On May 7, 2019 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the first quarter ended March 31, 2019 and provided pipeline updates (Press release, AnaptysBio, MAY 7, 2019, View Source [SID1234535886]).

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"2019 is set to be an important year for AnaptysBio, with multiple top-line data readouts from our wholly-owned pipeline, initiation of a new Phase 2b trial of etokimab in eosinophilic asthma and submission of an IND for our next development candidate in our wholly-owned pipeline," said Hamza Suria, president and chief executive officer of AnapytsBio. "We look forward to advancing each of these programs as we work to bring novel treatments to patients with severe inflammatory diseases."

Etokimab (ANB020 Anti-IL-33 Program)

In September 2018, the Company reported positive interim top-line data from its Phase 2a proof-of-concept clinical trial of etokimab in adult patients with severe eosinophilic asthma. The Company will present the full data from this trial at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress. AnaptysBio also plans to initiate a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial of etokimab in eosinophilic asthma in 2019.

The Company is conducting a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab, with top-line data expected in the second half of 2019.

AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.

ANB019 (Anti-IL-36 Receptor Program)

The Company is conducting a single arm, open-label Phase 2 trial of ANB019 in approximately 10 patients with generalized pustular psoriasis, or GPP, also known as the GALLOP trial, with top-line data expected in mid-2019.

The Company is conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $484.2 million as of March 31, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $16.0 million. The decrease primarily relates to cash used for operating activities.

Research and development expenses were $20.6 million for the three months ended March 31, 2019, as compared to $11.8 million for the three months ended March 31, 2018. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional

personnel-related expenses including share-based compensation during the three months ended March 31, 2019.

General and administrative expenses were $4.1 million for the three months ended March 31, 2019, as compared to $3.9 million for the three months ended March 31, 2018. The increase was primarily attributable to additional personnel-related expenses, including share-based compensation.

Net loss was $22.1 million for the three months ended March 31, 2019, or a net loss per share of $0.82, as compared to a net loss of $15.1 million for the three months ended March 31, 2018, or a net loss per share of $0.63.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the second half of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with top-line data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP. AnaptysBio has previously presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the first half of 2020.

On May 7, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported two presentations at the 2019 American College of Mohs Surgery (ACMS) Annual Meeting held in Baltimore from May 2-5 (Press release, Castle Biosciences, MAY 7, 2019, View Source [SID1234537263]).

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Progress in the development of a prognostic gene expression profile test in cutaneous squamous cell carcinoma (cSCC) was highlighted in an oral presentation. The total number of deaths from cSCC, one of the most common cancers in the U.S., is approaching or surpassing that from melanoma. Many patients with cSCC will have a favorable prognosis, but 25-40% of high-risk subsets will experience metastasis or develop recurrences. Current cSCC staging systems are evolving but more accurate methods of risk prediction are needed to appropriately direct workup and treatment. The goal of this development program is to identify and validate a clinical test that improves upon existing clinicopathologic staging systems to identify patients who have a high risk for regional/distant metastasis and enable more informed clinical management decisions.

In an ongoing development study, primary cSCC specimens with associated clinical outcome data were accrued from 18 centers. The discovery phase of the program included determining genes identified for their expression in recurrent and non-recurrent tumors. Researchers successfully identified genes that exhibited significant differential expression in cSCC samples from patients who experienced a recurrence, including several specific to regional/distant metastasis. In an archival training cohort of 122 patients, gene expression data from 140 candidate genes were used to identify a preliminary gene set and predictive algorithm.

To assess the predictive value of this assay, Kaplan-Meier survival analysis was performed in an independent validation cohort of 107 patients. Results from the analysis support the predictive value of the test to identify two groups of patients with significantly different risk for regional/distant metastasis (p<0.0001). The positive predictive value of the test in this preliminary validation study was 60%, which compares favorably to the performance of current staging systems in this cohort.

Based on these preliminary validation results, an expanded validation program for the cSCC prognostic test is now underway, including additional archival studies and a prospective validation study.

"The continued progress toward validation of this prognostic test for cSCC demonstrates that improvements in risk identification based on tumor biology are feasible," said Sarah T. Arron, M.D., Ph.D., University of California San Francisco and the San Francisco VA Health System, an investigator in the study. "Clinical use of a validated prognostic test such as this could help inform clinical decisions on staging and adjuvant therapy, and improve upon currently used staging systems."

Second study presented at ACMS

A second study presented as a poster at ACMS highlighted results from a meta-analysis evaluating the performance of the DecisionDx-Melanoma gene expression profile test in four unique, independent patient cohorts.

Results from this meta-analysis with 1,479 patients from four independent cohorts confirm that the DecisionDx-Melanoma test is a significant, independent predictor of recurrence and metastasis in patients with Stage I-III melanoma. Patients identified as highest risk (Class 2B) by the DecisionDx-Melanoma test were 2.9 times more likely to experience recurrence than those identified as lowest risk (Class 1A, p<0.0001), independent of other clinicopathologic features. The meta-analysis, a statistical method considered to be among the highest level of evidence (Level 1A) for prognostic tests, supports the use of the DecisionDx-Melanoma gene expression profile test to inform patient management decisions.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (cSCC), a non-melanoma skin cancer, is one of the most common cancers. Approximately 200,000 patients per year are diagnosed with cSCC with high-risk features. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients each year die from their disease. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients who develop metastatic disease are misidentified as low risk. This may lead to over and undertreatment of a substantial number of cSCC patients. To address this clinical need, Castle Biosciences is developing a gene expression profile test designed to improve upon current staging systems and identify patients with cSCC at high risk for metastasis or recurrence, in order to enable more informed clinical decisions regarding adjuvant therapy and other management options.

On May 6, 2019 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the first quarter ended March 31, 2019 (Press release, AmpliPhi Biosciences, MAY 6, 2019, View Source [SID1234535744]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial results release.

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"We remain on track and excited for the closing of our merger with C3J Therapeutics, which we expect later this month," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "As we continue to progress towards the initiation of our clinical trial of AB-SA01 for the treatment of S. aureus bacteremia later in 2019, we look forward to the combined efforts and capabilities of Armata Pharmaceuticals, offering both natural and synthetic phage therapies to treat antibiotic-resistant infections."

Recent Business Highlights

In January 2019, AmpliPhi and C3J Therapeutics, Inc., a privately held clinical-stage biotechnology company focused on the development of novel synthetically engineered bacteriophage products, announced a definitive agreement under which a wholly owned subsidiary of AmpliPhi will merge with C3J in an all-stock transaction, subject to shareholder approval. Certain existing C3J shareholders have agreed to purchase $10.0 million of common stock of the combined company immediately following the closing of the merger, subject to customary conditions. The financing will help fund further development of the combined company’s preclinical and clinical programs, and is expected to close immediately following the completion of the merger. Management expects the merger will close in mid-May 2019.
First Quarter 2019 Financial Results

Research and development (R&D) expenses for the first quarter of 2019 were $1.5 million, consistent with the first quarter of 2018.
General and administrative (G&A) expenses were $2.1 million for the first quarter of 2019 compared to $1.6 million for the first quarter of 2018. The increase of $0.5 million was primarily due to higher professional fees in the first quarter of 2019.
Net cash used in operating activities for the first quarter of 2019 was $2.6 million, as compared to $3.5 million for the first quarter of 2018.
Cash and cash equivalents at March 31, 2018 totaled $5.5 million.
As of May 6, 2019, there were approximately 33.5 million shares of common stock outstanding.

On May 6, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Wednesday, May 15 at 8:30am Eastern Time to report first quarter ended March 31, 2019 financial results and to provide a corporate update (Press release, VBL Therapeutics, MAY 6, 2019, View Source [SID1234535763]).

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Wednesday, May 15th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13690495
Webcast: View Source

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.