Lisata Therapeutics(LSTA)

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Lisata Therapeutics (LSTA) Investor Presentation - Slideshow
2023-03-10 13:53
2nd line Esophageal SCC (after failure on first line IO) Sponsor/Partner Qilu Pharmaceutical (funds all development in China) Phase 2b, double-blind, placebo-controlled, randomized study evaluating LSTA1 + SoC (Qilu-produced nab-paclitaxel and gemcitabine) vs. placebo + SoC Objective response rate, progression free survival, overall survival Safety 47 • Sponsor/Partner: Qilu Pharmaceutical (funds all development in China) Gemcitabine + Qilu produced nab-paclitaxel + LSTA1 3.2 mg/kg Disease Progression MORPH ...
Lisata Therapeutics(LSTA) - 2022 Q3 - Earnings Call Transcript
2022-11-13 17:53
Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants John Menditto - VP, IR and Corporate Communications Dave Mazzo - CEO David Slack - President and Chief Business Officer James Nisco - VP, Finance and Treasury Kristen Buck - EVP, Research and Development and Chief Medical Officer Conference Call Participants Peter Enderlin - MAZ Partners Shubhendu Roy - Brooklyn Capital Markets Operator Welcome to the Lisata Therapeutics Third Quarter 2 ...
Lisata Therapeutics(LSTA) - 2022 Q3 - Quarterly Report
2022-11-10 21:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 001-33650 LISATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Del ...
Lisata Therapeutics (LSTA) presents at LD Micro Main Event XV - Slideshow
2022-10-25 18:24
LISTHER ATAPEUTICS A Targeted Therapy Delivered David J. Mazzo, Ph.D. Chief Executive Officer LD Micro Main Event XV| October 2022 Nasdaq: LSTA www.lisata.com Copyright ©2022 Lisata Therapeutics, Inc. All rights reserved. Forward-looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, i ...
Lisata Therapeutics(LSTA) - 2022 Q2 - Earnings Call Transcript
2022-08-05 02:59
Caladrius Biosciences, Inc. (CLBS) Q2 2022 Results Conference Call August 4, 2022 4:30 PM ET Company Participants John Menditto - VP, IR & Corporate Communications David Mazzo - President, CEO Kristen Buck - EVP, Research and Development & CMO James Nisco - VP, Finance & Treasury Conference Call Participants Kumar Raja - Brookline Capital Pete Enderlin - MAZ Partners Operator Welcome to the Caladrius Biosciences' Second Quarter 2022 Financial Results and Business Update Conference Call. Currently all partic ...
Lisata Therapeutics(LSTA) - 2022 Q2 - Quarterly Report
2022-08-04 20:44
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 001-33650 CALADRIUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Dela ...
Lisata Therapeutics(LSTA) - 2022 Q1 - Earnings Call Presentation
2022-05-06 21:11
caladrius Developing Innovative Therapies that Treat or Reverse Disease David J. Mazzo, PhD President & Chief Executive Officer M ay 5 , 2 0 22| N a s d a q : C L B S 2 Information regarding disclosures Forward-Looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this com ...
Lisata Therapeutics(LSTA) - 2022 Q1 - Earnings Call Transcript
2022-05-06 03:29
Financial Data and Key Metrics Changes - Research and development expenses for Q1 2022 were $3.3 million, down from $5.1 million in Q1 2021, reflecting a focus on advancing the ischemic repair platform and related trials [11] - General and administrative expenses increased to $3.3 million in Q1 2022 from $3 million in Q1 2021, primarily due to higher fees related to potential strategic transactions [12] - Net losses decreased to $4.2 million in Q1 2022 from $8.1 million in Q1 2021 [12] - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities of approximately $88.5 million, positioning it well for projected capital obligations [13] Business Line Data and Key Metrics Changes - The company advanced its CD34-positive cell therapy development pipeline, initiating a proof-of-concept study for CLBS201 in diabetic kidney disease [6] - The merger with Cend Therapeutics is expected to create a financially sound NASDAQ-listed company with a diverse product development pipeline [7] Market Data and Key Metrics Changes - The biotech sector, as measured by the XBI, is down approximately 35% year-to-date, with the aggregate enterprise value of the biotech sector down about 70% since February 2021 [29] - IPO and follow-on offerings are down nearly 100% year-over-year, indicating a challenging fundraising environment for life science companies [30] Company Strategy and Development Direction - The merger with Cend Therapeutics aims to diversify and derisk the development pipeline, focusing on oncology and solid tumor indications [31][32] - The company is excited about the potential of CEND-1, which could enhance the efficacy of existing cancer therapies [56] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging financial environment characterized by high inflation and tightening capital availability, emphasizing the need for proactive strategies [29][31] - The merger is seen as a critical step to control the company's destiny and address current headwinds [31] Other Important Information - The SAKIGAKE designation for HONEDRA in Japan allows for prioritized regulatory consultation and potentially expedited approval processes [18] - The company is focusing on securing a partner in Japan for HONEDRA, with several companies expressing interest pending regulatory guidance [37] Q&A Session Summary Question: Will the PMDA guidance be based on the pre-consultation meeting? - Management confirmed that the pre-consultation meeting will provide clear guidance on how to proceed with the regulatory process [35] Question: What is the status of finding a partner in Japan for HONEDRA? - Management indicated that there are more than six companies in diligence expressing serious interest, with expectations of closing a transaction increasing after receiving guidance from the PMDA [37] Question: What is happening with CLBS201 in diabetic kidney disease? - Management confirmed that the first patient has been treated, and the second patient was dosed recently, with plans to proceed based on the data safety monitoring board's review [39] Question: What is the strategy for data release regarding HONEDRA? - Management stated that full data sets will be released after discussions with regulatory authorities to avoid jeopardizing the review process [44] Question: What are the challenges faced in the XOWNA trial? - Management highlighted obstacles related to COVID-19, supply chain issues, and the need to amend protocols, but confirmed that additional sites have been added [46] Question: When will the proxy statement for the merger be filed? - Management aims to file the proxy statement by the end of May or early June, pending completion of financial audits [50] Question: Can you provide details on Cend stockholders? - Management noted that Cend is a closely held private company with less than 10 major shareholders [51] Question: What parameters determine the ownership ratio in the merger? - Management explained that the ratio will be based on valuations considering market potential, existing deals, and liabilities [53] Question: Is there high IP protection for Cend's technology? - Management confirmed that there is a high level of IP protection for the technology [58] Question: Will pricing affect partnerships for CD34 programs? - Management acknowledged that perceptions of high costs for autologous therapies may hinder partnerships, but emphasized the cost-effectiveness of their processes [60]
Lisata Therapeutics(LSTA) - 2022 Q1 - Quarterly Report
2022-05-05 20:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 001-33650 Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 CALADRIUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Del ...
Lisata Therapeutics(LSTA) - 2021 Q4 - Earnings Call Transcript
2022-03-23 00:52
Financial Data and Key Metrics Changes - Research and development expenses for Q4 2021 were $4.2 million, a 43% increase compared to $2.9 million in Q4 2020, and $17.7 million for the full year 2021, up approximately 91% from $9.3 million in 2020 [8][10] - General and administrative expenses for Q4 2021 were $2.7 million, a 6% increase from $2.5 million in Q4 2020, and $11.4 million for the full year 2021, a 15% increase from $9.9 million in 2020 [10] - Net losses were $27.5 million for the year ended December 31, 2021, compared to $8.1 million for 2020 [10] Business Line Data and Key Metrics Changes - The company focused on advancing its ischemic repair platform, including the FREEDOM trial, XOWNA, CLBS16, and the Phase 1 trial for CLBS201 [9][34] - HONEDRA in Japan received SAKIGAKE Designation, which allows for prioritized consultation and a reduced review time for registration applications [21][22] Market Data and Key Metrics Changes - The company successfully raised $90 million in new capital growth proceeds in 2021, providing financial security to focus on its business plan [13] - As of December 31, 2021, the company had cash, cash equivalents, and marketable securities of approximately $95 million, projected to fund operations for several years [14] Company Strategy and Development Direction - The company aims to identify and evaluate strategic development opportunities to enhance shareholder value beyond its current pipeline [7] - There is a focus on securing additional development assets to diversify the product candidate portfolio [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by the COVID-19 pandemic and financial markets while advancing development programs [7] - The company is optimistic about its prospects and sees a bright future ahead, driven by the advancement of its existing portfolio and potential new assets [37] Other Important Information - The company has suspended enrollment efforts for HONEDRA to minimize operational and financial burdens due to delays caused by the pandemic [25] - The FREEDOM trial for XOWNA is experiencing enrollment challenges due to COVID-19 and changes in diagnostic technology [32][59] Q&A Session Summary Question: Strategic development options and stage of development - Management prefers assets that are already in the clinic, ideally with Phase 1 data, and is looking at numerous assets due to market volatility [42][44] Question: Alternative avenues for HONEDRA - Management is exploring various strategies, including using existing data for potential partnerships, rather than incurring additional costs for enrollment [47][49] Question: Near-term trend of R&D spending - R&D spending is expected to be conservative, with completed capital spend on HONEDRA and limited costs anticipated for the DKD study [51] Question: Clarity on CMD program enrollment - Enrollment challenges are attributed to COVID-19 impacts on hospital staffing and changes in diagnostic technology, with hopes for improvement by late summer or early fall [55][60] Question: Stock repurchase consideration - Management believes that developing assets is a better use of capital than repurchasing stock, as share price is currently tied to cash balance [62][63] Question: Future direction regarding assets or corporate acquisitions - The company is evaluating both asset acquisitions and potential corporate purchases, depending on the situation and available opportunities [65]