Capital Increase in Genmab as a Result of Employee Warrant Exercise

On July 6, 2021 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 47,974 shares as a consequence of the exercise of employee warrants (Press release, Genmab, JUL 6, 2021, View Source [SID1234584615]).

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The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

Proceeds to the company are approximately DKK 42.04 million. The increase corresponds to approximately 0.07% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No. 1767 of November 27, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,668,714 which is made up of 65,668,714 shares of a nominal value of DKK 1 each, corresponding to 65,668,714 votes.

IDEAYA Announces Proposed Public Offering of Common Stock

On July 6, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUL 6, 2021, View Source [SID1234584631]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $12 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) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under the Company’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities 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 by email at [email protected]; 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]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 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.

XBiotech Announces Dividend to Holders of Common Stock

On July 6, 2021 XBiotech Inc.’s (NASDAQ: XBIT) ("XBiotech") Board of Directors reported that it has declared an extraordinary cash dividend of approximately $2.50 per share, or up to an aggregate of $75 million, to holders of its common stock (Press release, XBiotech, JUL 6, 2021, View Source [SID1234584616]). This one-time, special dividend will be payable on July 23, 2021 to stockholders of record at the close of business on July 16, 2021.

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"XBiotech’s proven ability to develop highly valued drug candidates, revenue from contract operations, judicious deployment of operating capital, absence of debt, and very significant emerging opportunities in our pipeline, has created the balance sheet flexibility that enables us to provide shareholders this dividend," commented John Simard, chairman and CEO of XBiotech.

The Company cannot guarantee any future dividends. The declaration and payment of future dividends, if any, will be at the sole discretion of the Company’s Board of Directors based on its consideration of various factors, including the Company’s operating results, financial condition and anticipated capital requirements.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Biocytogen/Eucure Biopharma’s CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA

On July 6, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing antibody drugs with independent intellectual property rights, reported that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for YH001 (anti-CTLA-4) and YH003 (anti-CD40) in the United States (Press release, Eucure, JUL 6, 2021, View Source [SID1234584632]).

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A phase II, non-randomized, multi-center clinical study will evaluate the use of YH001 in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody (Toripalimab) for the treatment of advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). A phase II, open-label, multi-center study will evaluate the safety and efficacy of YH003 combined with Toripalimab for the treatment of PD-1-resistant unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC). Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China. The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approvals signify "a milestone" for Eucure Biopharma. "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials. This is not only an affirmation of the clinical safety and preliminary efficacy of these two products, but also an affirmation of Biocytogen’s drug discovery platform and in vivo drug efficacy screening model. I am very pleased to see that the Eucure team was able to advance clinical development so efficiently. We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world. With our RenMice HiTS Platform, Eucure’s clinical pipeline will continue to expand with potentially novel best-in-class and first-in-class mAbs for oncologic, viral and autoimmune diseases."

About YH001

YH001 is a humanized IgG1 monoclonal antibody targeting CTLA-4. YH001 enhances the immune response against tumor cells and promotes removal of regulatory T cells from the tumor microenvironment. In phase I first-in-human dose-escalation studies in patients with advanced solid tumors conducted in Australia and China, YH001 has shown best-in-class potential with an improved safety profile compared to Ipilimumab (Yervoy), and promising preliminary efficacy when used in combination with Toripalimab.

About YH003

YH003 is a humanized IgG2 agonistic antibody targeting CD40, a receptor that promotes the activation of antigen-presenting cells and the effector activity of anti-tumor T cells. CD40 activation is a key regulatory point in tumor immunotherapy, effectively transforming cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Available clinical data from the YH003 phase I dose-escalation trial indicates a desirable safety profile when combined with Toripalimab, and a potential breakthrough treatment for PD-1-refractory melanoma.

Cardiff Oncology to Participate in a Fireside Chat at the William Blair Biotech Focus Conference 2021

On July 6, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that Dr. Mark Erlander, chief executive officer of Cardiff Oncology, will participate in a fireside chat and virtual 1×1 investor meetings at the William Blair Biotech Focus Conference 2021 taking place virtually from July 14-15, 2021 (Press release, Cardiff Oncology, JUL 6, 2021, View Source [SID1234584650]).

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Details on the fireside chat can be found below.
Date: Thursday, July 15, 2021
Time: 12:00 – 12:45 PM ET
Webcast Link:
View Source

A replay of the fireside chat will be available by visiting the "Events" section of the Cardiff Oncology website after its conclusion and will be archived on the Company website for 30 days.