Regulatory Approvals - Bristol Myers Squibb's Breyanzi received approval as the first CAR T-cell therapy for marginal zone lymphoma [1] - Gamida Cell Ltd.'s Omisirge became the first hematopoietic stem cell transplant therapy for severe aplastic anaemia [2] - Fondazione Telethon's Waskyra is noted as the first cell-based gene therapy for Wiskott-Aldrich syndrome and the first approved cell and gene therapy product from a non-profit applicant [2] Drug Approvals Overview - In 2025, a total of 44 novel drugs have received FDA approval, a decrease from 50 approvals in the previous year [3] - Anticipated regulatory decisions and approvals are expected in January 2026 [3]

TORONTO and HAIFA, Israel, June 21, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the "Company" or "NurExone"), a pioneering biopharmaceutical company, welcomes Dr. Yona Geffen, as a consultant, to support the Company's preclinical and clinical activities. Dr. Geffen, who currently serves as Vice President of Research and Development at Gamida Cell Ltd. ("Gamida Cell"), brings over two decades of extensive experience in leading clinical and drug development in ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38716 GAMIDA CELL LTD. (Exact Name of Registrant as Specified in its Charter) Israel Not Applicable (State or other jurisdiction ...

CALGARY, Alberta, April 08, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ:XRTX, TSXV:XRTX, Frankfurt: ANUA WKN: A3UNZ))), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, welcomes Abigail Jenkins, a biotech industry veteran with deep experience with the commercialization of therapies for renal and cardiovascular disease, to its Board of Directors. Abigail "Abbey" L. Jenkins, M.S., is the current ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________. Commission File Number: 001-38716 (Registrant's telephone number, including area code) Israel Not Applicable (State or other jurisdiction of incorpora ...

Restructuring Agreement - The restructuring support agreement is part of a proposed restructuring under the Israeli Insolvency and Financial Rehabilitation Law, 2018, and involves a Chapter 15 case in the Bankruptcy Court[6]. - The Company Parties intend to commence Israeli debt arrangement proceedings promptly after the agreement effective date, which is set for March 26, 2024[8]. - The restructuring transactions will include negotiations with consenting creditors regarding the capital structure of the Company Parties[8]. - The agreement outlines that the completion of the restructuring transactions is subject to definitive documents and the approval rights of the involved parties[4]. - The restructuring support agreement is protected by confidentiality provisions due to its nature as a product of settlement discussions[3]. - The agreement does not constitute an offer or acceptance regarding any securities or a solicitation under Israeli insolvency law[2]. - The Company Parties will seek necessary approvals from the Israeli Court for the plan under the Israeli Debt Arrangement Proceeding[28]. - The restructuring plan will require the entry of an order by the Israeli Court confirming the plan and necessary approvals from the Company Parties[39]. - The agreement includes provisions for potential parallel proceedings, including additional liquidation or restructuring actions as necessary[8]. - The restructuring support agreement is designed to facilitate negotiations and actions in support of the restructuring transactions[9]. - The restructuring plan aims to streamline operations, potentially reducing costs by 15% over the next two years[51]. - The restructuring plan will be filed immediately after the Agreement Effective Date and requires court approval in the Israeli Debt Arrangement Proceedings[145]. - The restructuring transactions will also involve a Chapter 15 case in the U.S. Bankruptcy Court for the District of Delaware[145]. - The restructuring transactions are subject to the terms and conditions of the Definitive Documents and the Restructuring Support Agreement[145]. - The restructuring process is designed to protect the interests of all stakeholders involved, including creditors and equity holders[145]. - The restructuring plan involves the exchange of 100% of the $75 million principal amount of 5.875% exchangeable senior notes due 2026 for equity interests in the reorganized company[147]. - The restructuring transactions are subject to key milestones, including the initiation of the Israeli Debt Arrangement Proceeding by March 27, 2024[149]. - The restructuring plan includes comprehensive releases for all claims against the company parties, effective upon the confirmation order and plan effective date[154]. - Released company parties are exculpated from liability for actions related to the Israeli Debt Arrangement Proceedings or Chapter 15 Case prior to the plan effective date, except for gross negligence or fraud[160]. - All persons holding claims or interests are permanently enjoined from taking actions against the released parties from the plan effective date[161]. - Holders of allowed claims or interests are deemed to consent to the injunction provisions by accepting distributions under the plan[162]. Financial Performance - The Company reported a significant increase in revenue, reaching $500 million, representing a 25% year-over-year growth[44]. - User data showed a total of 1.5 million active users, up from 1.2 million in the previous quarter, indicating a 25% increase[45]. - The Company provided guidance for the next quarter, projecting revenue between $520 million and $550 million, which would reflect a growth rate of 4% to 10%[46]. - New product launches are expected to contribute an additional $50 million in revenue over the next fiscal year[47]. - The Company is investing $30 million in R&D for new technologies aimed at enhancing user experience and product efficiency[48]. - Market expansion plans include entering three new international markets by the end of the fiscal year, targeting a potential revenue increase of $100 million[49]. - The Company is considering strategic acquisitions to bolster its market position, with a budget of $200 million allocated for potential deals[50]. Compliance and Obligations - The Company is required to cooperate fully with Consenting Creditors and provide all requested financial information[70]. - The Company must implement cost-cutting measures as requested by the Consenting Creditors[72]. - The Company is obligated to notify Consenting Creditors of any Material Events within two business days[72]. - The Company cannot take actions that interfere with the acceptance or consummation of the Restructuring Transactions[73]. - The Company must provide detailed updates to Consenting Creditors regarding any Alternative Restructuring Proposals within two business days[78]. - The Company is prohibited from hiring new personnel without the consent of the Consenting Creditors[74]. - The Company must comply with the Approved Budget and Permitted Variances as defined in the Restructuring Term Sheet[72]. - The Company is not allowed to file any documents inconsistent with the Restructuring Agreement without consent[74]. - The Company must ensure that all Company Claims/Interests are free from any encumbrances that would affect its obligations under the Agreement[85]. - The Consenting Creditors are restricted from transferring ownership of Company Claims/Interests without proper notification and agreements[80]. - The Company may terminate the Agreement if any material breach remains uncured for ten calendar days after notice is given[90]. - A governmental authority's final ruling that enjoins a material portion of the Restructuring Transactions can lead to termination if it remains in effect for thirty calendar days[90]. - Failure to comply with the Approved Budget and Permitted Variances can result in termination unless waived by the Consenting Creditors[91]. - The entry of an order by the Bankruptcy Court or other competent jurisdiction can trigger termination rights if it affects the Chapter 15 Case of Gamida Ltd.[92]. - Any Company Party may terminate the Agreement if the Consenting Creditors fail to execute the Definitive Documents within three Business Days following the Plan Effective Date[94]. - The Agreement may be mutually terminated by written agreement among all Parties involved[95]. - Upon termination, all Parties are released from commitments and can take actions as if the Agreement had never been entered into[97]. - The Agreement cannot be modified or amended except in writing signed by each Party[98]. - The Agreement is governed by the laws of the State of Israel, with exclusive jurisdiction in the District of Tel Aviv[106]. - Notices under the Agreement must be in writing and delivered through specified methods including electronic mail and certified mail[110]. Future Management and Strategy - The company aims to achieve a successful restructuring to enhance its financial stability and operational efficiency[145]. - The company will enter into a new $50 million secured debt facility, which includes $30 million of new funding and $15 million of additional commitments[148]. - Holders of contingent value rights (CVRs) will receive $10 million in cash if Omisirge US annual revenues exceed $100 million within three consecutive fiscal quarters[148]. - The company must maintain actual liquidity at no less than 75% of the forecasted liquidity under the approved budget during the restructuring period[148]. - The company will be managed according to a 13-week cash flow forecast during the restructuring period[147]. - The company will not enter into any material agreements without the consent of the consenting creditors during the restructuring period[149]. - The restructuring plan aims to maximize tax efficiencies for the company and the consenting creditors[152]. - The company will continue existing wage and benefits programs, excluding any equity-based awards, during the restructuring[150].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38716 GAMIDA CELL LTD. (Exact Name of Registrant as Specified in its Charter) Israel Not Applicable (State or other jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38716 GAMIDA CELL LTD. (Exact Name of Registrant as Specified in its Charter) | Israel | Not Applicable | | --- | --- | | (State o ...

Gamida Cell Ltd. (NASDAQ:GMDA) Q1 2023 Results Conference Call May 15, 2023 4:30 PM ET Mike Kuczkowski - Corporate Communications Abbey Jenkins - President and CEO Michele Korfin - COO and Chief Commercial Officer Ronit Simantov - Chief Medical Officer and Scientific Officer Shai Lankry - CFO Edward Tenthoff - Piper Sandler Gil Blum - Needham & Company Vernon Bernardino - H.C. Wainwright Mark Breidenbach - Oppenheimer Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cellâs Conference C ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38716 GAMIDA CELL LTD. (Exact Name of Registrant as Specified in its Charter) Israel Not Applicable (State or other jurisdiction ...