On July 27, 2022 SHINE Technologies, LLC (SHINE), a next-generation nuclear technology company, reported the company has submitted a Drug Master File (DMF) with the U.S. Food and Drug Administration for non-carrier-added lutetium-177 (Lu-177) chloride, a radiopharmaceutical at the forefront of precision cancer treatment (Press release, Shine Medical Technologies, JUL 27, 2022, View Source [SID1234618509]).

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In targeted cancer therapy, the cancer-killing radioisotope Lu-177 is paired with a cancer-seeking molecule to form a smart compound that directly targets and attacks cancer cells.

SHINE is the emerging leader in the production of this medical radioisotope. With its proprietary technology, SHINE intends to be the industry’s only vertically integrated producer of Lu-177, providing a reliable and scalable supply without the need for aging nuclear reactors.

The DMF submission provides confidential detailed information about facilities, procedures, or articles used in the manufacturing, processing, and storing of drugs. It is a clear commitment to the several companies that have requested letters of authorization to access SHINE’s drug master file in support of their clinical trials which are underway to fight cancer. And it is also an important step in SHINE’s path to meeting the increasing global demand for Lu-177.

"As global demand for lutetium-177 increases, SHINE is poised to scale our operations and be the preferred partner for customers seeking a high-quality, reliable supply of lutetium-177," said Chris Vessell, general manager of SHINE’s Therapeutics Division.

"We’ve been producing lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submittal represents the next step in getting our product into regular commercial use." said Greg Piefer, founder and CEO of SHINE Technologies. "We’re looking forward to growing our vertically-integrated and sustainable process to ensure the world has scalable access to these game-changing, cancer-destroying products as new therapies are approved."

On July 27, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will present at the following investor conferences in August (Press release, Delcath Systems, JUL 27, 2022, View Source [SID1234617645]):

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BTIG Biotechnology Conference 2022 on August 9, 2022.
Canaccord Genuity 42nd Annual Growth Conference: Presentation to take place on August 10, 2022 at 12:30PM ET. A webcast of the presentation will be available at: View Source
To learn more or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

On July 27, 2022 Nuvectis Pharma, Inc (Nasdaq: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology, reported that it has entered into definitive agreements with healthcare-focused institutional and accredited investors for the issuance and sale of 1,924,689 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $8.25 per share and preferred investment option (Press release, Nuvectis Pharma, JUL 27, 2022, View Source [SID1234617156]). The investors also purchased preferred investment options to purchase up to an aggregate of 1,924,689 shares of common stock. The preferred investment options will have an exercise price of $9.65, will become exercisable commencing six months following date of issuance and will have a term of three and one-half years from the date of issuance.

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Gross proceeds to Nuvectis from the offering are expected to be approximately $15.9 million, before deducting placement agent fees and other offering expenses payable by the Company.

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

The closing of the private placement is expected to occur on or about July 29, 2022, subject to the satisfaction of customary closing conditions. Nuvectis intends to use the net proceeds from the private placement for working capital and general corporate purposes

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the preferred investment options and pre-funded warrants).

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.

On July 27, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its first fiscal quarter ended June 30, 2022 on Thursday, August 11, 2022 (Press release, Beyond Air, JUL 27, 2022, View Source [SID1234617097]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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On July 27, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported it will report financial results for the second quarter of 2022 after market close on Wednesday, August 10, 2022 (Press release, Pulse Biosciences, JUL 27, 2022, View Source [SID1234617096]). Company management will host a corresponding conference call beginning at 1:30pm PT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source