On May 10, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported participation at upcoming industry conferences (Press release, Immutep, MAY 10, 2019, View Source [SID1234536213]).

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Conference:
New York Academy of Sciences, Frontiers in Immunotherapy

Dates:
May 14-15, 2019

Venue:
The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York, USA

Participation:
Frédéric Triebel, CSO & CMO of Immutep, will participate in a panel discussion titled "Novel Approaches from Biotech"

Conference:
World Advanced Therapies & Regenerative Medicine Congress & Expo 2019

Dates:
May 15-17, 2019

Venue:
Business Design Centre, London, UK

Presentation Title:
Combining a soluble LAG-3 protein with an anti-PD-1 antibody in phase I-II trials

Presenter:
Frédéric Triebel, CSO & CMO of Immutep

Conference:
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Dates:
May 31 – June 4, 2019

Venue:
McCormick Place, Chicago, IL, USA

Abstract Number and Title: TPS2667, "A multicenter, phase II study of soluble LAG-3 (Eftilagimod Alpha) in combination with pembrolizumab (TACTI-002) in patients with advanced non-small cell lung cancer (NSCLC) or head and neck squamous cell carcinoma (HNSCC)."

Poster Session: Developmental Immunotherapy and Tumor Immunobiology

Session Data and Time: Saturday, Jun 1, 8:00 – 11:00 a.m. CDT

Location: Hall A, Poster Board Number: #299b

Abstract Number and Title: TPS2651, "The "INSIGHT" Trial: Two new strata of an explorative, open-labeled phase I study evaluating the feasibility and safety of subcutaneous IMP321 injections (LAG-3Ig fusion protein, eftilagimod alpha) combined with either standard-of-care drug therapy or PD-L1 inhibition (avelumab) in advanced-stage solid tumor entities."

Poster Session: Developmental Immunotherapy and Tumor Immunobiology

Session Data and Time: Saturday, Jun 1, 8:00 – 11:00 a.m. CDT

Location: Hall A, Poster Board Number: #291b

On May 10, 2019 ESSA Pharma Inc. (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2019 (Press release, ESSA, MAY 10, 2019, View Source [SID1234536180]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Last quarter was a transformative period for ESSA as we selected EPI-7386 as our lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC"), supported by the preclinical data we have accumulated to date. We are extremely excited about the potential of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. "We are progressing with IND-enabling studies and are on track to enter clinical studies with EPI-7386 in the first quarter of 2020."

Recent Company Highlights

Announced the nomination of EPI-7386 as the lead clinical candidate for the treatment of mCRPC. EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor. Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogen therapies are inactive. Preclinical data shows EPI-7386 is significantly more potent, metabolically stable and more effective than the prior clinical candidate, EPI-506. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date.
Presented posters at the 2019 Genitourinary Cancers Symposium (ASCO-GU) and also at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the choice to develop EPI-7386.
Selected for an oral moderated poster presentation at the 2019 American Urological Association (AUA) Annual Meeting on May 4, 2019 in Chicago, Illinois, which provided preclinical information on the class of next-generation anitens and expanded on the preclinical characterization of ESSA’s recently declared investigational new drug ("IND") candidate, EPI-7386.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $3.4 million ($0.54 loss per common share based on 6,311,098 weighted average common shares outstanding) for the quarter ended March 31, 2019, compared to a net loss of $4.4 million ($0.83 loss per common share based on 5,287,605 weighted average common shares outstanding) for the quarter ended March 31, 2018.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2019 were $1.5 million compared to $2.0 million for the quarter ended March 31, 2018. The decreases in R&D expenditures for the quarter were primarily related to ESSA’s continued focus on preclinical research related to the ESSA’s next-generation aniten compounds in the current period. Costs in the comparative period included termination costs in relation to ESSA’s conclusion of its Phase I clinical study of EPI-506 in September 2017.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2019 were $1.8 million compared to $2.2 million for the quarter ended March 31, 2018. The decreases in the quarter primarily reflected decreased corporate activity, resulting in decreased professional and regulatory fees.
Liquidity and Outstanding Share Capital
Cash on hand at March 31, 2019, was $8.6 million, with working capital of $5.4 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, which totaled $26 million, less operating expenses in the intervening period.

As of March 31, 2019, the Company had 6,311,098 common shares issued and outstanding, and 1,654,000 common shares issuable on the exercise of prepaid warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.

In addition, as of March 31, 2019 there were 474,937 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.35 per ESSA common share and 1,149,961 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.59 per common share.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

On May 10, 2019 LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, reported the availability of a newly-approved companion diagnostic by the U.S. Food and Drug Administration (FDA), the therascreen FGFR mutation assay by RGQ RT-PCR, which is now available for ordering from LabCorp and its Integrated Oncology specialty laboratory (Press release, LabCorp, MAY 10, 2019, View Source [SID1234536162]).

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QIAGEN developed the assay, which is used to assess the eligibility of patients with urothelial cancer for treatment with the newly approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech, Inc. (Janssen). This is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Since 2018, the Company collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostic tests. The availability of this new assay reflects LabCorp’s continued leadership in precision medicine. For more than 20 years, LabCorp Diagnostics and Covance Drug Development have been involved in the development, commercialization and launch of companion and complementary diagnostics, and together they have supported more FDA-approved companion diagnostics than any other company.

The therascreen FGFR mutation analysis assay is the first to be introduced through LabCorp’s participation in QIAGEN’s Day-One Lab Readiness program, under which LabCorp will make novel companion diagnostics available for use by physicians soon after the FDA has approved a new treatment and its associated test.

"LabCorp is committed to bringing precision testing to patients as quickly as possible," said Marcia Eisenberg, PhD, chief scientific officer, LabCorp Diagnostics. "Our work on studies supporting regulatory approval of the therascreen FGFR mutation analysis companion diagnostic for BALVERSA, and our commitment to make the test available to physicians and patients as soon as possible after approval, aligns with our mission to improve health and improve lives. LabCorp offers end-to-end support for diagnostic development and accelerated commercialization, distinctly positioning us at the intersection of research and patient care."

Urothelial cancer, or transitional cell carcinoma (TCC), is the most prevalent form of bladder cancer, which constitutes the sixth most common type of cancer in the U.S. According to the American Cancer Society, more than 80,470 new cases of bladder cancer will be diagnosed in 2019, and will result in approximately 17,600 deaths. For patients with metastatic disease, outcomes are dire, with a relative five-year survival rate of only five percent.

For more information about LabCorp’s full menu of companion and complementary diagnostic tests, visit www.integratedoncology.com.

BALVERSA is a trademark of Janssen Biotech, Inc.

therascreen is a trademark of QIAGEN

On May 10, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Shalini Sharp, the company’s Chief Financial Officer, will present at the Bank of America Merrill Lynch Healthcare Conference on Tuesday, May 14, 2019 at 3:40 p.m. PT in Las Vegas, NV (Press release, Ultragenyx Pharmaceutical, MAY 10, 2019, View Source [SID1234536172]).

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The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On May 9, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2019 (Press release, G1 Therapeutics, MAY 9, 2019, View Source [SID1234536038]).

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"Following meetings with regulatory authorities, we have clarity on a path to submitting marketing applications in the U.S. and Europe for trilaciclib based on existing data from our three trials in small cell lung cancer patients," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "Our goal is to make trilaciclib available to patients across the globe as quickly as possible and we are encouraged with regulators’ understanding of this new approach to protecting patients from the damaging effects of chemotherapy."

Raj Malik, M.D., Chief Medical Officer added, "Trilaciclib is the first in a deep pipeline of clinical-stage programs with near-term data readouts expected. We anticipate presenting new data on our next two programs – lerociclib and G1T48 – later this year. Based on promising early results in our Phase 1 clinical trial of G1T48 in ER+ breast cancer, we plan to present proof-of-concept data in the third quarter."

Clinical, Operational and Executive Team Updates

Plan to submit U.S. and European regulatory filings for trilaciclib: The company announced plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC) based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and discussions with European regulatory authorities. G1 intends to file a New Drug Application (NDA) with the FDA in 2020 and submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to an NDA filing. Full press release available here.

Executive team change: Jennifer Moses, who has been with the company for four years and most recently served as Vice President, Finance, has been appointed Chief Financial Officer. Barclay "Buck" Phillips, who had served as CFO and Senior Vice President, Corporate Development since 2017, departed the company to pursue other interests and opportunities.

First investor day presentation: The G1 management team provided a comprehensive overview of the company’s three clinical development programs and outlined the commercialization strategy for trilaciclib. External experts Jeffrey Crawford, M.D., Co-director, Solid Tumor Therapeutics Program, Duke Cancer Institute and Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator,

discussed chemotherapy-induced myelosuppression and trilaciclib’s potential to protect the bone marrow from damage by chemotherapy and improve patient outcomes. The webcast is available on the G1 website here.

First Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $347.8 million as of March 31, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $25.9 million for the first quarter of 2019, compared to $20.7 million for the first quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2019, compared to $1.6 million for the first quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2019 were $18.1 million, compared to $17.3 million for the first quarter of 2018. The increase in expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2019 were $7.8 million, compared to $3.4 million for the first quarter of 2018. The increase in expense was largely due to an increase in compensation due to headcount increase, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $24.0 million for the first quarter of 2019, compared to $20.4 million for the first quarter of 2018.

Anticipated Milestones for 2019

Expect to complete pre-NDA meeting with the FDA.

Report additional data from all four randomized Phase 2 trilaciclib clinical trials.

Present proof-of-concept data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in 3Q19.

Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso (osimertinib) in non-small cell lung cancer in 3Q19.

Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2019 ended March 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code:7988598. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.