On November 1, 2019 Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported the completion of its previously announced registered direct offering to a healthcare-focused institutional investor priced at-the-market, of (i) 300,000 shares of common stock and accompanying warrants to purchase an aggregate of 300,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 1,830,493 shares of common stock and accompanying warrants to purchase an aggregate of 1,830,493 shares of common stock (Press release, Tetraphase, NOV 1, 2019, View Source [SID1234550199]). Each share of common stock and accompanying common stock warrant were sold together at a combined price of $3.755, and each pre-funded warrant and accompanying common stock warrant were sold together at a combined price of $3.745. Each pre-funded warrant has an exercise price of $0.01 per share, is exercisable immediately and is exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant has an exercise price of $3.62 per share, is exercisable immediately and expires five years from the date of issuance.

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The net proceeds to the Company from the offering, after deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are approximately $7.0 million. The Company intends to use the net proceeds from the offering for the commercialization of XERAVA as well as for working capital and other general corporate purposes.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

A shelf registration statement relating to the securities offered in the registered direct offering described above was filed with the Securities and Exchange Commission (SEC) on January 25, 2018 and declared effective by the SEC on February 5, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus related to the offering has been filed with the SEC and may be obtained, for free by visiting EDGAR on the SEC website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

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

On November 1, 2019 Minomic International Ltd reported that it has entered into a research collaboration agreement with Sienna Cancer Diagnostics Ltd (ASX: SDX) ("Sienna" or "the Company"), a medical technology company developing and commercialising innovative cancer-related tests, to develop a proprietary test for the early detection of pancreatic cancer (Press release, Minomic, NOV 1, 2019, View Source [SID1234550126]).

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This will be the first application of Sienna’s capture technology that was acquired in April 2019. The general capture technology is trademarked as SIEN-NET and the specific exosome capture technology as EXO-NET. Sienna will provide EXO-NET beads which rapidly and specifically capture exosomes (nanoparticles shed from cells into the bloodstream) from blood and other body fluids.

Several independent studies have indicated that exosomes from pancreatic cancer patients contain a protein called glypican-1 (GPC-1). Minomic holds a strong intellectual property position around GPC-1 with four families of patents already completing Patent Cooperation Treaty applications. Based on the data, the companies have agreed to enter into a collaboration to conduct research to determine the feasibility of producing an assay for the accurate screening, diagnosis and prognosis of pancreatic cancer.

About pancreatic cancer

Pancreatic ductal adenocarcinoma (PDAC) is the most lethal cancer in humans, with a five-year survival rate of less than 10%. Cancer Australia estimates that 3,599 new cases of pancreatic cancer will be diagnosed in Australia in 2019[1]. Notably, due to the asymptomatic nature of early-stage pancreatic cancer and the lack of a non-invasive early-stage diagnostic assay, approximately 80–85% of cases at initial diagnosis present with unresectable advanced or metastatic disease. The median survival time for these patients is only 3–14 months[2].

A biomarker assay that can specifically detect asymptomatic premalignant or early malignant tumours and predict the response to treatment would greatly benefit these patients[3]. Minomic and Sienna aim to deliver such an assay through this collaboration.

"Minomic International Ltd is excited to work with Sienna to develop this opportunity to extend the use of our GPC-1 antibody beyond prostate cancer detection", said Minomic’s Chief Executive Officer Dr Brad Walsh.

"We are pleased to have entered into this collaboration with Minomic, and we are very hopeful that it will result in the development of a novel and reliable assay for the detection of pancreatic cancer to add to the company’s pipeline of cancer diagnostic tests. It is a perfect first application for our proprietary biomarker capture technology, SIEN-NET", said Sienna’s Chief Executive Officer, Carl Stubbings.

The companies will share the costs of the proof of concept stage of the development.

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[1] View Source

[2] Lu H, Niu F, Liu F, Gao J, Sun Y, Zhao X. Elevated glypican-1 expression is associated with an unfavorable prognosis in pancreatic ductal adenocarcinoma. Cancer Med 2017; 6(6):1181–1191

doi: 10.1002/cam4.1064

[3] Qi Z-H, Xu H-X, Zhang S-R, Xu J-Z, Li S, Gao H-L, Jin W, Wang W-Q, Wu C-T, Ni Q-X, Yu X-J, Liu L.

The significance of liquid biopsy in pancreatic cancer. J Cancer 2018; 9(18): 3417-3426. doi: 10.7150/jca.24591

On November 1, 2019, Varian Medical Systems, Inc. (the "Company") reported that entered into the Amendment No. 2 to Credit Agreement (the "Amendment") to its Credit Agreement dated as of April 3, 2018 (the "Credit Agreement"), by and among the Company, certain lenders party thereto, and Bank of America, N.A., as administrative agent, swing line lender and letter of credit issuer (Filing, 8-K, Varian Medical Systems, NOV 1, 2019, View Source [SID1234550401]). The Amendment, among other things, reduces the aggregate principal amount available under the revolving credit facility provided under the Credit Agreement from $1.8 billion to $1.2 billion, reduces the commitment fee, adds a $500 million sublimit for multi-currency borrowings, increases the letter of credit sublimit to $225 million, extends the maturity date from April 2023 to November 2024 and adds BNP Paribas and Goldman Sachs to the lender group.

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On November 1, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three months ended September 30, 2019, as well as provide guidance on expected revenues and operating expenses for the third quarter 2019, after the close of the U.S. financial markets on Tuesday, November 5, 2019 (Press release, Opko Health, NOV 1, 2019, View Source [SID1234550185]).

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OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Tuesday, November 5, 2019.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Tuesday, November 5, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 7270239
WEBCAST: OPKO 3Q19 Results Conference Call
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 7270239. The replay can be accessed for a period of time on OPKO’s website at OPKO 3Q19 Results Conference Call.

On November 1, 2019 Biodesix, Inc., reported that it has completed acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States, further extending the company’s blood-based lung cancer diagnostic portfolio (Press release, Biodesix, NOV 1, 2019, View Source [SID1234550186]). The United Kingdom-based company’s U.S. commercial and lab operations, including a Clinical Laboratory Improvement Amendments (CLIA) lab in DeSoto, Kansas, today transitioned to Biodesix. The Kansas lab is the sole U.S. provider of the EarlyCDT Lung test.

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"Biodesix is a leader in the development and delivery of blood-based diagnostic solutions for lung cancer. The completion of the acquisition of Oncimmune in the U.S. is emblematic of our continued growth in providing support across the continuum of patient lung care," said David Brunel, CEO of Biodesix. "Oncimmune shares this commitment, and we are proud to continue our partnership. We are both dedicated to robust science and quality, while putting the individual patient experience first."

Biodesix will offer complementary tests that help empower physicians to stratify patients into distinct nodule management pathways. The EarlyCDT Lung test helps physicians determine if an incidental pulmonary nodule (IPN) is potentially cancerous, while the Nodify XL2TM Test is used to help physicians identify those IPNs with a very low risk of cancer. In addition to lung nodule management, the EarlyCDT Lung test may have future utility in lung cancer screening. Results from Early detection of Cancer of the Lung Scotland (ECLS), a randomized controlled study of 12,209 people at high risk of developing cancer, were presented at the International Association for the Study of Lung Cancer’s (IASLC) 2019 World Conference on Lung Cancer in Barcelona.

"We are delighted to be working with Biodesix, a company with a successful track record of commercializing clinical diagnostic lung tests in the U.S. and that is dedicated to improving patient management and outcomes. In the near term, EarlyCDT Lung is a very synergistic addition to the Nodify XL2 test in helping physicians manage IPNs. Longer term, the addition of a screening indication for EarlyCDT Lung in the U.S. will fully realize the value of the test and will ultimately save lives through earlier detection of lung cancer," said Adam M. Hill, M.D., Ph.D., CEO of Oncimmune.