Data highlights efti efficacy and potential central role in cancer therapy

Data presented SITC (Society for Immunotherapy of Cancer) not only further supports eilagimod alpha ("ei") efficacy in metastac breast ("mBC") and head and neck ("HNSCC") cancers, but also highlights a potenal central role for ei across cancer therapy. Interim overall survival (“OS”) from the AIPAC was already posive, this final data is slightly improved with a clear 2.9 month increase in OS with ei+ paclitaxel. While this was not stascally significant, there was a significant increase

Immutep Limited (IMM-AU): LAG-3 therapies taking immunology to the next level

LAG-3 targeted drugs look increasingly likely to take cancer therapy to the next level. Uniquely focussed, Immutep continues to accumulate data supporting the efficacy its LAG-3 agonist Eftilagimod alpha ("Efti") in a variety of cancers and drug combinations. Data from the TACTI-002 study in non-small cell lung cancer ("NSCLC") and positive signals in head and neck suggest the drug may extend the benefits of anti-PD-1 / L1 immune checkpoint inhibitors ("ICI"); without additional toxicity. While

Efti combos move towards centre stage at ASCO

Data presented at the ASCO further supports the use of eftilagimod alpha ("efti") in PD-1 / PD-L1 immune checkpoint inhibitor ("ICI") combinations. These include data in 1st line NSCLC (non-small cell lung cancer) and 2nd line HNSCC (head and neck cancer). The new Phase 2 TACTI-002 interim results show that 7 patients have now seen complete responses to the efti-pembrolizumab ("pembro") combo (2 in 1st line NSCLC and 5 in 2nd line HNSCC). Treatment was well tolerated in the total 127 patients. W

BMS shows LAG-3 - PD-1 combo boosts PFS in melanoma

Bristol Myers Squibb just announced that RELATIVITY-047 evaluang combinaon of its an-LAG-3 Relatlimab with Opdivo had a significant benefit on progression-free survival. The Phase 2  3 trial in paents with untreated or unresectable melanoma showed a PFS of 10.12 months with the relatlimab combo compared to 4.63 months with Opdivo alone. This is the first me a treatment regimen has shown benefit over PD-1 alone in melanoma. These data to be presented at ASCO (American Society for Clinical O

BMS study identifies LAG-3 - PD-1 as potential "key strategy'

Bristol Myers Squibb just announced that RELATIVITY-047 evaluating combination of its anti-LAG-3 Relatlimab with Opdivo had met its primary endpoint. The Phase 2 / 3 trial in patients with untreated or unresectable melanoma showed a benefit of relatlimab comb compared Opdivo alone; full data to be presented at up-coming meetings. These data are clearly positive for Immutep's partnered anti-LAG-3 LAG525 currently in Phase II with Novartis. With Immutep's Eftilagimod alpha ("efti") also showing po

Targeting first-line head and neck with Merck & Co

Immutep announced they are extending their partnership with Merck & Co ("MSD") to develop an eilagimod alpha ("ei") pembrolizumab ("pembro") combinaon as a first line therapy for HNSCC (head and neck cancer). The planned randomized controlled trial TACTI-003 trial involving 160 paents builds on impressive Phase 2 TACTI-002 data (also with MSD), which showed a doubling of overall response rate with ei-pembro in normally unresponsive PD-1  PD-L1 second line HNSCC paents, including 3 complet

Door re-opens to first eftilagimod alpha approval

Newly released overall survival ("OS") data from Immutep’s Phase IIb AIPAC study in metastatic breast cancer (“mBC”) shows eftilagimod alpha (“efti”) chemotherapy combination meaningfully benefits subgroups representing >60% of the patient population. In patients <65 years or with low starting monocyte count efti plus paclitaxel increased OS by +7.1 months and +9.4 months respectively, in comparison to paclitaxel plus placebo (p<0.05). CD8 T cell analysis saw a sustained elevation in the efti gr

Striking support for efti - checkpoint inhibitor combos

Data presented at the SITC further support the use of eftilagimod alpha ("efti") in PD-1 / PD-L1 immune checkpoint inhibitor ("ICI") combinations. These include very encouraging data in normally unresponsive 2nd line HNSCC (head and neck cancer) and 2nd line NSCLC (non-small cell lung cancer) and, as well as further indications of improved responses in the second 1st line NSCLC expansion cohort. The new Phase 2 TACTI-002 interim results show that 5 patients have now seen complete responses to th

More evidence of efti-PD-1 / L1 survival benefit at ESMO

Data at ESMO from TACTI-002 further highlights the impressive benefits of eftilagimod alpha ("efti") and PD-1 / PD-L1 immune checkpoint inhibitor combinations on progression-free survival ("PFS") in 1st line NSCLC (non-small cell lung cancer) and 2nd line HNSCC (head and neck cancer). INSIGHT-004 continues to suggest efti-PD-1 / PD-L1 benefits in normally ICI-resistant cancers. TACTI-002 continues to show that overall response rate ("ORR") in HNSCC with efti-ICI combo outperforms historic data f

ASCO data underscores efti-PD-1 / L1 synergy

Further data from TACTI-002 and first initial data INSIGHT-004 trials released at ASCO provide further evidence of synergy between eftilagimod alpha ("efti") and PD-1 / PD-L1 immune checkpoint inhibitors. Previously released TACTI-002 data had indicated that efti plus Merck & Co's pembrolizumab generated responses in first line NSCLC patients with even with low PD-L1 levels. The new data confirms this and indicates progression-free survival ("PFS") >9 months. It also confirms potential benefit i

First in class opening the cancer immune throttle

Immutep continues to accumulate data supporting the use of Eftilagimod alpha ("efti") in cancer therapy. Data from the TACTI-002 study in non-small cell lung cancer ("NSCLC") and positive signals in head and neck suggest the drug may extend the benefits of immune checkpoint inhibitors ("ICI"); boosting ORR (Overall Response Rate) to >50% from the usual 10% - 20% with PD-1 / PD-L1 ICIs alone. While the AIPAC Phase IIb in metastatic breast cancer ("mBC") fell short of significance in overall progr

Efti breast trial: Down certainly not out

Given high expectations and market backdrop, disappointing AIPAC Phase IIb metastatic breast cancer data has hit the stock hard. While the lack of a statistically significant improvement in overall progression free survival ("PFS") compared to chemotherapy alone is a substantial set back, the stock decline would suggest that Eftilagimod alpha ("efti") is dead; not so in our view. Although the current data will not support the hoped for regulatory approval in mBC, patient subgroup responses and o

Efti-pembro combo: A new option in NSCLC?

Immutep released more encouraging data from the TACTI-002 trial testing lead asset eftilagimod alpha ("efti") plus Merck & Co.'s anti-PD-1 pembrolizumab (Keytruda) in 1L & 2L non-small cell lung cancer ("NSCLC") and 2L head and neck squamous cell carcinoma ("HNSCC") ahead of a presentation today at 34th German Cancer Congress. The data demonstrates tumour responses at all levels of PDL-1 expression from >50% to <1%. At more than 7 months the trial has also yet to reach median progressionfree sur

Encouraging TACTI-002 data presented at SITC

Immutep presented more mature data from the TACTI-002 trial testing lead asset eftilagimod alpha ("efti") plus Merck & Co.'s anti-PD-1 pembrolizumab (Keytruda) in 1L & 2L non-small cell lung cancer ("NSCLC") and 2L head and neck squamous cell carcinoma ("HNSCC") at the Annual Meeting of the Society for Immunotherapy of Cancer ("SITC"). Key updates include: (1) the overall response rate ("ORR") is consistent with data previously reported in September; (2) 12 patients remain on therapy; (3) median

Updated TP of A$0.80 reflects share consolidation

We are updating our target price ("TP") for Immutep to A$0.80 per share (from A $0.080 per share) to reflect the recent share consolidation of 10:1. The new number of outstanding shares is 387,712,231 (vs. 3,877,122,311 previously).

Warpaint London+ (W7L, House Stock at 375p) - Trading ahead of expectations - +10% upgrade implied

The Hardman & Co Monthly: April 2024

Feature article: Steady as she goes, but could be better: A review of investment company liquidity since 2016 Liquidity is the lifeblood of equity markets. The measurement of liquid asset availability to a market or company is a way of gauging a market’s health. This article builds on our previous work, which analysed the liquidity data for non-financial trading companies, by applying the same analytical techniques to the investment companies (IC) space. We analyse liquidity for ICs as a whol

Avon Protection - Unmasking its growth potential

Avon Protection’s capital markets day highlighted its continued focus on medium-term margin expansion (targeting operating margin of 14–16%), concentrating on its core business of respirators and head protection. The unwinding of the armour business, alongside the consolidation of Team Wendy (acquired in H220) should enable Avon to benefit from rising global defence spending. Its strong relationship with the US DoD, and organic growth opportunities with recurring revenue from necessary product r

Hybridan Small Cap Feast - 15 April 24

15th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: Change of Market: TheWorks (WRKS.L) a multi-channel value retailers of books, arts and crafts, stationery, toys and games, offering customers a differentiated propositio

Morning Note – 9 April 2024

Morning Note – 8 April 2024

Hybridan Small Cap Feast - 17 April 24

17th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi

Hardman & Co Research: Tissue Regenix (TRX) - Six consecutive periods of >20% growth

TRX is focused on the development and commercialisation of two proprietary processing technologies for the repair of soft tissue (dCELL®) and bone (BioRinse®). It has a broad portfolio of products used in biosurgery, orthopaedics and dental markets. Investment in tissue processing, manufacturing capacity and strong commercial partners, together with its “4S” strategy, has generated six consecutive reporting periods of strong growth, with TRX turning EBITDA-positive in 2023. Further growth in 202

Cambridge Nutritional Sciences - H1 2024 interims: Executing a newly focussed st

Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We

Venture Life Group - Strong organic growth; focus on EBITDA

Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli

Morning Note – 22 March 2024

Hardman & Co Healthcare Index: 2023 – Capital demands dent performance

The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (

Diaceutics | FY23 update – 22% revenue growth, £16.7m YE cash

Diaceutics has released a trading statement for the year to December 2023 guiding to revenue growth of 22% YoY to £23.7m, up 19% on a constant currency basis. The order book jumped 57% to £26.6m, of which c£12.3m is expected to be realised in FY24, and which currently stands at £30.8m. The proportion of recurring revenue continues to increase and is now over 50% (FY22 35%). Cash at YE23 stood at £16.7m, indicating a near halving of the rate of cash burn in 2H23 compared to 1H23. We adjust our FY

Zoetis Inc.: Launch Of CircoMatch & Other Drivers, Financial Forecasts, DCF & Comparables Valuation, ESG & Other Risks (02/23)

Zoetis delivered a decent set of results for the last quarter of 2022 meeting analyst expectations as well as the high end of its management guidance. Despite the economic challenges, ongoing pandemic recovery, and the political unpredictability brought on by the war in Ukraine, they delivered operational growth for the year in each of their top 13 markets. The company's unique companion animal portfolio drove its 8% operational revenue increase for the year, growing 14% operationally. In compar

Morning Note – 12 February 2024