On June 16, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported the dosing of the first patient enrolled in the Phase 2 dose expansion stage of the cavrotolimod (AST-008) Phase 1b/2 clinical trial (ClinicalTrials.gov identifier: NCT03684785) (Press release, Exicure, JUN 16, 2020, View Source [SID1234561139]).

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"We believe this milestone marks an important step toward fulfilling an unmet treatment need for Merkel cell carcinoma patients who have been resistant to checkpoint inhibitor antibody therapy," said Dr. Douglas Feltner, Chief Medical Officer of Exicure.

The Phase 2 dose expansion stage includes two cohorts of patients with advanced or metastatic cancer: patients with Merkel cell carcinoma (MCC) and patients with cutaneous squamous cell carcinoma (CSCC). MCC is a rare, aggressive skin cancer considered more deadly than melanoma. Risk factors for MCC include sun exposure and a weakened immune system. Advanced or metastatic CSCC is an uncommon form of skin cancer associated with significant morbidity and mortality.
The dose expansion stage is designed to assess the anti-tumor response rate of cavrotolimod plus checkpoint inhibitor treatment, the safety and tolerability of the combination, and drug pharmacodynamics and pharmacokinetics. Patients enrolled in the dose expansion cohorts must have recently documented tumor progression despite anti-PD-1 or anti-PD-L1 antibody monotherapy.

About Cavrotolimod (AST-008)
Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications. In December 2019, Exicure announced preliminary results from the Phase 1b stage of the clinical trial including potential signs of anti-tumor activity with cavrotolimod in combination with pembrolizumab in patients with MCC. To date, 20 patients in the Phase 1b stage of the clinical trial have been dosed, and no cavrotolimod-related serious adverse event or dose-limiting toxicity has been reported. The most commonly reported adverse events were injection site reactions and flu-like

symptoms. In the second quarter of 2020, Exicure initiated Phase 2 dose expansion cohorts of intratumoral cavrotolimod in combination with approved checkpoint inhibitors to treat two cohorts of patients with advanced or metastatic MCC or CSCC. Each cohort is expected to enroll up to 29 patients whose tumors have progressed on anti-PD-1/PD-L1, or programmed cell death protein 1/programmed death-ligand 1, antibody monotherapy.

On June 16, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company") reported the pricing of its previously announced public offering of 76,923,077 shares of its common stock (or common stock equivalents in lieu thereof) at a price to the public of $0.325 per share of common stock (or common stock equivalent) (Press release, Actinium Pharmaceuticals, JUN 16, 2020, View Source [SID1234561156]). The aggregate gross proceeds from this offering are expected to be approximately $25.0 million, before deducting placement agent fees and other estimated offering expenses payable by Actinium. The offering is expected to close on or about June 19, 2020, subject to satisfaction of customary closing conditions.

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

Actinium intends to use the net proceeds from the offering to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, prepare and submit a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") and Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA") as well as commercialization activities for Iomab-B in the United States. Net proceeds from this offering will also be used to progress Phase 1 trials for its refocused CD33 program to the proof of concept stage, to support its AWE Technology Platform, Iomab-ACT program, research and development and for general working capital needs.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on October 12, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and, when available, may be obtained for free on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, by telephone: (646) 975-6996 or by e-mail: [email protected].

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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 16, 2020 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") reported the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 ("May Notes") pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the "November Notes" and, together with the May Notes, the "Original Notes") pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, Bristol-Myers Squibb, JUN 16, 2020, View Source [SID1234561123]).

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The May Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with the Bristol Myers Squibb’s acquisition of Celgene Corporation ("Celgene") and to pay related fees and expenses. The November Notes were issued in a private offering upon the completion of Bristol Myers Squibb’s offers to exchange ("prior exchange offers") any and all outstanding notes issued by Celgene.

Bristol Myers Squibb is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the May Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the issuance of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. Bristol Myers Squibb will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

Bristol Myers Squibb will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on July 15, 2020 (as the same may be extended by Bristol Myers Squibb with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, Bristol Myers Squibb will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

A Registration Statement on Form S-4 (File No. 333-238533) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on May 20, 2020 and was declared effective on June 15, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated June 16, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent in connection with the Registered Exchange Offers, at (866) 924-2200 (U.S. toll-free) or (212) 430-3774.

On June 16, 2020 eTheRNA immunotherapies NV (‘eTheRNA’ or ‘The Company’), a clinical-stage company developing immunotherapies from its proprietary mRNA TriMix platform for the treatment of cancer and infectious diseases, reported that it has successfully raised Euro 34 million in a Series B equity financing round (Press release, eTheRNA, JUN 16, 2020, View Source [SID1234561140]). All existing investors – LSP (the Netherlands), PMV (Belgium), Boehringer Ingelheim Venture Fund (Germany), Fund+ (Belgium) and Omega Funds (USA) – are participating in the round. They are joined by Grand Decade, a BVI subsidiary owned by China Grand Pharmaceutical and Healthcare Holdings Ltd (‘GP(HK)’; HKSE Stock code 00512), BNP Paribas Fortis Private Equity (Belgium), Yijing Capital (China) and Novalis LifeSciences LLC (USA). GP(HK) and eTheRNA have also agreed outline terms for a possible exclusive strategic partnership for mRNA manufacturing, independent research and development, production and commercialization in Greater China.

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Proceeds of the financing will fund continued development and commercialization of proprietary mRNA technologies and a range of therapeutic products. eTheRNA’s TriMix platform is a core differentiating component in the Company’s product programs and comprises three mRNAs encoding proteins that act together to significantly increase immune responses. TriMix has demonstrated broad application across major cancer types, both preclinically and clinically, offering the prospect of therapeutic vaccines and localised tumor treatments acting synergistically with standard of care treatments. To facilitate its product development activities eTheRNA has developed a proprietary lipid nanoparticle (LNP) platform to enable intravenous delivery of various (neo)antigens, which in combination with TriMix results in unprecedented immune responses. Not only will eTheRNA start clinical development of its internal programs for intravenous mRNA delivery, the Company will also explore partnering opportunities. In infectious diseases, eTheRNA’s technologies are being deployed in an eTheRNA-led international consortium which is developing a cross-strain protective SARS-CoV-2 mRNA vaccine for high risk populations.

Dr Russell Greig, Chairman eTheRNA, commented: "The growing evidence of TriMix’s robustness and versatility as a differentiating immune stimulatory platform in a number of clinical indications was a key factor in the successful conclusion of this new funding round. We are excited that the current Series B financing provides eTheRNA with the opportunity to advance its oncology and infectious diseases pipeline further into the clinic, with the primary objective being to demonstrate clinical proof-of-concept in the near term, including for its proprietary LNP platform enabling intravenous delivery of (neo)antigens. We are delighted with the response from both existing and new investors. In addition, the strategic partnership with China Grand Pharma opens a wealth of opportunities in this potentially vast market and we are looking forward to concluding this partnership."

On June 16, 2020 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $60 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUN 16, 2020, View Source [SID1234561157]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $9 million of shares of its common stock. 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.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) preclinical and clinical development of IDE397, its MAT2A inhibitor development candidate, and other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, and a DNA Damage Target, or DDT, as well as its share of costs for targeting WRN under the previously announced Collaboration, Option and License Agreement with GSK, (ii) ongoing early clinical development of IDE196, its PKC inhibitor, and binimetinib, a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada, as combination therapy in metastatic uveal melanoma, or MUM and other solid tumors having GNAQ/11 hotspot mutations, as well as ongoing clinical trials evaluating IDE196 as monotherapy in such indications, (iii) biomarker research and development activities and (iv) working capital and other general corporate purposes.

J.P. Morgan, Citigroup and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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.