Initial data for CT-0525, lead product candidate for anti-HER2 program, expected by year-end 2024
Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025
Nominated first in vivo CAR-M development candidate targeting Glypican-3 to treat hepatocellular carcinoma under the Moderna Collaboration in the second quarter of 2024
Cash and cash equivalents of $40.4 million and $2.0 million received in July under the Moderna Collaboration expected to fund the Company into the third quarter of 2025
PHILADELPHIA, Aug. 8, 2024 – Carisma Therapeutics Inc. CARM (NASDAQ) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the quarter ended June 30, 2024, and highlighted recent business updates.
“We’ve achieved considerable clinical and research advancements this year, and I’m excited about our strong momentum and clear focus for the next 12 months,” noted Steven Kelly, President and Chief Executive Officer of Carisma. “The CT-0508 program has provided us with invaluable insights. Looking ahead, we are dedicating our efforts to our lead asset, CT-0525, which is actively enrolling patients with initial data expected by the end of 2024. We have also made significant progress in our in vivo oncology and fibrosis programs. The nomination of a development candidate in collaboration with Moderna marks a significant step forward. We believe our robust development pipeline offers multiple potential value drivers in both the near and long term.”
Second Quarter 2024 Highlights and Future Goals
Ex Vivo Oncology
- CT-0525 (Anti-HER2 chimeric antigen receptor monocyte (CAR-Monocyte))
- On May 16, 2024, Carisma dosed the first patient in the Phase 1 clinical trial for CT-0525, a gene-modified autologous CAR-Monocyte cellular therapy for solid tumors overexpressing HER2.
- By June 25, 2024, the FDA granted Fast Track designation for CT-0525.
- Anticipated initial data from the Phase 1 trial by the conclusion of 2024.
- CT-0508 (Anti-HER2 chimeric antigen receptor macrophage (CAR-Macrophage))
- As of July 2024, all clinical activities for CT-0508 and its sub-study with pembrolizumab have concluded.
- On July 9, 2024, Carisma revealed an analysis showing anti-tumor activity in 75% of evaluable HER2 3+ patients using CT-0508.
- By August 8, 2024, Carisma presented updated results from the Phase 1 sub-study indicating safety, tolerability, and potential efficacy for the CT-0508 and pembrolizumab combination.
In Vivo Oncology
- GPC3+ solid tumors (CAR-M + mRNA/LNP; Moderna Collaboration)
- On
The Rise of Carisma: A Glimpse into Its Exciting Ventures
Carisma Pioneering Cancer Treatment
Carisma recently unveiled the first development candidate arising from its association with ModernaTX Inc. This in vivo chimeric antigen receptor macrophage and monocyte, known as CAR-M, takes aim at Glypican-3, promising a breakthrough remedy for solid tumors, particularly hepatocellular carcinoma. The impact of this innovation is paramount, especially in the context of liver cancer’s alarming ascent as a leading cancer-related fatality in the United States.
Following this milestone, Carisma clinched a significant $2.0 million payment, underscoring the tangible progress in their collaboration with Moderna. The Company anticipates shedding light on the preclinical data of this development candidate at an imminent medical symposium, fueling optimism and curiosity within the medical fraternity.
Advancements in Fibrosis and Immunology
Delving into the realm of fibrosis, Carisma’s stride continues as they gear up to showcase additional preclinical data focusing on liver fibrosis at the renowned event, The Liver Meeting 2024. Scheduled for November 15-19 in San Diego, CA, this presentation promises invaluable insights into the Company’s ongoing endeavors in combating liver ailments.
Looking ahead, Carisma foresees the nomination of a development candidate for its liver fibrosis initiative in the opening quarter of 2025, reaffirming its commitment to pioneering solutions in the domain of immunology and fibrosis.
Reshaping Corporate Landscape
In an intriguing wave of corporate transitions, Carisma introduced luminaries David Scadden, M.D., and Marella Thorell to its Board of Directors, infusing a wealth of experience spanning clinical research and financial realms. Simultaneously bidding adieu to former Directors Regina Hodits and Björn Odlander, the Company continues its strategic reshuffling to enhance operational efficacy and strategic direction.
Further fortifying its scientific advisory arsenal, Carisma welcomed Scott Friedman, M.D., and Ira Tabas, M.D., Ph.D., to its Scientific Advisory Board, tapping into their profound expertise in navigating the intricacies of liver fibrosis. This strategic maneuver underscores the Company’s unwavering pursuit of top-tier talent to steer their transformative patient-centric initiatives.
Financial Flourish in Q2 2024
With a keen eye on the financial landscape, Carisma’s second-quarter report for 2024 revealed cash and cash equivalents of $40.4 million, demonstrating a resilient financial stance. On the developmental front, research and development expenses saw a decrease, primarily attributed to operational optimizations and strategic realignment.
General and administrative expenses also witnessed a downturn, owing to prudent financial governance and prudent allocation of resources. Noteworthy was the narrowing of net losses, a testament to Carisma’s strategic prudence and operational efficiency in nurturing sustainable growth trajectories.
Promising Outlook
As Carisma forges ahead on its transformative odyssey, buoyed by promising developments, the Company’s outlook appears robust. With a judicious blend of innovation, strategic realignment, and financial acumen, Carisma stands poised to make indelible strides in reshaping the medical landscape and offering beacon-like solutions to patients worldwide.
The Bright Horizon Ahead
Financial Stability Encapsulated
Carisma is charting a course into the future with confidence, bolstered by its substantial cash and cash equivalents of $40.4 million as of June 30, 2024. This financial foundation is anticipated to provide sustenance for the company’s operations well into the third quarter of 2025, serving as a rock-solid base upon which to build its endeavors.
The Innovative CT-0525
At the heart of Carisma’s trajectory lies CT-0525, a groundbreaking ex vivo gene-modified cellular therapy designed to combat solid tumors overexpressing the human epidermal growth factor receptor 2 (HER2). Representing a pioneering approach, CT-0525 is undergoing rigorous evaluation in a Phase 1 clinical trial, offering hope to patients facing advanced/metastatic HER2-overexpressing solid tumors. This novel therapy has the potential to revolutionize the treatment landscape by overcoming key obstacles in solid tumor therapy.
A Glimpse into Carisma Therapeutics
Carisma Therapeutics Inc. is not merely an entity; it is a beacon of innovation in the realm of biopharmaceuticals. Leveraging its unique macrophage and monocyte cell engineering platform, the company is dedicated to crafting transformative immunotherapies for cancer and other severe ailments. Headquartered in Philadelphia, PA, Carisma’s focus on engineered macrophages and monocytes represents a pioneering leap in the integration of innate and adaptive immune responses to combat disease.
Navigating Forward with Care
Looking ahead with optimism, Carisma embraces the future while heeding the importance of caution. The company’s foray into uncharted territories of cellular therapy is not without risks. Challenges such as regulatory hurdles, clinical trial outcomes, and financial exigencies loom on the horizon. Nonetheless, Carisma remains resolute in its pursuit of groundbreaking treatments, undeterred by the uncertainties that accompany innovative endeavors.
For Further Exploration
For investors and stakeholders keen on delving deeper into Carisma’s journey, a treasure trove of information awaits in the company’s financial filings and reports. To grasp the full spectrum of risks and rewards entwined with Carisma’s mission, a thorough perusal of its disclosures is advised. Each statement and projection bears the weight of possibility and uncertainty, shaping the narrative of Carisma’s future ventures.
An In-Depth Review of Carisma Therapeutics Inc.’s Unaudited Consolidated Balance Sheets
Examining Asset Values
When delving into the world of financial figures, numbers don’t just convey amounts; they paint a portrait of a company’s vitality. The assets section of Carisma Therapeutics Inc.’s
Drilling into Current Assets
In the current assets segment, cash holds court. It’s the lifeblood of any organization, and Carisma Therapeutics Inc.’s figures reflect a steady reservoir. With a decrease from previous
The Labyrinth of Property and Equipment
Property and equipment figures encapsulate a tangible foundation, a testament to a company’s operational capacity. Carisma Therapeutics Inc.’s net property and equipment values
Leasing Rights and Deferred Costs
The nebulous realm of operating leases and deferred financing costs gestures towards the future. Their values in Carisma Therapeutics Inc.’s balance sheets indicate a balance between
Embrace the balance sheets as a looking glass into the financial soul of Carisma Therapeutics Inc. They speak a language of stability, adaptability, and strategic foresight in
An Insightful Dive into Financial Stature
Assets Revealed
When exploring total assets, the figures paint an impressive picture. Ranging from $59,339 to $89,554, these numbers indicate a substantial financial fortitude.
Unveiling Liabilities and Equity
As we shift our gaze towards liabilities and stockholders’ equity, intriguing details emerge.
The World of Current Liabilities
Within the realm of current liabilities, accounts payable stand prominently. From $2,033 to $3,933, these numbers narrate a tale of fiscal responsibility.
A Closer Look
Accrued expenses, deferred revenue, operating lease liabilities, and finance lease liabilities also demand our attention. Each amount portrays a unique aspect of financial standing, offering investors a comprehensive view.
Concluding Note
From the sturdy foundation of assets to the intricate web of liabilities and equity, the financial landscape of the entity reveals a story of prudence and strategic management, inviting stakeholders into a world of economic exploration.
Unlocking the Ceilings and Floors of Financial Fortitude
Current Liabilities Snapshot
Emphasizing the present, the total current liabilities stand at 15,908 units, a firm hand on the financial pulse. The numbers speak with eloquence, painting a vivid picture of the fiscal health of the enterprise.
Deferred Revenue Dynamics
Looking towards the future, the deferred revenue wraps up at 45,000 units, a robust figure that hints at a tapestry of forthcoming opportunities and commitments. A number that resonates with the company’s long-term vision.
Operational Lease Liabilities
Leaping into the realm of operational facilities, the lease liabilities tallied at 860 units signify a residence of stability, grounding the enterprise in the real-world fiscal terrain. A cornerstone of unwavering composure amidst economic whims.
Finance Lease Liabilities Exploration
Delving into finance realms, the 328 units lining the balance sheets mirror a structure of adaptability and responsiveness to the financial currents. A buoyant raft navigating the waters of economic fluctuation.
Other Long-term Liabilities Expedition
Venturing into uncharted territories, the 926 units of other long-term liabilities signify an exploration of financial frontiers. A map of unconventional commitments hinting at a horizon of untapped potential.
Liabilities Consolidated View
Collating the financial ecosystems, the total liabilities stand firm at 63,022 units, a tapestry of obligations that symbolize the foundation on which financial maneuvers are made. A robust fortress of financial acumen.
Equity Quandary
In the equity quo, a blank slate awaits, a canvas primed for future brushstrokes of financial expression. A moment of pause before the next chapter of fiscal storytelling unfolds.
Stockholders’ Equity Highlights
Embarking on the equity odyssey, the tale of preferred stock remains untold, while the common stock narrative encompasses 41,544,975 shares – a saga unfolding with every shift in the financial landscape.
A Window into Carisma Therapeutics Inc.’s Financial Horizon
Exploring Financial Frontiers
The financial landscape of Carisma Therapeutics Inc. reveals a shifting terrain, where numbers dance and balance sheets speak a language of their own. The company’s unaudited consolidated statements of operations and comprehensive loss lay bare a tale of numbers, comma separated and meticulously accounted for.
Traversing Time: A Comparative Journey
In a comparison that spans time, the figures for the three months ending June 30, 2024, and those of the prior year, 2023, present an intriguing narrative. Collaboration revenues, the lifeblood of the company, surged to $9,197 in 2024, a stark rise from the $3,560 reported in the corresponding period of 2023.
The Balancing Act: Equity and Liabilities
When it comes to total stockholders’ equity, a contrast akin to night and day emerges. The 2024 standing at $360 seems modest when juxtaposed with the robust $26,532 recorded in 2023. On the flip side, total liabilities and stockholders’ equity in 2024 amount to $59,339, a far cry from the weighty $89,554 reported in 2023.
Dissecting Financial Metrics
Research and Development: Investing in Innovation
With expenditures totaling $15,307, the commitment to research and development is evident. This allocation indicates a proactive stance towards innovation and growth. Comparatively, the figure of $18,518 suggests a willingness to invest for the future, positioning for long-term success.
General and Administrative: Operational Overhead
The outlay towards general and administrative expenses portrays a necessary operational overhead. At $5,560, the expenditure illustrates a focus on efficiency and effectiveness. In contrast, the higher amount of $6,007 underscores a concerted effort towards bolstering organizational capabilities.
Total Operating Expenses: Balancing Investment
The aggregate of operating expenses at $20,867 hints at a strategic approach to financial management. This sum conveys a judicious balance between investing for growth and controlling costs. Conversely, the figure of $24,525 signals a push towards optimizing operational efficiencies amidst financial pressures.
Operating Loss: Navigating Challenges
An operating loss of ($11,670) implies a challenging landscape where cost management is crucial. This deficit underscores the need for strategic adjustments to steer the company towards profitability. Contrastingly, a larger operating loss of ($20,965) points to intensified efforts required to overcome hurdles and drive financial performance.
Interest Income (Expense), Net: Financial Gains and Losses
The net interest income of $508 represents a positive financial outcome, signaling potential gains. This revenue source demonstrates a favorable position in capital management. In comparison, a higher net interest income of $1,177 signals an even stronger financial position and potential for increased returns.
Pre-tax Loss: Evaluating Financial Health
A pre-tax loss of ($11,162) indicates financial challenges that need to be addressed effectively. This metric serves as a barometer for the company’s financial health and management strategies. Conversely, a more substantial pre-tax loss of ($19,788) necessitates concerted efforts to realign business strategies and optimize financial performance.
Income Tax Expense: Fiscal Responsibility
An income tax expense of $— reflects prudent fiscal planning and adherence to regulatory requirements. This fiscal responsibility is indicative of a disciplined approach towards tax obligations. In contrast, a decreased income tax expense of ($88) suggests a need for potential tax planning strategies to enhance financial outcomes.
Net Loss: Financial Outcomes
A net loss of $ (11,162) underlines the necessity for financial course correction and strategic planning. This metric highlights the importance of efficient operations and revenue generation to offset losses. Similarly, a higher net loss of $ (19,876) calls for robust financial strategies and targeted initiatives to reverse the negative trend and restore profitability.
Analyzing Carisma Therapeutics’ Financial Performance
Net Loss and Weighted-average Shares
In the realm of financial jargon, where the beat of the stock market sets the tone, Carisma Therapeutics faces a poignant downturn. The figures, blunt instruments of this fiscal orchestra, reveal a net loss per common share that lingers at $(0.27) in the basic and diluted realms. As the weighted-average shares of the common stock outstanding paint their own somber tale – standing at 41,543,553 – investors brace for impact. This narrative finds itself tangled within the threads of a market in perpetual motion, where stories of loss and struggle are not uncommon.
Comprehensive Loss and Unrealized Gains
Within the pages of Carisma Therapeutics’ financial report, the concept of comprehensive loss looms large, a shadow cast upon the hopeful horizon. The net loss, a staggering $(11,162), echoes through the corridors of investment news, leaving whispers of uncertainty in its wake. Meanwhile, the unrealized gain on marketable securities, a mere 129, stands as a flicker of hope amidst the prevailing gloom, a bittersweet note in a symphony of financial flux.
Final Thoughts on Financial Performance
As the dust settles on Carisma Therapeutics’ second-quarter 2024 financial results, a complex tapestry of numbers and narratives emerges. This tale, filled with triumphs and tribulations, captures the essence of a company navigating the turbulent waters of the financial world. Investors, ever watchful, interpret the signs, seeking meaning in the ebb and flow of figures that dictate the rhythm of the market.
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