bluebird bio, Inc. Announces Pricing of $120 Million Public Offering of Common Stock

On January 19, 2023 bluebird bio, Inc. (Nasdaq: BLUE) ("bluebird") reported the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.00 per share, before deducting underwriting discounts and commissions (Press release, bluebird bio, JAN 19, 2023, View Source [SID1234626344]). bluebird also granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds from the public offering are expected be $120 million, before deducting underwriting discounts and commissions and offering expenses payable by bluebird and assuming no exercise of the underwriters’ option to purchase additional shares of common stock. All shares in the offering are to be sold by bluebird.

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Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC are acting as joint book running managers for the offering.

bluebird intends to use the net proceeds of the offering (i) to support commercialization and manufacturing for its two approved gene therapies, ZYNTEGLO and SKYSONA; (ii) to accelerate future commercialization activities for its gene therapy candidate, lovotibeglogene autotemcel (lovo-cel) for sickle cell disease, if approved; and (iii) to fund working capital and other general corporate purposes.

The offering is expected to close on or about January 23, 2023, subject to customary closing conditions.

The offering is being made pursuant to an effective shelf registration statement on Form S-3, including a prospectus, that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 18, 2020 and was automatically effective upon filing. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC. A final prospectus supplement will be filed with the SEC and will form a part of the effective registration statement. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by phone at (866) 471-2526, or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 155 Long Island Avenue, Edgewood, NY 11717, by phone at (866) 803-9204, 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 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 jurisdiction.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include, without limitation, statements regarding the consummation of the offering, the terms of the offering and the anticipated use of the net proceeds from the offering. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. These risks include, but are not limited to: the risk that we may not realize expected cost savings from the restructuring, including the anticipated decrease in operational expenses, at the levels we expect; we may encounter additional delays in the development of our programs, including the imposition of new clinical holds or delays in resolving existing clinical holds, that may impact our ability to meet our expected timelines and increase our costs; the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to use cash more quickly than we expect or change or curtail some of our plans or both; our expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be seen in additional patients treated with our product candidates; the risk that additional insertional oncogenic or other reportable events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time; the risk that our eli-cel, beti-cel and lovo-cel programs may be subject to further delays in their development, including but not limited to the imposition of new clinical holds; the risk that lovo-cel may not be approved within the priority review timeframe or at all; and the risk that any one or more of our products and product candidates, including eli-cel, beti-cel or lovo-cel, will not be successfully developed, approved or commercialized. The forward-looking statements included in this press release are made only as of the date of this press release and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Investor Presentation

On January 19, 2023 Encysce Biosciences presented its investor presentation (Presentation, Ensysce Biosciences, JAN 19, 2023, View Source [SID1234626338]).

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INDICATIVE ANNOUNCEMENT FZ-AD004 ANTIBODY DRUG CONJUGATE FOR INJECTION FOR THE TREATMENT OF ADVANCED SOLID TUMORS RECEIVED THE ACCEPTANCE NOTICE FOR THE INVESTIGATIONAL NEW DRUG APPLICATION

On January 18, 2023 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.* (the "Company") reported that has received the Acceptance Notice (《受理通知書》) issued by the National Medical Products Administration of the PRC (the "NMPA") (Filing, Shanghai Fudan-Zhangjiang, JAN 18, 2023, View Source [SID1234633120]). The board of directors (the "Board") of the Company is pleased to announce that, the Company has received the Acceptance Notice (《受理通知書》) issued by the National Medical Products Administration of the PRC (the "NMPA"). The investigational new drug (the "IND") application for Phase I clinical trial of FZ-AD004 antibody drug conjugate for injection (Trop2-BB05 ADC, the "Drug") for the treatment of advanced solid tumors has been accepted. Relevant information is as follows: ABOUT THE DRUG Drug name: FZ-AD004 antibody drug conjugate for injection Registration type: Class 1 therapeutic biological products Application matter: Registration of Clinical Trial of Domestic Production of Pharmaceutical Product Acceptance No. CXSL2300047 Applicant: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd Review conclusion: Accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People’s Republic of China.-2-In recent years, the Company has built a new Linker-Drug platform ("BB05 Platform") with independent intellectual property rights in respect of small molecule. The Drug is the second new generation antitumor antibody-drug conjugate (ADC) drug on the BB05 Platform. It is composed of monoclonal antibodies against human trophoblast cell surface glycoprotein antigen ("TROP-2") target coupled with BB05. TROP-2 is expressed at different levels, and its expression level is significantly increased in various carcinomas, such as breast cancer, lung cancer, and stomach cancer. The Drug can bind to high TROP-2-expressed tumor cells and endocytosis, releasing small molecule cytotoxic drugs (topoisomerase I inhibitors) in lysosomes by protease cleavage to kill the tumor cells. The Drug is intended to be developed for the treatment of advanced solid tumors including but not limited to lung cancer, breast cancer, gastric cancer, esophageal cancer, colorectal cancer, urothelial cancer, bladder cancer and endometrial cancer, etc. Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, and the long cycle and numerous stages in the process, there are uncertainties in drug pre-clinical research, clinical trial and commercialization. These many stages make it susceptible to uncertainties and therefore, investors are advised to make cautious decisions and pay careful attention to investment risks. The Company will actively facilitate the above research and development project and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict accordance with relevant regulations.

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Charles River and Rznomics Announce RNA-based Anticancer Gene Therapy Manufacturing Alliance

On January 18, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) and Rznomics Inc., a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, reported a viral vector contract development and manufacturing organization (CDMO) partnership (Press release, Charles River Laboratories, JAN 18, 2023, View Source [SID1234626365]). Rznomics will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

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RZ-001 is the first ribozyme-based RNA reprogramming approach approved by the US Food and Drug Administration (FDA) for evaluation in patients. The treatment was developed utilizing Rznomics’ proprietary RNA reprogramming and editing technology and takes the form of an adenoviral vector that expresses an hTERT targeting ribozyme to treat hepatocellular carcinoma (HCC) patients. HCC is the most common type of primary liver cancer, accounting for 80 percent of cases worldwide.

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA in October, allowing the initiation of an international clinical study in HCC patients. Early-phase trials have also commenced in Korea following IND approval for RZ-001 from the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA) in June.

Adenoviral Vector Manufacturing Services

Charles River has standardized protocols for cell culture, transfection, and downstream purification, as well as a validated platform process with a proven track record. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring the highest quality production.

Expanding its comprehensive cell and gene therapy portfolio to span viral vector, plasmid DNA, and cell therapy production, through the acquisitions of Vigene Biosciences, Cobra Biologics, and Cognate BioServices in 2021, Charles River offers end-to-end support and supply chain simplification for advanced therapy medical product (ATMP) developers.

Approved Quotes

"This collaboration with Rznomics will tap into our industry-leading CDMO capabilities and we are thrilled that our expertise will help to bring RZ-001, a potentially curative therapy, to HCC patients." – Birgit Girshick, Corporate Executive Vice President and Chief Operating Officer, Charles River
"We are proud to have achieved FDA approval to begin Phase I/IIa trials and excited to take this next step with Charles River. A reliable and experienced manufacturing partner is of utmost importance, and we are keen to continue building this relationship to enable us to bring our leading pipeline, RZ-001, into clinical development." – Seong-wook Lee, President and Chief Executive Officer, Rznomics

Johnson & Johnson to Participate in the SVB Securities Global Biopharma Conference

On January 18, 2023 Johnson & Johnson (NYSE: JNJ) reported it will participate in the SVB Securities Global Biopharma Conference on Wednesday, February 15th. Biljana Naumovic, Worldwide Vice President, Oncology and Peter Lebowitz, Global Therapeutic Head, Oncology will represent the Company in a virtual session scheduled at 1:00 p.m. (Eastern Time).

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This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

The audio webcast replay will be available approximately 48-hrs after the webcast.