Stockwinners Market Radar for April 08, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:04 EDT AT&T, Discovery Inc. close WarnerMedia transaction - Discovery, Inc. (DISCA, DISCB, DISCK) and AT&T (T) announced that they have closed their transaction to combine the WarnerMedia business with Discovery. The combination creates a premier standalone global media and entertainment company, Warner Bros. Discovery, Inc., which will begin trading on the Nasdaq with the start of trading on Monday, April 11, under the new ticker symbol "WBD."

17:30 EDT Medical Properties Trust CFO Hamner sells 285,000 common shares - In a regulatory filing, Medical Properties Trust CFO Steven Hamner disclosed the sale of 285,000 common shares of the company on April 7 at a price of $21.04 per share.

16:44 EDT Micron names Mark Murphy as EVP and CFO, effective April 18 - The Board of Directors of Micron Technology (MU) has appointed Mark Murphy to serve as Executive Vice President and CFO, effective as of April 18. As of the effective date, Sumit Sadana will cease serving as Interim CFO and will continue to serve in his role as Executive Vice President and Chief Business Officer. Prior to joining the company, Murphy served as the CFO of Qorvo (QRVO) a provider of radio frequency solutions, since June 2016.

16:30 EDT Lowe's names Brandon Sink CFO - Lowe's announced the appointment of Brandon Sink as executive vice president, chief financial officer, effective April 30, 2022. Sink, currently senior vice president, retail finance of Lowe's, will succeed Dave Denton, who is stepping down as executive vice president, chief financial officer to pursue another opportunity at a publicly traded company outside the industry. Denton will work closely with Sink and the Lowe's leadership team to ensure a seamless transition. "Brandon is a highly accomplished executive, and we are excited for him to take on the role of CFO," said Marvin R. Ellison, Lowe's chairman, president and CEO. "During his nearly 12-year career at Lowe's, Brandon has worked closely with our executive leadership team and has demonstrated a deep understanding across all facets of our business. His appointment reflects our succession planning process and the talent across our company. He is a proven leader with strong financial and operational acumen, and I look forward to working together as we execute our strategy and continue to grow our market share, expand operating margins and deliver meaningful shareholder value."

16:17 EDT IO Biotech presents new data from MM1636 Phase 1/2 trial - IO Biotech announced updated efficacy data and subgroup analyses from the MM1636 Phase 1/2 clinical trial evaluating IO102-IO103 as investigational agents in metastatic melanoma in an e-poster presentation at the American Association of Cancer Research conference, being held April 8-13, 2022 in New Orleans, Louisiana. "We are excited to present these further data demonstrating three-year survival probability of 73% for IO102-IO103 in combination with nivolumab in patients with metastatic melanoma," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "Based on these data, clinical activity of the combination of IO102-IO103 with nivolumab is encouraging. We look forward to advancing IO102-IO103 through clinical development to deliver a new treatment option for patients in need." Data highlights from the e-poster titled, "High clinical efficacy in poor prognosis patients with metastatic melanoma treated with an IDO/PD-L1 peptide vaccine in combination with nivolumab" are outlined below: All 30 patients were evaluated after completing the IDO-PD-L1 vaccination schedule in combination with nivolumab as of the December 1, 2021 data cut-off and after a median follow up of 2.7 years; the three-year OS probability was 73%; the median progression free survival was 25.3 months; Confirmed overall response rate was 73% with 46.7% of patients obtaining complete responses in poor prognosis patients; a response rate of 81.8% was seen in patients with elevated baseline LDH-levels; in patients classified as M1c at baseline response rate was 88.2%; In a subgroup analysis, a response rate of 94.1% was observed in PD-L1+ patients and 61.5% in PD-L1 patients; Immune-related adverse events were comparable to those in patients receiving nivolumab monotherapy. No additional toxicity was observed in poor prognosis patients

16:07 EDT Apple raises App Store prices in six countries - Apple announced upcoming tax and price changes for apps and in-app purchases on the App Store. In the next few days, prices of apps and in-app purchases, excluding auto-renewable subscriptions, on the App Store will increase in Cambodia, Hungary, Kazakhstan, Kyrgyzstan, Pakistan, and Uganda. The increases also consider the following tax changes: Cambodia: New value-added tax of 10% for developers based outside of Cambodia; Kazakhstan: New value-added tax of 12%; Kyrgyzstan: New value-added tax of 12% for developers based outside of Kyrgyzstan, and; Uganda: New value-added tax of 18%. In addition, prices on the App Store in Indonesia will not change, but proceeds for developers based outside of Indonesia will be adjusted to reflect an increase of value-added tax from 10% to 11%. Once these changes go into effect, the Pricing and Availability section of My Apps will be updated, Apple said. Reference Link

15:25 EDT Jury awards Seagen damages of $41.82M in Daiichi Sankyo patent case - Seagen announced that a jury in the U.S. District Court for the Eastern District of Texas found that Daiichi Sankyo infringed Seagen's U.S. Patent No. 10,808,039 by selling in the United States its Enhertu product. Seagen was awarded damages of $41.82M for past infringement of the patent. In addition, Seagen will request additional royalty payments for future sales of Enhertu in the United States through the life of the patent. "We are pleased that the jury recognized the validity of asserted claims of our patent and found that Daiichi Sankyo willfully infringed our proprietary technology without permission," said Clay Siegall, Ph.D., President and Chief Executive Officer, Seagen. "As a pioneer and leader in antibody-drug conjugate (ADC) technology, protecting our intellectual property is essential to our ability to continue developing innovative therapies for cancer patients in need." In addition to the damages the jury awarded for past infringement, Seagen will request the court to award a royalty on Daiichi Sankyo's future sales in the United States of Enhertu until patent expiry in November 2024. The court will determine the amount of these payments in a decision Seagen anticipates later this year. In a related matter, on April 7, 2022, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office granted a request on rehearing and instituted two post grant review proceedings brought against certain claims of U.S. Patent No. 10,808,039. Seagen intends to vigorously defend the patent in the PGRs. Separately, Seagen is engaged in an arbitration it brought against Daiichi Sankyo over ownership of certain technology used by Daiichi Sankyo in trastuzumab deruxtecan and several other drug candidates. In the arbitration, which remains ongoing, Seagen contends that the linker and other ADC technology used in these compounds are improvements to Seagen's pioneering ADC technology, the ownership of which is automatically assigned to Seagen under the 2008 collaboration agreement between Daiichi Sankyo and Seagen. A decision in the arbitration case is expected by mid-2022.

14:54 EDT SCWorx announces preliminary court approval of shareholder derivative settlement - SCWorx announced that on March 25, the U.S. District Court for the Southern District of New York preliminarily approved a settlement agreement resolving three shareholder derivative lawsuits involving the company. Under the terms of the settlement, the insurers for the director defendants will make a cash payment to legal counsel for the shareholder derivative plaintiffs to cover their legal fees and the company will adopt certain corporate governance reforms within 60 days of court approval of the settlement, in exchange for which all parties will be released from all claims related to the derivative class action litigation. The settlement resolves all claims asserted against the director defendants without any admission, concession or finding of any fault, liability or wrongdoing by the company or any of the director defendants, the company stated.

13:53 EDT Knight-Swift revises timing of Q1 earnings release - Knight-Swift Transportation announced it has revised the timing of its 2022 first quarter earnings release and now expects to release its first quarter results after market close on Wednesday, April 20. Additionally, Knight-Swift will host a live conference call with analysts and investors to discuss the earnings release, the results of operations, and other matters following its earnings press release on Wednesday, April 20, at 4:30 p.m. EDT.

13:44 EDT Adagene announces preclinical data on antibody candidates - Adagene announced preclinical data showcasing the potential first and best-in-class profile of new antibody candidates. Data are being presented at the American Association for Cancer Research Annual Meeting, taking place in New Orleans, Louisiana from April 8-13, 2022. Posters are available in the Publications section of the company's website at www.adagene.com. Key takeaways from the four posters include: ADG206, an anti-CD137 agonistic POWERbody with tailor-made efficacy and safety profiles by strong crosslinking and tumor selective activation for single agent and combinational cancer immunotherapy: This masked, IgG1 Fc-engineered anti-CD137 POWERbody combines conditional activation in the tumor microenvironment with strong agonistic activity through heightened FcgammaR-mediated crosslinking for therapeutic potential in either single agent or combination regimens. Preclinical data demonstrated that ADG206 was well tolerated and had robust anti-tumor activity as a single agent in multiple tumor models, with 4-fold stronger anti-CD137 agonistic activity of its activated form than a benchmark antibody in development for T cell co-activation. ADG206 also demonstrated enhanced anti-tumor activity in combination with other checkpoint inhibitors, including anti-PD-1 or anti-CTLA-4 therapy. Adagene is preparing to submit an IND or equivalent filing for ADG206 during 2022. ADG153-G1 SAFEbody, a differentiated masked anti-CD47 antibody of IgG1 subclass, demonstrates in vivo anti-tumor activity consistent with enhanced ADCC/ADCP effects and significantly reduced RBC-related and antigen sink liabilities: This masked anti-CD47 IgG1 SAFEbody is differentiated by its strong antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis activity designed to realize the full potential of anti-CD47 therapy for both hematologic and solid tumor indications. Preclinical data demonstrated that ADG153 IgG1 was well tolerated, did not induce human hemagglutination and significantly reduced anemia-related and antigen sink liabilities. In particular, ADG153 IgG1 at a 10 mg/kg dose demonstrated only an 8 percent decrease in red blood cell counts, compared to a 49 percent decrease with a benchmark antibody which is in IgG4 format. Results also showed that ADG153 IgG1 demonstrated greater anti-tumor activity than the benchmark. Adagene is preparing to submit an IND or equivalent filing for ADG153 during 2022. ADG138, A Novel HER2CD3 POWERbody Integrating Bispecific TCE with Precision Masking to Control Cytokine Release Syndrome and On-Target Off-Tumor Toxicity for Single Agent and Combination Therapies in HER2-Expressing Solid Tumors: This novel HER2xCD3 POWERbody is masked on both arms with an impressively high therapeutic index relative to its parental non-masked TCE in both HER2 high and low expressing solid tumors, supporting its development for HER2-expressing solid tumors as a single agent and in combination with other immune modulating agents. Preclinical data demonstrated the excellent safety profile of ADG138, including 100-fold greater reduction in cytokine release compared to its parental TCE. Results showed that ADG138 has potent anti-tumor activity in HER2 high and low expressing tumors, as well as resistant/refractory tumors, relative to a benchmark antibody. ADG138 also had synergistic anti-tumor activity in HER2 positive tumors when combined with anti-CD137 or anti-PD-1 therapy, or tumor targeted CD28 bispecific antibody. ADG138 is currently in IND-enabling studies. Tumor-targeted CD28 bispecific POWERbody for safe and synergistic T cell-mediated immunotherapy: CD28 bispecific POWERbody TCEs exhibit enormous potential to fulfill the promises of safe and durable T cell-mediated synergistic immunotherapies when combined with CD3 bispecific POWERbody TCEs and/or checkpoint inhibitors. Enabled by Adagene's suite of antibody platform technologies, preclinical data demonstrated the potential to mitigate the serious safety concerns of CD28 activation and make custom designed antibodies targeting a highly conserved epitope with broad species reactivity. Multiple tumor associated antigen xCD28 POWERbodies are in progress, such as B7-H3xCD28 and HER2xCD28, which can also be combined with the company's CD3 TCEs to achieve safe, powerful and durable immunotherapy for solid tumors through combination of the fundamental mechanisms and pathways across the cancer immunity cycle.

13:40 EDT Repare Therapeutics to present phase 1/2 TRESR trial data at AACR - Repare Therapeutics announced it has been selected for an oral presentation of clinical data from its ongoing Phase 1/2 TRESR trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR, as well as two additional poster presentations at the upcoming 2022 AACR Annual Meeting held in New Orleans on April 8-13. The company also announced that it will host a conference call with accompanying slides for analysts and investors on Monday, April 11, 2022 at 6:30 p.m. Eastern Time. "As with any new therapeutic class, differentiation among early product candidates is what ultimately determines success in the clinic and a path toward registration. In the context of data published as recently as today, we are confident that RP-3500 is a highly differentiated and potentially leading ATR inhibitor. We continue to draw on a wealth of data from the comprehensive Phase 1 monotherapy module of our Phase 1/2 TRESR trial of RP-3500 to begin establishing its therapeutic potential. We look forward to seeing these data presented at AACR and discussing RP-3500's ongoing and future development plans," commented Lloyd Segal, President and CEO of Repare.

13:38 EDT Affimed says it reached 'safe and well-tolerated' Phase 2 dose in AFM24 study - Affimed announced data from the dose escalation phase of the phase 1/2a study with the company's Innate Cell Engager AFM24 as monotherapy at the Annual Meeting of the American Association of Cancer Research. A poster will be presented on April 11 during the Phase I Clinical Trials 1 session. The poster presentation includes data of 29 heavily pretreated patients with a variety of tumors known to express EGFR, who have received AFM24 as weekly infusions across six dose levels from 14 mg to 480 mg. AFM24 demonstrated a well-managed safety profile. The most frequent treatment-emergent adverse events were infusion-related reactions, nausea and headache. Stable disease was observed as best response in 8 of 24 response-evaluable patients. The pharmacokinetic and CD16A receptor occupancy data demonstrate good target engagement at doses of 320 mg and 480 mg. Pharmacodynamic activity was observed at doses of 160 mg and higher. The recommended phase 2 dose was determined at 480 mg based on safety and tolerability, exposure and CD16A receptor occupancy. The maximum tolerated dose was not reached by the treatment regimen up to 480 mg. Enrollment in the dose escalation has continued at a dose of 720 mg for the purpose of collecting additional data on safety and tolerability. "Having reached a safe and well-tolerated recommend phase 2 dose with pharmacologic and pharmacodynamic activity is a major milestone for the AFM24 program," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "This has been important for the initiation of a broad development program assessing the efficacy of AFM24 as monotherapy and in combinations, and we're planning to provide first updates on the studies in 2022."

13:37 EDT Sonnet BioTherapeutics announces preclinical data at AACR - Sonnet BioTherapeutics announced that data from preclinical studies of the company's proprietary Fully-Human Albumin Binding candidates, SON-1010, SON-1210, and SON-1410, will be presented in a poster session at the American Association for Cancer Research, or AACR, Annual Meeting 2022, April 8-13 "We are excited about these data that support tumor growth reduction following administration of both SON-1210 and SON-1410 in a B16-F10 melanoma model in mice. Specifically, these new data elucidate the potential for transitioning tumors from being immunologically 'cold' to clinically responsive and 'hot'. We look forward to dosing the first patient in the forthcoming clinical trial with our SON-1010 compound, an event that will set the table for our continued development of the SON-1210 and SON-1410 bispecific candidates," said John Cini, Ph.D. Chief Scientific Officer and Co-Founder of Sonnet BioTherapeutics.

13:34 EDT Cardiff Oncology announces data on onvansertib-PARPi combo at AACR - Cardiff Oncology announced the results of preclinical studies evaluating the anti-cancer activity of onvansertib in combination with the PARP inhibitor, or PARPi, olaparib in PARPi-resistant patient-derived xenograft ovarian cancer models. The results are featured in a poster presentation at the American Association for Cancer Research, or AACR, Annual Meeting, which is taking place from April 8-13. Preclinical studies featured in the AACR poster evaluated onvansertib-olaparib combination treatment in three olaparib-resistant patient-derived xenograft ovarian cancer models. Two of the three PDX models used were cisplatin-sensitive with a mutated BRCA1 gene, while the third was cisplatin-resistant with wild type BRCA1. BRCA1-mutant tumor cells are deficient for homologous recombination-mediated DNA repair and are initially sensitive to PARPi. This suggests that PARPi resistance was acquired in the MNHOC22 and MNHOC266 tumors due to the restoration of HR-mediated DNA repair, while being naturally conferred in MNHOC316DDP tumors due to continuous HR-proficiency. Data showed that combining onvansertib with olaparib led to a statistically significant survival benefit compared to treatment with either agent alone in each of the three evaluated PDX models. Results showed the combination was well tolerated. "In these studies, we sought to evaluate how combining onvansertib with PARP inhibition, an approved maintenance treatment for ovarian cancer, might mitigate the known phenomenon of acquired tumor resistance to PARP inhibitors. We are very pleased with the results, which showed onvansertib and olaparib synergistically combining to generate strong activity against PARPi-resistant patient-derived ovarian cancer models. Given the current lack of effective treatment options for patients showing PARPi resistance, we believe these data are supportive of evaluating this combination within a PARPi-resistant clinical setting," said Tod Smeal, Ph.D., chief scientific officer at Cardiff Oncology.

13:31 EDT Kura Oncology reports preclinical data on tipifarnib in NSCLC - Kura Oncology reported preclinical data supporting the potential of its farnesyl transferase inhibitor tipifarnib to prevent emergence of resistance to the epidermal growth factor receptor tyrosine kinase inhibitor osimertinib in EGFR mutant non-small cell lung cancer. The new findings, generated through a collaboration with INSERM, are being presented at the American Association for Cancer Research Annual Meeting in New Orleans. A copy of the poster, entitled "Tipifarnib prevents emergence of resistance to osimertinib in EGFR mutant NSCLC," is available at www.kuraoncology.com. A copy of the manuscript is also available at www.biorxiv.org while it undergoes scientific peer-review for publication. Using Rho-pathway inhibitor screening, researchers at INSERM found that tipifarnib induced a complete clearance of drug-tolerant dormant cells, a potential mechanism of resistance to EGFR-targeted therapy in NSCLC. Several farnesylated targets were identified that appear to control the ability of tumor cells to enter and exit a drug-tolerant state. In parallel, using preclinical in vivo models of EGFR-mutated lung tumors, co-treatment with tipifarnib durably prevented relapse to osimertinib for up to six months, with no evidence of toxicity. Collectively, this mechanistic and translational research strongly supports the potential use of a FTI to prevent or delay the adaptive response to osimertinib in patients with EGFR-mutated NSCLC. Kura is preparing to initiate a Phase I clinical trial of tipifarnib in combination with osimertinib in treatment-naive locally advanced/metastatic EGFR mutated NSCLC and expects to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, the lead development candidate in its next-generation FTI program, through investigational new drug-enabling studies. Kura plans to submit an IND application for KO-2806 in the fourth quarter of 2022.

13:28 EDT Editas Medicine reports engineered iNK cell preclinical data - Editas Medicine announced in vitro and in vivo preclinical data on the enhanced tumor killing capacity of modified induced pluripotent stem cell-derived natural killer cell therapies using Editas Medicine's proprietary gene editing platform. The approach employed in this research is being developed to create allogeneic, investigational NK cell therapy medicines with potentially enhanced and prolonged activity against solid tumors. The Company reported these data in a poster available today at the American Association for Cancer Research conference in New Orleans. Editas scientists will also present the poster in a session on Sunday, April 10. The poster reports that the Company generated gene edited iPSC clones, which were then differentiated into iNK cells and assessed for in vitro and in vivo anti-tumor activity. iPSCs were edited at an essential gene exon using both the Company's proprietary SLEEK technology and engineered AsCas12a nuclease to knock-in both CD16 and membrane-bound IL-15. Edited iNK cells were designed to increase antibody-dependent cellular cytotoxicity, when combined with tumor-targeting antibodies, and prolong iNK cell persistence in vivo. Key findings include: Edited iNK cells in combination with trastuzumab showed significantly enhanced tumor killing compared with wild type iNKs in an in vitro 3D SKOV-3 ovarian tumor spheroid assay. Evaluation in an in vivo mouse solid tumor SKOV-3 cancer model demonstrated that edited iNK cells combined with trastuzumab induced significant reduction in tumor burden compared with WT iNK cells plus trastuzumab and trastuzumab only, resulting in complete tumor clearance in 6 of 8 treated mice over the course of the 144-day experiment. Additionally, when combined with trastuzumab, edited iNKs significantly increased survival over WT iNK cells in the solid tumor SKOV-3 mouse model. At day 144, 100% of edited iNK-treated mice were alive, compared with less than half of the WT iNK-treated mice. Edited iNKs were detected in the peritoneum of the treated mice through the end of the experiment at day 144, demonstrating that the knocked-in mbIL-15 maintained iNK survival for a prolonged period in the absence of exogenous cytokine support.

13:26 EDT Nkarta announces new preclinical data at AACR - Nkarta (NKTX) announced the presentation of four preclinical data abstracts focused on its natural killer cell platform and pipeline at the American Association for Cancer Research, or AACR, Annual Meeting 2022. "The data we presented at this year's AACR meeting highlight the breadth and diversity of our scientific efforts, as we continue to expand our ability to deliver off-the-shelf cell therapies with the potential to disrupt the cancer treatment landscape. Our research activities are designed to extend the capabilities of NK cells, to lay the groundwork for further pipeline programs - including our pioneering NK+T cell program - and to implement cutting edge translational methods to support our ongoing clinical programs. Our findings reported at AACR further support exploration of multiply edited CD70 CAR NK cells for clinical application, one focus of our ongoing collaboration with our partners at CRISPR Therapeutics," said James Trager, PhD, Chief Scientific Officer of Nkarta.

13:25 EDT Nuvalent says NVL-520 showed 'strong preclinical activity' in study - Nuvalent announced new data to support broad clinical exploration of its parallel lead programs NVL-520 - a ROS1-selective inhibitor - and NVL-655 - an ALK-selective inhibitor. NVL-520 and NVL-655 are central nervous system-penetrant kinase inhibitors designed to specifically solve for the dual challenges of kinase resistance and selectivity commonly observed with currently available inhibitors. "We are pleased to share new data today resulting from our continued collaborations with leading investigators in ROS1 and ALK research, which we believe further demonstrate the potential for our highly selective inhibitors to be differentiated within the dynamic treatment landscapes for non-small cell lung cancer, or NSCLC, and beyond. These preclinical data support the inclusion of various fusion partners and resistance mutations in our ARROS-1 and ALKOVE-1 clinical trials for ROS1- and ALK-positive NSCLC, respectively, as well as the inclusion of exploratory cohorts for other advanced solid tumors outside of NSCLC," said James Porter, Ph.D., CEO of Nuvalent.

13:22 EDT Corbus presents first preclinical data for CRB-601 at AACR - Corbus Pharmaceuticals announced the first preclinical data for CRB-601 are being presented in a poster at the American Association for Cancer Research, or AACR, Annual Meeting being held from April 8-13. The in vitro preclinical data presented demonstrate the high affinity of CRB-601 for alphavb8 and the resulting effect on TGFb. The data also show significant inhibition of tumor growth in a syngeneic model of colon cancer by CRB-601, both as a single agent and in combination with anti PD-1 treatment. These effects are supported by the coincident increase in CD8-positive T cells in the tumor microenvironment. Corbus is currently developing CRB-601 as a potential treatment for solid tumor cancers, and the program is advancing toward an IND submission in the first half of 2023. "The increase of tumor infiltration by T-cells stimulated by CRB-601 is quite exciting. The effects of CRB-601 are consistent with the proposed mechanism of blocking TGFb activation, which can potentially enable an anti-tumor immune response and be an effective adjunct to immune checkpoint therapies. We are excited to bring this mechanism of action to the clinic and define the potential benefit it could bring to patients," commented Rachael Brake, Ph.D., Chief Scientific Officer of Corbus.

13:21 EDT Rubius Therapeutics trading resumes

13:20 EDT Cardiff Oncology announced updated clinical data from Phase 2 mCRPC trial - Cardiff Oncology announced updated clinical data and new biomarker analyses from its ongoing Phase 2 trial of onvansertib in combination with abiraterone/prednisone in metastatic castrate-resistant prostate cancer, or mCRPC, patients. The data are featured in a poster presentation at the American Association for Cancer Research, or AACR, Annual Meeting, which is taking place both virtually and in-person from April 8-13. The primary efficacy endpoint of the mCRPC trial is disease control rate at 12 weeks, which is defined by a decline or stabilization of PSA levels. Each of the trial's three arms has evaluated a different dosing schedule of onvansertib alongside abiraterone and prednisone administered throughout the respective treatment cycle. Arm A evaluated 24 mg/m2 onvansertib on Days 1-5 of 21-day cycles, Arm B evaluated 18 mg/m2 onvansertib on Days 1-5 of 14-day cycles, and Arm C is evaluating 12 mg/m2 onvansertib on Days 1-14 of 21-day cycles. "Results from the mCRPC trial demonstrate clinically meaningful disease control rates in patients showing early resistance to abiraterone. As the dose density of onvansertib was increased in three consecutive Arms - A, B and C - we observed an increase in disease control rates with both PSA stabilization and radiographic stable disease twelve weeks into treatment and some of these patients have experienced durable stabilization. Pre-clinical data suggest that the synergistic effect is independent of androgen receptor signaling," said David Einstein, M.D., principal investigator at Beth Israel Deaconess Medical Center.

13:18 EDT Zentalis announces initial clinical data on ZN-c3 at AACR meeting - Zentalis Pharmaceuticals announced initial efficacy and safety data from the ongoing Phase 1b trial of ZN-c3 in combination with chemotherapy in patients with platinum-resistant or -refractory ovarian cancer. Data were reviewed as a clinical poster during the American Association of Cancer Research Annual Meeting, being held in New Orleans, Louisiana on April 8-13, 2022. The ongoing Phase 1b dose-escalation trial is evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics and pharmacodynamics of ZN-c3 in combination with standard chemotherapies in platinum-resistant or -refractory ovarian cancer. The study consists of four combination dose cohorts: ZN-c3 + PLD, ZN-c3 + carboplatin, ZN-c3 + paclitaxel, and ZN-c3 + gemcitabine, and is enrolling a more advanced patient population, with the inclusion of platinum-refractory patients and higher prior rates of bevacizumab treatment, than similar trials that included a Wee1 inhibitor. At the time of the data cutoff on January 28, 2022, 56 patients - which were enrolled across three of the cohorts - were evaluated for safety, the primary endpoint, and 43 were response-evaluable. The fourth cohort, ZN-c3 + gemcitabine, had not begun enrollment at the time of the data cutoff. The evaluation of the recommended Phase 2 dose remains ongoing. ZN-c3 was generally well-tolerated in combination with chemotherapy and exhibited lower hematologic toxicity and a better gastrointestinal tolerability profile in comparison to the Wee1 inhibitor class. As of the cutoff date, the most common treatment-related adverse events at all grades included nausea, neutropenia, thrombocytopenia, vomiting and anemia. Interim data from the Phase 1 monotherapy USC expansion cohort receiving ZN-c3 greater than or equal to300mg QD were also released today. ZN-c3 is potentially a best-in-class Wee1 inhibitor and is in an ongoing potentially registrational Phase 2 trial for USC patients. Updated data from the USC expansion cohort of the Phase 1 monotherapy trial will be presented at the mini symposium on April 11, 2022 at 2:50 p.m. CT. In addition, Zentalis has three preclinical posters demonstrating the broad potential of ZN-c3 in multiple settings including AML, overcoming PARP resistance, and in novel biology when combined with our BCL-2 inhibitor, ZN-d5. These findings further support ZN-c3 as a potential cornerstone treatment, creating a significant market opportunity across a broad range of solid and liquid tumors. Initial clinical data of ZN-c5 in combination with CDK 4/6 inhibitors demonstrated excellent safety and tolerability. Drug-drug interactions were seen with ZN-c5 doses; however, ZN-c5 is not expected to have DDIs with commonly used medicines or ZN-c3 at relevant doses. Uniquely among the leading oral SERDs, ZN-c5 demonstrated meaningful bone protectant activity in ovariectomized mice, highlighting a further point of differentiation within the oral SERD class, along with excellent tolerability. Zentalis believes this profile positions ZN-c5 well for an adjuvant setting. Zentalis plans to initiate a combination study of ZN-c5 + ZN-c3 in ER+/HER2- CDK 4/6i-resistant breast cancer patients in 2022.

13:17 EDT Caribou Biosciences data supports an expected IND application for CB-011 in 2022 - Caribou Biosciences announced the presentation of positive preclinical data for its allogeneic, immune-cloaked, anti-BCMA CAR-T cell therapy candidate, CB-011, being developed for the treatment of relapsed or refractory multiple myeloma. The data are being presented at the American Association for Cancer Research Annual Meeting, April 8-13, 2022, in New Orleans. The data demonstrate that CB-011 CAR-T cells are cytotoxic against BCMA-expressing tumor cells and are resistant to killing by both allogeneic T cells and natural killer cells. In a tumor xenograft model of MM, CAR-T cells expressing a CAR containing a proprietary humanized anti-BCMA antibody fragment that is used in CB-011 markedly prolonged antitumor activity compared to CAR-T cells expressing a benchmark anti-BCMA CAR. Caribou is conducting Investigational New Drug application-enabling safety studies to support a planned IND application submission in 2022 for CB-011 in r/r MM. The data demonstrate that CB-011 CAR-T cells are cytotoxic against BCMA-expressing tumor cells and are resistant to killing by both allogeneic T cells and natural killer cells. In a tumor xenograft model of MM, CAR-T cells expressing a CAR containing a proprietary humanized anti-BCMA antibody fragment that is used in CB-011 markedly prolonged antitumor activity compared to CAR-T cells expressing a benchmark anti-BCMA CAR. "We believe that an off-the shelf approach has the potential to provide an important therapeutic option for people with multiple myeloma, many of whom are not well served by current therapies," said Rachel Haurwitz, Ph.D., Caribou's president and chief executive officer. "We look forward to submitting an IND application in 2022 for CB-011, our second cell therapy candidate. It is an important element of our allogeneic CAR-T cell therapy platform targeting a range of hematologic malignancies."

13:16 EDT Rubius Therapeutics trading halted, volatility trading pause

13:16 EDT C4 Therapeutics trading resumes

13:15 EDT Kronos Bio data show potential of KB-0742 in breast, lung, ovarian cancers - Kronos Bio shared preclinical data on its internally discovered, highly selective, oral cyclin dependent kinase 9 inhibitor, KB-0742, adding to evidence that the compound has the potential to treat certain MYC-amplified and transcriptionally addicted solid tumors. The data will be presented in three posters at the American Association for Cancer Research Annual Meeting 2022, which begins today in New Orleans. The company will also present findings on a liquid biopsy assay platform that it has developed to potentially assess patient responses in the next stage of the ongoing Phase 1/2 clinical trial of KB-0742. In the first poster, researchers evaluated 11 tumor types using immortalized cell lines, including patient-derived cell line, patient-derived organoid and patient-derived xenograft models. Of the 11 cancer types, triple-negative breast cancer, ovarian cancer and lymphoma showed good responses to KB-0742. Tumor regressions were observed in the three models of ovarian cancer. For triple-negative breast cancer and ovarian cancer, immortalized cell lines and patient-derived cell lines indicated lower half maximal inhibitory concentration values with increased MYC amplification or expression, and in vivo assessments using PDX models showed good correlation of tumor growth inhibition and MYC amplification/expression. The data also showed antitumor activity of greater than 50% tumor growth inhibition in several xenograft models of lymphoma, including one double-hit model. Based on the analysis, the researchers concluded that triple-negative breast and ovarian cancer showed the strongest correlation between sensitivity to KB-0742 and MYC expression. In a second poster, KB-0742 was evaluated in certain tumors that rely on dysregulated activity of a particular transcription factor to drive their malignant phenotype. These include the fusion gene EWS-FLI1 in Ewing sarcoma, PAX3/7-FOXO1 fusions in rhabdomyosarcoma, and brachyury (T) in chordoma. The activity of KB-0742 was assessed in vivo using two PDX models of chordoma. These findings provide additional rationale for the use of KB-0742 as a potential treatment for chordoma, sarcoma and other transcriptionally addicted tumors. In a third poster at AACR, the company evaluated KB-0742 in small-cell lung cancer. In a panel of six PDO small-cell lung cancer models with different treatment histories, KB-0742 was active in the models, regardless of treatment history. In a separate study of four treatment-naive PDO models, KB-0742 was active in three transcription factor-driven subtypes of small-cell lung cancer, and the response correlated significantly with c-MYC and MYCL expression. Together, these data support the evaluation of KB-0742 as a potential treatment for small-cell lung cancer.

13:13 EDT AbCellera presents data on new T cell engager platform - AbCellera announced the release of data on its new T cell engager platform at the American Association for Cancer Research annual meeting. "AbCellera's poster presentation describes the discovery, characterization, and validation of a diverse panel of CD3-binding antibodies that can be used to develop bispecific CD3 T cell engagers for new cancer treatments," the company said in a statement. It added, "AbCellera used its technology stack to discover a panel of CD3-binding antibodies from humanized mice. Bioinformatic analysis revealed high sequence diversity, including somatic hypermutation, a range of CDR3 lengths, and diverse V gene usage. The panel was also found to be functionally diverse, including a broad range of CD3 affinities and T cell activation potencies. Biophysical characterization demonstrated that AbCellera's CD3-binding antibodies have favorable developability properties, which may reduce the time and technical risks of downstream protein engineering, including low mean hydrophobicity, self-association, and polyspecificity."

13:13 EDT Monte Rosa Therapeutics presents preclinical data on MRT-2359 - Monte Rosa Therapeutics announced preclinical data underscoring the role of GSPT1 as a key regulator of protein translation in Myc-driven tumors and highlighting MRT-2359 as a potent and selective GSPT1-directed MGD. The data will be presented in a poster presentation titled, "Identification of MRT-2359, a Potent, Selective and Orally Bioavailable GSPT1-directed Molecular Glue Degrader for the Treatment of Cancers with Myc-induced Translational Addiction," at the American Association for Cancer Research Annual Meeting in New Orleans. The data being presented at the AACR meeting are based on preclinical studies and analyses of real-world data derived from patient tumor samples. Findings include the following: MRT-2359 induces degradation of GSPT1 and associated downregulation of N-Myc and its transcriptional output, leading to preferential anti-proliferative activity in lung cancer cell lines with high L-Myc and N-Myc mRNA expression. MRT-2359, when administered orally, demonstrates anti-tumor activity in xenograft and patient-derived xenograft models of non-small cell lung cancer and small cell lung cancer with high L-Myc and/or N-Myc mRNA expression levels or neuroendocrine features. MRT-2359 had limited activity in low L-Myc or N-Myc NSCLC models, further corroborating the selective vulnerability of Myc-driven tumors to GSPT1 degradation. Analyses of real-world data indicate that approximately 15% of NSCLC and 70% of SCLC have high L-Myc and/or N-Myc mRNA expression. Collectively, these data support the clinical development of MRT-2359 in Myc-driven solid tumors, with an initial focus on NSCLC and SCLC.

13:11 EDT Omega Therapeutics: OTX-2002 supresses c-Myc gene expression in trial - Omega Therapeutics will present preclinical data highlighting the potential of its lead Omega Epigenomic Controller, OTX-2002, to regulate overexpression of the c-Myc oncogene in models of hepatocellular carcinoma in a poster presentation at the American Association for Cancer Research Annual Meeting 2022, taking place in New Orleans, Louisiana, April 8-13, 2022. Key findings: A single dose of OTX-2002 induced durable changes in the epigenetic profile of the MYC gene; OTX-2002 reduced MYC mRNA expression and protein levels over approximately 2 weeks in vitro; Downregulation of MYC in multiple HCC cell lines resulted in significant loss in viability of MYC-addicted cancer cells while sparing normal cells; In murine xenograft HCC models, OTX-2002 significantly reduced tumor growth and was well-tolerated. Cumulatively, these data support the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for the clinical development of OTX-2002 in the first half of 2022.

13:11 EDT Calithera announces preclinical synthetic lethality program findings at AACR - Calithera Biosciences shared new data from the company's preclinical synthetic lethality program. The findings, which are now available as an e-poster and will be presented live on April 11 at the American Association for Cancer Research, or AACR, Annual Meeting, validate the synthetic lethal interaction between the gene paralogs vacuolar protein sorting-associated protein 4A, or VPS4A, and 4B, or VPS4B, and "provide the first preclinical evidence supporting a newly discovered series of compounds designed to target these proteins for cancer treatment," the company said. In the AACR presentation, Calithera researchers describe how they mined CRISPR genetic loss-of-function data and associated molecular datasets from the Cancer Dependency Map Project Datasets to identify pairs of gene paralogs, which they then prioritized for potential drug targets. This work resulted in the identification of VPS4A and VPS4B as promising targets. The researchers then conducted multiple studies to validate the paralog gene pair, demonstrating that cells with VPS4B homozygous or heterozygous loss are sensitive to VPS4A knock down while cells without VPS4B loss are not. In addition, simultaneously knocking down VPS4A and VPS4B consistently resulted in cell death. "Our discovery of a novel series of VPS4A inhibitors is an important validation of our platform. We are now advancing these inhibitors through lead optimization," said Susan Molineaux, CEO of Calithera.

13:10 EDT Merus presents preclinical data on MCLA-129 at AACR meeting - Merus released pre-clinical data highlighting the mechanism of action of MCLA-129. The poster, that is currently available virtually, will be presented at the American Association for Cancer Research Annual Meeting 2022 in New Orleans, Louisiana on Sunday, April 10, 2022. Observations in the preclinical presentation include: MCLA-129 inhibits ligand-induced EGFR and c-MET receptor dimerization and phosphorylation; MCLA-129 promotes ADCC and ADCP of NSCLC cells; MCLA-129 significantly inhibits growth of a patient-derived EGFR exon20ins tumor in a preclinical xenograft model. These data provide support for the ongoing phase 1/2 study of MCLA-129 in patients with solid tumors, including NSCLC with EGFR exon20ins. MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial consisting of dose escalation followed by a planned dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity in patients with advanced solid tumors. MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd, which permits Betta to develop MCLA-129 exclusively in China, while Merus retains global rights outside of China. Merus plans to provide a clinical update in the second half of 2022.

13:08 EDT Biomea Fusion: BMF-219 showed strong cytotoxic activity in trial - Biomea Fusion presented new data at the American Association of Cancer Research Annual Meeting demonstrating BMF-219's activity in multiple preclinical models of DLBCL, MM, and KRAS human ex vivo tumor models and cell lines in poster presentations. In addition, the company presented a Trial In Progress poster presentation detailing the design of Biomea's ongoing Phase I clinical trial. In comparison to two highly specific KRAS G12C inhibitors, BMF-219 exhibited broader potency across KRAS-mutated cell lines and ex vivo PDX tumor models indicating pan-KRAS activity with over 90% growth inhibition in most of these models. Additionally, BMF-219 showed the potential to increase the depth of response across G12C cell lines, notably achieving a higher percentage of cell killing in G12C colorectal cancer cells compared to the commercially available KRAS inhibitor sotorasib and another clinical-stage KRAS inhibitor. Additionally, BMF-219 exhibited robust growth inhibition as a single agent against high-grade B-cell lymphoma cell lines that are known to have low response to standard of care, as well as in multiple MM cells with TP53 and RAS mutations at similar drug concentrations. A targeted pan-KRAS inhibitor has the potential to treat the 25-35% of NSCLC, 40-45% of CRC, and ~90% of pancreatic cancer patients who have KRAS-mutant tumors. If approved, BMF-219 could be an effective treatment for relapsed/refractory DLBCL and MM, where patients have a significant unmet need despite a large armamentarium of therapeutic options. Additionally, we believe BMF-219 has the potential to be an effective therapeutic option for menin-dependent acute leukemias, including the greater than45% of AML patients that are believed to have menin-dependent disease.

13:06 EDT Jazz Pharmaceuticals: JZP815 active in multiple tumor pre-clinical models - Jazz Pharmaceuticals and collaboration partner Redx Pharma presented data showing the pan-RAF kinase inhibitor, JZP815, was active in multiple RAF- and RAS-mutant tumor pre-clinical models, with a pharmacokinetic profile that may provide drug exposure required for target engagement in humans. Pre-clinical data of JZP815 administered orally as both a monotherapy and in combination with mitogen-activated protein kinase pathway inhibitors were presented at the American Association for Cancer Research 2022 Annual Meeting. Key findings of several pre-clinical models include: JZP815 inhibited all 3 RAF kinase family members at low-to-sub nanomolar potencies in biochemical assays. JZP815 did not induce significant paradoxical pathway activation, observed with approved first generation BRAF-selective inhibitors, while demonstrating equivalent cellular potencies for MAPK pathway inhibition driven by either mutant RAF monomers or dimers or mutant RAS-induced RAF dimers in tumor cells. JZP815 significantly inhibited tumor growth, including inducing tumor regression, as a single agent in multiple mouse xenograft solid tumor models harboring RAS and/or BRAF mutations. JZP815's pharmacokinetic profile sustained on-target pathway pharmacodynamic responses in a predictable dose and time dependent manner. JZP815 demonstrated enhanced activity when combined with inhibitors of other MAPK pathway components including MEK1/2, SOS1, SHP2 and EGFR inhibitors in both class 2 and class 3 mutant BRAF patient-derived tumor cells ex vivo, and KRAS mutant NSCLC and colorectal cancer xenografts in vivo. Jazz acquired JZP815 from Redx Pharma, and the two companies are collaborating on this pre-clinical research. Jazz plans to submit an IND for JZP815 this year.

13:06 EDT Oncolytics reports 'positive' long-term survival data from ReoGlio trial - Oncolytics Biotech announced positive long-term survival data from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme. The results, which are the subject of a presentation at the American Association for Cancer Research Annual Meeting, show a substantial and durable efficacy signal in newly diagnosed GBM patients and demonstrate the safety and tolerability of the studied treatment combination in this indication. "These results provide further evidence suggesting that the long-term survival benefits pelareorep delivers to breast cancer patients may be extended to a variety of indications," said Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. "I am highly encouraged by the two-year survival rate and median overall survival observed in ReoGlio and view the relative increases these metrics show in the high dose cohort as a promising sign of this therapy combination's dose-dependent activity in GBM. ReoGlio's long-term results are also consistent with the positive progression-free survival data that were previously reported and confirm pelareorep's favorable safety profile in this new indication. Collectively, these findings highlight pelareorep's potential to drive clinical benefit in GBM patients, who are historically very challenging to treat and in urgent need of novel therapies."

13:06 EDT C4 Therapeutics presents data from Cohort A of Phase 1/2 trial of CFT7455 - C4 Therapeutics presented data from Cohort A of its ongoing Phase 1/2 clinical trial of CFT7455, a novel degrader targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin's lymphomas. The data will be presented at the American Association for Cancer Research Annual Meeting on Tuesday, April 12, 2022, at 9 AM CT by Sagar Lonial, M.D., FACP. C4T designed CFT7455 to be highly potent and selective against its intended targets, IKZF1/3. The Phase 1/2 trial is designed to primarily investigate safety, tolerability, and anti-tumor activity. Secondary and exploratory objectives are to characterize the PK and pharmacodynamic profile of CFT7455. The Phase 1 portion of the study explores CFT7455 as a single agent in patients with relapsed or refractory MM and NHL, as well as in combination with dexamethasone in patients with RRMM. Following identification of a recommended dose and schedule. the Phase 2 portion of the trial is expected to expand to the following four investigational arms: in RRMM, single agent CFT7455; in RRMM, CFT7455 combined with dexamethasone; in peripheral T-cell lymphoma, single agent CFT7455; and in mantle cell lymphoma, single agent CFT7455. Cohort A, the first cohort in the clinical trial, explored CFT7455 as a single agent and enrolled five patients with MM. All patients in Cohort A were highly refractory and heavily pre-treated, having received a median of five prior lines of therapy (range of 4-14), including both lenalidomide and pomalidomide. The starting dose in the trial was 50 undefined and all patients in Cohort A received single agent CFT7455 for 21 days of the 28-day treatment cycle. The data cut-off date was January 14, 2022. At the time of this data cut-off, two patients remained on therapy; however, these patients have since discontinued treatment. Summary of Data from Cohort A: Safety: Four patients received single agent CFT7455 at the starting dose of 50 undefined per day. Two of these patients were dose reduced to 25 undefined per day due to neutropenia, a known on-target toxicity associated with IKZF1/3 degraders. The fifth patient enrolled at a starting dose of 25 undefined per day based on the recommendation of the safety review committee. Two dose-limiting toxicities were observed at the 50 undefined per day starting dose, both consistent with on-target activity: Grade 4 neutropenia lasting more than 5 days: A delay in initiating treatment in Cycle 2, in the setting of persistent Grade 3 neutropenia. No patient experiencing neutropenia had a concurrent infection or fever. There were no serious adverse events reported and no adverse events resulted in death or treatment discontinuation. Pharmacokinetics and Pharmacodynamics: CFT7455 was rapidly absorbed, with a plasma half-life of approximately two days. Accumulation of drug was observed up to four-fold by day 15 and achieved exposures at 50 undefined that were equivalent to predicted highly active exposures based on pre-clinical studies. CFT7455 demonstrated deep and durable degradation of IKZF1/3, as quantified by mass spectrometry, throughout Cycle 1. Efficacy: Responsiveness was measured based on International Myeloma Working Group criteria. Three patients had best observed reductions in the difference of serum free light chain ranging from 41 percent to 78 percent. One patient had an increase of 56 percent in dFLC. The patient who achieved a 78 percent reduction in dFLC did not achieve a partial response under IMWG criteria due to the presence of measurable plasmacytomas, which were assessed as stable. Three patients had a best response of stable disease. Two patients had a best response of progressive disease. C4T has completed modeling of the Cohort A data and believes alternative dosing regimens are expected to increase the therapeutic index by allowing time for adequate neutrophil maturation during the days off drug, with limited impact on efficacy. Patients are enrolling in Cohort B1, exploring CFT7455 as a monotherapy for RRMM, and Cohort C, exploring CFT7455 as a monotherapy for NHL. Cohorts B1 and C have a starting dose of 25 undefined per day at an alternative dosing schedule. Each cohort will proceed with dose finding in parallel, with the goal of achieving a recommended Phase 2 dose in each of MM and NHL.

13:04 EDT Theseus Pharmaceuticals announces preclinical data at AACR meeting - Theseus Pharmaceuticals announced preclinical data characterizing next-generation pan-variant EGFR inhibitors that will be detailed in a live poster presentation at the American Association for Cancer Research, or AACR, 2022 Annual Meeting, being held April 8-13, in New Orleans, Louisiana. The poster highlights advanced lead compounds for use in non-small cell lung cancer, or NSCLC, that have been observed to potently inhibit the kinase activity, both in vitro and in vivo, of all major single-, double-, and triple-mutant EGFR variants, including T790M and C797S, with selectivity over wild-type EGFR and the ability to penetrate the central nervous system. "Up to half of all non-small cell lung cancer tumors are driven by activating mutations in EGFR and up to 90 percent of those mutations are found in exons 19 and 21. Furthermore, as patients progress through lines of treatment, a substantial percentage of patients' tumors may develop one or more additional EGFR mutations that cause resistance to treatment. At Theseus, we have developed a series of potent and selective, single molecule, fourth-generation EGFR inhibitors that are designed to inhibit all major classes of EGFR activating and resistance mutations that contribute to later-line clonal heterogeneity in patients who have been failed by current approved therapies. We are finalizing preclinical studies to characterize our lead compounds and look forward to designating a development candidate in the third quarter of this year," said William Shakespeare, Ph.D., President of Research and Development at Theseus.

13:02 EDT Royalty Pharma to present new clinical, preclinical data at AACR Meeting - Repare Therapeutics announced it has been selected for an oral presentation of clinical data from its ongoing Phase 1/2 TRESR trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR, as well as two additional poster presentations at the upcoming 2022 AACR Annual Meeting held in New Orleans on April 8-13, 2022. "As with any new therapeutic class, differentiation among early product candidates is what ultimately determines success in the clinic and a path toward registration," commented Lloyd M. Segal, President and CEO of Repare. "In the context of data published as recently as today, we are confident that RP-3500 is a highly differentiated and potentially leading ATR inhibitor. We continue to draw on a wealth of data from the comprehensive Phase 1 monotherapy module of our Phase 1/2 TRESR trial of RP-3500 to begin establishing its therapeutic potential. We look forward to seeing these data presented at AACR and discussing RP-3500's ongoing and future development plans."

13:02 EDT Phio says preclinical data on PH-894 demonstrates antitumor efficacy in model - Phio Pharmaceuticals presented new preclinical data showing PH-894, a self-delivering RNAi compound targeting the bromodomain-containing protein 4, provides abscopal efficacy toward untreated distal tumors and potentiates the efficacy of systemic anti-PD-1 antibody therapy. These new data will be presented at the American Association for Cancer Research, or AACR, Annual Meeting 2022, which is being held in New Orleans, Louisiana, from April 8-13. "We are excited by these new data on PH-894, our second product candidate, for various reasons. First, these data show that local administration of PH-894 resulted in systemic efficacy, similar to what we have shown with PH-762. In addition, these studies have shown PH-894 to be a potent standalone treatment in a challenging model, while also enhancing the efficacy of systemic anti-PD-1 antibodies. We believe these data provide a strong rationale for the clinical use of PH-894 as a monotherapy, as well as in combination with systemic PD-1 therapy. Considering the novel mechanism of action of PH-894, there is potential for it to play an important role in treating patients who do not respond to anti-PD-1 therapy, or patients who progress after initially responding to such therapy, addressing an important medical unmet need," said Dr. Simon Fricker, Phio's VP of Research & Development.

13:02 EDT Blueprint Medicines says SYMPHONY results support development expansion - Blueprint Medicines Corporation announced proof-of-concept data from the Phase 1/2 SYMPHONY clinical trial of BLU-945, an investigational precision therapy for advanced EGFR-mutant non-small cell lung cancer. The trial results showed early evidence of safety and clinical activity consistent with preclinical data, supporting plans to expand development of BLU-945 in combination with multiple agents including osimertinib, with the goal of preventing or treating tumor resistance to prolong patient benefit. The data were reported today at the American Association for Cancer Research Annual Meeting 2022 in New Orleans. Early data from the ongoing Phase 1 dose escalation part of the SYMPHONY trial showed dose-dependent decreases in circulating tumor DNA and radiographic tumor reductions, including a partial response in a patient treated with 400 mg once daily, the highest dose tested as of the data cutoff date. Pharmacokinetic results showed BLU-945 exposures at higher doses were associated with broad EGFR mutation coverage, including the activating L858R mutation with or without the osimertinib-resistant C797S mutation. BLU-945 was generally well-tolerated, with no significant adverse events associated with wild-type EGFR inhibition. The maximum tolerated dose and recommended Phase 2 dose have not yet been identified, and dose escalation is continuing. Blueprint Medicines is initiating a SYMPHONY trial cohort assessing BLU-945 in combination with osimertinib in patients with second-line or later EGFR-mutant NSCLC, following disease progression on osimertinib. After the selection of a recommended Phase 2 combination dose regimen, the company plans to initiate an expansion cohort with registration potential in biomarker-selected second-line patients, as well as an expansion cohort in front-line patients, by the end of 2022. Additional combinations with BLU-701, chemotherapy and antibody-drug conjugate therapy are planned across multiple mutation profiles and lines of therapy.

12:07 EDT Fastly higher after TheDeal discusses potential buyout interest - Shares of Fastly (FSLY) are up 55c, or 3%, to $18.28 near midday after The Deal reported, according to contacts, that it was told this month that "a company such as" Alphabet's (GOOGL) Google could seek to buy Fastly in an effort to improve its content delivery network.

12:00 EDT Vapotherm falls -10.5% - Vapotherm is down -10.5%, or -83c to $7.06.

12:00 EDT LXP Industrial Trust falls -14.1% - LXP Industrial Trust is down -14.1%, or -$2.21 to $13.43.

12:00 EDT Borr Drilling rises 15.1% - Borr Drilling is up 15.1%, or 59c to $4.47.

11:51 EDT FTC says Walmart, Kohl's to pay $5.5M total over false marketing around 'bamboo' - The Federal Trade Commission has used its Penalty Offense Authority to take action against national retailers Kohl's (KSS) and Walmart (WMT) for falsely marketing dozens of rayon textile products as bamboo. Both companies also are charged with making deceptive environmental claims, touting that the "bamboo" textiles were made using ecofriendly processes, while in reality converting bamboo into rayon requires the use of toxic chemicals and results in hazardous pollutants. The Commission has asked the court to order Kohl's and Walmart to stop making deceptive green claims or using other misleading advertising, and pay penalties of $2.5M and $3M, respectively, by far the largest penalties in this area. The complaints and proposed orders were filed by the U.S. Department of Justice on the FTC's behalf. "Kohl's and Walmart are paying millions of dollars under the FTC's Penalty Offense Authority for mislabeling their rayon products as bamboo," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "False environmental claims harm both consumers and honest businesses, and companies that greenwash can expect to pay a price." Reference Link

11:36 EDT Nissan aims to launch EV with in-house, all-solid-state batteries by FY28 - Nissan unveiled its prototype production facility for laminated all-solid-state battery cells, which the company aims to bring to market in 2028. "This prototype facility, within the Nissan Research Center in Kanagawa Prefecture, is aimed to further promote the development of all-solid-state-batteries. Under its long-term vision, Nissan Ambition 2030, Nissan aims to launch an EV with all-solid-state batteries developed in-house by fiscal 2028. It plans to establish a pilot production line at its Yokohama Plant in fiscal 2024, with materials, design and manufacturing processes for prototype production on the line to be studied at the prototype production facility. Nissan believes all-solid-state batteries can be reduced to $75 per kWh in fiscal 2028 and to $65 per kWh thereafter, placing EVs at the same cost level as gasoline-powered vehicles. All-solid-state batteries are expected to be a game-changing technology for accelerating the popularity of electric vehicles," the company stated.

11:18 EDT Google partners with iFixit for Pixel repairs - In a company blog post, Google's COO of consumer hardware, Ana Corrales said, "We want you to have a great experience with your Pixel phone, and that includes easy access to high-quality and safe device repair if your phone is ever damaged. That's why we're working with iFixit to make it easier for independent repair professionals and skilled consumers with the relevant technical experience to access the genuine Google parts they need to repair Pixel phones. Starting later this year, genuine Pixel spare parts will be available for purchase at ifixit.com for Pixel 2 through Pixel 6 Pro, as well as future Pixel models, in the U.S., UK, Canada, Australia and EU countries where Pixel is available. The full range of spare parts for common Pixel phone repairs - things like batteries, replacement displays, cameras and more - will be available either individually or in iFixit Fix Kits, which include tools like screwdriver bits and spudgers." Reference Link

10:51 EDT Blockstream says construction starts on joint bitcoin plant project with Block - Blockstream announced construction has begun on a new solar-powered Bitcoin mining facility, calling the news "a significant development that supports the previously announced project between Blockstream and Block." The 3.8 Megawatt Tesla Solar PV array and 12 megawatt-hours Tesla Megapack will power the open-source, solar-powered Bitcoin mining facility at a Blockstream Mining site in the United States, Blockstream stated in a press release. "By collaborating on this full-stack, 100% solar-powered Bitcoin mining project with Blockstream, using solar and storage technology from Tesla, we aim to further accelerate Bitcoins synergy with renewables" said Neil Jorgensen, Global ESG Lead at Block and Project Lead for Blocks Bitcoin Clean Energy Initiative.

10:00 EDT Vapotherm falls -10.5% - Vapotherm is down -10.5%, or -83c to $7.06.

10:00 EDT ETFS Physical Palladium Shares rises 9.6% - ETFS Physical Palladium Shares is up 9.6%, or $20.00 to $229.00.

10:00 EDT System1 rises 17.0% - System1 is up 17.0%, or $4.56 to $31.37.

09:55 EDT Kaleido Biosciences trading resumes

09:47 EDT Triton International falls -6.3% - Triton International is down -6.3%, or -$4.05 to $60.01.

09:47 EDT LXP Industrial Trust falls -10.2% - LXP Industrial Trust is down -10.2%, or -$1.59 to $14.04.

09:47 EDT Paysafe rises 9.0% - Paysafe is up 9.0%, or 27c to $3.26.

09:41 EDT Blue Water Vaccines Inc trading resumes

09:36 EDT Blue Water Vaccines Inc trading halted, volatility trading pause

09:32 EDT Kaleido ceases operations, delists shares and fires all employees - Kaleido Biosciences said delivered formal notice to the Nasdaq that it intends to voluntarily delist its common stock in connection with the cessation of all its operations. Kaleido expects to file a Form 25 with the Securities and Exchange Commission on or about April 18 to effect the voluntary delisting and that the delisting will be effective on or about April 28. On April 8, Daniel Menichella tendered his resignation from the company's board and all committees on which he served. The decision to resign was not the result of any disagreements. In addition, the employment of Daniel Menichella, the company's principal executive officer and named executive officer, William Duke, its principal financial and accounting officer and named executive officer, and (Johan van Hykckama Vlieg, a named executive officer, was terminated effective immediately in connection with the company's cessation of operations. The board voted to immediately wind-down and cease all of Kaleido's ongoing operations. The employment of all of the company's remaining employees was terminated effective immediately.

09:21 EDT BioCryst sinks after pausing trial enrollment in PNH studies - Shares of BioCryst Pharmaceuticals after falling after the company announced that it has paused enrollment in clinical trials with BCX9930 while it investigates elevated serum creatinine levels seen in some patients. During the investigation, the company will not enroll new patients in the REDEEM-1, REDEEM-2 or RENEW clinical trials. Patients currently enrolled in the trials are continuing on study drug at this time. BCX9930 is an oral Factor D inhibitor for the treatment of complement-mediated diseases. The REDEEM-1 and REDEEM-2 trials are for patients with paroxysmal nocturnal hemoglobinuria and the RENEW study is for patients with C3 glomerulopathy, immunoglobulin A nephropathy and primary membranous nephropathy. Shares of BioCryst are down 28%, or $4.94, to $12.94 in premarket trading following the news.

09:18 EDT Bioventus announces expansion of TheraSkin coverage - Bioventus announced that TheraSkin coverage now includes three out of the four largest commercial plans in the U.S. along with Medicare and several regional commercial plans. Bioventus' TheraSkin is a cellular and tissue-based treatment for difficult to heal chronic wounds and this expanded coverage adds more than 17 million medical lives to the existing coverage.

09:15 EDT BioCryst pauses enrollment in BCX9930 clinical trials - BioCryst Pharmaceuticals announced that the company has paused enrollment in clinical trials with BCX9930 while the company investigates elevated serum creatinine levels seen in some patients. During the investigation, the company will not enroll new patients in the REDEEM-1, REDEEM-2 or RENEW clinical trials. Patients currently enrolled in the trials are continuing on study drug at this time.

09:02 EDT Arthur J. Gallagher acquires Churchills International Consulting, no terms - Arthur J. Gallagher & Co. announced the acquisition of Nottingham, England-based Churchills International Consulting. Terms of the transaction were not disclosed. Founded in 1974, Churchills International Consulting offers comprehensive employee benefits programs to corporate clients, with a focus on the technology sector.

09:02 EDT Novavax, SII receive EUA for Novavax' COVID-19 vaccine in Thailand - Novavax and Serum Institute of India announced that the Thailand FDA has granted emergency use authorization for Novavax' protein-based vaccine for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is manufactured and marketed by SII under the brand name Covovax.

08:47 EDT FSD Pharma announces cancellation of shares issued to former CEO - FSD Pharma announced, pursuant to a court endorsement, the cancellation of 504,888 Class B subordinate voting shares previously issued to the company's former CEO Raza Bokhari. This follows the prior cancellation of 156,278 Class B subordinate voting shares previously issued to certain former directors of the company. To cancel the shares previously issued to Raza Bokhari, FSD was forced to seek an order from the Ontario Superior Court.

08:32 EDT Planet Green Holdings enters share exchange agreement with Allinyson - Planet Green Holdings announced that on April 8, the company has entered into a Share Exchange Agreement with Allinyson Ltd. and each shareholder of Allinyson. Pursuant to the Share Exchange Agreement, the company will acquire 100% of issued and outstanding equity interests of Allinyson. Allinyson is a company incorporated in the State of Colorado and owns subsidiaries in Hong Kong and China. It develops and operates online games, and generates substantially its revenue from selling advertising placements through major advertising platforms such as Meta Platforms and Fyber. Pursuant to the Share Exchange Agreement, Planet Green Holdings will issue 7.5M shares of its common stock to the Allinyson Sellers in exchange for the transfer of 100% of their equity interests of Allinyson. The transaction is subject to closing conditions that are customary for transactions of this type

08:20 EDT General Healthcare technology to be used in Oak Valley Health IR suite - Oak Valley Health has completed construction on a new innovative 2,465 sq. ft. interventional radiology, IR, suite with the first in Canada GE Healthcare Allia IGS 7 system giving patients more access to leading-edge treatments and procedures. Using highly advanced imaging guidance, the Allia IGS 7 will allow interventional radiologists to diagnose and treat complex and intricate cases using minimally invasive procedures. "The backlog in non-urgent patient care, combined with today's growing disease burden demands new solutions to help clinicians manage today's evolving needs," says Heather Chalmers, President & CEO, GE Canada. "Powered by GE Healthcare's Edison intelligence platform, the Allia imaging system offers the first AI-driven imaging chain that may reduce radiation dose and contrast forinterventional procedures. Ultimately, this will enable the team at Oak Valley Health to increase patient access and surgical capacity for the York, Durham regions."

08:14 EDT NGM Biopharmaceuticals to present late-breaking poster presentations at AACR - NGM Biopharmaceuticals provided additional detail on two late-breaking poster presentations it will give on Wednesday, April 13, 2022, at the American Association for Cancer Research, AACR, Annual Meeting. NGM Bio will also give an oral presentation on April 10, 2022 at the AACR meeting featuring preclinical data for the lead program in its myeloid checkpoint inhibitor portfolio, NGM707, a dual ITL2/ILT4 antagonist antibody. The late-breaking presentations will feature preclinical data supporting the development of NGM831, an ILT3 antagonist antibody product candidate, and NGM438, a LAIR1 antagonist product candidate. A Phase 1/2 clinical trial of NGM707 is currently underway and will evaluate NGM707 as a monotherapy and in combination with KEYTRUDA in patients with advanced solid tumors. An initial data readout from the Phase 1a monotherapy dose escalation portion of this trial is expected in the second half of 2022. NGM Bio recently announced the initiation of a Phase 1/1b clinical trial evaluating NGM831 as a monotherapy and in combination with KEYTRUDA in patients with advanced solid tumors. NGM438 is anticipated to enter the clinic later this quarter. NGM831 Late-Breaking Poster Presentation: "Preclinical characterization of NGM831, an ILT3 antagonist antibody for the treatment of solid tumors." Per the AACR abstract, in preclinical studies NGM831 demonstrated the ability to bind human and primate ILT3 with high affinity and specificity, and to block the interaction of ILT3 with both of its reported ligands: fibronectin and ApoE. In a gene expression profiling experiment, treatment of tolerogenic dendritic cells with NGM831 in the presence of fibronectin decreased their expression of inhibitory and 'scavenger' receptors, as well as classical markers of an immune-suppressive myeloid cell phenotype, and increased the expression of genes involved in antigen presentation. Taken together, these results demonstrate that NGM831 blocked fibronectin-mediated immunosuppression and promoted myeloid cell reprogramming. NGM438 Late-Breaking Poster Presentation: "Preclinical development of NGM438, a novel anti-LAIR1 antagonist monoclonal antibody for the treatment of collagen-rich solid tumors." Per the AACR abstract, NGM Bio's preclinical research demonstrated that LAIR1 was expressed on circulating and intratumoral immune cells of cancer patients, and LAIR1-expressing cells were commonly found in collagen-rich tumor stroma. NGM438 reversed collagen-induced immune suppressTaken together, these results suggest that NGM438 may inhibit LAIR1-mediated collagen-driven immune suppression alone and in combination with checkpoint inhibition.

08:13 EDT Mace Security announces review of strategic alternatives - Mace Security International announced that, in response to third party inquiries and some preliminary discussions, its Board of Directors, supported by management, has commenced a process to explore and evaluate potential strategic alternatives for the Company. These alternatives may include continuing as a standalone company, merging with another party or other forms of strategic transactions or alliances. The Company has not set a formal timetable for this review, nor has it made any decisions related to strategic alternatives at this time. While the Company is pursuing opportunities, there is no assurance that the process will result in a transaction. The Company does not expect to make additional public comment regarding these matters unless and until the Board has determined that such disclosure is appropriate or required.

08:10 EDT Genetic Technologies reports cash balance of A$11.43M - Highlights: Year to date growth in revenue of 475%; Cash receipts of A$2M in quarter 3, an increase of 9% on the prior quarter, and mainly comprising EasyDNA product sales; GeneType Multi-Risk Test received NATA accreditation and CMS certification; Phase 1 of geneType Multi-Risk Test launched for physicians targeting 50% of annual mortalities and morbidities in six serious diseases; US Patent granted for COVID-19 Risk Test; Leveraging EasyDNA acquisition by progressing a 'One company two brands' strategy; Launched our Virtual Sales Rep with Hahn Healthcare in Australian General Practice with sales supporting the creation of our geneType Hubs; and cash balance of A$11.43M, providing 21 months runway for investing in growth initiative. CEO Simon Morriss stated: "These approvals mark an important step for the Company to initiate the commercialization of the Multi-Risk Test to physicians in Australia and the USA. We are also very pleased to announce the granting of a US patent for our COVID-19 Risk Test, which provides a strong foundation for the ongoing commercialization of this test to provide improved outcomes for patients at risk of developing severe COVID-19 disease."

08:09 EDT Cybin announces WIPO publishes international patent application for psychedelics - Cybin announced that the World Intellectual Property Organization, or WIPO, published an international patent application covering a range of inhalation delivery methods across multiple psychedelic molecules, further strengthening its long-term intellectual property position of psychedelic-based programs.

08:07 EDT Sun Communities closes acquisition of Park Holidays UK for $1.3B - Sun Communities announced the closing of its previously announced acquisition of Park Holidays UK. The Company acquired 40 owned and two managed communities in the UK primarily located in irreplaceable, seaside locations in the south of England. The aggregate purchase price for Park Holidays is EUR 950M, or approximately $1.3B. The Company issued SUI common stock with a value of approximately $33M at closing, and paid the balance of the purchase price in cash. "We are excited to welcome the Park Holidays properties, team members, holiday homeowners and guests to the Sun family, marking another important milestone in our growth and evolution. The Park Holidays' business model is similar to and complementary with Sun's Manufactured Housing platform," stated John McLaren, the Company's President and Chief Operating Officer. "Combining the strengths of our team alongside the skilled and experienced Park Holidays team, this acquisition provides us with the opportunity to establish a strong presence within the highly fragmented UK market. We look forward to executing on Sun's proven acquisition, expansion and development strategies in the UK through Park Holidays, further expanding our best-in-class portfolio and accelerating our growth."

08:07 EDT Molecular Templates to host webinar on immuno-oncology for solid tumors - Molecular Templates announced that it will host a webinar on a unique approach to immuno-oncology for solid tumors on Wednesday, April 13, 2022 at 8:00 am Eastern Time. The webinar will feature a presentation from medical expert David Spigel, MD, of the Sarah Cannon Research Institute, who will discuss Molecular Templates' program, MT-6402, and the implications of the Phase 1 data as it relates to treating patients with a variety of PD-L1-expressing solid tumors. MT-6402 is the first of the Company's 3rd generation ETBs to enter the clinic. It is designed to induce potent anti-tumor effects via PD-L1 targeting through mechanisms including Shiga-like Toxin A ribosomal inactivation and CMV antigen-seeding technology, both of which may overcome the limitations of approved checkpoint inhibitors.

08:05 EDT Applied UV appoints John Andrews as CEO - Applied UV announced that John Andrews has joined the company serving as CEO and a member of the board of directors. Andrews has over 30 years of senior leadership experience in telecom and technology companies, both public and private.

08:04 EDT Advaxis announces publication of ADXS-PSA in The Oncologist - Advaxis (ADXS) announced the publication of results of their KEYNOTE-46 Phase 1/2 open-label, double-arm trial of ADXS-PSA with KEYTRUDA in patients with metastatic, castration-resistant prostate cancer, mCRPC. The paper, titled "ADXS31 142 Immunotherapy +/- Pembrolizumab Treatment for Metastatic Castration-Resistant Prostate Cancer: Open-Label Phase I/II KEYNOTE-046 Study," has been published online in The Oncologist. The KEYNOTE-46 trial was conducted in conjunction with Merck (MRK) and evaluated ADXS-PSA, one of Advaxis' Listeria monocytogenes-based immunotherapies, alone and in combination with KEYTRUDA, Merck's anti-PD-1 therapy. As of the January 28, 2020, data cut off, 50 patients with mCRPC were enrolled with evaluable responses in Advaxis' Ph 1/2 trial of ADXS-PSA alone and ADXS-PSA in combination with KEYTRUDA. The median overall survival, OS, in 13 patients treated with ADXS-PSA alone was 7.8 months with progression free survival, PFS, of 2.2 months. The median OS on ADXS-PSA combined with KEYTRUDA was 33.7 months, while median PFS was 5.4 months. 56.8% of patients on combination therapy and 30.8% on monotherapy showed stable disease. In addition, patients in the combination arm who had prior docetaxel treatment had an OS of 16.0 months, while patients with prior visceral metastasis had an OS of 16.4 months. The combined therapy was safe and well tolerated in this heavily pretreated population. All patients had more than one treatment-related adverse event, mostly transient Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue, with no additive toxicity on the combination therapy.

07:45 EDT Biofrontera Inc. expects cash to fund operations for at least 12 months - Cash and cash equivalents as of December 31, 2021 were $24.5 million, compared with $8.1 million as of December 31, 2020. During 2021, Biofrontera received net proceeds of $41.8 million including $14.9 million from the sale of common stock in its IPO, $13.6 million from a private placement and $13.2 million from warrants exercised for its common stock. The Company believes its cash and cash equivalents are sufficient to fund its operations for at least the next 12 months.

07:33 EDT LivePerson has 'constructively engaged in dialogue with Starboard' since Feb. - LivePerson issued the following statement: "LivePerson welcomes feedback from investors, and regularly engages with shareholders on various financial, strategic and governance topics. Members of the LivePerson Board and management team have constructively engaged in dialogue with Peter Feld and Starboard Value since the fund's disclosure of its investment in February. LivePerson remains committed to serving the best interests of all shareholders. LivePerson is the market leader in Conversational Artificial Intelligence with a best-in-class platform used by thousands of the world's top brands to better understand customer intents, connect across channels and deliver meaningful outcomes. In 2021, the company hit a milestone of 1.5 billion total conversations on its platform, demonstrating the breadth and depth of its scalability and data assets and further strengthening its competitive moat for delivering high quality Conversational AI. LivePerson's full year 2021 revenue grew 28% year-over-year to approximately $470 million, driven by over 40% growth in AI-powered messaging volume in its Conversational Cloud, and 28% growth in total messaging conversations. The company has generated more than 250% total return for shareholders over the past five years. The company is executing on its strategic priorities and profitable growth plan, as previously announced, and will update shareholders when it reports results for the first quarter of fiscal year 2022. The Board will present its recommendations regarding director nominees for election at the company's 2022 Annual Meeting in the company's definitive proxy statement, accompanying GOLD proxy card and other relevant documents to be filed with the SEC."

07:32 EDT AC Immune names Howard Donovan CHRO, Chris Roberts interim CFO - AC Immune announced senior management changes. Howard Donovan will join the Company as Chief HR Officer and be appointed to the Executive Committee. Joerg Hornstein, CFO, will leave in the second half to pursue a new opportunity. Christopher Roberts, Associate Vice President, Finance, was promoted to Vice President, Finance and appointed interim CFO. Julian Snow, Associate Vice President, Financial Reporting, was promoted to Vice President, U.S. Finance & Corporate Development. Donovan has been at the World Economic Forum since 2015, where he led People Services and was responsible for global reward, employee experience, people insights, strategic sourcing, new office launches, and business partnering with the Board of Directors across its locations in Switzerland, United States, China, Japan and India. Roberts, as a member of AC Immune's finance leadership team, directs the financial operations of the Company, including reporting, treasury, tax, and budgeting. He also leads key finance transformation initiatives including R&D budgeting and automation. Snow, as a member of AC Immune's finance leadership team, leads SEC reporting, including Form 20-F, Form 6-K and other public filings. He leads internal control design in preparation for SOX 404(b) compliance and is the main communication liaison with external auditors and regulators regarding all SEC, PCAOB, IFRS and other audit related matters.

07:14 EDT Guardforce to integrate Blue Pin Guest Services Robot - Guardforce announced it has entered into a mutual agreement with Blue Pin to integrate BP's Guest Services Robot into the company's concierge robots and co-market the integration within the hotel industry.

07:07 EDT Guardforce enters agreement with Blue Pin for GSR integration - Guardforce AI announced it has entered into a mutual agreement with Blue Pin to integrate BP's Guest Services Robot into the Company's concierge robots and co-market the integration within the hotel industry. This integration between Guardforce AI and BP will enable a series of self-services including online booking, check-in, and check-out. Commencing on April 1, 2022, Guardforce AI began testing the GSR technology in the Asia Pacific region which is well known for entertainment and hospitality. This cooperation with BP allows Guardforce AI to expand the usability and application of its robotic solutions, which can be duplicated in other regions where the Company has operations.

07:05 EDT Microbix Biosystems presents HPV product results at EUROGIN - Microbix Biosystems announces it will present performance results of its Quality Assessment Products, QAPs, supporting Human Papillomavirus, HPV, molecular-diagnostic screening-tests at the 2022 annual congress of the European Research Organization on Genital Infection and Neoplasia, EUROGIN, taking place in Dusseldorf, Germany from April 10-12, 2022. At EUROGIN, Microbix will be exhibiting alongside leading diagnostics firms that provide screening-tests for detection of HPV infections. Microbix has QAPs to support tests for eight high-risk HPV types available for sale in Canada, Europe, the United States, and other commercially-important jurisdictions under its "REDx Controls" or "PROCEEDx" brand names. Microbix will also review performance of its multiplex high-risk HPV QAPs in supporting quality management of testing for high-risk types of HPV via full and extended genotyping assays. Its poster presentation is titled "Performance of full and extended genotyping assays using a new high-risk HPV multiplex panel." The poster details the performance of multiplex high-risk HPV QAPs in supporting BD Onclarity assays. Furthermore, Microbix is announcing a collaboration with Copan Italia S.p.A. and key opinion leaders at VCS Pathology to advance self-collection HPV molecular diagnostic testing. A presentation titled "Validation of MSwab medium for the elution of FLOQSwabs for human papillomavirus detection on six commercial PCR-based HPV assays" will demonstrate new self-sampling tools for HPV screening programs.

07:03 EDT Renren announces software license agreement with Guangzhou Yupu - Renren announces that the company, has signed a Software License and Distribution Agreement with Guangzhou Yupu Software Technology Co. The License Agreement gives Renren, through its subsidiary SaaS Logistics US, Inc., a perpetual, exclusive, and irrevocable license to modify, sell, and commercially exploit the licensed software worldwide except in Mainland China for a one-time consideration of RMB2M, or $0.31M. In conjunction with the License Agreement, Renren entered into an employment agreement with Mr. Rui Song, Guangzhou Yupu's former CEO. Song will serve as CEO of SaaS Logistics US, Inc. The company expects to further develop and grow its suite of driver-centric SaaS-based services with the acquired software license assets.

07:02 EDT Brookdale Senior Living reports March occupancy - The company increased sequential weighted average occupancy by 30 bps and month-end occupancy by 60 bps, with growth across each segment. First quarter sequential weighted average occupancy change was relatively flat compared to typical seasonal decline, representing the best first quarter sequential occupancy change in ten years. Achieved over 2,000 move-ins during March, the highest number of move-ins since August 2019.

07:00 EDT Crowdstrike targets over $5B in annual recurring revenue - Sees its total addressable market at $44B from $36B in 2021 from its current portfolio. Sees its potential total addressable market growing to $126B when accounting for its planned offerings. Sees company "growing its market share in a growing market", having expanded share to 14.2% last year from 12.2% in 2020. Comments taken from investor presentation slides.Reference Link

06:51 EDT Designer Brands to reinstate 5c per share quarterly dividend - The company announced that the company's board of directors has approved the reinstatement of the company's regular quarterly cash dividend to shareholders, starting in the first quarter of fiscal 2022. A dividend of 5c per share of Class A common stock will be paid on May 6 to shareholders of record as of the close of business on April 22. The dividend will be paid out of the company's capital surplus as defined under the Ohio General Corporation Law.

06:34 EDT Otis Worldwide receives results of Zardoya tender offer - Otis Worldwide received the results of its voluntary public tender offer to acquire the remaining 49.98% interest in Zardoya Otis it does not currently own. The Spanish National Securities Exchange Commission, or CNMV, announced acceptances of the tender offer representing 214,017,076 shares or 45.49% of shares outstanding, which will bring total Otis ownership of Zardoya Otis to 95.51%. The voluntary tender is expected to settle on April 12. Upon settlement, Otis will own more than 95% of the outstanding Zardoya Otis shares, and the company will execute a squeeze out provision to acquire the remaining interest. The execution of the squeeze out transaction will result in the automatic delisting of the Zardoya Otis shares from the Madrid, Barcelona, Bilbao and Valencia stock exchanges, which is expected to occur in early-May.

06:24 EDT Cnooc commences Weizhou 12-8E oilfield development project - Cnooc announced that Weizhou 12-8E oilfield development project has commenced production. The Weizhou 12-8E oilfield development project is located in Beibu Gulf in the South China Sea, with average water depth of about 30 meters. In addition to fully utilizing the existing processing facilities of Weixinan oilfields, a total of seven development wells are planned, including six oil production wells and one production water reinjection well. The project is expected to reach its average daily production of approximately 4,700 barrels of crude oil in 2022, with its peak production of approximately 10,000 barrels of crude oil per day. The company holds 51% interest of Weizhou 12-8E oilfield development project.

06:05 EDT Gravity: Ragnarok Labyrinth NFT pre-registration reaches 1M accounts in SE Asia - Gravity announced that Ragnarok Labyrinth NFT has reached 1M accounts in the pre-registration in Southeast Asia and the game will be officially launched on April 13. Ragnarok Labyrinth NFT is the first NFT game of Gravity which applies P2E system to The Labyrinth of Ragnarok, a mobile Time Effective MMOPRG game, reflected user's demands in Southeast Asia. The number of pre-registered accounts has exceeded 1M in 22 days, on April 7 since it was started on March 17. The final record is expected to be much higher as the current number of pre-registered accounts is growing rapidly. At the same time, Gravity revealed that Ragnarok Labyrinth NFT is scheduled to be released in Southeast Asia on April 13. The pre-installation has been available on Google (GOOG, GOOGL) Playstore since April 7 and it will be available on Apple (AAPL) App Store since April 11. Users can pre-register in official website before launching. Furthermore, Gravity is holding the event to provide ONBUFF points worth of 10 Onit to all users if more than 300,000 accounts have been achieved in the pre-registration before its official launching, and users who will pre-register during the rest period can receive ONBUFF points unconditionally. After the official launching, 1M Zeny will be paid to all users to celebrate over 1M pre-registered accounts.

06:01 EDT Littelfuse to acquire C&K Switches for enterprise value of $540M - Littelfuse announced it has entered into a definitive agreement with an affiliate of Sun Capital Partners to acquire C&K Switches at an enterprise value of $540M. Founded in 1928, C&K Switches is a designer and manufacturer of high-performance electromechanical switches and interconnect solutions with a strong global presence across a broad range of end markets, including industrial, transportation, aerospace, and datacom. Headquartered in Waltham, Massachusetts, with facilities located around the world, C&K Switches has annualized sales of over $200M. The transaction is subject to customary closing conditions and regulatory approvals and is expected to close during the second calendar quarter of 2022. C&K Switches will be reported within the company's Electronics reporting segment. Littelfuse expects to finance the transaction consideration through a combination of cash and debt.

05:49 EDT Gol Linhas announces capital increase - GOL Linhas announced that on the date hereof its board of directors approved a capital increase of up to 67,347,010 preferred shares in the amount of R$2,873,696,916.70 and a minimum of 22,224,513 preferred shares in the amount of R$948,319,969.71.

05:44 EDT WISeKey signs MOU with Government of Seychelles to create digital platform - WISeKey announced that it is helping governments prepare for the Metaverse. Recent developments have forced governments around the world to take steps to quickly understand how Metaverse is challenging the traditional conception of sovereignty. Citizens can use their digital identities to conduct Metaverse-government transactions like, voting, pay their taxes, get married, while they also run private activities such as work, meet, collaborate, shop, stroll, watch movies and concerts, and do almost anything else they could do in the real world. WISeKey has recently signed a memorandum of understanding, or MoU, with the Government of Seychelles, represented by the Department of Information Communications Technology, or DICT, to initiate a pilot project for the development of a Digital Identity platform for Seychelles. The Digital Identity platform is expected to be integrated with different national initiatives especially the eGovernment and potentially eTourism and eHealth. Last year WISeKey also signed two MoUs with the Government of Gibraltar and the Mayor of La Linea de la Concepcion, for the development of a joint 4th Industrial Revolution Center of Excellence.

05:40 EDT STMicroelectronics, GlobalFoundries, CEA and Soitec to collaborate on FD-SOI - CEA, Soitec, GlobalFoundries (GFS) and STMicroelectronics (STM) have announced a new collaboration in which they intend to jointly define the industry's next generation roadmap for FD-SOI technology. Semiconductors and FD-SOI innovation are of strategic value to France and the EU as well as to customers globally. FD-SOI offers benefits for designers and customer systems including lower power consumption as well as easier integration of additional features such as connectivity and security, a key feature for automotive, IoT and mobile applications.

05:35 EDT Volvo sees SEK 4B negative impact in Q1 due to Russia sanctions - Since the war in Ukraine started and sanctions were imposed, all sales, service and production in Russia have been suspended. The Volvo Group has total assets of approximately SEK 9B related to Russia, of which approximately SEK 6B is cash items that could be materialized over the coming years. In Q1, assets amounting to approximately SEK 4B will be provided for and have a negative impact on operating income, primarily in the financial services segment. In 2021, approximately 3% of the group's net sales were attributable to Russia.