Castle Biosciences Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On December 18, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), reported the closing of its previously announced underwritten public offering of 4,600,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 600,000 shares, at a public offering price of $58.00 per share (Press release, Castle Biosciences, DEC 18, 2020, View Source [SID1234573091]). The gross proceeds to Castle from the offering, including the shares sold pursuant to the underwriters’ option, before deducting the underwriting discounts and commissions and other offering expenses payable by Castle, were $266.8 million.

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SVB Leerink and Baird acted as joint bookrunning managers in the offering. Canaccord Genuity acted as passive bookrunner and BTIG and Lake Street Capital Markets acted as co-managers in the offering.

The securities described above were offered by Castle pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Castle and became effective by rule of the Securities and Exchange Commission (the "SEC") on December 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone at (800) 792-2473, or by email at [email protected].

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 offer or 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.

Nanobiotix Announces Closing of Underwriters’ Option to Purchase Additional ADSs

On December 18, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – Nasdaq: NBTX – the ‘‘Company’’), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the closing of an additional 1,095,000 American Depositary Shares ("ADSs") pursuant to the full exercise of the underwriters’ option to purchase additional ADSs in connection with the Company’s initial public offering on the Nasdaq Global Select Market (Press release, Nanobiotix, DEC 18, 2020, View Source [SID1234573090]).

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The 1,095,000 additional ADSs were sold at $13.50 per ADS, the same public offering price as in the initial public offering. Consequently, the total number of ordinary shares issued amounts to 8,395,000, including 6,540,000 in the form of ADSs, and the total net proceeds (including the sale of the additional ADSs pursuant to the exercise of the underwriters’ option), after deducting underwriting commissions and estimated offering expenses payable by Nanobiotix, from the initial public offering were approximately $100.4 million (€82.8 million)1. The Company believes that the total net proceeds, together with its cash and cash equivalents, will be sufficient to fund its operations through the middle of the second quarter of 2023.

Nanobiotix’s ordinary shares are listed on the regulated market of Euronext in Paris under the ticker symbol "NANO". Nanobiotix’s ADSs began trading on the Nasdaq Global Select Market on December 11, 2020 under the ticker symbol "NBTX".

Jefferies LLC acted as global coordinator and joint book-running manager for the global offering, and Evercore Group, L.L.C. and UBS Securities LLC acted as joint book-running managers for the U.S. offering. Gilbert Dupont acted as manager for the European offering.

The initial public offering was made only by means of a prospectus. A copy of the prospectus relating to the initial public offering was filed with the U.S. Securities and Exchange Commission and may be obtained from Jefferies LLC, 520 Madison Avenue New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 888-474-0200, or by email at [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at 888-827-7275, or by email at [email protected].

Allocation of the Share Capital

The following table presents the expected allocation of the Company’s share capital following the initial public offering, to the Company’s knowledge:

(1) 6,540,000 of which are ordinary shares represented by ADSs

Janux Therapeutics Announces Collaboration with Merck to Develop Novel Drug Candidates for Immuno-Oncology using T Cell Engager (TRACTr) Technology

On December 18, 2020 Janux Therapeutics, reported a strategic collaboration and license agreement with Merck, known as MSD outside the United States and Canada, to discover, develop and commercialize innovative, next generation T cell engager immunotherapies for the treatment of cancer (Press release, Janux Therapeutics, DEC 18, 2020, View Source [SID1234573083]). The goal of the collaboration is to use Janux’s proprietary Tumor Activated T Cell Engager (TRACTrTM) technology to engineer novel, T cell engager drug candidates directed against two cancer targets selected by Merck. Under the terms of the agreement, Merck has received an exclusive worldwide license to products and intellectual property developed from this collaboration. In exchange, Janux will be eligible to earn up to $500.5 million per target in upfront and milestone payments plus royalties on sales of any product derived from the collaboration. Merck will fund research and development performed under the collaboration.

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T cell engagers are an emerging class of immunotherapies that bind to a tumor cell and recruit a patient’s T cells to eradicate tumor cells, but previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to overcome these limitations by integrating tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. In preclinical studies, Janux TRACTr drug candidates have demonstrated comparable anti-tumor efficacy relative to standard T cell engagers but lack the associated liabilities related to cytokine release, healthy tissue toxicities, or systemic immune activation.

"At Janux, we have developed a technology to engineer best-in-class T cell engagers that are potent and highly tumor specific, which is essential for an immune response that kills tumor cells but spares healthy tissue," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "Partnering with Merck, a world leader in immuno-oncology, provides us with important expertise and resources in developing next generation T cell engager therapies that will make immunotherapy work for more cancer patients."

Y-mAbs Signs Distribution Agreement with Swixx for DANYELZA® (naxitamab-gqgk) and Omburtamab in Eastern Europe

On December 18, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that it has entered into a distribution agreement with Swixx BioPharma AG ("Swixx") to be the exclusive distributor of the Company’s antibodies, DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in Eastern Europe, including Russia (Press release, Y-mAbs Therapeutics, DEC 18, 2020, View Source [SID1234573081]). DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration ("FDA") on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The Company plans to resubmit its ("BLA") to the FDA for omburtamab by the end of 2020 or in early 2021.

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The distribution agreement includes the European territories of Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Serbia, Slovakia and Slovenia. Under the terms of the agreement, Swixx will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory. In addition, Swixx will submit registration files on behalf of Y-mAbs in certain parts of the territory. All other unpartnered geographies worldwide remain with the Company. Financial details were not disclosed.

"We are very pleased to enter this distribution agreement with Swixx, and hope to see a DANYELZA and omburtamab, if approved, being made available to appropriate children with unmet medical needs in Eastern Europe and Russia," said Thomas Gad, founder, Chairman and President at Y-mAbs.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compounds and in Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

Y-mAbs Signs License Agreement with SciClone for DANYELZA® (naxitamab-gqgk) and Omburtamab in China

On December 18, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that it has entered into a license agreement with SciClone Pharmaceuticals International Ltd ("SciClone") to be the exclusive co-development and commercialization partner of the Company’s antibodies, DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in China (Press release, Y-mAbs Therapeutics, DEC 18, 2020, View Source [SID1234573080]). DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration ("FDA") on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The Company plans to resubmit its Biologics License Application ("BLA") to the FDA for omburtamab by the end of 2020 or in early 2021.

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The license agreement includes Greater China, including Mainland China, Taiwan, Hong Kong and Macau. Under the terms of the agreement, SciClone will employ its development, sales, marketing and regulatory expertise to commercialize DANYELZA and omburtamab, if approved, in the territory. All other unpartnered geographies worldwide remain with the Company. Under the terms of the agreement, SciClone will pay Y-mAbs a $20 million upfront payment with the potential for Y-mAbs to receive up to $100 million in additional development, regulatory and sales milestone payments for both programs, as well as double-digit royalties on net sales for DANYELZA and omburtamab in the territory.

"We are very pleased to enter this license agreement with SciClone, and hope to see a DANYELZA and omburtamab, if approved, being made available to appropriate children with unmet medical needs in China. This partnership marks an important milestone in our aim to make our lead product and product candidate globally available," said Thomas Gad, founder, Chairman and President at Y-mAbs.

"DANYELZA and omburtamab were initially identified and sourced from Memorial Sloan Kettering Cancer Center in New York, and have been developed by Y-mAbs as novel therapies. We believe these antibodies show great promise," said Hong Zhao, President and Chief Executive Officer of SciClone. "We are excited to partner with Y-mAbs team to commercialize DANYELZA for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, if approved. This strategic partnership recognizes SciClone’s capability as a leading biotech company with integrated platform of development and commercialization."

Researchers at MSK developed DANYELZA and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compounds and in Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.