Stockwinners Market Radar for November 05, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:00 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Berkshire Hathaway (BRK.A, BRK.B) reported Q3 operating earnings of $10.76B vs. $7.65B last year. Q3 Insurance Underwriting operating earnings were up to $2.42B vs. ($1.07B) last year, Insurance-Investment income operating earnings rose to $2.47B from $1.41B last year, and Berkshire's BNSF Railway Operating earnings were down at $1.22B vs. $1.44B last year. 2. Lucid Group (LCID) cut prices of its Air range of luxury sedans earlier this week for a limited time ahead of the holiday season, amid stiff competition and slowing demand for electric vehicles, Reuters says. High-interest rates have hit demand for EVs, and auto manufacturers, led by the world's most valuable automaker Tesla (TSLA), have responded by cutting prices, the publication says. Lucid slashed the price of its Air Touring model to $87,500 from $95,000 and the more powerful Grand Touring by $10,000 to $115,600. 3. Technology stocks have gotten hit-but not all of them equally. It's time to take a look at Meta Platforms (META), Jacob Sonenshine writes in this week's edition of Barron's. Meta's stock is down just 0.1% since earnings and has recovered more than half of its post-release loss. It's down only 5% from its 52-week high, better than the other members of the Big Seven except Microsoft (MSFT). What's more, the stock held price support at $275 and looks to be heading higher, the author says, adding that Meta's business remains strong and is continuing to grow. 4. Comcast (CMCSA) subsidiary Universal's "Five Nights at Freddy's" stays atop the domestic box office with another $19.4M in its second outing and as it crossed the $100M mark domestically. The high-profile "Dune: Part Two" was set to open this weekend but the movie's release was pushed out to 2024 due to the actors strike prohibition on stars doing any promotion. Overseas, "Five Nights at Freddy's" earned an estimated $35.6M for a foreign cume of $103.5M and a global tally of $217.1M. 5. Chevron (CVX) and Vestis (VSTS) saw positive mentions in this week's edition of Barron's.

16:13 EST MoonLake announces landmark Phase 2 results for Nanobody sonelokimab - MoonLake Immunotherapeutics announced positive top-line results from its global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with active psoriatic arthritis. The ARGO trial, which enrolled 207 patients, met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg achieving an American College of Rheumatology 50 response compared to those on placebo at week 12. Specifically, for the 60mg and 120mg doses with induction, respectively, 46% and 47% of patients treated with sonelokimab achieved ACR50; 78% and 72% of patients achieved ACR20; and 29% and 26% achieved ACR70. The primary analyses were based on the most stringent type of analysis for such trials, intention-to-treat with non-responder imputation. As expected, the 60mg dose without induction did not reach statistical significance, confirming the 60mg and 120mg with induction as the potential dose regimens to carry forward into Phase 3. All key secondary endpoints were met for the 60mg and 120mg doses with induction. The key secondary endpoint Psoriasis Area and Severity Index 90 was met for all doses with induction; 77% of patients responding at week 12 to the 60mg dose. For this dose, 58% of patients achieved complete skin clearance at week 12. PASI responses across dose arms were consistent with the previously reported Phase 2b data of sonelokimab in moderate-to-severe plaque-type psoriasis, with the 120mg dose achieving the highest responses for PASI100 in patients with more severe skin lesions. Other clinically relevant secondary endpoints, such as Minimal Disease Activity, the modified Nail Psoriasis Severity Index, the Leeds Enthesitis Index and the patient self-reported Psoriatic Arthritis Impact of Disease, each show promising levels of response at week 12. Adalimumab was used as an active reference to validate responses across arms. Sonelokimab 60mg and 120mg numerically outperformed adalimumab on the primary endpoint and all key secondary endpoints, with the observed deltas further supporting the potential for sonelokimab as a future leading therapy. The patient discontinuation rate in the ARGO trial was low at week 12, similar to what was observed in previous trials of sonelokimab in psoriasis and hidradenitis suppurativa. The safety profile of sonelokimab in ARGO was consistent with previously reported studies with no new safety signals. The results suggest that, as early as week 12, the Nanobody sonelokimab reaches levels of clinical response at or above those seen with other therapies tested in similarly stringent trials. The high performance of sonelokimab and its favorable safety profile continue to support the potential of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases.

06:59 EST TriSalus Life Sciences presents additional Phase 1 clinical data - TriSalus Life Sciences (TLSI) presented additional Phase 1 clinical data during the late-breaker oral presentation session at the Society of Immunotherapy for Cancer 2023 Annual Meeting. The PERIO-01 Phase 1 study for uveal melanoma with liver metastases, studied SD-101 delivered via PEDD with the TriNav Infusion System in combination with intravenous checkpoint inhibitors. The data presented today at SITC demonstrate that SD-101 is well tolerated when given by the PEDD method and is associated with immunologic effects both within the liver and systemically, which may enable better outcomes with systemic checkpoint inhibition. The Progression-Free Survival, Disease Control Rate, and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are encouraging for UMLM and for other indications under development. At the optimal biologic dose of SD-101 in combination with nivolumab, the median PFS was 11.7 months with an 81% DCR. PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM. The study consists of dose-escalation cohorts of SD-101 alone or with immune checkpoint inhibition. At the data cutoff as of September 29, 2023, 56 patients were enrolled, with each having received at least one dose of SD-101. Of the patients with available data, 16 patients were treatment-naive and 40 had failed at least one prior line of therapy, including 8 patients on 3rd or greater line of treatment. SD-101 infused via PEDD in combination with systemic checkpoint inhibition was well tolerated, with an overall serious grade 3/4 adverse event rate related to treatment of 11%, and no such events at the optimal SD-101 dose level of 2 mg in combination with nivolumab. The most common adverse events overall were gastrointestinal, fatigue, and skin toxicity, with the majority being minor. Encouraging early efficacy signals were noted in the UMLM patients treated in PERIO-01. Overall, the ctDNA molecular response rate was 65% using specified time points, and 82% when analyzing the best on-treatment response. Clearance of ctDNA was noted in 59% of subjects when assessing the best on-treatment response. There was an 81% disease control rate at 2 mg SD-101 via PEDD with nivolumab. Across all subjects, two partial responses and five minor responses were documented as the best on-treatment response. The median progression free survival at the optimal dose of SD-101 via PEDD in combination with nivolumab was 11.7 months with a 1-year overall survival rate of 86%. Among PERIO-01 patients who received SD-101 via PEDD in combination with intravenous nivolumab, there was evidence of increases in CD8+ T cells, CD4+ T cells, and natural killer cells within their liver metastases. Gene expression analysis by Nanostring revealed increased TLR signaling, interferon signaling, cytokine signaling, Th1 T cell activation, and lymphocyte activation. At the optimal SD-101 dose of 2 mg in combination with nivolumab, decreases in monocytic myeloid derived suppressor cells, M2 macrophages, and regulatory T cells were found in liver metastases. Along with predicted immune changes within liver metastases, encouraging peripheral immune signals were detected. Increases in IFNgamma, soluble IL2-receptor, IL-15, IL-18, T cell activation, and NK cell proliferation were found in the blood. Overall, the data emerging from the PERIO-01 and PERIO-03 also presented at SITC indicate immunologic changes are occurring within the liver and pancreas, with favorable safety profiles. Patients with liver metastases in the PERIO-01 study have had favorable outcomes despite pre-treatment.

06:52 EST Candel Therapeutics presents preclinical data from enLIGHTEN Discovery Platform - Candel Therapeutics presented two posters during the 2023 Society for Immunotherapy of Cancer Annual Meeting in San Diego focused on the enLIGHTEN Discovery Platform. The first poster titled "Development of enLIGHTEN Alpha-201 herpes simplex viral vectors encoding payloads targeting the tumor microenvironment" reports preclinical characterization of the enLIGHTEN viral chassis Alpha-201. Profiling of biological responses to Alpha-201 unveiled its potential to orchestrate changes in the tumor microenvironment, supportive of effective anti-tumor immune responses to immune checkpoint inhibitor treatment. In preclinical models, Alpha-201 displayed enhanced peripheral blood mononuclear cell-mediated cancer cell killing and immune activation when armed with certain immunostimulatory payload combinations which was predicted in silico using the enLIGHTEN Advanced Analytics suite. These data validate Candel's novel approach for in silico prediction of payload combinations and selection of indication-specific payloads with anti-tumoral activity using human datasets as a tool to accelerate, improve and de-risk certain aspects of the development of transformative viral immunotherapies. The second poster titled "A novel viral immunotherapeutic targeting the CD47/SIRPalpha axis demonstrates potent anti-tumor effects" describes the design of the first experimental agent based on the enLIGHTEN Discovery Platform, Alpha-201-macro1. This investigational agent is comprised of an immunostimulatory and oncolytic engineered viral chassis armed with a novel gene payload that is designed to interfere with the CD47/SIRPalpha pathway.