BerGenBio - No surprises as bemcentinib strategy progresses

BerGenBio’s (BGBIO’s) Q122 results are generally in line with recent trends, with a Q122 operating loss of NOK78.6m (-6% y-o-y). The reduction was largely due to lower clinical trial expenses as the company is now preparing for its next studies on lead candidate bemcentinib. Operating cash outflows increased year-on-year to NOK74.2m (vs NOK70.8m in Q121) primarily due to working capital movements, resulting in the company finishing the quarter with NOK367m in net cash, which, at current burn rat

BerGenBio - Focusing in on 1L NSCLC and COVID-19

BerGenBio (BGBIO) has announced an updated business strategy for its lead drug candidate, oral AXL inhibitor bemcentinib, which will focus on first-line (1L) non-squamous non-small cell lung cancers (NSCLCs) carrying the STK11 mutation and on hospitalised COVID-19 patients. The decision to move bemcentinib to the 1L setting could significantly broaden its target population among NSCLCs, given that c 20% of such cancers carry the STK11 mutation (~30,000 patients). Following encouraging data from

BerGenBio - Checking its course

With a new CEO at the helm, BGBIO has completed an internal review and outlined its strategic priorities for bemcentinib. Building on impressive Phase II BGBC003 data presented at both EHA and ASH in 2021, a randomised, placebo-controlled trial for second-line AML is due to start H222. We assume the trial will be registrational, but note this is subject to outcomes from its discussions with regulators. In NSCLC, data from the ongoing Phase II BGBC008 trial are expected during H122 and should p

BerGenBio - Martin Olin succeeds Richard Godfrey as CEO

BerGenBio (BGBIO) has announced the appointment of a new chief executive officer (CEO), Martin Olin, with effect from 8 September 2021. Martin Olin has more than two decades of executive experience in the pharmaceutical and biotechnology industry and previously served as CEO of Symphogen, a clinical-stage biotech developing monoclonal antibody based treatments for a variety of cancers, prior to its acquisition by Servier in 2020. While the timing of this announcement does come as a surprise, we

BerGenBio - Advancing towards pivotal studies

BerGenBio (BGBIO) has made continued progress in H121 in advancing the development of lead asset bemcentinib (an oral, once-a-day, highly selective AXL inhibitor). A deluge of data presentations from Phase II studies in COVID-19, AML and NSCLC continue to highlight the broad potential of this first-in-class treatment. Discussions with regulators are ongoing regarding a pivotal study in relapsed AML in combination with LDAC, which could enable potential approval and launch in 2024. COVID-19 prese

BerGenBio - FDA grants fast track designation

BerGenBio (BGBIO), a pioneer in AXL biology and the development of AXL inhibitors, has two clinical-stage assets: selective tyrosine kinase inhibitor bemcentinib and functional blocking monoclonal antibody tilvestamab. FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment. BGBIO has also presented data from the ong

BerGenBio - Bemcentinib preliminary data in COVID-19

BerGenBio (BGBIO) has announced preliminary data for lead asset bemcentinib, an oral once daily highly selective AXL inhibitor for the treatment of severe COVID-19 infections requiring hospitalisation. In the Phase II ACCORD-2 and BGBC020 trials, treatment with bemcentinib led to numerically fewer deaths versus standard of care up to day 29. Preliminary analysis of the primary endpoint, time to clinical improvement of at least two points on the WHO nine-point ordinal scale, or live discharge fro

BerGenBio - AXLeration of data catalysts in 2021

BerGenBio (BGBIO) has made steady progress during 2020. Lead asset bemcentinib (oral, once a day, highly selective AXL inhibitor) reported encouraging efficacy data from ongoing Phase II trials. Multiple catalysts expected in 2021 will define BGBIO’s clinical trial strategy in AML/MDS and/or NSCLC. The FY20 operating loss was significantly higher than in FY19 (NOK261.1m vs NOK204.4m) due to higher set-up costs and increased investment in programme expenses. We expect operating expenses to increa

BerGenBio - Progressing towards key inflection points

BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020. Following these data, we anticipate a registrational Phase III study of bemcentinib plus low-dose cytarabine (LDAC) in relapsed elderly AML patients to start in 2021. We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted). Bemcentinib is an oral, first-in-class, highly selective AXL tyrosine kina

Promising results in relapsed AML presented at ASH conference

Updated clinical data in MDS and AML studies presented this weekend Reported overall response rate of 45% (5/11) in relapsed AML Reported overall response rate of 36% (8/22) in HR-MDS The data continue to support the benefit of bemcentinib in MDS and AML

BerGenBio - Bemcentinib leading the AXL charge

BerGenBio (BGBIO) is a pioneer in AXL biology and the development of AXL inhibitors: selective tyrosine kinase inhibitor (TKI) bemcentinib and functional blocking monoclonal antibody tilvestamab. AXL expression is a negative prognostic marker in most cancers. Its upregulation drives aggressive disease including drug resistant, immune-evasive and metastatic cancers, as well as fibrosis and viral infection. AXL signalling is the essential mediator of EMT and immune suppression. Selective AXL inhib

Summary from SITC presentation

BerGenBio presented results from its ongoing study in NSCLC The presented data was in checkpoint refractory patients No new response data was presented Next data trigger is the ASH conference, December 6th, for the AML study

R&D Day Highlights with path to market

Clinical and pre-clinical data First route to market presented in AML 2L relapsed AML chosen as ideal path to registration Potential pivotal study to start in 2021

Updated results in AML study

Abstract released by ASH today, earlier than expected Updated results from study combining bemcentinib with LDAC in AML Initial results show promise in newly diagnosed and relapsed patients Full dataset will be presented December 6th at the ASH conference

Strong growth in core underpins FY expectations

EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just

Hybridan Small Cap Feast 09/08/22

Dish of the day Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports

Morning Note – 3 August 2022

Hybridan Small Cap Feast 16/08/22

Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports to over 40 count

Hybridan Small Cap Feast 05/08/22

Dish of the day Joiners: Inteliqo Limited has joined the Access Segment of AQSE Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners. Leavers: Menzies (John) plc and Sanne Group have left the Premium Segment of the Main Market. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a sup

WHI First Light: Spectra Systems, ARC Minerals, KEFI Gold & Copper, Dekel Agri-vision, NetScientific & LifeSafe Holdings

Spectra, a leader in machine-readable high speed banknote authentication, brand protection technologies and gaming security software, has announced its first commercial sale of a Banknote Disinfection System (BDS) to an Asian central bank. The BDS system, utilising Spectra's patented technology, contributes to the safety of central bank staff who handle banknotes incoming from circulation, which may carry bacterial and viral pathogens. The system is a plug and play technology as it does not req

The Hardman & Co Monthly: August 2022

Feature article: Utility regulation – Changes afoot - Patching up a tainted model While the gas supply crisis – and its price implications – have dominated the UK price regulated sectors in recent months, other issues have arisen that have seriously tainted the price regulation system itself. Indeed, it is fair to ask whether it is ‘’fit for purpose’’. Back in 1984, price regulation, via an unsophisticated RPI-x formula, was introduced to prevent the privatised British Telecom (BT) from abusin

Hybridan Small Cap Feast 16/06/2022

*A corporate client of Hybridan LLP Dish of the day Joiners: No Joiners Today. Leavers: No Leavers Today. What’s cooking in the IPO kitchen? LifeSafe Holdings, a fire safety technology business with innovative fire safety products, intends to join AIM. LifeSafe has developed what the Directors believe to be market disrupting, eco-friendly fire safety protection products to both protect (via fire extinguishers) and detect (via carbon monoxide, smoke and heat alarms) fires. At the cent

WH Ireland: NetScientific (NSCI) - Portfolio company PDS Biotechnology provides a business update and Q2 2022 financial results

NetScientific is an active transatlantic life sciences, sustainability and technology investment and commercialisation group. Portfolio company, NASDAQ-listed PDS Biotechnology (PDSB), in which NSCI holds a 4.72% equity stake, announced on 8 August 2022, a business update along with Q2 2022 results to the end of June 2022.

Growth on an accelerating path

Smith & Nephew’s growth acceleration and margin expansion in Q2 should continue in H215, more reflecting internal changes than improvements in market fundamentals. Its c 13% premium on 2015 P/E to its global ortho peers is supported by its brisker growth and strategic value.

LIBERUM: Medica Group PLC* - Strong update with all divisions growing

Hybridan Small Cap Feast 11/07/22

iners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen? Georgina Energy, an early-stage resource company with a strategy of actively pursuing the exploration, commercial development and monetisation of helium, hydrogen and hydrocarbon interests located in the Amadeus and Officer Basins in Northern and Western Australia intends to join AIM. Georgina Energy has two principal onshore interests. The first, the Mount Winter Prospect is located in the Amadeus Basin in No

Hybridan Small Cap Feast 12-07-2022

*A corporate client of Hybridan LLP Dish of the day Joiners: Warehouse REIT (WHR.L) has transferred to AIM from the Main Market. Leavers: No leavers today. What’s cooking in the IPO kitchen? Georgina Energy, an early-stage resource company with a strategy of actively pursuing the exploration, commercial development and monetisation of helium, hydrogen and hydrocarbon interests located in the Amadeus and Officer Basins in Northern and Western Australia intends to join AIM. Georgina

Wegovy’s supply + brewing competition concerns overshadow a decent Q2

In Q2, Novo continued its strong run, driven by strong growth momentum seen in both Obesity and GLP-1 Diabetes franchise. However, emerging and potential competition from Eli Lilly’s Mounjaro in Diabetes and Obesity, respectively, and Wegovy’s run of supply scars made investors jittery. Moreover, the group’s ever-expensive valuations and lack of sizable progress beyond diabetes are some of the other key reasons for a cautious stance on the Danish pharma giant.

Pfizer Inc.: The Biohaven Acquisition, Financial Forecasts, DCF & Comparables Valuation, ESG & Other Risks (05/22)

Pfizer had a phenomenal 2021 given the upside of the Covid-19 vaccine and medication. An estimated 1.4 billion patients have been reached by the company with its vaccines and medicines. Pfizer’s position has been upgraded from fourth to second over big bio-pharmacy companies. In R&D, its investments have been increased, and it has started 13 pivotal clinical studies. The company is increasing its investments in Covid-19 medication, Paxlovid and widening its distribution. The strength of the comp