahem AB (publ) announced that they will report Q3, 2024 results on Jun 19, 2024
お知らせ • Apr 19Aptahem Plans to Perform A Proof-Of-Concept Phase 2 Study in Patients with Its Lead Candidate Apta-1Aptahem 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).
お知らせ • Mar 27Aptahem Reports Top Line Results from the Fih Study with Apta-1Aptahem 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 08New major risk - Shareholder dilutionThe 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).
お知らせ • Mar 03+ 2 more updatesAptahem AB (publ), Annual General Meeting, May 15, 2024Aptahem AB (publ), Annual General Meeting, May 15, 2024.
Reported Earnings • Mar 03Full 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).
お知らせ • Sep 16Aptahem AB (publ) Reports Promising Outcome from the Additional Analyses on the Mechanism on Lead Candidate Apta-1 in the FIH StudyAptahem 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 03Second quarter 2023 earnings releasedSecond quarter 2023 results: Net loss: kr2.74m (loss widened 53% from 2Q 2022).
お知らせ • Jul 17Aptahem AB (publ) Announces in Aptahem's FIH Study Further Analytic Studies Will Be PerformedAptahem 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.
お知らせ • Jun 10+ 1 more updateAptahem AB (publ) to Report Nine Months, 2023 Results on Oct 26, 2023Aptahem AB (publ) announced that they will report nine months, 2023 results on Oct 26, 2023
お知らせ • Jun 01Aptahem AB (Publ) Announces the Completion of an Additional Cohort in the Ongoing Double-Blinded Randomized Placebo Controlled Clinical First in Human StudyAptahem 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.
お知らせ • Feb 11Dutch Ethics Committee Approves Aptahem AB (Publ)'s Second Dose Cohort in the Clinical First in Human Study in Healthy VolunteersAptahem 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.
お知らせ • Jan 22+ 3 more updatesAptahem AB (publ), Annual General Meeting, Jun 01, 2023Aptahem AB (publ), Annual General Meeting, Jun 01, 2023.
お知らせ • Dec 30Aptahem AB (publ) Announces First Cohort Dosed in Aptahem's FIH StudyAptahem 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.
お知らせ • Dec 16Aptahem AB (Publ), Announces First Subjects Dosed in Fih StudyAptahem 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.
お知らせ • Dec 06Aptahem AB (publ) Announces First Subjects Screened in Aptahem's FIH Study with Apta-1Aptahem 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.
お知らせ • Dec 02Aptahem Reports Added Positive and Significant Biological Effect in an Extended Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1Aptahem 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 16No independent directorsFollowing 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.
お知らせ • Nov 11Aptahem AB (publ) Receives Full Regulatory Approval to Start the FIH Study with Apta-1Aptahem 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.
お知らせ • Sep 20Aptahem AB (publ) Submit Regulatory Approval to Initiate Clinical Phase 1 StudyAptahem 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.
お知らせ • Jun 23Aptahem AB (publ) Confirms Lead Candidate Apta-1 Shows Very Good Tolerability in GLP Tox StudiesAptahem 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.
お知らせ • Jun 01Aptahem (Publ) Announces Executive ChangesAptahem (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 27No independent directorsFollowing 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.
お知らせ • Feb 22Aptahem AB (publ) Reports Additional Positive Biological Effect in A Corona Virus-Induced Acute Lung Injury Model Treated with Apta-1Aptahem 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.
お知らせ • Feb 05Aptahem Appoints Karin Aschan as New Regulatory Affairs DirectorAptahem 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.
お知らせ • Feb 01Aptahem AB (Publ) Appoints Thomas Rupp as CMC DirectorAptahem (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.
お知らせ • Jul 07Aptahem AB (publ) Receives Intention to Grant from the European Patent Office for the Protection of Patent Family 2Aptahem 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.
お知らせ • Jul 01Aptahem AB (Publ) Receives Notice of Allowance from the US Patent OfficeAptahem 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.
お知らせ • Mar 10Aptahem Signs A Non Binding Term Sheet for Development, Manufacturing and Distribution of Apta-1 for Sepsis in EuropeAptahem 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.
お知らせ • Feb 25Aptahem AB (publ) Signs Agreement with Collaboration Partner LGC Group to Initiate the GMP Manufacturing of Apta-1Aptahem 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 19New 90-day low: kr1.30The 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 27New 90-day low: kr1.33The 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.
お知らせ • Jan 13+ 2 more updatesAptahem AB (publ) to Report Fiscal Year 2020 Final Results on Apr 08, 2021Aptahem AB (publ) announced that they will report fiscal year 2020 final results on Apr 08, 2021
Is New 90 Day High Low • Jan 07New 90-day low: kr1.38The 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 22New 90-day low: kr1.39The 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 13New 90-day low: kr1.61The 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 16New 90-day low: kr1.76The 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.
お知らせ • Oct 06Aptahem AB (publ) to Report Q3, 2020 Results on Nov 30, 2020Aptahem AB (publ) announced that they will report Q3, 2020 results on Nov 30, 2020
Is New 90 Day High Low • Sep 30New 90-day low: kr2.07The 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.