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Elbit Medical Technologies

Portfolio progress continues

Update | Pharmaceutical & healthcare | 06 Sep 2018

Elbit Medical Technologies’ portfolio of investments continues to demonstrate progress on multiple fronts. InSightec is gaining ground on the reimbursement front, with Medicare providing coverage for beneficiaries in a total of 16 US states for the use of magnetic resonance imaging and high-intensity focused ultrasound (MRgFUS) for essential tremor (ET) treatment. Moreover, Gamida Cell recently announced that the FDA has granted NiCord orphan drug designation for the treatment of haematopoietic stem cell transplantation (HSCT) and it is currently enrolling patients in its Phase III trial to treat high-risk haematological malignancies.

Clal Biotechnology Industries

Progress on multiple fronts

Update | Pharmaceutical & healthcare | 23 Aug 2018

Clal Biotechnology Industries’ (CBI’s) portfolio of investments continues to make headway. MediWound is in advanced discussions with multiple third parties interested for a strategic transaction. With $23m in proceeds from its recent financing, Anchiano Therapeutics (previously BioCanCell) plans to initiate the first of two trials for its lead development programme in H218. Lastly, Gamida Cell recently reported preliminary safety and efficacy data from its donor-derived natural killer (NK) cell expanded ex vivo with nicotinamide (NAM) Phase I study in patients with lymphoma and multiple myeloma.

International Stem Cell

Biomedical sales more than double

Update | Pharmaceutical & healthcare | 20 Aug 2018

International Stem Cell (ISCO) reported Q218 revenues of $3.0m, up 72.4% compared to Q217 mainly due to the biomedical business, which had quarterly revenues of $2.7m, up 103.1% compared to the same quarter last year. The operating profit of the biomedical business also increased substantially, up 139.6% to $1.1m. With regard to the Phase I trial of ISC-hpNSC in Parkinson’s disease (PD), the company has successfully dosed the first patient of the third cohort and expects to release interim six-month results from the second cohort in Q318.

4SC

Domatinostat R&D ramp-up in H218

Update | Pharmaceutical & healthcare | 17 Aug 2018

During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).

Imugene

Checkpoint inhibitor vaccine programme accelerated

Outlook | Pharmaceutical & healthcare | 16 Aug 2018

Imugene has in-licenced a pipeline of B-cell vaccines that complements and advances its in-house programme. The deal has brought forward significant value-creation opportunities while maintaining Imugene's focus on B-cell vaccine technologies. It accelerates the key PD-1 and PD-1/HER2 combo programmes by two years compared to its original pipeline. The company is well funded to accelerate key clinical studies for the newly combined pipeline. Our valuation is A$147m or 4.1 cents per share.

Celyad

Allogeneic trial approved in colorectal cancer

Update | Pharmaceutical & healthcare | 02 Aug 2018

The FDA’s sign off on Celyad’s first clinical trial design for its allogeneic NRK CAR T-cell therapy (CYAD-101) is an important milestone. The study, possibly staring in Q4 2018, mirrors the current colorectal SHRINK trial a combination of autologous CYAD-01 therapy with FOLFOX chemotherapy. This gives Celyad the lead in a mass-market solid cancer where allogeneic therapy is likely to be essential. The indicative value has been increased to EUR 1,090m (EUR 89 per share) from EUR 1,040m (EUR 84 per share) pending further data.

ReNeuron Group

Exosomes rise further

Flash note | Pharmaceutical & healthcare | 20 Jul 2018

ReNeuron’s capital markets day highlighted the potential for the company’s exosome nanomedicine platform to be a source of both product and licensing revenues. This morning’s announcement of a collaboration between PureTech Health and Roche on PureTech’s milk-derived exosome platform highlights the attractiveness of ReNeuron’s neuronal stem cell-derived exosome platform.

Oryzon Genomics

Awaiting for eventful 2019

Outlook | Pharmaceutical & healthcare | 18 Jul 2018

The next year is shaping up to be transformative for Oryzon with two data readouts from Phase IIa trials with ORY-2001 in Alzheimer’s disease (AD) and multiple sclerosis (MS). In addition, an innovative design basket trial with ORY-2001 in several neuropsychiatric disorders may also deliver first results next year. Oryzon is resuming the development of ORY-1001 in acute myeloid leukaemia (AML) and small-cell lung cancer (SCLC). While Roche’s departure was a setback in 2017, the stars started to align again after the Biogen Abeta antibody data provided a much-needed boost for AD research industry and indirectly for Oryzon’s ORY-2001. Furthermore, a fundamental study published in Cell described the potential of LSD1 inhibition in immunooncology setting adding a new dimension to ORY-1001’s potential. We value Oryzon at EUR 328m or EUR 9.6/share (vs EUR 9.4/share).

Elbit Medical Technologies

Two promising private assets

Initiation | Pharmaceutical & healthcare | 28 Jun 2018

Elbit Medical Technologies is an Israel-based healthcare investment company traded on the TASE. It is invested in two private companies: InSightec is a commercial-stage medical device company marketing a non-invasive thermal tissue ablation therapy in three indications and Gamida Cell is a cell and immune therapy company developing a universal bone marrow transplant (BMT) product for haematological malignancies. Although their recent offerings of NIS182m of convertible notes lengthen the cash runway it raises the prospect of dilution in 2022. In addition, the parent company Elbit Imaging (~89% owned) has its own challenges. We value Elbit Medical at NIS407m or NIS1.76 per share.

Celyad

Developing a sophisticated clinical strategy

Update | Pharmaceutical & healthcare | 21 Jun 2018

Celyad has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at EUR 1,040m, EUR 84 per share.

TxCell

Lonza to make CAR Tregs

Update | Pharmaceutical & healthcare | 12 Jun 2018

TxCell has announced that Lonza, the biopharmaceutical and cell manufacturing global specialist, will produce its CAR Tregs. TxCell uses a robust manufacturing design to give low inter-patient variability with potentially consistent therapeutic results. The time needed to transfer and validate the process in Lonza will push the IND filing to H119, formerly by Q418 but with security of supply. TxCell has drawn EUR 5.4m of convertible loans ytd and is seeking longer-term funding or a partnering deal. The indicative valuation remains at EUR 87.9m.

Solid State

Battery packs to power warehouse robots

QuickView | General Industrials | 12 Jun 2018

Solid State has announced that it has received contracts with a major UK smart warehouse solutions provider and robotics manufacturer to supply ruggedised power units for autonomous robots operating in cold storage warehouses. The contracts have a combined value of £4.3m. Deliveries will commence in H219 and continue into FY20, with potential for additional recurring revenues from the supply of replacement cells, which are consumable items, in later years. The contracts are supportive of consensus estimates, which are unchanged.