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Regulatory Information

  • Regulatory Status: Appointed representative
  • ID Number: 725161

Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
AVCT AVACTA GROUP

Trinity Delta Lighthouse: Avacta

Trinity Delta view: Updated SGC data in 30-patients confirm that the efficacy and safety signals seen in Phase Ia are consistent and meaningful. Maturing data from the Phase 1b cohort will guide design of the Phase II/III registration study in SGC. Whilst clearly important, we view the real significance of this encouraging data as providing the proof-of-concept for Avacta’s FAP-targeted pipeline. Although faridoxorubicin has a clear clinical, and commercial, role, the greater value of Avacta’s p...

12/18/25 December 18, 2025 1 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
OBD Oxford BioDynam...

Trinity Delta Lighthouse: Oxford BioDynamics

Trinity Delta view: Oxford BioDynamics’ focus is maintaining the building sales momentum, growing PSE test volumes to 500 per month within 12 months. Stated objectives within this timeframe include: (1) signing a partnership or distribution deal for PSE (with an upfront fee, milestones, and royalties); (2) out-licensing or partnering a test (most likely CiRT, NST, or ME/CFS); (3) establishing CiRT in the NCCN guidelines; (4) initiating the monetisation of the 3D genomics platform (EpiSwitch Orio...

OBD OXFORD BIODYNAMICS
12/16/25 December 16, 2025 1 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
HCM Hutchison China...

HUTCHMED: Pipeline potential underpins long-term growth prospects

HUTCHMED’s recent R&D update highlighted multiple catalysts expected over the next 12-24 months, including the launches of new products and regulatory decisions on new indications for existing products which will be key for near- and mid-term revenue growth in China. Ex-China, partner AstraZeneca has guided towards Phase III SAFFRON top-line data in H126, with savolitinib remaining on track to become HUTCHMED’s second global asset. Longer-term, the proprietary ATTC platform offers significant po...

HCM HUTCHISON CHINA MEDITECH LTD SPONSORED ADR
12/15/25 December 15, 2025 1 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
SCLP Scancell Holdin...

Trinity Delta Lighthouse: Scancell

Trinity Delta view: The data from the SCOPE study of Scancell’s “off the shelf” cancer vaccine SCIB1/iSCIB1+ continue to show a clinically meaningful and commercially relevant improvement over currently achievable treatments. The safety and tolerability also remain attractive, with the iSCIB1+/CPI combination comparable to SoC alone. Positive discussions with regulatory authorities mean investor attention will now focus on the design, timing, and, importantly, funding of the pivotal Phase III re...

SCLP SCANCELL HOLDINGS
12/09/25 December 9, 2025 1 EN
Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner
SCLP Scancell Holdin...

Scancell: Abundant development opportunities in immuno-oncology

Scancell’s investment case centres on the potential of the lead oncology programmes from its highly promising ImmunoBody and Moditope “off the shelf” platforms. Following the successful outcome from the SCOPE trial, iSCIB1+ has been selected as the optimal ImmunoBody candidate to progress into a potentially registrational trial. Forthcoming discussions with the FDA should define the registrational trial design. Other 2025 catalysts include further SCOPE data, plus early data from the RCC (renal ...

SCLP SCANCELL HOLDINGS
11/17/25 November 17, 2025 1 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
SAN SANOFI
REDX REDX PHARMA

Trinity Delta Lighthouse: Redx Pharma

Trinity Delta view: he importance of the ROCK pathways has been known for some time, but the chemistry is complex and historically identifying safe and effective selective inhibitors has proved challenging. Redx Phama has a proven medicinal chemistry expertise and has generated what, in our view, is a possible “best-in-class” small molecule. RXC007 is one of two in-house assets (the other is RXC004, a porcupine inhibitor in Phase II trials) and two partnered programmes (with AstraZeneca and Jazz...

SAN SANOFI
REDX REDX PHARMA
09/08/21 September 8, 2021 2 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
HCM Hutchison China...

Trinity Delta Lighthouse: HUTCHMED

Trinity Delta view: The timing of the fund raise follows hot on the heels of data presented at the ASCO 2021 conference and updates at a recent investor event on several new late-stage programmes to be initiated which highlighted the strength and depth of HUTCHMED’s late-stage pipeline. The in-house discovery platform has generated 10 tyrosine kinase inhibitors that have progressed into the clinic: both as monotherapy and, importantly, in combinations, in China and globally. The first product wa...

HCM HUTCHISON CHINA MEDITECH LIMITED
06/21/21 June 21, 2021 2 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
FUM Futura Medical ...

Trinity Delta Lighthouse: Futura Medical

Trinity Delta view: Although MED3000’s imminent approval in Europe was flagged in March, the receipt of the official documentation paves the way for commercialisation discussions for a number of geographies to proceed at pace. The timings remain uncertain, but we would expect to see a number of deals in place within the next six months. For these geographies, the key sensitivity shifts from regulatory risk to execution risk, particularly the nature and scope of the commercialisation agreements. ...

FUM FUTURA MEDICAL PLC
04/30/21 April 30, 2021 2 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
NXTMS NEXSTIM LTD

Trinity Delta Lighthouse: Nexstim

Trinity Delta view: The oversubscribed rights issue is tangible evidence of support for management’s growth strategy. Demonstrating the value of NBT in accelerated iTBS protocols for severe depression is a key component of the 2020-24 strategic plan. The new funds will also support other plans for NBT and NBS growth and enable achievement of several near and mid-term goals. Updating our Nexstim rNPV model for the raise results in a valuation of €50.6m (€0.08 per share) against our prior €44.2m (...

04/08/21 April 8, 2021 2 EN
Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek
AGY Allergy Therape...

Trinity Delta Lighthouse: Allergy Therapeutics

Trinity Delta view: The start of the biomarker study of Allergy Therapeutics’ peanut allergy vaccine candidate represents a step forward for this development programme and should facilitate a smooth transition into Phase I later this year. It is the first VLP-based vaccine in Allergy’s portfolio and addresses a sizeable and underserved market. The collaboration with Imperial College is significant as both the peanut allergy biomarker study and the wider collaboration should generate important ne...

AGY ALLERGY THERAPEUTICS PLC
01/05/21 January 5, 2021 2 EN

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