On June 1, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 22,044,447 shares of its common stock, including 3,333,334 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares, and of pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock (Press release, BioCryst Pharmaceuticals, JUN 1, 2020, View Source [SID1234560722]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $115 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst.

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BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVAB/ALPIVAB; and capital expenditures and other general working capital needs.

J.P. Morgan and Piper Sandler acted as joint book-running managers for the offering. H.C. Wainwright & Co. and JMP Securities acted as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-866-803-9204 or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

On June 1, 2020 AVEO Oncology (NASDAQ: AVEO) reported that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC) (Press release, AVEO, JUN 1, 2020, View Source [SID1234560721]). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.

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"The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option," said Michael Bailey, president and chief executive officer. "We look forward to working closely with the FDA over the coming months during their review of our application. In parallel, we continue to focus on commercial-readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval."

The NDA submission is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. The application is also supported by three additional trials, including an active comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to sorafenib in first line RCC, and two Phase 2 studies, Study 902, the open-label, crossover clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first line RCC. In total, data from over 1,000 clinical trial subjects support the application.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory

submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

on June 1, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it has commenced an underwritten public offering of $75 million of shares of its common stock (Press release, Intellia Therapeutics, JUN 1, 2020, View Source [SID1234560720]). Intellia also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies and SVB Leerink are acting as joint book-running managers for the proposed offering. The 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.

The shares of common stock are being offered by Intellia pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; by telephone at (800) 808-7525, ext. 6218; or email: [email protected]; or by accessing the SEC’s website at www.sec.gov.

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.

On June 1, 2020 TapImmune Presented the Corporate Presentation (Presentation, TapImmune, JUN 1, 2020, View Source [SID1234560719]).

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On June 1, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological research, reported that its subsidiary Sapphire Biotech, Inc. ("Sapphire") has started pre-clinical animal drug studies on its new compound, SPX-1009 (Press release, AXIM Biotechnologies, JUN 1, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-begins-pre-clinical-pharmacokinetic-animal-drug-studies-on-its-cancer-drug-compound-spx-1009 [SID1234560718]).

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"We look forward to the next step in the race to finding a cure for cancer," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "After very positive in vitro studies, this pharmacokinetic animal study will tell us whether we have a potential drug candidate for humans. Because it is an analog of a drug that has already completed animal studies, we expect positive results."

Quiescin Sulfhydryl Oxidase 1 (QSOX1), an enzyme that is over-expressed by tumor cells in numerous cancers, has been shown to be involved in cancer invasion and metastasis. Earlier this year, Sapphire acquired exclusive license rights to a small molecule, SBI-183. SBI-183 has been proven to inhibit the enzymatic activity of QSOX1 and suppress tumor cell invasion in vitro and metastasis of MDA-MB-231 breast tumor cells in vivo. SBI-183 also suppressed human xenograft primary kidney tumor growth by 86 percent compared to controls.

Sapphire scientists have generated and tested over 90 analogs of SBI-183 and discovered that one analog, SPX-1009, was tenfold more potent than SBI-183 in suppressing tumor invasion and metastasis in vitro. Further testing revealed that SPX-1009 suppressed invasion of breast, kidney and pancreas tumor cells in 2D and 3D invasion assays at tenfold lower concentrations than the parent compound SBI-183.

Oral and intravenous therapy (IV) formulations of SPX-1009 are being tested in pharmacokinetic animal studies to determine the optimal route of treatment.

"We are hopeful that SPX-1009 will block metastasis in patients which, after all, is what causes death in the vast majority of cancer patients," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech.