Stockwinners Market Radar for May 06, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:01 EDT Methode Electronics announces CEO transition - Methode Electronics "announced that Kevin Nystrom, a partner and managing director at AlixPartners LLP, has been appointed interim CEO, effective immediately. The company has previously disclosed its ongoing engagement with AlixPartners for various consulting services, including cost reduction and financial advisory. Mr. Nystrom succeeds Avi Avula, who resigned from his position as President and Chief Executive Officer. Methode's Board of Directors, with the assistance of executive search firm Spencer Stuart, has initiated a search to identify a permanent CEO. The Methode Board also announced the appointment of Mark Schwabero, current director and former Chairman, Chief Executive Officer and Director of Brunswick Corporation, as Vice Chairman of the Board, effective immediately. In this role, Mr. Schwabero will work closely with Mr. Nystrom to provide counsel and support the execution of the Company's strategic and operational initiatives until a permanent successor has been appointed. The company's former President and Chief Executive Officer, Donald W. Duda, remains a strategic consultant to Methode through January 2025 and will continue to provide support during the transition period."

18:09 EDT Braemar Hotels & Resorts to sell La Jolla Torrey Pines for $165M - Braemar Hotels & Resorts "announced notable capital market activities and strategic update. The Company announced today that it has signed a definitive agreement to sell the 394-room Hilton La Jolla Torrey Pines located in La Jolla, California for $165 million. Including anticipated capital expenditures of $40 million, the sale price represents a 7.2% capitalization rate on net operating income for the trailing twelve months ended March 31, 2024. The transaction is expected to be completed by August 2024, but closing is subject to several customary conditions, including approval from the City of San Diego, the ground lessor. Additionally, the Company is evaluating the sale of two more hotels, subject to market conditions, to be completed in 2024 and 2025, respectively. The Company also announced today that, by utilizing cash on hand, it has fully repaid the outstanding $30 million loan associated with the 143-room Cameo Beverly Hills hotel located in Los Angeles, California. Over the past several months, the Company has diligently worked through its refinancing program and, subject to the pending sale of Hilton La Jolla Torrey Pines, Braemar has refinanced or paid off all of its 2024 debt maturities. Additionally, the Company announced plans to redeem $50 million of its non-traded preferred and/or public preferred stock this year, utilizing proceeds from the sale of the Hilton Torrey Pines."

17:18 EDT Artesian Resources raises quarterly dividend 2% to 29.55c per share - The dividend is payable May 28, 2024 to shareholders of record at the close of business on May 17, 2024.

17:12 EDT Bowman Consulting raises FY24 adjusted EBITDA view to $63M-$69M from $59M-$65M - The Company is "adjusting its FY24 outlook for net service billing to be in the range of $382M to $397M and Adjusted EBITDA in the range of $63M to $69M. The current outlook for 2024 is based on completed acquisitions as of the date of this release and does not include contributions from any future acquisitions."

17:10 EDT AST SpaceMobile appoints Andrew Johnson as Chief Legal Officer - AST SpaceMobile announced the appointment of Andrew Johnson as Chief Legal Officer. Johnson has assumed his new role effective May 6. Johnson brings over 24 years of diverse legal experience across emerging markets, capital markets and international operations to AST SpaceMobile's executive team. He most recently served as Executive Vice President, Chief Legal Officer and Chief Corporate Development Officer for 3D Systems Corporation, a publicly traded company that provides comprehensive 3D printing solutions in the industrial and healthcare segments. In that role, his responsibilities focused on leading mergers and acquisitions efforts, establishing strategic partnerships, and overseeing global legal matters, including corporate securities, contracts, litigation, labor, and employment. Johnson holds a JD from the University of Virginia, an MBA from the University of Michigan, and is a Miami University summa cum laude graduate. Johnson steps into the role previously held by Brian Heller, the outgoing Executive Vice President, General Counsel, and Secretary, during a strategic phase of growth for AST SpaceMobile.

16:57 EDT T2 Biosystems announces distribution agreement in Qatar - T2 Biosystems announced the execution of a territory exclusive distribution agreement in Qatar. Under the terms of the agreement, T2 Biosystems will sell T2Dx Instruments, the T2Bacteria Panel, the T2Candida Panel, and the T2Resistance Panel through the newly appointed distributor. The execution of this exclusive distribution agreement further expands T2 Biosystems' commercialization in the Middle East.

16:53 EDT Air Transport Services says made significant progress toward positive cash flow - CEO Joe Hete states: ""We have made significant progress toward achieving positive free cash flow in 2024. The expansion of our flying agreement with Amazon should only help reach that goal. Our amended agreement also provides opportunity for a combination of up to ten lease extensions and/or additional assigned aircraft, beyond the initial ten we will bring into service this year. Furthermore, CAM is well-positioned to lease additional freighters to other customers with minimal incremental capital investment as market demand improves. We look forward to further cash flow improvement next year, with increased Adjusted EBITDA and even lower capex."

16:47 EDT TopBuild to acquire Insulation Works, terms undisclosed - TopBuild has entered into an agreement to acquire Insulation Works, based in Wickes, Arkansas. Insulation Works services the residential and light commercial end markets in Arkansas and the surrounding states, and agricultural buildings nationally. Insulation Works has three locations across Arkansas and generates approximately $28M in annual revenue. The transaction is expected to close in May.

16:42 EDT FDA accepts priority review for Merus Zeno BLA for NRG1+ NSCLC, PDAC treatment - Merus announced that the U.S. Food and Drug Administration or FDA has accepted for priority review a Biologics License Application or BLA for the bispecific antibody zenocutuzumab, Zeno, in patients with neuregulin 1 fusion or NRG1+ non-small cell lung NSCLC and NRG1+ pancreatic PDAC cancer. "FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need," said Dr. Andrew Joe, Chief Medical Officer at Merus. "Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies." The FDA has granted Breakthrough Therapy Designation or BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy.

16:37 EDT Cooper-Standard expects to continue leveraging new program launches in FY24 - The company said, "Industry projections for full-year global light vehicle production in 2024 are similar to levels realized in 2023. In this broad macro industry view, the Company expects to continue leveraging new program launches and enhanced commercial agreements to drive further growth above the market. In addition, the Company expects to continue driving operational efficiency and improvement through additional aggressive lean cost structure initiatives. As these initiatives were not contemplated when the 2024 business plan was developed, we believe successful implementation will drive meaningful additional margin expansion and should represent upside to the Company's original full-year guidance, assuming industry production volumes achieve planned levels. The Company expects to provide a formal update to full-year guidance when it reports Q2 results."

16:34 EDT Cabot raises quarterly dividend to 43c per share from 40c - The dividend is payable on June 14, 2024, to stockholders of record at the close of business on May 31, 2024.

16:26 EDT Lumen names Chad Ho as Chief Legal Officer - Lumen Technologies announced it has appointed Chad Ho as executive vice president and chief legal officer. His appointment will begin in June. He succeeds Stacey Goff, whose legacy includes a distinguished 26-year career with Lumen and its predecessors. It's anticipated that Goff will remain with the company for a few weeks after Ho's appointment to ensure a smooth transition.

16:24 EDT IFF chief financial and business transformation officer Richter to retire - IFF announced that Glenn Richter, IFF's Chief Financial and Business Transformation Officer, plans to retire Dec. 31, 2024 after a three-year tenure with the company. A succession process has been initiated to evaluate internal and external candidates to succeed Richter as CFO. "During his time at IFF, Glenn has driven multiple actions to improve our balance sheet and position the company for financial success," said Erik Fyrwald, IFF CEO. "We have benefited from his experience and commitment to transformation. Notably, the work he has led on portfolio optimization, strategy development and our shared services agenda have positioned IFF to drive long-term profitable market share growth. The Board and I are grateful for all Glenn has helped IFF accomplish, and we appreciate his ongoing leadership of the finance function and support in identifying his successor and ensuring a smooth transition." Richter has been with IFF since 2021, leading global finance.

16:23 EDT Everi Holdings terminates stock repurchase program - Everi Holdings announced that it has terminated its stock repurchase program effective May 2, 2024. On May 3, 2023, the Company's Board of Directors approved the stock repurchase program under which the Company was authorized to repurchase an amount not to exceed $180 million of the Company's common stock through November 3, 2024. The Company repurchased 7.5 million shares of common stock, at an average price of $13.40 per share, for an aggregate amount of $100 million, under the Stock Repurchase Program. As of December 31, 2023, the remaining availability under the Stock Repurchase Program was $80 million. The Company has not repurchased shares of common stock under the Stock Repurchase Program subsequent to December 31, 2023.

16:18 EDT Beachbody Company reports Q1 DAU/MAU 33.2% vs. 32.5% last year - Reports Q1 Total Streams 25.6M vs. 29.7M last year.

16:17 EDT CompoSecure declares special cash dividend of 30c per share - CompoSecure's Board of Directors has declared a special cash dividend of 30c per share to Class A shareholders. The Company has also declared a corresponding distribution of $0.30 per share to Class B unitholders of CompoSecure Holdings, Both the dividend and distribution will be payable on June 11, 2024 to Class A shareholders and Class B unitholders of record as of May 20 and will be funded by cash on the Company's balance sheet. The total amount of cash disbursed to Class A shareholders and Class B unitholders is expected to be approximately $24.2 million. The Board may consider future special and recurring dividends and distribution payments in accordance with the Company's governance documents and borrowing arrangements.

16:04 EDT Axon to acquire Dedrone, terms not disclosed - Axon announced it has entered into a definitive agreement to acquire Dedrone, a global company in airspace security. Axon's mission to Protect Life finds a powerful ally in Dedrone, whose innovative technologies provide immense value to public safety and national security entities worldwide by protecting against increasing drone threats and advancing the use of Drones as First Responders. Ultimately, upon completion of the acquisition, Dedrone will strengthen Axon's ability to help customers safeguard their communities, improve response to critical incidents and protect even more lives in more places. The transaction is subject to customary closing conditions and is expected to close in the second half of 2024. The terms of the transaction were not disclosed.

16:02 EDT Heidrick & Struggles sees Q2 revenue $255M-$275M, consensus $264.82M

15:44 EDT Fastenal reports April net sales up 10.8% to $649.2M - Earlier, Fastenal reported April net sales were up 10.8% from last year to $649.2M and that daily sales were up 0.7% to $29.51M. Reference Link

14:55 EDT Plutonian Acquisition Corp trading resumes

14:44 EDT Novo Nordisk purchases B shares worth DKK 5.428B from Novo Holdings A/S - Novo Nordisk A/S has entered into an agreement to purchase 6,311,250 B shares of DKK 0.10 at a value of DKK 5.427,801,225B from Novo Holdings A/S as part of Novo Nordisk A/S' 2024 share repurchase programme of up to a total of DKK 20B to be executed during a 12-month period beginning February 6. The transaction price is DKK 860.02 per share and has been calculated as the three-day volume weighted average market price from May 2 to May 6 in the open window following the announcement of Novo Nordisk A/S' quarterly financial results, the company stated.

13:28 EDT Nucor falls after hot roiled coal price cut amid 'limited' activity - Nucor shares are moving lower after the company announced a hot roiled coal price cut. "Recently, spot order activity has been limited and not reflective of underlying demand due to a variety of competitive factors, including what appear to be increasing volumes of speculative purchases of additional tons through contract mechanisms at discounted prices. Our CSP aims to provide our customers an accurate price that takes into account these and other relevant market factors, while also offering our customers superior lead times. As a result of the above, effective immediately, the CSP HRC base price for the week of May 6th will be $760/ton for all producing mills, except CSI, where our CSP HRC base price will be $840/ton." The base price is down from $825 per ton. Shares of Nucor are down 2% to $170.78 in afternoon trading.

13:15 EDT Banco Sabadell rejects merger proposal from BBVA - Banco Sabadell (BNDSF) commented on BBVA's (BBVA) "unsolicited, indicative and conditional proposal" to merge with Banco Sabadell. "The Board believes that the Proposal significantly undervalues the potential of Banco Sabadell and its standalone growth prospects. The Board is highly confident in Banco Sabadell's growth strategy and its financial targets and is of the view that Banco Sabadell's standalone strategy will create superior value for its shareholders. Furthermore, the recent material decline and volatility in the BBVA share price increases the uncertainty around the value of the Proposal," Sabadell said in a statement. The board concluded that it is not in the best interest of Banco Sabadell and its shareholders and has therefore rejected BBVA's proposal.

12:03 EDT Beyond Meat announces Beyond Stack burger now at Whole Foods Market - Beyond Meat (BYND) announced that another Beyond Meat product will be available at Whole Foods Market (AMZN) stores nationwide with the addition of the smash-style Beyond Stack Burger. "Endlessly customizable and easy-to-cook, the Beyond Stack Burger goes from frozen to finished in six minutes in a skillet and can be eaten as a single patty or stacked multiple patties high, making it the perfect option to recreate popular smash-style burgers at home," Beyond Meat said. Reference Link

12:01 EDT Telephone and Data rises 9.9% - Telephone and Data is up 9.9%, or $1.42 to $15.78.

12:00 EDT GameStop falls -15.1% - GameStop is down -15.1%, or -$2.49 to $13.98.

12:00 EDT Bowlero falls -16.0% - Bowlero is down -16.0%, or -$2.00 to $10.49.

11:31 EDT NetApp appoints Dallas Olson as CCO - NetApp (NTAP) announced Dallas Olson as the company's new Chief Commercial Officer, reporting to NetApp's President, Cesar Cernuda. As NetApp's CCO, Olson will oversee sales strategy driving business growth in key areas including AI and Keystone through specialist teams, enhance market presence, optimize sales models, foster strategic partnerships, champion a customer-centric approach, and drive initiatives to maintain NetApp's position as a market leader primed for accelerated growth. Most recently, Olson led global go-to-market strategy and revenue operations for Cisco (CSCO).

11:22 EDT Noodles & Company says Steak Stroganoff sold out at restaurants nationwide - Noodles & Company announced that guests have completely sold out its LTO Steak Stroganoff. On April 10, 2024, Noodles re-introduced Steak Stroganoff to its menu for a limited time, and in a few short weeks, the dish completely sold out at restaurants nationwide. More than 110,000 bowls of Steak Stroganoff were sold within the first two weeks of launch, making the dish one of Noodles' top-selling limited time offering in history. Noodles is bringing Steak Stroganoff back in the next few weeks to give guests one last chance to try it before it's gone once again.

10:41 EDT Bowlero says April SSS up over 6% - Notes that comps were positive in February and March. Comments taken from Q3 earnings conference call.

10:21 EDT Spirit Airlines: Engine recall could ground 70 planes by end of 2025 - Comments taken from Q1 earnings conference call.

10:08 EDT Betterware de Mexico announces expansion to U.S. market - Betterware de Mexico has expanded to the U.S. market as Betterware U.S. The brand will have its new office headquarters located in Dallas, Texas. International expansion is one of the cornerstones of Betterware's growth strategy and the U.S. launch coincides with the company's multi-year period of consistent, organic growth. The decision to expand into the U.S. was a natural choice because of its proximity to Mexico, and an untapped customer base that already has some familiarity with the brand. The company thoughtfully chose Dallas as the home for its U.S. headquarters because of the city's superior distribution network and access to Texas' growing talent pool. Betterware's Global CEO Andres Campos believes the U.S. expansion is key to unlocking further growth.

10:06 EDT Tyson Foods sees 'a lot of factors at play' for rest of year

10:05 EDT Tyson Foods says in 'pretty good position to win' no matter where consumers shop

10:01 EDT Medical Properties Trust falls -9.6% - Medical Properties Trust is down -9.6%, or -47c to $4.40.

10:00 EDT Bowlero falls -19.5% - Bowlero is down -19.5%, or -$2.43 to $10.06.

10:00 EDT Bausch + Lomb rises 8.2% - Bausch + Lomb is up 8.2%, or $1.11 to $14.71.

09:54 EDT Marshall & Ilsley Corporation trading resumes

09:47 EDT Alpha Metallurgical falls -6.8% - Alpha Metallurgical is down -6.8%, or -$22.78 to $309.99.

09:47 EDT Bowlero falls -15.4% - Bowlero is down -15.4%, or -$1.92 to $10.57.

09:47 EDT REV Group rises 7.7% - REV Group is up 7.7%, or $1.79 to $25.05.

09:46 EDT Wetouch announces $15M in new orders - Wetouch Technology announces the launch of its highly anticipated second-generation touchable screen products. These innovative offerings redefine user experience with unmatched responsiveness, durability, and state-of-the-art design, solidifying Wetouch's position as an industry innovator and leader. "Several prominent international clients, including Siemens in Germany, as well as Canon and Sharp in Japan, have already placed orders for our latest products. These orders will contribute around $15 million of new sales revenue for this fiscal year, emphasizing the remarkable market demand and the superior quality and performance of Wetouch's cutting-edge touchscreen solutions. The company is expecting more orders in the future."

09:45 EDT EyePoint Pharmaceuticals trading resumes

09:41 EDT Tyson Foods: U.S. chicken production issues 'not a short term fix'

09:37 EDT Integra LifeSciences trading resumes

09:34 EDT Beneficient trading halted, volatility trading pause

09:32 EDT Integra LifeSciences trading halted, volatility trading pause

09:27 EDT VivoPower chairman, CEO Kevin Chin to increase shareholding to 13.5% - VivoPower has announced that Executive Chairman and CEO, Kevin Chin, is increasing his shareholding in the Company by a net total of 100,000 shares, representing approximately 2.7% of the undiluted number of issued and outstanding shares of the Company. This is expected to be through a combination of on-market and off-market transactions.

09:27 EDT Scinai Immunotherapeutics receives and appeals Nasdaq delisting notice - Scinai Immunotherapeutics received a letter on April 30 from the Listing Qualifications Department of Nasdaq notifying the company that, due to the company's non-compliance with the minimum $1.00 bid price requirement, the company's ADSs would be scheduled for delisting from Nasdaq and would be suspended for trading at the opening of business on May 7 unless the company timely requests a hearing before an independent Nasdaq Hearings Panel. The company has appealed the delisting determination and requested a hearing before the Panel. Such a request automatically stays any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel after the hearing. The company also approved a ratio change of the ADSs to its non-traded ordinary shares, increasing the number of ordinary shares represented by each ADS from 400 to 4,000, which is equivalent to a reverse split of 1 for 10. The anticipated effective date of the ratio change is May 21. The company expects that the ratio change will correct the ADS trading price non-compliance issue, which in turn, because corrected prior to the hearing, would make the need for a hearing moot. If the ratio change does not correct the non-compliance prior to the hearing, the Company will request an extension of time sufficient to regain compliance vis-a-vis the referenced ratio change or, if necessary, a further ratio change. During the period before the hearing, if any, the ADSs shares will continue to trade on Nasdaq.

09:24 EDT ADNOC terminates talks to buy stake in Braskem - In a regulatory filing, Braskem S.A. informs its shareholders and the market in general that it received the following correspondence sent by its controlling shareholder Novonor S.A.: "Dear Sirs, We refer to the negotiations with ADNOC International Limited - Sole Proprietorship L.L.C. on a potential transaction involving the transfer of shares held by NSP Investimentos S.A. - Em Recuperacao Judicial, controlled by Novonor S.A. - Em Recuperacao Judicial, issued by Braskem S.A.. We have been informed by Adnoc that they have no interest in continuing the process of analysis and negotiations with Novonor on the Potential Transaction. Novonor remains fully engaged in the process, in line with its commitment to its related parties. Being that what is required of us at this time, we endorse this correspondence." The filing added: "Braskem informs that it will continue to support the Shareholders signatories to the Company's Shareholders' Agreement and will keep the market informed about relevant developments, in compliance with applicable laws." Reference Link

09:20 EDT Tyson Foods: : Uncertainties remain around key commodity costs

09:19 EDT Gaucho Group observes 'notable surge' in Buenos Aires real estate market - Gaucho Group announced its analysis and response to recent data showing that property sales prices in Buenos Aires have registered the largest increase in the past six years. According to a monthly report prepared by Zonaprop, the first four months of 2024 have seen an accumulated increase of 1.9%, with a year-on-year rise of 2.5%. The recent uptick in property values in Buenos Aires is an encouraging indicator of economic vitality in the region. Gaucho Holdings believes this trend is a precursor to what may be a broader, country-wide increase in real estate prices. The anticipated introduction of more favorable lending rates and potential new mortgage offerings, linked to policy changes under the administration of President Javier Milei, could further enhance this upward trajectory. "Our real estate portfolio stands to benefit significantly from the strengthening market dynamics in Buenos Aires," said Scott Mathis, CEO and Founder of Gaucho Group Holdings, Inc. "The current increase in property sales prices not only underscores the enduring value of real estate investments in the area but also aligns with our expectations for further market expansion as new economic policies are introduced. We may anticipate a country-wide increase of up to 28% in real estate values over the next 12 months following the reintroduction of mortgage financing. For Gaucho Holdings' vineyard estate lots at Algodon Wine Estates in San Rafael, Mendoza, and our luxury boutique hotel in Buenos Aires, Algodon Mansion, we believe there could be a combined increase in value of approximately $35 million this year."

09:18 EDT Nuburu awarded $850,000 NASA contract - Nuburu announced it has been awarded an $850,000 Phase II contract by the National Aeronautics and Space Administration, or NASA, to advance blue laser power transmission technology as a unique solution to dramatically reduce the size and weight of the equipment needed for Lunar and Martian applications. This contract award builds upon Nuburu's successful Phase I Small Business Innovation Research announced in August 2023.

09:16 EDT Safety Shot provides shareholder update on progress, strategic vision - Safety Shot released a shareholder update to highlight the Company's progress and strategic vision to maximize long-term shareholder value. In the last several months, the Company has accomplished tremendous milestones which include: Launching Safety Shot; Releasing Safety Shot for sale on the e-commerce platform Amazon; Announcing a strategic distribution agreement with a leading brand-building agency and distributor based in Los Angeles, to amplify its presence in the vibrant Southern California market; Gearing up to launch Safety Shot in Las Vegas and Los Angeles retail stores by the end of the Q2 2024; Nearing completion of the Company's clinical trial to measure the effectiveness of Safety Shot in reducing blood alcohol content by supporting its metabolism; Amassing an impressive portfolio of celebrities and influencers; Making several pivotal management changes to drive growth for the Company

09:14 EDT Lexaria announces research program to evaluate DehydraTECH-GLP-1 drugs - Lexaria Bioscience announces an applied research program to evaluate certain molecular characteristics of DehydraTECH processed with the glucagon-peptide 1 drug, semaglutide, related to its mode of action and performance. The research will be conducted in partnership with the National Research Council of Canada. This work program will evaluate the molecular properties of DehydraTECH-processed pure semaglutide using simulated gastric fluid thereby mimicking conditions in the human gut. A battery of testing methods will be employed, including polyacrylamide gel electrophoresis, size exclusion chromatography, matrix assisted laser desorption ionization mass spectrometry and dynamic light scattering. Parameters to be examined will include the oligomerization potential of DehydraTECH-processed pure semaglutide in gastric fluid, relative to published literature showing that semaglutide delivered from commercially available Rybelsus occurs in simple monomeric form in the human gut amenable to permeation of the gastric epithelium for delivery systemically. Identifying the molecular behaviour of DehydraTECH-processed pure semaglutide compositions will complement Lexaria's 2024 animal and human pharmacokinetic and pharmacodynamic studies and could ultimately lead to alternative formulations with enhanced performance. Initial pilot clinical testing in humans announced earlier this year using a DehydraTECH-semaglutide capsule composition formulated using crushed Rybelsus tablets evidenced that DehydraTECH processing led to 43% higher peak levels of semaglutide in blood than the unprocessed Rybelsus tablet. A reduction in adverse event incidence along with significant improvements in blood sugar control was also evidenced in that study with the DehydraTECH-processed Rybelsus compared to the unprocessed Rybelsus. The research program is expected to complete in early August and results will be reported as soon as possible thereafter.

09:11 EDT Portillo's appoints Correia as CIO, Scarpino as CMO - Portillo's announced the appointments of Keith Correia as Chief Information Officer, CIO, and Nick Scarpino as Chief Marketing Officer, CMO. Both leaders will play key roles for the business as Portillo's expands and scales nationwide. Correia joins Portillo's after serving as Chief Information Officer at Steak 'n Shake. Scarpino re-joined the company in 2015, and brings a proven track record of innovative marketing strategies to his new role as the company's first CMO.

09:10 EDT Turbo Energy files patent application in Spain for its Sunbox product - Turbo Energy announced it has filed a patent application with the Spanish Patent and Trademark Office, OEPM, for its Sunbox Commercial & Industrial product. This product, which is already available on the market, offers the most efficient and adaptable solution for both isolated and grid-connected projects. Additionally, the product allows for existing solar installations of any brand to be managed by the Sunbox system, thus expanding a user's photovoltaic production capability as needed.

09:08 EDT Freddie Mac announces tender offer for certain STACR notes - Freddie Mac has commenced a fixed-price cash tender offer for the purchase of any and all of the STACR Notes listed beginning Monday, May 6, 2024. Freddie Mac is the holder of the owner certificate issued by each Trust and, as a result, the sole beneficial owner of each Trust. Freddie Mac has engaged Nomura Securities International, Inc. and BofA Securities, Inc. as lead dealer managers and CastleOak Securities, L.P. as co-dealer manager for the Offer. Freddie Mac is offering to purchase any and all of the Notes listed. The applicable Total Consideration to be paid by Freddie Mac to holders that tender Notes accepted for purchase pursuant to the Offer will be calculated based on the original principal amount of such tendered and accepted Notes, the applicable factor, and the applicable Tender Offer Consideration identified in the table below, plus any accrued and unpaid interest under the applicable Debt Agreement or Indenture upon the terms and subject to the conditions set forth in the Offer to Purchase dated May 6, 2024 and related Notice of Guaranteed Delivery dated May 6, 2024. Capitalized terms used and not otherwise defined herein will have the meaning ascribed to such terms in the Offer to Purchase. The tender offer period will commence on Monday, May 6, 2024, and expire at 5 p.m. New York City time on Friday, May 10, 2024 unless extended.

09:07 EDT BlackLine appoints Jimmy Duan as Chief Customer Officer - BlackLine has appointed Jimmy Duan as Chief Customer Officer, effective May 6th. Prior to BlackLine, he served as EVP and chief customer officer at cloud experience management pioneer Medallia and was a member of the executive team when they went public. Before that, he served as EVP and chief technology officer at CallidusCloud, a global sales performance management leader.

09:06 EDT Collective Audience appoints Cary Tilds to Advisor Collective - Collective Audience has appointed Cary Tilds to its Advisor Collective, a new community of strategic advisors who share a commitment to the transformation of the AdTech, MarTech and digital media for benefit of advertisers and publishers. Tilds is an award-winning digital advertising executive with 30 years of experience driving digital strategies, marketing, technology and innovation for Fortune 500 media giants that include WPP, Mindshare, Omnicom, and Ford Motor Company.

09:05 EDT AGBA Group says Triller merger 'ushers in new era of value creation' - The company said, "AGBA Group Holding reaffirms its unwavering dedication to creating shareholder value through a collaborative team effort and strategic initiatives. Since going public via a SPAC in November 2023, AGBA's team of over 1,500+ employees has worked tirelessly everyday in delivering steady growth persistently quarter after quarter maintaining our market leadership. At the same time, we work constantly testing and creating partnership and acquisition opportunities that would provide important long-term strategic advantages. The $4 billion merger of AGBA and Triller announced on April 18, is a direct result of such team efforts. AGBA's shares have traded well. As a result, we are pleased that AGBA has been informed by The Nasdaq Stock Market that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. Our teams have wasted no time in joining forces and collaborating closely across all areas of operations and planning. The integration efforts are well underway, leveraging the expertise and synergies of both organizations to drive enhanced stakeholder value. As we progress through the integration and regulatory approval process, our teams remain motivated and confident in the merger's potential to unlock new growth opportunities and deliver enhanced value to our stakeholders."

09:04 EDT Twilio announces Chris Koehler appointed Chief Marketing Officer - Twilio announced that Chris Koehler has been appointed Chief Marketing Officer. Chris brings over 25 years of expertise in customer engagement and marketing technology, and a proven track record of driving growth and innovation at industry-leading companies. As CMO, Chris will report to Chief Executive Officer Khozema Shipchandler, and oversee Twilio's global marketing strategy, focusing on expanding brand awareness in Twilio's key markets and amplifying product innovation. He will play a pivotal role in growing market share across Twilio Communications and Segment, and driving messaging and positioning for Twilio's customer engagement platform, which combines communications, data, and AI to unlock greater value for customers.

09:04 EDT Delcath Systems' Hepzato Kit in melanoma meets primary Phase 3 endpoint - Delcath Systems announced the publication of results from the pivotal Phase 3 FOCUS study of Hepzato Kit - melphalan/Hepatic Delivery System - in patients with unresectable metastatic Uveal Melanoma on May 5 in the journal Annals of Surgical Oncology. The FDA approved Hepzato Kit in 2023 based on the results from the pivotal FOCUS study. The primary efficacy endpoint of the FOCUS study was Overall Response Rate, which was 36.3%, including 7.7% of patients with Complete Response. 37.4% of patients had Stable Disease. ORR achieved in the FOCUS study was compared to a Meta-analysis of historic data. ORR of 36.3% in the FOCUS study was statistically significantly better than the pooled ORR estimate of 5.5% in the historical control group. Safety and tolerability of HEPZATO KIT treatment reported in the FOCUS study was comparable with published clinical experience with Chemosat in Europe. Hepzato is the only liver-directed treatment for unresectable mUM patients approved by the FDA.

09:03 EDT Synopsys to sell Software Integrity Group unit to Clearlake, Francisco for $2.1B - Synopsys announced it has entered into a definitive agreement with Clearlake Capital Group and Francisco Partners, two global private equity firms, for the sale of its Software Integrity Group business in a transaction with a total value of up to $2.1B, including up to $475M in cash payable upon Francisco Partners and Clearlake achieving a specified rate of return in connection with one or more liquidity transactions. Upon completion of the transaction, the business will emerge as a newly independent application security testing software provider. The existing Software Integrity Group management team is expected to lead the newly independent, privately held company after the transaction closes. The name of the new standalone entity will be announced at a later date. Synopsys is committed to a seamless transition for the Software Integrity Group team, customers, and partners. The transaction, which was unanimously approved by Synopsys' Board of Directors, is currently expected to close in the second half of 2024, subject to customary closing conditions including the receipt of required regulatory approvals.

09:02 EDT Synopsys to sell Software Integrity Group unit to Clearlake, Francisco for $2.1B

08:52 EDT Robinhood drops after disclosing 'Wells Notice' from staff of SEC - Robinhood disclosed that on May 4, Robinhood Crypto received a "Wells Notice" from the staff of the Securities and Exchange Commission stating that the staff has advised Robinhood that it made a "preliminary determination" to recommend that the SEC file an enforcement action against the company. The potential action may involve a civil injunctive action, public administrative proceeding, and/or a cease-and-desist proceeding and may seek remedies that include an injunction, a cease-and-desist order, disgorgement, pre-judgment interest, civil money penalties, and censure, revocation, and limitations on activities, Robinhood said in a regulatory filing. As previously disclosed, Robinhood Crypto has received investigative subpoenas from the SEC regarding, among other topics, the company's cryptocurrency listings, custody of cryptocurrencies, and platform operations. Robinhood Crypto "has cooperated with this investigation," the company noted. Robinhood shares are down 3% to $17.43 in premarket trading.

08:47 EDT Forafric to boost crushing capacity expansion with new operating facility lease - Forafric Globa announced it has entered into a 10-year renewable contract to lease and operate an existing milling facility located in the Meknes-Fes region of Morocco. This marks a significant milestone in the expansion of the Company's milling capabilities and positions Forafric for continued growth. This expansion is expected to increase the Company's milling capacity by approximately 470 tons of soft wheat and 130 tons of durum per day for an aggregate increase in total production of approximately 600 tons per day. The contract is subject to regulatory approvals and other customary closing conditions. The Company expects to transition operations to Forafric in the third quarter of 2024.

08:39 EDT 1847 Holdings re-engages ShareIntel to investigate potentially illegal trading - 1847 Holdings has re-engaged Shareholder Intelligence Services to utilize their patented, proprietary service offerings to obtain share trading analytic metrics designed to help coordinate, monitor and enhance corporate governance, shareholder communication, regulatory compliance and surveillance of trading in the Company's shares in an effort to allow Company to better monitor trading activity, including potential violations of SEC Regulation SHO, which governs stock and option share locate, closeout and fail to deliver requirements.

08:35 EDT Alpha Tau presents preclinical data at 2024 ESTRO - Alpha Tau Medical announced the presentation of new preclinical data at the 2024 congress of the European Society for Radiotherapy and Oncology, ESTRO, currently taking place in Glasgow, UK, examining observed responses in distant untreated tumors, otherwise known as an abscopal effect, generated by Alpha DaRT in pancreatic cancer tumors in mice. The Company's Chief Medical Officer, Dr. Robert Den, delivered a company presentation during the weekend entitled "Innovative Use of Radium-224 for Intralesional Treatment of Various Forms of Solid Tumors." In these preclinical studies, mice were initially inoculated intracutaneously with the Panc02 or KPC murine cell lines, and then shortly thereafter were inoculated with a secondary tumor of the same cell line in a distant site. The first tumor was treated with Alpha DaRT sources 9-10 days after inoculation, or with an inert source as a control, and the size of the secondary untreated tumor was measured every 3-4 days thereafter for 29 days. The percent change in tumor volume over time was assessed and compared between the groups with Repeated Measures ANOVA models. A statistically significant decline in secondary tumor growth rate was found at days 21, 25 and 29 in those mice that received Alpha DaRT sources in the first tumor compared to those that received inert sources in the first tumor. A similar pattern was also observed when examining the Panc02 and KPC tumor models individually rather than grouped in one larger analysis.

08:34 EDT SRIVARU completes production model of PRANA 2.0 - SRIVARU Holding completed the internal testing of its PRANA 2.0 electric motorcycle, resulting in a full production model being submitted for final certification by applicable road and safety authorities. Additionally, the Company reports that its complete supply network is in place for production of the PRANA 2.0 upon final certification.

08:33 EDT Myomo announces 1st sum reimbursements to Medicare Part B under new CMS fees - Myomo announced that the Centers for Medicare & Medicaid Services CMS through their regional contractors known as the DME MACs, have remitted and paid lump sum reimbursements to the Company and are beginning to reimburse orthotics and prosthetics providers for MyoPros delivered to Medicare Part B beneficiaries. The amounts paid were based on the fees published by CMS for the Company's Healthcare Common Procedures Coding System codes L8701 and L8702, which became effective on April 1 . All four regional DME MAC's have remitted lump sum reimbursements, and payments have been received for a number of patients of the Company and O&P providers based on the published fee schedule.

08:33 EDT Ohmyhome Q1 saw 'significant growth' vs last year - Rhonda Wong, CEO and Co-founder of Ohmyhome, commented, "We are excited about our technological advancements and strategic initiatives, including the acquisition of the property management segment. The company remains committed to its vision of becoming the most trusted and comprehensive property solution for everyone through the use of technology, as we continue to deliver long-term value to our shareholders and customers."

08:32 EDT TC Biopharm executes second non-binding LoI for acquisition - TC BioPharm today announced the execution of a non-binding letter of intent to acquire a privately-held biotechnology company pursuing the development of innovative Chimeric Antigen Receptor T-cell, or CAR-T, therapies for the treatment of refractory cancers and solid tumors. This agreement is the second such agreement in as many months shows TCBP's commitment to its M&A strategy aimed at expanding its therapeutic platform. The target acquisition has developed a number of proprietary approaches to re-engineer CARs to better target solid tumors. In addition, the target acquisition is also developing a novel, allogeneic CAR-T for the treatment of autoimmune diseases. There can be no assurance that a definitive agreement will be executed or that the proposed transaction will be consummated on the terms or timeframe currently contemplated.

08:28 EDT Rhythm Pharmaceuticals presents data from Phase 3 pediatrics trial - Rhythm Pharmaceuticals announced that the Company delivered three presentations - one oral and two posters - at The Pediatric Endocrine Society's, PES, Annual Meeting held May 2-5, 2024 in Chicago, IL. In the oral presentation, Rhythm showcased data that was previously announced on December 6, 2023, from its 52-week, Phase 3 pediatrics trial in patients between the ages of 2 and younger than 6 years with Bardet-Biedl syndrome or obesity due to proopiomelanocortin or leptin receptor deficiency. Treatment with setmelanotide achieved the primary endpoint with a 3.04 mean reduction in BMI-Z score and 18.4 percent mean reduction in body mass index.

08:27 EDT Ocean Power demonstrates advanced AI solutions in North Atlantic - Ocean Power Technologies announced it has completed multiple offshore demonstrations for potential customers of its Artificial Intelligence capable Maritime Domain Awareness Solution, Merrows. These demonstrations were conducted using the recently deployed Next Generation PowerBuoy. Philipp Stratmann, CEO and President of Ocean Power Technologies, expressed his enthusiasm about this milestone, stating, "There is no better tool to onboard new customers than to see our PowerBuoy based Maritime Domain Awareness Solution in its natural element, the open ocean. These field demonstrations truly highlight the advanced algorithms of the Merrows offering. They are helping us advance and accelerate our sales efforts and continue the revenue growth trajectory we have reported."

08:26 EDT Infinera expects to file Annual Report on Form 10-K on or before May 13 - Infinera Corporation expects to file its fiscal year 2023 Annual Report on Form 10-K on or before May 13, 2024. The company, along with its auditors, is continuing to make progress with the normal year-end close process. The company also announced that it expects to release its financial results for the first quarter of fiscal 2024 and outlook for the second quarter of fiscal 2024, after the market closes on May 14, 2024.

08:25 EDT Fortrea Holdings reschedules release of Q1 financial results - Fortrea announced an updated issuance date for the company's first quarter 2024 financial results. The Company requires additional time to work through accounting and discontinued operations matters primarily as a result of entering into a definitive agreement in March 2024 to divest assets relating to the Company's Enabling Services segment. Fortrea will now release its first quarter 2024 financial results before the market opens on Monday, May 13, 2024, rather than on Tuesday, May 7, 2024, as previously announced. The company will host a conference call at 8:00 am ET on the date of release to review its financial results and conduct a question-and-answer session.

08:23 EDT Panbela Therapeutics announces issuance of new patent in US, Canada - Panbela Therapeutics announced an Issue Notification for the US continuation patent US 11,925,613 B2 and Canadian patent CA 3003149 titled "EFLORNITHINE AND SULINDAC, A FIXED DOSE COMBINATION FORMULATION". These patents claim a novel composition of a fixed dose combination of eflornithine and sulindac, which is called Flynpovi. The product was developed in collaboration with Sanofi, an innovative global healthcare company. Flynpovi is Panbela's lead investigational product for the treatment of patients with Familial Adenomatous Polyposis. The patents are valid until 2036, have issued in the US, Australia, Mexico, Taiwan, and Chile. The application is under review in additional countries. Jennifer Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, "We're excited to have this patent in Canada as well as the continuation in the US. Expansion of our patent portfolio further supports our global clinical programs. First issued in the United States in 2021 and now in several other territories, this patent covers the novel co-formulation of Flynpovi, our lead FAP product in development."

08:21 EDT Gorilla, MTI enter strategic alliance for advanced manufacturing hub in Egypt - Gorilla Technology Group announced a strategic partnership with Misr Trade & Investment Group. The partnership reinforces both parties' commitment to revolutionizing the global cybersecurity market with advanced technological solutions and optimized supply chain strategies. Gorilla and MTI are joining forces to establish a state-of-the-art manufacturing plant in Egypt that will drive technological advances and foster economic growth in the region. This manufacturing plant will serve as a hub for producing cutting-edge Customer Premises Equipment tailored to meet the evolving needs of governmental and enterprise sectors worldwide. The partnership between Gorilla and MTI extends across three key areas of collaboration: Technology and Knowledge Sharing and Development: By pooling resources and talent, Gorilla and MTI aim to accelerate the development of advanced network appliances and intelligent edge solutions focused on performance and reliability. Market Development and Sales Channel Expansion: Through joint marketing efforts, channel partner development, and targeted sales initiatives, the partnership plans to advance into important government and business markets with tailored offerings. Establishing a strong distribution and reseller network will help Gorilla and MTI improve their market presence and make their products more readily available, with an emphasis on increasing sales and customer satisfaction. Supply Chain and Logistics Optimization: Gorilla and MTI are committed to optimizing supply chain and logistics operations to ensure timely and cost-effective delivery of raw materials and finished goods. Leveraging MTI's local logistics networks, customs expertise, and storage facilities, the partnership will streamline operations, reduce lead times, and enhance the overall customer service experience.

08:19 EDT Allarity exceeds Nasdaq's minimum equity requirement - Allarity Therapeutics announced that its stockholders' equity is significantly above the $2.5 million minimum required by Nasdaq Listing Rule 5550(b)(1). The Company is in the process of obtaining official written confirmation from Nasdaq, which will reinstate its full compliance with Nasdaq listing requirements. In line with this progress, Allarity plans to formally request the Securities and Exchange Commission to withdraw its Registration Statement on Form S-1, which was originally submitted to the SEC on October 30, 2023. This decision follows a thorough reassessment of the company's financial position, reflecting the recent improvement in equity status. The Company will disclose the updated equity amount in its forthcoming Form 10-Q as part of its routine financial disclosures. This Form 10-Q is expected to be filed on May 14, 2024, and will provide stockholders with detailed insights into the Company's financial situation.

08:18 EDT Ocuphire Pharma announces presentation on APX3330 at ARVO 2024 - Ocuphire Pharma announced that clinical data from its ZETA-1 trial evaluating APX3330 in diabetic retinopathy on a validated binocular person-level scale was presented yesterday at the Association for Research in Vision and Ophthalmology Annual Meeting, taking place May 5-9, 2024 in Seattle, Washington. Presentation Highlights: ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023. A subset analysis was conducted to evaluate the efficacy of APX3330 in slowing DR progression using the target population of the planned Phase 2/3 study and the Food and Drug Administration's-agreed upon registration endpoint of a 3-step change on a binocular diabetic Retinopathy Severity Scale. This 17-step person-level scale accounts for the DRSS scores of the two eyes and then anchors the step to the worse eye. The subset comprised 68 participants from the ZETA-1 trial who had a baseline DRSS score of 47 or 53 in at least one eye and 43, 47 or 53 in the other eye. Analysis of the ZETA-1 Phase 2 subset using the binocular person-level scale showed that no participants in the APX3330 group had a greater than or equal to 4-step worsening at week 24 compared to 15.2% in the placebo group, representing a 100% reduction between groups. Similarly, only 5.7% of APX3330-treated subjects had a greater than or equal to 3-step worsening at week 24 compared to 15.2% of placebo subjects, representing a 62.5% reduction between groups. Fewer participants in the APX3330 group developed proliferative diabetic retinopathy by week 24 compared to the placebo group. APX3330 showed favorable safety and tolerability, with similar ocular adverse events between APX3330 and placebo groups.

08:17 EDT Sensus Healthcare announces sale of first SRT-100 Vision System to Asia - Sensus Healthcare announces the sale of the first SRT-100 Vision system in Asia, to Far Eastern Memorial Hospital in Taiwan. The hospital, which has more than 1,000 beds, is one of the largest private hospitals in Taiwan. Far Eastern Memorial Hospital also plans to publish research on possible new indications for the SRT-100 Vision, which may be instrumental in the support of label expansion beyond non-melanoma skin cancer and keloids worldwide.

08:16 EDT Wendy's adds U.S. Chief Marketing Officer Lindsay Radkoski to Senior Leadership - Wendy's announced that Lindsay Radkoski, U.S. Chief Marketing Officer, will join the company's Senior Leadership Team and report to CEO Kirk Tanner. Radkoski joined the company in 2011 in the Investor Relations function and worked in roles of increasing responsibility in Finance and Marketing, including VP of National Marketing before being appointed U.S. Chief Marketing Officer in March 2023.

08:13 EDT Akoya Biosciences opens Operations and Manufacturing Center in Marlborough - Akoya Biosciences has opened its Operations and Manufacturing Center of Excellence in Marlborough, Massachusetts to meet the accelerating demand for its spatial biology solutions and the increased utilization of the company's PhenoCycler-Fusion and the PhenoImager HT platforms. "Spatial biology is transforming drug discovery, translational sciences, and clinical research, and advancing our ability to understand biology, disease progression, and patients' response to therapy," said Brian McKelligon, CEO of Akoya Biosciences. "The vast potential of spatial biology, combined with the higher throughput and plex capabilities of our systems, are driving increased demand for our reagents. We expect our investment in the Manufacturing Center of Excellence will drive operational efficiencies, allowing us to better serve our customers, deliver reagents at increasing scale, and further broaden our portfolio of reagents to unlock new market opportunities."

08:13 EDT Enphase Energy expands IQ8 commercial microinverter deployments in NA - Enphase Energy announced that installers of Enphase products across North America, NA, have seen growing deployments of IQ8 Commercial Microinverters. "Our goal at Enphase is to equip solar installers with the tools they need to grow their business and create happy customers," said Mehran Sedigh, senior vice president of sales at Enphase Energy. "Our dedicated solution for the small commercial market is designed with the needs of installers and commercial facility operators in mind, while also supporting the adoption of renewable energy even further."

08:10 EDT Atlas Energy increases quarterly dividend to 22c per share - The board of directors of Atlas declared an increased dividend to common stockholders of 22c per share, or approximately $24.1M in aggregate to shareholders. The dividend includes a 16c per share base dividend and a 6c per share variable dividend. The dividend will be payable on May 23 to shareholders of record at the close of business on May 16.

08:09 EDT Sagimet Biosciences announces appointment of Chauche as CFO - Sagimet Biosciences announced the appointment of Thierry Chauche as Chief Financial Officer, effective today, May 6, 2024. Most recently Chauche served as Chief Financial Officer of Provention Bio

08:06 EDT Whitestone REIT exposes new information on nominee Bruce Schanzer - Whitestone has received new information revealing that Erez Asset Management nominee Bruce Schanzer colluded in late 2023 with terminated Whitestone Chairman and CEO James Mastandrea in an attempt to acquire Whitestone. For context, in January 2022, Whitestone Trustees David Taylor and Nandita Berry guided the Board in terminating Chairman and CEO, James Mastandrea. They have since spearheaded an effort, along with Whitestone's new management team, to reset the Company on a new trajectory. This newly obtained material - an investor "pitch" presentation that Erez developed in 2023 - puts a clear spotlight on the ulterior motives of Mr. Schanzer, who it is revealed "has had a number of meetings with Mastandrea" and believes that Mastandrea "will be cooperative and supportive of an Erez-led effort to acquire Whitestone". "The willingness of ...Mastandrea and...Pillarstone to be constructive regarding an Erez approach" demonstrates that Erez, Mastandrea and Pillarstone are acting in concert. It also reveals a pattern of lies and deception by Schanzer, supported by a track record of conflicted, self-dealing transactions. Schanzer and Mastandrea's collusion could also be an attempt by Mastandrea to settle the score with those who held him accountable and terminated his employment for cause: David Taylor and Nandita Berry.

08:04 EDT Regulus' Phase 1b trial of ADPKD candidate advances to Cohort 4 - Regulus Therapeutics initiated screening in the of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the fourth cohort will receive an open label fixed dose of 300 mg of RGLS8429 every other week for three months. Regulus' team expects to share further updates as they become available, including topline data from the third cohort in the middle of this year.

08:02 EDT White Mountains appoints David Mondrus as CFO - White Mountains Partners, a White Mountains operating company, announced that David Mondrus has joined as CFO and Financial Operating Partner. Prior to joining White Mountains Partners, he was a Finance Director at The Riverside Company, a private equity firm focused on acquiring growing companies in the lower middle market. David began his career at KPMG LLP in the Assurance practice.

07:56 EDT FDA posts 510(k) approval of Outset Medical's TabloCart - The FDA posted on its website 510(k) premarket notification approval of Outset Medical's TabloCart with prefiltration. The stock in premarket trading is up 11% to $3.48. Reference Link

07:51 EDT Fairfax Financial announces passing of Eric Salsberg - Fairfax Financial announces with great sadness the passing of Eric P. Salsberg, who joined Fairfax in 1988 after acting as counsel to Fairfax on every major transaction it undertook since its founding in 1985. Rick served as Vice President - Corporate Affairs and Corporate Secretary for Fairfax, and provided strategic advice and guidance on countless transactions undertaken by the company over the years.

07:43 EDT Gryphon Digital Mining produces 40 bitcoin in April - Gryphon Digital Mining has released its unaudited operational update for April 2024. Key highlights for the month: Produced approximately 40 bitcoin; Approximately $2.6 million in value based on an average April bitcoin price of $66,183; Production of 1.33 BTC/day on average, or about $88,244/day; Achieved bitcoin efficiency of 43 BTC/EH; New Company record average self-mining hashing power of 914 PH/s in April; Machine upgrade program completed with the installation of Bitmain S21 200 TH/s machines; 21 bitcoin in treasury as of April 30, 2024; Average machine efficiency improved to 28.7 J/T in April; Scope 1 and Scope 21 operations continue to be 100% electrified by zero-carbon emitting Hydro power. "April signified the beginning of our post go-public improvement program as we ordered and installed a batch of state-of-the-art Bitmain S21 200 TH/s machines to upgrade our mining fleet. The result of this effort was a new Company all-time high in average hashing power at 914 PH/s as well as a new Company all-time best in average mining efficiency at 28.7 J/T as our new machines are currently tracking to be 43% more efficient than the machines they replaced," noted Rob Chang, CEO of Gryphon. "For the month, we earned bitcoin valued at approximately $2.6 million based on an average bitcoin price of $66,183, which includes record setting days when bitcoin mining transaction fees were particularly valuable."

07:40 EDT Tradeweb Markets reports April ADV 1.94T, an increase of 61% - Tradeweb Markets reported total trading volume for the month of April 2024 of $41.9T. Average daily volume or ADV, for the month was $1.94 T, an increase of 69.1% year-over-year YoY. In April 2024, Tradeweb records included: ADV in fully electronic U.S. High Grade credit; Share of fully electronic U.S. High Grade TRACE ADV in global repurchase agreements ...Fully electronic U.S. credit ADV was up 96.1% YoY to $8.0bn and European credit ADV was up 19.4% YoY to $2.3B. Higher U.S. credit volumes were driven by increased client adoption, most notably in request-for-quote or portfolio trading and Tradeweb AllTrade . Tradeweb captured a record 19.7% share of fully electronic U.S. High Grade TRACE, and 7.3% share of fully electronic U.S. High Yield TRACE. Increases in European credit volumes were driven by continued client adoption of portfolio trading, unique dealer selection tool and session-based trading.

07:38 EDT NextEra Energy names Kirk Crews as chief risk officer - NextEra Energy announced that Kirk Crews is appointed to the role of executive vice president and chief risk officer, NextEra Energy. Crews will be succeeded in his present role by Brian Bolster, who is appointed executive vice president, finance and CFO, NextEra Energy.

07:38 EDT ETFS Capital urges stockholders of WisdomTree to vote against re-elections - ETFS Capital Limited, the largest combined owner of common stock of WisdomTree, with ownership of approximately 10% of the outstanding Common Stock, which together with its Series A Preferred Stock would represent approximately 18% of the Company's outstanding Common Stock on an as-converted basis, announced that it has released a letter to its fellow WisdomTree stockholders and filed a definitive proxy statement with the Securities and Exchange Commission in connection with WisdomTree's 2024 Annual Meeting of Stockholders, which is scheduled for June 12, 2024. WisdomTree Stockholders Urged to Vote AGAINST the Re-Election of Chairman Win Neuger, Director Anthony Bossone, And CEO And Director Jonathan Steinberg on GOLD ETFS Proxy Card

07:36 EDT Dime Community announces expansion in Williamsburg - Dime Community Bancshares announced that it has hired a deposit-focused Group that will cover the Williamsburg market. The Group will be led by John McDonough and Emanuel "Manny" Diconimakis. The Group was previously employed with the former Signature Bank and its successor, Flagstar Bank. Stuart Lubow, President and Chief Executive Officer of Dime said, "We are excited to announce the addition of another talented deposit-focused Group in the strategically important market of Brooklyn. Dime, which was founded in Williamsburg in 1864, has always been a key part of the fabric of this vibrant neighborhood. It gives us great satisfaction to stay true to our roots and expand our presence in Williamsburg through the hiring of John and Manny. We continue to capitalize on the disruption in our marketplace and execute our growth plan in a thoughtful and targeted manner."

07:25 EDT Allot Ltd. appoints Eyal Harari as CEO - Allot Ltd. (ALLT) announced the appointment of Eyal Harari as its CEO effective May 6, 2024. He will be replacing Mr. Erez Antebi. At the request of the company's Board of Directors, Mr. Antebi has agreed to assist Mr. Harari during a transition period and thereafter, to continue to provide consulting services to the company. Prior to joining Allot, between November 2019 and January 2024, Mr. Harari served as CEO of Radcom (RDCM).

07:22 EDT Zentek, Triera announces results against avian influenza using aptamer tech - Zentek announces that its wholly-owned subsidiary Triera Biosciences has prioritized the development of a prophylaxis and therapeutic for highly pathogenic avian influenza and reports initial test results. Background and Highlights: Universal aptamer has been selected for influenza virus, including H5N1; Binding affinity of influenza aptamer is better than aptamer used for SARS-CoV-2, which has demonstrated improved protection over leading monoclonal antibodies in animal models; Development prioritized given current global HPAI H5N1 outbreak. In vivo testing to begin immediately; World Health Organization deems current H5N1 outbreak "enormous concern," priority target for numerous governments around the world; Provisional patent filed on influenza virus-targeting aptamer. The recent avian influenza H5N1 outbreak which began in 2020, has reached a critical stage, according to the World Health Organization. Recently, the world has been placed on watch as H5N1 has crossed into livestock in the U.S. and H5N1 RNA sequences have been detected in the milk supply. The chief scientist of the World Health Organization, Dr. Jeremy Farrar, has expressed "enormous concern" to public health as the transmission of the virus has increased amongst livestock. H5N1 has the potential to lead to a severe pandemic with a historic mortality rate as high as 52% in the limited human cases to date. Over the last few years, H5N1 has led to the death of millions of poultry with wild birds and land and marine mammals also infected. Government agencies have expressed their concern of an H5N1 outbreak and their interest to develop further assets that could either treat or prevent further transmission of H5N1 to the human population. There is also interest for new options to mitigate the spread of H5N1 amongst livestock as this could have a potentially devastating impact on the food supply and the economy - along with providing an opportunity for the virus to better adapt to mammals, which increases risk to humans. Due to the growing concern of HPAI, Triera has recently prioritized the development of a universal aptamer for influenza. The mechanism of neutralizing the H5N1 virus is comparable to the mechanism used by C19HBA against the SARS-CoV-2 virus. More specifically, the aptamer is believed to bind to and neutralize multiple subtypes of the HA surface protein, preventing the virus from entering healthy cells and spreading infection. Lead aptamer sequences for influenza have already been selected by the Li Lab at McMaster University for the creation of a universal influenza aptamer. These lead candidates have been tested using a dot blot assay and biolayer interferometry to assess the binding affinity to the H5 protein for avian influenza. The lead monomer candidates for influenza are binding with an affinity less than one nanomolar, which compares favourably to the monomer used to form C19HBA. The team at McMaster have used the proprietary multivalent aptamer technology to synthesize lead therapeutic and prophylactic candidates. In the coming weeks, the neutralization and therapeutic potential of these lead candidates will be assessed through in vitro and in vivo tests conducted by the Miller Laboratory. These results will be used to guide further optimization with the goal of having a final lead therapeutic candidate ready for pre-clinical testing as soon as possible. If the H5N1 high binding aptamer program generates promising results, Triera will provide regular updates to government agencies responsible for the management and response to H5N1. Triera's ultimate goal is to develop an avian flu infectious management system that combines the use of diagnostics, prophylaxis and therapeutics leading to a simple strategy that detects, protects and treats based on the same multivalent aptamer agent.

07:19 EDT WisdomTree board urges stockholders to vote for director nominees at AM - The Board of Directors of WisdomTree ssued a letter urging its stockholders "to protect their investment by voting "FOR" all of WisdomTree's highly qualified director nominees at the upcoming 2024 Annual Meeting of Stockholders on June 12." WisdomTree has demonstrated strong momentum with its current strategy and is in a pivotal phase of execution and growth. Our Board oversees the management team in developing and shaping that strategy, a relationship that has benefitted greatly from the Board's mix of deep knowledge from its longer-standing directors and fresh perspectives from six of its nine directors who joined the Board since 2021. Each director brings extensive experience and valuable insights that provide key support to the Company and its growth strategy. Dissident stockholder Graham Tuckwell, founder and Chairman of ETFS Capital Limited, has launched another disruptive campaign against three of WisdomTree's directors - his third attempt against the Board in the past three years - that is a waste of time and resources and not in the best interests of the Company and all of its stockholders. WisdomTree is focused on its long-term strategy and on continuing to realize value across its traditional ETP business, while growing its highly integrated digital assets business. Mr. Tuckwell's misguided campaign will only serve to distract the Company from achieving its objectives. WisdomTree strongly urges stockholders to support all nine of WisdomTree's directors, including the three directors against whom Mr. Tuckwell is currently campaigning: Jonathan Steinberg, Win Neuger and Anthony Bossone."

07:17 EDT Optex Systems announces $3.8M order for laser protected periscopes - Optex Systems Holdings has been awarded a new contract from a U.S. Government Prime Contractor, in support of the Armored Multi-Purpose Vehicle. The order value is $3.8 million with deliveries over the next 14 months.

07:16 EDT Allete to be acquired for $67.00 per share in cash - Allete and a partnership led by Canada Pension Plan Investment Board, or CPP Investments, and Global Infrastructure Partners, jointly announced that they have entered into a definitive agreement under which the partnership will acquire Allete for $67.00 per share in cash, or $6.2B including the assumption of debt. In connection with the merger, CPP Investments and GIP will acquire all of the outstanding common shares of Allete for $67.00 per share in cash representing an enterprise value of approximately $6.2B, including Allete's net debt. This represents a premium of approximately 19.1% to Allete's closing share price on December 4, 2023, the date prior to a media article reporting that Allete was exploring a sale. The consideration also represents a 22.1% premium to the 30-day volume weighted average share price prior to that date. The acquisition was unanimously approved by Allete's board of directors and is expected to close in mid-2025, subject to the approval of Allete's shareholders, the receipt of regulatory approvals, including by the MPUC, PSCW and FERC, and other customary closing conditions. Dividends payable to Allete shareholders are expected to continue in the ordinary course until the closing, subject to approval by Allete's board of directors. Upon completion of the acquisition, Allete's shares will no longer trade on the New York Stock Exchange, and Allete will become a private company.

07:15 EDT N2OFF's Save Goods to target hemp flower market in California - N2OFF announced that its subsidiary Save Foods is set to target the hemp flower market in California. The Company recently announced that the California Department of Pesticide Regulation approved and registered the use of Save Foods' pre-harvest treatment, FieldProtect, based on compliance with provisions of California laws and regulations pertaining to pesticide registration.

07:14 EDT BioCryst sees 2024 ORLADEYO revenue $390M-$400M - The company said, "Based on the team's success in accelerating ORLADEYO patients through the U.S. reauthorization process faster than anticipated, the company is adjusting its outlook for full year 2024 global net ORLADEYO revenue to be between $390 million and $400 million, the top end of its prior guidance range. The company expects full year 2024 operating expenses to be between $365 million and $375 million, flat to full year 2023 operating expenses. This operating expense outlook does not reflect non-cash stock compensation expense, or one-time expenses related to the previously announced workforce reduction implemented in the first quarter of 2024. Based on the company's disciplined approach to capital allocation, and the adjusted revenue guidance for ORLADEYO, the company is even more confident that it will achieve a full-year operating profit in 2024, be approaching quarterly positive earnings per share and positive cash flow in the second half of 2025, and be profitable on an EPS basis, with positive cash flow, for full year 2026. The company expects it can achieve these financial milestones without raising additional funds and does not intend to draw the additional $150 million of debt available to it from Pharmakon."

07:13 EDT Stellantis Pro One achieves number 1 spot in Middle East, Africa region - Stellantis Pro One commercial vehicles offensive delivered an "excellent" performance in the first quarter of 2024, accounting for one-third of Net revenues reported by Stellantis, the company said. The performance highlights the strength of Stellantis Pro One in global markets and puts it on track to achieve global leadership in commercial vehicles by 2027 and reach the targets outlined in the Dare Forward 2030 strategic plan. Stellantis Pro One Middle East and Africa region market share reached 26% in the first quarter of 2024. In addition, it maintained the No. 1 position in both EU30 and South America regions. For EU30 BEV sales for the quarter, Pro One takes the top spot with 33% market share, with the Peugeot brand leading across the region.

07:12 EDT Bluebird Bio completes commercial cell collection for LYFGENIA - bluebird bio announced that it has completed the first commercial cell collection for LYFGENIA or lovotibeglogene autotemcel, a one-time gene therapy for the treatment of sickle cell disease in patients with a history of vaso-occlusive events. LYFGENIA was approved by the FDA in December 2023 and is the most deeply studied gene therapy for sickle cell disease, with the longest follow-up in the field. "Seeing people living with sickle cell disease receive gene therapy in the real world is a vision that has fueled bluebird for more than 10 years," said Andrew Obenshain, president and CEO, bluebird bio. "This historic moment comes nearly a century after sickle cell disease was the first genetic disorder to be characterized at the molecular level, and almost a decade after bluebird initiated clinical development for LYFGENIA. We are grateful to the patients, caregivers, researchers, and clinicians whose work made this milestone possible, and look forward to continued partnership with the sickle cell disease community."

07:11 EDT BioCryst to advance avoralstat into DME clinical trial in 2025 - The company said, "The goal with our pipeline is to continue bringing selected, highly differentiated rare disease products to the market, and to reproduce the commercial success we have delivered with ORLADEYO. Milestones in the next 18 months include: The ongoing proof-of-concept trial with BCX10013, an oral Factor D inhibitor, remains on track. The company expects to partner or discontinue the program later this year. Enrollment is complete in the APeX-P pediatric trial. Data from the trial will support a regulatory filing in 2025 to expand the ORLADEYO label to enable children as young as two years of age to receive ORLADEYO. ORLADEYO would be the first oral prophylactic therapy for children with HAE. The company expects to advance BCX17725, its KLK-5 inhibitor for the treatment of Netherton syndrome, into the clinic by the end of 2024. Netherton syndrome is a rare, lifelong genetic disorder that often presents in neonates or infancy with red, scaly and inflamed skin and susceptibility to recurrent skin infections. Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections. Currently, there is no approved treatment for Netherton syndrome. In 2025, the company plans to advance avoralstat, a plasma kallikrein inhibitor, into a clinical trial of patients with diabetic macular edema. DME is the most common cause of vision loss in individuals with diabetes and at least one-third of patients have persistent DME despite anti-VEGF therapies, which are administered via monthly injection. By delivering avoralstat with Clearside's SCS microinjector directly into the suprachoroidal space of the eye in the clinical trial, avoralstat could inhibit plasma kallikrein at the sites of edema formation in DME disease, the retinal and choroidal vascular endothelium. With its low solubility, the drug could persist in the eye at the site of disease for a long duration, resulting in less frequent injections."

07:10 EDT Can-Fite BioPharma receives notice of allowance from EPO - Can-Fite BioPharma announced it received a Notice of Allowance from the European Patent Office for its patent application titled "An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction". This invention addresses the use of the CF602 drug candidate as an oral or topical drug for patients such as diabetics, who suffer from erectile dysfunction, and cannot use the current drugs on the market.

07:09 EDT Brookfield Asset Management, Castlelake enter strategic partnership - Brookfield Asset Management announced that they have entered into an agreement whereby Brookfield will acquire a 51% stake in Castlelake's fee-related earnings. The amount of capital to be invested will be approximately $1.5B, including capital to be invested in Castlelake's investment strategies by Brookfield Reinsurance. The partnership will allow Castlelake and Brookfield to collaborate and expand Castlelake's differentiated asset-based investment business. Craig Noble, CEO of Brookfield Credit said, "We are thrilled to be partnering with Castlelake, a leading asset-based private credit business with an exceptional management team. There is strong demand for Castlelake's leading private credit strategies, and tremendous growth potential in the asset class. We look forward to helping Castlelake scale their business, and the addition of their capabilities enables us to better serve our clients around the world. With growing demand from investors for diverse credit strategies, this multi-trillion market has significant tailwinds that will help drive the growth of our $300 billion credit business over the next decade."

07:08 EDT Omega Therapeutics sees cash runway into 1Q25 - As of March 31, 2024, the Company had cash and cash equivalents totaling $60.0 million. This cash balance, along with a cost reduction and strategic prioritization initiative that occurred during the first quarter, is expected to fund operations into Q1 2025.

07:06 EDT Foghorn Therapeutics provides update on programs, upcoming milestones - Key Recent Program Updates and Upcoming Milestones: FHD-286: AML Update. Foghorn initiated a Phase 1 trial of FHD-286 in combination with decitabine or low-dose cytarabine in relapsed and/or refractory AML patients, with the first patient dosed during the third quarter of 2023. Dose escalation is ongoing with initial clinical data expected in the second half of 2024 . Tyrosine Kinase Inhibitor Resistance. Preclinical data is expected in the second quarter of 2024. FHD-909: Dosing of first patient in Phase 1 trial for FHD-909 in BRG1-mutated NSCLC is expected in the second half of 2024. Drug Discovery Platform: Potential for five additional INDs in the next four years.

07:04 EDT Bristol Myers' application for Opdivo plus Yervoy validated by EMA - Bristol Myers announced that the European Medicines Agency - EMA - has validated its Type II variation application for Opdivo - nivolumab - plus Yervoy - ipilimumab - for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. The EMA's validation of the application confirms the submission is complete and begins the EMA's centralized review process. The submission is based on results from the CheckMate -8HW study, in which Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival vs. investigator's choice of chemotherapy for the first-line treatment of patients with MSI-H/dMMR mCRC. The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints. The safety profile for the dual immunotherapy combination remained consistent with previously reported data.

07:03 EDT Axsome Therapeutics expects cash to fund operations into cash flow positivity - Cash and cash equivalents totaled $331.4 million at March 31, 2024, compared to $386.2 million at December 31, 2023.

07:01 EDT RedHill Biopharma issued Chinese patent Notice of Allowance covering opaganib - RedHill Biopharma announced the issue of a new Chinese patent Notice of Allowance covering opaganib as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration, valid through 2035.

06:50 EDT BioNTech CFO: Q1 revenue reflects the 'seasonal demand for COVID-19 vaccines' - "We started the year making good progress across our oncology pipeline. We dosed the first patient in our second pivotal Phase 3 trial and aim to have ten or more potentially registrational trials by the end of 2024. Revenues in the first quarter reflect the seasonal demand for COVID-19 vaccines, and we expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4 of 2024. With a strong cash position of EUR 16.9 billion, we are well positioned to invest in our innovative R&D pipeline and scale the business for commercial readiness in oncology," said Jens Holstein, CFO of BioNTech. "We remain committed to seizing the opportunity to transform the way cancer and infectious diseases are treated, especially with our tremendous experience in using our mRNA platforms. We will focus the remainder of the year on executing and delivering on this vision with the aim to drive sustainable long-term growth and to create future value for patients, society and our shareholders."

06:48 EDT BioNTech sees FY24 CapEx EUR 400M-EUR 500M - Sees FY24 R&D expenses EUR 2.4B-EUR 2.6B; SG&A expenses EUR 700M-EUR 800M.

06:39 EDT Norfolk Southern shareholder Ancora issues letter to Board - Norfolk Southern Ohio-based shareholder Ancora Holdings issued a letter to the Board of Directors of Norfolk Southern focusing on topics that include recent public statements from CEO Alan Shaw, Board Chair Amy Miles and Corporate Governance Committee Chairperson Jennifer Scanlon about the firm's engagement with the Brotherhood of Locomotive Engineers and Trainmen Division of the International Brotherhood of Teamsters - the BLET - and the Brotherhood of Maintenance of Way Employees Division of the International Brotherhood of Teamsters - the BMWED -. Highlights of the letter include: "...we're writing to publicly address the false and misleading claims that a subset of you have been making on behalf of the company. We ask that the Board ensures no further misrepresentations are disseminated about our appropriate engagement with Teamsters affiliates and other topics that are relevant to the outcome of the Annual Meeting of Shareholders...The BLET and the BMWED - which collectively represent 41.5% of Norfolk Southern's unionized workforce - issued public statements of support for Ancora's nominees and not the current leadership...Norfolk Southern affirmatively stated that Ancora (i) entered into agreements on behalf of the Company, (ii) violated the Railway Labor Act, (iii) committed a crime and (iv) gave away shareholder value via purported backroom deals. These statements are simply unsupported by facts...In light of the foregoing points, we hope the several members of the Board who are credible, effectively experienced and open-minded guide the Company to accommodate our multiple requests to cease making false and unsupported claims. Our unaffiliated nominees look forward to moving past this contest and partnering with those of you who continue to serve to do what is best for Norfolk Southern over the near-term and long-term. A lot needs to be fixed in order to drive shareholder-friendly governance and enhanced service, safety and value."

06:36 EDT Lilium announces firm order of 20 Lilium Jets - Lilium announced their partnership with advanced air mobility operator UrbanLink to operate Lilium Jets in South Florida. As part of the agreement, UrbanLink will purchase 20 Lilium Jets, with scheduled pre-delivery payments, and become the first airline in the U.S. fully committed to integrating eVTOL aircraft into its fleet.

06:28 EDT Novavax stockholder Shah Capital issues letter against board re-election - Novavax stockholder Shah Capital, which beneficially owns approximately 7.5% of the outstanding common stock of Novavax, issued a statement to stockholders regarding its intended efforts at the 2024 Annual Meeting of Stockholders scheduled for June 13. Highlights of the statement include:"Novavax's upcoming Annual Meeting presents an opportunity to send a strong and clear message to the company's board of directors and management - that stockholders cannot afford the status quo and the time for meaningful Board refreshment is now!...we have lost faith that the current directors have the ability or willingness to adapt to market pressures and take the steps we believe are necessary to address its continuing dismal performance. As a result, Shah Capital today filed a preliminary proxy statement to solicit stockholders to vote AGAINST the re-election of Richard H. Douglas, Margaret G. McGlynn, and David Mott, each of the company's Class II Directors up for election at the Annual Meeting. In our view, the Company's current management has failed to implement effective strategies to turn the business around despite its rapidly shrinking share price, necessitating material and immediate board refreshment. Novavax remains today one of the most shorted stocks on NASDAQ. The decision to launch this campaign follows our repeated attempts to constructively engage with the Board. We strongly believe in the value of Novavax's deep IP portfolio and Matrix-M adjuvant platform and that there is a vast and currently untapped market for non-mRNA protein vaccines...The Board regrettably has been unresponsive to our suggestions...Shah Capital further believes that the maintenance and expansion of the Company's generous compensation programs for its executive management and directors, given the Company's continuing poor performance and recent massive stockholder dilution is inappropriate...We reiterate our position that Novavax must urgently adopt a more innovative and dynamic sales and marketing strategy. Specifically, that the company should target key Covid segments in its marketing, such as direct-to-patient outreach for individuals aged 60+ and residents of southern states, as well as develop more effective regulatory stakeholder management, particularly with the FDA..."

06:10 EDT GlycoMimetics' uproleselan does not meet Phase 3 endpoint in AML - GlycoMimetics announced topline results from its Phase 3 global pivotal study of uproleselan in 388 patients with R/R AML. In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone. Patients treated with uproleselan had a median overall survival of 13 months, compared to 12.3 months in the placebo arm. Adverse events were consistent with known side effect profiles of chemotherapy used in the study. The randomized, double-blind, placebo-controlled Phase 3 clinical study evaluated uproleselan in combination with MEC or FAI in patients with R/R AML. The primary endpoint of the study was overall survival without censoring for transplant. Secondary endpoints included incidence of severe oral mucositis, complete remission rate and remission rate. A total of 388 patients across 70 sites in nine countries were randomized 1:1 between treatment and placebo arms.

06:08 EDT GlycoMimetics reports cash and cash equivalents of $31.3M as of March 31 - This is compared to $41.8M as of December 31, 2023. "While the outcome of our Phase 3 study in R/R AML is not what we hoped, we wish to thank the investigators, the participating patients and their families for their dedication to this large, well-controlled randomized study," said CEO Harout Semerjian. "We are thoroughly analyzing the data in collaboration with medical, statistical and regulatory experts and are committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting."

06:05 EDT ADC Therapeutics reports initial data from Phase 2 trial of ZYNLONTA - ADC Therapeutics announced that initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA demonstrated a high response rate in patients with relapsed/refractory marginal zone lymphoma. In this study, ZYNLONTA was generally well-tolerated and safety was consistent with the known profile, with two patient discontinuations. One patient discontinued after cycle 2 and a second patient discontinued after cycle 4 due to a toxicity, which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 and 6 months, respectively.

05:23 EDT Cellectis announces completion of $140M investment from AstraZeneca - Cellectis (CLLS) announced that, following clearance from the French Ministry of Economy and satisfaction of all other closing conditions, AstraZeneca (AZN) completed the additional equity investment of $140M in Cellectis, as previously announced by Cellectis on November 1 and 15, 2023. As part of the additional investment, AstraZeneca subscribed for 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis pursuant to the authorizations granted by the extraordinary general meeting of the shareholders of Cellectis held on December 22, 2023. Prior to their conversion into ordinary shares, the "class A" convertible preferred shares have single voting rights and will not be eligible for double voting rights under any circumstances, and the "class B" convertible preferred shares have no voting rights except with respect to any distribution of dividends or reserves. Both classes of preferred shares enjoy a liquidation preference and are convertible, at AstraZeneca's direction, into the same number of ordinary shares with the same rights as the outstanding ordinary shares. Immediately after the additional investment, AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the company. In addition, the appointment of Marc Dunoyer and Tyrell Rivers as members of the board of directors of Cellectis, decided by the extraordinary general meeting of the shareholders of Cellectis held on December 22, 2023 and conditioned upon the completion of the additional investment, is now effective. In the absence of a public offering, no prospectus will be established in France or outside of France in connection with the additional investment.

05:13 EDT Calliditas setanaxib trial misses primary endpoint, meets secondary endpoints - Calliditas Therapeutics announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck, or SCCHN. The analysis showed statistically significant improvements in progression-free survival, or PFS, as well as in overall survival, or OS, with statistically significant changes in tumor biology consistent with the mechanism of action of setanaxib. The trial is a randomized, placebo-controlled, double-blind Phase 2 study investigating the effect of setanaxib 800mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks with the full dataset reflecting all patients having had the opportunity to complete at least 15 weeks of treatment. The basis for the analysis consisted of a dataset of 55 patients with recurrent or metastatic SCCHN and moderate or high CAF-density tumors. A tumor biopsy was taken prior to randomization and then again after at least nine weeks of treatment. The treatment groups were well-balanced with no clinically relevant differences between the groups observed at baseline. Patients treated with pembrolizumab and setanaxib showed statistically significant improvements in key secondary endpoints, such as progression-free survival, and statistically significant improvement in overall survival compared to patients treated with pembrolizumab and placebo. There was also an improvement in disease-control rate in setanaxib-treated patients, with 70% in the setanaxib arm showing a best response of at least stable disease compared to 52% in the placebo arm. No significant difference in the primary endpoint of best percentage change from baseline in tumor size was observed. Transcriptomic analysis of tumor biopsy samples showed a statistically significant increase in CD8+ T-cells in tumor tissue from patients treated with setanaxib, indicating an increase in tumor immunological activity consistent with the mechanism of action of setanaxib. The tolerability of setanaxib when given with pembrolizumab was generally good, with no new safety signals identified. The company is conducting additional clinical trials with setanaxib and will read out its Phase 2 trial in PBC in Q3 of 2024 and is expecting the investigator led Phase 2 trial in IPF to provide top line data in Q4 of 2024, subject to recruitment. There is also an ongoing Phase 2 proof of concept trial in Alport syndrome, which is expected to deliver top line data in 1H, 2025. The company plans to arrange an R&D day in Stockholm later this month to provide additional details regarding the Phase 2 trial and other data supporting the mechanism of action of setanaxib. Further details will be provided by way of a press release.