launched or updated products, which may or may not meet our and their expectations, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports ...

We discuss these and other risks and uncertainties in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our periodic reports and other filings we make with the SEC from time to time. Given these uncertainties, you should not place undue reliance on the forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required ...

Company Overview - Praxis Precision Medicines is a Boston-based biotechnology company focused on developing novel therapies for neurological and psychiatric disorders characterized by neuronal imbalance [6] - The company has a pipeline targeting major depressive disorder, essential tremor, and rare epilepsies, emphasizing precision medicine and targeted treatments [6] - As of February 17, 2026, the company's stock price was $328.04, reflecting a significant increase of 320% over the prior year [8] Financial Performance - The company reported a trailing twelve months (TTM) revenue of $7.46 million and a net income loss of $273.04 million [4] - Praxis ended 2025 with $926 million in cash and investments, supplemented by an additional $621 million in financing in January 2026, extending its financial runway into 2028 [10][11] - Research and development spending for 2025 reached $267 million, indicating a late-stage push across multiple programs [11] Recent Developments - On February 17, 2026, Perceptive Advisors LLC disclosed a purchase of 431,432 shares of Praxis Precision Medicines, valued at approximately $80.34 million, increasing its stake significantly [2] - The quarter-end value of Perceptive Advisors' position in Praxis increased by $505.38 million due to the share purchase and subsequent stock price movement [2] - Praxis has submitted two New Drug Applications (NDAs) to the FDA for ulixacaltamide in essential tremor and relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) [10] Market Position and Strategy - The company operates a biopharmaceutical business model focused on research, clinical development, and commercialization of proprietary drug candidates [9] - Praxis targets healthcare providers and specialists in neurology and psychiatry, aiming to address unmet medical needs in these fields [9] - The recent increase in portfolio weightings for Praxis reflects a transition from a pipeline story to a pending commercial launch, indicating potential for rapid changes in investor sentiment [7]

Core Insights - Celcuity is focused on developing targeted cancer therapies and diagnostic platforms, particularly in precision medicine for oncology [1][6] - Perceptive Advisors increased its stake in Celcuity by 203,881 shares, valued at approximately $16.76 million, reflecting confidence in the company's growth potential [2][7] - Celcuity's share price surged 700% over the past year, indicating strong market performance and investor interest [7][11] Company Overview - As of February 17, 2026, Celcuity's stock price was $107.32, with a market capitalization of $4.97 billion and a net income of -$162.72 million [4] - The company operates a clinical-stage biotechnology model, focusing on proprietary drug candidates and diagnostic technologies, with future revenue expected from licensing and partnerships [8] Product Development - Celcuity's lead drug candidate, Gedatolisib, has received FDA acceptance for a New Drug Application with a PDUFA goal date of July 17, 2026, based on Phase 3 trial data [9][10] - Gedatolisib has been granted Breakthrough Therapy and Fast Track designations, indicating its potential significance in treating advanced breast cancer [9] Investment Implications - Perceptive Advisors' stake in Celcuity represents 5.62% of its reported assets under management (AUM), suggesting a strong conviction in the company's future [7][11] - The upcoming regulatory decision on Gedatolisib is critical for long-term investors, as it will determine the drug's market entry and potential revenue generation [11]

Core Insights - Hims & Hers Health, Inc. (HIMS) is establishing itself as a leading digital health platform focused on personalized, technology-enabled care, expanding its offerings across various life stages and health conditions [1][8] - The company has launched new specialties in women's health, including menopause and perimenopause, and in men's health with a low testosterone category, providing tailored treatment plans [1][8] - Hims & Hers is advancing into proactive, data-driven care with the introduction of Labs for comprehensive health monitoring and a multi-cancer early detection blood test [2][8] Company Developments - Hims & Hers has introduced a dedicated menopause and perimenopause specialty on the Hers platform, along with a low testosterone category on the HIMS platform, enhancing its service offerings [1][8] - The launch of Labs allows customers to monitor key health markers over time, supported by provider-guided action plans, and includes a multi-cancer early detection blood test for over 50 cancer types [2][8] - The company is making strategic investments in AI, diagnostics, and global expansion to create a connected healthcare platform that prioritizes personalized, preventive care [2][8] Financial Performance - Hims & Hers shares have decreased by 67.9% over the past year, underperforming the industry average decline of 32.8% [7] - The Zacks Consensus Estimate for HIMS' earnings per share in 2025 indicates a significant improvement of 77.8% compared to 2024 [9] - HIMS' forward 12-month price-to-sales ratio is 1.3X, which is lower than the industry average of 3.7X and its five-year median of 2.7X, reflecting a Value Score of C [11]

Management describes the Precision Medicine segment as a strategic engine that validates therapeutic targets and builds physician relationships rather than just a cash generator. The company has pivoted toward an internal innovation model for R&D to capture higher value, citing the high market premiums paid for early-stage radiopharmaceutical assets. Vertical integration through over $0.5 billion in infrastructure investment is viewed as a critical moat due to the complex logistics and short shelf lif ...

Launching two additional products pending regulatory outcomes: Pixclara (Pixlumia in Europe) for glioblastoma and Zircaix for renal cancer.Continuing to grow approved products, including building on the launch of Gozetotide and the FDA approval of Gleolan in 2025.He also said the precision medicine business is more than a cash generator, calling it strategic validation of therapeutic targets, a way to streamline clinical trials, and an avenue to deepen relationships with physician stakeholders. Looking ahea ...

Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to $804 million, marking its third consecutive year of double-digit revenue growth [17][19] - EBITDA improved by 25% to $216 million, driven by strong demand for Illuccix and the launch of Gleolan [19][23] - The gross margin remained stable at 53%, with a significant portion of gross margin generated from the precision medicine business [22][23] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional $113 million [19][23] - The precision medicine business generated approximately $400 million in gross margin, with 94% of the gross margin coming from this segment [20][23] - Investments in product development totaled $157 million, focusing on late-stage pipeline projects [22] Market Data and Key Metrics Changes - The precision medicine portfolio delivered $622 million in revenue, with sequential growth every quarter, even during challenging market conditions [30] - The company is expanding its market presence, with Illuccix now available in 17 countries and marketing authorizations in over 24 markets [35] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investments ranging from $200 million to $240 million in 2026 [26] - A dual product strategy for Illuccix and Gleolan is in place to manage economic needs and reimbursement preferences effectively [58][60] - The company is focused on expanding its product offerings, indications, and geographical reach, particularly in key markets like the U.K., Germany, and China [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving approximately 20% revenue growth in 2026, with guidance set at $950 million to $970 million [28][29] - The company is committed to reinvesting earnings into R&D and commercial growth rather than optimizing near-term earnings per share [68] - Management highlighted the importance of clinical credibility and operational reliability in sustaining market leadership [32][33] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials expected to generate significant data this year [47] - The ProstACT Global study is progressing well, with recruitment for part two ramping up [48][49] Q&A Session Questions and Answers Question: When might we see data for 591, the safety data? - The company is completing clinical case report forms and will disclose the data simultaneously with the FDA submission, with no delays expected from the FDA side [54][56] Question: Can you elaborate on the early performance of the two-product strategy for Illuccix and Gleolan? - The two-product strategy allows the company to manage economic needs and reimbursement preferences effectively, adapting to changes in the reimbursement environment [58][60] Question: Will the company reinvest earnings to achieve close to zero NPAT for F-26, F-27, and F-28? - The company will reinvest the majority of earnings back into R&D and commercial growth, with no profit objective for the next two years [68] Question: How much growth in precision medicine revenue is coming from markets outside of the U.S.? - Currently, 95% of revenue is U.S.-based, but the company expects this mix to change as it expands into other markets like Japan [74]

Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to AUD 804 million, marking its third consecutive year of double-digit revenue growth [15][17] - EBITDA improved by 25% to AUD 216 million, driven by strong demand for Illuccix and the launch of Gozellix [17][20] - The gross margin remained stable at 53%, with 94% of gross margin generated from the precision medicine business [19][20] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional AUD 113 million [17][20] - The precision medicine business demonstrated a 28% increase in operating profit and a 25% increase in EBITDA [20] - The company invested AUD 157 million into product development, focusing on its late-stage pipeline [19] Market Data and Key Metrics Changes - The precision medicine portfolio delivered AUD 622 million in revenue, up 22% year-over-year, with sequential growth every quarter [28] - Illuccix is now available in 17 countries with reimbursement secured, and marketing authorizations exist in over 24 markets [32] - The company anticipates a 25% growth in precision medicine revenue in 2026, driven by the full year of RLS revenue [26] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investment in the range of AUD 200 million to AUD 240 million for 2026 [24] - A dual product strategy for Illuccix and Gozellix is expected to enhance market share and manage economic needs of healthcare accounts [56] - The focus remains on reinvesting revenues back into the business rather than optimizing near-term earnings per share [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another year of double-digit revenue growth, with guidance set at AUD 950 million to AUD 970 million for 2026 [26][27] - The company is committed to disciplined financial management and anticipates strong momentum heading into 2026 [25][27] - Management highlighted the importance of clinical credibility and operational reliability in sustaining market leadership [30] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials identified as priorities for the year [46] - The ProstACT Global study is progressing well, with recruitment for part two ramping up [47] - The company is focused on expanding its product offerings and indications, particularly in key markets like China and Japan [32][33] Q&A Session Summary Question: When might data for 591 be available? - Management indicated that the company is not waiting on the FDA and will disclose data as soon as it is available [52][54] Question: Insights on the two-product strategy for Illuccix and Gozellix? - The two-product strategy allows the company to manage economic needs and adapt to changing reimbursement environments [56][59] Question: Will earnings be reinvested to achieve close to zero NPAT for F-26, F-27, and F-28? - Management confirmed that the majority of earnings will be reinvested back into the company for growth initiatives [66][67] Question: How much growth in precision medicine is coming from markets outside the US? - Currently, 95% of revenue is US-based, but the company expects this mix to change as it expands into other markets [72] Question: Thoughts on the collaboration with Atley and Stanford focusing on astatine-211? - Management expressed excitement about the potential of astatine-211 and its fit within the product portfolio [76]

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Clinical-stage precision medicine oncology - **Key Programs**: Nine clinical programs, with a focus on uveal melanoma and other oncology indications Key Points and Arguments Upcoming Catalysts - **Darovasertib**: Lead molecule for uveal melanoma, with an upcoming top-line data release for the combination with crizotinib in metastatic uveal melanoma expected by the end of March 2026. The company has triggered the required 130 events for analysis [2][5] - **Neoadjuvant and Adjuvant Studies**: Enrollment in a neoadjuvant study is ongoing, with plans to begin an adjuvant study in Q2 2026 [3][4] Clinical Data Expectations - **Control Arm Expectations**: The control arm is expected to show a median progression-free survival (PFS) of 2-3 months and overall survival (OS) of about 13 months based on historical data [9][10] - **Darovasertib and Crizotinib Combination**: Previous data indicated a median PFS of about 7 months and OS of 21 months, significantly better than standard therapies [10][12] - **Response Rates**: Standard therapies show a response rate of around 10%, while the combination therapy has shown a response rate exceeding 30% [10] Study Design and Patient Demographics - The study focuses on HLA-A2 negative patients with metastatic uveal melanoma, comparing the combination therapy to standard care, which varies by region [8][9] - The study design includes frequent patient scans every six weeks, which may lead to earlier detection of progression compared to traditional three-month scans [15] Regulatory and Filing Timelines - **FDA Filing**: The company anticipates a six-month timeline to file for accelerated approval post-data release, with a review period of at least six months [30] - **HLA-A2 Positive Group**: Data from HLA-A2 positive patients will be presented in two chapters, with the first chapter expected to show early efficacy data [31][32] Other Pipeline Developments - **DLL3 TOPO1 ADC**: Currently in phase I studies, with initial data expected by the end of 2026. The U.S. study has launched, and early safety data is anticipated [47][48] - **MTAP Inhibitor IDE397**: Ongoing studies in combination with Trodelvy for MTAP-deleted urothelial cancer, with promising early data [59][60] - **Combination Strategies**: The company is exploring various combination therapies, including those targeting PRMT5 and CDKN2A, to enhance treatment efficacy in MTAP-deficient tumors [66][68] Market Position and Future Outlook - IDEAYA aims to set a new standard for uveal melanoma treatment, addressing a significant unmet medical need with limited existing therapies [22][14] - The company has a strong cash position of approximately $1.05 billion, providing a runway into 2030, positioning it well for upcoming clinical milestones [5] Additional Important Information - The company emphasizes the importance of data integrity and the potential for positive outcomes based on historical performance metrics [12][26] - Discussions with the FDA regarding potential label expansions and real-world data integration are ongoing, particularly for HLA-A2 positive patients [33] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA Biosciences' strategic focus on advancing its oncology pipeline and addressing critical patient needs in uveal melanoma and other cancer indications.