Cartesian Therapeutics Announces $130M PIPE Financing and Positive Phase 2b Data for Descartes-08 in Myasthenia Gravis

Jul 02, 2024 23:01 CST Updated 23:01

Cartesian Therapeutics

Pharmaceutical R&D Developer

HBM Healthcare Investments

Venture Capital Firm

Invus

Equity Investment Firms

Schooner Capital

A Firm Focused on Venture Capital

Surveyor Capital

Financial Services Company

July 2,Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company pioneering mRNA cellular therapies for autoimmune diseases, announced that it has signed aPIPE Financing, which is expected to generate gross proceeds of approximately US$130 million for the company before deducting placement agent fees and other issuance costs. The PIPE financing is expected to close around July 3, 2024, subject to customary closing conditions.

PIPE financing includes the participation of new and existing investors, including HBM Healthcare Investments, Invus, Schooner Capital, Surveyor Capital, Dr. Timothy A. Springer, and other institutional investors.

Pursuant to the terms of the Securities Purchase Agreement, the Company sold an aggregate of 3,563,247 shares of common stock ("Common Stock") and 2,937,903 shares of Series B Non-Voting Convertible Preferred Stock ("Series B Preferred Stock") at a purchase price of $20.00 per share. Each share of Series B Preferred Stock is convertible into one share of Common Stock, subject toCartesianApproval by shareholders, as well as certain beneficial ownership limitations set by the purchasers of Series B preferred stock.

The Company intends to use the net proceeds from the PIPE financing, together with the Company’s existing cash, cash equivalents and marketable securities, to fund its pipeline programs and for general corporate purposes and working capital.

CartesianToday also announced itsDescartes-08Positive results from the Phase 2b trial.Descartes-08 is the company'sThe main candidate product is an autologous product targeting B-cell maturation antigen (BCMA).mRNAEngineered Chimeric Antigen Receptor T-Cell Therapy (mRNA CAR-T). It is designed as an outpatient treatment, without the need for lymphodepleting chemotherapy required by conventional CAR-T cell therapy.Descartes-08Previously granted Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation by the U.S. FDA for the treatment of MG.

Primary Endpoint

The trial achieved the primary endpoint with statistical significance in the pre-specified mITT efficacy population, with 71% (10/14) receivingDescartes-08Patients treated improved by 5 points or more in the MGC score at month 3, compared to 25% (3/12) of patients receiving placebo (p=0.018).

In addition, the trial also achieved the primary endpoint with statistical significance in the per-protocol population, among those receivingDescartes-08Among the treated patients, 69% (11/16) showed an improvement of 5 points or more in the MGC score at Month 3, compared to 33% (5/15) in the placebo group (p=0.048).

Secondary Endpoint

Consistent with the results reported from the open-label portion of the Phase 2a trial,Descartes-08Responders showed significant improvement in MG severity grades at Month 3 (mean MG-ADL=-5.6; MGC=-8.3; QMG=-5.0; QoL-15r=-7.9). As of the data cutoff date of June 19, 2024, the improvements observed at Month 3 were sustained or further improved in patients assessed during follow-up at Month 4 (n=5) and Month 6 (n=3).

Safety Results

Descartes-08Continued to demonstrate good safety in supporting outpatient administration without the need for lymphodepleting chemotherapy. Consistent with the results from the open-label portion of the Phase 2a trial, it was observed thatDescartes-08It was well-tolerated, with transient adverse events mostly being mild. Notably, there were no cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.

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