Immunocore Prices Upsized Convertible Senior Notes Offering

On January 31, 2024 Immunocore Holdings plc (Nasdaq: IMCR) reported the pricing of $350.0 million aggregate principal amount of 2.50% convertible senior notes due 2030 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Immunocore also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $52.5 million aggregate principal amount of the notes (Press release, Immunocore, JAN 30, 2024, View Source [SID1234639745]). The sale of the notes is expected to close on February 2, 2024, subject to the satisfaction of customary closing conditions. The offering was upsized from the previously announced offering of $300.0 million aggregate principal amount of convertible senior notes.

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The notes will be senior, unsecured obligations of Immunocore and will accrue interest at a rate of 2.50% per annum, payable semi-annually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024. The notes will mature on February 1, 2030, unless earlier converted, redeemed or repurchased.

Holders may convert all or any portion of their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, Immunocore will deliver for each $1,000 principal amount of converted notes a number of ordinary shares represented by American Depositary Shares (the "ADSs") (each currently representing one of Immunocore’s ordinary shares), equal to the conversion rate. The conversion rate will initially be 10.5601 ADSs per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $94.70 per ADS). The initial conversion price represents a premium of approximately 40.0% above the last reported sale price of $67.64 per ADS on the Nasdaq Global Select Market on January 30, 2024. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if Immunocore delivers a notice of optional redemption or a notice of tax redemption, Immunocore will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of optional redemption or notice of tax redemption, as the case may be.

Immunocore may not redeem the notes prior to February 5, 2027, except in the event of certain tax law changes as described in the indenture that will govern the notes. Immunocore may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after February 5, 2027 if the last reported sale price of ADSs has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Immunocore provides notice of optional redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date. No sinking fund is provided for the notes.

If Immunocore undergoes a "fundamental change" (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Immunocore to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

Immunocore estimates that the net proceeds from the offering will be approximately $338.4 million (or approximately $389.3 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Immunocore. Immunocore intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to accelerate its clinical pipeline and for ongoing commercial expansion. In addition, Immunocore intends to repay in full loans outstanding under its loan agreement with investment funds managed by Pharmakon Advisors, LP. Immunocore intends to use any remaining proceeds for other working capital and general corporate purposes.

The offer and sale of the notes, the ADSs deliverable upon conversion of the notes and the ordinary shares represented thereby have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs deliverable upon conversion of the notes or the ordinary shares represented thereby, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

CG Oncology Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On January 30, 2024 CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, reported the closing of its upsized initial public offering of 23,000,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 3,000,000 additional shares, at an initial public offering price of $19.00 per share (Press release, CG Oncology, JAN 30, 2024, View Source [SID1234639730]). All of the shares were offered by CG Oncology. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $437.0 million. CG Oncology’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "CGON."

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Morgan Stanley, Goldman Sachs & Co. LLC and Cantor acted as joint book-running managers for the offering. LifeSci Capital acted as co-manager for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on January 24, 2024. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

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 offer or sale of these securities in any state or 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.

New Publication Demonstrates Signatera’s Ability to Risk Stratify and Detect Recurrence Early in Resected Stage I-II Lung Cancer

On January 30, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in The Journal of Thoracic and Cardiovascular Surgery demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to risk stratify and detect recurrence early in patients with resected stage I-II non-small cell lung cancer (NSCLC) (Press release, Natera, JAN 30, 2024, View Source [SID1234639729]). The full study can be found here.

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Worldwide, lung cancer is the second most commonly diagnosed cancer. In the U.S., NSCLC accounts for 81% of all lung cancer diagnoses.1 About 25-30% of NSCLC patients are diagnosed with stage I-II disease.2,3 These patients typically undergo curative-intent complete surgical resection and may be treated with adjuvant systemic therapy. However, 30–55% of patients develop disease recurrence within the first five years after surgery, and five-year overall survival ranges from 68-92% for stage I and 53-60% for stage II NSCLC patients respectively.4,5,6

Given the significant risk of recurrence and death in NSCLC, it is critical to accurately risk-stratify patients to identify who may derive benefit from additional treatment after surgery. In addition, there is a need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms at a time when therapy might provide greater clinical benefit.

This study investigated the association of circulating tumor DNA (ctDNA) status with recurrence-free survival (RFS), as well as changes in clinical practice after a positive ctDNA result in patients with resected stage I-II NSCLC. A total of 378 serial plasma samples from 108 NSCLC patients were analyzed after surgical resection, with a median clinical followup of 16 months.

Key findings include:

Patients who were ctDNA-positive within 6 months post-resection and prior to adjuvant treatment were 53-times more likely to recur (p<0.0001) as compared to ctDNA-negative patients.
ctDNA detection demonstrated a median lead time of 5.5 months when compared to confirmation of recurrence by radiographic imaging.
Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment.
"This study demonstrates that serial monitoring with Signatera can identify patients who are most likely to benefit from adjuvant systemic therapy and/or more intensified imaging," said Minetta Liu, MD, chief medical officer of oncology at Natera. "With measurable clinical impact in 100% of Signatera MRD-positive cases, this study supports the utility of Signatera in the management of non-metastatic, resected NSCLC."

The study builds on previous Signatera data across early- and late-stage NSCLC. This includes a 2023 publication in Frontiers in Oncology, demonstrating Signatera’s ability to risk stratify and detect progression early in unresectable NSCLC,7 as well as the EMPower Lung-1 trial presented at the 2023 ASCO (Free ASCO Whitepaper) annual meeting, which showed Signatera’s ability to monitor response to immunotherapy and predict clinical outcomes in advanced NSCLC patients.8 This recent work also builds upon the 2017 TRACERx Nature publication that first reported Signatera’s ability to detect relapse early with high sensitivity and specificity in patients with resected NSCLC.9

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.

Agilent Announces Collaboration with Incyte to Develop Advanced Companion Diagnostics in Hematology and Oncology

On January 30, 2024 Agilent Technologies Inc. (NYSE: A) reported an agreement with Incyte that will bring together Agilent’s expertise and proven track record in the development of companion diagnostics (CDx) to support the development and commercialization of Incyte’s hematology and oncology portfolio (Press release, Agilent, JAN 30, 2024, View Source [SID1234639728]).

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The value of the companion diagnostics market is predicted to expand to nearly US $14B by 2030,1 driven in part by the power of these tests to inform treatment decisions for a growing range of cancers and other chronic diseases. Developed for use with targeted therapeutics, companion diagnostics are used to evaluate expression of biomarkers and identify patients that are likely to benefit from treatment with the targeted therapeutic products.

The agreement between Agilent and Incyte allows the companies to collaborate on CDx development programs. This will enable Agilent to continue to expand its companion diagnostics portfolio with novel biomarkers and Incyte to leverage Agilent’s expertise in IVD assay development, global regulatory approvals, and commercialization to support clinical trials as well as the potential registration and commercialization of CDx in the United States and Europe.

Paul Beresford, vice president and general manager of Agilent’s Companion Diagnostics Division, discussed the significance of the partnership: "Leveraging the power of companion diagnostics, we are strategically transforming the treatment paradigm for a broad spectrum of cancers. By working together, Agilent and Incyte hope to expedite the development of innovative precision medicine products, potentially paving the way for enhanced patient health outcomes."

Jeff Jackson, group vice president of Translational Medicine at Incyte added: "Agilent’s expertise in the development of companion diagnostics is impressive, as is their regulatory and commercialization record. We are excited about the collaboration and look forward to working together to innovate in support of patients."

With an established and growing portfolio of world-class chemistries and technologies, Agilent has a strong track record as a provider and partner for companion diagnostics development across the precision oncology sector. This year, Agilent celebrates the 25th anniversary of HercepTest, a critical tool for assessing HER2 expression in breast cancers. Since the launch of HercepTest, Agilent has introduced several additional CDx tests. Among these, the PDL-1 IHC 22C3 franchise has been particularly successful, offering a continually expanding range of tests for assessing PDL-1 expression.

WuXi XDC Enters into Partnership with Multitude Therapeutics and HySlink Therapeutics, Novel Linker-Payload Technology Enabling Clients to Accelerate ADC Discovery and Development

On January 30, 2024 WuXi XDC (2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on ADC and the other types of bioconjugate market; and Multitude Therapeutics, a clinical stage biotechnology company renowned for ADC platform technologies, reported that they have reached a comprehensive partnership in drug-linker technology, which is co-developed with HySlink Therapeutics ("HySlink"), and CRDMO services spanning from discovery to commercialization (Press release, Multitude Therapeutics, JAN 30, 2024, View Source [SID1234639726]). WuXi XDC signed a Memorandum of Understanding (MOU) with HySlink on the same day.

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WuXi XDC will provide a fully integrated, one-stop bioconjugate platform and end-to-end CRDMO services. As WuXi XDC’s strategic partner, Multitude Therapeutics will provide proprietary T-Moiety linker technologies, co-developed with HySlink. Both parties will synergize their strengths to build more efficient ADC technology in terms of novel T-moiety linkers, camptothecin derivative conjugation and high DAR value, among others. This platformization of new technologies will enable our clients to accelerate the discovery of preclinical ADC candidates (PCCs) and develop more novel bioconjugates; and improve the development efficiency and rate of success.

Dr. Jimmy Li, CEO of WuXi XDC, commented, "The proprietary drug-linker technology has unique advantages and, when fused with our open-access bioconjugate platform, enables customers to achieve rapid delivery of T-moiety exatecan ADC preclinical candidates, with the potential benefit of expanding the therapeutic window of existing ADC drugs. We are pleased to join hands with Multitude to remain continuously innovative and enhance our technological capabilities to meet our clients’ needs. By leveraging our full range of in-depth industry expertise, we are on the path to creating the world’s leading bioconjugate platform, which empowers the industry, broadly, deeply and fully. "

Multitude and HySlink, stated, "WuXi XDC has exceptional capability as a leading global CRDMO. We are very excited to form a strong alliance in the technical area. Our proprietary new T-Moiety linker can significantly enhance the therapeutic effect of ADCs. The higher stability of the linker and the hydrophilic shielding effect can improve the overall stability of antibody-drug conjugates, extend the drug’s half-life, and potentially overcome multi-drug resistance in tumors. Without increasing side effects, it can further enhance the therapeutic window of existing ADC drugs (related research was published in Cancer Discovery 2023;13(4):950-73). Our collaboration aims to help more ADC developers gain stable and rapid access to these payload linkers, in a bid to benefit patients worldwide."