reports
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Avacta: Targeting the tumour microenvironment with pre|CISION
Avacta’s growing knowledge base and expertise is cementing its leadership position in FAP-enabled biotherapeutics. Lead clinical asset, AVA6000 (FAP-Dox) is the first of a series of pre|CISION-based modalities that have the potential to improve the therapeutic index of many highly potent yet systemically toxic oncology drugs. Other novel programmes AVA6103 (FAP-EXd) and AVA7100 (an Affimer-drug conjugate platform) further broaden the potential utility of the pre|CISION platform. Progress into th...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta LIghthouse: Scancell
Trinity Delta view: Data from the SCOPE study are reassuring and pave the way for the planned randomised adaptive Phase II/III trial. Assuming continuing positive results at week 25 for both Cohorts 1 and 3, investor attention will understandably centre on the funding of this potentially pivotal study. Our forecast cash runway extends to Q325, beyond these SCIB1/iSCIB1+ milestones and Modi-1 data in H125; however, our cash assumptions do not include any potential licensing deals for the GlyMab a...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Arecor Therapeutics: AT220 sales building momentum
AT220, which we believe to be Fresenius’s Tyenne (tocilizumab), was discussed in detail during management’s Q324 results call. In its first year post-launch in Europe it has gained impressive clinical traction, posting a 19% share within the EU5 markets. The US is also performing well, following FDA approval in March 2024, with keen interest from major buying institutions. The product-specific Q-code was granted in late-October, opening the gateway to greater uptake as prescribing hurdles are re...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: These early preclinical data provide first insights into the broad potential of Avacta’s pre|CISION technology and the emerging highly innovative pipeline. These novel PDC and AffDC therapeutics have the potential to deliver a variety of known potent drugs (payloads) directly to the TME, limiting systemic toxicities and improving the therapeutic window. These data, plus validation from AVA6000 (September 2024 Lighthouse), indicate that pre|CISION chemistry could overcome some...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Oxford BioDynamics: Commercialising cutting edge diagnostics
Oxford BioDynamics is leading the way in 3D genomic diagnostics, developing innovative and clinically robust tests using its proprietary EpiSwitch platform. EpiSwitch CiRT (Checkpoint Inhibitor Response Test), predicts a patient’s response to cancer immunotherapy, and the PROWES registry study is underway to generate uptake and to support inclusion in key guidelines. EpiSwitch PSE, for prostate cancer, has recently been launched and is initially targeting the concierge medicine sector in the US....
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Scancell: SCOPE readouts in sight; SCIB1 data in Q424
Key clinical data for the lead cancer vaccines are approaching, with the first readout expected during Q424 for SCIB1 in advanced melanoma. Scancell is aiming to show that SCIB1 can meaningfully improve outcomes for patients, targeting an ambitious >70% response rate (ORR). If this is achieved, this would vastly exceed current 50% ORRs, but is a realistic aim, in our view, given prior SCIB1 data. Results from the improved next-generation iSCIB1+ are expected H125. Assuming positive outcomes, Sca...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: ANGLE
Trinity Delta view: All the building blocks remain in place at ANGLE to deliver sustainable long-term growth from both Products and Services. However, in the near-term, resources will be appropriately focused on maximising the Pharma Services opportunity to capitalise on the recent momentum in this business. As and when conditions improve in the Products business, ANGLE is prepared and has the elements in place to re-invigorate this revenue stream. Whilst the slowdown in Products will impact nea...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: Avacta is transitioning into a developer of innovative highly targeted specialist oncology products. Lead asset, AVA6000, has successfully demonstrated the pre|CISION platform’s ability for tumour-specific delivery of potent and toxic actives with minimal systemic effects. Broader data indicating that lower FAP activity is still sufficient for active drug release, extends the applicability of the pre|CISION platform to other FAP-expressing tumour types (FAPmid), using novel w...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Arecor Therapeutics
Trinity Delta view: The key value driver for Arecor with the biggest upside potential is the diabetes and obesity franchise, in our view. The highly positive Phase I data for lead asset AT278, a potential disruptor insulin, strongly support conducting a pump study, and we believe Arecor is well positioned to determine the most optimal route forward. In addition, whilst early-stage, the oral GLP-1 programme could have significant commercial potential, and progress will help validate oral delivery...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
HUTCHMED: Flow of catalysts continues, with more into 2025
HUTCHMED continues to focus on clinical and commercial delivery from its most advanced in-house pipeline assets. The goal is sustainable profitability from FY25 onwards, with an expectation for FY24 Oncology/Immunology consolidated revenues of $300-$400m, driven by targeted 30-50% growth in marketed product sales and royalties. First Japan approval of fruquintinib for advanced metastatic colorectal cancer (mCRC) is a key achievement, although the remainder of 2024 into early-2025 should bring fu...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta LIghthouse: Scancell
Trinity Delta view: Key upcoming SCIB1 data in advanced melanoma are largely de-risked given prior results, in our view, and Scancell is already preparing for future SCIB1/iSCIB1+ development, pending full SCOPE data, including from iSCIB1+ in H125. A potentially pivotal adaptive Phase II/III trial is being planned and critical elements to ensure rapid progression are being addressed. We believe this indicates confidence in the outcome of the ongoing SCOPE trial, appropriate in our view given pr...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: Data presented at ESMO 2024 provide further proof of concept, confirming that AVA6000 works as designed at both Q3W and more frequent Q2W dosing, with selective targeted release of the drug warhead (doxorubicin) in the TME, resulting in lower toxicities than standard doxorubicin and preliminary efficacy in cancers that over-express FAP and are doxorubicin sensitive. These data should guide dose and indication selection for the planned expansion cohorts in H224. Excitingly, PK...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Arecor Therapeutics: EASD 2024: Positive Phase I for AT278 in Type II ...
Detailed data from the Phase I study in Type II diabetes (T2D) of Arecor’s lead asset AT278, a unique ultra-rapid and ultra-concentrated insulin, were presented at the European Association for the Study of Diabetes (EASD) 2024 meeting. These data confirm its attractive profile, with faster onset and stronger early glucose-lowering effect in comparison to gold standard fast-acting insulin NovoRapid/NovoLog (NovoNordisk). Clinical data to date suggest a pertinent and highly differentiated profile ...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Futura Medical: Earlier US Eroxon launch brings forward profitability
We have upgraded our revenue forecasts and valuation following interim results and the earlier and imminent US launch by partner Haleon, which we previously anticipated in 2025. The US launch, expected in October, will trigger a milestone and recurring royalties on net Eroxon sales. Commercial success in the US will be transformational, ensuring Futura’s sustainable and growing profitability. Meanwhile, existing partners outside of the US continue to execute on launches, with Eroxon now availabl...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Futura Medical
Trinity Delta view: Futura Medical has successfully transitioned into a commercial stage healthcare company that is now profitable and cash generative. The much-anticipated US launch by Haleon is imminent, and commercial success in the US would be transformational, ensuring Futura Medical’s sustainable and growing profitability. Continued launches by partners, coupled with ongoing learnings from real-world evidence that confirm Eroxon’s unique position and potential, all bode well for future Ero...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: HUTCHMED continues to execute consistently, with in-market sales growth driving revenues, an optimised and well-balanced pipeline with near-term additional approvals and launches in China and globally, and a sharp focus on costs. These should help achieve consolidated Oncology/Immunology revenues towards the upper end of maintained FY24 guidance and could also provide sustainable profitability earlier than anticipated. Partner Takeda continues to drive Fruzaqla US sales momen...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Futura Medical
Trinity Delta view: As we have stated before, Futura Medical’s investment case has shifted firmly onto commercial execution. The highly successful initial launches of Eroxon, its novel topical gel for ED (erectile dysfunction), by partner Cooper Consumer Health in the UK and Belgium are being followed by roll-outs across the major European markets. Other geographies have also successfully launched. However, in our view, it is the US that could prove transformational as commercial success in the ...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Arecor Therapeutics
Trinity Delta view: New funds are welcome, and will allow Arecor to invest judiciously in Tetris Pharma to drive Ogluo sales, whilst also continuing to expand the technology platform to include oral delivery of peptides as well as developing enhanced injectables, with these potentially generating meaningful future income streams through deals and partnerships. The funds also remove recent working capital headwinds. The key value driver for Arecor remains the diabetes franchise, with further deve...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: The depth of HUTCHMED’s innovative pipeline is becoming increasingly apparent as clinical data disclosures are made. Management focus on developing potential first-in-class or best-in-class therapies that address sizable markets where there are either limited or inadequate treatment options should bring benefits to patients and payors, and to investors. The profile of the three assets highlighted at the R&D event provide greater confidence in the mid-term prospects for HUTCHM...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
HUTCHMED: Data at EHA 2024 heighten focus on sovleplenib
HUTCHMED’s clinical data presentations at the European Hematology Association (EHA) 2024 congress have provided meaningful insights into sovleplenib’s efficacy and safety profile. This is the first HUTCHMED immunology/haem-oncology asset to be filed in China, with a potential approval decision in ≥2L immune thrombocytopenia (ITP) expected late-2024. The prospect of China approvals for sovleplenib and follow-on indications for fruquintinib, as well as the first potential fruquintinib regulatory d...
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