On November 18, 2021 Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic "off-the-shelf" gene-edited iNK (NK cells derived from iPSC) and CAR (Chimeric Antigen Receptor) Natural Killer (NK) cells derived from induced pluripotent stem cells (iPSCs) and Flex-NK cell engager multifunctional antibodies, and Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, reported that they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics (Press release, Cellectis, NOV 18, 2021, View Source [SID1234595789]).

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The amended financial terms include an equity stake totaling $20 million in Cytovia stock as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia.

"We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products that will leverage the high-precision of TALEN to perform gene-editing to minimize the risk of off-target effects and unlock the full potential of NK cells as a first line of defense against cancer. Cytovia’s internal research and development, and manufacturing teams are actively developing multiple gene-edited therapeutic candidates and optimizing our technology platform towards next generation products," said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics.

Cellectis is developing custom TALEN, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license under the patent rights over which Cellectis has the control in this field, including in China, enabling Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications.

"We are thrilled at the progress Cytovia has accomplished in the past year," said Dr. André Choulika, CEO of Cellectis. "Cytovia has attracted a world-class scientific team and is advancing its clinical candidates in areas of significant unmet medical need, sharing Cellectis’ mission to provide life-saving off-the-shelf allogeneic cell therapy to patients."

On November 18, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported an underwritten public offering of American Depositary Shares ("ADSs") (Press release, RedHill Biopharma, NOV 18, 2021, View Source [SID1234595788]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an additional 15 percent of the number of ADSs offered in the public offering.

Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form S-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

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On November 18, 2021, Thermo Fisher Scientific (Finance I) B.V. ("Thermo Fisher International"), an indirect, wholly-owned finance subsidiary of Thermo Fisher Scientific Inc. (the "Company"), reported that issued €1,700,000,000 aggregate principal amount of Floating Rate Senior Notes due 2023 (the "Floating Rate Notes"), €550,000,000 aggregate principal amount of 0.000% Senior Notes due 2023 (the "2023 Notes") and €550,000,000 aggregate principal amount of 0.000% Senior Notes due 2025 (the "Sustainability Notes", and, together with the Floating Rate Notes and the 2023 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951) 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 (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, NOV 18, 2021, View Source [SID1234595787]). The Company has fully and unconditionally guaranteed the Notes on a senior unsecured basis (the "Guarantee" and, together with the Notes, the "Securities").

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The Securities were issued under an indenture, dated as of August 9, 2016 (the "Base Indenture"), and the Fourth Supplemental Indenture, dated as of November 18, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), among Thermo Fisher International, as issuer, the Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee.

The Floating Rate Notes will mature on November 18, 2023, the 2023 Notes will mature on November 18, 2023 and the Sustainability Notes will mature on November 18, 2025. Interest on the Floating Rate Notes will be paid quarterly in arrears on February 18, May 18, August 18 and November 18 of each year, commencing on February 18, 2022.

Prior to October 18, 2025, in the case of the Sustainability Notes, and at any time, in the case of the 2023 Notes, Thermo Fisher International may redeem such series of 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 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 being redeemed (assuming, with respect to the Sustainability Notes, that the Sustainability Notes to be redeemed matured on October 18, 2025), discounted to the date of redemption on an annual basis (ACTUAL/ACTUAL (ICMA)), using a discount rate equal to the Comparable Bond Rate (as defined in the Indenture) plus, in each case, 10 basis points, plus, in each case, accrued and unpaid interest on the Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after October 18, 2025, the Company may redeem the Sustainability Notes, in whole at any time or in part from time to time, at a redemption price equal to 100% of the principal amount of the Sustainability 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, Thermo Fisher International 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 accrued and unpaid interest, if any, to, but excluding, the date of repurchase.

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

The Guarantee is a general unsecured obligation of the Company. The Guarantee ranks equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company and will rank senior in right of payment to any existing and future indebtedness of the Company that is subordinated to the Guarantee. The Guarantee is also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and is structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries (other than, with respect to Thermo Fisher International, the Notes).

The Indenture contains limited affirmative and negative covenants of the Company and Thermo Fisher International. 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 stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of each of the Company and Thermo Fisher International to merge or consolidate or sell all or substantially all of their respective 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 Thermo Fisher International 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, U.S. counsel to the Company and Thermo Fisher International, has issued an opinion to the Company and Thermo Fisher International, dated November 18, 2021, regarding the legality of the Securities, and Linklaters LLP, Dutch counsel to Thermo Fisher International, has issued an opinion to Thermo Fisher International, dated November 18, 2021, regarding the Notes. Copies of these opinions are filed as Exhibits 5.1 and 5.2 hereto, respectively.

The foregoing description of certain of the terms of the Indenture does not purport to be complete and is qualified in its entirety by reference to the full text of each 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.

On November 18, 2021 Immunomic Therapeutics, Inc. (‘ITI’), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that Kristen Batich, MD, Ph.D. and a team from Duke University School of Medicine will present clinical data at the 2021 Society for Neuro-Oncology (SNO) Annual Meeting being held in Boston, MA, November 18-21st, 2021 (Press release, Immunomic Therapeutics, NOV 18, 2021, View Source [SID1234595786]).

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The data to be presented at the SNO meeting are from three sequential clinical trials utilizing Cytomegalovirus (CMV)–specific dendritic cell vaccines that encode the chimeric CMV protein LAMP-pp65 in patients with primary Glioblastoma. The patients were given serial vaccination through adjuvant temozolomide cycles. The Phase II ATTAC study (NCT00639639) led to an expanded cohort trial (ATTAC-GM: NCT00693639) resulting in positive immunologic and clinical response. The larger confirmatory trial, ELEVATE (NCT02366728), revealed significantly longer overall survival (OS) in patients randomized to LAMP pp65 RNA loaded DC vaccines combined with tetanus-diphtheria booster. The results demonstrate that a CMV pp65-LAMP RNA-pulsed dendritic cell vaccination was associated with positive immunologic and clinical response in patients with glioblastoma (GBM).

"The clinical data to be presented demonstrates the potential impact of our UNITE technology platform, powered by LAMP, and will help validate our therapeutic approach utilizing vaccines to treat difficult cancers like glioblastoma," said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics, Inc. "We are encouraged by the immunological response shown with this patient group and we look forward to Dr. Batich’s presentation of these positive findings at the SNO meeting."

Abstract Session: Clinical Trials I

Title: Reproducibility of clinical trials using CMV-targeted dendritic cell vaccines in patients with glioblastoma
Category: CTIM-10
Date and Time: Friday, November 19, 2021 4:45 PM – 4:50 PM EST
Location: Ballroom C, Hynes Convention Center, Boston, MA

Presenter:

Kristen A. Batich, MD, PhD
Duke University Medical Center
Durham, United States

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improve survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP-1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On November 18, 2021 Calliditas Therapeutics reported that (Press release, Calliditas Therapeutics, NOV 18, 2021, View Source [SID1234595785])

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"Following on from the positive top line read out of Part A our Phase 3 study, we initiated a structured process to select our commercial partner for Nefecon in Europe. In this case, the result of the process was a partnership with Stada Arzneimittel, which has proven to be an excellent match. We also took the opportunity to complement our predominant source of equity capital with a $75m credit line from Kreos.

In the third quarter, the U.S. Food and Drug Administration (FDA) requested further analyses of data from the NeflgArd clinical trial in connection with our NDA submitted for approval under the FDA’s Accelerated Approval Program. The FDA classified the additional analyses received as a major amendment to the NDA and extended the PDUFA goal date by three months from September 15, 2021 to December 15, 2021. The third quarter also saw the European Medicines Agency (EMA) deciding to revert to standard review timelines for our submission, which we estimate will result in the issuance of an opinion in Q1, 2022. We remain confident that we have presented a compelling data package and look forward to continuing our regulatory interactions with the goal of making an approved treatment available for patients in need.

We remain ready for commercial launch in the US. Our field medical directors are in dialogue with nephrologists across the country and we are proceeding with market access related conversations as well as other pre-commercial activities. We are excited about our strong US capabilities reflected by the highly experienced and well-prepared team in place."

Renée Aguiar-Lucander, CEO

Summary of Q3 2021
July 1 – September 30, 2021

Net sales amounted to SEK 198.2 million for the three months ended September 30, 2021. No net sales were recognized for the three months ended September 30, 2020.
Operating profit (loss) amounted to SEK 7.9 million and SEK (104.9 million) for the three months ended September 30, 2021 and 2020, respectively.
Earnings (loss) per share before dilution amounted to SEK 0.21 and SEK (2.77) for the three months ended September 30, 2021 and 2020, respectively.
Cash amounted to SEK 1,163.8 million and SEK 1,396.9 million as of September 30, 2021 and 2020, respectively.
Significant events during Q3 2021, in summary
In July 2021, Calliditas signed a loan agreement of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of EUR 97.5 million (approx. $115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million (approx. $37m) before transaction costs.
In September 2021, Calliditas announced that the FDA extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.
In September 2021, Calliditas announced that the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.
Investor presentation November 18, 14:30 CET
Audio cast with teleconference, Q3 2021, November 18, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Year-end Report for the period January 1 – December 31, 2021 February 24, 2022