reports
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: Prioritisation of the Therapeutics division continues, with Christina Coughlin’s appointment as CEO (having been on the Board since March 2022 and Head of R&D since February 2024). Once the Diagnostics division has been divested, Avacta will become a fully focused biotech company. This strategy is underpinned by the proprietary pre|CISION platform, and lead peptide drug conjugate AVA6000. Completion of the two-weekly safety study and progression into dose expansion cohorts du...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Futura Medical: Eroxon poised for launch in key US market
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 now being followed by roll-outs across the major European markets. The much-anticipated launch in the commercially important US market by consumer healthcare giant Haleon is expected before February 2025. Launches in Other Regions are anticipated throughout...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: The proprietary pre|CISION platform is key to Avacta’s investment case, hence updated data that continue to support key hypotheses for AVA6000 are reassuring. Future efficacy data from studies planned to start in H224 will be key, and could also help to more broadly validate pre|CISION. The recent £31.1m fundraise (March 2024 Lighthouse), which provides a cash runway of c 24 months ie into early 2026, will be used to advance the therapeutics pipeline, in particular AVA6000, a...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Futura Medical
Trinity Delta view: Following the recent Trading Update, there are few surprises within Futura’s FY23 financial results, with costs remaining tightly controlled. Focus on the potential US launch by partner Haleon is understandable, given the US commercial opportunity is likely the most significant. Hence, comments that preparations towards the US launch are progressing well, together with Haleon confirming launch is expected within 12 months, are reassuring. Whilst there continue to be limited i...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
HUTCHMED: Executing consistently on the road to breakeven
China commercial execution, the prospect of further approvals and launches globally and in China, plus a strong balance sheet means HUTCHMED is well positioned to achieve its goal of sustainable profitability from FY25. Having made significant progress during FY23, most notably with the FDA approval and US launch of first global product Fruzaqla (fruquintinib) in November 2023 (impressively generating $15.1m of in-market sales), its FY24 outlook is for continuing strong product revenue growth ac...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Redx Pharma
Trinity Delta view: The plan to delist from AIM is disappointing but, in our view, understandable. The shares have failed to reflect the value inherent in the business and, importantly, the future potential. As we have stated in previous notes, Redx has a solid track record of delivery, with six molecules in the clinic and four major partnering deals over the past five years. The announcement prompts us to suspend our Redx Pharma forecasts and valuation with immediate effect. For context, our la...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Arecor Therapeutics
Trinity Delta view: Arecor’s formulation expertise underpins both the in-house clinical pipeline and the partnered Specialty Hospital Products programmes. Investor attention is understandably focused on the diabetes franchise, hence the upcoming AT278 Phase I data are eagerly anticipated. Although still at the earliest stages, this partnership with TRx Biosciences for an oral GLP-1 product not only addresses a highly commercially attractive segment but, if successful, could provide complementary...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Avacta
Trinity Delta view: The upsized fundraise of £31.1m (gross), together with existing cash of £16.6m (at 1 January 2024), are expected to provide a cash runway of c 24 months (ie into early 2026) covering a number of value inflection points in AVA6000’s development pathway, which could bring opportunities for non-dilutive funding for the broader pre|CISION platform. Monetising Diagnostics through divestment would also bring in non-dilutive funding, but may, in our view, be targeted for later in th...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: HUTCHMED’s path to profitability continues to be supported by solid commercial execution in China, the prospect of additional approvals and launches in China and globally, and a solid balance sheet. Several pipeline assets could reach the market by 2025, including other global fruquintinib launches by Takeda (Europe and Japan regulatory decisions in advanced mCRC are anticipated in 2024); fruquintinib indication expansion in China (2L gastric cancer filed; potential 2024-25 f...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Redx Pharma: Ready to ROCK as RXC008 enters the clinic
Redx Pharma’s differentiated ROCK inhibitor assets hold much promise in the treatment of a variety of serious and intractable fibrotic conditions. Hence, the start of a Phase I trial with second ROCK programme RXC008 is an important milestone. The preclinical data for RXC008 are extensive and, if replicated in the clinic, suggest that RXC008 could have a unique role in the treatment of fibrostenotic Crohn’s disease, a debilitating condition that requires repeated surgical interventions. Meanwhil...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: Fruquintinib’s commercial prospects are a key contributor to HUTCHMED’s path to profitability, which is supported by the growing traction and market share capture of its China oncology products, additional potential approvals and launches (by partner Takeda) of fruquintinib in international markets, and a solid balance sheet. Fruquintinib’s potential approval in a second indication in China (2L gastric cancer) as well as tiered royalties on annual net sales in Takeda’s market...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Redx Pharma
Trinity Delta view: The Jazz KRAS deal covers an under the radar programme only recently disclosed by Redx, further underscoring the strength of its medicinal chemistry expertise in discovering differentiated small molecules that address hard to drug targets in oncology and fibrosis. Business development activities also contribute non-dilutive funding, in this case extending the cash runway into 2025, beyond 2024 catalysts, thus allowing optionality around value creation from the highly attracti...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Futura Medical
Trinity Delta view: Revenues appear to be broadly tracking just ahead of our expectations, even with the challenges of forecasting first launches. Re-ordering patterns will be a key determinant of longer-term success, and whilst visibility is not unexpectedly limited given the early stage of launch, we believe the commitment shown by Cooper through extension of the existing agreement is an encouraging sign and likely reflects initial in-market success and trends, in our view. We continue to beli...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Arecor Therapeutics
Trinity Delta view: Investor attention is focused on the diabetes franchise, hence the upcoming AT278 Phase I data are eagerly anticipated. However, an interesting growth story is emerging as Arecor continues to execute on new deals, with further partnerships expected. These have the potential to drive meaningful future royalties from multiple partners, building on the continued momentum from existing assets and partners. The second Specialty Hospital deal, commercial validation of Arecor’s form...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Scancell: Heading into important 2024 clinical catalysts
Scancell has a number of important clinical catalysts upcoming in 2024 for its lead cancer vaccines, which are the strategic focus. Readouts include further Phase II data for SCIB1 in advanced skin cancer, first clinical data with second-generation iSCIB1+, and key CPI combination data for Modi-1 in multiple solid tumours. Commercial prospects for these will likely be maximised through partnerships, and positive data could catalyse interest and discussions, in our view. In addition, Scancell’s a...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
ANGLE: Building content to drive widespread adoption
ANGLE’s investment case rests on where Parsortix’s position in mainstream cancer diagnostics eventually lands. The place of liquid biopsies is now established and, increasingly, the additional clinical value that CTC (circulating tumour cells) assays bring is becoming clear. Addressing the many, varied opportunities directly is challenging and time consuming, with numerous barriers to overcome. Management is creating industry awareness through its demonstration and acceleration activities, which...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: Arecor Therapeutics
Trinity Delta view: Sanofi’s acquisition of INBRX-101 fits in with its portfolio growth strategy and its focus and reputation in rare diseases, and the $1.7bn+ deal value underscores INBRX-101’s attractiveness. For Arecor this is further commercial validation for its formulation expertise and ability to create clearly differentiated assets. INBRX-101 is Arecor’s second most advanced partnered asset, behind biosimilar AT220 (believed to be Fresenius Kabi’s tocilizumab) which launched in Europe in...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Redx Pharma: Anticipating clinical momentum and catalysts in 2024
Redx Pharma’s pipeline focus is on its differentiated ROCK portfolio targeting serious and debilitating fibrotic diseases. The c £14m October fund raise extended the cash runway beyond key H124 catalysts, providing greater optionality around value creation from these assets. Topline Phase IIa data expected in H124 from lead compound zelasudil (RXC007), a next-generation selective ROCK2 inhibitor under evaluation for IPF (idiopathic pulmonary fibrosis), coupled with the potential to lift the FDA ...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Avacta: Tailored tumour targetting with pre|CISION
Avacta’s proprietary pre|CISION platform is key to the investment case, and further details on lead programme AVA6000, a tumour targeted form of the chemotherapy doxorubicin, continue to support key hypotheses. Data show that AVA6000 is selectively activated at the target tumour site, resulting in lower toxicities, improved tolerability, and greater potency. This has translated into promising, albeit early, signs of clinical activity. AVA6000’s clinical success will help to validate pre|CISION, ...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Arecor Therapeutics: Second in-house Specialty Hospital deal
Arecor’s co-development and exclusive licence option agreement with a leading global medical products company demonstrates further strategic execution in securing revenue generating partnerships for its proprietary portfolio of Specialty Hospital products. It also further validates the attractiveness and relevance of its Arestat formulation expertise in developing novel products, the first of which (biosimilar AT220) was launched earlier this year. Specialty Hospital licensing agreements form a ...
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