On May 6, 2019 Veloxis Pharmaceuticals A/S (OMX: VELO) reported its Interim Report for the first three months of 2019 (Press release, Veloxis Pharmaceuticals, MAY 6, 2019, View Source [SID1234535782]). This Company Release should be read in conjunction with Veloxis’s full Interim Report for the first three months of 2019, which is attached to this release and also available on Veloxis’s website at: View Source

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Product revenue for Q1 2019 was tUSD 14,261, an increase of 96% compared with the same period last year.
US revenue increased 91% to tUSD 12,285
EU revenue increased 133% to tUSD 1,961
Over 91% of US transplant centers have utilized Envarsus since its launch.
Cash balance, tUSD 28,394 on March 31.
Veloxis reported a net income of tUSD 111 for the first quarter of 2019 compared to a net loss of tUSD 4,030 for the same period in 2018.
In connection with the Interim Report, Veloxis’s CEO, Craig Collard said:

"Veloxis is off to a terrific start in 2019 as sales of Envarsus continue to accelerate through the first quarter. We are seeing increased interest from the transplant community driven largely by the approval of the de novo indication in December 2018. We are very excited about what this means for the Envarsus franchise long-term and look forward to a successful year."

Outlook for 2019

Veloxis maintains its 2019 outlook of revenues to be in the range of USD 58 – 68 million and operating income before accounting for stock compensation in the range of USD 4 – 10 million.

Conference Call

A conference call will be held tomorrow, May 7, 2019 at 4:00 p.m. CET (Denmark); 3:00 p.m. GST (London); and 10:00 a.m. EST (New York).

To access the live conference call, please dial one of the following numbers:

DK: +45 32 72 75 18

UK: +44 (0) 203 009 5710

US: +1 917 720 0178

Confirmation Code: 7877813

Following the conference call, a recording will be available on the Company’s website: View Source

About Envarsus

Envarsus is a novel formulation of tacrolimus designed using advance technology which allows for increased bioavailability and controlled, smooth delivery, resulting in in once daily dosing, a lower total daily dose requirement, and lower peak concentrations with less fluctuation.

In addition to the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus, Envarsus is now FDA-approved for use in de novo kidney transplant patients as of December 2018. That means more patients, including hard-to-treat patients such as rapid metabolizers, can benefit from once-daily controlled-release Envarsus. Envarsus is marketed as Envarsus XR in the Unites States.

On May 6, 2019 Luminex Corporation (NASDAQ:LMNX) reported financial results for the first quarter 2019 (Press release, Luminex, MAY 6, 2019, View Source [SID1234535781]). Financial and operating highlights for the quarter include:

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First quarter consolidated revenue of $82.4 million compared to the first quarter 2018 revenue of $82.7 million.
In the first quarter, flow cytometry contributed revenue of approximately $11.4 million, offsetting the revenue loss of LabCorp Women’s Health.
Royalty revenue of $14.2 million grew 16% over the first quarter 2018. This reflects $149 million of royalty-bearing end user sales on Luminex technology, an increase of approximately 10% over the comparable period in 2018.
Sample-to-Answer revenue grew 16% over the 1st quarter of 2018 and we placed approximately 50 sample-to-answer molecular systems under contract during the first quarter of 2019. Active sample-to-answer customers approximated 625 in the quarter.
Gross margins of 56% in the first quarter, directly affected by the departure of LabCorp revenue coupled with the Flow Cytometry acquisition and integration.
First quarter GAAP net income was approximately $3.0 million, or $0.07 per diluted share, primarily driven by a discrete tax benefit of $6.6 million in the current quarter related to a tax benefit emanating from the Company’s Canadian subsidiary. On a non-GAAP basis, the Company had a net loss of $3.0 million, or losses of $0.07 per diluted share (see Non-GAAP reconciliation).
"I am pleased with our first quarter results and the continued progress we are making across the company," said Nachum "Homi" Shamir, President & CEO. "I am very excited about our future. We have two more quarters to go until we emerge as a much more diversified company with increasing momentum that is past the loss of LabCorp," continued Shamir. "During this time, we will continue to build a strong foundation through both our sample to answer portfolio and life sciences businesses. By the end of this year, we believe Luminex will be growing at a double digit rate, have improved gross margins, and will return to consistent profitability and cash flow."

FINANCIAL OUTLOOK AND GUIDANCE

The Company intends to provide annual revenue guidance, to be updated, as appropriate, at each quarterly reporting period. Luminex anticipates its second quarter 2019 revenue to be between $80 million and $83 million and reaffirms its full year 2019 revenue guidance of between $337 million and $343 million.

CONFERENCE CALL

Management will host a conference call at 3:30 p.m. CDT / 4:30 p.m. EDT, Monday, May 6, 2019 to discuss the operating highlights and financial results for the first quarter 2019. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at View Source Simply log on to the web at the address above, go to the Company section and access the Investor Relations link. Please go to the website at least 15 minutes prior to the call to register, download and install any necessary audio/video software. If you are unable to participate during the live webcast, the call will be archived for six months on the website using the ‘replay’ link.

At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at www.luminexcorp.com.

Statements made in this release that express Luminex’s or management’s intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding expected revenue and cost savings and projected 2019 performance, including revenue guidance. The words "believe," "expect," "intend," "estimate," "anticipate," "will," "could," "should" and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company’s actual results or performance could differ materially from those anticipated or projected in such forward-looking statements. Factors that could cause Luminex’s actual results or performance to differ materially include risks and uncertainties relating to, among others, concentration of Luminex’s revenue in a limited number of direct customers and strategic partners, some of which may be experiencing decreased demand for their products utilizing or incorporating Luminex’s technology, budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of internal resource planning challenges; market demand and acceptance of Luminex’s products and technology, including ARIES, MultiCode, xMAP, VERIGENE, Guava, Muse, Amnis and NxTAG products; Luminex’s ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels; Luminex’s ability to obtain and enforce intellectual property protections on Luminex’s products and technologies; the impact on Luminex’s growth and future results of operations with respect to the loss of the LabCorp women’s health business; Luminex’s ability to successfully launch new products in a timely manner; dependence on strategic partners for development, commercialization and distribution of products; risks and uncertainties associated with implementing Luminex’s acquisition strategy, Luminex’s challenge to identify acquisition targets, including Luminex’s ability to obtain financing on acceptable terms; Luminex’s ability to integrate acquired companies or selected assets, including the Flow-Cytometry assets recently acquired from Millipore Sigma, into Luminex’s consolidated business operations, and the ability to fully realize the benefits of Luminex’s acquisitions; the timing of and process for regulatory approvals; competition and competitive technologies utilized by Luminex’s competitors; fluctuations in quarterly results due to a lengthy and unpredictable sales cycle; fluctuations in bulk purchases of consumables; fluctuations in product mix, and the seasonal nature of some of Luminex’s assay products; Luminex’s ability to comply with applicable laws, regulations, policies and procedures; the impact of the ongoing uncertainty in global finance markets and changes in governmental and governmental agency funding, including effects on the capital spending policies of Luminex’s partners and end users and their ability to finance purchases of Luminex’s products; changes in principal members of Luminex’s management staff; potential shortages, or increases in costs, of components or other disruptions to Luminex’s manufacturing operations; Luminex’s increasing dependency on information technology to improve the effectiveness of Luminex’s operations and to monitor financial accuracy and efficiency; the implementation, including any modification, of Luminex’s strategic operating plans; the uncertainty regarding the outcome or expense of any litigation brought against or initiated by Luminex; risks relating to Luminex’s foreign operations, including fluctuations in exchange rates, tariffs, customs and other barriers to importing/exporting materials and products in a cost effective and timely manner; difficulties in accounts receivable collections; Luminex’s ability to monitor and comply with foreign and international laws and treaties; and Luminex’s ability to comply with changes in international taxation policies; budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of material resource planning challenges; reliance on third party distributors for distribution of specific Luminex-developed and manufactured assay products, as well as the risks discussed under the heading "Risk Factors" in Luminex’s Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward-looking statements, including the financial guidance and 2019 outlook, contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

On May 6, 2019 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the first quarter ended March 31, 2019 (Press release, Syndax, MAY 6, 2019, Syndax Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Clinical and Business Update [SID1234535780]). In addition, the Company provided a clinical and business update. As of March 31, 2019, Syndax had $92.7 million in cash, cash equivalents and short-term investments.

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"We are pleased to report that E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, has passed its fourth interim overall survival analysis," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "E2112 was designed to replicate the compelling overall survival results obtained in the Phase 2b ENCORE 301 trial which led to Breakthrough Therapy designation. The next overall survival assessment is expected in the fourth quarter of this year. We remain confident in the potential that the addition of entinostat to exemestane will result in a positive survival benefit, which would allow us to file for full regulatory approval in this indication."

Dr. Morrison added, "We also look forward to filing an IND for SNDX-5613, our targeted menin inhibitor, later this quarter. Supported by a robust preclinical dataset, we believe this therapeutic class has the potential to make a meaningful impact for patients with genetically-defined acute leukemias for whom limited effective therapies exist."

Pipeline Updates

Entinostat

ECOG-ACRIN has informed the Company that following its fourth preplanned interim overall survival (OS) analysis, the E2112 trial will continue as planned until either an OS benefit is observed, or the final target number of events occur. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. The next interim analysis for the OS endpoint is scheduled for 4Q19, with a final OS assessment, if necessary, to be conducted in 2Q20. Any positive OS assessment would enable the Company to file for full regulatory approval. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a statistically significant OS benefit.

At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held March 29 – April 3, 2019, Syndax presented data from the non-small cell lung cancer (NSCLC) and melanoma cohorts of the ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy. These data provided further evidence that the addition of entinostat to pembrolizumab may overcome resistance to immunotherapy in melanoma and NSCLC patients whose disease progressed on or after anti-PD-1 therapy. As the Company has previously indicated, following availability of positive E2112 OS results, it will determine whether to advance its entinostat-PD-1 combination programs into one or more registration trials.

SNDX-5613

Syndax continues to expect to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its targeted menin inhibitor, SNDX-5613, later this quarter, with the initiation of a Phase 1 clinical trial in a defined subset of acute leukemia patients expected to follow shortly thereafter.

SNDX-6352

The Company continues to anticipate initial results from the Phase 1 dose escalation trial of SNDX-6352, Syndax’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD) in the second half of the year. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

First Quarter 2019 Financial Results

As of March 31, 2019, Syndax had cash, cash equivalents and short-term investments of $92.7 million and 31.6 million shares and share equivalents issued and outstanding.

In March 2019, Syndax issued 4.5 million shares of its common stock and prefunded warrants at an offering price of $6.00, as well as warrants to purchase up to 4.5 million shares of its common stock, with half at an exercise price of $12.00 per share and the remaining half at an exercise price of $18.00 per share. As a result of the offering, Syndax received aggregate net proceeds of approximately $27.4 million.

First quarter 2019 research and development expenses decreased to $11.3 million from $15.3 million. The first quarter decrease was primarily due to reduced CMC activities and decreased clinical activities.

General and administrative expenses for the first quarter 2019 decreased to $3.9 million from $4.8 million. The decrease was primarily due to decreased pre-commercialization expenses and decreased professional fees.

For the three months ended March 31, 2019, Syndax reported a net loss attributable to common stockholders of $14.3 million or $0.53 per share compared to $19.4 million or $0.79 per share for the prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the second quarter and full year 2019. For the second quarter and full year 2019, research and development expenses are expected to be $9 to $10 million and $46 to $50 million, respectively, and total operating expenses are expected to be $13 to $14 million and $60 to $64 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 6, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4292817
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On May 6, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at two upcoming investor conferences (Press release, Jazz Pharmaceuticals, MAY 6, 2019, View Source [SID1234535779]).

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Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Tuesday, May 14, 2019 at 8:00 a.m. PDT / 4:00 p.m. IST. Dan Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
RBC Capital Markets Global Healthcare Conference in New York on Tuesday, May 21, 2019 at 9:00 a.m. EDT / 2:00 p.m. IST. Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of each webcast will be available for at least one week following each presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On May 6, 2019 VolitionRx Limited (NYSE American: VNRX) reported it will host a conference call on Thursday, May 9 at 8:30 a.m. Eastern time to discuss its financial and operating results for the first quarter of 2019 in addition to providing a business update (Press release, VolitionRX, MAY 6, 2019, View Source [SID1234535778]).

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Event: VolitionRx Limited First Quarter 2019 Earnings and Business Update Conference Call
Date: Thursday, May 9, 2019
Time: 8:30 a.m. Eastern time
U.S. & Canada Dial-in: 1-855-327-6837 (toll free)
U.K. Dial-in: 0 808-101-2791 (toll free)
Toll/International: 1-631-891-4304
Conference ID: 10006803

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events that have taken place in the first quarter of 2019, and milestones for the remainder of 2019 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 23, 2019. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 10006803.