Affimed (AFMD) Earnings Call Presentation
2025-07-03 07:10
AFM24 (EGFR) + atezolizumab in NSCLC - In EGFRwt NSCLC, the Disease Control Rate (DCR) was 76% (25/33 patients), with 48% (16/33) showing tumor shrinkage and an Objective Response Rate (ORR) of 21% (1 CR, 6 PRs)[16] - In EGFRmut NSCLC, the DCR was 71%, with 41% (7/17) showing tumor shrinkage and an ORR of 24% (1 CR, 3 PRs)[16] - Preliminary median Progression-Free Survival (PFS) in EGFRwt NSCLC was 5.6 months, with 36% of patients ongoing[33, 49] - Patients without prior taxane exposure in EGFRwt NSCLC showed a 25% ORR and a preliminary median PFS of 74 months[47, 53] - Post-hoc analysis showed increasing AFM24 exposure resulted in higher ORR, with the highest exposure group (Q4) achieving a 5455% ORR and a 9091% DCR[68] Acimtamig (AFM13) + AlloNK® in r/r HL - In relapsed/refractory Hodgkin Lymphoma (r/r HL), the ORR was 864% (19/22 patients), including a 545% Complete Response (CR) rate[16, 91] - All patients in the LuminICE-203 study were refractory to brentuximab vedotin (BV) and checkpoint inhibitors (CPIs)[80] AFM28 in r/r AML - In the highest dose level (300 mg), a composite complete remission rate (CRcR) of 40% (4/10 patients) was achieved in relapsed/refractory Acute Myeloid Leukemia (r/r AML)[16, 107]
Franklin Covey(FC) - 2025 Q3 - Earnings Call Presentation
2025-07-03 07:08
Greatness Starts Here We transform organizations by building exceptional leaders, teams, and cultures that get results. © FranklinCovey Co. All rights reserved. PROPRIETARY AND CONFIDENTIAL INVESTOR UPDATE Third Quarter Fiscal 2025 Forward-Looking Statements/Non-GAAP This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based upon management's current expectations and are subject to various risks and u ...
Celcuity (CELC) Earnings Call Presentation
2025-07-03 07:08
Gedatolisib: A Novel PAM Inhibitor - Gedatolisib, a pan-PI3K/mTOR inhibitor, shows potential as a highly potent and cytotoxic agent with a differentiated mechanism of action and pharmacokinetic profile[7, 23] - Gedatolisib has demonstrated compelling preliminary results in HR+/HER2- advanced breast cancer (ABC) patients, with a median progression-free survival (mPFS) of 48 months in 1st line and 12.9 months in 2nd line settings[7, 23] - Gedatolisib is more potent against each node than other PAM inhibitors, with >300X higher potency and 1.5x – 2.8x higher cytotoxicity than other PAM inhibitors in vitro[30] - Gedatolisib has a lower rate of Grade 3/4 hyperglycemia (>95% lower) and treatment-related discontinuations (>80% lower) compared to approved PI3K inhibitors[31] Clinical Development and Market Opportunity - Celcuity is conducting a Phase 3 study in 2nd line HR+/HER2- ABC patients and expects to begin enrolling a Phase 3 study in 1st line patients in Q2 2025[7, 158] - The PAM pathway is the most frequently altered pathway in solid tumors (38%), yet drug revenues from PAM inhibitors are a small fraction of other targeted therapy classes[10, 18] - The potential patient population for PAM inhibitors in breast and prostate cancers is estimated to be >500,000 in the US, EU5, and Japan[10] - US market opportunity for Gedatolisib in HR+/HER2- Breast Cancer and Advanced Prostate Cancer is estimated at ~$5-$6 Billion for 2L ABC Post-CDKi + AI, ~$10B+ for 1L ABC ET Sensitive, ~$3B for 1L ABC ET Resistant, $6-$8B for High Risk EBC Adjuvant, $8B+ for 1L/2L mCRPC Post-ARi, $10B+ for 1L mCRPC, $6-$8B for nmCRPC, $10B+ for mHSPC[52] Financial Position - Celcuity has cash, cash equivalents, and short-term investments of $205 million as of Q1 2025, expected to fund operations through 2026[8, 159]
Jaguar Health (JAGX) Earnings Call Presentation
2025-07-03 07:05
Jaguar Health, Inc. (NASDAQ: JAGX) What's Different????? 3 NASDAQ:JAGX • The classic definition of insanity: Doing the same thing over and over again and expecting a different result • Equally crazy — changing the approach and expecting to get the same results Overview – May 2025 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts conta ...
Eton Pharmaceuticals (ETON) Earnings Call Presentation
2025-07-03 06:58
This document contains forward-looking statements concerning Eton Pharmaceuticals, Inc. ("Eton", the "Company," "we," "us," and "our"). The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following ...
Xilio Therapeutics (XLO) Earnings Call Presentation
2025-07-03 06:50
Unleashing the Potential of Immuno-Oncology Therapies June 5, 2025 © 2025 Xilio Therapeutics, Inc. 1 Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, timing and expectations related to: development timelines and anticipated milestones for Xilio's programs; the receipt of future contingent payments under Xilio's coll ...
Neurogene (NGNE) Earnings Call Presentation
2025-07-03 06:48
NGN-401 for Rett Syndrome - NGN-401, a gene therapy leveraging EXACT transgene regulation technology, is being developed for Rett syndrome [15] - Rett syndrome affects an estimated 6,000-9,000 patients in the U S [20] - The worldwide incidence of Rett syndrome is estimated at 1 in 10,000 females [20] - Phase 1/2 data showed durable improvements, including a two-point improvement in CGI-I in all participants [38] - All four participants in the Phase 1/2 trial achieved a CGI-I rating of "Much Improved" [41] - The company expects to announce additional Phase 1/2 clinical data in the second half of 2025 [64] Clinical Trial and Regulatory Updates - The FDA has accepted the conversion of the Phase 1/2 trial to a registrational trial for NGN-401 [28] - The Embolden registrational trial is designed as an open-label, single-arm, baseline-controlled study [27] - The proposed number of participants in the Embolden trial is 18, subject to FDA feedback [28] - The company anticipates providing a regulatory update regarding the registrational trial in the first half of 2025 [64] Manufacturing and Financials - Neurogene has a 42,000 sq ft in-house AAV manufacturing facility in Houston, with 6,000 sq ft of cleanrooms [11] - The company's cash runway is expected to fund operations into early 2028 [6, 64]
Caesars Entertainment(CZR) - 2025 Q1 - Earnings Call Presentation
2025-07-03 06:34
Company Performance Highlights - Caesars Digital generated over $1.2 billion of TTM Net Revenue and $155 million of Adjusted EBITDA [19] - Caesars Digital's Q1 '25 TTM Net Revenue is 20% above Q1 '24 TTM [19] - Caesars Digital's Q1 '25 TTM Adjusted EBITDA is 230% above Q1 '24 TTM [19] - Las Vegas properties generated over $1.0 billion of TTM Adjusted EBITDAR [30] - Regional properties' capital spend comprises approximately 65% of Q1 2025 Regional segment Adjusted EBITDAR [33] - Caesars Digital's iGaming net gaming revenue increased by 53% YoY in Q1 2025 to $118 million [56, 59] Financial Outlook - The company anticipates $1.35 billion in master lease rent [41] - The company's current weighted average cost of debt is 6.5%, implying $775 million of full-year interest expense [41] - The company projects mid-point capital expenditures of $606 million for 2025, excluding Caesars Virginia JV [41] - The company estimates cash income taxes at approximately 5% of Adjusted EBITDAR [41]
Franklin Covey(FC) - 2025 Q3 - Earnings Call Transcript
2025-07-02 22:02
Financial Data and Key Metrics Changes - Revenue for the third quarter was $67.1 million, down 9% year-over-year and 4% year-to-date, but up 13% sequentially [29] - Adjusted EBITDA was $7.3 million, exceeding expectations and higher than the top end of the guidance range of $4 million to $6.5 million [6][33] - Operating expenses increased to $53.5 million, primarily due to restructuring charges and increased selling, general, and administrative expenses [30] Business Line Data and Key Metrics Changes - The Enterprise Division generated 70% of total revenue, with revenue of $47.3 million, down from $51.9 million in the prior year [34] - The Education Division's revenue was $18.6 million, down 8% compared to the prior year, but subscription revenue grew 13% [39] - Adjusted EBITDA for the Education Division decreased to $2.1 million from $3.1 million last year due to lower revenue [39] Market Data and Key Metrics Changes - North America segment revenue was $37.1 million, a decrease of $3.5 million from the prior year, with subscription and subscription services revenue down 4% year-to-date [35] - International direct operations revenue was $7.5 million, a decrease of $1 million, primarily due to challenging business conditions in Asia and the UK [36] - The balance of billed deferred subscription revenue in North America was $45 million, down from $47.2 million in the prior year [36] Company Strategy and Development Direction - The company is focused on cost reductions while maintaining investments in growth initiatives, particularly in the Enterprise North America business [6][32] - A new Chief Marketing Officer has been appointed to accelerate marketing efforts and penetrate the total addressable market [22] - The company expects to grow its education business year-over-year despite uncertainties, with strong demand for its "Leader in Me" program [25][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate economic uncertainties and continue winning large deals [8][46] - The revised revenue guidance for the fiscal year is now between $265 million and $275 million, reflecting ongoing uncertainties and timing risks [9][42] - Management anticipates a meaningful increase in adjusted EBITDA and free cash flow in fiscal year 2026 due to cost reduction actions [43] Other Important Information - The company has completed cost reduction initiatives that are expected to yield annualized savings of $8 million in fiscal year 2026 [32] - The percentage of clients in multi-year contracts increased from 55% to 58%, indicating a strong client retention strategy [21] Q&A Session Summary Question: Can you share milestones regarding the enterprise division's performance? - Management highlighted the increase in new logos and expansion within existing clients, emphasizing the separation of sales teams for better focus [51][53] Question: What are the expectations for new school additions in the education division? - Management expects to meet or exceed the previous year's new school additions, citing the effectiveness of the "Leader in Me" solution [62][63] Question: Can you break down the guidance reduction by segment? - The reduction primarily stems from timing issues in service delivery and ongoing uncertainties affecting enterprise clients [65][68] Question: How does the company foresee the current environment impacting fiscal year 2026? - Management is planning for continued scrutiny of budgets and tariffs, but remains committed to navigating through these challenges [74][75] Question: What is the current adoption rate of AI service delivery? - Approximately 43% of clients are using the AI sales coach, with expectations for increased adoption as the technology evolves [85]
Franklin Covey(FC) - 2025 Q3 - Earnings Call Transcript
2025-07-02 22:00
Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $67.1 million, down 9% year-over-year and 4% year-to-date, but up 13% sequentially [27] - Adjusted EBITDA was $7.3 million, exceeding expectations and down from $13.9 million in the prior year [30][31] - Gross margin remained strong at approximately 76.5% of revenue, flat year-over-year [27] - Operating expenses increased to $53.5 million, primarily due to restructuring charges and increased selling, general, and administrative expenses [28] Business Line Data and Key Metrics Changes - The Enterprise Division generated 70% of total revenue, with Q3 revenue at $47.3 million, down from $51.9 million in the prior year [32] - The Education Division's revenue was $18.6 million, down 8% year-over-year but grew 1% year-to-date [36] - Subscription revenue in the Education Division increased by 13% to $11.8 million [36] Market Data and Key Metrics Changes - The North America segment revenue was $37.1 million, a decrease of $3.5 million from the prior year, affected by government actions [33] - International direct operations revenue was $7.5 million, down $1 million due to challenging business conditions [34] - The number of multi-year contracts in North America increased from 55% to 58% [34] Company Strategy and Development Direction - The company is focused on cost reductions while maintaining investments in growth initiatives [5][6] - A new Chief Marketing Officer has been appointed to accelerate marketing efforts and penetrate the total addressable market [21] - The company expects to grow its education business year-over-year despite uncertainties [22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertain external environment affecting investment decisions and cost scrutiny [5] - Revised revenue guidance for the fiscal year is now between $265 million and $275 million, with adjusted EBITDA guidance widened to $28 million to $33 million [7][40] - Confidence remains in the fundamental strengths of the business and the potential for future growth [7] Other Important Information - The company has completed cost reduction initiatives that are expected to yield significant savings in the coming fiscal year [6][29] - Deferred subscription revenue increased by 7% year-over-year, indicating a strong foundation for future growth [31] Q&A Session Summary Question: Can you share milestones regarding the enterprise division's performance? - Management noted improvements in new logo sales and expansion within existing clients, with a focus on off-cycle expansion opportunities [50][52] Question: What are the expectations for new school additions in the education division? - Management expects to meet or exceed the previous year's new school additions, citing strong demand for their solutions [60][61] Question: Can you break down the guidance reduction by segment? - The reduction primarily stems from timing issues in service delivery and ongoing uncertainty affecting enterprise clients [63][66] Question: How do you foresee the current environment impacting fiscal 2026? - Management is planning for continued scrutiny of budgets and uncertainty in the enterprise level due to tariffs and other factors [70][71] Question: What is the current status of deferred revenue growth relative to total revenue growth? - Management explained that deferred revenue growth is driven by invoiced amounts from prior years, and they expect future growth to translate into reported revenue [73][78] Question: What is the adoption rate of AI service delivery among clients? - Approximately 43% of clients are using the AI sales coach, with expectations for continued growth in this area [81]