reports
- Jacob Mekhael
Autolus FIRST LOOK: FY24 results hold no surprises, upcoming R&D day
Yesterday before US market opens, Autolus reported unsurprising FY24 results with a cash position of $ 588m (YE23: $ 239.6m), sufficient to drive Aucatzyl's (obe-cel, CD19 CAR-T) launch in r/r adult ALL, and advance the company's pipeline towards pivotal autoimmune data. While the company did not share sales figures/patients dosed with Aucatzyl in the US (1Q25 sales figures to be communicated during the quarterly update), management confirmed that the launch is tracking well compared to their ex...
- Jacob Mekhael
Hyloris FIRST LOOK: FY24 results come with a detailed pipeline update
Hyloris reported FY24 results with YE24 cash of € 23.6m (YE23: € 30.4m). Revenue grew to € 8.5m (from € 2.1m), though we note this included one-off milestone payments ($ 2.1m as well as an additional undisclosed amount). We are encouraged by the planned 9 regulatory submissions by YE26, though point out that US filing fees range $ 2-4m. Additionally, Hyloris will require extra funding to commercialise the near-term cardiology products in the US and is exploring multiple options. As such, while w...
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Lewi
Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financi...
Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch progressing on track with 33 authorized treatment centers as of March 19, 2025, following US FDA approval on November 8, 2024Obe-cel MHRA and EMA marketing authorizations expected in H2 2025Initial six patients dosed in Phase 1 dose confirmation trial in Systemic Lupus Erythematosus (SLE) Company to provide clinical development program updates, including plans for expansion in autoimmune diseases, at R&D investor event to be held on...
- Jacob Mekhael
Hyloris FIRST LOOK: Positive IDMC recommendation for Alenura phase 2 i...
Hyloris announced that the independent data monitoring committee (IDMC) reviewed the phase 2 trial of Alenura (bladder instillation combining lidocaine and heparin) in interstitial cystitis/bladder pain syndrome (IC/BPS) and concluded that there were no safety concerns and that the efficacy signals observed justified continued investigation. The recommendation is a positive sign for the program particularly as the IDMC saw unblinded data, though we note that they also recommended that the enrolm...
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Couvreur
- Wim Hoste
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Lewi
- Jacob Mekhael
Hyloris FIRST LOOK: Positive study results for Dofetilide IV, plans FD...
Hyloris announced positive results from a pivotal clinical study evaluating its proprietary Dofetilide IV formulation (potassium channel blocker), an antiarrhythmic to treat atrial fibrillation. Based on company guidance of FDA submission in the coming months, the product could be approved in the US by 2026 taking into account the 10 month FDA review timeline, and we look forward to learn more about the company's US commercialisation plans for its cardiology products. Note that Hyloris has previ...
Autolus Therapeutics to Report Fourth Quarter 2024 Financial Results a...
Autolus Therapeutics to Report Fourth Quarter 2024 Financial Results and Host Conference Call on March 20, 2025 LONDON, March 06, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced that it will release its fourth quarter and full year 2024 financial results and operational highlights before open of US markets on Thursday, March 20, 2025. Management will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT to dis...
- Sharad Kumar S.P
Holdings Report - February 2025 KBCS Holdings Universe Returns 3.7% Du...
1M Performance - Absolute: During Feb'25 (1M period), the KBCS Holdings Universe posted a return of +3.7% which was mainly driven by single-asset holdings (+11.1%) while multi-asset holdings posted a modest return of +0.5%. The 3 top performers during the period were Heineken Holding (+21.3%), KBC Ancora (+6.9%) and Ackermans & van Haaren (+4.4%) while the 3 worst performers were Financière de Tubize (-6.3%), Compagnie du Bois Sauvage (TINC; -6.6%) and Whitestone Group (-6.8%). YTD Performance...
GBLB GROUPE BRUXELLES LAMBERT SA
HAL HAL TRUST
DIE D'IETEREN SA
SOF SOFINA SA
SOLV SOLVAC S.A.
GIMB GIMV NV
QFG QUEST FOR GROWTH
ACKB ACKERMANS & VAN HAAREN NV
TUB FINANCIERE DE TUBIZE S.A.
HEIO HEINEKEN HOLDING N.V.
KBCA KBC ANCORA SCA
TEXF TEXAF
BREB BREDERODE S.A.
TINC TINC COMM. VA
EXO EXOR N.V.
ROCK WHITESTONE GROUP
Autolus Therapeutics to Participate in Upcoming Investor Conferences
Autolus Therapeutics to Participate in Upcoming Investor Conferences LONDON, March 05, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in two upcoming investor conferences. Jefferies Biotech on the Beach SummitManagement to host investor meetingsDate: March 11, 2025Location: Miami, FL Leerink Global Biopharma ConferenceFireside Chat PresentationDate and time: March 12, 2025; 8:40am EDT / 12:40pm G...
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Wim Hoste
- Jacob Mekhael
- Thomas Vranken
Hyloris FIRST LOOK: New pipeline addition with RedHill & valacyclovir ...
Hyloris announced a new licensing agreement with RedHill Biopharma to bring in ex-US rights for ondansetron ER, a serotonin blocker that provides relief from nausea and vomiting with chemotherapy, radiotherapy and post-operative recovery. Meanwhile, the FDA accepted oral liquid valacyclovir's regulatory submission for review with a PDUFA date set for October 12, 2025. We intend to incorporate ondansetron ER in a future update of our model and look forward to the valacyclovir decision, while reit...
- Sharad Kumar S.P
Holdings Report - January 2025 KBCS Holdings Universe Returns 3.1% Dur...
1M Performance - Absolute: During Jan'25 (1M period), the KBCS Holdings Universe posted a return of +3.1% which was mainly driven by multi-asset holdings (+3.3%) while single-asset holdings posted a slightly lower return of +2.7%. The 3 top performers during the period were Sofina (+10.6%), Financière de Tubize (+7.5%) and Whitestone Group (+6.4%) while the 3 worst performers were Gimv (-2.0%), The Infrastructure Company (TINC; -3.4%) and Texaf (-5.1%). YTD Performance - Relative: On a YTD bas...
GBLB GROUPE BRUXELLES LAMBERT SA
HAL HAL TRUST
DIE D'IETEREN SA
SOF SOFINA SA
SOLV SOLVAC S.A.
GIMB GIMV NV
QFG QUEST FOR GROWTH
ACKB ACKERMANS & VAN HAAREN NV
TUB FINANCIERE DE TUBIZE S.A.
HEIO HEINEKEN HOLDING N.V.
KBCA KBC ANCORA SCA
TEXF TEXAF
BREB BREDERODE S.A.
TINC TINC COMM. VA
EXO EXOR N.V.
ROCK WHITESTONE GROUP
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Hyloris New reformulation product addition in gastric acid conditions
Hyloris announced that it has entered into an exclusive licensing agreement to develop a ready-to-use formulation for intravenous (IV) administration of pantoprazole (proton pump inhibitor, PPI) to treat gastric acid-related conditions. According to management, there is limited clinical development required as the efficacy of the reference drug has already been established, and Hyloris expects to enter the first markets (likely US and EU) in 3 years. Note that according to guidance from the 1H24...
- Jacob Mekhael
Autolus PREVIEW: Aucatzyl US launch in r/r ALL could re-rate stock
Autolus' lead CAR-T Aucatzyl secured FDA approval in r/r adult ALL in 4Q24, and its differentiated safety profile vs. Tecartus is viewed favourably by KOLs. While the company is not planning to announce the first sale, we learned from management that they have product in production as we speak. We preview Aucatzyl's US launch and point out that reliable production will be key to secure prescriber confidence and sales, and view Autolus as well prepared to execute on that front. We lay out multipl...
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
EXMAR NV: 1 director
A director at EXMAR NV bought 22,135 shares at 11.500EUR and the significance rating of the trade was 50/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly show...
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