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AstraZeneca will highlight momentum of practice-changing cancer medicines across its robust pipeline at ASCO 2023

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Tagrisso plenary presentation will demonstrate significantly improved overall survival for patients with early-stage resectable EGFR-mutated lung cancer. Enhertu will show potential across a broad range of advanced HER2-expressing advanced cancers. Lynparza and Imfinzi combination will demonstrate delay in progression in newly diagnosed advanced ovarian cancer without a tumour BRCA mutation.

AstraZeneca advances its ambition to revolutionise cancer care with new data across its industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2 to 6 June 2023.

More than 130 abstracts will feature 22 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including 11 oral presentations and a late-breaking plenary presentation of overall survival (OS) results from the ADAURA Phase III trial of Tagrisso (osimertinib) in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) lung cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our unwavering commitment to continually raising the standard of cancer care for patients with high unmet needs is evident in our data at ASCO this year. With our leading portfolio of medicines in lung cancer, our ambition is to have the right AstraZeneca medicine for more than half of all patients with this disease by 2030. We will showcase significant steps toward that goal with overall survival data from ADAURA that reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “We are extending the benefits of our practice-changing cancer medicines, including Tagrisso, Imfinzi and Lynparza, while also investing in new scientific platforms such as T-cell engagers and cell therapy to attack cancer from multiple angles and advance the next wave of options for patients. At ASCO, the extraordinary momentum for our antibody drug conjugate collaboration portfolio continues with data for Enhertu underscoring its potential across many HER2-expressing tumour types beyond breast, lung and gastric, and updated results for datopotamab deruxtecan that reinforce our confidence in this TROP2-directed treatment.”

Improving outcomes across lung cancer settings

A late-breaking plenary presentation will showcase OS results from the ADAURA Phase III trial evaluating Tagrisso in early-stage (IB, II and IIIA) EGFR-mutated non-small cell lung cancer (NSCLC).

Several posters will describe trials-in-progress of Imfinzi (durvalumab) that further reinforce the Company’s progress toward moving lung cancer treatment to earlier stages of disease. These include NeoCOAST-2 evaluating Imfinzi in multiple novel immunotherapy combinations in resectable, early-stage NSCLC; PACIFIC-4 in combination with standard of care stereotactic body radiation therapy in medically unresectable Stage I/II NSCLC; PACIFIC-8 in combination with anti-TIGIT monoclonal antibody domvanalimab in unresectable Stage III NSCLC; and PACIFIC-9 in combination with novel immunotherapies oleclumab or monalizumab in patients with unresectable Stage III NSCLC.

Additionally, several presentations and posters will highlight the Company’s commitment to improving outcomes in advanced lung cancer with next-wave treatments and novel combinations. These include:

  • An oral presentation of updated results from the TROPION-Lung02 Phase Ib dose escalation and expansion trial of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated or pretreated, advanced or metastatic NSCLC without actionable genomic alterations. TROPION-Lung02 is the first trial to show results for an antibody drug conjugate (ADC) plus an immune checkpoint inhibitor combination with or without chemotherapy in this setting.
  • Interim results from the ARTEMIDE-01 Phase I trial assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC. The Company is advancing rilvegostomig into Phase III development this year.
  • A trial-in-progress poster describing the EGRET Phase I trial, a first-in-human study evaluating AZD9592, an EGFR/cMET bispecific ADC, in patients with advanced solid tumours including in combination with Tagrisso in metastatic EGFRm NSCLC. This is the Company’s first bispecific ADC to enter the clinic and has shown a promising efficacy and safety profile in preclinical models.
  • A trial-in-progress poster describing the LATIFY Phase III trial of ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Imfinzi in patients with locally advanced or metastatic NSCLC who progressed on or after anti-PD-(L)1 and platinum-based therapy. This combination has previously demonstrated promising efficacy in this setting in the ongoing HUDSON Phase II trial.
  • A trial-in-progress poster detailing the TROPION-Lung04 Phase Ib dose escalation and expansion study of Dato-DXd in various immunotherapy combinations with or without carboplatin in patients with previously untreated advanced or metastatic NSCLC, including recently initiated cohorts with bispecific immunotherapies rilvegostomig and volrustomig.

Showcasing the potential of Enhertu across multiple HER2-expressing tumours

Several presentations will reinforce the potential of Enhertu (trastuzumab deruxtecan) in a broad range of HER2-expressing tumours with significant unmet need, including gynaecological, genitourinary, gastrointestinal and breast cancers.

A late-breaking oral presentation of interim results from the DESTINY-PanTumor02 Phase II trial will highlight the efficacy and safety of Enhertu in heavily pretreated patients across multiple HER2-expressing advanced solid tumours including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers. In March, Enhertu met the prespecified target for objective response rate and demonstrated durable responses across multiple HER2-expressing tumour types in this trial.

Additionally, an oral presentation of primary results from the DESTINY-CRC02 Phase II trial will be presented, demonstrating the safety and efficacy of Enhertu in patients with HER2-positive advanced colorectal cancer with progression following standard-of-care treatment. This trial was initiated based on positive data for Enhertu in the DESTINY-CRC01 Phase II trial.

Another oral presentation will feature a pooled benefit-risk analysis from the DESTINY-Breast01, 02 and 03 trials of Enhertu in patients with breast cancer aged 65 and older compared to those younger than 65.

Potential to transform outcomes across tumours by attacking cancer from multiple angles

A late-breaking oral presentation will feature interim progression-free survival (PFS) results from the DUO-O Phase III trial evaluating a combination of Lynparza, Imfinzi, chemotherapy and bevacizumab in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. In April, it was announced that DUO-O demonstrated a statistically significant and clinically meaningful improvement in PFS for this Lynparza and Imfinzi combination versus chemotherapy plus bevacizumab alone.

Data will be also shared from a post-hoc exploratory analysis of the SERENA-2 Phase II trial in patients with advanced ER-positive breast cancer who have disease recurrence or progression after endocrine therapy. The analysis will show PFS data for patients treated with next-generation selective estrogen receptor degrader (ngSERD) camizestrant versus Faslodex (fulvestrant) based on the type of ESR1 mutation at baseline, detected via circulating tumour DNA. Previously presented primary results from SERENA-2 demonstrated PFS benefit with camizestrant irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors.

Data will also be shared from a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of Calquence (acalabrutinib) versus zanubrutinib in relapsed or refractory chronic lymphocytic leukemia, based on data from the ASCEND and ALPINE Phase III trials.

In addition, interim Phase I results evaluating AZD0486 (TNB-486), a CD19/CD3 next-generation T-cell engager, will show the potential of targeting CD19 in heavily pretreated patients with follicular lymphoma.

Results from a Phase Ib/II dose escalation and expansion trial of the novel immunotherapy oleclumab in combination with Imfinzi and chemotherapy will also be presented in patients with metastatic pancreatic cancer, including those with high levels of CD73 expression.

A poster discussion will feature health-related quality-of-life results from the PROpel Phase III trial of Lynparza plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Two presentations will focus on immune-mediated adverse events (imAEs) in the HIMALAYA Phase III trial of Imfinzi plus Imjudo (tremelimumab) in 1st-line unresectable liver cancer, including an oral presentation on outcomes by imAE occurrence and a poster on temporal patterns of imAE occurrence.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan; with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

Key AstraZeneca presentations during ASCO 2023

Lead Author Abstract Title Presentation details (CDT)
Tumour drivers and resistance
Herbst, R Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR mutated‑ (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Abstract #LBA3Plenary Session 4 June 20232:17pm
Oliveira, M Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 Phase 2 trial. Abstract #1066Poster Session Breast Cancer—Metastatic 4 June 20238:00am
Antibody drug conjugates
Meric-Bernstam, F Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) interim results. Abstract #LBA3000Oral Abstract Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology5 June 20238:00am
Raghav, K Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-overexpressing/amplified (HER2+) metastatic colorectal cancer (mCRC): Primary results from the multicenter, randomized, Phase 2 DESTINY-CRC02 study. Abstract #3501Oral Abstract Session Gastrointestinal Cancer—Colorectal and Anal4 June 20238:12am
Krop, I An age-specific pooled analysis of trastuzumab deruxtecan (TDXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03. Abstract #1006Oral Abstract Session Breast Cancer—Metastatic 5 June 20231:30pm
Goto, Y TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC). Abstract #9004 Oral Abstract Session Lung Cancer—Non-Small Cell Metastatic6 June 202310:57am
Aggarwal, C EGRET: A first-in-human study of the novel antibody-drug conjugate (ADC) AZD9592 as monotherapy or combined with other anticancer agents in patients (pts) with advanced solid tumors. Abstract #TPS3156Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology3 June 20238:00am
Borghaei, H TROPION-Lung04: Phase 1b, multicenter study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy ± carboplatin in advanced/metastatic non-small cell lung cancer (mNSCLC). Abstract#TPS3158Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology3 June 20238:00am
DNA damage response
Harter, P Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled Phase III DUO-O trial. Abstract #LBA5506Oral Abstract Session Gynecologic Cancer3 June 20235:12pm
Armstrong, A Health-related quality of life (HRQoL) and pain outcomes for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone (abi) and olaparib (ola) versus (vs) abi and placebo (pbo) in the Phase III PROpel trial. Abstract #5012Poster Discussion Genitourinary Cancer—Prostate, Testicular, and Penile Session 3 June 20231:27pm
Immuno-Oncology
Hübner, H RNA expression levels from peripheral immune cells, a minimally invasive liquid biopsy source to predict response to therapy, survival and immune-related adverse events in patients with triple negative breast cancer enrolled in the GeparNuevo trial. Abstract #1011Oral Abstract SessionClinical Science Symposium:  Harnessing the Breast Cancer Immune Response3 June 2023 1:51pm
Lau, G Outcomes by occurrence of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC). Abstract #4004Oral Abstract Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary 2 June 20233:57pm
Besse, B LATIFY: Phase 3 study of ceralasertib + durvalumab vs docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer that progressed on or after anti-PD-(L)1 and platinum-based therapy. Abstract #TPS9161Poster Session Lung Cancer—Non-Small Cell Metastatic4 June 20238:00am (CDT)
Rohrberg, K Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-experienced advanced/metastatic non-small-cell lung cancer (NSCLC): First report of ARTEMIDE-01. Abstract #9050Poster Session Lung Cancer—Non-Small Cell Metastatic4 June 20238:00am
Guisier, F NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC). Abstract #TPS8604Poster Session Lung Cancer—Non-Small Cell Local Regional/Small Cell/Other Thoracic Cancers4 June 20238:00am
Robinson, C Phase 3 study of durvalumab with SBRT for unresected stage I/II, lymph-node negative NSCLC (PACIFIC-4/RTOG3515). Abstract #TPS8607Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers4 June 20238:00am
Özgüroğlu, M Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8). Abstract #TPS8609Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers4 June 20238:00am
Barlesi, F Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9). Abstract #TPS8610Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers4 June 20238:00am
Ganti, A The prognostic value of patient reported outcomes (PROs) and clinical/demographic variables in the CASPIAN study. Abstract #8516Poster Discussion Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers4 June 202311:45am
Lau, G Temporal patterns of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC). Abstract #4073Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary5 June 20238:00am
Coveler, A Safety and clinical activity of oleclumab (O) ± durvalumab (D) + chemotherapy (CT) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A Phase 1b/2 randomized study. Abstract #4136Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary5 June 20238:00am
Haematology
Kittai, A A matching-adjusted indirect comparison (MAIC) of the efficacy and safety of acalabrutinib (acala) versus zanubrutinib (zanu) in relapsed or refractory chronic lymphocytic leukemia (RR CLL). Abstract #7540Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia5 June 20238:00am
Nair, R High complete response rate with TNB-486 in relapsed/refractory follicular lymphoma: Interim results an ongoing Phase 1 study. Abstract #7524Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia5 June 20238:00am

Notes

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts

For details on how to contact the Investor Relations Team, please click here. For media contacts, click here.

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Månadsrapport mars, 03-2024

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De första vårtecknen har vi fått se under månaden som gått – eller rättare sagt, publicering av årsredovisning och kallelse till årsstämman. Årsredovisningen hittar du på vår hemsida under finansiella rapporter, och kallelse till årsstämma hittar du i pressmeddelande 04.

Bofaktabladen för kv. Hercules finns ute på hemsidan för den som är nyfiken att se hur lägenheterna kommer att se ut i det norra husets 40 olika lägenheter. i dagsläget kan du se dem i två olika filer, en fil för varje uppgång. Framgent kommer varje lägenhet publiceras för sig.

K21 rapporterar att arbeten pågår med källarväggar för det södra huset. Arbeten med stommen och utfackningsväggarna för det norra huset fortsätter fram till augusti. Vid sidan av detta sker arbeten med dagvattenmagasin och rörkulvert, samt återfyllnad av mark mot källarväggarna.

Uthyrningen av det norra huset har vi startat och det är vår Sofia som är ansvarig för projektet. Lägenheterna tilldelas genom vår bostadskö, som man också hittar mer info om på vår hemsida.

Handläggningen för ansökan om ändrad detaljplan för fastigheten fortsätter och SBF har varit ute på plats och fått sig en uppfattning om fastigheten. Vi försöker ha tålamod när vi väntar på alla förberedelser och steg i processen som alltid sker i liknande ärende hos kommunen.

Ett annat varmt välkommet ”vårtecken” är det senaste uttalandet från Riksbanken att inflationen är på väg att stabiliseras och om inflationsutsikterna fortsätter att vara gynnsamma kan styrräntan troligen sänkas i maj eller juni. Vi ser fram emot att se hur de utlovade räntesänkningarna påverkar de lån vi omförhandlar framöver.

Torslanda-Öckerötidningen rapporter att den konkreta byggstarten för batterifabriken togs i mitten av mars, anläggningsarbetet startade dock i höstas. Totala ytan för batterifabriken kommer uppgå till 175 000 m2 och beräknas innebära investeringar om ca 23 miljarder kronor. När fabriken är klar kommer den ha en kapacitet att bygga ca 250 000 bilar om året, eller med andra ord en kapacitet 20 gigawattimmar. Möjlighet kommer finnas att utöka till 50 gigawattimmar om året. Enligt VD för Västsvenska handelskammaren innebär utlovandet av 3 000 nya jobb till fabriken i förlängningen upp till 3 eller 4 gånger så många arbetstillfällen. Detta bör betyda att efterfrågan på bostäder, både permanenta hyresrätter och tillfälliga boendeformer som finns i vårt lägenhetshotell, kommer att öka i Torslanda och kringliggande områden. 

Snart är vi klara med anställningsprocessen och kan välkomna en ny biträdande förvaltare till vårt team. Det stora antalet ansökningar vi haft vittnar om att det kan vara svårt att få arbete i dagens konjunkturläge för de som läser med inriktning mot fastigheter och förvaltning. För vår del har detta inte varit en nackdel utan snarare tvärtom, då vi haft förmånen att få se många kvalitativa CV och träffa flera väldigt goda kandidater. Jag är säker på att den person som vi till sist kommer överens med om anställning kommer kunna bidra med mycket gott till företaget.

Glad påsk!

På återhörande.

Emilie Loft
VD

Emilie Loft
0709 76 89 03
emilie@amhult2.se

Amhult 2 AB är ett fastighetsbolag som prospekterar 44 000 m2 mark i Amhult, Torslanda, för att bygga ett nytt modernt köpcenter samt boendeområde i blandad stadsbebyggelse. En av idéerna är att området skall förena stadens och landets fördelar. Amhult 2 är noterat på Spotlight Stock Market sedan den 16 maj 2005 under kortnamnet AMH2 B och handlas via banker och fondkommissionärer.

DOTTERBOLAG

Terrester AB
 Postflyget 7
423 37 Torslanda
Telefon: 031-92 38 35

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FlexQube får order värd 7,3 MSEK

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Pressmeddelande 2024-03-29, 12:30 CET

FlexQube har fått en order på materialställage från ett företag inom robot- och automationssektorn i USA värd c:a 7,3 miljoner kronor. Produkterna som är en integrerad del av kundens lösning, kommer att levereras med start i andra kvartalet och sedan kontinuerligt under 2024 och tillverkas i FlexQubes amerikanska produktionsenhet i Duncan, South Carolina.

Om FlexQube

FlexQube är ett teknikföretag med huvudkontor i Göteborg och dotterbolag i USA, Mexiko, Tyskland och England. FlexQube erbjuder lösningar för vagnbaserad materialhantering med hjälp av ett patenterat modulärt koncept. FlexQube utvecklar och designar kundanpassade lösningar för både robotiserad och mekanisk vagnlogistik. Genom det egenutvecklade och unika automationskonceptet kan FlexQube erbjuda robusta och självkörande robotvagnar. FlexQube har mer än 100 kunder i 38 länder med primära marknader i Nordamerika och Europa.

FlexQubes kunder finns inom tillverkningsindustri, distributions- och lager. Vi representerar några av de mest framgångsrika företagen i världen med en betydande andel representerad på Fortune 500-listan. Dessa företag finns inom fordonsindustrin, elfordonstillverkning, e-handel, tunga lastbilar, industriell automation och detaljhandelslogistik.

För mer information, kontakta:

CEO, Mårten Frostne marten.frostne@flexqube.com +46 721 55 19 37
 

Aktien (FLEXQ) handlas på Nasdaq First North. FNCA Sweden AB är bolagets Certified Adviser. Läs mer på www.flexqube.com.

Denna information är sådan som FlexQube AB (publ) är skyldigt att offentliggöra i enlighet med EU-förordningen om marknadsmissbruk. Informationen lämnades genom ovanstående kontaktpersoners försorg för offentliggörande den 29 mars 2024, kl. 12:30 CET.

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AEGIRBIO AVGER BOKSLUTSKOMMUNIKÉ OCH REDOGÖR FÖR VÄSENTLIGA HÄNDELSER

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SAMMANFATTNING AV BOKSLUTSKOMMUNIKÉN

Med bolaget eller AegirBio AB avses AegirBio AB med organisationsnummer 559222-2953

Fjärde kvartalet i koncernen jämfört med samma period 2022

• Nettoomsättningen uppgick till 0 (0) MSEK

• Totala intäkter uppgick till 2,9 (0) MSEK

• Resultatet före skatt uppgick till -10,9 (-318,3) MSEK. 

• Kassabehållningen var vid slutet av kvartalet 12,1 (14,6) MSEK efter erhållen likvid om totalt 46,3 MSEK i första kvartalet till följd av utnyttjande av teckningsoptioner och konvertibellånet från Atlas.

Årets resultat i koncernen 2023 (2023-01-01 – 2023-12-31)

• Nettoomsättningen uppgick till 0 (1,7) MSEK

• Totala intäkter uppgick till 4,6 (5,2) MSEK

• Resultatet före skatt uppgick till -61,2 (-364,3) MSEK

• Resultat per aktie uppgick till -2,38 (-18,9)

• Soliditeten uppgick till -3% (60%)

Väsentliga händelser under och efter periodens utgång

2023

• AegirBio fortsätter att stärka upp sin organisation genom Dr. Vasiliki Fragkou som COO från 1 november 2023. Dr. Fragkou´s ledarskap som COO kommer att stärka företagets position som branschledare och driva innovation som i slutändan gynnar både patienter och vårdgivare. Dr. Fragkou kommer att ersätta Dr. Nils Paulsson.

• AegirBio fokuserar på RADx projektet och beslutar därför att inte längre upprätthålla CE-märkningen för MagniaReader therapeutic drug monitoring (TDM) testning. 

• AegirBio utser Christel Dahlberg till CFO med tillträde den 1 februari 2024. Christel Dahlberg har agerat som interim CFO för AegirBio sedan april 2023.

• Atlas Special Opportunities, LLC, påkallar partiell konvertering av utestående konvertibler till ett nominellt belopp om 5 MSEK.

 2024

• Den välrenommerade gastroenterologen Dr. Adam S. Cheifetz blir en del av AegirBios Scientific Advisory Board. Dr. Cheifetz är chef vid Center for Inflammatory Bowel Disease vid Beth Israel Deaconess Medical Center samt professor i medicin vid Harvard Medical School, tillför oöverträffad expertis inom området gastroeterologi, särskilt vid behandling av Crohns sjukdom, ulcerös kolit och andra inflammatoriska tarmsjukdomar. 

• AegirBios utökar sitt Scientific Advisory Board med professor Iain L.C Chapple, framstående tandläkare. Professor Chapple tillför erfarenhet och expertis till bolagets vetenskapliga råd och kommer att vara en av nycklarna till AegirBios strategi att mäta specifika biomarkörer i saliv med bolagets digitala plattform, för att förbättra den allmänna hälsan. 

• Finansinspektionen begär yttrande från AegirBio.

Marco Witteveen – CEO

Presenting the Q4 report, a reflection of our progress 

As we approach the conclusion of a fruitful year, I am delighted to share with you the Q4 report, summarizing our recent endeavors and celebrating the accomplishments that position us for continued success. This report will not only highlight our organizational achievements and cost management but will also spotlight significant scientific leadership appointments. 

Organizational Settling and Focused Pursuit

In a period characterized by relative tranquility, our focus on organizational consolidation and undivided attention to the RADx project have been unwavering. The establishment of a stable platform and strong leadership positions us favorably as we navigate the challenges and opportunities ahead.

RADx Project 

The RADx project continues to play a pivotal role in our strategic roadmap, and we are diligently progressing towards milestones 1 and 2 as scheduled. This success stands as a testament to the unwavering dedication and collaborative synergy of our teams in both the US and UK. Not only does this achievement reinforce our commitment to transparency, but it also underscores the project’s promising trajectory.

Scientific Leadership Appointments and Vision for a Scientific Advisory Board

As part of our ongoing commitment to scientific excellence, we have been aiming to establish a Scientific Advisory Board, recognizing the invaluable benefits such a board could bring to our strategic initiatives. This vision aligns with our dedication to advancing cutting-edge solutions and ensuring the highest standards of scientific rigor within our organization.

I am delighted to announce that in Q1-24, we had the excellent opportunity to welcome two esteemed professionals to our team. Dr. Adam S. Cheifetz, a renowned Gastroenterologist, now leads our Therapeutic Drug Monitoring solution, bringing invaluable expertise to this critical area. 

Furthermore, Professor Iain L. C. Chapple has joined our Scientific Advisory Board, bringing a wealth of experience as a distinguished dental professional. His insights will be pivotal in advancing our strategy to measure specific biomarkers in saliva through our digital platform, contributing to our overarching goal of improving overall health.

Financial Prudence and Cost Management 

Our commitment to financial prudence has yielded commendable results. Despite increased RADx project costs, we have successfully reduced overall expenses by 7.2 MSEK compared to 2022, a decrease with 11%. This achievement reflects our disciplined approach to contract negotiations and a strategic focus on essential expenditures.

Year-End Reflection and Future Endeavors

Looking back over the year, the success of our reorganization is evident. The strengthened synergy between entities and enhanced team spirit positions us well for the future. While celebrating our achievements, we remain mindful of the work ahead and are dedicated to building upon our successes.

Investor-Centric Perspective

This report is crafted with our investors in mind, highlighting the strengths that define our company. The addition of esteemed leaders, coupled with the achievement of RADx milestones, underscores our commitment to excellence. We stand poised for continued growth, and our achievements throughout the year are a testament to the dedication of the entire AegirBio team.

As we close this chapter, I extend my sincere gratitude to each member of the team for their unwavering commitment. Together, we have navigated challenges, celebrated successes, and positioned AegirBio for a future of continued growth and innovation.

Denna information är sådan som AegirBio är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning (EU nr 596/2014). Informationen lämnades, genom angiven kontaktpersons försorg, för offentliggörande 2024-03-29 08:48 CET.

För ytterligare information, vänligen kontakta:
Marco Witteveen, CEO Aegirbio AB

Epost: ir@aegirbio.com
 

AegirBio i korthet

AegirBio är ett svenskt diagnostikföretag som grundades 2019 för att erbjuda tester för att övervaka och optimera doseringen av biologiska läkemedel via sin unika patenterade teknologiplattform. I juni 2020 noterades AegirBio på Nasdaq First North Growth Market. Bolagets ambition är, förutom att föra ut innovativ diagnostisk teknologi till marknaden, att göra diagnostik mer tillgänglig, enklare att använda och att ge korrekta och lätt överförbara resultat. För mer information, se Aegirbios hemsida www.aegirbio.com

Bolagets Certified Adviser är Eminova Fondkommission AB, adviser@eminova.se

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