On August 28, 2019 Arix Bioscience plc (LSE: ARIX) ("Arix") a global venture capital company focused on investing in and building breakthrough biotech companies, reported its interim results for the period ended 30 June 2019 (Press release, Arix Bioscience, AUG 28, 2019, View Source [SID1234539093]).
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Operational highlights
£11.4 million commitment to Imara, a new portfolio company focused on sickle cell disease and other hemoglobinopathies, with a novel drug candidate in human trial
$283 million of proceeds raised by Arix portfolio companies in the first half of 2019
Harpoon (T cell engagers) raised net proceeds of $70.7 million in a Nasdaq IPO, in which Arix invested $6.0 million (£4.7 million)
Autolus (CAR-T cell immunotherapy) completed a $108.8 million follow-on financing in which Arix invested a further $5.0 million (£3.8 million)
Aura Biosciences (Choroidal Melanoma) completed a $40.0 million Series D financing, in which Arix committed a further $4.5 million (£3.4 million)
Imara (Haematology) completed a $63.0 million Series B financing, in which Arix committed $15.0 million (£11.4 million)
Continued clinical progress in the portfolio, with 28 clinical trials live as at 30 June 2019
Atox Bio completed enrolment of its Phase 3 ACCUTE study for necrotising soft tissue infections (NSTI). The company has also moved the Phase 2 sepsis associated acute kidney injury (AKI) study into a Phase 3 clinical trial, following feedback from the FDA
Aura Biosciences presented further positive safety and efficacy data from the ongoing AU-011 Phase 1b/2 study for choroidal melanoma
Autolus reported encouraging initial data from its AUTO1 programme in paediatric acute lymphoblastic leukaemia (pALL) and adult acute lymphoblastic leukaemia (aALL), as well as early results from its AUTO3 programme in diffuse large B-cell lymphoma (DLBCL). In August, post period end, Autolus announced the prioritisation of AUTO1 and goal of taking this into registration trials for aALL by year end
Harpoon initiated the HPN536 Phase 1/2a clinical trial for the treatment of ovarian cancer and other mesothelin-expressing solid tumours
Imara reported encouraging initial Phase 2 data from its IMR-687 clinical study for patients with sickle cell disease
Pharmaxis initiated a Phase 1 clinical trial of an anti-fibrotic Lysyl Oxidase (LOX) inhibitor focused on treating myelofibrosis and/or pancreatic cancer
VelosBio initiated the VLS-101 Phase 1 clinical study for the treatment of haematological cancers
Verona initiated a Phase 2b study with nebulized ensifentrine as add-on to long-acting bronchodilator and a first Phase 2 study with metered-dose inhaler formulation. In August 2019, post-period end, Verona reported positive Phase 2 data with dry powder inhaler formulation
Financial highlights
Net Asset Value of £231.8 million (December 2018: £270.2 million), 171 pence per share (FY 2018: 200 pence per share). Equates to 14.5% decline in NAV per share for the first six months of 2019 versus a 32% increase for in 2018
Net downward gross portfolio revaluation of £34.0 million1 over the period, predominantly due to a 51% decline in Autolus’ share price, despite the company’s strong fundamentals
Gross Portfolio Value of £167.8 million (December 2018: £175.5 million)
£26.3 million of capital deployed into the gross portfolio during the period (HY 2018: £12.6 million)
Half year loss before tax: £44.8 million (HY 2018: £29.3 million profit before tax)
Key anticipated milestones
The company notes key milestones anticipated by its portfolio companies over the next 18 months:
Artios expects to file an investigational new drug (IND) application for its lead programme Polθ by the end of 2020
Atox Bio expects to announce results from the ACCUTE Phase 3 clinical study in necrotising soft tissue infections in the fourth quarter of 2019
Atox Bio expects to announce results from the REAKT Phase 3 clinical study in acute kidney infections in the second half of 2020
Aura Biosciences expects to initiate the AU-011 Phase 3 clinical study for choroidal melanoma in the first half of 2020
Autolus expects to initiate a Phase 2 registration trial of AUTO1 in aALL in the fourth quarter of 2019 and present updated Phase 1 data at The American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019
Autolus expects to present interim Phase 1 data for the Alexander study of AUTO3 in DLBCL at ASH (Free ASH Whitepaper) 2019 and initiate a Phase 2 trial in the second quarter of 2020, pending regulatory feedback
Autolus expects to present updated Phase 1 results for the CARPALL study of AUTO1 in pALL at ASH (Free ASH Whitepaper) 2019
Autolus expects next generation (NG) programmes for AUTO1, AUTO2, AUTO3 and AUTO6 to enter the clinic in 2020
Harpoon expects to present interim results from the HPN424 Phase 1 clinical study in metastatic castration resistant prostate cancer in the first half of 2020
Harpoon expects to present proof of concept data from its HPN536 Phase1/2a clinical trial for ovarian and other mesothelin-expressing solid tumours in 2020
Harpoon expects to initiate the HPN217 Phase 1 trial for the treatment of multiple myeloma and the HPN328 Phase 1 clinical study in small cell lung cancer in 2020
Imara expects to announce updated results from its IMR-687 Phase 2 clinical study in sickle cell disease in the second half of 2019
Imara expects to initiate a Phase 2 trial for thalassemia in the first quarter of 2020
Iterum expects to announce results from the SURE 2 Phase 3 clinical study in complicated urinary tract Infections and the SURE 3 Phase 3 clinical study in complicated intra-abdominal infections in the second half of 2019
Iterum expects to announce results from its SURE 1 Phase 3 clinical study in uncomplicated urinary tract infections in the first half of 2020
LogicBio expects to initiate the LB-001 Phase 1/2 clinical study for the treatment of methylmalonic acidemia in the first half of 2020
Pharmaxis expects to announce Phase 1 results from its Systemic LOX inhibitor for myelofibrosis and/or pancreatic cancer in the second half of 2019
Pharmaxis partner Boehringer for AOC3 inhibitor expected to announce results of Phase 2a trials in NASH in the second half of 2019 and diabetic retinopathy in the first half of 2020
Pharmaxis expects its Mannitol Business (Aridol and Bronchitol) to turn profitable from 2020. If Bronchitol is approved by the FDA for patients in the US, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and mid to high teen percentage royalties on in‐market net sales in the first quarter of 2020
Verona expects to initiate a Phase 3 clinical study for nebulized ensifentrine as maintenance treatment for COPD in 2020
Verona expects to announce Phase 2 results from a pressurized metered-dose inhaler (pMDI) formulation in the second half of 2019, with final data expected in the first quarter of 2020
Joe Anderson, Chief Executive Officer of Arix Bioscience plc, commented:
"Over the period our portfolio has continued to make good progress, with a number of companies reaching important clinical milestones and completing additional financing rounds. The portfolio is well balanced and our companies well capitalised to reach important inflection points.
"In the year ahead, we see key multiple clinical and development milestones scheduled across the portfolio and we look forward to providing regular updates on progress."
Conference Call and Presentation Information
Arix management will host a presentation and conference call today, 28 August, at 12:30 pm BST/ 7:30am EST, to discuss the company’s financial results and operational update.
To listen to the webcast and view the accompanying slide presentation, please go to: View Source