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Carisma Therapeutics (CARM) Investor Presentation - Slideshow
2023-04-24 03:48
Cautionary Note Regarding Forward-Looking Statements Regarding Carisma Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) risks associated with the possible failure to realize certain anticipated benefits o ...
Sesen Bio (SESN) Investor Presentation - Slideshow
2023-03-02 19:54
• Remaining amount would fund wind-down of operations and reserves for current, potential future and unknown liabilities Long Delay • Up to six months or more after an additional stockholder vote to approve dissolution and liquidation • Up to three years to fully settle after wind down Significant Uncertainty • Near-term special cash dividend without a concurrent transaction extremely unlikely outside the statutory dissolution process • Amount and timing of an initial distribution in a dissolution and liqui ...
Carisma Therapeutics (CARM) - 2022 Q4 - Annual Report
2023-02-27 16:00
Securities registered pursuant to Section 12(b) of the Act: If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of ...
Carisma Therapeutics (CARM) - 2022 Q3 - Quarterly Report
2022-11-06 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or othe ...
Carisma Therapeutics (CARM) - 2022 Q2 - Quarterly Report
2022-08-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or other jur ...
Carisma Therapeutics (CARM) - 2022 Q1 - Quarterly Report
2022-05-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or other ju ...
Carisma Therapeutics (CARM) - 2021 Q4 - Annual Report
2022-02-27 16:00
(Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be file ...
Carisma Therapeutics (CARM) - 2021 Q3 - Quarterly Report
2021-11-07 16:00
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value SESN The Nasdaq Stock Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period f ...
Carisma Therapeutics (CARM) - 2021 Q2 - Quarterly Report
2021-08-08 16:00
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value SESN The Nasdaq Stock Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from t ...
Carisma Therapeutics (CARM) - 2021 Q1 - Earnings Call Transcript
2021-05-10 15:36
Financial Data and Key Metrics Changes - The company ended Q1 2021 with approximately $110 million in cash and cash equivalents, significantly strengthening its cash position [29] - There was a strong increase in stock price and market capitalization compared to the end of 2020 [29] Business Line Data and Key Metrics Changes - The company is focused on the commercial readiness of Vicineum, with plans to begin promotion to physicians and patients upon potential approval in August 2021 [10][15] - The anticipated global peak sales for Vicineum are projected to be between $1 billion and $3 billion [15] Market Data and Key Metrics Changes - In the U.S., the company is preparing for a late cycle meeting with the FDA in July, with a target PDUFA date of August 18, 2021 [10][12] - In Europe, the company received conditional acceptance of the proprietary brand name Vicineum, with potential approval expected in early 2022 [11] - The IND for Vicineum was approved in China, allowing for clinical trials to assess efficacy and safety [12] Company Strategy and Development Direction - The company aims to launch a best-in-class therapeutic that improves patient outcomes while reducing overall healthcare costs [15] - A customer engagement strategy has been developed, targeting approximately 300 key opinion leaders and 2,000 high-prescribing physicians [16][18] - The company plans to utilize a contract sales organization to support its sales efforts, with 35 representatives across four geographic regions [18] Management's Comments on Operating Environment and Future Outlook - Management believes there is a clear regulatory path forward for Vicineum, with significant unmet needs in bladder cancer [6][33] - The company anticipates early commercial success by mid-2022, driven by the differentiated clinical profile of Vicineum [10][15] - Management highlighted the importance of urologists in the treatment decision-making process and the potential for strong advocacy from patients, payers, and physicians [41][47] Other Important Information - The manufacturing process for Vicineum is designed to be reliable and robust, utilizing world-class manufacturing partners [22][24] - The company is strategically managing its balance sheet through stage-gated investments focused on high-priority initiatives [30] Q&A Session Summary Question: Can you comment on the design of the Phase 3 studies for Vicineum? - Management indicated that the FDA's guidance suggests eligibility for either full or accelerated approval, with a confirmatory trial planned if required [36][39] Question: What will change in terms of views on the company once Vicineum hits the market? - Management believes that the market will come to understand the powerful role of urologists and the advocacy from patients, payers, and physicians, which could significantly enhance the company's value [41][46] Question: What should we expect regarding the confirmatory study before the approval decision? - Management confirmed readiness to launch a confirmatory trial in the less than adequate BCG population, regardless of whether the FDA requires it [54] Question: What is the expected ramp-up in SG&A costs with the contract sales organization? - Management expects annual costs of approximately $10 million to $15 million for the contract sales organization, with sufficient cash to fund operations through Q4 2021 [58][59]