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 10, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results and business highlights for the first quarter ended March 31, 2019 (Press release, Stemline Therapeutics, MAY 10, 2019, View Source [SID1234536138]).

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"Since ELZONRIS became commercially available in January, we have been very pleased with the progress we have made executing our launch plan," stated Robert Francomano, SVP and Global Head of Commercial. "Our entire organization is working hard to ensure patients with BPDCN have access to ELZONRIS. Although still early, we believe the launch is progressing extremely well and remain poised for a very successful 2019 and beyond."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "We have built a solid foundation for growth, driven by our launch of ELZONRIS for patients with BPDCN. We are executing our commercial plan, including pursuing ongoing efforts to unlock additional value from ELZONRIS in other indications as well as from our entire pipeline, all with the goal of improving the lives of patients with cancer around the world."

First Quarter 2019 Financial Results Review

Net revenue for ELZONRIS was $5.05 million for the quarter ended March 31, 2019. Stemline began commercial sales of ELZONRIS within the United States in January 2019.

Stemline ended the first quarter with $124.4 million in cash, cash equivalents and investments. For the first quarter, Stemline had a net loss of $27.4 million. Cash expenditures for the first quarter of 2019 was $21.9 million.

Research and development expenses were $17.0 million for the first quarter of 2019, which reflects an increase of $4.3 million compared with $12.7 million for the first quarter of 2018. The higher cost was primarily driven by expense recorded related to repayment of research funding as a result of the first commercial sale of ELZONRIS.

Selling, general and administrative expenses were $16.0 million for the first quarter of 2019, which reflects an increase of $10.1 million compared with $5.9 million for the first quarter of 2018. The increase in costs were primarily attributable to launch expenses in support of the commercialization of ELZONRIS.

Recent Corporate Developments and Program Highlights

ELZONRIS (tagraxofusp) — Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

· ELZONRIS was approved by the FDA on December 21, 2018 and commercially available for patients with BPDCN in the U.S. in January 2019.

· The New England Journal of Medicine published the pivotal trial results in its April 25th edition.

· We submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in January 2019 seeking marketing approval in Europe. The MAA was granted accelerated assessment and is currently under review.

ELZONRIS — Market Expansion Efforts

· We are conducting clinical trials to evaluate ELZONRIS in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

· Based on clinical results observed in patients with CMML and MF, we are evaluating next steps, including potential registrational pathways. For CMML, we intend to provide our registration-directed plans mid-year.

·We are also evaluating additional expansion opportunities, including maintenance therapy after stem cell transplant in patients with BPDCN.

· In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients, including those enriched for CD123+ expression.

· We expect to provide periodic updates on these programs throughout this year and next at scientific conferences.

ASCO Conference

· ELZONRIS clinical trial data in CMML and MF have been selected for two poster presentations at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in June.

Other pipeline candidates

·We expect to provide periodic updates on our other product candidates, SL-701, SL-801, SL-901, and SL-1001, later this year.

Conference Call Information

Stemline will host a conference call and live webcast today at 8:00 a.m. ET to discuss first quarter 2019 financial results and recent business activities. The conference call can be accessed by dialing 1-800-667-5617 (domestic) or 1-334-323-0509 (international) and referring to conference ID 2090827.

The live webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page. The webcast will be archived and made available for replay on the company’s website shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123

CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple

myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.