AIVITA Biomedical to Present at Upcoming Regenerative Medicine, Oncology and Investor Conferences in November

On November 1, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be presenting at the following regenerative medicine and investor conferences in November (Press release, AIVITA Biomedical, NOV 1, 2019, View Source [SID1234550179]):

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Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting
Oral Presentation
Presenter: Dr. Daniela Bota, MD, PhD, University of California, Irvine; AIVITA GBM Principal Investigator
Title: Phase II trial of therapeutic vaccine consisting of autologous dendritic cells loaded with autologous tumor cell antigens from self-renewing cancer cells in patients with newly diagnosed glioblastoma
Time: November 6-10, 2019
Location: Gaylord National Hotel & Convention Center, National Harbor, MD

The Regenerative Medicine Consortium of the Gulf Coast Consortia for Biomedical Sciences
Oral Presentation
Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO
Title: Clinical and Commercial Application of Scaled Human Stem Cell Derivates
Time: November 8, 4:00 PM CT
Location: Bioscience Research Collaborative, Houston, TX

NYC Oncology Investor Conference
Oral Presentation
Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO
Title: AIVITA Corporate Presentation
Time: November 12, 4:50 PM – 5:10 PM
Location: Rockefeller Center, New York, NY

Society for NeuroOncology Annual Meeting
Poster Presentation
Title: Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with newly diagnosed glioblastoma.
Time: November 20-24, 2019
Location: JW Marriott Desert Ridge, Phoenix, AZ

Y-mAbs Announces Closing of Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

On November 1, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the closing of its public offering of 5,134,750 shares of its common stock, at a public offering price of $28.00 per share, which includes the exercise in full of the underwriters’ option to purchase 669,750 additional shares of common stock (Press release, Y-mAbs Therapeutics, NOV 1, 2019, View Source [SID1234550198]). The aggregate gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $143.8 million. All of the shares of common stock were offered by the Company. Y-mAbs’ common stock is listed on The Nasdaq Global Select Market under the ticker symbol "YMAB."

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Morgan Stanley, J.P. Morgan and BofA Securities acted as the joint book-running managers for the offering. Wedbush PacGrow and H.C. Wainwright & Co. acted as co-managers for the offering.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the Securities and Exchange Commission (SEC) on October 30, 2019. A final prospectus supplement relating to the offering was filed with the SEC on October 31, 2019. Copies of the final prospectus relating to the offering are available on the SEC’s website at www.sec.gov. The prospectus and prospectus supplement relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; or BofA Securities, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected].

The shares of common stock described above are being offered by Y-mAbs pursuant to its shelf registration statement on Form S-3 (Reg. No. 333-234034), including a base prospectus, that was filed with the SEC on October 1, 2019 and declared effective by the SEC on October 15, 2019. The securities are being offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

TETRAPHASE PHARMACEUTICALS ANNOUNCES COMPLETION OF $8 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET

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.

Minomic and Sienna enter collaboration agreement to develop pancreatic cancer test

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

Entry Into a Material Definitive Agreement

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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