Cartesian Therapeutics(RNAC)

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Cartesian Therapeutics(RNAC) - 2024 Q3 - Quarterly Report
2024-11-07 12:19
Financial Performance - Total revenue for the three months ended September 30, 2024, was $6.551 million, compared to $17.738 million for the same period in 2023, representing a decrease of approximately 63.1%[12] - Operating expenses for the three months ended September 30, 2024, were $19.616 million, down from $67.822 million in the same period in 2023, a reduction of about 72.6%[12] - The net loss for the three months ended September 30, 2024, was $24.183 million, compared to a net loss of $42.052 million for the same period in 2023, indicating an improvement of approximately 42.5%[12] - The company reported a net loss of $67,171,000 for the nine months ended September 30, 2024, compared to a net loss of $42,052,000 for the same period in 2023, indicating an increase in losses of approximately 59.8%[21] - The company reported a net loss of $24.2 million for the three months ended September 30, 2024, compared to a net loss of $9.0 million for the same period in 2023[41] - Net loss for the nine months ended September 30, 2024 was $67.2 million, an increase of $25.1 million or 60% compared to a net loss of $42.1 million for the same period in 2023, primarily due to changes in the fair value of the CVR liability and Series A Preferred Stock forward contract liability[183] Revenue Sources - The company reported collaboration and license revenue of $39.111 million for the nine months ended September 30, 2024, compared to $17.738 million for the same period in 2023, an increase of approximately 120.5%[12] - Collaboration and license revenue for the three months ended September 30, 2024 was $0, a decrease of $6.6 million or 100% compared to $6.6 million for the same period in 2023, primarily due to reduced revenue from the Sobi License and Astellas Agreement[160] - Collaboration and license revenue for the nine months ended September 30, 2024 was $39.1 million, an increase of $21.4 million or 121% compared to $17.7 million for the same period in 2023, driven by revenue from the Sobi License and Astellas Agreement[172] Expenses - Research and development expenses for the nine months ended September 30, 2024, totaled $33.799 million, down from $49.408 million in the same period in 2023, a decrease of about 31.6%[12] - Research and development expenses for the three months ended September 30, 2024 were $11.4 million, a decrease of $1.6 million or 12% from $13.0 million in the same period in 2023, mainly due to reductions in clinical expenses[162] - General and administrative expenses remained consistent at $6.6 million for the three months ended September 30, 2024, compared to the same period in 2023[164] - General and administrative expenses increased to $23.0 million for the nine months ended September 30, 2024, up from $18.4 million in the same period in 2023, reflecting higher personnel and professional fees related to the Merger[176] Cash and Liquidity - The company had cash, cash equivalents, and restricted cash of $220,867,000 at the end of the reporting period, compared to $80,980,000 at the end of the previous year, representing an increase of approximately 172.5%[21] - As of September 30, 2024, the Company reported cash, cash equivalents, and restricted cash totaling $220.9 million, with $1.7 million restricted for lease commitments[27] - The company anticipates that its existing cash resources will fund operations for at least the next 12 months, but may need to seek additional financing sooner if actual results differ from management's estimates[193] Shareholder Equity and Stock - The weighted-average common shares outstanding for the three months ended September 30, 2024, were 21,471,408, compared to 5,160,150 for the same period in 2023, reflecting a significant increase in share count[12] - The company executed a 1-for-30 reverse stock split on April 4, 2024, affecting all share-related figures in the financial statements[19] - The Company has authorized shares of common stock for future issuance totaling 13,215,543 as of September 30, 2024, including 974,954 for warrants and 5,544,719 for Series A Preferred Stock[89] Acquisitions and Mergers - The Company acquired the assets of Old Cartesian on November 13, 2023, in a stock-for-stock transaction, issuing 224,099 shares of common stock and 384,930.724 shares of Series A Preferred Stock[34] - The total purchase price for the acquisition of Old Cartesian was $168.5 million, allocated as follows: $2.7 million for common stock forward contracts, $155.3 million for Series A Preferred Stock forward contracts, and $10.4 million for stock options[37] - The net assets acquired from Old Cartesian were valued at $168.5 million after accounting for the liabilities[39] Future Outlook and Risks - The company is focused on maximizing the value of its pipeline of product candidates and expects to incur losses in the future as it continues its development activities[5] - The ongoing geopolitical tensions and macroeconomic conditions, including inflation and interest rates, are expected to impact the company's operations and financial position[5] - The Company anticipates continued operating losses due to research and development costs[29] Collaboration Agreements - The Company entered into a License and Development Agreement with Astellas Gene Therapies in January 2023, indicating ongoing collaboration efforts[101] - The Company received a $10.0 million upfront payment from Astellas for the exclusive license of its IdeXork technology, with potential future payments of up to $340.0 million based on development and sales milestones[102] - The Company has a collaboration with Ginkgo Bioworks, with potential milestone payments of up to $85 million in cash under the First Ginkgo Agreement and up to $207 million in cash under the Second Ginkgo Agreement[120][121] Debt and Financing - The company extinguished the 2020 Term Loan with a total payoff amount of $22.3 million, including a principal amount of $19.8 million and a final payment fee of $2.3 million[76] - The company completed a private placement in July 2024, resulting in gross proceeds of approximately $130.0 million from the issuance of 3,563,247 shares of common stock and 2,937,903 shares of Series B Preferred Stock[144] Research and Development - The company is developing its lead product candidate, Descartes-08, for myasthenia gravis, with positive results observed in a Phase 2 clinical trial[142] - The company has not generated any revenue from product sales and relies on collaboration and license revenue, which fluctuates based on the timing of fees and reimbursements[148]
Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting
GlobeNewswire News Room· 2024-10-15 11:00
GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) during the 2024 Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual ...
Cartesian Therapeutics, Inc. (RNAC) Moves 26.9% Higher: Will This Strength Last?
ZACKS· 2024-10-04 14:15
Cartesian Therapeutics, Inc. (RNAC) shares soared 26.9% in the last trading session to close at $22.82. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 33.7% gain over the past four weeks. The recent surge in the stock price is driven by positive investor expectations regarding the company's pipeline of novel mRNA cell therapy for autoimmune diseases. Cartesian is currently assessing its lead candidate, Descartes-08, in two separ ...
Cartesian Therapeutics Seems A 'Strong Buy' After Positive Phase 2 Results
Seeking Alpha· 2024-09-17 13:45
Cartesian Therapeutics, Inc. (NASDAQ: RNAC ) focuses on mRNA-based cell therapies for autoimmune diseases and oncology. The company leverages its proprietary RNA Armory platform to engineer cells to produce therapeutic proteins. This technology supports autologous, allogeneic, and in vivo transfection, allowing accurate and My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in comput ...
Cartesian Therapeutics, Inc. (RNAC) Q2 Earnings and Revenues Top Estimates
ZACKS· 2024-08-08 13:35
Cartesian Therapeutics, Inc. (RNAC) came out with quarterly earnings of $0.54 per share, beating the Zacks Consensus Estimate of a loss of $0.81 per share. This compares to loss of $2.10 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 166.67%. A quarter ago, it was expected that this company would post a loss of $0.81 per share when it actually produced a loss of $1.97, delivering a surprise of -143.21%. Over the last four qu ...
Cartesian Therapeutics(RNAC) - 2024 Q2 - Quarterly Report
2024-08-08 11:07
Financial Performance - Total revenue for the three months ended June 30, 2024, was $33.445 million, a significant increase from $5.249 million for the same period in 2023, representing a growth of 536%[13] - Operating income for the three months ended June 30, 2024, was $13.757 million, compared to an operating loss of $18.638 million for the same period in 2023[13] - Net income for the three months ended June 30, 2024, was $13.836 million, a turnaround from a net loss of $11.387 million in the same period last year[13] - Basic net income per share for the three months ended June 30, 2024, was $0.58, compared to a loss of $2.23 per share for the same period in 2023[13] Expenses - Research and development expenses for the three months ended June 30, 2024, were $12.661 million, down from $17.782 million for the same period in 2023, indicating a reduction of 29%[13] - General and administrative expenses increased to $7.027 million for the three months ended June 30, 2024, compared to $6.105 million for the same period in 2023, reflecting a rise of 15%[13] - The company reported stock-based compensation expense of $3.022 million for the second quarter of 2024, compared to $6.059 million in the same quarter of 2023, reflecting a 50% decrease[21] - Total stock-based compensation expense for the three months ended June 30, 2024, was $1.591 million, compared to $3.022 million for the same period in 2023, representing a decrease of 47.4%[77] Cash Flow and Liquidity - Cash used in operating activities for the second quarter of 2024 was $30.363 million, up from $18.660 million in the second quarter of 2023, indicating a 62% increase in cash outflow[21] - The company reported a total cash, cash equivalents, and restricted cash balance of $88.896 million at the end of June 2024, down from $115.004 million at the end of June 2023[21] - As of June 30, 2024, the Company had cash, cash equivalents, and restricted cash totaling $88.9 million, with an additional $124.4 million raised from a Private Placement in July 2024[26] - The Company reported total outstanding receivables of $31.7 million, representing billings for the Phase 3 DISSOLVE program[92] Mergers and Acquisitions - The company completed a private placement in November 2023, raising approximately $60.25 million through the issuance of 149,330.115 shares of Series A Preferred Stock[23] - The company acquired the assets of Old Cartesian in November 2023, exchanging shares based on a fixed ratio, resulting in the issuance of 224,099 shares of common stock and 384,930.724 shares of Series A Preferred Stock[23] - The total consideration for the merger with Old Cartesian was valued at $168.5 million, which included $155.3 million for Series A Preferred Stock and $10.4 million for stock options[34] - The Company recorded goodwill of $48.2 million related to the merger, primarily attributable to the assembled workforce and deferred tax liabilities[35] Future Outlook and Growth - The company anticipates potential growth opportunities in its market size and product pipeline, although specific projections were not detailed in the report[8] - The company is focused on maximizing the value of its product candidates and expanding its manufacturing capabilities to support future growth[8] - The Company is developing mRNA cell therapies for autoimmune diseases, with ongoing preclinical and clinical development efforts[23] - The Company is in the early stages of product candidate development and has not completed any product candidates to date[26] Risks and Challenges - The company is subject to significant risks typical of the biotechnology industry, including the need for substantial capital for research and development[24] - The Company has not recorded any U.S. federal or state income tax benefits due to uncertainty in realizing future benefits from net losses and credits[110] - The Company may need to seek additional funding sooner than expected if actual results differ from management's estimates[26] Stock and Equity - Weighted-average common shares outstanding for the three months ended June 30, 2024, were 16,723,479, compared to 5,114,747 for the same period in 2023, showing an increase of 227%[13] - The Company has authorized shares of common stock for future issuance totaling 12,794,858, which includes 975,132 shares from warrants and 5,544,719 shares from Series A Preferred Stock[74] - The Reverse Stock Split on April 4, 2024, consolidated every 30 shares of common stock into one share, effective on the Nasdaq Global Market under the symbol "RNAC"[73] - The Series B Preferred Stock will automatically convert into common stock upon stockholder approval, subject to certain beneficial ownership limitations[115] Revenue Recognition - Revenue recognized from the Astellas Agreement during the three months ended June 30, 2024, was $0.5 million, compared to $0.8 million in the same period of 2023[88] - The Company recognized revenue of $32.8 million related to the Sobi License during the three and six months ended June 30, 2024, including a $30.0 million development milestone[92] - The Company received a one-time upfront payment of $75.0 million from Sobi for the exclusive license to develop SEL-212[91] Contractual Obligations - The Company is obligated to pay tiered royalties to Ginkgo and Genovis based on annual net sales of collaboration products, ranging from low-single digit to high-single digit percentages[102][104] - The Company has paid an aggregate of $7 million in upfront and milestone payments under the 3SBio License as of June 30, 2024[109] - The Company plans to terminate the Genovis Agreement effective September 13, 2024, and the AskBio Collaboration Agreement effective December 13, 2023[104][108]
Cartesian Therapeutics Announces New Employment Inducement Grants
Newsfilter· 2024-07-08 20:05
GAITHERSBURG, Md., July 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company developing mRNA cell therapies for the treatment of autoimmune diseases, today announced the granting of inducement awards to new employees. On July 1, 2024, the Company issued to these employees options to purchase an aggregate of 35,198 shares of the Company's common stock with an exercise price of $24.27, the closing trading price of the Company's common ...
Cartesian Therapeutics Announces New Employment Inducement Grants
GlobeNewswire News Room· 2024-07-08 20:05
GAITHERSBURG, Md., July 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company developing mRNA cell therapies for the treatment of autoimmune diseases, today announced the granting of inducement awards to new employees. On July 1, 2024, the Company issued to these employees options to purchase an aggregate of 35,198 shares of the Company's common stock with an exercise price of $24.27, the closing trading price of the Company's common ...
Cartesian Therapeutics Strengthens Board of Directors with Appointment of Kemal Malik
GlobeNewswire News Room· 2024-07-02 20:05
GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the appointment of Kemal Malik, MBBS to its Board of Directors. Dr. Malik brings to Cartesian over 30 years of global development, regulatory, and commercial expertise at leading pharmaceutical organizations. "We are thrilled to welcome Dr. Malik, a proven leader and industry veteran, to ...
Cartesian Therapeutics Strengthens Board of Directors with Appointment of Kemal Malik
Newsfilter· 2024-07-02 20:05
Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company's lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systematic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company's clinical-stage pipeline also includes Descartes-15, a next-generation, autolog ...