Arena Pharmaceuticals to Participate in Upcoming Investor Conferences

On August 28, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that members of its senior management team will participate in the upcoming investor conferences (Press release, Arena Pharmaceuticals, AUG 28, 2019, View Source [SID1234539098]):

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Wells Fargo Global Healthcare Conference – Presenting on Wednesday, September 4, at 8:30 AM EDT in Boston
Citi Biotech Conference – Hosting investor meetings on Thursday, September 5, in Boston
A live audio webcast of the Wells Fargo presentation will be available under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the events.

BioMarin to Participate in Morgan Stanley 17th Annual Global Healthcare Conference on September 10, 2019 in New York

On August 28, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Dan Spiegelman, Executive Vice President and Chief Financial Officer, will present at the Morgan Stanley 17th Annual Global Healthcare Conference on September 10, 2019 at 8:35am ET in New York (Press release, BioMarin, AUG 28, 2019, View Source [SID1234539097]). To access the live webcast, please visit the investor section of the BioMarin website, www.biomarin.com. A replay will also be archived on the site for at least one week following each event.

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BiondVax Welcomes New Chairman of the Board and Announces Second Quarter 2019 Financial Results

On August 28, 2019 BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reported the appointment of a new Chairman of the Board of Directors and financial results for the quarter ended June 30, 2019 (Press release, BiondVax Pharmaceuticals, AUG 28, 2019, View Source [SID1234539096]).

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Mr. Mark Germain, who has served as BiondVax’s Vice Chairman of the Board of Directors since June 2018, has been appointed Chairman, effective September 30, 2019. Based in New York, and having served as founder, director, chairman of the board, and/or investor in over twenty biotech companies, and with experience assisting in arranging corporate partnerships, acquiring technology, entering mergers and acquisitions, and executing financings, Mr. Germain is well suited to help guide BiondVax’s ongoing corporate development. Among his current positions, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and serves as a director on the board of the Israeli company Pluristem Therapeutics Inc. (NASDAQ: PSTI). Professor Avner Rotman, who has served as BiondVax’s Chairman since 2005, will continue to serve as a Director.

Mr. Mark Germain commented: "It has been a great pleasure to work with Ron and his team this past year, and the rest of the board, and I’m honored to be elected Chairman at this exciting time for the company. Recent events have positioned BiondVax to become a successful manufacturer and marketer of its M-001 universal flu vaccine candidate. In July we closed on a financing of US$20M predominantly supported by our largest shareholder, Marius Nacht, bringing his ownership in the company to approximately 42%. This financing, the 24 million Euros made available by the European Investment Bank, and other resources now provide us with the means to complete our Phase 3 pivotal trial (with a total of approximately 12,000 participants), scale up manufacturing and begin preparation for commercialization."

Dr. Ron Babecoff, BiondVax’s President and CEO, commented, "I have had the pleasure of working closely with Mark Germain since he joined our Board of Directors last year. I am confident that his experience and knowledge of the pharmaceutical ecosystem, in addition to his relevant international connections, will prove beneficial as we progress through our ongoing pivotal clinical efficacy Phase 3 trial, and upscale production capacity in our manufacturing facility."

Continuing, Babecoff noted, "Over Professor Rotman’s term as Chairman, BiondVax has grown from a preclinical company to a Nasdaq-listed company. On a personal note, I wish to thank Avner for his leadership, guidance, and support that helped me and the company navigate through the many challenges we encountered over the years."

Second Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.566 (NIS/$US) as at June 30, 2019.

Second quarter operating expenses were NIS 19.7m ($5.5m) compared with NIS 30.7m for the second quarter of 2018;
Second quarter R&D expenses amounted to NIS 15.2m ($4.3m) compared with NIS 29.2m for the second quarter of 2018;
As of June 30, 2019, BiondVax had cash and cash equivalents of NIS 33.9 million ($9.5 million) as compared to NIS 75.9m as of December 31, 2018. Expenses are related to execution of planned ongoing operations including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility. These figures do not include the $20 million raised in a rights offering that concluded near the beginning of Q3 in July 2019.

Ionis Pharmaceuticals to present at upcoming investor conferences

On August 28, 2019 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, reported that management will present a company overview at the following investor conferences (Press release, Ionis Pharmaceuticals, AUG 28, 2019, View Source [SID1234539094]):

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2019 Wells Fargo Healthcare Conference on Thursday, September 5, 2019 in Boston, MA; and
17th Annual Morgan Stanley Global Healthcare Conference on Tuesday, September 10, 2019 in New York, NY.
The above listed dates are subject to change. Details on presentation times or changes to presentation dates can be found on the Company’s website. Please check www.ionispharma.com for the latest information.

A live webcast of the presentations will be available on the Investors & Media section of the Ionis website. The replays will be available within 48 hours and will be archived for a limited time.

Arix Bioscience plc: Interim Results for the Six Months Ended 30 June 2019

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