Exosomes become the sole focus going forward

Following the decision not to invest further in hRPC development and seek a partner, there was a steep fall in ReNeuron’s share price. ReNeuron is switching staff and cash into the exciting, but early-stage exosome platform. Investor confidence and full recognition of exosome value will need to be established. ReNeuron has seven exosome research collaborations with more under discussion. It has shown that targeted exosomes can deliver a potent growth factor to the brain in an animal model, a fin

Exosomes float into focus in H1 FY21 results

ReNeuron continues to recruit patients into the extension Phase 2a of its crucial Phase 2a trial of human retinal progenitor cells (hRPC) for retinitis pigmentosa (RP). All nine planned patients should have been treated by the end of 2021 allowing an interim readout by the end of March 2022. This will help ReNeuron to evaluate how to progress the project. The investment case rests largely on a hRPC licensing deal. On the exosome platform, ReNeuron reported the specific delivery of a potent growt

hRPC update in Q122 plus exosome brain research

Recruitment resumed the Phase 2a trial of the lead programme hRPC in retinitis pigmentosa (RP) with the treatment of the first UK-patient in Oxford. The protocol gives greater infection control after the safety issue (a possible infection) in June. Five patients were treated up to mid-October and the remaining four could be treated by December 2021. By late March 2022, ReNeuron expects to give an interim update. The full data set should be available around mid-2022. This will enable regulatory d

ReNeuron Group - Extension trial to produce data in Q122

ReNeuron has announced that the nine-patient Phase IIa (2m cell dose) extension study (halted in June after a presumed eye infection case) has fully restarted with five patients left to treat. Two patients are scheduled for treatment in October. The company expects to report some data by March 2022, which could potentially open the way to a crucial partnering deal. Full efficacy data at six months post-treatment should be available around the middle of 2022. Our valuation remains £190m.

5 Small caps to Buy - August 2021

Historically, small caps stocks have outperformed larger listed companies after economic downturns and this trend is ringing true once again, with smaller stocks offering better returns in the wake of the Covid-19 pandemic. It is currently an exciting time to be invested in smaller companies and for those with a keen eye for detail that can identify companies with financial strength and strong management teams, there is potentially lots of upside available.

ReNeuron Group - Extension trial back on track but with data delay

The key news in the FY21 results statement was the restart of the Phase IIa (2m cell dose) extension study after a June safety halt due to a presumed intraocular eye infection (endophthalmitis). If some trial data is available by Q4 of CY21, this could open the way to a crucial partnering deal from probably mid-2022. The 12-month data from the first (1m dose) Phase IIa cohort showed stable responses with the two best patients seeing a doubling of their visual acuity. Preclinical projects in exos

hRPC study confirmed back on track

Recruitment has resumed in the US into the Phase 2a trial of the lead programme hRPC in retinitis pigmentosa (RP) after an investigation following the presumed bacterial infection that caused its temporary suspension last month. We expect resumption in the UK and Spain by August after regulatory confirmation. The quick resolution of this issue seems to have caused only a modest, one quarter, delay. The three-month data on the higher dose (2m cell) extension arm is due in Q4 2021 and will be impo

ReNeuron Group - Short delay to hRP trial, data now likely in Q421

There has been a safety halt to the lead human retinal progenitor cell (hRPC) project. The issue was an eye infection in one patient following a successful surgical implantation of the hRPC. The cause is under investigation. If, as we assume, the trial restarts in the next few months, data should be available by Q421, a delay of perhaps three months. This is not significant within the overall developmental pathway and good data are needed to secure any future partnership from mid-2022. The valua

Investment summary - Advancing the regenerative potential of stem cells

ReNeuron (RENE) is clinical stage developer of stem cell therapies and technologies which offer promising regenerative potential in previously untreatable diseases. RENE’s lead human retinal progenitor cell (hRPC) programme is in Phase IIa studies in US and UK for the debilitating congenital group of blindness causing diseases, Retinitis Pigmentosa (RP). RENE has developed promising data to show that hRPC provides a robust and consistent benefit in the key clinical measure of Visual Acuity, and

ReNeuron Group - Continuing to gain clinical data in eye disease

After an eventful 2020, ReNeuron released updated 12-month Phase ll data in January on its lead human retinal progenitor cell (hRPC) project. This continues to show a consistent and robust, sustained average gain in visual acuity in retinitis pigmentosa (RP). A continuation study in nine patients using two million cells is underway with three- and six-month data due over H2 CY21 and the first three patients treated. This will facilitate partnering negotiations. A pivotal hRPC study may start in

Funded beyond key clinical milestones

ReNeuron’s Dec’20 £17.5m raise now means the Group is sufficiently funded through key upcoming milestones for its lead hRPC candidate and the exosome platform – mitigating a previous pivotal issue. 2021 could promise to be the critical year for the Group, with the potential to unlock value from its programmes well beyond its current modest market value. We refresh our forecasts post yesterday’s analyst briefing, and reiterate our positive stance.

ReNeuron Group - Funding to complete Phase IIa and other projects

ReNeuron is focused on human retinal progenitor cell therapy (hRPC) for retinitis pigmentosa (RP). Ongoing Phase IIa data show a stable average gain in visual acuity. A nine-patient continuation Phase IIa study is underway at a higher dose. A placing of £15m and an open offer of up to £2.5m at 70p/share, totalling up to £17.5m before costs, are planned to give at least 18 months cash to complete the Phase IIa, potentially initiate a pivotal study in H2 CY22 and progress preclinical exosome and o

Cenkos: Healthcare Sector - Ward Round

Weekly round-up of AIM-listed healthcare news. Venture Life Group, GENinCode, Kromek, Alliance Pharma, Polarean Imaging, Benchmark Holdings, Ondine Biomedical, Verici Dx, Faron Pharmaceuticals, Avacta Group, Abingdon Health, Open Orphan, Belluscura, Hutchmed (China), Oxford Biodynamics

LIBERUM: Futura Medical* - Strategy on track, FM71 data in Sept

Shield Therapeutics - FY results: focus on funding and growing the US

Full-year results were in line with the preliminary guidance issued in early 2022. Feraccru revenues in Europe increased with a 60% increase in volumes and the US commercialisation of Accrufer continues, with broader insurance coverage (100m lives covered). As with many small cap companies, access to growth capital is currently difficult; however, the group has raised a $10m loan from a major shareholder providing a cash runway till end-2022. Our assumption is that further funding comes from deb

SHORE CAPITAL - Warpaint London+ (W7L) - House Stock at 113p

Record H1 as distribution widens and offer resonates

Trading continues to track ahead of expectations, which have been upgraded twice so far YTD. There is clear evidence the growth strategy is bearing fruit. Distribution gains are increasing brand reach both in the UK and overseas. This appears to be an ideal time for its on-trend value-for-money proposition to gain traction, potentially with counter-cyclical characteristics as consumers start trading down. After the recent pull-back, valuation is undemanding for a 3-yr EPS CAGR of 13% with risk p

Cenkos: OptiBiotix Health Plc -- Final results

OptiBiotix has reported final results for the year to December 2021, with revenues growing 45% to £2.2m and the EBITDA loss increasing to £1.0m, reflecting the increased investment in the business. Post-period end, OptiBiotix has continued to return value to shareholders through the successful spin-out and listing of its ProBiotix Health division. Future growth of the company is supported by commercial agreements with large partners and a substantial pipeline of opportunities through its 2nd gen

Morning Note – 30 June 2022

Next Gen XPLOR and D2C

Belluscura has announced the launch of the next generation X-PLOR portable oxygen concentrator and expanded distribution through a D2C offering and partnership distribution plan for smaller DMEs.

Hybridan Small Cap Feast 30/06/2022

Dish of the day Joiners: Visum Technologies has joined the AQSE Growth Market. The Company's business is to own and operate an "on-ride" video and photographic camera system that it sells and/or licenses to customers (being theme parks, ride manufacturers, souvenir imaging providers, and other leisure operators). Leavers: No Leavers Today. What’s cooking in the IPO kitchen? Immediate acquisitions (IME.L) is to re-join AIM via a Reverse Takeover of Fiinu Holdings Limited. Once complete the Compan

SHORE CAPITAL - Oxford BioDynamics+ (OBD) - House Stock at 16p

Hybridan Small Cap Feast 20/06/2022

Joiners: No Joiners Today. Leavers: Tungsten Corp and Sensyne Health have both left AIM. Hibernia REIT has left the Main Market. What’s cooking in the IPO kitchen? Visum Technologies seeking admission to The AQSE Growth Market. The Company's business is to own and operate an "on-ride" video and photographic camera system that it sells and/or licenses to customers (being theme parks, ride manufacturers, souvenir imaging providers, and other leisure operators). Due 30 June. LifeSafe Holdings, a fi

CMA conclusion; small bolt-on; and in line trading

An update from CVS this morning covering conclusion of the CMA process, a further acquisition and update on trading. The CMA investigation into the acquisition of Quality Pet Care (QPC) is now complete, thereby bringing to an end a 9 month process. As part of the undertaking, CVS yesterday completed the sale of QPC for cash proceeds of c.£9m, implying a c.£12m impairment. Whilst the CMA episode has clearly been a setback, it does not seem to have fundamentally impaired ongoing M&A ambitions give

Positive AGM statement

The strong momentum from Q4-21 has continued into H1-22, with revenues expected to be up by more than 22% YoY. The outlook remains positive supported by strong industry demand and market share gains in the UK, where the group’s sustainability and affordability credentials are increasingly resonating. Whilst some macro pressures remain, these look to be manageable. We therefore make no change to our forecasts at this stage, but are highly encouraged by current trends and remain optimistic for the

LIBERUM: SourceBio International* - Scaling growth and trading well

Continued growth and margin improvement prompt further upgrades

A positive AGM update confirms strong revenue growth has continued YTD and further margin improvement means management again expect EBITDA to be materially ahead of expectations. The business model is now settled, with additional distributors appointed in the US which should help drive further penetration into the Primary Care market there. China revenues were strong and with no sign yet of any slowdown, despite being cognisant of renewed lockdowns there. Gross margins have remained robust on po