reports
- Sean Conroy
Ultimovacs - Steadfast commitment to UV1 progression
Despite the recent setback with the INITIUM trial (first-line treatment of patients with unresectable or metastatic malignant melanoma), Ultimovacs has reinstated its commitment to press on with its clinical development of its cancer vaccine, UV1, across other target indications. The principal near-term focus will be on the anticipated results of Phase II FOCUS (head and neck cancer) and DOVACC (ovarian cancer) trials in Q324 and H125, respectively, and will inform its subsequent strategic direc...
- Sean Conroy
OSE Immunotherapeutics - AbbVie deal clears antitrust hurdle
OSE has announced that its licence agreement with AbbVie has cleared antitrust review and has become effective. As previously noted, this is expected to support OSE’s runway extension into 2026, past key milestones and readouts for in-house assets Tedopi (non-small cell lung cancer, US Phase III trials expected to commence in Q224) and Lusvertikimab (ulcerative colitis, Phase II readouts expected in mid-2024). Following the Federal Communications Commission (FCC) mandatory waiting period, OSE is...
- Sean Conroy
Actinogen Medical - First patient dosed in Phase IIb XanaMIA study
Actinogen Medical announced that the first randomised patient in its Phase IIb XanaMIA trial of lead candidate Xanamem received their first treatment on Friday 12 April. This study is designed to enrol c 220 patients with cognitive impairment (CI) associated with biomarker-positive mild-to-moderate Alzheimer’s disease (AD), as confirmed through an elevated level of phosphorylated Tau-181 (pTau-181) protein in their blood at baseline. The study has commenced at 13 Australian sites and will concen...
- Sean Conroy
Cereno Scientific - CS014 (thrombosis) progresses towards the clinic
Cereno Scientific has taken a step closer to advancing its second asset, CS014, a novel HDAC inhibitor with epigenetic effects, to the clinic with the submission of the clinical trial application (CTA) to the European Medicines Agency (EMA). The CTA is for the first-in-human Phase I trial for CS014, which Cereno is developing for thrombosis prevention, without increased risk of bleeding. We believe this has the potential to address the main limitation of current standard-of-care antithrombotic m...
- Sean Conroy
OSE Immunotherapeutics - Funding accelerates Tedopi clinical developme...
Despite the challenging macroeconomic environment, OSE announced an encouraging funding win with the receipt of €8.4m in non-dilutive public funding from Bpifrance (a French public sector financing institution). Proceeds will be directed to support the upcoming registrational Phase III study of lead asset Tedopi, in second-line treatment in HLA-A2 positive non-small cell lung cancer (NSCLC) patients with secondary (acquired) resistance to anti-PD-(L)1 immunotherapy. This announcement follows the...
- Sean Conroy
Basilea Pharmaceutica - CARB-X grant for preclinical programs
In the lead up to its capital markets day, Basilea Pharmaceutica announced it has received initial funding of up to US$0.9m through a grant from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership backed by governments and foundations, for its preclinical antibiotics program. CARB-X is focused on supporting early-stage antibacterial research and development, and this grant is expected to support development work up until clinical candid...
- Sean Conroy
Oryzon Genomics - FDA green light for SCLC combination trial
With the FDA investigational new drug (IND) application clearance, Oryzon can commence its Phase I/II cooperative research and development agreement (CRADA) trial sponsored by the National Cancer Institute (NCI; part of the National Institutes of Health) with Dr Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) as the principal investigator. This trial will evaluate iadademstat in combination with immune checkpoint inhibitors (ICIs) for the treatment of first-line extensive...
- Sean Conroy
IRLAB Therapeutics - Beyond PD-LID, a closer look at PD-psychosis
While IRLAB Therapeutics’ immediate focus is on advancing mesdopetam in levodopa-induced dyskinesia (PD-LID) following the recent green light from the FDA for its Phase III trial design, we expect the Parkinson’s disease-psychosis (PD-P) programme to be revived as the lead programme progresses towards commercialisation. We continue to see label expansion opportunities in this indication for IRLAB as we model a 2032 PD-P launch with a 20% probability of success (PoS). PD-P is a common occurrence,...
- Sean Conroy
Oryzon Genomics - Third time is a charm; INNOVATIVE SME Seal
For the third consecutive time, Oryzon Genomics has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation. This external recognition highlights Oryzon’s key R&D activities, including its lead central nervous system (CNS) asset, vafidemstat, and lead oncology asset, iadademstat, and overall contributions to the field of epigenetics. Along with the acknowledgement, the INNOVATIVE SME Seal may allow Oryzon to benefit from certain tax deductions and incentives, as well...
- Sean Conroy
Mendus - Gross proceeds of c SEK69m to advance pipeline
Mendus has reported gross proceeds of c SEK69.1m from the exercise of series TO3 warrants that were issued in connection with the July 2023 raise of SEK317m. Management anticipates that these proceeds will extend the cash runway to Q325 and will be applied to progress its clinical pipeline, mainly in preparation for a registrational trial for lead cancer vaccine vididencel, targeting acute myeloid leukaemia (AML) in the maintenance setting. Management expects the registrational study to commence...
- Sean Conroy
Basilea Pharmaceutica - Zevtera crosses key US regulatory hurdle
Basilea has announced the FDA approval of its second lead asset, Zevtera (ceftobiprole), for the treatment of severe bacterial infections (three indications), marking a major commercial win. The US is the most commercially lucrative market for Zevtera, accounting for 85–90% of its total market potential. Zevtera is already approved in several countries (including in Europe) and the FDA nod is based on three Phase III studies (including the ERADICATE and TARGET studies with R&D partly funded by t...
- Sean Conroy
SIGA Technologies - Positive signals abound
SIGA Technologies announced a strategic step in fortifying its distribution partner, Meridian, allowing greater control over planning and executing its international development efforts, a key growth pillar. The amended terms allow the company to actively manage future promotion activities outside the US (effective 1 June 2024). While Meridian will continue to administer existing international contracts, we expect the renegotiated terms to benefit the bottom line in the medium term as SIGA gains...
- Sean Conroy
Sareum Holdings - A decisive period ahead for SDC-1801
Sareum Holdings’ H124 results highlighted the company’s swift progress for lead asset SDC-1801, since gaining regulatory approval in Australia to start human studies in mid-CY23. SDC-1801, a TYK2/JAK1 inhibitor targeting the autoimmune space, has reported a good safety profile to date and top-line data for the ongoing Phase Ia study are expected in Q2 CY24, a key catalyst for the company. The TYK2 class’s safety and efficacy has been validated by the likes of Sotyktu and TAK-279, and SDC-1801’s ...
- Sean Conroy
Immix Biopharma - Reaffirmed long-term focus on outpatient CAR-T
Immix Biopharma is continuing its strategic pivot towards exploring non-traditional indications for its CAR-T asset, NXC-201, leading with relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). This tactical approach targets opportunities with a potential first mover advantage and the strategy is expected to be consolidated in 2024 with the initiation of the Phase Ib NEXICART-2 study in the US and the selection of the first autoimmune indication for NXC-201. Readouts in ALA are expecte...
- Sean Conroy
OSE Immunotherapeutics - Pipeline momentum builds into FY24
OSE Immunotherapeutics’ (OSE’s) FY23 update summarised an active period for its clinical pipeline that was capped by the post-period $713m deal with AbbVie for preclinical asset OSE-230. The company is anticipated to hit meaningful milestones in 2024 with its lead immuno-oncology asset, Tedopi, gearing up for the confirmatory pivotal Phase III trial in Q224 and lead immuno-inflammation programme, Lusvertikimab, set to report Phase II top-line results in mid-2024. OSE-230 (being developed as a tr...
- Sean Conroy
Mendus - Regulatory green light for CADENCE trial
The Human Research Ethics Committee (HREC) has provided the green light to commence enrolment for Mendus’s AMLM22-CADENCE trial from April 2024. This Phase II trial in collaboration with the Australasian Leukaemia and Lymphoma Group, a clinical trial research group focused on haematological cancers, will evaluate lead cancer vaccine vididencel, in combination with standard of care oral azacitidine (Onureg) as a maintenance treatment for acute myeloid leukaemia (AML). A pivotal global registratio...
- Sean Conroy
Recce Pharmaceuticals - R&D advance (A$11.18m) extends runway
Recce Pharmaceuticals recently received A$11.18m as an R&D advance credit through an arrangement with Endpoints Capital for the R&D tax credit rebates that Recce expects to receive for FY23/FY24 and FY25. We believe this non-dilutive source of funding should extend Recce’s operating runway into FY25. Recce is also continuing to advance its intravenous (IV) R327 formulation in its ongoing Phase I/II study in healthy volunteers, having recently started the 20-minute (3,000mg) dosing cohort. We hav...
- Sean Conroy
Immix Biopharma - Marching towards US clinical trials for NXC-201
Immix Biopharma is closer to dosing its first US patient for lead CAR-T asset NXC-201, with the appointment of the Memorial Sloan Kettering Cancer Center as the main clinical site for the company’s US multi-site NEXICART-2 trial assessing NXC-201 in relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). NXC-201 targets B-cell maturation antigen (BCMA) and is differentiated by its low neurotoxicity and short cytokine release syndrome (CRS) duration to date, supporting Immix’s long-term ...
- Sean Conroy
IRLAB Therapeutics - FDA thumbs up to mesdopetam’s Phase III plan
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now ...
- Sean Conroy
ReNeuron Group - Termination of coverage
Edison Investment Research is terminating coverage on ReNeuron Group (RENE). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our website.
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.