On February 13, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter and full year 2019 financial results on Monday, February 24, 2020, after the close of the U.S. financial markets (Press release, Clovis Oncology, FEB 13, 2020, View Source [SID1234554285]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss fourth quarter and full year 2019 results on Monday, February 24 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (866) 393-4306, International participants (734) 385-2616, conference ID: 1255036.

On February 13, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the investigational medicine tucatinib (Press release, Seattle Genetics, FEB 13, 2020, View Source [SID1234554301]). This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The filing is based on the results of HER2CLIMB, a randomized pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone. HER2CLIMB trial results were recently presented at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine(NEJM). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 20, 2020. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.

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"The FDA’s filing of the tucatinib NDA marks an important step forward for patients with locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are working collaboratively with the FDA throughout the review process to bring this important medicine to patients as quickly as possible."

The NDA for tucatinib was submitted in December 2019 and is being reviewed under the Real-Time Oncology Review (RTOR) Pilot Program. The review of the tucatinib NDA is also being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among participating international partners. Tucatinib was recently granted Breakthrough Therapy designation by the FDA in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1. This designation was based on data from the pivotal HER2CLIMB trial.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. An estimated 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.1 Between 15 and 20 percent of breast cancer cases worldwide are HER2-positive.2 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.2, 3, 4 In patients with metastatic breast cancer, the most common site of first metastasis is in bone, followed by lung, brain, and liver.5, 6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.2, 7 Despite recent treatment advances, there is still a significant need for new therapies that can impact metastatic disease, especially brain metastases. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2-positive metastatic breast cancer after progression on T-DM1.8, 9, 10

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 targeted agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

In addition to HER2CLIMB, tucatinib is being evaluated in a randomized, double-blind, placebo-controlled, multi-center phase 3 trial of tucatinib called HER2CLIMB-02. This trial is evaluating tucatinib in combination with T-DM1 compared to T-DM1 alone, in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. The primary endpoint is progression-free survival (PFS) per RECIST criteria. Secondary endpoints include overall survival, objective response rate and duration of response. This global trial is expected to enroll approximately 460 patients. More information about the phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.

Tucatinib is also being evaluated in a multi-center, open-label, single-arm phase 2 clinical trial known as MOUNTAINEER, with tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wildtype metastatic or unresectable colorectal cancer. The primary endpoint of the trial is overall response rate by RECIST criteria. Duration of response, PFS, overall survival and safety and tolerability of the combination regimen are secondary objectives. Results for the first 26 patients were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress. Enrollment of up to 110 patients is ongoing. More information about the MOUNTAINEER trial, including enrolling centers

On February 13, 2020 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 a corporate update and reported financial results for the fiscal first quarter ended December 31, 2019 (Press release, ESSA, FEB 13, 2020, View Source [SID1234554317]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This past calendar year was a transformative year for ESSA, and we are excited to continue the momentum into 2020. Preparations for an IND filing are nearly complete 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 shortly thereafter," stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "From our successful acquisition of Realm Therapeutics and fundraising efforts in 2019, ESSA ended the year with $45.9M in cash. Our current cash balance allows us to complete the Phase 1 monotherapy dose-escalation study and an expansion phase to that study. We expect to enroll approximately 18 patients at multiple well-known US and Canadian medical institutions in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort. In addition, we believe the Company is sufficiently funded to also conduct a combination study of EPI-7386 with currently utilized antiandrogens in prostate cancer patients with earlier stages of the disease. We look forward to presenting additional preclinical data at upcoming conferences in the first half of 2020".

Recent Corporate Highlights

Abstracts were accepted for presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Advances in Prostate Cancer Research on March 14, 2020 and the 2020 American Urological Association Annual Meeting on May 18, 2020.
On February 13, 2020, a poster abstract of EPI-7386 was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) GU highlighting preclinical data including new data showing EPI-7386 activity in an enzalutamide-resistant patient-derived xenograft model and favorable safety results from our IND-enabling studies.
In October 2019, the Company paid off the balance of its $3.6M debt facility, leaving the Company with no outstanding debt.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $4.6 million ($0.22 loss per common share based on 20,762,374 weighted average common shares outstanding) for the quarter ended December 31, 2019, compared to a net loss of $2.7 million ($0.43 loss per common share based on 6,305,283 weighted average common shares outstanding) for the quarter ended December 31, 2018.
Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended December 31, 2019 were $2.6 million compared to $1.3 million for the quarter ended December 31, 2018. The increase in R&D expenditures for the 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 quarter ended December 31, 2019 were $2.1 million compared to $1.2 million for the quarter ended December 31, 2018. The decrease in the quarter is primarily due to share-based payments made as a result of stock options issued in the period.
Liquidity and Outstanding Share Capital

Cash on hand at December 31, 2019 was $45.9 million, with working capital of $45.5 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of December 31, 2019, the Company had 20,762,374 common shares issued and outstanding.

In addition, as of December 31, 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 5,311,500 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.43 per common share.

On February 13, 2020 Replimune Group Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a corporate update, highlighting the progress of its key programs (Press release, Replimune, FEB 13, 2020, View Source [SID1234554262]).

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"Based on the early data in our lead indication of CSCC, we believe there is a high probability of success in our ongoing randomized registration-directed clinical trial of RP1 in combination with Libtayo compared to Libtayo alone, and we are also looking forward to starting an additional trial to test RP1 as a monotherapy in solid organ transplant recipients with CSCC. This is a patient population for whom immune checkpoint blockade is contraindicated due to the substantial risk of rejection of the transplanted organ and for whom the incidence of CSCC is particularly high," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Deaths from CSCC in the US approach the levels of those from melanoma, suggesting a significant initial commercial opportunity. In addition to reporting further data from our lead indications and initial clinical data with RP2 during 2020, we look forward to announcing the expansion of the clinical development plan for RP1 into additional indications as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."

Program Highlights

Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. RP1 is Replimune’s first clinical product candidate and is based on a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. RP2 is a version of RP1 that in addition to expressing GALV-GP-R and GM-CSF also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands – CD40L and 4-1BBL – together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, with the goal of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote the expansion of cellular and memory immune responses.

RP1 in combination with Libtayo in CSCC: Enrollment in the 240-patient registration-directed Phase 2, randomized, controlled clinical trial is ongoing and is expected to take approximately 18 to 24 months with enrollment intended in the US, Australia, Canada, United Kingdom and European Union.
RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, metastatic bladder cancer, and MSI-H/dMMR tumors: The Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with Opdivo remains on track with initial data from completely enrolled or ongoing skin cancer cohorts expected in mid-2020 with further data from all four cohorts expected to be available by year-end.
RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients: The Company has initiated recruitment in a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients.
RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company remains on track to initiate a 30 patient Phase 1/2 clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC in the first half of 2020.
RP2 alone and in combination with Opdivo: The ongoing Phase 1 clinical trial evaluating the safety, tolerability, and optimal dose for further development of RP2 alone and in combination with Opdivo remains on track with initial data from this all-comers clinical trial expected by the end of 2020.
RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial of RP3 alone and in combination with anti-PD-1 therapy remains on track to initiate in 2020.
Corporate Highlights

Organization transitioning into a late-stage clinical development company and preparing for commercialization. Replimune continues to grow and evolve its leadership team as it transitions into a late-stage clinical development company with the recent appointment of Jean Franchi as Chief Financial Officer and the transition of Robert Coffin, Ph.D. from Chief Executive Officer into the newly created role of President and Chief Research & Development Officer. As previously announced, Philip Astley-Sparke has moved from part-time Executive Chairman to now full-time Chief Executive Officer, and together with Robert Coffin will co-lead the company going forward.
Completed building manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s product candidates with sufficient capacity to support full commercialization. The facility is now fully operational and technology transfer activities are underway.
Financial Highlights

Replimune strengthened the balance sheet in the quarter closing with $180.9 million in cash, cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019, an increase of $46.1 million. Our increased cash operating expenses were offset by $99.7 million of net proceeds from financing activities.

Based on our current operating plan, we expect our current cash, cash equivalents, and short-term investments will be sufficient to fund operating expenses and capital expenditure requirements into the second half of calendar year 2022.

Research and development expenses for the quarter ended December 31, 2019 were $11.9 million compared with $7.9 million for the same period in the prior year. The increase was driven by increased headcount and services supporting advancement of our lead program RP1 into phase II trials, additional trials, and initiating work in RP2 and RP3.

General and administrative expenses were $4.7 million for the quarter ended December 31, 2019 compared with $2.3 million for the same period in the prior year. The increase was primarily driven by increased headcount and related expense, professional fees, and facility expansion.

Replimune reported a net loss of $16.2 million for the quarter ended December 31, 2019 compared with $7.7 million for the same period in the prior year.

On February 13, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020 (Press release, Corcept Therapeutics, FEB 13, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-0 [SID1234554286]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call Information

To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.