On July 19, 2021 Brickell Biotech, Inc. (Nasdaq: BBI) ("Brickell" or the "Company"), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,064,517 shares of common stock of the Company at a price to the public of $0.62 per share, less underwriting discounts and commissions (Press release, Vical, JUL 19, 2021, View Source [SID1234585086]). The closing of the public offering is expected to occur on or about July 22, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has granted to the underwriter a 30-day option to purchase up to an additional 1,209,677 shares of common stock at the public offering price, less underwriting discounts and commissions.

The gross proceeds of the offering are expected to be approximately $5.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Brickell and assuming no exercise of the option to purchase additional shares. The Company intends to use the net proceeds of the offering for research and development, including clinical trials, working capital and general corporate purposes.

The shares of common stock described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254037) filed with the Securities and Exchange Commission ("SEC") and declared effective on March 17, 2021. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

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This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On July 19, 2021 Immunic, Inc. (the "Company") (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported the closing of an underwritten public offering of 4,500,000 shares of its common stock at a public offering price of $10.00 per share (Press release, Immunic, JUL 19, 2021, View Source [SID1234584952]).

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The Company received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $45.0 million.

Piper Sandler acted as sole book-runner for the offering. Ladenburg Thalmann & Co. Inc., Roth Capital Partners and Aegis Capital Corp. acted as co-managers for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.

The securities described above were offered by the Company pursuant to a shelf registration statement filed by the Company with the Securities and Exchange Commission ("SEC"), which was declared effective on November 24, 2020. A final prospectus supplement and accompanying prospectus related to the offering were filed with the SEC on July 16, 2021 and are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by telephone at (800) 747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 July 19, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has raised £1,000,000, before expenses, through a subscription by a high net worth individual (the "Subscriber") for 14,285,714 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 7p per share (the "Subscription Price") (the "Subscription") (Press release, Sareum, JUL 19, 2021, View Source [SID1234586708]).

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Under the terms of the Subscription, the new Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrant"), which can only be exercised following the Company’s closing middle market share price being above 9p per Ordinary Share for five consecutive days. The Subscription Price represents a premium of approximately 4.5 per cent. to the closing middle market price for Sareum Shares on 16 July 2021.

The net proceeds from the Subscription will be used to progress the Company’s SDC-1801 and SDC-1802 TYK2/JAK1 inhibitor drug development programmes as well as for working capital purposes. As noted in the Company’s Trading Update of 25 May 2021, the Company is targeting the completion of preclinical studies for SDC-1801 in Q3 2021, subject to successful progress. Clinical trial plans, including priority autoimmune indications and potential Covid-19 application, will also be developed in parallel, subject to additional funding being raised.

Application will be made for the 14,285,714 Subscription Shares, which will rank pari passu with the Company’s existing Ordinary Shares, to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") ("Admission"). It is anticipated that Admission will become effective at 8.00 am on 23 July 2021. The Subscription is subject to normal conditions including, inter alia, Admission.

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following the above issue of equity, the issued share capital of the Company will comprise 3,353,579,936 Ordinary Shares. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Dr Tim Mitchell, CEO of Sareum Holdings plc, said: "We are delighted that our proprietary TYK2/JAK1 development programmes are attracting such interest and new investment. With this new subscription, the total funds raised from recent subscriptions and warrant exercises is over £3.5 million. These new funds will allow us both to advance SDC-1801 into clinical development in autoimmune diseases, including the immune overreaction to Covid-19 and other viral infections, and to progress the preclinical development of our second TYK2/JAK1 inhibitor SDC-1802 against cancers."

On July 19, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to COSELA (trilaciclib) investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) (Press release, G1 Therapeutics, JUL 19, 2021, View Source [SID1234587574]). COSELA is currently being evaluated in PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study (NCT04799249) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC.

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Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and Rolling Review in which the Company can submit completed sections of its New Drug Application (NDA) for FDA review rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

"Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "It provides an important pathway to help expedite the development and regulatory review of COSELA in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types."

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15% to 20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating TNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with TNBC compared to other forms of breast cancer, and TNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

On July 19, 2021 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the third quarter of 2021 of $1.06 per share on the company’s common stock (Press release, Johnson & Johnson, JUL 19, 2021, View Source;johnson-announces-quarterly-dividend-for-third-quarter-2021-301336582.html [SID1234584953]). The dividend is payable on September 7, 2021 to shareholders of record at the close of business on August 24, 2021. The ex-dividend date is August 23, 2021.

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