On September 10, 2019 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that Brian J. Brille, Vice Chairman of the Company, will present at the 17th Annual Morgan Stanley Global Healthcare Conference on Tuesday, September 10, 2019, at 12:55 p.m. Eastern Time (Press release, Caris Life Sciences, SEP 10, 2019, View Source [SID1234539423]). The conference is being held at The Grand Hyatt Hotel in New York City.

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Mr. Brille will provide an overview of the business and discuss recent corporate achievements that position Caris to further extend its leadership in the market, in addition to taking questions from the audience.

Investors attending the conference who would like to schedule a one-on-one meeting with Caris executives may do so by contacting their Morgan Stanley representative.

On September 10, 2019 DelveInsight reported that it has launched Hormone Receptor positive/ Human Epidermal Receptor 2 negative Breast Cancer Market Insights, Epidemiology and Market Forecast- 2028 (Press release, Delve Insight, SEP 10, 2019, View Source [SID1234539424])

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HR+/ HER2- Breast Cancer market report covers a detailed overview and comprehensive insight of the HR+ / HER2- breast cancer Epidemiology and HR+/ HER2- breast cancer market in the 7 MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
HR positive/ HER2 negative breast cancer market report provides insights into the current and emerging HR positive/ HER2 negative breast cancer therapies.
HR positive/ HER2 negative breast cancer market report offers a global historical and forecasted market covering drug outreach in 7 MM.
HR positive/ HER2 negative breast cancer market report provides an edge that will help in developing business strategies, by understanding trends shaping and driving the Human Epidermal Receptor 2 negative Breast Cancer market.
"Among the 7MM countries, the United States had the highest HER2 negative breast cancer market size in 2017 that accounts for approximately 83.96% of the total market."

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At present, the growth of HR positive breast cancer market size is attributed to drugs that have been approved for Hormone Receptor positive breast cancer by the US FDA

Among the EU-5 countries, Germany had the highest HR-positive/HER2-negative breast cancer market size in 2017, which accounts for approximately 25.51% of the total market. Of the therapies prescribed as first-line breast cancer treatment, CDK4/6 inhibitors occupy the largest market share, of which Ibrance contributed the majority of the share, followed by Kisqali and Verzenio. The second position in the first-line treatment options is occupied by SERD class (Faslodex). Among the second and higher lines of therapy, CDK4/6 inhibitors occupy the largest breast cancer market share.

As the HR positive breast cancer mostly affects women. The treatment management of this specific cancer is complex and patient-centric, as treatment and outcomes differ significantly according to biomarker status among other patient characteristics, indicating a trend towards higher personalized medicine based upon patient biomarkers and physiologic characteristics.

Current treatment landscape is well-provided with treatment management. However, there is a lack of treatment and diagnostic guidelines specific to the ER-Positive breast cancer required for the management and diagnosis of ER-positive breast cancer. In recent years, there are many advancements in early detection, prevention, risk stratification, and therapeutic strategies, as well as supportive care for patients with breast cancer, and these have resulted in essential improvements in morbidity and mortality. There is a myriad of companies that are developing drugs for breast cancer treatment.

The expected launch of breast cancer emerging therapies is believed to create a positive impact on the HR positive/ HER2 negative breast cancer market size in the upcoming years.

SHR6390
TESETAXEL
RAD1901
IMMU-132
RG7440
Entinostat
MK-3475
EGL-5385-C-1701
MM-121
GSK525762 (Molibresib)
SAPANISERTIB (TAK-228)
Radium-223 dichloride
and many others
Some of the HR positive/ HER2 negative breast cancer companies are:-

Jiangsu HengRui Medicine Co.
Odonate Therapeutics
Radius Pharmaceuticals
Immunomedics
Roche Group
Syndax Pharmaceuticals
Merck Sharp & Dohme Corp
Eagle Pharmaceuticals
Merrimack Pharmaceuticals
GlaxoSmithKline
Millennium Pharmaceuticals
Bayer
and many others
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Table of contents

1. Key Insights

2. Hormone Receptor positive Breast Cancer Market Overview at a Glance

3. Human Epidermal Receptor 2 negative breast cancer Disease Background and Overview

4. HR 2 positive Epidemiology and Patient Population

5. Hormone Receptor of Positive Breast Cancer Country Wise-Epidemiology

5.1. United States

5.2. EU5 Countries

5.3. Germany

5.4. France

5.5. Italy

5.6. Spain

5.7. United Kingdom

5.8. Japan

6. Estrogen-Receptor Positive Breast Cancer Treatment

7. HER 2 negative Marketed Products

7.1. Ibrance (Palbociclib): Pfizer

7.2. PIQRAY (Alpelisib; BYL719): Novartis

7.3. Lynparza (olaparib): AstraZeneca Pharmaceuticals

7.4. Verzenio (Abemaciclib): Eli Lilly

7.5. Kisqali (Ribociclib; LEE011): Novartis Pharmaceuticals

7.6. Afinitor (Everolimus): Novartis

7.7. Faslodex (Fulvestrant) Injection: AstraZeneca

7.8. Arimidex (Anastrozole): AstraZeneca

7.9. Aromasin (Exemestane): Pharmacia and Upjohn Company

7.10. Femara (Letrozole): Novartis Pharmaceuticals

8. Unmet Needs

9. HR positive/ HER2 negative breast cancer breast cancer Emerging Drugs

9.1. Key Cross Competition

9.2. SHR6390: Jiangsu HengRui Medicine Co.

9.3. TESETAXEL: Odonate Therapeutics

9.4. RAD1901: Radius Pharmaceuticals

9.5. IMMU-132 (Sacituzumab Govitecan): Immunomedics

9.6. Ipatasertib (RG7440): Roche Group

9.7. Venclexta: Roche Group

9.8. Entinostat: Syndax Pharmaceuticals

9.9. Pembrolizumab (MK-3475): Merck Sharp and Dohme

9.10. Eribulin Mesylate: Merck Sharp & Dohme Corp.

9.11. MM-121: Merrimack Pharmaceuticals

9.12. GSK525762 (Molibresib): GlaxoSmithKline

9.13. SAPANISERTIB (TAK-228): Millennium Pharmaceuticals

9.14. Radium-223 dichloride: Bayer

9.15. EGL-5385-C-1701(fulvestrant): Eagle Pharmaceuticals

10. HR+/HER2- Post Menopause Breast Cancer Market Analysis (7MM)

11. The United States HR positive/ HER2 negative breast cancer Market Analysis

11.1. The United States HR positive/ HER2 negative breast cancer Market Outlook

11.2. United States HR positive/ HER2 negative breast cancer Market Size

12. EU-5 HR positive/ HER2 negative breast cancer Market Analysis

12.1. EU-5 HR positive/ HER2 negative breast cancer Market Outlook

12.2. Germany HR positive/ HER2 negative breast cancer Market Size

12.3. France HR positive/ HER2 negative breast cancer Market Size

12.4. Italy HR positive/ HER2 negative breast cancer Market Size

12.5. Spain HR positive/ HER2 negative breast cancer Market Size

12.6. The United Kingdom HR positive/ HER2 negative breast cancer Market Size

13. Japan Market Outlook

14. Market Drivers

15. Market Barriers

16. Appendix

17. DelveInsight Capabilities

18. Disclaimer

On September 10, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver, and inflammatory diseases, reported it has entered into a collaboration agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune, and metabolic diseases (Press release, Can-Fite BioPharma, SEP 10, 2019, View Source [SID1234539408]).

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It is widely recognized that the identification of specific receptors and pathways through which CBD operates is expected to greatly enhance the development of CBD-based pharmaceuticals. Can-Fite is uniquely positioned to contribute its deep pharmaceutical development expertise to the CBD market, based on findings published in peer reviewed scientific journals demonstrating that CBDs bind to the Gi protein-coupled A3 adenosine receptor (A3AR), which is over-expressed in pathological cells. Can-Fite is a global leader in the research and development of drugs that target A3AR.

There are two main components to the collaboration agreement:

Discovery, development, and commercialization of medical cannabis-based therapeutics: Can-Fite and Univo will jointly collaborate in the discovery of, and Can-Fite will have a first right to express interest to clinically develop, cannabis and cannabis components for the treatment of cancer, inflammatory, autoimmune, and metabolic diseases.

Development and commercialization of CBD screening assays: Can-Fite will develop a screening assay to identify therapeutically active cannabis components, and once developed, Univo will market the assay on a ‘fee for service’ basis to other pharmaceutical companies worldwide.

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026 and according to Zion Market Research, the global market for cell-based assays is estimated to reach $16.2 billion by 2025.

In this collaboration, Univo will provide Can-Fite with cannabis and cannabis components, as well as full access to its laboratories for both research and manufacturing. Can-Fite has agreed to pay Univo a total of $500,000 through two installments and is issuing to Univo approximately 19.9 million of its ordinary shares through a private placement, representing approximately 16.6% of Can-Fite’s ordinary shares outstanding after giving effect to the issuance. The companies will initially share ownership of intellectual property developed in this collaboration. Revenues derived from the collaboration will generally be shared between Can-Fite and Univo on the basis of each party’s contribution. Golan Bitton, Univo’s CEO, is being appointed to the Can-Fite board in connection with the collaboration agreement.

Dr. Pnina Fishman, Can-Fite CEO, commented, "This collaboration provides Can-Fite with new and very exciting business opportunities for utilizing our technology platform and expertise."

Golan Bitton, Univo’s CEO stated, "Can-Fite’s deep expertise in A3 adenosine receptors is a significant asset in our joint collaboration and we are pleased to have formed this alliance. Can-Fite has taken its drug candidates into Phase II and Phase III clinical studies and this makes Can-Fite highly suitable to take cannabis-based therapeutics into fully-fledged clinical development."

On September 10, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that results from the Phase 3 ClarIDHy study of TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma have been accepted for presentation in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held September 27 – October 1, 2019 in Barcelona (Press release, Agios Pharmaceuticals, SEP 10, 2019, View Source [SID1234539425]).

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The schedule for the presentation by Agios is as follows:

Date & Time: Monday, September 30, 2019 from 4:30 p.m. – 4:42 p.m. CET
Title: ClarIDHy: A global, phase 3, randomized, double-blind study of ivosidenib vs placebo in patients with advanced cholangiocarcinoma with an isocitrate dehydrogenase 1 (IDH1) mutation
Oral Abstract Session: Presidential Symposium III
Abstract: LBA10
Location: Barcelona Auditorium (Hall 2)
Presenter: Ghassan K. Abou-Alfa, Memorial Sloan-Kettering Cancer Center

Conference Call Information
Agios will host a conference call and live webcast with presentation slides on September 30, 2019 at 1 p.m. ET /7 p.m. CET to discuss the data from the ClarIDHy study. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 5209309. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On September 10, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the year ended June 30, 2019 (Press release, DelMar Pharmaceuticals, SEP 10, 2019, View Source [SID1234539409]).

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"This has been a productive quarter and year for DelMar as we have achieved multiple data milestones for both of our Phase 2 GBM trials for VAL-083," commented Saiid Zarrabian, DelMar’s President and Chief Executive Officer. "Most importantly, based on recent budget refinements, we now believe we have sufficient capital to achieve release of topline data for two of our three currently enrolling MGMT-unmethylated GBM patient groups. These topline results include the recurrent setting GBM trial being conducted at the MD Anderson Cancer Center and the first line GBM trial being conducted at Sun Yat-sen University Cancer Center in China. We anticipate results from both of these trials to be announced during the fourth quarter of calendar year 2020 and will be supported by the Company’s recent financings completed in June and August 2019. Additionally, we have also relocated our headquarters to San Diego to position ourselves for better access to required expertise as we advance our trials."

RECENT CORPORATE UPDATES

September 2019 – Moved corporate headquarters to San Diego, California
August 2019 – Closed an underwritten public offering with net proceeds of approximately $6.7 million
August 2019 – Provided update on Phase 2 clinical study on first line therapy in newly diagnosed MGMT-unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center. At the time of the update, nine patients were assessed as having achieved complete response, seven were assessed with stable disease, and one was assessed with disease progression
July 2019 – Enrolled first patient in adjuvant (pre-temozolomide maintenance) arm of Phase 2 open label study of VAL-083 being conducted at MD Anderson Cancer Center (MDACC)
July 2019 – Provided enrollment update of Phase 2 open label study of VAL-083 in recurrent GBM patients with MGMT-unmethylated status. As of this announcement, 56 of the planned 83 patients had been enrolled in the study being conducted at MDACC
June 2019 – Closed on registered direct financing with net proceeds of approximately $3.2 million
May 2019 – Expanded Scientific Advisory Board to include leading neuro-oncologists, Dr. David Reardon from Dana-Farber Cancer Center, Dr. Timothy Cloughsey from David Geffen School of Medicine, and Dr. Nicholas Butowski from UCSF and the Brain Tumor Center
April 2019 – Announced formation of Scientific Advisory Board, which includes current members of the Company’s board of directors, Dr. Napoleone Ferrara and Dr. John de Groot from the MD Anderson Cancer Center
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2019

At June 30, 2019, the Company had cash and cash equivalents on hand of approximately $3.7 million. In August 2019, the Company completed an underwritten public offering for net proceeds of approximately $6.7 million. The proceeds from the August 2019 financing combined with cash and cash equivalents on hand at June 30, 2019 are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2020.

For the year ended June 30, 2019, the Company reported a net loss of approximately $8.0 million, or $3.16 per share, compared to a net loss of approximately $11.1 million, or $5.42 per share, for the year ended June 30, 2018.