Sangamo Therapeutics Announces Second Quarter 2019 Conference Call and Webcast

On July 31, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company will release its second quarter 2019 financial results after the market closes on Wednesday, August 7, 2019 (Press release, Sangamo Therapeutics, JUL 31, 2019, View Source [SID1234538025]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 9582057. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 9582057.

Agilent Companion Diagnostic Gains Expanded FDA Approval in Esophageal Squamous Cell Carcinoma (ESCC)

On July 31, 2019 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use (Press release, Agilent, JUL 31, 2019, https://www.agilent.com/about/newsroom/presrel/2019/31jul-ca19019.html [SID1234537930]).

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The assay is now approved as an aid in identifying patients with ESCC for treatment with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). KEYTRUDA is approved for patients with recurrent locally advanced or metastatic ESCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, with disease progression on or after one prior line of systemic therapy.

PD-L1 IHC 22C3 pharmDx is the only companion diagnostic FDA-approved to aid in identifying ESCC patients for second-line treatment with KEYTRUDA. This is the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval in the United States.

"PD-L1 has been established as an essential biomarker for PD-1/PD-L1 checkpoint inhibitors," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "As a growing number of patients are becoming eligible for treatment with these inhibitors, pathologists’ confidence in their PD-L1 test is critical. With the approval of expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent is able to aid in the identification of patients with ESCC for treatment with KEYTRUDA, while providing pathologists the quality, reliability, and accuracy they need to ensure diagnostic confidence."

In the United States, esophageal cancer is expected to cause approximately 16,000 deaths in 2019.3 ESCC accounts for approximately 30% of all esophageal cancers diagnosed in the United States4 and has a 5-year survival rate of 12%.5

Agilent developed PD-L1 IHC 22C3 pharmDx in collaboration with Merck.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, with their therapeutic value being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC), cervical cancer, gastric or GEJ adenocarcinoma, urothelial carcinoma and head and neck squamous cell carcinoma (HNSCC) patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS). PD-L1 expression in HNSCC, urothelial carcinoma, cervical cancer, gastric or GEJ adenocarcinoma, and ESCC tissues is interpreted using Combined Positive Score (CPS).

BioInvent Announces Selection of First Target Discovered by BioInvent’s Proprietary F.I.R.S.TTM Technology Platform Under Collaboration With Pfizer Inc.

On July 31, 2019 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that Pfizer Inc. ("Pfizer") (NYSE: PFE) has selected the first target under the companies’ cancer immunotherapy research collaboration and license agreement, into which the companies entered in December 2016 to develop antibodies targeting tumor-associated myeloid cells (Press release, BioInvent, JUL 31, 2019, View Source [SID1234537949]).

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The selection of a target triggers a payment from Pfizer to BioInvent of $300,000. Under the terms of the 2016 agreement, potential selection and development of antibodies directed against this target, as well as potential selection of further targets and development of antibodies directed at them, would allow BioInvent to be eligible for further milestone payments.

Martin Welschof, CEO of BioInvent, said: "Selection of this first target shows that our collaboration with Pfizer is successfully progressing. We believe this is an important validation of our F.I.R.S.TTM technology platform, which is a patient-centric approach allowing for the discovery of human antibodies and targets using our high-quality n-CoDeR antibody library."

Luminex Corporation Reports Second Quarter 2019 Financial Results And Increase In Quarterly Dividend

On July 31, 2019 Luminex Corporation (Nasdaq: LMNX) reported financial results for the second quarter 2019 (Press release, Luminex, JUL 31, 2019, View Source [SID1234537966]). Financial and operating highlights for the quarter include:

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Second quarter consolidated revenue increased 4% to $83.1 million from $79.6 million in the second quarter 2018.
Flow cytometry contributed revenue of approximately $13.2 million, or 16% of total consolidated revenue in the second quarter, offsetting the revenue loss of LabCorp Women’s Health.
Royalty revenue of $12.8 million grew 11% over the second quarter 2018. This reflects over $140 million of royalty-bearing base end user sales on Luminex technology, an increase of approximately 10% over the comparable period in 2018.
Sample-to-Answer revenue grew 29%, and sample-to-answer assay revenue grew 31%, over the second quarter of 2018. Additionally, we placed 48 sample-to-answer molecular systems under contract during the second quarter of 2019. Active sample-to-answer customers approximated 640 in the quarter.
Gross margins of 54% in the second quarter, directly affected by the departure of LabCorp revenue coupled with the Flow Cytometry acquisition and integration. Gross margin on the flow revenues individually was 43% and gross margins on the pre-existing non-flow revenues was 57%.
On a GAAP basis, the Company had net losses of $4.9 million in the second quarter 2019, or $0.11 per diluted share, primarily driven by the departure of LabCorp revenue and the integration of the Flow Cytometry acquisition.
The company is increasing its quarterly dividend by 50% to $0.09/share effective immediately with a record date of September 26, 2019 and a payment date of October 17, 2019.
"I am very pleased with the continued progress we are making across the company," said Nachum "Homi" Shamir, President & CEO. "Consistent with our previously communicated plans, we expect to end this year as a much more diversified company with increasing momentum and an exciting portfolio," continued Shamir. "We believe that by the end of 2019, we will have returned to consistent profitability and cash flow, and will be growing at an accelerated organic rate with an improving gross margin position. Due to our confidence in the future of the company and our desire to share our success with our shareholders, we have increased our quarterly dividend by 50% to $0.09/share."

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 third 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, Wednesday, July 31, 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.

The Company makes reference in this release to "non-GAAP net loss" which excludes costs associated with legal proceedings, severance costs, and discrete tax impacts; some of which are unpredictable and can vary significantly from period to period; and certain other recurring and non-recurring expenses. The Company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the Company’s ongoing operating performance while improving comparability to prior periods, and, as such may provide investors with an enhanced understanding of the Company’s past financial performance and prospects for the future. In addition, the Company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income from operations, net income (loss), net income (loss) per share or expense information prepared in accordance with GAAP.

Adamis Pharmaceuticals Announces Proposed Public Offering of Common Stock and Warrants

On July 31, 2019 Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including respiratory disease, allergy and opioid overdose, reported that it intends to offer to sell shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering (Press release, Adamis Pharmaceuticals, JUL 31, 2019, View Source [SID1234538026]). The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock and/or warrants to purchase shares of its common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Raymond James & Associates, Inc. will act as the sole book-running manager for the proposed offering.

The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

The securities described above will be offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or by accessing the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Adamis Pharmaceuticals Corporation

Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused