On December 23, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that its chief executive officer, Dr. Amit Kumar, will present at the Biotech Showcase 2020 conference being held January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California (Press release, Anixa Biosciences, DEC 23, 2019, View Source [SID1234552578]).

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During the presentation, Dr. Kumar will highlight recent corporate and commercial achievements, including the U.S. launch of Anixa’s Cchek Prostate Cancer Confirmation (Cchek PCC) test, as well as anticipated milestones for its CAR-T based ovarian cancer therapeutic and breast cancer vaccine programs.

Details of the presentation are as follows:

Event:

Biotech Showcase 2020

Date:

Monday, January 13, 2020

Time:

11:00 a.m. (PST)

Track:

Franciscan A

Location:

Hilton San Francisco Union Square

Anixa will also host one-on-one meetings with investors and industry stakeholders during the event. Please contact Miriam Miller at Tiberend Strategic Advisors for availability or to follow-up after the conference.

Biotech Showcase is one of the industry’s largest annual healthcare investor and partnering conferences, bringing together biopharmaceutical and life sciences company executives, investors, sector analysts, bankers and industry stakeholders. More than 400 presentations from mid-, small- and micro-cap public and private companies are expected to present at the event. Qualified investors and buy- and sell-side analysts are invited to request a complimentary registration to attend Biotech Showcase and its sister event, Digital Medicine & Medtech Showcase. For more information click here.

On December 23, 2019 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open access technology platform for biologics, the all-in-one solution for research, development and manufacturing offers biological preparations, reported the "Special Award to Investors in Ireland " at the Asia Matters Global Business Summit 2019 (Press release, WuXi Biologics, DEC 23, 2019, View Source [SID1234552594]). This is Ireland’s only Asian think tank that specifically deals with trade, investment and economic issues, as well as international relations between the EU and Asia.

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The "Special Award to Investors in Ireland " is given to a newly established company that invests in Ireland. The emphasis is on a long-term and significant contribution to economic growth, employment, research and corporate social responsibility (CSR). Last year, WuXi Biologics a "Factory of the Future" for the production of biologicals was built in Dundalk. A second investment was announced last month by its subsidiary WuXi Vaccines. A new vaccine production facility is to be built at the Dundalk site.

"We are extremely pleased to receive this award from Asia Matters . It demonstrates the great progress we are making in Ireland, "said Dr. Chris Chen , CEO of WuXi Biologics, speaking at the summit." Based on our leading expertise and expertise in the high-growth biology business, we will continue to be our local and global partners provide a robust and world-class supply chain for the benefit of patients around the world. "

On December 23, 2019 SciTech Development reported that the U.S. Food and Drug Administration (FDA) has accepted Investigational New Drug (IND) Application for ST-001 nanoFenretinide, an experimental treatment for T-cell non-Hodgkin’s lymphoma (NHL) (Press release, SciTech Development, DEC 23, 2019, View Source [SID1234552595]).

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The FDA approved IND provides clearance for ST-001 nanoFenretinide to enter the clinic. SciTech’s Phase I clinical trial will be conducted at the Rush University Medical Center (Chicago, IL) under the guidance and direction of Timothy M. Kuzel, MD, FACP, Samuel G Taylor III MD Professor of Oncology, Chief, Division of Hematology/Oncology/Cell Therapy; Deputy Director, Clinical Affairs, Rush University Cancer Center (Principal Investigator, PI). The study is planned to enroll patients with relapsed/refractory (R/R) T-Cell NHL and is scheduled to begin in mid-2020 with the potential to advance to a registration trial in late 2021.

"The IND approval is an important step to enabling the collection of first-in-human safety data for nanoFenretinide. We hope to provide required data for eventual full registration of this potential treatment for cutaneous T-cell lymphoma to meet the continuing unmet needs of this rare disease population," said Dr. Kuzel.

SciTech’s ST-001 nanoFenretinide technology is a cancer drug employing a nanoparticle suspension for intravenous administration. ST-001 is comprised of nanoparticle-sized fenretinide in a patented combination with carefully selected phospholipids. SciTech’s product pipeline includes nanoFenretinide formulations for the treatment of several cancer indications.

"FDA approval of our IND for ST-001 is a significant milestone in the development of our SciTech Drug Delivery Vehicle (SDV) program," said Earle Holsapple, President of SciTech Development. "Moving forward, and in addition to the previously granted Orphan Drug Status (Feb. 1, 2018) for the treatment of peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), we intend to make use of other FDA expedited programs including fast track designation, priority review and expedited new drug application (NDA) approval in bringing ST-001 nanoFenretinide to market."

SciTech Development will present an update at the Biotech Showcase on Monday, January 13, 2020 at 11:15am (PST) at the Hilton San Francisco Union Square Hotel (Room: Franciscan B), 333 O’Farrell Street, San Francisco, CA. Qualified investors can register to attend Biotech Showcase free of charge and SciTech personnel will be available during the annual JPMorgan Healthcare Conference in San Francisco. For ST-001 nanoFenretinide investment and partnering opportunities contact Earle Holsapple | +1-313-263-4887 | [email protected]

On December 23, 2019 Neogen Corporation (NASDAQ: NEOG) reported that its revenues for the second quarter of its 2020 fiscal year, which ended Nov. 30, were $107,803,000, compared to the previous year’s second quarter revenues of $107,098,000 (Press release, Neogen, DEC 23, 2019, View Source [SID1234552596]). Current year-to-date revenues were $209,227,000, compared to $206,724,000 for the same period a year ago.

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The second quarter was the 111th of the past 116 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the last 14 years.

Second quarter net income was $16,276,000, or $0.31 per share, compared to the prior year’s $16,051,000, also $0.31 per share. Net income for the second quarter was benefitted by an effective tax rate of 15.3%; the rate in last year’s second quarter was 18.5%. Current year-to-date net income was $30,928,000, or $0.59 per share, compared to $31,288,000, or $0.60 per share, for the same period a year ago.

"For the quarter, we had strong performance in a number of our businesses, but we continue to fight challenges in our animal safety markets," said John Adent, Neogen’s president and chief executive officer. "Our overall genomics business continued to grow nicely, with revenues up 17%, driven by strong performance at our U.S. operations; these results were augmented by significant revenue increases at our newest global genomics locations in Australia and Canada.

"Our second quarter featured solid growth from our core food safety diagnostic product lines, including our food allergen, general sanitation, and foodborne pathogen testing products," Adent continued. "Despite continuing currency headwinds, our international revenues, which now include sales into 129 countries, increased 6% in the quarter."

Neogen’s gross margin was 47.3% of sales in its second quarter of the current year, compared to 46.7% recorded in the same quarter of the prior fiscal year. The change in margin percentage was the result of a product mix shift towards Food Safety products, which have higher margins, and gross margin improvements within our domestic genomics business. Operating income was $18,272,000, or 16.9%, for the second quarter, compared to $18,246,000, or 17.0%, in the same quarter a year ago.

"We continue to generate strong operating cash flow, but our sales results were again adversely affected by the impact of the strong dollar. In a neutral currency environment, we would have reported approximately $1 million more in revenues in the current quarter," said Steve Quinlan, Neogen’s chief financial officer. "Our balance sheet is strong, and our acquisition team is working on a number of opportunities that have the potential to drive future growth."

Revenues for the company’s Food Safety segment increased 6%, all organic, during the second quarter compared to the prior year quarter, from $53,750,000 to $56,854,000. The segment’s increase was led by a 14% rise in global sales of test kits to detect food allergens, with particular strength in sales of gluten, milk, egg and tree nut kits. This sales increase was aided by the introduction of a test kit for coconut in the past year, which represented the 19th allergen for Neogen’s comprehensive line of food allergen test kits.

Of note in the Food Safety segment’s current second quarter results was a 21% increase in sales of general sanitation tests. These tests include the product line to detect adenosine triphosphate (ATP) on food contact surfaces and in liquids. Sales of Neogen’s line of foodborne pathogen (e.g., Listeria and Salmonella) detection products also increased 11% in the current quarter compared to the prior year quarter. The increase was led by a 25% increase in sales of tests to detect Listeria, including Listeria Right Now, which detects and reports the bacteria in environmental samples in under 60 minutes — without the need to enrich samples. These increases were partially offset by a 29% decrease in sales of the company’s drug residue product line, the result of lower demand at our European distributor.

In the current quarter, revenues from international sources increased to 41% of total revenues, compared to 39% in the prior year quarter. Highlights of the current quarter included a 20% increase in revenues in our Brazilian operations, largely due to increased insecticide sales to governmental agencies, which overcame the loss of a large commercial lab customer that performs drug testing of truck and bus drivers in that country. Other international highlights within the quarter included a 7% revenue increase at our Neogen Europe operations; revenues that rose 5% at Mexico-based Neogen Latinoamerica; Neogen China’s increase of 40%, albeit from a smaller base; and Neogen Australasia’s quarterly revenue increase of 18%.

Neogen’s Animal Safety segment reported revenues of $50,949,000 for the second quarter of the 2020 fiscal year, compared to $53,348,000 in the prior year second quarter, a decrease of 4%, primarily the result of continued soft market conditions in our animal protein markets and inventory destocking within our distribution channels. Partially offsetting this was strong growth in the genomics testing business, a 28% increase in sales of the company’s disposable syringes, and a 15% increase in veterinary marking products.

Revenues from Neogen’s worldwide animal genomics business increased 17% in the second quarter of fiscal 2020 compared to the prior year. In the quarter, revenues from Neogen’s companion animal genomics business more than doubled as the company gained market share within the veterinary market. Neogen’s cattle genomics business remained strong, both for associations and for commercial producers, with revenues up from the prior year, and the company’s swine genomics business rose compared to the prior year quarter.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing, and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

On December 23, 2019 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or the Company, reported entering into an agreement with funds affiliated with an institutional investor providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of Series B1 convertible preferred stock and warrants to purchase common stock for aggregate gross proceeds of $3.9 million (Press release, Idera Pharmaceuticals, DEC 23, 2019, View Source [SID1234552581]). In connection with the agreement for the private placement, the investors in the private placement will pay Idera an upfront option fee of approximately $6.2 million. Under the agreement, Idera also agreed to sell to the investors, at their option and subject to certain conditions including stockholder approval to increase Idera’s authorized shares of common stock, shares of Series B2, Series B3 and Series B4 convertible preferred stock and warrants to purchase common stock for aggregate gross proceeds of up to an additional $87.6 million over a 21 month period after stockholder approval is received. The Company has the right to decline the Series B4 investment if its common stock trades at $7.60 for 20 days out of 30 days subsequent to the closing of the Series B3 investment.

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The transaction was priced at-the-market under the Nasdaq rules. The Series B1 convertible preferred stock and associated warrant had a combined purchase price on an as converted basis of $1.645. The warrants to purchase common stock have an exercise price of $1.52 per share and an exercise period commencing on issuance and a term of seven years.

The Company plans to use the proceeds from the financing primarily to fund the completion, of the ongoing ILLUMINATE-301 clinical trial of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma. The Company also plans to use the subsequent proceeds, if exercised, to fund the potential NDA filing and commercial launch of tilsotolimod along with the ongoing ILLUMINATE-206 trial, and for general corporate purposes.

The shares of convertible preferred stock and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. Idera has granted the purchasers resale registration rights for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 Tilsotolimod (IMO-2125)

Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, provide benefit for some patients, but these therapies are limited in patients whose immune responses are missing or weak. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.