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NANOBIOTIX Executes Definitive Agreement to Restructure Existing Loan With the European Investment Bank

On October 18, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported execution of a final agreement with the European Investment Bank ("EIB") to re-align approximately €30.7 million in outstanding debt obligations with the Company’s expected development and commercialization timelines (Press release, Nanobiotix, OCT 18, 2022, View Source [SID1234622135]). Nanobiotix previously announced agreement-in-principle with EIB for this restructuring on September 12th, 2022.

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The original finance contract and royalty agreement established between Nanobiotix and EIB in July 2018 included an initial tranche of €16.0 million drawn in October 2018 and repayable in a single installment at maturity in 2023; and a second tranche of €14.0 million granted in March 2019 and repayable in semi-annual installments of principal and interest after a two-year grace period. The agreement also included a commitment to an annual royalty payment in the low single-digits over a six-year period beginning January 2021.

Terms and Conditions of the Restructuring Agreement

The newly executed restructuring agreement enables Nanobiotix to defer repayment of the remaining €25.3 million in principal for both tranches up to June 2029.

Under the terms of the agreement, €5.4 million in interest accrued on the first tranche since 2018 will be restructured as payment-in-kind ("PIK") and will be deferred up to October 2024. Going forward, principal from the first tranche will accrue interest at the rate of 6% annually, with such interest being capitalized and due as PIK interest at maturity. Interest on the remaining €9.3 million in principal from the second tranche will continue to accrue at a 5% fixed rate paid in semi-annual installments through June 2029.

The annual royalty payment remains in the low single-digits and continues to cover a six-year period but has been re-aligned to begin as of the first year of NBTXR3 commercialization.

The restructuring agreement also includes a new milestone payment of €20 million due in June 2029.

While the restructuring of the finance and royalty agreement is intended to align debt obligations with the Company’s anticipated commercial timelines, the agreement contains provisions that would accelerate the maturity and repayment schedule, should Nanobiotix generate commercial revenue prior to June 2029. Specifically, principal and interest accrued on the first tranche following the amendment would be due in a single installment at the earlier of four years after commercialization or June 2029. Semi-annual principal repayments for the second tranche would resume with a maturity date at the earlier of three years following commercialization or June 2029. Finally, an accelerated redemption schedule for the new €20 million milestone payment would be triggered calling for the repayment in two equal installments due one year and two years after commercialization, respectively.

Further, should the company secure non-dilutive capital through the execution of any business development deal, the €5.4 million PIK interest payment associated with the first tranche would be due by October 2023 and an accelerated redemption schedule for the new €20 million milestone payment would be triggered. The accelerated redemption schedule would reflect a prorated payment amount not exceeding 10% of any upfront or milestone payment received by Nanobiotix with any remaining balance of the €20 million milestone payment due at maturity.

As part of the restructuring, Nanobiotix has agreed to maintain a minimum cash balance equal to the outstanding principal owed to EIB. All other covenants included in the 2018 finance contract remain unchanged.

Myovant Sciences Announces New Employment Inducement Grants Under NYSE Rule 303A.08

On October 18, 2022 Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, reported that it approved equity awards for 10 new employees with a grant date of October 17, 2022 pursuant to Myovant’s 2020 Inducement Plan (Press release, Myovant Sciences, OCT 18, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-new-employment-inducement-grants-7 [SID1234622134]). The equity awards were granted to the employees joining Myovant in accordance with NYSE’s Listed Company Manual Rule 303A.08.

The new employees received, in the aggregate, restricted stock units (RSUs) to purchase 96,500 common shares of Myovant. One-fourth of the shares underlying each employee’s RSU will vest on the one-year anniversary of the grant date, with the balance of the common shares vesting in twelve equal quarterly installments thereafter, in each case, subject to each such employee’s continued employment with Myovant on such vesting dates. The RSUs are subject to the terms and conditions of the 2020 Inducement Plan and the applicable RSU agreements.

LIXTE BIOTECHNOLOGY ANNOUNCES APPROVAL OF A PHASE 1B/2 RANDOMIZED TRIAL OF DOXORUBICIN +/-LB-100 IN ADVANCED SOFT TISSUE SARCOMAS TO BE CONDUCTED BY THE SPANISH SARCOMA GROUP

On October 13, 2022 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), ("LIXTE" or the "Company"), a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, reported that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) has authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS) (Press release, Lixte Biotechnology, OCT 18, 2022, sec.gov/Archives/edgar/data/1335105/000149315222028641/ex99-1.htm [SID1234622133]).

Dr. John Kovach, the founder and CEO of LIXTE, said, "The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined with doxorubicin in soft tissue sarcomas. Doxorubicin alone has been the cornerstone of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 has consistently enhanced the anti-tumor activity of doxorubicin without apparent increases in toxicity. The interim analysis of this clinical trial will be done before full accrual is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone."

Dr. Kovach continued, "This study was designed and will be carried out by the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS). GEIS was formed in 1994 by oncologists from four hospitals and has grown to include members from more than 60 medical centers across Spain. For relatively uncommon but life-threatening diseases like ASTS, GEIS has shown that it is essential for many institutions to collaborate and accrue a large enough group of patients needed to timely evaluate promising new treatments. We are delighted that GEIS has chosen to study whether LIXTE’s lead clinical compound, LB-100, can significantly improve the anti-tumor activity of doxorubicin, the current clinical standard, an only marginally effective treatment for previously untreated ASTS. The clinical trial is expected to begin later this year or during the first quarter of 2023; up to 170 patients will be entered onto the trial, which is expected to be completed within two and a half years. This rapid rate of patient accrual is only possible through the collaborative efforts of GEIS oncologists."

Dr. Javier Martín-Broto, Coordinating Investigator of the trial, medical oncologist at the Fundación Jiménez Díaz University Hospital (Madrid) and GEIS Co-Founder, commented, "Although there has been an increase in overall survival in advanced sarcoma in recent years, this gain has not been accompanied by advances in first line therapy. Anthracyclines, and specifically doxorubicin, is still the standard initial treatment. The growing list of negative phase III trials indicates to us that sarcoma therapy is in crisis. It is true that sarcoma encompasses more than 60 different subtypes and, for some of them, substantial advances have emerged. But it is also true that the most frequent sarcoma subtypes desperately need a turning point. One promising topic of research is the combination of doxorubicin with drugs that are able to impair the mechanisms of DNA repair. LB-100 has demonstrated synergistic action in in vivo preclinical mesenchymal tumors. GEIS will lead a European initiative to conduct a Phase 1/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas."

Dr. Kovach added, "We believe that authorization of this trial by AEMPS should facilitate approval of other LB-100 protocols in EU countries.

JOHNSON & JOHNSON REPORTS 2022 THIRD-QUARTER RESULTS

On October 18, 2022 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2022. "Our third quarter performance demonstrates our continued strength and resilience across all three of our businesses," said Joaquin Duato, Chief Executive Officer (Filing, 8-K, Johnson & Johnson, OCT 18, 2022, View Source [SID1234622132]). "Through the ongoing efforts of our teams around the world, we continue to navigate the dynamic macroeconomic environment and remain focused on delivering transformative healthcare solutions. Looking ahead, I remain confident in our business and ability to continue advancing our innovative portfolio and pipeline."

OVERALL FINANCIAL RESULTS:
a3q22overallfinancialresula.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
Note: values may have been rounded

REGIONAL SALES RESULTS:
a3q22regionalfinancialresua.jpg

1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:
a3q22salesbysegment002a.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on
operational changes
Note: Values may have been rounded

THIRD QUARTER 2022 SEGMENT COMMENTARY:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health

Consumer Health worldwide adjusted operational sales increased 4.8%*. Major contributors to growth include upper respiratory and analgesic products in the over-the-counter franchise, NEUTROGENA and AVEENO in Skin Health/Beauty and Women’s Health products outside the United States.

Pharmaceutical

Pharmaceutical worldwide adjusted operational sales grew 9.2%*, driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases and IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer.

MedTech

MedTech worldwide adjusted operational sales grew 8.1%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, Trauma in Orthopaedics and wound closure products in General Surgery.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:

The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the Company’s website at news releases, as well as
www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory Decisions STELARA (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis (Press Release)
European Commission Approves IMBRUVICA (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (Press Release)
Janssen Marks First Approval Worldwide for TECVAYLI (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma (Press Release)
U.S. FDA Approves IMBRUVICA (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease (Press Release)
Data Release Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations (Press Release)
Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma (Press Release)
TREMFYA (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance with Earlier Treatment in Adults with Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study (Press Release)
Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 381
(Press Release)
STELARA (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis1
(Press Release)
Janssen Announces Late-Breaking Data from Two Gene Therapy Programs at the American Academy of Ophthalmology 2022 Annual Meeting (Press Release)
Product Launches Biosense Webster Launches the OCTARAY Mapping Catheter with TRUEref Technology (Press Release)
Johnson & Johnson Vision Introduces All Purpose EDOF, TECNIS Symfony OptiBlue IOL, the Latest PC-IOL Powered by InteliLight Technology (Press Release)
Johnson & Johnson Vision Launches New Contact Lens Innovation to Help Meet the Needs of Digitally Intense Lifestyles: ACUVUE OASYS MAX 1-Day (Press Release)
Biosense Webster Launches HELIOSTAR in Europe, the First Radiofrequency Balloon Ablation Catheter, Enabling Physicians to Perform More Efficient Cardiac Ablations1
(Press Release)
Other Johnson & Johnson Announces $5 Billion Share Repurchase Program (Press Release)
Johnson & Johnson Appoints Larry Merlo as Non-Executive Chair Designate of Planned New Consumer Health Company (Press Release)
Johnson & Johnson Announces Kenvue as the Name for Planned New Consumer Health Company (Press Release)

. 1 Subsequent to the quarter

FULL-YEAR 2022 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

($ in Billions, except EPS) October 2022 July 2022
Adjusted Operational Sales1,2,5
Change vs. Prior Year
6.7% – 7.2% 6.5% – 7.5%
Operational Sales2,5/ Mid-point2,5
Change vs. Prior Year / Mid-point
$97.5B – $98.0B / $97.8B
6.7% – 7.2% / 7.0% $97.3B – $98.3B / $97.8B
6.5% – 7.5% / 7.0%
Estimated Reported Sales3,5/ Mid-point3,5
Change vs. Prior Year / Mid-point
$93.0B – $93.5B / $93.3B
1.8% – 2.3% / 2.1% $93.3B – $94.3B / $93.8B
2.1% – 3.1% / 2.6%
Adjusted Operational EPS (Diluted)2,4/ Mid-point2,4
Change vs. Prior Year / Mid-point
$10.70 – $10.75 / $10.73
9.2% – 9.7% / 9.5% $10.65 – $10.75 / $10.70
8.7% – 9.7% / 9.2%
Adjusted EPS (Diluted)3,4 / Mid-point3,4
Change vs. Prior Year / Mid-point
$10.02 – $10.07 / $10.05
2.3% – 2.8% / 2.6% $10.00 – $10.10 / $10.05
2.1% – 3.1% / 2.6%

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: October 2022 = $1.04 and July 2022 = $1.05 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.

Instil Bio Announces First Patient Dosed with ITIL-306, our First Engineered TIL Therapy Using the CoStAR Platform Targeting Folate Receptor Alpha (FRα), in Non-Small Cell Lung Cancer

On October 18, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that the first patient has been dosed in a Phase 1 dose escalation study of ITIL-306 (NCT05397093 View Source;draw=2&rank=2) for the treatment of multiple solid tumors (Press release, Instil Bio, OCT 18, 2022, View Source [SID1234622130]). ITIL-306 is Instil’s first genetically-engineered Costimulatory Antigen Receptor-TIL (CoStAR-TIL) therapy.

"The successful initiation of the Phase 1 study of ITIL-306 underscores our commitment to evolving TIL therapy, using strategies to enhance product efficacy and safety, with the goal to achieve durable remissions in patients with treatment-refractory solid tumors," said Bronson Crouch, Chief Executive Officer of Instil Bio.

Instil’s first-in-human Phase 1 study of ITIL-306 is an open-label, multicenter study in patients with non-small cell lung cancer, ovarian cancer, and renal cell carcinoma. Patients in the first dose cohort will receive a target dose of one billion CoStAR-transduced TILs after receiving a reduced intensity lymphodepletion regimen and no post-infusion interleukin-2. The study will evaluate safety of ITIL-306 in addition to efficacy and translational endpoints. The company anticipates reporting initial clinical data from the Phase 1 trial in 2023.

ITIL-306 is an autologous TIL cell therapy engineered with a novel and proprietary CoStAR molecule that is activated by folate receptor alpha (FRα) to provide robust costimulatory signals within the tumor microenvironment. CoStAR builds on the key advantages of native TILs to enhance the cytokine release, cytolytic activity, and proliferation of TILs in the tumor microenvironment. Previously published preclinical data ( View Source ) demonstrates the ability of CoStAR-T cells to enhance tumor control in vivo in the absence of exogenous IL-2, supporting a treatment regimen free of IL-2 in the Phase 1 study of ITIL-306.