On December 5, 2023 Thermo Fisher Scientific reported the company issued $1,000,000,000 aggregate principal amount of 5.000% Senior Notes due 2026 (the "2026 Notes"), $1,000,000,000 aggregate principal amount of 5.000% Senior Notes due 2029 (the "2029 Notes") and $500,000,000 aggregate principal amount of 5.200% Senior Notes due 2034 (the "2034 Notes" and, collectively with the 2026 Notes and the 2029 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3 (File No. 333-263034) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (Press release, Thermo Fisher Scientific, DEC 5, 2023, View Source [SID1234638162]). The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture"), and the Twenty-Eighth Supplemental Indenture, dated as of December 5, 2023 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee.

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The 2026 Notes will mature on December 5, 2026, the 2029 Notes will mature on January 31, 2029 and the 2034 Notes will mature on January 31, 2034. Interest on the 2026 Notes will be paid semi-annually in arrears on June 5 and December 5 of each year, commencing on June 5, 2024. Interest on the 2029 Notes and the 2034 Notes will be paid semi-annually in arrears on January 31 and July 31 of each year, commencing on July 31, 2024.

Prior to November 5, 2026, in the case of the 2026 Notes, December 31, 2028, in the case of the 2029 Notes, and October 31, 2033, in the case of the 2034 Notes (each, a "Par Call Date"), the Company may redeem each series of the Notes, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes of such series to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Notes of such series being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such Notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus 10 basis points, in the case of the 2026 Notes, 15 basis points, in the case of the 2029 Notes, and 15 basis points, in the case of the 2034 Notes, plus, in each case, accrued and unpaid interest on the Notes of such series being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem some or all of each series of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings, Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of the Company. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company and rank senior in right of payment to any existing and future indebtedness of the Company that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities or commitments of its subsidiaries.

The Indenture contains limited affirmative and negative covenants. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of capital stock of any of our direct or indirect subsidiaries that owns a Principal Property and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of the Company to merge or consolidate or sell all or substantially all of its assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of the Company under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued an opinion to the Company, dated December 5, 2023, regarding the Notes. A copy of this opinion is filed as Exhibit 5.1 hereto.

The foregoing description is qualified in its entirety by reference to the full text of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.

Item 8.01. Other Events.

The sale of the Notes was made pursuant to the terms of an Underwriting Agreement, which the Company entered into on November 28, 2023 (the "Underwriting Agreement"), with BofA Securities, Inc., Morgan Stanley & Co. LLC, U.S. Bancorp Investments, Inc. and Wells Fargo Securities, LLC, as representatives of the several underwriters named in Schedule A to the Underwriting Agreement.

The Company expects that the net proceeds from the sale of the Notes will be approximately $2.48 billion, after deducting underwriting discounts and estimated offering expenses. The Company intends to use the net proceeds of the Offering for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, working capital and capital expenditures or the repurchase of its outstanding equity securities or the Company may temporarily invest the net proceeds in short-term, liquid investments until they are used for their ultimate purpose.

The foregoing description is qualified in its entirety by reference to the full text of the Underwriting Agreement, which is filed with this report as Exhibit 1.1 hereto and is incorporated herein by reference.

On December 5, 2023 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported the pricing of an underwritten public offering of 9,482,758 shares of its common stock at a public offering price of $29.00 per share (Press release, SpringWorks Therapeutics, DEC 5, 2023, View Source [SID1234638161]). All of the shares in the offering are being sold by SpringWorks. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $275.0 million. The offering is expected to close on or about December 7, 2023, subject to the satisfaction of customary closing conditions. In addition, SpringWorks has granted the underwriters a 30-day option to purchase up to an additional 1,422,413 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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

An automatic shelf registration statement on Form S-3ASR (including a prospectus) relating to these securities has been filed with the Securities and Exchange Commission (SEC) and has become effective.

The offering is being made only by means of a prospectus and prospectus supplement that form part of the automatic shelf registration statement. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526 or by email at [email protected]; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1115 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9544, 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 December 5, 2023 Replimune Group, Inc., a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, reported results from the primary analysis of the CERPASS trial evaluating RP1 in combination with cemiplimab for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) and provided initial data for all patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial (Press release, Replimune, DEC 5, 2023, View Source [SID1234638160]). The company also shared a new data snapshot from the IGNYTE cohort of anti-PD1 failed non-melanoma skin cancer (NMSC) patients and data from the ARTACUS trial evaluating RP1 as monotherapy for skin cancer in patients who have had solid organ or hematopoietic cell transplants.

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"Data from across our skin cancer program clearly show that RP1 is an active agent both as monotherapy and in combination with anti-PD1 therapy in multiple settings, giving us further confidence in the potential of RP1 to be an important treatment option for skin cancer patients," said Philip Astley-Sparke, CEO of Replimune. "The overall data from the CERPASS study indicate that treatment with RP1 in combination with cemiplimab led to clinically meaningful activity with a higher rate of complete responses and favorable duration of response versus cemiplimab alone. Further, the positive data from the full 140 patient anti-PD1 failed melanoma cohort in the IGNYTE trial shows approximately 1 in 3 patients treated with RP1 in combination with nivolumab achieved a durable response which we believe is supportive of our planned submission of a BLA in 2H 2024 for this high unmet need patient population."

Results from the CERPASS Trial in CSCC
The CERPASS clinical trial was a global, randomized study enrolling 211 patients randomized 2 to 1 to receive RP1 plus cemiplimab versus cemiplimab standard of care for patients with locally advanced or metastatic CSCC. The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
The study did not meet either of the two primary endpoints of complete response rate (CRR) or overall response rate (ORR) as assessed by blinded independent central review. RP1 in combination with cemiplimab increased the CRR versus cemiplimab alone (38.1% vs. 25%, p=0.040), which was just short of the required threshold for statistical significance in this study (p<0.025). Notably, among the 83 patients with locally advanced disease, the complete response rate in the RP1 plus cemiplimab group was 48.1% versus 22.6% in the cemiplimab only group. The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692). Importantly, RP1 in combination with cemiplimab also increased duration of response (DOR) as compared to cemiplimab alone (hazard ratio 0.45), however, these data are immature and further follow up is required. Of note, RP1 plus cemiplimab provided particularly meaningful clinical activity for many patients with difficult to treat, disfiguring tumors that typically have the greatest impact on quality of life, given their size and location.

There was also an imbalance in baseline tumor burden across the treatment groups which may have impacted the number of responses seen. A significantly greater number of patients with high baseline tumor burden (larger than 10 cm in total diameter) were treated in the RP1 plus cemiplimab group as compared to the cemiplimab alone group (23% of RP1 plus cemiplimab treated patients had high baseline tumor burden vs. 12.5% of cemiplimab only patients). In a pre-specified analysis, patients with total tumor burden less than or equal to 10 cm had a CRR of 43% in the RP1 plus cemiplimab group versus 27% in the cemiplimab only group. For those patients with tumor burden greater than 10 cm, CRR was 21.9% in the RP1 plus cemiplimab group versus 11.1% in the cemiplimab only group.

The trial will continue as planned to assess DOR, progression free survival (PFS) and overall survival (OS) with greater maturity.

Treatment-related adverse events with RP1 plus cemiplimab were predominantly additional transient Grade 1-2 "flu-like" symptoms being seen as compared to cemiplimab alone, including fatigue, pyrexia, pruritis, nausea, hypothyroidism, chills, diarrhea, asthenia, infusion-related reaction, rash, rash maculo-popular, and vomiting. There was a range of Grade 3 events occurring in one patient each in the RP1 plus cemiplimab arm (16.5%), except for fatigue, rash maculo-popular, and immune-mediated hepatitis which occurred in 2 patients each. Grade 4 events were one each of immune-mediated myocarditis and myocarditis. There were no Grade 5 treatment-related adverse events.

Initial Data from All Patients in the IGNYTE Cohort of RP1 in Anti-PD1 Failed Melanoma
The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year. Data are also included for 16 patients from the initial cohort representing a total of 156 patients in this treatment setting.

In the RP1 plus nivolumab group (n=156), the ORR was 31.4% with a CR rate of 12% showing activity consistent with the prior snapshot of 91 anti-PD1 failed melanoma patients. As of this report, there are 5 patients still on study with the opportunity for response. In the full population, almost half of patients failed combination therapy with ipilimumab plus nivolumab as compared to the earlier snapshot where approximately a third were ipilimumab and nivolumab failures. Approximately 50% of patients experienced clinical benefit, defined as CR, PR, or stable disease (SD). Of responders, 100% are ongoing at more than six months with 78% of responses still ongoing as of November 6, 2023. Responses reported for this snapshot were investigator-assessed. RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 "on target" side effects, observed.

In this cohort, responses were seen across disease stages, including complete responses in patients with stage IVM1b/c disease. Responses are highly durable with median DOR greater than 24 months, and often deepening over time. Preliminary OS data are promising. The primary analysis by independent central review will be triggered once all patients have had at least 12 months of follow up in March 2024.

Treatment-related adverse events associated with RP1 in combination with nivolumab in this cohort were predominantly Grade 1-2 constitutional type events (> 5% of patients), including fatigue, chills, pyrexia, nausea, influenza-like illness, pruritis, diarrhea, injection site pain, vomiting, headache, rash, myalgia, asthenia, decreased appetite, and injection site reaction, with a low incidence of Grade 3-5 events. Grade 4 events were one each of lipase increased, cytokine release syndrome, myocarditis and hepatic cytosis and the Grade 5 treatment-related adverse event was one event of immune mediated myocarditis, which was attributed to nivolumab and is an expected immune mediated adverse event for nivolumab.

IGNYTE Regulatory Update
The company recently participated in a Type C meeting with the U.S. Food and Drug Administration (FDA). During the discussion, the FDA acknowledged that the anti-PD1 failed melanoma population is one of unmet need. The FDA agreed with an anti-PD1 failed melanoma confirmatory study design concept consisting of a 2-arm randomized trial with physician’s choice of treatment as a comparator arm in the study population. Full protocol development is currently underway. The proposed Phase 3 confirmatory trial should be initiated by the time of an application under the accelerated approval pathway. After following all patients for at least 12 months and pending central review by RECIST v1.1, BLA submission for RP1 in combination with nivolumab is planned for 2H 2024.

Data Overview from Phase 1/2 ARTACUS Clinical Trial of RP1 Monotherapy
As previously presented, treatment with RP1 monotherapy in the Phase 1/2 ARTACUS clinical trial in skin cancer patients who have had solid organ or hematopoietic cell transplants led to an ORR of 34.8% (8 of 23 evaluable patients, including 5 CRs and 3 partial responses). These patients are generally not eligible for anti-PD1 therapy which could precipitate transplant rejection. Most responses were ongoing as of the data cutoff date of September 18, 2023. There was no evidence of allograft rejection. RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

Initial Data Snapshot from the IGNYTE Cohort of RP1 in Anti-PD1 Failed NMSC
The NMSC data reported from the IGNYTE trial is from the first 30 patients enrolled in the cohort, all with at least 6 months of follow up, including patients with CSCC, MCC, basal cell carcinoma, and angiosarcoma. The data show that treatment with RP1 in combination with nivolumab led to an ORR of 30% (9 of 30 patients) which is consistent with data from the anti-PD1 failed melanoma cohort with approximately a third of patients responding and 60% demonstrating clinical benefit. The combination of RP1 and nivolumab was well tolerated in this patient population with a safety profile consistent with the overall experience seen with this treatment regimen to date in skin cancer.

Portfolio Update
As previously shared, the company presented strong data with RP2 in uveal melanoma during a plenary session at the 20th International Congress of the Society for Melanoma Research in November. Based on the data in this population, planning is underway for a randomized controlled clinical trial of RP2 in second line (2L) uveal melanoma with the company intending to investigate other rare cancer opportunities as target indications.

To focus on near term priority studies, including the RP1 Phase 3 confirmatory study in anti-PD1 failed melanoma and the RP2 registrational study in uveal melanoma, RP2/3 development in squamous cell carcinoma of the head and neck (SCCHN) and colorectal cancer (CRC) is being discontinued. The 2L hepatocellular carcinoma (HCC) trial will continue with RP2 only. At this time, development of RP3 will be discontinued.

As of September 30, 2023, cash and investments total $496.8M. We expect that the reprioritization of the portfolio will extend the cash runway into early 2026.

Conference Call Details
Replimune will host a conference call and webcast today at 8:00 a.m. ET. Listeners can register for the conference call via this link. Analysts wishing to participate in the question and answer session should use this link. The webcast and slides of the presentation can be accessed in the Investors section of Replimune’s website at www.replimune.com. A replay of the webcast will be available on Replimune’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

On December 5, 2023 Odyssey Therapeutics, Inc., a biotechnology company pioneering next-generation precision immunomodulators and oncology medicines, reported the closing of a $101 million Series C financing round led by Ascenta Capital with participation from new and existing investors, including OrbiMed, SR One, General Catalyst, Foresite Capital, Woodline Partners LP, HBM Healthcare Investments, Colt Ventures, BlackMars Capital GmbH, Creacion Ventures, funds and accounts advised by Fidelity Management & Research Company, funds and accounts advised by T. Rowe Price Associates, Inc., Catalio Capital Management, Walleye Capital, Alexandria Venture Investments, Racing Beach Ventures LLC, The Healthcare Innovation Investment Fund LLC, an investment fund associated with Leerink Partners, Ab Magnitude Ventures, KB Investment, The Global BioAccess Fund, and multiple leading global investors (Press release, Odyssey Therapeutics, DEC 5, 2023, View Source [SID1234638159]). This Series C financing brings the total capital raised since founding in late 2021 to $487 million. Proceeds will support the advancement of multiple programs into clinical studies and the continuation of investment in discovery to build a sustainable model for therapeutic innovation.

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"Odyssey has rapidly advanced a portfolio of immunology and oncology therapeutics with the goal of providing transformative medicines for large numbers of patients in need and several of these molecules have the potential to enter the clinic in the next 12 months," said Gary D. Glick, Ph.D., founder and CEO of Odyssey. "For us, success is defined as bringing safe and effective medicines to patients with serious diseases, with support from Ascenta and our other investors driving our pipeline into the future. We welcome Dr. Lorence Kim, co-founder and managing partner of Ascenta Capital, to our board to join us in achieving this mission."

Dr. Kim brings a wealth of strategic, financial and operational acumen from the biotechnology and pharmaceutical sectors to Odyssey’s board. Notably, during his tenure from 2014 to 2020 as Moderna’s chief financial officer, he raised $4.4 billion to build the company’s technology platform, advance multiple clinical programs and invest in mRNA infrastructure. Prior to Moderna, Dr. Kim advised established pharmaceutical and emerging biotech companies as co-head of biotechnology investment banking at Goldman Sachs.

"Odyssey’s accomplished team of scientists and executives with numerous prior successes in discovery, development and commercialization has made tremendous progress in only two years," said Lorence Kim, M.D. "Dr. Glick has successfully created a sustainable and capital-efficient model that primes Odyssey to be a hub for immunology and oncology therapeutic innovation, and I look forward to working with him, the board and leaders on the management team in the years ahead."

From its headquarters in Boston, Odyssey has built a comprehensive drug discovery and development platform merging both computational and experimental technologies. This unique set of tools enables Odyssey to identify drug targets with the highest clinical potential in a modality-agnostic fashion. In just two years, the company has moved multiple programs forward from ideation to a portfolio of high-value product candidates.

"Odyssey continues to accelerate multiple pre-clinical programs in immunology and oncology," said Jeff Leiden, M.D., Ph.D., Chairman of the Odyssey board. "By raising additional capital from world-class investors and adding a board member with expertise in drug development and company building, we are positioning Odyssey for success over the next several years as our pipeline enters clinical development."

On December 5, 2023 IN8bio, Inc., a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported the Company will host a conference call on Tuesday, December 12, 2023 at 8:30 am ET (Press release, In8bio, DEC 5, 2023, View Source [SID1234638157]). The event will highlight data presented at the ASH (Free ASH Whitepaper) 65th Annual Meeting in a poster presentation on December 11, 2023 starting at 6:00 pm PT. The Company’s INB-100 trial is focused on investigating the potential of harnessing donor-derived allogeneic gamma-delta T cells for the treatment of patients with hematological malignancies following hematopoietic bone marrow transplantation (HSCT).

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Speakers on the call will include IN8bio’s management team, as well as key oncology thought leader Michael Bishop, MD, Director of the David and Etta Jones Center for Cellular Therapy at the University of Chicago, who will be highlighting gamma-delta T cells as a clinical strategy to prevent relapse of patients with hematological malignancies. Dr. Bishop is a prominent clinical investigator of acute leukemias, with a focus on improving transplant outcomes and preventing relapse. He is a faculty member and a member of the planning committee for the ASTCT/EBMT Conference on Relapse After Transplant and Cellular Therapy. Dr. Bishop previously served as a senior investigator and as the clinical head of stem cell transplantation for the National Cancer Institute (NCI) at the National Institutes of Health.

Conference Call Details
IN8bio will host a conference call and webcast on Tuesday, December 12, 2023, at 8:30 am ET to review the updated data from the poster presentation at ASH (Free ASH Whitepaper). The webcast can be accessed here and will also be available under the "Events and Presentations" section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.

About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with hematologic malignancies following HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.