Exicure, Inc. Added to Russell 2000® Index

On June 29, 2020 Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that it has been added to the Russell 2000 index. This addition was effective June 26, 2020 (Press release, Exicure, JUN 29, 2020, View Source [SID1234561541]).

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"We are pleased that Exicure has reached this important milestone," said Dr. David Giljohann, Exicure’s Chief Executive Officer. "We look forward to telling a growing set of investors about our clinical progress in neurology, oncology, and ophthalmology using our genetic medicines," concluded Dr. Giljohann.

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CRISPR THERAPEUTICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON SHARES

On June 29, 2020 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported that it is commencing an underwritten public offering of $325,000,000 of common shares (Press release, CRISPR Therapeutics, JUN 29, 2020, View Source [SID1234563988]). In addition, the underwriters will have a 30-day option to purchase up to an additional $48,750,000 of common shares at the public offering price less the underwriting discount.

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Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the 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 common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to 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]; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

Rakuten Medical Receives Conditional Early Approval Designation from Japanese Health Ministry for its Lead Drug, ASP-1929, to Treat Recurrent Head & Neck Cancer

On June 29, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS) (Press release, Rakuten Medical, JUN 29, 2020, View Source [SID1234561523]). Compared to standard review the CEAS speeds up the approval process, bringing potentially life-saving treatments to patients faster.

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Rakuten Medical is developing precision cell-targeting investigational therapies on its Illuminox technology platform. ASP-1929, the first investigational drug developed on this platform, is currently undergoing Phase III clinical development for the treatment of recurrent head and neck cancer.

Rakuten Medical submitted a Japanese Biological License Application (JBLA) for this drug on March 26, 2020 – based on results of Phase I / II clinical trials. In addition – on March 19, 2020 – the company applied for Japan approval of the laser illumination system which is utilized in conjunction with ASP-1929.

"This prestigious designation confirms the potential of our technology to bring the light of hope to cancer patients as quickly as possible," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical regarding the Conditional Early Approval designation of ASP-1929. "This designation further validates the success of our ongoing work and inspires us to rapidly develop additional innovative therapies on the Illuminox platform for the benefit of patients suffering from cancer."

Genprex Added to Russell 3000® Index

On June 29, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it was added to the Russell 3000 Index after the market closed on Friday, June 26, 2020 as part of the 2020 Russell U.S. Indexes reconstitution (Press release, Genprex, JUN 29, 2020, View Source [SID1234561542]).

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"Genprex is excited to be a member of the Russell 3000 Index, and we look forward to sharing our story and unique approaches for the treatment of lung cancer and diabetes with a wider group of investors," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "We believe the Company’s future is bright as we work to secure better outcomes for patients suffering from these serious medical conditions."

In January 2020, Genprex was awarded U.S. FDA Fast Track designation for use of GPX-001 (quaratusugene ozeplasmid) combined with Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company also signed in early 2020 an exclusive license agreement with the University of Pittsburgh for a preclinical diabetes gene therapy candidate that has the potential to cure Type 1 and Type 2 diabetes. Earlier this year, the Company significantly strengthened its balance sheet through "at the market" capital raises without warrants, plus the exercise by investors of most outstanding Company warrants, aggregating approximately $28 million in proceeds to the Company. The funds will support the Company’s research and development programs and other corporate uses and initiatives, which could include strategic transactions.

The Russell 3000 Index includes the 3,000 publicly traded companies on the Nasdaq and NYSE exchanges with the largest market capitalizations. FTSE Russell, a leading global index provider, determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes (i.e. growth or value). Each June, the Russell 3000 index is reconstituted to reflect market capitalization changes over the prior year. This closely watched market event impacts more than $9 trillion in investor assets benchmarked to or invested in products based on the Russell U.S. indices.

Achieve Life Sciences Announces Pricing of $6 Million Registered Direct Offering

On June 29, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 14,634,146 shares of common stock at a price of $0.41 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses (Press release, OncoGenex Pharmaceuticals, JUN 29, 2020, View Source [SID1234561524]). The offering is expected to close on or about July 1, 2020, subject to customary closing conditions.

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Lake Street Capital Markets LLC is acting as exclusive placement agent for the registered direct offering.

The shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-229019), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 11, 2019. The Company intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at [email protected].