On May 10, 2019 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its first quarter ended Mar. 31, 2019 (Press release, Insys Therapeutics, MAY 10, 2019, View Source [SID1234536195]).

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RECENT HIGHLIGHTS

Appointed Andy Long as chief executive officer; in parallel promoted Andrece Housley as chief financial officer; and Dr. Venkat Goskonda as chief scientific officer
Continued advancement of strategic alternatives for opioid-related assets
Furthered discussions on capital planning and the evaluation of strategic alternatives with Lazard (See Liquidity Update below)
Progressed R&D programs with a $10.5 million investment in the first quarter of 2019:
Submitted NDA for naloxone nasal spray
Received guidance from FDA following end of Phase 2 meeting for epinephrine nasal spray
Completed enrollment of second cohort in childhood absence epilepsy Phase 2 study
Active enrollment in the Company-sponsored CBD Prader-Willi syndrome (Phase 2) trial
Company-sponsored CBD Infantile Spasms Phase 3 study terminated; the closure of this trial is unrelated to efficacy or safety but was due to challenges related to recruitment of patientsPresented poster on proprietary epinephrine nasal spray at American Academy of Allergy, Asthma & Immunology Annual Meeting
Awarded National Institute on Drug Abuse (NIDA) grant for a series of clinical studies designed to evaluate the effects of pharmaceutical-grade cannabidiol on craving and relapse prevention in opioid use disorder
Financial Highlights

Net revenue for the first quarter of 2019 was $7.6 million, compared to $23.9 million for the first quarter of 2018, driven primarily by declines in the TIRF market and a $3.9 million reduction of inventory in the channel
Gross margin was 40.0 percent for the first quarter of 2019, compared to 90.8 percent in the same period of 2018 due to write-off of excess inventory
Sales and marketing investment was $4.1 million for the first quarter of 2019, compared to $9.1 million for the first quarter of 2018 as a result of managing commercial resources in line with market conditions
Research and development investment decreased to $10.5 million for the first quarter of 2019, compared to $12.3 million for the first quarter of 2018 due to fluctuations in the timing of clinical trials
General and administrative expense of $11.0 million for the first quarter of 2019 increased as compared to $9.6 million in the first quarter of 2018 as a result of professional advisory fees
Legal expense increased to $25.7 million for the first quarter of 2019, compared to $10.3 million in the first quarter of 2018, as a result of the company’s legal proceedings, including expenses associated with indemnification of John Kapoor in connection with his trial, which represented $18.1 million of the first quarter 2019 expense. Management is disputing the reasonableness of certain indemnification-related expenses for this quarter and prior periodsThe company accrued $73.9 million for potential contingent losses related to outstanding legal matters in the first quarter of 2019 compared to $0.7 million in the first quarter of 2018
Income tax expense of $1.2 million for the first quarter of 2019 compared to an expense of $0.2 million during the first quarter of 2018
Net loss for the first quarter of 2019 was ($123.8 million), or ($1.66) per basic and diluted share, compared to a net loss of ($20.4 million), or ($0.28) per basic and diluted share, for the first quarter of 2018. Adjusted net loss for the first quarter of 2019 was ($0.55) per basic and diluted shareAdjusted EBITDA loss for the first quarter of 2019 was ($44.1 million), compared to Adjusted EBITDA loss of ($14.9 million) in the prior-year quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release
The company had $87.6 million in cash, cash equivalents and short-term and long-term investments with no debt outstanding as of Mar. 31, 2019
Liquidity Update

As further discussed in our Form 10-Q for the period ended Mar. 31, 2019 (the "Form 10-Q"), while the company has no outstanding debt, available liquidity is limited to $87.6 million in cash and cash equivalents and investments as of Mar. 31, 2019, and the company expects to have continued negative cash flows from operating activities. The company has experienced recurring and increasing losses from operations over the previous 18 months due to significant declines in the TIRF market and significant legal expenses resulting from the investigation by the U.S. Department of Justice ("DOJ") and other significant litigation matters to which we are subject. As reported in the Form 10-Q, we have estimated liabilities of approximately $240.3 million as of Mar. 31, 2019 for proposed settlements of our various litigation matters, and there are other matters for which we have not been able to determine a reasonable estimated loss. Furthermore, we are uncertain if we will be able to complete a final settlement with the DOJ because of the Company’s inability to fulfill demands made by the DOJ, including the execution of a security agreement related to the assets of the company to collateralize payments under the settlement. These factors raise substantial doubt about the company’s ability to continue as a going concern within one year of the issuance date of the unaudited condensed consolidated financial statements.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our audited consolidated financial statements, and it is likely that investors will lose all or a part of their investment.

Management’s plans, in order to meet our operating cash flow requirements, include the pursuit of strategic alternatives related to the sale or licensing of the Company’s assets. As previously disclosed, on November 5, 2018, the company announced a process to review strategic alternatives for its portfolio of opioid-related assets, including SUBSYS, as well as formulations of buprenorphine and the combination of buprenorphine/naloxone. There are no assurances that the company will be successful in implementing a strategic plan for the sale of its assets in order to address its impending liquidity constraints. If the company cannot successfully implement its strategic plan for the sale of its assets, and/or reach an agreement with the DOJ, its liquidity, financial condition and business prospects will be materially and adversely affected. Accordingly, it may be necessary for the company to file a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in order to implement a restructuring. Therefore, trading in our securities is highly speculative. Our Board of Directors has not made any decisions related to any strategic alternatives at this time.

On May 10, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter of 2019 (Press release, Y-mAbs Therapeutics, MAY 10, 2019, View Source [SID1234536194]).

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"We believe Y-mAbs is adapting very well to its new role as a public company, and we are very pleased with our first quarter financial results, especially seen in conjunction with our clinical progress moving closer to our expected target of being able to file BLAs for both of our two lead pediatric drug candidates, naxitamab and omburtamab in 2019. These are exciting times for Y-mAbs," stated Thomas Gad, Founder, President and Head of Business Development and Strategy.

Dr. Moller, Chief Executive Officer continued, "We believe we have achieved the planned clinical progress with both the naxitamab and omburtamab trials during the first quarter of 2019 and we are confident that we can expect to complete the recruitment of patients for these pivotal trials for both compounds by mid 2019. We are excited to move these two antibody compounds forward to registration, and we have also initiated treatment of patients with our bispecific GD2xCD3 antibody. We believe this underlines our position as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatrics cancers."

First Quarter 2019 Financial Results

Y-mAbs reported a net loss of $15.9 million, or $0.47 per basic and diluted share, for the first quarter of 2019, compared to a net loss of $7.5 million, or $0.28 per basic and diluted share, for the first quarter of 2018.

Cost and Operating Expenses

Research and Development

Research and development expenses were $12.5 million for the quarter ended March 31, 2019, compared to $6.2 million for the corresponding period of 2018, an increase of $6.3 million. The increase in research and development expenses primarily reflects the following:

·$4.3 million increase in outsourced manufacturing for our lead product candidates, naxitamab and omburtamab

·$1.3 million increase in outsourced research and supplies to support expanding development activities

·$0.8 million increase in personnel costs

General and Administration

General and administrative expenses were $3.7 million for the quarter ended March 31, 2019, compared to $1.3 million for the same period of 2018, an increase of $2.4 million. Such increase in general and administrative expenses was primarily reflects the following expenses:

·$1.4 million increase in personnel costs

·$0.3 million increase in commercial infrastructure

Cash and Cash Equivalents

The Company had approximately $134.2 million in cash and cash equivalents as of March 31, 2019 compared to $147.8 million as of December 31, 2018. The decrease of $13.6 million was primarily attributable to the increased costs of operation.

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 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 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.