On August 29, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming investor conferences (Press release, Kura Oncology, AUG 29, 2019, View Source [SID1234539110]):

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A panel discussion entitled "Focusing the Laser on Precision Oncology" at Citi’s 14th Annual Biotech Conference in Boston at 9:30 a.m. ET / 6:30 a.m. PT on September 5, 2019; and

An analyst-led discussion at H.C. Wainwright 21st Annual Global Investment Conference in New York at 12:50 p.m. ET / 9:50 a.m. PT on September 10, 2019.
A live audio webcast of both discussions will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available immediately following the event.

On August 29, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF) today reports its financial results for the year ended April 30, 2019 (Press release, ImmunoPrecise Antibodies, AUG 29, 2019, View Source [SID1234539109]). The financial statements and related Management’s Discussion and Analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue: ImmunoPrecise achieved record annual revenue of $10,926,268 in fiscal 2019 compared to $5,441,349 in fiscal 2018. This represents a 100% increase in revenue as a result of its completed acquisitions of IPA Europe (formerly ModiQuest Research), and IPA’s ability to grow its core business and expand into higher revenue service offerings in therapeutic discovery.

Gross Margin: ImmunoPrecise increased its gross margin to $5,294,634 from $2,451,026 in 2019. In percentage terms, the Company’s gross margin increased to 48% from 45% in 2018. The higher margin in 2019 was mostly attributable to the Company’s increased focus on larger programs with higher margins at its new B-cell lab, as well as increased efficiencies in operations.

Net Loss: ImmunoPrecise recorded a net loss of $7,617,467 during the year ended April 30, 2019, compared to net loss of $5,171,103 for the year ended April 30, 2018. The net loss increased in 2019, primarily as a result of the acquisitions of U-Protein and IPA Europe, which required higher expenses in all facets of the business in order to manage a global landscape. $1,312,403 of the costs incurred during the year ended April 30, 2019, were one-time costs which are not expected to be incurred again.

Growth Initiatives in Fiscal 2020:

Asset Building: While CRO services remain the mainstay of the Company, ImmunoPrecise has worked continuously on building an intellectual property estate and portfolio of proprietary methods and physical assets through collaborations, joint ventures, acquisitions and in-licensing. The onboarding of existing assets with regard to equipment, technologies, IP and licenses within the Company’s EU operations has been compounded by active research and development at all operational sites this year. This includes the on-going development of new service offerings to be rolled out in the fiscal year 2020, but more notably, internal, discovery programs focused on novel, therapeutic antibodies, primarily in the field of immuno-oncology.

Talem Therapeutics: Recently, the Company formed Talem Therapeutics (Talem), based in Cambridge, Massachusetts, to support its internal, therapeutic, discovery programs. Talem is structured to secure assets during their discovery and development stage and seek out strategic partnerships with clinical-stage pharma and biotech companies, where it will aid in the out-licensing or sale of the therapeutics for clinical trials. The ability for investors to support individual assets or portfolios in Talem generates an asymmetrical opportunity for investments, while avoiding ImmunoPrecise’s shareholders dilution. The depth and speed of IPA’s offerings enables Talem to customize each program and leverages the Company’s expertise and technologies in antibody discovery.

Global Integration and Cost Synergies: ImmunoPrecise integrated IT services, including the global service desk, and decreased cost and risk while removing collaboration barriers, including tools that allow for communicating in different languages. They have also begun to capture synergies after the global integration of sales, marketing, R&D, management, and legal services. IPA has prepared for the integration of fundamental business services such as payroll, financial controls, and an Oracle suite of enterprise software. They will continue to enhance these integrations, as well as create synergies in additional areas such as M&A communications and tax integration.

B cell SelectTM and DeepDisplayTM : IPA Canada and IPA Europe have both been designated as approved CROs for the world’s leading, transgenic animal platform producing human antibodies, and exercised an advantage in optimizing services for various transgenic animal vendors. The Company made strategic investments in R&D activities to develop proprietary technologies enabling the application of their B cell SelectTM and DeepDisplayTM platforms to a broad range of transgenic animal species and strains.

The Market:

CRO Services and Therapeutic Development: In an attempt to streamline, many large pharmaceutical companies are limiting the number of external CRO vendors that can be contracted. This is particularly promising for those CROs that fill multiple niches in the discovery and manufacturing pipeline. The key players serving the monoclonal antibodies market are Pfizer, Inc., GlaxoSmithKline plc, Novartis AG, Merck & Co., Inc, Amgen, Inc., Abbott Laboratories, AstraZeneca, Eli Lilly and Company, Mylan N.V., Daiichi Sankyo Company, Ltd., Bayer AG, Bristol Myers Squibb Co., Johnson & Johnson Services, Inc., Biogen Inc., Thermo Fisher Scientific, Inc., Sanofi Genzyme, F. Hoffmann-La Roche Ltd., and Novo Nordisk A/S2. In 2016 alone, Novartis invested 9 billion USD and Pfizer invested 7.9 billion USD in R&D3. This is of little surprise given the global monoclonal antibody market was valued at USD 85.4 billion in 2015 and is expected to reach a value of USD 138.6 billion by 20241.

1 Healthcare Insights Life Sciences, CRO Sector Fundamentals Remain Hot for M&A Consolidation, July 3, 2019.
2Monoclonal Antibodies (mAbs) Market Size Worth $138.6 Billion By 2024, Nov. 2016
3Monoclonal Antibody Market 2019-2025 Growth, Key Players, Size, Demands and Forecasts, April 2019

"We continue to expand our therapeutic offerings as a global, full-service antibody provider to pharmaceutical and biotech companies internationally, and to accelerate our volume of large-scale, therapeutic programs. Simultaneously, IPA sets itself on a path of Antibody Discovery and IP estate-building through Talem Therapeutics, which will expand our clinical partnerships and continue to build our IP estate" commented Dr. Jennifer Bath, President and CEO of the Company.

On August 29, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease (Press release, Hoffmann-La Roche, AUG 29, 2019, View Source [SID1234539107]). Roche’s VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination.

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"For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great."

This approval is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel and showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p<0.0001) in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells. At the second interim analysis, Tecentriq and nab-paclitaxel showed a clinically meaningful overall survival (OS) improvement of seven months vs placebo and nab-paclitaxel in the PD-L1-positive population (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54 –0.93). OS results in the PD-L1-positive population were not formally tested due to the hierarchical design of the study as statistical significance was not met for OS in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72–1.02, p=0.078).

The assessment of PD-L1 on tumour-infiltrating immune cells is essential for identifying the patients with TNBC benefiting from this Tecentriq combination. PD-L1 expression status in the IMpassion130 study was assessed by the VENTANA PD-L1 (SP142) assay.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The nature and incidence of severe adverse events (SAEs) and Grade 3–4 adverse events (AEs) were consistent with the known safety profiles of the individual study drugs or the underlying disease. SAEs were reported in 23% of people receiving Tecentriq plus nab-paclitaxel compared to 18% of people receiving chemotherapy alone. Grade 3–4 AEs were reported in 49% of people receiving Tecentriq plus nab-paclitaxel compared to 42% of people receiving chemotherapy alone.

Currently, there are seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.

About the IMpassion130 study
The IMpassion130 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS in the ITT population and in the PD-L1-positive population. Performing a test for statistical significance for OS in the PD-L1-positive population is dependent upon OS results from all randomised patients. Secondary endpoints include objective response rate and duration of response.

About triple-negative breast cancer
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2-4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.3

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-postive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On August 29, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the first quarter of fiscal year 2020 on September 5, 2019 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, AUG 29, 2019, View Source [SID1234539106]). Members of Avid’s senior management will discuss financial results for the first quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

On August 29, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company is scheduled to present at the Citi 14th Annual Biotech Conference in Boston on Thursday, September 5, 2019 at 12:00 p.m. ET (Press release, Agios Pharmaceuticals, AUG 29, 2019, View Source [SID1234539105]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.