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."

On December 19, 2019 Cullinan Oncology, LLC reported the initiation of dosing with VK-2019, Cullinan Apollo’s first-in-class EBNA1 inhibitor for Epstein Barr Virus positive (EBV+) cancers and CLN-081, Cullinan Pearl’s novel epidermal growth factor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC) (Press release, Cullinan Oncology, DEC 19, 2019, View Source [SID1234552528]). Cullinan Apollo and Cullinan Pearl are subsidiaries of Cullinan Oncology.

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VK-2019 and CLN-081 represent the first two small molecules targeting oncogenic drivers from the Cullinan Oncology pipeline. Each clinical study is a global Phase 1/2a study that utilizes an accelerated dosing schema, followed by expansion cohorts to fully characterize both safety and efficacy.

"We are grateful to our many collaborators for helping us bring these innovative medicines to patients," stated Owen Hughes, CEO of Cullinan Oncology, LLC. "We are hopeful that our medicines have the potential to positively impact the lives of those living with EBV+ nasopharyngeal carcinoma and NSCLC driven by EGFR exon 20 insertion mutations. We look forward to bringing additional targeted therapies into the clinic in the coming quarters."

About VK-2019

VK-2019 is a first-in-class EBNA1 inhibitor for EBV+ cancers. Epstein-Barr Virus (EBV) is a well-established driver of various cancers and is critically reliant on the viral DNA-binding factor EBNA1 for viral genome maintenance. In preclinical models of EBV-associated cancers, VK-2019 eliminated EBV, resulting in tumor growth inhibition. VK-2019 originated at the Wistar Institute and was licensed by Cullinan Apollo in 2018.

About CLN-081

CLN-081 (formerly TAS6417) is an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. CLN-081 is initially in development to target NSCLC driven by EGFR exon 20 insertion mutations. CLN-081 was developed by Taiho Pharmaceuticals and was licensed by Cullinan Pearl in 2019.

On December 19, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it has named Scott Gottlieb, M.D., and Nalie Agustin, as the keynote speakers for the 37th Annual Miami Breast Cancer Conference (Press release, Physicians’ Education Resource, DEC 19, 2019, View Source [SID1234552527]). This year’s keynote presentations will take place at the Fontainebleau in Miami Beach, Florida.

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"We are honored to have Dr. Gottlieb and Nalie join us at this year’s legacy Miami Breast Cancer Conference," said Phil Talamo, president of PER. "Dr. Gottlieb has an incredible amount of experience in the field of health care access and public health advocacy and Nalie is such an inspirational breast cancer advocate that will provide a remarkable patient perspective to the audience."

Gottlieb is a physician and served as the 23rd commissioner of the Food and Drug Administration (FDA) from 2017-2019. His work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping health care delivery, and expanding consumer choice and safety. Under his leadership, the FDA advanced new frameworks for the modern and safe and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs and digital health devices. Gottlieb is widely published in leading medical journals and periodicals, including The Wall Street Journal, The New York Times and The Washington Post. Fortune magazine has recognized him as one of the "World’s 50 Greatest Leaders" in 2018 and in 2019, and he was named one of Time magazine’s "50 People Transforming Healthcare in 2018." Gottlieb will present his scientific keynote speech on Saturday, March 7 at 11:40 a.m.

Agustin is an author, speaker and wellness advocate thriving with metastatic breast cancer. She has openly chronicled her life on social media and her blog Nalie.ca since she was diagnosed with breast cancer at only 24 years old in 2013. Since then, she has amassed a large and loyal community of women seeking for hope and inspiration. Her creativity, authenticity and positive outlook have opened doors to many opportunities including being featured on Apple’s iPhone X billboards and in The American Cancer Society’s YOUnited Against Breast Cancer campaign alongside celebrities like French Montana, DJ Khaled, Kristen Chenoweth and more. She has been the Ambassador for the Canadian Breast Cancer Foundation for several years and is the spokesperson for her local hospital. Agustin is also the co-host of Thriver Talks, a podcast giving weekly tips on how to heal and live your best life beyond cancer and is currently co-authoring The Thriver’s Guide with Stephanie Seban, launching in 2020. Agustin will present her patient keynote speech on Saturday, March 7 at 11:10 a.m.

For 37 years, the Miami Breast Cancer Conference has brought together surgical, medical and radiation oncologists, as well as geneticists, pathologists, radiologists and supportive-care specialists, to foster awareness of state-of-the-art treatments for all stages and subtypes of breast cancer, provide expert perspectives on areas of clinical uncertainty or controversy, and encourage attendees to engage in cross-team cooperation in their clinics.