Medigene - Q319 results highlight successful year to date

Enrolment of patients in Medigene’s MDG1011 Phase I/II trial continues, albeit at a slower rate than initially expected, with initial data from the first three dose cohorts expected in Q420. Following promising interim data earlier in the year, the company forecasts that top-line dendritic cell (DC) vaccine data will be presented in Q120. In expanding the clinical pipeline, Medigene has announced that MDG1021 (HA-1 targeting TCR) will start its clinical programme in H120. Partnerships continue t

Cancer - Strategy for affordable care

The cancer burden is growing globally. Each year >18 million people are diagnosed, nearly 10 million die and the estimated economic cost exceeds $1 trillion. From early diagnosis to late-stage disease, cancer care often involves inappropriate or unnecessary interventions that drive costs but provide limited clinical benefit. Coupled with an increased understanding of cancer biology and rapid technological advances, this has been driving momentum for precision medicine, leading to patient and soc

Medigene - Positive momentum continued in H119

Medigene continued its positive momentum in H119 announcing a new partnership (Roivant/Cytovant), expansion of its internal pipeline (MDG1021), sale of a legacy asset (Veregen) and progression of a partnered product (Bluebird MAGE-A4). Patient enrolment in Medigene’s MDG1011 trial in multiple myeloma (MM), acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) is ongoing and we forecast initial data in H120. The company reiterated its FY19 financial guidance of an EBITDA loss of €23–2

Medigene - New assets, new partnerships

Medigene continues to position itself as a leader in cellular therapies by the expansion of both its internal pipeline (MDG1021) and external partnerships (Roivant/Cytovant). The company has announced MDG1021 (HA-1 targeting TCR) will start its clinical programme in 2020. A new partnership with Roivant/Cytovant (total deal terms >$1bn) demonstrates the ongoing value third parties see in Medigene’s technology and expertise. Medigene’s MDG1011 trial in multiple myeloma (MM), acute myeloid leukaemi

Medigene - Promising dendritic cell data in AML

Medigene has reported top-line interim data from its Phase I/II clinical trial testing its dendritic cell (DC) vaccine in acute myeloid leukaemia (AML) patients (n=20) who were in complete remission. After a 12-month treatment period, overall survival was 89% (n=18/20) and progression-free survival was 60% (n=12/20). These early data are comparable to those of patients treated with allogeneic stem cell transplants. However, relapses are common in AML and long-term data are needed to determine th

Medigene - Successful manufacturing of first TCR therapy

Medigene’s MDG1011 trial in MM, AML and MDS is ongoing and the first MDG1011 TCR cell product has been successfully produced. Additionally, procedures to speed up patient enrolment are being rolled out, including the simplification of enrolment criteria and the addition of new trial centres. We continue to forecast that clinical data from both the Phase I part of the MDG1011 Phase I/II clinical TCR trial and the now fully enrolled Phase I/II dendritic cell (DC) vaccine trial will be available in

Medigene - Financial strength through trial readouts

In H118, Medigene announced several key developments including the start of its MDG1011 Phase I/II TCR clinical trial, a gross capital raise of €32.3m (which expands cash reach past 2019) and the expansion of its bluebird partnership to cover a total of six targets (worth potentially US$1.5bn in milestones plus royalties). The MDG1011 Phase I/II clinical trial is enrolling patients and we forecast that the Phase I part of the TCR trial and the now fully enrolled Phase I/II DC vaccine trial will

Medigene - bluebird bio back for more

Medigene has announced an expansion of its bluebird partnership, giving significant external validation of its T-cell receptor (TCR) technology platform. The full partnership now covers six targets and is worth potentially US$1.5bn in development and commercial milestones, in addition to royalties on any future sales. Medigene’s own internal pipeline continues to advance with its MDG1011 Phase I/II TCR clinical trial now enrolling patients. Additionally, we forecast that the Phase I part of the

Medigene - TCR enters the clinic

Medigene has started its TCR Phase I/II clinical trial, making it one of the few clinical TCR companies globally. Combined with the completed enrolment of the Phase I/II DC vaccine trial, Medigene is positioning itself at the forefront of the next wave of cell and gene therapies. We expect initial data packages from both trials in 2019. We have updated our MDG1011 assumptions, rolled forward our model, adjusted for the sale of the US rights to Veregen, and delayed our assumed DC vaccine out-lice

Medigene - TCR clinical trial initiation imminent

Medigene’s Q3 results are in line with our forecasts. The company has submitted its Phase I/II clinical trial application for its lead TCR cellular immunotherapy product candidate MDG1011 and anticipates initiation of the trial by year end. In addition to the upcoming trial initiation, Medigene has made numerous scientific and technological achievements in 2017, including presentations on its automated TCR identification platform and preclinical data on MDG1011. Partners have presented compassio

Transition to prominent immunotherapy player

Medigene’s H1 results are in line with our expectations and represent the completion of its transformation into a prominent T-cell immunotherapy player. Highlights from H1 include submission of a clinical trial authorisation (CTA) to begin its first clinical T-cell trial and a fund-raising of €20.7m (gross). We maintain our valuation at €315m, but expect upside as it executes on its strategy over the next 12-18 months.

Next step taken toward its first TCR clinical trial

Medigene has announced that it has submitted a clinical trial authorisation application (CTA) to begin its first clinical trial with its proprietary T-cell receptor (TCR) modified T cells. If approved, the trial will evaluate it as an immunotherapy to treat a range of blood cancer indications and will be one of the first in Germany of TCR-modified cells. The trial is expected to start by the end of 2017. This submission triggers a final milestone payment of €2m for the Trianta acquisition (Janua

Funded to execute clinical development strategy

Medigene recently announced a placing of €20.7m gross (issuing 1.96m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This leaves it well funded (pro forma cash €67.7m) to advance both its DC vaccine programmes and TCR programme. We expect 2017 to be a year of important progress for Medigene, in particular the start of its first company-initiated TCR clinical study. We have increased our rNPV-based valuatio

Fund-raising to accelerate clinical programme

Medigene has announced a placing of €20.7m gross (issuing 2m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This was achieved with an accelerated book build process and became effective today. The fund-raising was over-subscribed and included both existing institutional shareholders and new specialised healthcare investors. We place our financial forecasts and valuation under review to assess the full imp

Becoming an increasingly prominent player

Medigene is well funded (FY16 cash €52.6m) to advance both its DC vaccine programmes and TCR programme. We expect a number of important milestones in 2017; specifically, we expect newsflow from its most advanced technology (DC vaccines) in Phase I/II studies for AML (complete enrolment) and the start of its first company-initiated T-cell receptor (TCR) clinical study. We have increased our rNPV-based valuation to €293m (vs €233m), to reflect the increase in the TCR programme probability to 13% (

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

Morning Note – 9 April 2024

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 – 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 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 (

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

Morning Note – 22 March 2024

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

Creo Medical - Solid FY23 lays the groundwork for 2024

Creo Medical has released a trading update for FY23, an active year for the company, with progress made across all business segments. Traction improved in H223, following Speedboat Inject’s European clearance for upper gastrointestinal (GI) procedures and the accelerated approval and launch of Creo’s slimmest electrosurgical device, Speedboat UltraSlim. Top-line growth was supported by continued streamlining of the cost structure, resulting in a better-than-expected underlying EBITDA loss (impro

Warpaint London + (W7L, House Stock at 382p) - Late-year sparkles– another double-digit upgrade to FY23F EPS

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