Exact Sciences Announces Debt Exchange Transaction and Private Placement of Convertible Senior Notes

On April 11, 2024 Exact Sciences Corp. (Nasdaq: EXAS) (the "Company"), a leading provider of cancer screening and diagnostic tests, reported that on April 10, 2024 it entered into privately negotiated exchange and purchase agreements (the "Agreements") with certain holders of the Company’s 0.3750% Convertible Senior Notes due 2028 (the "Existing Notes") (Press release, Exact Sciences, APR 11, 2024, View Source [SID1234642007]). Pursuant to the Agreements, the Company has agreed to issue to the holders $620.7 million aggregate principal amount of a new series of 1.75% Convertible Senior Notes due 2031 (the "New Notes") in exchange for (i) the retirement of $359.7 million aggregate principal amount of the holders’ Existing Notes, and (ii) payment to the Company of approximately $266.8 million in cash. The closing of the transaction is expected to occur on April 17, 2024, subject to customary closing conditions.

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The New Notes will mature on April 15, 2031 (the "Maturity Date"), unless earlier repurchased, redeemed or converted. The New Notes are senior unsecured obligations of the Company and bear interest at a rate of 1.75% per year, payable semi-annually in arrears on October 15 and April 15 of each year, beginning on October 15, 2024.

Prior to October 15, 2030, the New Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, until the close of business on the second scheduled trading day immediately preceding the Maturity Date. The New Notes will be convertible into cash, shares of the Company’s common stock (plus, if applicable, cash in lieu of any fractional share), or a combination of cash and shares of the Company’s common stock, at the Company’s election.

On or after April 17, 2029, the Company may redeem all or any portion of the New Notes at 100% of the principal amount plus accrued and unpaid interest if the last reported sale price of Common Stock has been at least 130% of the conversion price for a specified period of time.

If a "fundamental change" occurs prior to the Maturity Date, subject to certain conditions, holders may require the Company to repurchase for cash all or any portion of their New Notes at a repurchase price equal to 100% of the principal amount of the New Notes to be repurchased plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

The conversion rate for the New Notes is initially 10.0644 shares per $1,000 principal amount of New Notes, which is equivalent to an initial conversion price of approximately $99.36 per share of common stock representing a conversion premium of 35% over the last reported sale price of $73.60 per share of the Company’s common stock on the Nasdaq Stock Market on April 10, 2024. The conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. In addition, holders of the New Notes who convert their New Notes in connection with a "make-whole fundamental change" or redemption, will, under certain circumstances, be entitled to an increase in the conversion rate.

XMS Capital Partners LLC acted as sole placement agent for the transaction.

K&L Gates LLP represented Exact Sciences Corporation and Kramer Levin Naftalis & Frankel LLP represented the placement agent in the transaction.

The offer and sale of the New Notes and any shares of common stock issuable upon conversion of the New Notes have not been registered under the Securities Act of 1933 or any other securities laws, and the New Notes and any 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 shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor (AR) Protein Degrader ARV-766 for the Treatment of Prostate Cancer

On April 11, 2024 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported it has entered into an exclusive strategic license agreement with Novartis (NYSE: NVS) for the worldwide development and commercialization of ARV-766, Arvinas’ second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer (Press release, Arvinas, APR 11, 2024, View Source [SID1234642006]). The transaction also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis.

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"We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer. This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments."

Under the terms of the transaction agreements, Novartis will be responsible for worldwide clinical development and commercialization of ARV-766 and will have all research, development, manufacturing, and commercialization rights with respect to the preclinical AR-V7 program. Arvinas will receive an upfront payment in the aggregate amount of $150.0 million. Under the License Agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766.

Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.

About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Preclinically, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies.

Summit Therapeutics to Present at the Stifel 2024 Targeted Oncology Forum

On April 10, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the Stifel 2024 Targeted Oncology Forum, which will be held virtually April 16-17, 2024 (Press release, Summit Therapeutics, APR 10, 2024, View Source [SID1234642002]). Dr. Maky Zanganeh, Chief Executive Officer and President, Robert W. Duggan, Chairman and Chief Executive Officer, Manmeet Soni, Chief Operating Officer & Chief Financial Officer, Dave Gancarz, Chief Business & Strategy Officer, and Dr. Allen S. Yang, Chief Medical Officer, will participate in a fireside chat on behalf of our organization surrounding the development of our innovative investigational bispecific antibody, ivonescimab, on Tuesday April 16, 2024 at 2:30pm ET.

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The presentation will be available live from our website: www.smmttx.com. An archived version will be available on our website following the presentation.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

MEI Pharma to Present at the Stifel 2024 Virtual Targeted Oncology Forum

On April 10, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported that David Urso, president and chief executive officer of MEI Pharma, will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on Tuesday, April 16 at 1:30 PM Eastern Time (Press release, MEI Pharma, APR 10, 2024, View Source [SID1234642001]).

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Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section of the Company’s investor relations website View Source A replay of the webcast will be made available following the event.

Innate Pharma Presents at AACR 2024 Preclinical Efficacy of Its Pre-IND Drug Candidate IPH45, a Novel Nectin-4 Antibody Drug Conjugate

On April 10, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that first preclinical data for its asset IPH45, a novel and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4, were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (Press release, Innate Pharma, APR 10, 2024, View Source [SID1234642000]).

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In preclinical studies, data demonstrated that IPH45 effectively inhibits Nectin-4 expressing tumor growth both in vitro and in vivo, including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma PDX (patient-derived xenografted) mice models, across Nectin-4high and Nectin-4low expression levels. In addition, IPH45 has an additive anti-tumor effect to anti-PD1 treatment in vivo and has a favorable safety profile in relevant animal toxicology models.

"IPH45 is a novel and differentiated Nectin-4 ADC with preclinical efficacy in tumor types with various expression levels of Nectin-4. Its exatecan payload allow for higher bystander-effect and a broader therapeutic index than MMAE-ADCs," commented Prof. Eric Vivier, DVM, PhD, Chief Scientific Officer at Innate Pharma. "These promising results underscore the potential of IPH45 to provide new solutions for patients in a variety of Nectin-4 expressing cancers, beyond Nectin-4high expressing bladder. Based on these encouraging data, we are eagerly advancing IPH45 towards clinical trials."

The presentation is available on Innate Pharma’s website.

About IPH45

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. IPH45 is a novel exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4. In non-clinical models, IPH45 is well tolerated and shows anti-tumor efficacy in vitro and in vivo. IPH45 is progressing towards First in Human study.