On August 29, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported that management will participate in a fireside chat at the Morgan Stanley 17th Annual Global Healthcare Conference in New York City on Monday, September 9, 2019 at 1:40 p.m. ET (Press release, Kaleido Biosciences, AUG 29, 2019, View Source [SID1234540068]).

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A live audio webcast will be available through the Investors & Media section of Kaleido’s website at View Source An archived replay will be accessible for 90 days following the event.

On August 28, 2019 iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), reported financial results for the Quarter ended June 30, 2019 (Press release, iCo Therapeutics, AUG 28, 2019, View Source [SID1234551419]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

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Stated Andrew Rae, President and CEO of iCo Therapeutics Inc.,"Q2 efforts were significant in laying a foundation for the corporate milestones we expect in late 2019 and early 2020."

Q2 2019 Financial and Operational Highlights

During the quarter, the Company continued to participate in Immune Pharmaceutical’s bankruptcy proceedings ensuring iCo’s interests with respect to iCo-008 were presented to the Court.

Following feedback from an Australian IRB, requiring iCo to conduct a multi-dose escalation analysis in a number of healthy subjects prior to diseased subjects, iCo is currently working to revise its ethics application. iCo currently expects to commence recruitment of subjects in early Q4 2019 and will provide further details on study design upon ethics approval.

Subsequent to Q2, on August 16, 2019, the Company closed a non-brokered financing issuing 41,200,000 units at $0.05 per unit for aggregate gross proceeds of $2,060,000.

Financial results for Quarter ended June 30, 2019

We incurred a total comprehensive loss of $386,359 for the quarter ended June 30, 2019 compared to a total comprehensive loss of $620,227 for the quarter ended June 30, 2018, representing a decreased loss of $233,868. The decrease in the loss is primarily the result of lower research and development expenses recognized during 2019 offset by higher general and administrative expenses and lower other income.

Research and development expenses were $156,333 for the quarter ended June 30, 2019 compared to $671,359 for the quarter ended June 30, 2018, representing a decrease of $515,025. The decrease related to lower contract research expenses related to the Oral Amp B Phase 1 clinical study. This study was completed in 2018.

For the quarter ended June 30, 2019 general and administrative expenses were $241,512 compared to $200,966 for the quarter ended June 30, 2018, representing an increase of $40,546. The increase reflects increased professional fees during the quarter.

Liquidity and Outstanding Share Capital

As at June 30, 2019, we had cash and cash equivalents of $114,162 compared to $10,140 as at December 31, 2018. As at August 28, 2019, we had an unlimited number of authorized common shares with 150,657,713 common shares issued and outstanding.

On August 28, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2019 (Press release, MEI Pharma, AUG 28, 2019, View Source [SID1234539062]).

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"It was a very productive year, with each of the four clinical-stage programs within our oncology portfolio advancing in development, led by ME-401 and the initiation of our global Phase 2 study which may support an accelerated approval of a marketing application with FDA, the BeiGene clinical collaboration to combine ME-401 with zanubrutinib, BeiGene’s BTK inhibitor, and a regional licensing deal with Kyowa Kirin for the development and commercialization of ME-401 in Japan," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We were also pleased to report the progress made from all our programs as featured at key medical meetings including ICML 2019, ASCO (Free ASCO Whitepaper) 2019 and ASH (Free ASH Whitepaper) 2018."

Dr. Gold continued: "Looking to the year ahead, we are in a great position to continue strengthening our foundation and creating value through data generation across our development pipeline, evaluating drug combination opportunities, unlocking innovations like the intermittent schedule for ME-401, and exploring additional collaboration and licensing opportunities to most effectively leverage the potential of our drug candidates."

Fiscal Year 2019 and Recent Highlights

ME-401 for B-Cell Malignancies

In October 2018, MEI (the Company) entered into a clinical collaboration to evaluate in patients with B-cell malignancies the safety and efficacy of ME-401 in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase ("BTK") inhibitor
In October 2018, MEI entered into a license, development and commercialization agreement granting Kyowa Kirin Company exclusive rights to develop and commercialize ME-401 in Japan. MEI received a $10.0 million upfront payment and is eligible to receive up to $87.5 million in additional development and commercialization milestones, and royalties on sales.
In December 2018, the Company initiated the ongoing Phase 2 clinical trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma which may support an accelerated approval of a marketing application with FDA.
In December 2018, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the Company presented interim results from the ongoing Phase 1b study demonstrating that ME-401 continues to be associated with overall high objective response rates as a single agent and in combination with rituximab. Lower rates of Grade 3 adverse events of special interest were observed in patients on the intermittent dosing schedule.
In June 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the International Conference on Malignant Lymphoma (ICML), the Company presented updated data from the ongoing ME-401 Phase 1b study demonstrating an 80% overall response rate in patients with relapsed or refractory follicular lymphoma and an 83% overall response rate in patients with relapsed or refractory follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma. The intermittent dosing schedule demonstrated comparable overall response rates with a lower rate of delayed Grade 3 adverse events of special interest (≤10%) compared to the continuous dosing schedule.
Voruciclib for B-Cell Malignancies and Acute Myeloid Leukemia ("AML")

In December 2018 at ASH (Free ASH Whitepaper), the Company presented preclinical data demonstrating that voruciclib synergistically induced apoptosis at clinically relevant concentrations when combined with venetoclax (marketed as Venclexta) in human derived AML cells lines and patient samples.
ME-344 for Solid Tumors

In June 2019 at ASCO (Free ASCO Whitepaper), the Company presented the data from an investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with early HER2-negative breast cancer. The data demonstrated proof of biologic anti-tumor activity as measured by a statistically significant reduction in Ki67, a measure of cell proliferation that is highly correlated with tumor response, in patients treated with ME-344 compared to an increase in the group receiving saline.
Pracinostat for Myelodysplastic Syndrome ("MDS")

In December 2018 at ASH (Free ASH Whitepaper), the Company and Helsinn Healthcare presented interim results from the ongoing Phase 2 study evaluating pracinostat in combination with azacitidine for the treatment of patients with IPSS-R high/very high-risk of MDS. The data demonstrate a 9% discontinuation rate due to adverse events, a substantially lower rate than observed in an earlier Phase 2 study, as well as an encouraging 36% complete response rate among patients receiving at least 6 cycles of treatment.
In February 2019, the Company and Helsinn Healthcare published data in the medical journal, Blood Advances, from a Phase 2 study evaluating the safety and efficacy of pracinostat in combination with azacitidine for the treatment of patients suffering from AML who cannot undergo treatment with intensive chemotherapy. The full article can be found here.
Corporate Highlights

In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso continues as the Company’s general counsel and head of corporate development.
In July 2019, Tamar Howson, M.S., MBA a highly experienced business development executive with over 30 years of service in the pharmaceutical and biotechnology industry joined the Board of Directors.
Fiscal Year 2019 Financial Results

As of June 30, 2019, MEI had $79.8 million in cash, cash equivalents, short-term investments, and common stock proceeds receivable, with no outstanding debt.
For the year ended June 30, 2019, cash used in operations was $39.4 million, compared to $21.0 million for 2018
Research and development expenses were $32.3 million for the year ended June 30, 2019, compared to $17.0 million for 2018. The increase was primarily related to increased activities in all clinical programs including development costs associated with ME-401 and voruciclib.
General and administrative expenses were $14.6 million for the year ended June 30, 2019, compared to $9.8 million for 2018. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses incurred during the year ended June 30, 2019.
MEI recognized revenues of $4.9 million for the year ended June 30, 2019, compared to $1.6 million for the year ended June 30, 2018. Revenues resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin license agreements. Revenue increased due to higher levels of research and development activities during the year ended June 30, 2019.
Net loss was $16.8 million, or $0.24 per share, for the fiscal year ended June 30, 2019, compared to net loss of $40.1 million, or $0.97 per share for 2018. The Company had 73,544,576 shares of common stock outstanding as of June 30, 2019, compared with 70,406,283 shares as of June 30, 2018.
The adjusted net loss for the fiscal year ended June 30, 2019, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $44.5 million.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, August 28, 2019, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 48926540. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.

On August 28, 2019 Viva Biotech Holdings ("the "Group" or "Viva Biotech"; stock code: 1873.HK), reported its interim results for the six months ended 30 June 2019 (the "Review Period"). During the Review Period, amid the boom of global patent drug market, Viva Biotech firmly seized the rising opportunities in the industry and realized significant growth leveraging on its world-leading structure-based early stage drug discovery platform (Press release, Viva Biotech, AUG 28, 2019, View Source [SID1234539078]). The Group’s revenue recorded a significant increase of 83.9% to approximately RMB142.3 million compared with the same period last year, and the net profit excluding extraordinary profit or loss increased by 47.4% to approximately RMB98.6 million.

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Upholding the mission of becoming a cradle for promising biotechnology startups around the world, Viva Biotech has developed a scalable business model combining the conventional cash-for service (CFS) model and unique equity-for-service (EFS) model, under which the Group can effectively promote the development of biotech start-ups with promising prospects while maintaining stable cash inflows from CFS customers, and enjoy the rising potential of its intellectual property value.

Solid Growth of CFS Business Provided Sustained and Stable Cash flow

For the CFS business segment, leveraging on its world-leading technology platforms and premium services, sound reputation among peers, and extensively diverse and ever-growing quality customer base, Viva Biotech realized the growth in both the number of customers and customer orders, fueling the revenue from CFS business segment to increase significantly by 72.2% to approximately RMB105 million, contributing a steadily growing cash flow to the Group. As of June 30, 2019, the Company’s orders on hand reached 243 with total contract value amounting to RMB207 million, representing an increase of approximately 59% from the corresponding period last year.

Actively Expand EFS Project Sources for Future Growth

For the EFS business segment, the Group has established a systemic, scientific and modularized incubation platform with strong technical barriers, and participated in the drug discovery process of incubated companies to benefit from their growth. During the Review Period, the Group actively sought for project expansion and subsequent financing channels with greater focus on bio-macromolecule, gene and cell therapy. In the first half of 2019, the Group added 10 startups to its incubation portfolio and contributed additional investment in two incubated companies, building momentum to its future growth. In 1H2019, revenue from the EFS business segment reached approximately RMB36.94 million, representing a year-on-year increase of 127.8%.

Actively Improving Technology Platforms and Incubation Platform Capacity

In terms of technology platforms, the Group is taking the initiative in building new technology platforms such as the Cryo-SEM and HDX MS, and is also committed to further expanding the technology fields such as new drug discovery and biological detection of bio-macromolecules. The Group is expanding the area of its laboratories in the Zhangjiang High-Tech Park, Shanghai, by approximately 5,000 square meters. As of now, the new laboratories are under trial operation. The Group proposes to constantly optimize and improve the scalability and sustainability of its EFS model and enhance the platform capacity of incubation system. It will also strengthen the technology platform linkage of CFS model, participate in and accelerate its research and development progress in real time, and advise the incubated companies on strategy formulation and commercialization channels.

Dr. Mao Chen, Chairman, Chief Executive Officer and Executive Director of Viva Biotech Holdings said: "The constant boom in the global patent drug market and emergence of innovative biotechnology serves as the major drivers of the drug development outsourcing market. The PRC is also setting the stage for R&D of global innovative drug and attracting capital inflows. Leveraging on Viva Biotech’s R&D services of early stage drug development and incubation services of innovative drug startups, we are well-positioned at the early R&D stage of new drugs and are able to have access to the entrance of the flow of quality customers and potential startups. We will grasp the historical opportunity by enhancing operating efficiency, reinforcing talent recruitment and introducing new technologies, thus to proactively establish and constantly improve the sustainability and scalability of our technology platforms and incubation platforms. The Company will also leverage on its superior positioning in the upstream of the industry, constantly strengthen the penetration to the downstream, and establish a win-win ecological circle through the ‘Service + Capital’ multi-dimensional layout alongside the industry chain integration. We will strive to realize sustainable and quality growth to maximize the return for investors."

"Service + Capital" Multi-dimensional Layout Alongside the Industry Chain Integration

Looking forward to the future, Viva Biotech will be committed to a multi-domain, multi-level and light-asset industrial chain layout, and an investment layout of the whole industrial chain with multi-fund and multi-professional platforms. The Group will maintain a high degree of stickiness with customers and incubation portfolio companies, build an open cooperation platform for global biopharmaceuticals innovators, and establish an ecological circle composed of scientists, biotechnology startups, large pharmaceutical enterprises, research institutes, investment institutions, academic institutions, clinical institutions, hospitals and other industry participants.

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.