Cartesian Therapeutics, Inc. - RNAC STOCK NEWS

Cartesian Therapeutics (NASDAQ: RNAC) announced positive updated results from its Phase 2b trial of Descartes-08 for myasthenia gravis treatment. The trial showed deepening responses over time, with participants experiencing a 5.5-point reduction in MG-ADL at Month 4, and durable responses through Month 12. The company outlined its planned Phase 3 AURORA trial, set to commence in 1H2025, which will evaluate approximately 100 participants. The Phase 2b trial demonstrated a favorable safety profile supporting outpatient administration without preconditioning chemotherapy. Notably, participants without prior biologic therapy exposure showed particularly strong responses, with a 6.6-point average MG-ADL reduction at Month 4.

Cartesian Therapeutics (NASDAQ: RNAC) announced it will present updated efficacy and safety data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis at the 2nd Annual Cell Therapy for Autoimmune Disease Summit in Philadelphia. The presentation, titled 'Perspectives on Bringing Cell Therapies to the Autoimmune Space: From Concept to Clinic,' will be delivered by Chief Medical Officer Miloš Miljković on December 3, 2024. The company will host a conference call and webcast with key opinion leader Dr. James F. Howard Jr. to discuss the updated data and planned Phase 3 trial design.

Cartesian Therapeutics (NASDAQ: RNAC) has granted inducement awards to two new employees on November 4, 2024. The awards consist of options to purchase 4,854 shares of common stock at an exercise price of $19.11 per share. The options will vest 25% on November 4, 2025, followed by three equal annual installments until full vesting on November 4, 2028. These ten-year term options were granted under the Company's Amended and Restated 2018 Employment Inducement Incentive Award Plan and comply with Nasdaq Listing Rule 5635(c)(4).

Cartesian Therapeutics (NASDAQ: RNAC) reported Q3 2024 financial results and business updates. The company plans to initiate a Phase 3 trial of Descartes-08 for myasthenia gravis in 1H2025 following FDA discussions. Key highlights include: $220.9M in cash expected to support operations into mid-2027, ongoing Phase 2 trial for systemic lupus erythematosus, and first-in-human Phase 1 trial of Descartes-15. Q3 financial results show R&D expenses of $11.4M, G&A expenses of $6.6M, and a net loss of $(24.2M) or $(1.13) per share.

Cartesian Therapeutics (NASDAQ: RNAC) announced that safety and tolerability data for Descartes-08, their lead mRNA cell therapy candidate, will be presented at the 66th ASH Annual Meeting in December 2024. The presentation will focus on their autologous mRNA-engineered CAR-T therapy targeting BCMA. The poster presentation, titled 'Safety and Tolerability of BCMA-Directed mRNA CAR T-Cell Therapy in Multiple Myeloma and Autoimmune Diseases,' will be delivered by CMO Miloš Miljković. The poster was also selected for inclusion in the ASH Poster Walk on Blood Immunology & Cellular Therapy.

Cartesian Therapeutics (NASDAQ: RNAC) presented data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) at the 2024 MGFA Scientific Session of the AANEM Annual Meeting. The trial achieved its primary endpoint with statistical significance, with 71% of Descartes-08 treated patients showing ≥5-point improvements in MG Composite score at Month 3 compared to 25% in the placebo group (p=0.018).

Descartes-08, an autologous mRNA-engineered CAR-T therapy targeting BCMA, demonstrated a favorable safety profile supporting outpatient administration without preconditioning chemotherapy. The treatment was associated with reduced anti-AChR antibody titer levels and did not lead to decreased vaccine titers or increased infection rates.

Cartesian plans to hold an End-of-Phase 2 meeting with the FDA by year-end 2024 to discuss initiating a Phase 3 clinical trial of Descartes-08 in MG.

Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company focusing on mRNA cell therapies for autoimmune diseases, has announced inducement awards for five new employees. On October 1, 2024, the company granted these employees options to purchase a total of 60,961 shares of common stock at an exercise price of $17.11 per share, which was the closing price on Nasdaq on the grant date.

The options were issued under the company's Amended and Restated 2018 Employment Inducement Incentive Award Plan and approved by the board of directors. They will vest 25% on October 1, 2025, followed by three equal annual installments, becoming fully vested on October 1, 2028. The options have a ten-year term and were granted under Nasdaq Listing Rule 5635(c)(4) as an inducement for employment.

Cartesian Therapeutics (NASDAQ: RNAC) has received FDA Rare Pediatric Disease Designation for Descartes-08, its lead mRNA cell therapy candidate for treating juvenile dermatomyositis (JDM). Descartes-08 is an autologous mRNA-engineered CAR-T therapy targeting BCMA, designed for administration without preconditioning chemotherapy. The company plans to file an IND for a Phase 2 pediatric basket study by year-end, focusing on neurology and rheumatology autoimmune indications, including JDM.

This designation recognizes Descartes-08's potential as a therapeutic option for an underserved pediatric population. If approved for JDM, Cartesian may qualify for a priority review voucher, which can expedite future marketing applications.

Cartesian Therapeutics (NASDAQ: RNAC), a clinical-stage biotech company focusing on mRNA cell therapies for autoimmune diseases, has granted an inducement award to a new employee. The award, issued on September 3, 2024, consists of an option to purchase 3,864 shares of the company's common stock at an exercise price of $13.12 per share. This price reflects the closing price of RNAC on Nasdaq on the grant date.

The option, approved by the board of directors, falls under the company's Amended and Restated 2018 Employment Inducement Incentive Award Plan. It has a four-year vesting schedule, with 25% vesting on September 3, 2025, and the remainder vesting in three equal annual installments until fully vested by September 3, 2028. The option has a ten-year term and was granted under Nasdaq Listing Rule 5635(c)(4) as an employment inducement.