On December 19, 2019 Haemonetics Corporation (NYSE: HAE) reported that the Company intends to publish third quarter fiscal year 2020 financial results at 6:00 am EDT on Tuesday, February 4, 2020 (Press release, Haemonetics, DEC 19, 2019, View Source [SID1234552535]). The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am EDT on February 4, 2020.

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The call can be accessed with the following information:

U.S. / Canada toll free (877) 848-8880; International (716) 335-9512
Conference ID required for access: 1906607

A live webcast of the call can be accessed on Haemonetics’ investor relations website. Webcast Link: View Source

Webcast replay will be available from February 4, 2020 after 11:00 am EDT.

On December 19, 2019 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan (rituximab) (Press release, Amgen, DEC 19, 2019, View Source [SID1234552534]). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.

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"The U.S. filing for ABP 798 marks an important milestone for Amgen, as it affirms our commitment to providing high quality biosimilars that offer more life-altering biological treatment options and contribute to the sustainability of healthcare systems," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with the FDA to bring ABP 798 to market."

ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is a CD20-directed cytolytic antibody that has been approved in many regions for, among other things, the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.

"We are excited about the progress that we’ve made to date through our partnership with Amgen, which includes the launch of the first two oncology therapeutic biosimilars in the U.S.," said David Nicholson, Ph.D., chief research and development officer at Allergan. "With ABP 798, we look forward to the opportunity to continue to provide additional treatment options to patients suffering from serious illnesses."

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies. The results of these studies confirmed no clinically meaningful differences between ABP 798 and Rituxan.

Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three that are approved in the European Union (EU).

About ABP 798
ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal antibody that has been approved in many regions for the treatment of, among other things, adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

On December 19, 2019 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal year ended September 30, 2019 (Press release, ESSA, DEC 19, 2019, View Source [SID1234552533]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This past year was ESSA’s most significant year of progress towards its goal of developing a novel prostate cancer therapy. Our discovery efforts led to the selection of a next generation N-terminal domain inhibitor of the androgen receptor ("aniten"), EPI-7386, that was nominated as the IND candidate. Preclinically, this potent compound exhibits a long half-life, and excellent pharmaceutical properties, while also demonstrating on-target specificity and anti-tumor activity against prostate cancer cell lines and animal models resistant to currently used anti-androgens. Preparations for an IND filing continue to advance and we remain on track to file the IND in the first quarter of 2020 with an initiation of the Phase 1 study of EPI-7386 expected in the first half of 2020," stated David Parkinson, MD, President and CEO of ESSA.

Dr. Parkinson continued, "With the $56 million raised through the acquisition of Realm Therapeutics, plc and the subsequent private placement, the Company has sufficient funds to complete the Phase 1 monotherapy dose-escalation study and an expansion phase to that study. In addition, the Company believes it is funded to be able to conduct a combination study of EPI-7386 with currently utilized antiandrogens in prostate cancer patients with earlier stages of the disease. 2020 will be another important year as we commence clinical development of EPI-7386 as a single agent in advanced prostate cancer as well as in combination with standard of care anti-androgens in earlier lines of therapy. The Phase I clinical trial will be conducted in men whose tumors are progressing (and therefore PSA levels are rising) despite therapy with one of the latest generation anti-androgen therapies. While patients will be selected for the trial on the basis of clinical considerations, a series of biological studies will characterize their individual tumor biology. In addition, we will continue the characterization of other aniten molecules in our pre-clinical pipeline."

Clinical and Corporate Highlights for 2019 Fiscal Year

On March 28, 2019, the Company nominated EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC")
On July 15, 2019, the Company appointed Dr. Alessandra Cesano as Chief Medical Officer
On July 31, 2019, the Company completed the acquisition of Realm Therapeutics, plc ("Realm"), which provided the Company with approximately $20M in additional funds
On August 23, 2019, the Company closed an equity financing for gross proceeds of $36 million
In October, the Company paid off the balance of its $3.6M debt facility, leaving the Company with no outstanding debt
Throughout the year, at multiple scientific conferences, the Company presented preclinical data characterizing the preclinical profile of EPI-7386 in various prostate cancer preclinical models
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $10.4 million ($1.24 loss per common share based on 8,433,441 weighted average common shares outstanding) for the year ended September 30, 2019, compared to a net loss of $11.6 million ($2.55 loss per common share based on 4,566,519 weighted average common shares outstanding) for the year ended September 30, 2018. The net loss for the fourth quarter ended September 30, 2019 was $1.0 million compared to a net loss of $2.3 million for the fourth quarter ended September 30, 2018.

Research and Development ("R&D") expenditures. R&D expenditures for the year ended September 30, 2019 were $6.7 million compared to $4.9 million for the year ended September 30, 2018. For the fourth quarter ended September 30, 2019, R&D expenditures were $2.0 million (net and gross), as compared to $0.9 million net of grants ($1.2 million gross) for the fourth quarter ended September 30, 2018. The increase in R&D expenditures for the full year and fourth quarter were primarily related to ESSA’s efforts in preparing an Investigational New Drug ("IND") application for its recently nominated clinical candidate, EPI-7386. Costs in the comparative period included preclinical research related to the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the year ended September 30, 2019 were $5.5 million compared to $5.9 million for the year ended September 30, 2018. For the fourth quarter ended September 30, 2018, G&A expenditures were $1.3 million, compared to $1.2 million for the fourth quarter ended September 30, 2018. The decrease in the full year is the result of a reduction in share-based payments, rent expense, and professional fees. The increase in the fourth quarter is a result of increased corporate activity following the acquisition of Realm, including directors fees, investor relations, and regulatory fees.
Liquidity and Outstanding Share Capital
Cash on hand at September 30, 2019 was $53.3 million, with working capital of $48.7 million, reflecting the aggregate gross proceeds of the completed August 2019 financing of $36 million, the acquisition of Realm which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of September 30, 2019, the Company had 20,762,374 common shares issued and outstanding.

In addition, as of September 30, 2019 there were 12,393,092 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001, and 473,688 other warrants at a weighted average exercise price of $34.36. There are 5,314,000 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.19 per common share.

On December 19, 2019 Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea, reported that the company filed an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) in Korea to initiate phase I/II study of BBT-176, a clinical candidate of targeted lung cancer therapy (Press release, BridgeBio, DEC 19, 2019, View Source [SID1234552532]).

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BBT-176, a novel epidermal growth factor receptor – tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). BBT-176 exhibited strong antitumor efficacy in xenograft models harboring C797S triple mutations including Del19/T790M/C797S and L858R/T790M/C797S. Furthermore, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

Since the EGFR C797S mutation was reported 3 years ago, as the first evidence of Tagrisso resistance, no major breakthroughs have been achieved to target the clinically relevant mutant variant that impedes covalent bond formation with irreversible EGFR inhibitors.[i]

The company plans to initiate dose escalation studies in advanced NSCLC patients in Korea next year and to develop further clinical studies in both Korea and the US afterwards. In the Phase I/II study with NSCLC patients, the safety, tolerability and efficacy of the candidate will be observed.

"We are proud of the IND submission for BBT-176, which has shown a potential to be developed as a highly mutant-selective, fourth-generation EGFR-TKI for NSCLC treatment," stated James Lee, CEO of Bridge Biotherapeutics. "Our team will make our best effort to develop novel targeted lung cancer therapy inhibiting C797S EGFR mutation."

BBT-176 was discovered by Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute, and was licensed to Bridge Biotherapeutics in December 2018 for the worldwide exclusive right for further development.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is split into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers. Overall, across 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is assumed 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.[ii]

On December 19, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that a planned review by an independent Data Safety Monitoring Board (DSMB) has analyzed safety data from ten weeks of treatment of the first patient enrolled in the NOX-A12 plus radiotherapy brain cancer trial (Press release, NOXXON, DEC 19, 2019, View Source [SID1234552530]). Based on this assessment, the DSMB has confirmed that it is appropriate to continue the recruitment of additional patients according to the study protocol.

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The clinical trial centers participating in the study have therefore initiated the recruitment of the remaining patients in the first of three escalating dose groups. Once each patient in the first cohort has received a four-weeks treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to proceed to the middle dose level of NOX-A12.

"We are encouraged by this initial confirmation of the safety profile of NOX-A12," commented Aram Mangasarian, CEO of NOXXON. "Following this analysis, the trial can progress as planned so the next patients can receive the treatment as part of the protocol. We remain focused on reaching our goal of obtaining data from the first cohort of patients in mid-2020, and from the second and third cohorts in the fourth quarter 2020 and the second quarter of 2021, respectively."