Progress Software (PRGS) Q2 2025 Earnings Call June 30, 2025 05:00 PM ET Speaker0 Hello, everyone, and welcome to Progress Software Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please note this event is being recorded. Now it's my pleasure to turn the call over to Michael Michekai, SVP of Investor Relations. The floor is yours. Speaker1 Thank you, Carmen. Good afternoo ...

Protagonist Therapeutics (PTGX) Update / Briefing June 30, 2025 04:30 PM ET Speaker0 Welcome to Protagonist Therapeutics June thirtieth Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, Monday, 06/30/2025. I will now turn the call over to Doctor. Corey Davis of LifeSci Advisors. Please go ahead. Speaker1 Thanks, Julian. Hello, everyone. Thanks ...

Progress Financial Results Q2 2025 Supplemental Information June 30, 2025 Forward Looking Statements This presentation contains statements that are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Progress has identified some of these forward-looking statements with words like "believe," "may," "could," "would," "might," "should," "expect," "intend," "plan," "target," "anticipate" and ...

Summary of Arcturus Therapeutics KOL Presentation on ARCT-810 Phase II Interim Data for OTC Deficiency Company Overview - **Company**: Arcturus Therapeutics - **Headquarters**: San Diego - **Focus**: mRNA medicines, specifically targeting rare liver diseases like ornithine transcarbamylase (OTC) deficiency [5][6] Industry Context - **Industry**: Biotechnology, specifically in the development of mRNA therapeutics for rare diseases - **Condition**: OTC deficiency is the most common urea cycle disorder with significant unmet medical needs [6][7] Key Points from the Presentation 1. **ARCT-810 Overview**: - ARCT-810 is an mRNA therapeutic designed to replace dysfunctional OTC enzymes, improving urea cycle activity, detoxifying ammonia, and potentially eliminating the need for liver transplants [6][7][8] - It utilizes Arcturus' proprietary lunar delivery platform for effective delivery to hepatocytes [7] 2. **Regulatory Designations**: - ARCT-810 has received multiple designations: orphan drug designation, orphan medicinal product designation, fast track designation, and rare pediatric disease designation [8] 3. **Phase II Study Design**: - Two Phase II studies were conducted: one in the US and one in Europe, focusing on safety, tolerability, and biomarker assessments [11][12] - The US study enrolled patients with more severe disease, while the European study included patients with stable disease [12] 4. **Biomarker Results**: - **Plasma Glutamine**: - In the European study, mean glutamine levels decreased from high to normal during treatment and began to rise again after four weeks post-treatment [13][14] - In the US study, glutamine levels normalized after three doses and remained normal for approximately twenty days [14] - **Ureagenesis Function**: - The new N15 assay showed significant increases in relative ureagenesis function (RUF) post-treatment, with a mean increase of 14.7% [16][17] - Two subjects achieved RUF levels above 50%, indicating clinically meaningful improvements [17] - **Ammonia Levels**: - Ammonia levels remained stable and within normal ranges after treatment, supporting the favorable glutamine and ureagenesis data [18] 5. **Safety Profile**: - The safety database included 40 participants, indicating that ARCT-810 was generally safe and well-tolerated [19] - No serious infusion-related reactions were reported, and adverse events were manageable [19][20] 6. **Next Steps**: - Arcturus plans to complete the ongoing Phase II US study and engage with regulatory agencies for a multi-biomarker driven pivotal trial [68][69] Additional Insights - **Clinical Implications**: - The KOLs emphasized the importance of normalizing diet and reducing the need for ammonia scavengers as key success metrics for OTC therapies [78][80] - mRNA therapies are viewed as a potential alternative to liver transplants, especially for severe cases [100][101] - **Comparison with Other Therapies**: - ARCT-810 is positioned as a more effective solution compared to existing ammonia scavengers, which do not restore urea cycle function [87][88] Conclusion - The interim data for ARCT-810 demonstrates promising results in reducing glutamine levels and improving urea cycle function, with a favorable safety profile. The company is poised to advance its clinical development and regulatory strategy to address the significant unmet needs in OTC deficiency treatment [67][68]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with over $190 million in cash, providing a runway through the first half of 2028 [4][22] - The company has extended its cash runway by a quarter and a half since the transaction with Biogen [6] Business Line Data and Key Metrics Changes - The company has three assets in clinical development: ATI-2138, ATI-45, and ATI-52, with ongoing studies in various indications [3][4] - ATI-45 is in phase three clinical studies in China for severe asthma and CRS with NP, and phase two studies in COPD [4] - A global phase two study in atopic dermatitis has been initiated, with sites in the US, Canada, and Europe [5][14] Market Data and Key Metrics Changes - The pipeline includes highly differentiated large and small molecule assets targeting multibillion-dollar addressable markets [4] - The company is actively seeking partners for ATI-45 in respiratory indications outside of China [14][15] Company Strategy and Development Direction - The company focuses on developing best-in-class therapeutics with a strong emphasis on both large and small molecule drug development [3] - Future plans include reporting top-line data from various studies in 2026, including those for ATI-2138 and ATI-45 [6][7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress and the potential of their pipeline, highlighting a rich catalyst calendar expected in 2026 [6][22] - The company aims to demonstrate the unique pharmacology and safety profile of its assets, particularly in atopic dermatitis and alopecia areata [20][21] Other Important Information - The company has made significant progress in clinical and preclinical plans since the transaction with Biogen [6] - The IND for the bispecific antibody ATI-52 was recently allowed, and phase one SADMAD work has begun [5][17] Q&A Session Summary Question: What are the next steps for the clinical studies? - The company plans to report top-line data from the phase two study of ATI-2138 imminently and initiate a clinical study in alopecia areata [6][20] Question: How does ATI-45 compare to competitors? - Management highlighted that ATI-45 has demonstrated enhanced potency compared to competitors like tezepelumab, with a greater than 60x inhibition of CCL 17 production [9][12] Question: What is the timeline for the next gen ITK selective molecule? - The company plans to file an IND for the next gen ITK molecule in 2026 and begin phase one work shortly thereafter [21][22]

Financial Data and Key Metrics Changes - The company is focused on minimizing dilution and maintaining a clean cap table, having renewed a $12 million line of credit and funding the business through selective capital raises [27] - The company aims to keep clinical trial costs low, achieving approximately half the typical cost per patient for Phase II trials, which usually range from $100,000 to $150,000 [28] Business Line Data and Key Metrics Changes - The lead asset, IGC-81, is in a Phase II trial for agitation in Alzheimer's dementia, with 146 participants currently enrolled across 22 sites [9][10] - The company has made significant progress on the CALMA trial, adding several new sites and utilizing geo-targeting strategies to enhance patient recruitment [5][12] Market Data and Key Metrics Changes - Agitation affects about 76% of Alzheimer's patients, with approximately 50 million Alzheimer's patients worldwide, including 7 million in the US [7] - The current market for Alzheimer's treatments includes cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a potential alternative [32][33] Company Strategy and Development Direction - The company is advancing its AI platform for early detection of Alzheimer's and has developed a new diagnostic model called MINT AD [20][23] - The strategy includes expanding the pipeline into GLP-1 based therapies, targeting both Alzheimer's and metabolic disorders, which could open up a multibillion-dollar market [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trial's progress and the potential for IGC-81 to serve as a disease-modifying therapy, which could significantly enhance the company's valuation [70][71] - The focus is on completing the Phase II trial and launching IGC-81 as a disease-modifying therapy, with positive results expected to drive higher valuations [69][70] Other Important Information - The company has been recognized by the NIH for innovation and is a finalist in the NIA Prepare Challenge for early Alzheimer's detection [24] - The AI model MINT AD aims to identify high-risk groups for Alzheimer's and predict cognitive decline, which could serve as a valuable tool for general practitioners [21][23] Q&A Session Summary Question: Insight into the competitive landscape for Alzheimer's drugs - Management highlighted that current treatments primarily include cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a differentiated oral therapy [32][33] Question: Adequacy of trial sites for current trials - Management confirmed that they have 22 sites and are using geo-targeting strategies to increase patient enrollment by approximately 200% [36] Question: Impact of social media on clinical trial costs - Management indicated that the cost of using social media for recruitment would be marginal, budgeting about $1,000 per recruited patient [41][42] Question: Timeline for CALMA trial completion - Management expects to finish the CALMA trial by March of next year, with ongoing discussions for future trials related to amyloid and tau [50][52] Question: Concerns regarding ARIA with current therapies - Management stated that IGC-81 is not a monoclonal antibody and does not expect ARIA, emphasizing its safety profile [56] Question: Positioning against traditional cannabis use - Management clarified that IGC-81 is a medication with controlled dosing and replicability, differentiating it from recreational cannabis [58][60] Question: Expectations for G&A expenses going forward - Management noted a refocus on key priorities, which has led to a reduction in G&A expenses, aiming to complete trials efficiently [63][66]

Financial Data and Key Metrics Changes - The company is focused on minimizing dilution and maintaining a clean cap table, having renewed a $12 million line of credit and funding through selective capital raises [26] - The cost per patient in Phase II trials is significantly lower than industry standards, with the company managing to conduct trials at about half the typical cost of $100,000 to $150,000 per patient [27] Business Line Data and Key Metrics Changes - The lead asset, IGC-81, is in a Phase II trial for agitation in Alzheimer's dementia, with 146 participants currently enrolled across 22 sites [9][10] - The company has made significant progress on the CALMA trial, adding several new sites and utilizing geo-targeting strategies to increase patient recruitment by about 200% [12][36] Market Data and Key Metrics Changes - Agitation affects approximately 76% of Alzheimer's patients, with around 50 million Alzheimer's patients worldwide and about 7 million in the U.S. [7] - The current Alzheimer's treatment landscape includes cognitive enhancers and recently approved disease-modifying therapies, but challenges remain regarding cost and eligibility [32] Company Strategy and Development Direction - The company is advancing its pipeline into the GLP-1 portfolio, which could target a multibillion-dollar market for metabolic disorders [25] - The focus is on completing the Phase II trial for IGC-81 and launching it as a disease-modifying therapy, with plans to initiate IND enabling studies for pipeline expansion [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trial's progress and the potential for IGC-81 to serve as a complementary or alternative solution in the symptomatic management of Alzheimer's [35] - The company is excited about the MINT AD AI model, which aims to help diagnose Alzheimer's risk factors and predict cognitive decline [22][64] Other Important Information - The company has been recognized by the NIH for innovation and was selected as a top finalist in the NIA Prepare Challenge for early Alzheimer's detection [23] - The beta version of the MINT AD model is operational and aims to assist general practitioners in diagnosing Alzheimer's [22] Q&A Session Summary Question: Insight into the competitive landscape - The current Alzheimer's treatment landscape includes cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a differentiated oral investigational therapy [32][34] Question: Adequacy of trial sites - The company currently has 22 sites and is using geo-targeting strategies to increase enrollment, projecting to meet enrollment targets without needing additional sites [36][37] Question: Cost implications of using social media for recruitment - The budget for recruiting new patients via social media is approximately $1,000 per patient, which will not significantly increase overall trial costs [41] Question: Timeline for CALMA trial top line results - The CALMA trial is expected to finish by March of next year, with the company internally aiming for a more aggressive timeline [49] Question: Concerns about ARIA with the drug - The medication is not a monoclonal antibody, so the company does not expect ARIA and has not seen any indications of it [55] Question: Positioning against traditional cannabis - The drug is a combination medication with controlled dosing, differentiating it from traditional cannabis use [57][60] Question: Future expectations for G&A expenses - The company has refocused on key priorities, which has led to a reduction in G&A expenses, aiming to complete trials and develop the MINT AD model [62][65]

Financial Data and Key Metrics Changes - The company has sufficient cash to complete its trials, with an expected cash runway extending into 2028, indicating no immediate financial overhang [8] Business Line Data and Key Metrics Changes - The lead compound, ABTX009, is currently in Phase 2b of the LOTUS trial, with results expected in mid-2026 [7] - The company is targeting hidradenitis suppurativa (HS), a severe skin disease, with a significant unmet medical need [5][12] Market Data and Key Metrics Changes - The HS market is evolving, with new therapies emerging, but there remains a substantial unmet need for more effective treatments [11][12] - The market for HS is projected to grow significantly, with conservative estimates suggesting it could reach $10 billion by 2035 [42] Company Strategy and Development Direction - The company aims to transition rapidly into Phase 3 trials following the Phase 2 results, with a potential BLA filing anticipated around 2029 [34] - The strategy includes differentiating ABTX009 from competitors by focusing on its higher potency and longer half-life compared to existing therapies [6][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the mechanism of action of ABTX009, highlighting its potential to treat additional immune-mediated inflammatory diseases [8] - The management noted that dermatologists are increasingly looking for new therapies due to the limitations of current treatments, indicating a favorable environment for new entrants [35][38] Other Important Information - The trial design for ABTX009 is similar to that of other recent studies, with a focus on clinically relevant endpoints [27] - The company is studying a diverse patient demographic across the US, Canada, Australia, and Europe, which may help in achieving robust treatment effects [31] Q&A Session Summary Question: Can you discuss the current state of HS and the effectiveness of emerging therapies? - Management highlighted that HS is a severe disease with significant pain and disability, and there is a growing recognition of the need for better therapies [11] Question: What differentiates ABTX009 from other IL-1 strategies? - Management emphasized that targeting IL-1 beta specifically is advantageous, as it plays a pivotal role in chronic inflammation associated with HS [20][21] Question: What are the expectations for the Phase 2 trial data readout in 2026? - The study is powered to show a placebo-subtracted efficacy rate of 25-30%, with a robust treatment effect expected [28][30] Question: How does the company plan to carve out a commercial niche in the HS market? - Management believes that with a differentiated side effect profile and superior efficacy, ABTX009 can capture a significant share of the market [39][42] Question: What are the potential additional indications for IL-1 beta? - Management mentioned several potential indications, including Crohn's disease and rheumatoid arthritis, highlighting the broad applicability of IL-1 beta targeting [43][44]

Investor Presentation NYSE: IDT Third Quarter Fiscal 2025 June 2025 ForwýrĀ-Looking Stýtāmānts All statements in this presentation that are not purely about historical facts, including, but not limited to, those in which we use the words "believe," "anticipate," "expect," "plan," "intend," "estimate, "target" and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment ...

Investor Presentation As of March 31, 2025 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based upon the current beliefs and expectations of Washington Federal's management and are subject to significant risks and uncertainties. The forward-looking statements in this presentation speak only as of the date of the presentation, and Washington Federal assumes no duty, and does not undertake, to update them. A ...