[Applause] [Music] Who am I. The eternal question. Am I right.Um, throughout my life, I've explored a series of relationships. And this includes not only my relationship with other people, but also my relationship with myself. In growing up, I've tried my best to figure out how I work and why I am the way I am.I'm still trying to figure this out. I'm a big believer in experiences and upbringing shaping who people grow up to be. I myself through my experiences and through other people that I've observed has ...

I'm wondering how many of you are familiar with this blue dog. Well, for those who are not, this is Bluey, an Australian preschool program about a family of four dogs. Bluey and Bingo and Chile Bandit.Now, Blueie is getting a lot of praise, not just by children and adults alike, but developmental psychologists and me. Thanks to writer Joe Braum's focus on child psychology, Blueie is refreshing in its handling of parenting and children's learning. And today I want to draw attention to a particular episode th ...

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Core Findings - Atai Life Sciences and Beckley Psytech Limited announced successful topline results from the Phase 2b trial of BPL-003, achieving primary and key secondary endpoints in patients with treatment-resistant depression [1][3][4] Efficacy Results - A single 12 mg dose of BPL-003 resulted in a statistically significant mean reduction of 11.1 points in depressive symptoms on the MADRS scale at Day 29, compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038) [3][4] - The 8 mg dose also showed significant improvement with a mean MADRS score reduction of 12.1 points at Day 29 (p = 0.0025) [4] - Both 8 mg and 12 mg doses demonstrated significant efficacy as early as Day 2, with mean reductions of 8.8 points and 8.9 points, respectively, compared to a 3.9 point reduction in the 0.3 mg group [6] - Durable effects were observed, with the 8 mg group showing a mean reduction of 10.8 points at Day 57 [7] Safety Findings - More than 99% of treatment-emergent adverse events were mild or moderate, with no serious adverse events reported [8] - The 8 mg dose was better tolerated than the 12 mg dose, with dose-related increases in discomfort and other mild side effects [8] - No instances of treatment-emergent suicidal intent or behavior were observed in the 8 mg or 12 mg groups [9] Future Developments - The study includes an ongoing eight-week open-label extension to evaluate the safety and efficacy of a second 12 mg dose, with data expected in Q3 2025 [9][10] - Atai Life Sciences announced a private placement of 18.3 million shares, raising approximately $50 million in gross proceeds [10] Transaction Update - The companies plan to combine in an all-share transaction, contingent on the success of the Phase 2b trial, expected to close in the second half of 2025 [2] Market Reaction - Following the announcement, ATAI stock rose by 28.3% to $2.81 in premarket trading [10]

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Summary of Atai Life Sciences (ATAI) Update / Briefing July 01, 2025 Company Overview - **Company**: Atai Life Sciences - **Focus**: Development of psychedelic therapies for mental health, specifically targeting treatment-resistant depression with the drug BPL-three Key Industry Insights - **Market Context**: Treatment-resistant depression is a significant public health issue, affecting millions globally and is the second leading cause of disability worldwide [12][12] - **Competitor Analysis**: SPRAVATO, a leading treatment in this space, achieved blockbuster status with approximately $930 million in sales in the U.S. in the previous year [47][47] Core Findings from Phase 2B Trial of BPL-three - **Trial Success**: The Phase 2b trial of BPL-three exceeded expectations, meeting both primary and secondary endpoints, demonstrating rapid and durable antidepressant effects [6][6][10][10] - **Efficacy**: - Significant reductions in MADRS scores were observed with both 8 mg and 12 mg doses compared to the active comparator (0.3 mg) [7][7] - The drug showed a robust effect lasting at least two months post-administration [42][42] - Approximately one-third of subjects were responders by day eight, maintaining this response through day 57 [27][27] - **Safety Profile**: - The drug was well tolerated, with 99% of adverse events being mild or moderate, and no serious drug-related adverse events reported [8][8][32][32] - No suicide-related safety signals were detected, which is critical given the population studied [36][36] Dosing and Administration Insights - **Dosing Strategy**: The 8 mg dose was identified as potentially optimal, showing comparable efficacy to the 12 mg dose with fewer side effects [25][25][30][30] - **Administration Time**: The treatment requires a short in-clinic time of approximately two hours, allowing for rapid discharge post-treatment, which aligns with the interventional psychiatry model [10][10][34][34] Future Development Plans - **Phase 3 Readiness**: The company is preparing to advance BPL-three into Phase 3 trials, with an end-of-phase 2 meeting with the FDA anticipated in Q3 2025 [45][45] - **Redosing Strategy**: Future studies will explore a potential redosing paradigm, likely within a two to three-month window, which would significantly improve treatment convenience compared to SPRAVATO [68][68] Competitive Advantages - **Unique Positioning**: Atai Life Sciences is positioned uniquely with BPL-three and VLS-one, both designed for a two-hour treatment paradigm, contrasting with competitors requiring multiple doses over extended periods [51][51][52][52] - **Commercial Scalability**: The single administration model with a two-hour follow-up is expected to enhance commercial scalability and patient convenience [51][51] Upcoming Milestones - **Data Releases**: Additional data from ongoing studies, including an open-label extension study, are expected in the near future, which will further inform the efficacy and safety profile of BPL-three [44][44] - **Regulatory Engagement**: The company plans to engage with regulatory bodies regarding potential breakthrough designations and the national review voucher program for expedited approval processes [117][117] Conclusion - **Overall Assessment**: The Phase 2b trial results for BPL-three indicate a promising new treatment option for patients with treatment-resistant depression, with a favorable safety profile and significant efficacy, setting the stage for further development and potential market entry [62][62]

Group 1 - The cross-border payment (CIPS) concept declined by 1.77%, ranking among the top declines in the concept sector, with stocks like Jida Zhengyuan and *ST Rindong hitting the limit down [1][2] - Major stocks in the CIPS sector that experienced significant declines include Sifang Jingchuang (-9.55%), Lakala (-8.10%), and New Guodu (-7.29%) [2][3] - The CIPS sector saw a net outflow of 3.937 billion yuan, with 45 stocks experiencing net outflows, and 15 stocks seeing outflows exceeding 100 million yuan [2][3] Group 2 - The top net outflow stock was Sifang Jingchuang, with a net outflow of 731 million yuan, followed by Lakala and New Guodu with outflows of 548 million yuan and 400 million yuan, respectively [2][3] - In contrast, the top net inflow stocks included Pudong Development Bank, Industrial Bank, and Ping An Bank, with net inflows of 208 million yuan, 135 million yuan, and 105 million yuan, respectively [2][3] - The overall market sentiment reflected a mixed performance, with some stocks in the CIPS sector showing gains, such as Sanwei Xinan (+5.14%), Jingda Co. (+3.36%), and Construction Bank (+2.86%) [1][2]

Financing Overview - atai Life Sciences has entered into subscription agreements for the purchase of 18,264,840 ordinary shares and pre-funded warrants to purchase an additional 4,566,210 shares, expected to generate gross proceeds of approximately $50 million [1][2] - The financing is co-led by Ferring Ventures S.A. and Apeiron Investment Ltd., with participation from healthcare-focused institutional investors such as Ally Bridge Group and ADAR1 [2][4] Use of Proceeds - The net proceeds from the financing will be utilized for general corporate purposes, including working capital and advancing the clinical development of atai's product candidates and programs [1][3] Clinical Development and Future Plans - atai aims to accelerate its efforts in delivering new therapeutic options for mental health challenges, with a clear Phase 3 plan anticipated by early 2026 [3] - The company is advancing its pipeline of psychedelic-based therapies, including VLS-01 for treatment-resistant depression and EMP-01 for social anxiety disorder, both in Phase 2 clinical development [7] Investment Rationale - Ferring Ventures S.A. emphasizes the transformative potential of psychedelics for mental health conditions and supports atai's innovation in this space [4] - The financing is seen as a strategic move to position atai for future commercialization as it transitions from a clinical-stage biotech to a fully integrated commercial company [3][4]

Core Insights - The Phase 2b clinical trial of BPL-003 demonstrated significant efficacy and safety in treating treatment-resistant depression (TRD) with a single dose [2][3][12] - A single 12 mg dose resulted in a mean reduction of 11.1 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to a 5.8 point reduction in the 0.3 mg comparator group [2][12] - The strategic combination of atai Life Sciences and Beckley Psytech is expected to create a global leader in psychedelic-based mental health therapies [4][6] Efficacy Findings - The study achieved its primary and all key secondary endpoints, with both 8 mg and 12 mg doses showing statistically significant reductions in depressive symptoms at all time points [6][12] - At Day 29, the 8 mg dose showed a mean MADRS score reduction of 12.1 points compared to the 0.3 mg control (p=0.0025) [2][12] - Improvements in MADRS scores were observed as early as one day after dosing, with effects maintained up to Week 8 [2][6] Safety Findings - BPL-003 was generally well-tolerated, with over 99% of treatment-emergent adverse events being mild or moderate [6][12] - No drug-related serious adverse events or suicide-related safety signals were reported [6][12] - The majority of patients were deemed ready for discharge within 90 minutes post-dose, indicating a potential fit within existing interventional psychiatry treatment paradigms [6][12] Study Details - The Phase 2b study was conducted at 38 sites across six countries, enrolling a total of 193 patients with moderate-to-severe TRD [5][6] - It is noted as the largest controlled clinical study to investigate mebufotenin, with a low drop-out rate of 90% [6][12] - Follow-up in the open-label extension stage is ongoing, with data expected in the third quarter of 2025 [11][12] Future Plans - atai and Beckley Psytech plan to engage with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design for TRD [3][12] - The strategic combination is expected to progress to shareholder approval stage following the positive Phase 2b results [4][6]

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