reports
- Sean Conroy
Mendus - Regulatory endorsement supports vididencel focus
Mendus’s lead asset, vididencel, is fast approaching the pivotal stages of development in acute myeloid leukaemia (AML), with recent endorsements from both the FDA and EMA (on the design of the planned registrational trial). Separately, Mendus has decided to cease further development for its second asset, ilixadencel, after the termination of its collaboration agreement with Institut Bergonié, sponsor of the REGOMUNE trial. We note that the termination was due to this basket study being prematur...
- Sean Conroy
VolitionRx - Termination of coverage
Edison Investment Research is terminating coverage on VolitionRx (VNRX), Murray Income Trust (MUT) and NioCorp Developments (NB). 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.
- Sean Conroy
Mendus - Vididencel shines in ALISON trial (ovarian cancer)
Mendus has reported positive top-line data for its Phase I ALISON trial, which is evaluating lead off-the-shelf cancer vaccine, vididencel, in high-grade serous ovarian carcinoma (HGSC). The news corresponds to an updated analysis of samples taken from the 17 HGSC patients treated with vididencel. Encouragingly, 12 out of 17 (71%) showed a vaccine-induced immune response (VIR) against at least one tumour antigen commonly upregulated with HGSC, highlighting the potential of vididencel as an activ...
- Sean Conroy
Recce Pharmaceuticals - BPOM clearance to start Phase III R327G study
Recce received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM (BPOM), to start its registrational Phase III study in Indonesia of RECCE® 327 topical gel (R327G) in diabetic foot infections (DFIs). This was the final hurdle that needed to be overcome before study enrolment can proceed, which is expected to start before the end of 2024. Top-line data from the 300-patient double-blinded Phase III study (with 200 patients in the R327 arm and 100 on placebo) are anticipate...
- Sean Conroy
Newron Pharmaceuticals - Evenamide licence agreement in Japan
Newron has entered into a licence agreement with EA Pharma, a subsidiary of Eisai, to develop, manufacture and commercialise evenamide, Newron’s proprietary modulator of the excessive release of glutamate for the treatment of schizophrenia. The transaction covers Japan and other designated Asian territories, meeting management’s target of securing a deal in Q424. Newron will receive an upfront payment of €44m, up to €73m in contributions to development and milestones, and will be eligible to tie...
- Sean Conroy
Basilea Pharmaceutica - Partner in place for US commercialisation of Z...
Following FDA approval in April 2024, Basilea has announced a much-anticipated partnership agreement with Innoviva Specialty Therapeutics for the commercialisation of Zevtera in the US. Deal terms include an upfront payment of US$4m, as well as tiered royalties on net sales in the high-teens to mid-20s percentage range. In addition, the company is eligible to receive up to US$223m in sales-related milestone payments. We view this as an important milestone and highly favourable transaction for Ba...
- Sean Conroy
Mendus - Gearing up for the pivotal stages of development
Mendus continues to make headway with its lead programme assessing cancer vaccine vididencel as a potential maintenance therapy for acute myeloid leukaemia (AML), with the latest update presented at the 66th annual American Society of Hematology (ASH) meeting in December. Mendus presented encouraging long-term survival data from the ADVANCE II trial investigating vididencel as monotherapy, which we believe bolsters the case for further development as it advances towards pivotal studies. With a n...
- Sean Conroy
Nykode Therapeutics - Repositioned to streamline clinical progress
Nykode Therapeutics is a clinical-stage biopharmaceutical company with a focus on novel immunotherapies. As part of its Q324 results, it announced a strategic repositioning as a leaner organisation, aiming to streamline its clinical development efforts. With US$124.6m in cash and a runway guided into 2030, Nykode is seeking partnerships for cancer vaccine candidates VB10.16 and VB10.NEO. Both are backed by encouraging early clinical data and have potentially large commercial opportunities, but t...
- Sean Conroy
Recce Pharmaceuticals - Topical R327G approaching pivotal stages
Recce Pharmaceuticals has made several strides in advancing its topical gel formulation (R327G) of lead anti-infective therapeutic drug candidate RECCE® 327 (R327) as a topical treatment for acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs). The company received Human Research Ethics Committee (HREC) approval to start a registrational Phase III DFI study in Indonesia, which, if successful, could lead to a commercial launch in South-East Asia in CY26....
- Sean Conroy
AFT Pharmaceuticals - Softer H1 on one-offs; recovery expected in H2
AFT Pharmaceuticals reported H125 revenues of NZ$86.7m, a 3.7% y-o-y increase, albeit lower than expected due to one-off factors such as inventory rationalisation by certain international customers and a prolonged doctors’ strike in South Korea (combined sales of NZ$10m vs NZ$18.2m in H124). These factors, along with continued R&D and marketing efforts, weighed on profits, with AFT reporting an operating loss of NZ$1.8m in H125 (profit of NZ$3.3m in H124). The strong domestic Australia and New Z...
- Sean Conroy
Cereno Scientific - A productive period with plenty more to come
Cereno Scientific has released its Q324 results, marking a productive and strategically significant period. Following the positive top-line data from the Phase IIa safety study of CS1 in pulmonary arterial hypertension (PAH), Cereno decided to concentrate its development programmes on rare diseases. Key developments included the selection of idiopathic pulmonary fibrosis (IPF) as the target indication for second asset, CS014, and the positioning of its preclinical asset, CS585, towards rare dise...
- Sean Conroy
OSE Immunotherapeutics - Full Lusvertikimab results reflect potential ...
OSE Immunotherapeutics’ final analysis of the CoTikiS trial in ulcerative colitis (UC) confirmed that Lusvertikimab met the primary endpoint with statistical significance, highlighting its potential to offer a clinically meaningful solution for the condition. In our view, this marks a positive step forward for the candidate, which, to our knowledge, has a unique mechanism of action to address chronic inflammatory and autoimmune diseases. We believe that OSE plans to advance this programme to the...
- Sean Conroy
SIGA Technologies - Strong order book moving into Q424
SIGA Technologies reported revenues of $10m in Q324, attributed primarily to deliveries under the $112.5m BARDA option, exercised in July 2024. Backed by a strong order book ($146m at end-Q324), the sales momentum has picked up pace in Q424 with another $51.2m and $8.5m of oral and IV TPOXX (IVT) delivered to the Strategic National Stockpile (SNS) in October 2024. We expect further deliveries in Q424 and early 2025 under the BARDA contract as well as the $9m US Department of Defense (DoD) order ...
- Sean Conroy
Sareum Holdings - SDC-1801 prepping to enter Phase II
Sareum Holdings’ FY24 results summarised an active period for lead asset SDC-1801, a dual TYK2/JAK1 inhibitor, which successfully completed Phase I trials in Australia and is now undergoing preparatory work to commence Phase II studies, likely in psoriasis patients. The recently reported unblinded data noted robust pharmacokinetic (PK)/pharmacodynamic (PD) properties and reiterated the drug’s desirable safety profile. While Sareum had previously proposed a smaller Phase Ib study, the plan has pi...
- Sean Conroy
IRLAB Therapeutics - Progress across the pipeline in Q324
IRLAB’s Q324 results highlighted progress across its clinical pipeline. Pirepemat cleared its final safety review and completed patient enrolment in the Phase IIb trial, making way for top-line readouts in Q125. IRL757 also made headway, reporting positive interim data from the first Phase I study and the initiation of a second study in older adults, triggering a US$2.5m (SEK26.6m) milestone payment from MSRD. Mesdopetam reported support from regulators in Germany and Portugal for the planned Ph...
- Sean Conroy
AFT Pharmaceuticals - H125 profitability weighed down by one-offs
AFT Pharmaceuticals has released a trading update ahead of its H125 results, expecting to report a c NZ$2m operating loss for the period ending September 2024, driven by one-off factors affecting the top line, as well as increased investments in expanding its international footprint. While the domestic Australian and New Zealand (ANZ) market continued to perform well (double-digit growth), stocking rationalisation by certain international customers, a doctors strike in South Korea (a key market ...
- Sean Conroy
Oryzon Genomics - Q3 results recap key upcoming inflection points
Oryzon has reported its Q324 results, the highlight of which was the borderline personality disorder (BPD) programme, with the final Phase IIb PORTICO data demonstrating vafidemstat’s potential to offer meaningful results in a condition with no approved drugs currently. A further boost was the positive FDA feedback for Phase III, and the next step will be the submission of a full trial protocol for PORTICO-2 (expected in Q125). Oryzon also made strides in strengthening its intellectual property ...
- Sean Conroy
Cereno Scientific - CMD highlights a ‘rare’ portfolio refocus
Cereno Scientific recently held a capital markets day (CMD), providing greater insight on its development pipeline and strategic objectives. The key takeaway was its decision to focus on the rare disease space across its three programmes, a move we believe was strategically driven to maximise potential clinical and commercial success, and to appeal to future partners. While lead asset CS1 is targeting pulmonary arterial hypertension (PAH), supported by Fluidda and CardioMEMS (pivotal studies exp...
- Sean Conroy
Actinogen Medical - A$11.1m capital raise completed
Actinogen Medical announced the successful completion of its A$3.0m share purchase plan (SPP), which closed 1.3x oversubscribed. With its previously disclosed A$8.1m share placement, total funds from the combined capital raising reached the targeted A$11.1m in gross proceeds. The company expects that the total proceeds will enable its operating runway to reach the release of top-line results for its XanaMIA Phase IIb/III trial in patients with mild-to-moderate Alzheimer’s disease (AD), expected ...
- Sean Conroy
Argent Biopharma - Valuation report
We value Argent at an un-risked net present value (NPV) of US$1.1bn. Adjusting for the company’s specified probabilities of success (PoS) for its three clinical programmes gives a risk-adjusted NPV (rNPV) of US$327m or US$6.7 per share. The highest contribution is from CannEpil (NPV of US$508m, PoS 35%), a Phase II, medical-grade cannabinoid being developed for drug-resistant epilepsy. CimetrA, a plant-derived formulation with preclinical and clinical activity as an anti-inflammatory agent, is t...
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.