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CARM 资讯
CARM 事件
ProKidney Appoints Kenneth Locke as Chief Technical Officer
ProKidney (PROK) announced the appointment of Kenneth Locke as chief technical officer. Locke joins ProKidney from Carisma Therapeutics (CARM), where he oversaw CMC, Quality and Regulatory functions and led technical strategy for first-in-human CAR Myeloid programs.
Carisma Therapeutics to Voluntarily Delist and Terminate Reporting Obligations
Carisma Therapeutics' Board of Directors has approved and the Company intends to proceed with the voluntary delisting of its common stock from The Nasdaq Stock Market and the deregistration of its common stock in order to suspend and ultimately terminate the Company's reporting obligations under the Securities and Exchange Act of 1934, as amended. As previously reported, as a result of the Company's previously disclosed noncompliance with the bid price, market value of listed securities, and market value of publicly held shares requirements set forth in Nasdaq Listing Rules 5450(a)(1), 5450(b)(2)(C), and 5450(b)(2)(A), respectively, the Company received a delist determination letter from Nasdaq on October 9 and the Company's common stock was suspended from trading on Nasdaq effective at the open of business on October 13. The Company's common stock commenced trading on the OTCID market tier operated by the OTC Markets Group on October 13, under the trading symbol "CARM." The Determination Letter indicated that, once all applicable appeal periods had lapsed, Nasdaq would file a Form 25 with the Securities and Exchange Commission to complete the delisting of the Company's common stock from Nasdaq. Notwithstanding, the Company today notified Nasdaq of its intention to voluntarily delist its shares of common stock from Nasdaq rather than await Nasdaq's filing of a Form 25 at some later date. The Company anticipates that it will file a Form 25 with the SEC to effect the delisting and deregistration of its common stock on or about December 15, and that the formal delisting of the Company's common stock from Nasdaq will become effective on or about December 25. Following the delisting of the Company's common stock from Nasdaq, the Company intends to file a Form 15 with the SEC to suspend and then terminate its reporting obligations under the Exchange Act. The Company will be relieved of all reporting obligations under the Exchange Act upon the effectiveness of the deregistration. The Company expects that the deregistration of its common stock will become effective 90 days after the filing of the Form 15 with the SEC.
Carisma Therapeutics, OrthoCellix enter definitive merger agreement
Carisma Therapeutics (CARM) and OrthoCellix, a wholly-owned subsidiary of Ocugen (OCGN), announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the development of OrthoCellix's NeoCart technology for the treatment of knee articular cartilage defects and plans to initiate a U.S. Food and Drug Administration-endorsed Phase 3 clinical trial for NeoCart. OrthoCellix is developing NeoCart as an autologous cartilage implant technology utilizing patient cells to repair articular cartilage defects of the knee. The novel platform merges a fortified 3D scaffold and patented bioprocessing technology to grow chondrocytes-the cells responsible for maintaining cartilage health-to produce adolescent-like cartilage at the time of implant. NeoCart has the potential to accelerate healing and reduce pain by creating a similar, functional joint surface to help patients return to normal activities and prevent complications associated with articular cartilage damage. OrthoCellix anticipates launching its Phase 3 clinical trial by the end of 2025. Previously, NeoCart received Regenerative Medicine Advanced Therapy designation and concurrence from the FDA on a single, confirmatory Phase 3 clinical trial to enable submission of a Biologics License Application. Under the terms of the merger agreement, OrthoCellix will merge with and into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a wholly-owned subsidiary of Carisma and the surviving company of the Merger. Carisma will issue to the pre-merger OrthoCellix stockholder shares of Carisma common stock as merger consideration in exchange for the cancellation of shares of capital stock of OrthoCellix. Carisma also expects to enter into subscription agreements for a private financing with Ocugen and other select investors, which is expected to close concurrently with the completion of the merger, to enable the combined company to complete the Phase 3 trial of NeoCart without any additional cost or investment from Ocugen. In connection with the closing of the proposed transactions, Carisma stockholders will be issued contingent value rights representing the right to receive certain payments from proceeds received by the combined company, if any, related to Carisma's pre-transaction legacy assets. Under the terms of the merger agreement, upon the closing of the proposed transactions and after giving effect to the contemplated $25M concurrent financing, OrthoCellix's stockholder and the other participants in the concurrent financing are expected to own approximately 90% of the combined company, and existing Carisma stockholders are expected to own approximately 10% of the combined company, each on a fully diluted basis. The percentage of the combined company that each company's former stockholders will own after completion of the merger is subject to adjustment based on Carisma's net cash at the closing and the proceeds from the concurrent financing, among other adjustments, in each case as described in the merger agreement. Upon the closing of the proposed transactions, "Carisma Therapeutics Inc." is expected to be renamed "OrthoCellix, Inc." and trade on the Nasdaq Capital Market under the ticker symbol 'OCLX.' The transaction has been unanimously approved by the board of directors of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including approvals by the stockholders of each company and the effectiveness of a registration statement to be filed with the Securities and Exchange Commission to register the shares of Carisma common stock to be issued in connection with the merger. In connection with the companies' entry into the merger agreement, directors and officers of Carisma and OrthoCellix's stockholder have executed support agreements, pursuant to which they have agreed to vote all of their shares of capital stock in favor of the merger or the issuance of Carisma equity in the merger, as applicable.
Carisma Therapeutics announces restructuring, 34% workforce reduction
Carisma Therapeutics announced a strategic reprioritization of its pipeline, cessation of development of CT-0525, and a reduction in the workforce by 34%. These measures will enable Carisma to focus its resources on advancing its in vivo macrophage engineering platform for the development of fibrosis, oncology and autoimmune disease therapies. This decision aligns Carisma's efforts with next-generation, high-potential programs addressing significant unmet patient needs while enhancing operational efficiency. "Following a comprehensive review of our portfolio, we have made the strategic decision to prioritize advancing our in vivo macrophage engineering platform," said Steven Kelly, President and Chief Executive Officer of Carisma. "The compelling data generated by both the Moderna-partnered in vivo CAR-M oncology programs as well as our internal liver fibrosis program underscore the potential to revolutionize treatment paradigms with an innovative and patient-centric approach." "These strategic initiatives, re-directing our investments to the in vivo macrophage engineering platform, discontinuing development of our anti-HER2 program and reducing our workforce, aim to streamline our operations and reduce operating expenses over time," Kelly continued. "While these decisions are very challenging, they are made in the best interest of our shareholders. We remain deeply grateful for the significant contributions of the employees departing Carisma." As part of the strategic restructuring, Carisma will reduce its workforce by 34%. The company expects the reduction in workforce to be substantially complete and to pay the majority of related reduction in workforce amounts by the end of the first quarter of 2025. The company is committed to supporting affected employees through this transition. As part of the workforce reductions, our Chief Financial Officer, Richard Morris, our General Counsel, Eric Siegel, and our Senior Vice President, Human Resources, Terry Shields, will leave the company effective December 31, 2024. Carisma expresses gratitude for their contributions. The company expects to incur approximately $2.7M in connection with the reduction in the workforce, which primarily represents one-time employee termination benefits directly associated with the workforce reduction.
Carisma Therapeutics reports data from its CAR-M therapy
Carisma Therapeutics (CARM) announced positive pre-clinical data on its anti-GPC3 in vivo chimeric antigen receptor macrophage and monocyte, or CAR-M, therapy for hepatocellular carcinoma, or HCC, developed in collaboration with Moderna (MRNA). The data demonstrated that the development candidate can successfully create CAR-M directly in vivo, reprogramming endogenous myeloid cells to target and destroy Glypican-3, expressing cancer cells. Pre-clinical results showed that the novel in vivo anti-GPC3 CAR-M therapy exhibits specificity for the GPC3 tumor antigen, driving potent dose-dependent cytotoxicity against GPC3+ tumor cells. Additionally, the CAR-M produced pro-inflammatory cytokines and adopted an inflammatory, activated macrophage phenotype upon antigen engagement. In both syngeneic and humanized tumor models, systemic administration of anti-GPC3 CAR mRNA/LNP significantly reduced tumor burden and suppressed metastasis to the liver. The therapy was well tolerated in mouse models, highlighting its potential as an off-the-shelf treatment for GPC3+ solid tumors, including HCC.
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