On October 31, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it plans to release unaudited financial results for the third quarter ended September 30, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, November 14, 2022 (Press release, Gracell Biotechnologies, OCT 31, 2022, View Source [SID1234622652]). The management team will host a live audio webcast and conference call at 8:00 AM Eastern Time.

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On October 31, 2022 plc ("Haleon") (LSE: HLN, NYSE: HLN) reported the expiration and final results of its previously announced offers to exchange seven series of outstanding unregistered notes issued by GSK Consumer Healthcare Capital US LLC (the "US Issuer") and GSK Consumer Healthcare Capital UK plc (the "UK Issuer", and together with the US Issuer, the "Issuers") (as set out below), which was launched on September 29, 2022, pursuant to a registration rights agreement entered into at the time of the original issuance of the notes (Press release, GlaxoSmithKline, OCT 31, 2022, View Source [SID1234622651]).

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Upon the terms and subject to the conditions set forth in the prospectus and the accompanying letter of transmittal dated September 29, 2022 (the "Exchange Offer Documents"), Haleon offered to exchange in seven concurrent, but separate, offers (the "Exchange Offers") any and all of the seven series of notes identified under "Title of Series of Original Notes" in the table below (collectively, the "Original Notes"), for a like principal amount of notes of the same series that have been registered under the Securities Act of 1933, as amended (the "Securities Act"), as described under "Title of Series of Exchange Notes" in the table below (collectively, the "Exchange Notes").

The Exchange Offers expired at 5:00 p.m. (Eastern time) on October 28, 2022 (the "Expiration Date"). The "Settlement Date" with respect to the Exchange Offers will be promptly following the Expiration Date and is expected to be November 2, 2022. Upon the settlement of the Exchange Offers, holders of Original Notes who validly tendered and did not validly withdraw such notes prior to the Expiration Date will receive a like principal amount of Exchange Notes of the applicable series.

The terms of each series of Exchange Notes to be issued upon the settlement of the Exchange Offers are substantially identical to the terms of the corresponding Original Notes of such series, except that the Exchange Notes have been registered under the Securities Act and the transfer restrictions, the special mandatory redemption provisions and registration rights applicable to the Original Notes will not apply to the Exchange Notes. As previously disclosed, the sole purpose of the Exchange Offers was to offer the holders of the Original Notes the opportunity to receive Exchange Notes that have been registered under the Securities Act and are expected to be listed on the New York Stock Exchange.

A Registration Statement on Form F-4 (the "Registration Statement") relating to the issuance of the Exchange Notes was filed with the Securities and Exchange Commission ("SEC") on September 29, 2022 and declared effective on October 27, 2022. The Exchange Offers were made pursuant to the terms and subject to the conditions set forth in a prospectus filed with the SEC dated as of October 27, 2022 (as the same may be amended or supplemented, the "Prospectus"), which forms part of the Registration Statement.

Global Bondholder Services Corporation acted as Exchange Agent for the Exchange Offers. Questions or requests for assistance related to the Exchange Offers or for additional copies of the Prospectus may be directed to Global Bondholder Services Corporation at (855) 654-2014. You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Exchange Offers.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (the "EEA"). For these purposes, a "retail investor" means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive (EU) 2014/65 (as amended, "MiFID II") or (ii) a customer within the meaning of Directive (EU) 2016/97(as amended, the "Insurance Distribution Directive"), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the "PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling of the New Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.

Any offer of the New Notes in any member state of the EEA will be made pursuant to an exemption under Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the Prospectus Regulation.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the United Kingdom (the "UK"). For these purposes, a "retail investor" means a person who is one (or more) of the following: (i) a retail client, as defined in point (8) of Article 2 of Regulation (EU) No 2017/565 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "EUWA"); or (ii) a customer within the meaning of the provisions of the Financial Services and Markets Act 2000 (as amended, the "FSMA") and any rules or regulations made under the FSMA to implement the Insurance Distribution Directive, where that customer would not qualify as a professional client, as defined in point (8) of Article 2(1) of Regulation (EU) No 600/2014 as it forms part of UK domestic law by virtue of the EUWA. Consequently, no key information document required by Regulation (EU) No. 1286/2014 as it forms part of UK domestic law by virtue of the EUWA (as amended, the "UK PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the UK has been prepared and therefore offering or selling the New Notes or otherwise making them available to any retail investor in the UK may be unlawful under the UK PRIIPs Regulation.

Any offer of the New Notes in the UK will be made pursuant to an exemption under Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of EUWA (the "UK Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the UK Prospectus Regulation.

In the United Kingdom, this press release is being distributed only to, and is directed only at (i) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the "Order"), and/or (ii) high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together referred to as "relevant persons"). This press release must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this press release relates is only available to, and will be engaged in with, relevant persons only.

On October 31, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of its previously announced underwritten public offering of 6,865,672 shares of Class A common stock at a price to the public of $33.50 per share (Press release, Nuvalent, OCT 31, 2022, View Source [SID1234622650]). All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $230.0 million. The offering is expected to close on November 3, 2022, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,029,850 shares of Class A common stock at the public offering price less underwriting discounts and commissions.

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J.P. Morgan, Cowen, Piper Sandler and BMO Capital Markets are acting as joint book-running managers for the offering.

The shares are being offered by Nuvalent pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on August 10, 2022, and declared effective by the SEC on August 16, 2022. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]; and BMO Capital Markets Corp., Attn: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, by telephone at (800) 414-3627, 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 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 October 31, 2022 Eucure Biopharma, a China-based clinical-stage biotechnology company focused on the development of antibody therapeutics, reported that it has entered into a collaborative agreement with ISU ABXIS Co., Ltd. (KOSDAQ: 086890), a Korea-based clinical stage company developing immuno-oncology drugs (Press release, Eucure, OCT 31, 2022, View Source [SID1234622649]).

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Under the terms of the agreement, ISU ABXIS will utilize the sequence of YH003, Biocytogen’s humanized agonistic anti-CD40 antibody currently in phase II clinical trials, to construct a few groups of tri-specific antibodies and develop cancer drugs for multiple indications using its technology platform. Eucure Biopharma will receive an upfront payment, milestone payments and royalties.

"Biocytogen utilized its unique evidence-based in vivo drug screening platform to obtain YH003, which has demonstrated a good preclinical safety and efficacy profile," said Dr. Rong Chen, Vice President of Biocytogen and CEO/CMO of Eucure Biopharma. "Further, YH003’s phase I clinical trials indicate good tolerability and safety profiles, as well as encouraging antitumor activities against several tumor types, including malignant melanoma and pancreatic cancer."

"CD40 is a key co-stimulator in adaptive immune responses," said Yeob Hwang, CEO of ISU ABXIS. "We are glad for the opportunity to utilize Biocytogen/Eucure Biopharma’s anti-CD40 antibody (YH003), as it has outstanding efficacy and safety profiles, both preclinically and clinically. These favorable properties will undoubtedly accelerate our tri-specific antibody development against tumors."

About YH003

YH003 is a humanized IgG2 agonistic CD40 antibody. 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, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. The phase I dose escalation study carried out in Australia indicated that YH003 combined with PD-1 mAb (toripalimab) had excellent safety and antitumor activity in patients with advanced solid tumors. Currently, YH003 is undergoing phase II multi-regional clinical trials (MRCTs) for the treatment of patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC) and melanoma.

On October 31, 2022 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported the publication of two additional major clinical studies relating to its lead product, IsoPSA, for prostate cancer (Press release, Cleveland Diagnostics, OCT 31, 2022, View Source [SID1234622648]).

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The first publication—appearing in the peer-reviewed journal, Urologic Oncology: Seminars and Original Investigations (the official journal of the Society of Urologic Oncology)—describes a large, prospective, multicenter clinical validation study led by Dr. Eric Klein, Emeritus Professor and Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic. In this study, investigators validated the diagnostic performance and predictive value of IsoPSA for both high-grade and any prostate cancer in men age ≥ 50 with total PSA ≥ 4 ng/mL, confirming that IsoPSA outperforms standard of care tests (total and % free PSA) in discriminating the risk of prostate cancer on subsequent biopsy and demonstrating the test’s potential to both reduce unnecessary biopsies and to improve the risk-benefit ratio for early detection of prostate cancer.

In this study, a total of 888 patients being evaluated for prostate cancer were enrolled at eight leading academic and community healthcare centers in the United States to validate the clinical performance of IsoPSA. This study demonstrated significant improvements in diagnostic accuracy vs. standard of care tests and provided support for a novel clinical paradigm that not only incorporates the use of IsoPSA following elevated PSA results, but also prior to MRI during prostate biopsy decision making.

This study highlights key attributes that differentiate IsoPSA in the early detection of prostate cancer including the ability of IsoPSA to distinguish the risk of both high‐grade and any‐grade of prostate cancer, diagnostic accuracy across a broad range of triggering total PSA levels (4‐100 ng/mL) seen in clinical practice, and the consistent and substantial diagnostic performance of the test in both biopsy naïve and prior negative biopsy patient groups.

"Our clinical validation study reaffirms that IsoPSA is a valuable tool that can provide urologists with critical information needed to determine which patients need to go to biopsy and which do not," said Dr. Klein. "I believe that IsoPSA will lead to fewer unneeded biopsies and reduce overdiagnosis of indolent prostate cancer and thereby reduce overtreatment."

In the second study, published in Urology (the "Gold Journal"), Benidir, et al. describe a retrospective analysis of real-world data representing outcomes associated with IsoPSA use. In the study, investigators evaluated patients who went on to radical prostatectomy following elevated IsoPSA values which triggered biopsy.

"In real world applications, our study demonstrated that IsoPSA does not select for any particular adverse pathologic feature upon radical prostatectomy. IsoPSA is a reliable tool for the identification of clinically significant prostate cancer," commented lead author Dr. Chris Weight of Cleveland Clinic.

As a non-biased, agnostic predictor of meaningful disease, IsoPSA was demonstrated to be valuable even in cases where biopsy histology and radiology may not accurately reflect the current biology of disease. Study investigators observed that many so-called "false positive" IsoPSA results may actually be true positives for high-grade cancer given that biopsies (the standard to which IsoPSA is compared in earlier prospective clinical studies) have been known to miss 20-30 percent of cancers. In this study, 99 percent of patients with IsoPSA indices greater than 6.0 (the IsoPSA threshold that triggers biopsy) had clinically significant prostate cancer on subsequent radical prostatectomy, the ultimate determinant of disease status.

"Cleveland Diagnostics is fully committed to supporting and publishing results from high quality studies. The clinical validation study adds to the already extensive stable of clinical evidence supporting IsoPSA, which indicates superior clinical performance and biopsy reductions," said Arnon Chait, PhD, Chief Executive Officer at Cleveland Diagnostics. "The independent real-world outcomes study is another example of the growing number of key publications authored by clinicians using the test in their practices, and supports the use of IsoPSA earlier in the diagnostic paradigm. Due to data such as those highlighted in these two important new publications, we continue to see rapid clinical adoption of the test, and expect that IsoPSA will become an integral part of every urologist’s workflow."

Together with the results of previously-published clinical validation, clinical utility, and cost effectiveness data, these new studies lend further support for the notion that IsoPSA has the ability to not only dramatically reduce the number of unnecessary procedures but also identify patients with clinically significant cancer that may even be missed by MRI and biopsy. This, in turn, could generate significant savings to the healthcare system and improve patient outcomes.