Stockwinners Market Radar for June 27, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:42 EDT Astellas Pharma shows positive topline results for VMS treatment - Astellas Pharma "announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms, or VMS, due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were COVID-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting."

19:27 EDT Flora Growth CEO and CFO resign - In a regulatory filing, Flora Growth stated: "On June 21, 2023, Hussein Rakine tendered his resignation as the CEO of Flora Growth Corp., a corporation organized under the laws of the Province of Ontario , with such resignation becoming effective June 25, 2023. Mr. Rakine intends to remain as a director on the Company's Board of Directors. Mr. Rakine's resignation as Chief Executive Officer was not due to any disagreement with the Company or the Board on any matter relating to the Company's operations, policies or practices. On June 25, 2023, Elshad Garayev tendered his resignation as the CFO of the Company, with such resignation becoming effective on such date. Mr. Garayev's resignation as Chief Financial Officer was not due to any disagreement with the Company or the Board on any matter relating to the Company's operations, policies or practices. On June 25, 2023, Jessie Casner tendered her resignation as the Chief Marketing Officer of the Company, with such resignation becoming effective on June 30, 2023. Ms. Casner's resignation as Chief Marketing Officer was not due to any disagreement with the Company or the Board on any matter relating to the Company's operations, policies or practices."

19:20 EDT ODP Corporation exec sells $1.67M in common stock - In a regulatory filing, ODP Corporation disclosed that its EVP John Gannfors sold 37K shares of common stock on June 23rd in a total transaction size of $1.67M.

18:18 EDT Allarity clarifies the reverse stock split will not be effected on June 27 - Allarity Therapeutics is issuing this press release to clarify the effective date of its contemplated reverse stock split. The Company is clarifying that the reverse stock split will not be effected on June 27, 2023, and will continue to trade without giving effect to the proposed reverse stock split until further notice. The effective date and time of the actual reverse stock split will be subsequently announced in a separate press release. At a special meeting of stockholders held on June 23, 2023, Allarity's stockholders approved a proposal to amend its Certificate of Incorporation, as amended, at the discretion of Allarity's Board of Directors, to effect a reverse stock split with respect to the Allarity's issued and outstanding common stock, par value $0.0001 per share, at a ratio between 1-for-15 and 1-for-50, with the ratio within such Range to be determined at the discretion of the Board, subject to the consent of the holder of Series A Preferred Stock and included in a public announcement.

17:56 EDT Xpel director Crumly sells 6,856 common shares - In a regulatory filing, Xpel director Richard Crumly disclosed the sale of 6,856 common shares of the company on June 26 at a price of $79.51 per share.

17:48 EDT Stellantis reports 10.6% stake in Archer Aviation - In a regulatory filing, Stellantis (STLA) disclosed a 10.6% stake in Archer Aviation (ACHR), representing 20.23M shares. The filing allows for activism.

17:37 EDT BeiGene insiders sell over 2,600 shares of stock - BeiGene officer Lai Wang disclosed in a regulatory filing the sale of 1,108 shares of company stock at $181.92 per share on June 26 for a total transaction amount of $201,567. The president of Xiaobin Wu sold 1,495 shares at $182.37, on the same day for a total transaction amount of $272,636.

17:35 EDT BT Brands comments on upcoming Noble Roman's shareholder vote - The company said, "Faced with a potentially crushing defeat in the upcoming shareholder vote, Noble Roman's has resorted to attempting to use a technical interpretation of its by-laws to exclude BT Brands' nominee from the ballot for the July 6, shareholder election. In an eleventh-hour move, Noble Roman's has taken the position that shares held in a brokerage account do not qualify as ownership for nominating a director candidate and soliciting a proxy. BT Brands and its CEO, Gary Copperud, own approximately 9% of the outstanding shares of Noble Roman's. In this latest move, Noble Roman's is disenfranchising its shareholders by preventing shareholders from having the opportunity to vote on a nominee in the upcoming board election. BT Brands notes it is reviewing its legal options under Indiana law and likely will challenge the latest move by Noble Roman's. We also expect to further address the fiduciary responsibility of the current Board of Directors to all shareholders." BT Brands Chairman Gary Copperud notes, "This move to deny shareholders the ability to vote for a director candidate in a fair and supervised election is another in a series of abusive attacks on the rights of Noble Roman's shareholders." Copperud further stated, "We have made our case to the Noble Roman shareholders. We believe we are hearing a consensus that the time for change at Noble Roman's is now." As a shareholder of Noble Roman's, the case we have laid out to our fellow shareholders is straightforward. Our concerns center around declining shareholder value and the Company's deteriorating financial condition, driven by increased borrowing and Mobley Family compensation of approximately $800,000 per year in cash, excluding other undetermined benefits and the value of option awards. We have noted to shareholders, who we believe are painfully aware of recent events at the Company, that the losses and the erosion of the Company's financial position coincide with the CEO term of management's nominee, Scott Mobley, son of Chairman and Chief Financial Officer Paul Mobley and include: Share price declining from $2.14 to 20 cents; Shareholders' equity falling from $14.9 million to under $1.9 million; Debt increasing from $2.7 million to $8.9 million; Eight years of compensation paid to the Mobleys totaling approximately $5.9 million - representing nearly 40 percent of the decline in shareholders' equity; Employment Agreements committing over $5.9 million in future cash compensation to the Mobleys; Stock option awards to Paul and Scott Mobley of approximately 21% of the outstanding shares have been made in the face of abysmal performance and without shareholder approval. Finally, Copperud noted, "Noble Roman's is facing many challenges related to its business and capital structure. Our goal as a shareholder is to assist the Company in addressing these challenges and to start moving Noble Roman's in a positive direction."

17:29 EDT AST SpaceMobile falls 18% to $5.20 after equity offering

17:23 EDT MEI Pharma issues statement in response to disclosure by Anderson and Cable Car - MEI Pharma issued a statement in response to the disclosure made by Anson Advisors and Cable Car Capital. The statement began: "Anson and Cable Car reiterated their formerly disclosed, unsolicited and non-binding proposal that our Board of Directors previously reviewed and rejected. The Board determined that the proposal provides no basis for futher discussions with them regarding an alternative transaction. We believe that the proposal and Anson and Cable Car's subsequent disclosures, including today's press release, are nothing more than an attempt to acquire the Company and our cash on hand without paying an appropriate premium to do so. In addition, we believe that the proposal would deprive the Company's stockholders of the opportunity to participate in the potential upside associated with the Company's existing programs as well as the further upside potential of the proposed transaction with Infinity Pharmaceuticals. We encourage our shareholders not to be confused by Anson and Cable Car's latest press release. Instead, shareholders should keep these facts in mind: The proposal by Anson and Cable Car significantly undervalues the Company. As part of its review, which included multiple factors, the Board, in consultation with the Company's financial and legal advisors, noted that the proposal was at a significant discount to the Company's cash position." The letter ended, "The recommendation by the MEI Board to proceed with the pending Infinity transaction remains unchanged". Stifel is serving as financial advisor to MEI Pharma and Morgan Lewis is serving as legal counsel.

17:12 EDT Salesforce COO Millham sells 1,654 common shares - In a regulatory filing, Salesforce president and COO Brian Millham disclosed the sale of 1,654 common shares of the company on June 26 at a price of $209.02 per share.

17:06 EDT General Dynamics awarded $768.66M Army contract - General Dynamics was awarded a $768.66M firm-fixed-price contract for Optionally Manned Fighting Vehicle Phase III and IV detailed design and prototype build and testing. Bids were solicited via the internet with five received. Work will be performed in Sterling Heights, Michigan, with an estimated completion date of December 25, 2027. FY23 research, development, test and evaluation, Army funds in the amount of $94.04M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:03 EDT Spirit AeroSystems announces contents of new contract with IAM - Spirit AeroSystems, Inc., a subsidiary of Spirit AeroSystems Holdings, announced the contents of a new four-year contract proposal unanimously agreed to by the bargaining committee of the Local Lodge 839 of the International Association of Machinists and Aerospace Workers. IAM union members will vote on approval on Thursday, June 29, at Hartman Arena in Park City, Kansas. The new proposed contract is a result of negotiations that began this past Saturday between the company and IAM officials, mediated by the Federal Mediation and Conciliation Service. "We listened closely and worked hard in our talks over the last several days to further understand and address the priorities of our IAM-represented employees," said Tom Gentile, President and CEO of Spirit AeroSystems. "We believe this new offer is fair and competitive and recognizes the contributions of our employees covered under this proposed agreement, enabling our ability to meet the growing needs of our customers and deliver value for our investors." Highlights of the new contract terms include: Exact same core healthcare plan; Sign on bonus of $3,000 cash; and increased pay, including a total wage increase of 9.5 percent in year one, guaranteed increase of 23.5 percent over the life of the contract, and annual bonuses and Cost of Living Allowance on top.

17:01 EDT Spirit AeroSystems advances new four-year contract with IAM - Spirit AeroSystems, a subsidiary of Spirit AeroSystems Holdings, announced the contents of a new four-year contract proposal unanimously agreed to by the bargaining committee of the Local Lodge 839 of the International Association of Machinists and Aerospace Workers, or IAM. IAM union members will vote on approval on Thursday, June 29, at Hartman Arena in Park City, Kan. The new proposed contract is a result of negotiations that began this past Saturday between the company and IAM officials, mediated by the Federal Mediation and Conciliation Service.

16:33 EDT Bayer initiates Phase III clinical development program QUANTI - Bayer has initiated the Phase III clinical development program called QUANTI, aiming to evaluate the safety and efficacy of gadoquatrane, an investigational extracellular macrocyclic gadolinium-based contrast agent for use in magnetic resonance imaging. Gadoquatrane is a highly stable MRI contrast agent featuring high relaxivity being studied to evaluate the potential of a substantially lower gadolinium dose for patients. The QUANTI clinical development program encompasses two large multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions), as well as one pediatric study, all investigating gadoquatrane at a dose of 0.04mmol Gd/kg body weight (bw). Thus, QUANTI development program investigates a gadolinium dose reduced by 60 percent compared to GBCAs dosed at 0.1mmol Gd/kg. The completion of a successful development program would demonstrate the lowest gadolinium dose for an MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method to obtain detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues to support physicians in answering critical medical questions in the diagnosis and monitoring of disease. "The demand for innovation in medical imaging to support diagnosis of diseases, guide treatment decisions and aid in therapy planning is growing as we see an increase in chronic diseases such as cancer and cardiac conditions," said Prof. Michael Forsting, Director, Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Essen, Germany. "The Phase III clinical program QUANTI is an important step in establishing the safety and efficacy of an investigational agent dosed at a substantially lower gadolinium dose."

16:32 EDT International Game reaches agreement with Dreamscape Companies - International Game Technology announced that the Company reached an agreement with Dreamscape Companies to provide its award-winning IGT ADVANTAGE casino management system to the Rio Hotel & Casino starting Q4 of this year. In addition to deploying the IGT ADVANTAGE system, Rio Hotel & Casino will leverage IGT's M5 content delivery solution to run Random Riches and Lucky Coin bonuses, IGT's Mobile Host and Mobile Responder employee convenience apps will elevate customer service, while the Taxable Accrual solution will help optimize player self-service jackpot processing.

16:31 EDT Canopy Growth reports KPMG resigned as independent registered public accountant - On June 22, KPMG, which had been serving as the independent registered public accounting firm of Canopy Growth Corporation, declined to stand for reelection and resigned as the company's independent registered public accounting firm, effective June 22, Canopy disclosed. The Audit Committee of the board of directors of the company accepted KPMG's resignation on the resignation date. "The audit report of KPMG on the company's consolidated financial statements for the fiscal years ended March 31, 2023 and March 31, 2022 did not contain an adverse opinion or a disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles, except that KPMG's report on the company's consolidated financial statements for the fiscal year ended March 31, 2023 included an explanatory paragraph related to the restatement of the consolidated financial statements for the fiscal year ended March 31, 2022 and included a separate paragraph stating the company has material debt obligations coming due in the short-term, has suffered recurring losses from operations and requires additional capital to fund its operations, which raise substantial doubt about its ability to continue as a going concern," the filing stated. KPMG's report dated June 22, 2023 indicates that the company did not maintain effective internal control over financial reporting as of March 31, 2023 because of the effect of material weaknesses on the achievement of the objectives of the control criteria, the filing noted.

16:29 EDT Group 1 Automotive exec sells $2.46M in common stock - In a regulatory filing, Group 1 Automotive disclosed that its SVP Peter Delongchamnps sold 10K shares of common stock on June 23rd in a total transaction size of $2.46M.

16:19 EDT Lear increases FY23 financial outlook - Lear increased the Company's FY23 financial outlook and Seating target margins during its Seating Product Day. Lear also shared details on its latest technologies and announced new business awards in Thermal Comfort Systems that will support market share gains and earnings growth in Seating. Highlights include increased 2023 outlook for net sales, core operating earnings and free cash flow; increased JIT seating market share target to 29% from 28% by 2027 and introduced overall Seating market share target of 32% by 2027; increased Seating target margin range to 8.5%-9.0% from 7.5%-8.5%; expect Seating adjusted earnings to increase by $700M from 2023 to 2027; 2023 Thermal Comfort Systems awards are more than 40% ahead of last year; targeting #1 or #2 market positions for key Thermal Comfort Systems product categories by 2027 Announced that Lear controls 259 patent assets on FlexAir and modularity; increased expected Thermal Comfort Systems total addressable market industry outgrowth to 4% from 2% annually through 2027; increased Thermal Comfort Systems revenue target to $1B from $800M by 2027; awarded first-to-market contract to supply INTU products on several future vehicle models with an ultra-luxury European automaker; awarded first FlexAir production contract on a crossover vehicle launching in 2024 with an Asian automaker; announced exclusive automotive license for FlexAir technology; and announced 16 development projects on 41 platforms for FlexAir and modularity.

16:17 EDT Blue Apron sees adjusted EBITDA profitability in Q2 of 2024 - Blue Apron "shared a business update following the previously announced closing of the transaction with FreshRealm on June 9, 2023. With the closing of the FreshRealm transaction, together with additional planned streamlining efforts that the Company previously identified and will continue to implement in the third quarter of 2023, the company expects to achieve Adjusted EBITDA profitability in the second quarter of 2024." CEO Linda Findley states: "We believe the closing of the transaction with FreshRealm and the payoff of our debt opened up a clearer path to long-term Adjusted EBITDA profitability. In parallel, with the shift to an asset-light model, we continue to reduce year-over-year cash burn, as disclosed on our first quarter earnings call, and we expect to continue to see year-over-year reduced cash burn following the closing of the FreshRealm transaction. In 2022, we shared our plan for achieving long-term, sustainable growth and reaching profitability through 'The Next Course.' Part of this three-year strategy included targeting Adjusted EBITDA profitability, by, among other things, building an ecosystem of partners and relationships that furthers our vision of Better Living Through Better Food. We believe that moving to an asset-light model via the FreshRealm transaction was the right next step to help us execute this strategy. As we move forward, we remain focused on managing our cost base and liquidity position to support profitable growth. We will continue to manage PTG&A in the retained Blue Apron business through additional headcount and other cost reductions in connection with the shift to the asset-light model, and expect to implement these cost reductions over the coming months. We are committed to open and transparent communication with our shareholders, and plan to continue to provide the market with additional updates as appropriate."

16:15 EDT Theriva Biologics granted orphan drug designation for VCN-01 from FDA - Theriva Biologics announced that the FDA has granted orphan drug designation to lead clinical candidate VCN-01, Theriva's systemic, selective, stroma-degrading oncolytic adenovirus for the treatment of pancreatic cancer. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care, or SoC, chemotherapy as a first line therapy for patients with pancreatic ductal adenocarcinoma, or PDAC. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

16:11 EDT Chimerix CEO Mike Sherman to retire, Mike Andriole to succeed - Chimerix announced the promotion of Mike Andriole, chief business officer and CFO, to president and CEO of Chimerix and his appointment to the board of directors. Andriole replaces Mike Sherman, who is retiring from his role as CEO and will become chairman of the board of directors. Martha Demski, the current board chair, will assume the role of lead independent director. These appointments will be effective on August 1.

16:06 EDT Rezolute provides to initiate sunRIZE study - Rezolute provided an update on its clinical development plans for RZ358, the company's product candidate for congenital hyperinsulinism. Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4, with topline results anticipated in the first half of 2025. The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies. The Phase 3 study follows the company's successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.

16:05 EDT Prothena announces Phase 3 VITAL results published in Blood journal - Prothena Corporation plc announced the publication of the Phase 3 VITAL clinical trial in Blood, a journal of the American Society of Hematology. The published data demonstrate that in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis, a statistically significant survival benefit of 74 percent was observed for those treated with birtamimab plus standard of care versus 49 percent in patients on placebo plus SOC at 9 months. All participants in the clinical trial received concomitant bortezomib-containing chemotherapy regimens as part of SOC. "For the first time, we have these important data published in a prestigious, peer-reviewed journal which show that treatment with birtamimab led to a survival benefit in patients with Mayo Stage IV AL amyloidosis and affirms its potential as a safe, well-tolerated and effective therapy," said Morie Gertz, MD, Hematologist, Chair emeritus Internal Medicine, Mayo Clinic. "AL amyloidosis is a rare and life-threatening disease in which patients have no treatment options despite the high fatality rate. We look forward to learning more about the survival benefit of birtamimab in patients with Mayo Stage IV AL amyloidosis from the confirmatory Phase 3 AFFIRM-AL clinical trial."

16:02 EDT National CineMedia plan of reorganization confirmed - National CineMedia announced its Plan of Reorganization has been confirmed by the United States Bankruptcy Court for the Southern District of Texas. This milestone comes less than three months after filing, representing a swift and significant stride forward in the Company's financial restructuring efforts. The company is expected to emerge from Chapter 11 on or around August or September 2023. Under the confirmed Plan, the company will eliminate its debt through the equitization of its secured debt. With a significantly stronger balance sheet, NCM LLC will be positioned to bolster its market-leading position with the financial resources to bring cutting-edge innovation to its advertising partners, continue to build its best-in-class data and attribution platform, and invest in growth strategies. Upon emergence, the company will maintain its existing corporate structure with National CineMedia, Inc. serving as the manager of NCM LLC. Additionally, the company intends to enter into an approximately $55M exit financing facility, which will be used to fund operations and growth initiatives. The existing management team will continue to lead the successfully reorganized company. "Today's announcement marks a major step forward in our financial restructuring, positioning the Company for long-term success," said Tom Lesinski, Chief Executive Officer of NCM. "As we charge ahead toward emergence, we will continue to deliver our full funnel of advertising solutions, connecting brands with NCM's young, diverse, and sought-after movie audiences. We extend our appreciation to our employees, customers, and partners for their unwavering support throughout this process and are excited to continue our work together in the future."

15:38 EDT Formula E expands CBS Sports partnership, strikes U.S. streaming deal with Roku - Formula E, the world's first all-electric FIA World Championship motorsports series, announced ground-breaking new broadcast distribution partnerships in the U.S. that will see long-standing partner CBS (PARA) air more live races than ever before and introduce Roku (ROKU) as the streaming home of Formula E. Beginning in January 2024, five races will air live on CBS Television Network and simulcast on Paramount+, with both channels already featured and integrated prominently on Roku's platform. Roku users who subscribe to Paramount+ can easily enjoy the races airing on the service through the Paramount+ app on Roku's Sports Experience. CBS Sports Network will also show one highlights programme per round. Formula E, CBS Sports, and Roku announced the pioneering multi-year broadcast deal for the U.S. market following the first ABB FIA Formula E World Championship race at the Portland International Raceway in Oregon. Last week, Formula E confirmed that the series will return to Portland in season 10 when the new broadcast partnership will be active.

15:15 EDT Regeneron trading resumes

14:58 EDT Allarity Therapeutics Inc trading halted, news pending

14:50 EDT Regeneron announces top-line, two-year data for aflibercept 8 mg PHOTON trial - Regeneron Pharmaceuticals announced top-line, two-year data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema, or DME. During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals after three initial monthly doses and were able to shorten or extend dosing intervals if pre-specified criteria were met. The longer-term data among aflibercept 8 mg patients who completed the trial demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through two years with: 89% maintaining greater than or equal to12-week dosing intervals through two years, compared to 93% through one year; 83% maintaining greater than or equal to16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year; 43% meeting the criteria for greater than or equal to20-week dosing intervals by week 96, including 16% and 27% who were eligible for 20- and 24-week dosing intervals, respectively. The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter of 2023, and the two-year data from both PHOTON and PULSAR are planned for presentation at an upcoming medical meeting. "The aflibercept 8 mg clinical trial program is the first to demonstrate that patients with diabetic macular edema can immediately be treated with every 12- or 16-week dosing after their initial monthly doses and experience lasting vision control. With these two-year results, Regeneron continues to raise the bar in clinical advancements for retinal treatments and remains committed to pursuing groundbreaking innovations in ophthalmology," said George Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Eylea.

14:45 EDT FDA issues CRL to Regeneron for Aflibercept 8 mg Biologics License Application

14:37 EDT TikTok launches monetization feature, "TikTok Creative Challenge" - TikTok blogged in part earlier: "Creators are at the heart of TikTok, driving creativity, culture and entertainment...To further recognize and reward creators for their creativity and drive the value of their content, we're introducing TikTok Creative Challenge...TikTok Creative Challenge is a new in-app feature that allows creators to submit video ads to brand challenges and receive rewards based on video performance. Creators can browse through the list of challenges, read the challenge's brief which displays the reward pool and details rules and requirements, and submit their video ad. The Creative Challenge gives creators full creative freedom over their ads, unlocking more opportunities for creators to collaborate with brands in a way that's most authentic to them...Once enrolled in the TikTok Creative Challenge, creators will have access to a number of resources including a dedicated Creator Community group and Mentor Program to connect with other creators to share knowledge, exchange insights and get rewarded." Publicly traded companies that may be impacted by this include Snap (SNAP), Meta Platforms (META), Twitter (TWTR). https://newsroom.tiktok.com/en-us/tiktok-creative-challenge

14:22 EDT Annovis Bio jumps 2% after filing of patent for crystalline form of buntanetap - Shares of the company are up 2% or 30c per share to $14.25 in late-day trading on Tuesday after announcing the creation of a novel crystalline form of buntanetap, ANVS402 , and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office. The patent is groundbreaking because ANVS402 offers significant advantages over the previous, less structured form, including better stability, higher purity, and longer half-life, improving buntanetap's effectiveness. ANVS402 is covered by a composition of matter claim as well as multiple claims for chronic and acute neurodegenerative diseases and for neuropsychiatric indications..."A new 20-year patent term means that we will be able to continue working on our robust pipeline, developing novel drug therapies for many of neurodegenerative diseases," said Maria Maccecchini, Ph.D., CEO of Annovis...Currently, Annovis is conducting ongoing clinical trials of its lead drug candidate buntanetap: a phase III study is testing the medication in early Parkinson's Disease, and a phase II/III study is testing the medication in moderate Alzheimer's Disease. ANVS402 is expected to replace buntanetap in future PD and AD clinical trials after completion of a bridging study in early 2024. In addition, the phase III Parkinson's Disease study recently received a positive safety review from the Data and Safety Monitoring Board DSMB. "Annovis is extremely excited about the potential of ANVS402 and its future iterations in the treatment of neurodegenerative diseases," said Michael Hoffman, chairman of Annovis.

14:14 EDT Faraday Future secures up to $105M funding commitment - Faraday Future Intelligent Electric announced an additional funding commitment of $90M plus the acceleration of an existing commitment of $15M. The investment round is led by an existing investor, ATW Partners funds, with participation from Senyun International. These commitments come from the Company's secured and unsecured facilities. Commitments under the unsecured facility are subject to certain closing conditions including an effective registration statement and FF stockholder approval. This funding commitment will support the ongoing production and delivery of FF's highly anticipated FF 91 electric vehicle and help the Company reach its long-term strategic goals, including: additional production scaling, further improvement of the sales and service system, global business development, as well as improving general day-to-day operating cash flow. Details about the financing can be found in our Form 8-K filed with the SEC today. "This remarkable display of support from our existing investor base serves as a powerful testament to their unwavering belief in FF's vision and its immense market potential. We are grateful to our investors and partners for their trust. This funding is another critical step for FFIE to complete immediate and medium-term strategic objectives. We are poised to continue moving forward to deliver the FF 91 Futurist Alliance to our users focused on our three-phase delivery plan," said Xuefeng Chen, CEO of Faraday Future. In addition, Metaverse Horizon Limited, an independent investment fund with investors including FF Global Partners, and V W Investment Holding Limited, an affiliate of a long-term shareholder of the Company, have waived closing conditions related to, and made prefunding contributions of, $25.2 million towards their previously announced May 2023 commitment of $100 million gross in Unsecured Notes to support FFIE's development. Furthermore, FFIE continues to pursue additional funding sources, including strategic investors, to foster additional business growth and to reduce future financing costs.

13:58 EDT Freyr: Major passenger vehicle OEM to join strategic energy transition coalition - FREYR has received an indication that a major passenger vehicle OEM intends to join FREYR's strategic energy transition coalition, alongside Caterpillar (CAT), Siemens AG (SIEGY), and Nidec (NJDCY). The partnership between FREYR and the OEM is expected to encompass a strategic alliance with the ambition to jointly produce fit-for-purpose passenger EV batteries.FREYR has assembled and successfully charged its first battery unit cells at the company's Customer Qualification Plant and is on schedule to ramp process automation, production, and testing of chargeable cells in H2 2023 and beyond. The semi-automated assembly of the first unit cells is the first major post-opening achievement at the CQP less than two years after FREYR announced its Final Investment Decision of the giga scale nameplate plant. Reference Link

12:24 EDT Stratasys to review revised unsolicited partial tender offer from Nano Dimension - Stratasys (SSYS) confirmed that Nano Dimension (NNDM) has increased the offer price of its unsolicited partial tender offer to acquire Stratasys ordinary shares not already owned by Nano from $18.00 to $20.05 per share in cash. Nano has also reduced the percentage of outstanding Stratasys ordinary shares being sought in the revised offer from between 38.8% and 40.8% to between 31.9% and 36.9%, and extended the offer period until 5:00 p.m., New York time, on July 24, unless further extended or earlier terminated. "Stratasys notes that, according to Nano, only 8% of outstanding Stratasys shares were tendered into the offer as of 11:59 p.m., New York time, on June 26, 2023. Consistent with its fiduciary duties, and in consultation with its independent financial and legal advisors, the Stratasys Board of Directors will carefully review and evaluate the Revised Offer to determine the course of action that it believes is in the best interests of the Company and Stratasys shareholders. Stratasys shareholders are advised to take no action at this time pending the Stratasys Board's review and evaluation of the Revised Offer. Stratasys intends to advise shareholders of the Stratasys Board's position regarding the Revised Offer within ten business days," the company stated in a press release. On May 25, Stratasys entered into a merger agreement with Desktop Metal, pursuant to which Desktop Metal (DM) agreed to combine with Stratasys in an all-stock transaction and the Stratasys board "has not changed its unanimous approval, recommendation and declaration of advisability of the previously announced transaction with Desktop Metal," the company added.

12:04 EDT HashiCorp acquires BluBracket to expand secrets management capabilities - HashiCorp announced it has acquired BluBracket, which it calls "an innovator in code security for developers and security engineers." With this acquisition, HashiCorp is expanding its product portfolio to enable customers to discover and manage their entire secrets inventory, the company stated. HashiCorp will initially integrate BluBracket's functionality into HashiCorp Vault as part of ongoing efforts to expand HashiCorp's zero trust capabilities with full secret lifecycle management by adding detection and remediation workflows, with new product capabilities expected later this year. "We are excited to welcome BluBracket to HashiCorp. Security is critical for cloud platform teams as they bring order and consistency to their companies' cloud adoption efforts, and BluBracket will help HashiCorp Vault expand into new areas as part of a more comprehensive lifecycle of managing secrets," said Dave McJannet, CEO, HashiCorp.Reference Link

12:00 EDT GreenTree Hospitality falls -7.9% - GreenTree Hospitality is down -7.9%, or -43c to $5.00.

12:00 EDT Xponential Fitness falls -34.1% - Xponential Fitness is down -34.1%, or -$8.56 to $16.55.

12:00 EDT Unity rises 12.2% - Unity is up 12.2%, or $4.47 to $41.20.

11:58 EDT Teamsters Union 'categorically denies' allegations made by Yellow in lawsuit - The Teamsters Union said it "categorically denies the baseless allegations made by Yellow Corporation in its frivolous lawsuit." The Teamsters union stated: "Yellow Corp.'s claims of breach of contract by the Teamsters are unfounded and without merit. After decades of gross mismanagement, Yellow blew through a $700 million bailout from the federal government, and now it wants workers to foot the bill... The company is misleading our members and the public. We have a contract with Yellow that expires March 31, 2024, and Teamsters are living up to it. Yellow's management knows they've failed this company and their workforce because they can no longer live up to the terms they once agreed to. This lawsuit is a desperate, last-ditch attempt to save face."

11:44 EDT U.S. video game spending rises 12% y/y in May, says Circana - Circana analyst Mat Piscatella said that May 2023 U.S. consumer spending on video game content, hardware and accessories totaled $4.1B, a 12% increase when compared to a year ago. Spending gains were seen across Content, Hardware, and Accessories. Year-to-date consumer spending was flat when compared to the same period in 2022, at $21.8B. Spending on video game content grew 9% in May when compared to a year ago, reaching $3.6B. Console full game and add-on content spending increased 58% when compared to May 2022, offsetting declines across Mobile and PC. Video game hardware spending increased 56% vs YA, to $338M. This is the highest VG hardware spend for a May month since the $427M reached in May 2008. Double-digit percentage growth in both PlayStation 5 (SONY) and Switch (NTDOY) dollar sales again offset declines on other platforms. Year-to-date hardware spending is now 23% higher when compared to the same period in 2022, at $2.2B. Switch was the best-selling hardware platform in both unit and dollar sales during May 2023. Consumer spending on Switch hardware reached an all-time May high for the platform, while unit sales were 2nd highest ever for the platform in a May month, trailing only May 2020. PlayStation 5 continues to lead the 2023 hardware market across both units and dollars, Piscatella said. Other publicly traded companies in the video game space include Microsoft (MSFT), Ubisoft (UBSFY), Take-Two (TTWO), Electronic Arts (EA), Activision Blizzard (ATVI), Tencent (TCEHY), and Roblox (RBLX). Reference Link

11:39 EDT Ryvyl announces strategic partnership with Visa in Europe - Ryvyl (RVYL) announced a strategic partnership between its wholly-owned subsidiary in Europe and Visa (V). "With Ryvyl EU being a fully licensed electronic money institute, this partnership will enable Ryvyl EU's customers to use Visa Direct, a state-of-the-art account-to-account transfer solution," the company said in a statement. Through the partnership, Ryvyl EU customers "will soon have access to highly advanced and convenient payment services via Visa Direct."

11:10 EDT Thumzup reports weekly paid posts up by over 3,000% since beginning of 2023 - Thumzup Media (TZUP) reports that the number of weekly paid posts made through its platform has grown by over 3,000% since the first week of January 2023. "We believe that the impressive growth in weekly usage of the Thumzup platform suggests that our service is resonating with businesses and users in the Westside of Los Angeles - and as the density of platform activity continues to increase, we believe it is becoming increasingly likely that a viral loop may form." stated Robert Steele, Founder and CEO of Thumzup. "We believe Thumzup's platform has the potential to disrupt the $208 billion online advertising industry, similar to how Uber (UBER) and Airbnb (ABNB) disrupted the transformed the transportation and hospitality industries, respectively."

10:22 EDT LanzaTech, Primetals renew ten-year cooperation agreement - Primetals Technologies and LanzaTech announced the signing of a renewed ten-year cooperation agreement to accelerate the deployment of integrated environmental solutions for the steel industry worldwide. Primetals Technologies builds on over 60 years of innovation in metals production and leverages the combined portfolio of predecessors Mitsubishi-Hitachi Metals Machinery and Siemens VAI, founded in 1938. Today, Primetals Technologies represents one of the longest standing global suppliers bringing new technology to the steel sector. LanzaTech's commercialized carbon recycling platform takes emissions from heavy industry, including from the steel industry, and transforms them into the building blocks to make fuels and chemicals. The renewed commitment cements a shared strategy for advancing the metallurgy industry's green transition: Primetals Technologies's focus on delivering multiple solutions for green steel combined with LanzaTech's novel carbon capture and utilization technology that turns waste to value. Under the previous agreement, the companies worked together on process integration and optimization of transforming steel emissions into commodity chemicals. Through this new ten-year agreement, Primetals Technologies and LanzaTech will enable more projects in the global iron and steel sector to adopt LanzaTech's carbon recycling technologies.

10:00 EDT TD Synnex falls -6.4% - TD Synnex is down -6.4%, or -$6.29 to $91.42.

10:00 EDT Unity rises 8.1% - Unity is up 8.1%, or $2.99 to $39.72.

10:00 EDT American Equity rises 16.7% - American Equity is up 16.7%, or $7.51 to $52.61.

09:47 EDT TD Synnex falls -7.2% - TD Synnex is down -7.2%, or -$6.99 to $90.71.

09:47 EDT Circor rises 8.1% - Circor is up 8.1%, or $3.86 to $51.78.

09:47 EDT American Equity rises 17.3% - American Equity is up 17.3%, or $7.79 to $52.89.

09:39 EDT CFPB confirms action against ACI Worldwide for processing unauthorized payments - The Consumer Financial Protection Bureau confirmed that it issued an order against ACI Worldwide and one of its subsidiaries, ACI Payments, for improperly initiating approximately $2.3B in unlawful mortgage payment transactions. ACI's data handling practices negatively impacted nearly 500,000 homeowners with mortgages serviced by Mr. Cooper. By unlawfully processing erroneous and unauthorized transactions, ACI opened homeowners to overdraft and insufficient funds fees from their financial institutions. Today's order requires ACI, among other things, to pay a $25Mcivil money penalty. "The CFPB's investigation found that ACI perpetrated the 2021 Mr. Cooper mortgage fiasco that impacted homeowners across the country," said CFPB Director Rohit Chopra. "While borrower accounts have now been fixed, we are penalizing ACI for its unlawful actions that created headaches for hundreds of thousands of borrowers."

09:37 EDT ACI Worldwide consents to issuance of CFPB consent order - ACI Worldwide announced that the company has consented to the issuance of a Consent Order with the U.S. CFPB relating to the previously disclosed inadvertent transmission of ACH files associated with one of the company's mortgage servicing customers to the ACH network during a test of the company's Speedpay bill payment platform in April 2021. "At the time, Speedpay was a recently acquired addition to ACI's portfolio, and the inadvertent transmission occurred shortly after the Company assumed management of Speedpay's legacy data environment. An internal review determined that ACI's policies and procedures were not followed. ACI took swift action to reverse the ACH entries and prevent any consumer loss. At all times during and after the error, consumers' money and personal information remained safe. ACI consented to the issuance of the Consent Order without admitting any wrongdoing to avoid the expense and distraction of litigation. The Company believes the prompt conclusion of this matter is the best path forward and is in the interest of its employees, shareholders, and customers. The settlement of a consumer class action arising out of the error was approved in court last month. ACI expects most of the costs will be covered by third parties in both matters. Under ACI's ownership, the Speedpay platform complies with a rigorous set of controls and oversight. Immediately after the inadvertent transmission, ACI adopted additional controls, including automation, to prevent such errors from occurring within the Speedpay environment." ACI has comprehensively implemented robust risk and information security programs that are routinely audited by regulators and assessed by independent third parties. ACI's policies, procedures and information systems remain strong and are continuously improving, as the Company constantly takes steps to ensure it meets ongoing regulatory, business and security requirements.

09:29 EDT Performance Shipping enters time charter contract for M/T P. Aliki - Performance Shipping has entered into a time charter contract with ST Shipping & Transport, for the 2010-built, 105,304 dwt, LR2 Aframax oil product tanker, the M/T P. Aliki. The gross charter rate will be based on a fixed floor rate of $45,000 per day for a period of minimum four months to a maximum of five and a half months at the option of the Charterer, plus a 50/50 profit share provision above the floor rate. The charter commenced on June 26, 2023 and is expected to generate approximately a minimum of $5.5M to a maximum of $7.5M in gross revenue depending on the duration of the charter, excluding any additional income that may be earned from the profit share provision.

09:25 EDT Anson, Cable Car vote against proposed MEI Pharma, Infinity transaction - Anson Funds and Cable Car Capital, collectively the beneficial owners of approximately 14.8% of the outstanding common stock of MEI Pharma, (MEIP), issued the following statement regarding the proposed combination of MEIP and Infinity Pharmaceuticals (INFI): "The Board has forsaken its duty to act in the best interests of stockholders through its misguided focus on the proposed merger with Infinity in the face of vocal opposition from stockholders and a subsequent all-cash acquisition proposal. Additionally, we believe the Board's determination that our proposed acquisition could not be 'reasonably expected' to lead to a superior proposal to the proposed transaction with Infinity is demonstrably incorrect. The Board's recent steps suggest a desire to continue down a self-serving path of value destruction. In particular, we note the decision to adopt new employment agreements, including a provision that compensates CEO David Urso if 'rights to the Infinity compound eganelisib are acquired by MEI in 2023 or 2024 in a transaction that is not the Merger.' This appears to be a blatant attempt to circumvent a potential adverse outcome with respect to the merger vote at the upcoming Special Meeting. We hereby place the Company on notice that if stockholders reject the merger, any subsequent in-licensing or similar transaction would contravene the will of the stockholders and amount to what we believe would be a clear-cut breach of the Board's duty of care. We intend to take all steps necessary to hold the Board accountable for its actions. Nevertheless, we reiterate our willingness to engage on the terms of our previously communicated proposal to acquire all shares of MEIP not owned by us for not less than $8.00 per share, plus a contingent value right representing the right to receive 80% of the net proceeds from any license or disposition of the Company's clinical assets. The Acquisition Proposal expires on July 13, 2023 and shall be considered withdrawn, within the meaning of the Infinity merger agreement, if not accepted prior to the stockholders meeting. As we indicated we would, Anson and Cable Car have voted against the proposed combination because we believe it undervalues the Company and will only lead to further value destruction."

09:23 EDT Texas Capital launches Texas Capital Initio onboarding solution - Texas Capital Bancshares announced the launch of Texas Capital Initio, an internally developed, proprietary digital onboarding solution designed to revolutionize the commercial banking experience by simplifying and accelerating the process of opening an account.

09:18 EDT Atossa Therapeutics board approves $10M stock repurchase program - Atossa Therapeutics announces that its Board of Directors has approved a share repurchase program with authorization to purchase up to $10M of its common stock through December 31, 2023.

09:17 EDT Jamf announces participation in CEO Action for Diversity & Inclusion pledge - Jamf announced its participation in the CEO Action for Diversity & Inclusion pledge. This powerful initiative brings together business leaders from various industries to foster a more inclusive workplace environment and drive meaningful change.

09:14 EDT Pizza Inn opens first franchise restaurant in New Zealand - Pizza Inn and Principal Master Licensee and Development Partner Ginny Singh have opened the first New Zealand Pizza Inn. The restaurant chain features signature pizzas, pastas, wings, salads, and desserts for delivery and carryout. Director of GJ Restaurants Ltd, Singh, plans to build a total of ten Pizza Inn restaurants in Auckland within the next three years and is specifically targeting expansion in Manukau, Henderson, and Albany.

09:09 EDT NuZee enters six-month contract with New To The Street - FMW Media's business TV show, New to The Street, announces the signing of a 6-month contract for filming and broadcasting tailored interviews and commercials about NuZee. New to The Street's TV anchors are to interview the management team at NuZee, Inc., with each show airing on New to The Street's televised syndicated outlets on Newsmax, Fox Business Network, and as sponsored programming on Bloomberg TV. Each interview will stream on the show's website: www.newtothestreet.com.

09:09 EDT Wrap Technologies' Wrap Realty exceeds 2022's total sales in six months - Wrap Technologies announced that year-to-date sales in 2023 for Wrap Reality, the Company's advanced virtual reality training system, have surpassed the total sales achieved for the platform in 2022. Wrap Reality has gained traction within the law enforcement community. "This achievement demonstrates the value that law enforcement agencies see with our virtual reality training platform," said Kevin Mullins, CEO of Wrap Technologies. "By focusing on realistic scenarios that emphasize communication skills and de-escalation, our platform empowers officers to excel in critical decision-making and enhances their preparedness for ever-evolving diversity of challenges law enforcement faces in the world today."

09:08 EDT Tenable Holdings announces Tenable Identity Exposure integration - Tenable announced the addition of several new identity-aware features that harness the power of artificial intelligence and machine learning to provide a unified view of all user identities and entitlement risks, whether on-prem or in the cloud. Tenable Identity Exposure now gives customers the most advanced vulnerability and asset risk prioritization capabilities to identify and disrupt attack paths through Active Directory. The solution is fully integrated within the Tenable One Exposure Management Platform.

09:07 EDT Eastman Kodak opens Textile Test Facility for textile developers, manufacturers - Kodak announces the opening of its Textile Test Facility which will provide a comprehensive range of testing services to textile developers, manufacturers and academic institutions to assess specific properties and performance attributes of fabrics. The offering leverages Kodak's infrastructure and expertise in advanced materials and chemicals and is an extension of the company's recent initiative in manufacturing light-blocking fabrics under the KODALUX brand name. The textile test facility is located in the company's Eastman Business Park in Rochester, NY. The new testing facility is ISO certified for providing NFPA 701 Fire Retardancy Testing for textile products. In addition, the facility will provide testing for Color Fastness, Light Blocking or Room Darkening, Tensile and Tear Testing, Stiffness Testing for objective characterization of hand/drape properties and Abrasion Testing. Testing procedures are based on established ASTM and or AATCC methodologies. "Our new service makes it easy for customers in the textile industry to access most sophisticated fabric testing procedures," said Terry Taber, Kodak's Chief Technical Officer and SVP, Advanced Materials & Chemicals. "Customers can rely on Kodak for the highest quality testing to help them meet the most exacting standards. Looking forward, we are committed to expanding the scope of this initiative with additional test resources to meet customer needs."

09:05 EDT Zoom Video launches Intelligent Director for Zoom Rooms - Zoom Video Communications announced the launch of the award-winning Intelligent Director for Zoom Rooms. For hybrid meetings with a Zoom Room, Intelligent Director uses AI and multiple cameras to provide the best image and angle of participants in the room so remote participants can see each person clearly, even in large conference rooms.

09:04 EDT Allbirds unveils design of net zero carbon shoe - Allbirds revealed its highly anticipated M0.0NSHOT, the world's first net zero carbon shoe - and is already urging the rest of the fashion industry to follow suit by giving away its entire toolkit. The high-top shoe boasts a landmark carbon footprint of net 0.0 kg CO2e. Carbon negative, regenerative wool wraps the entirety of the M0.0NSHOT for a striking, uniform look. Allbirds's co-founder Tim Brown took to the stage at the Global Fashion Summit in Copenhagen to unveil the shoe and call on industry competitors in the audience to create their own versions. To help them do so, Allbirds is open-sourcing the M0.0NSHOT methodology via its 'Recipe B0.0K': a toolkit detailing each step of the M0.0NSHOT's process, including materials, manufacturing, transportation, end-of-life, and carbon footprint calculation. The toolkit was distributed to the thousands of Global Fashion Summit attendees and is now available digitally on the Allbirds website for anyone to download - and, hopefully, implement.

09:03 EDT VivoPower announces distribution agreement with Ghana for Tembo's EUVs - VivoPower International announces that it has signed a definitive agreement with Fourche Maline, a fully indigenous Ghanaian engineering and technical services company for it to market, distribute and service Tembo-powered electric utility vehicles, EUV, across Ghana. Fourche Maline provides engineering and technical services in the local Ghana market to a number of the world's leading companies in the Oil & Gas, Mining, Power & Energy, and Food & Beverage sectors. Under the Agreement, Fourche Maline has committed to sell a total of 2,500 Tembo EUV conversion kits from execution of this Agreement over the next 5 years across Ghana and West Africa. Fourche Maline will be responsible for acquiring utility vehicles, converting the vehicles to ruggedised EUVs using Tembo conversion kits, selling the units to end-customers and providing after-sale servicing and maintenance with support from Tembo. Sectors where the Tembo EUV will be used are wide-ranging, including Mining but also Power, Oil & Gas, Government services, Insurance and Agriculture.

09:02 EDT AMD announces AMD Versal Premium VP1902 adaptive SoC - AMD announced the AMD Versal Premium VP1902 adaptive system-on-chip, the world's largest adaptive SoC. The VP1902 adaptive SoC is an emulation-class, chiplet-based device designed to streamline the verification of increasingly complex semiconductor designs. Offering 2X2 the capacity over the prior generation, designers can confidently innovate and validate application-specific integrated circuits and SoC designs to help bring next generation technologies to market faster.

08:58 EDT Caledonia Mining receives shareholder notification from BlackRock - Caledonia Mining (CMCL) received notification on June 26, 2023 from BlackRock (BLK) that on June 23, 2023 it had crossed a threshold for notification, with an interest in excess of 3% of Caledonia's issued share capital.

08:54 EDT Hyperscale cloud platform selects Innodata for AI LLM fine-tuning - Innodata announced that a cloud infrastructure and platform services company has selected Innodata to perform AI large language model fine-tuning and AI data annotation as a white-labeled service for its cloud and platform customers. Innodata anticipates kicking off the service with three of the cloud provider's customers next month.

08:52 EDT American Resources funds initial shipments of lithium ores - American Resources, as previously announced, has entered into an offtake from its South African partners and has funded and commenced the initial shipment of lithium spodumene to the United States for refining, with a goal of having refining capacity in the United States as well as large scale capacity throughout Africa. The Company is in site selection for its initial South African refining facility and has also narrowed down its U.S. based site selection for lithium refining capacity of 120,000 metric tons per year to four states. The initial locations chosen for site selections in the United States are at locations controlled by the Company or its partners. As previously stated, American Resources and its subsidiaries are collaborating with its South African partners on the site selection for a future African refining facility that will be located at or close to regional ports. This facility will process a majority of the materials from South Africa to significantly reduce the costs and carbon footprint associated with transporting unrefined lithium ores and will also add value to the local African communities by bringing new, cutting-edge technologies to the region. The facility is anticipated to process lithium spodumene ores in a manner that yields ultra-pure, battery-grade lithium carbonate or hydroxide, which can then be used as a commercial grade feedstock for either domestic battery manufacturers in the United States or local battery production in the area.

08:49 EDT Owlet announces 1-for-14 reverse stock split - Owlet announced that its Board of Directors has approved a 1-for-14 reverse stock split of its Class A common stock, $0.0001 par value per share that is expected to become effective on July 7 at 5:00 p.m. EDT. The shares of the Company's Common Stock are expected to begin trading on the New York Stock Exchange on a split-adjusted basis at the market open on July 10. No change will be made to the trading symbol for the Company's shares of Common Stock, "OWLT" in connection with the Reverse Split. The Company expects that the Reverse Split will allow the Company to regain compliance with the $1.00 minimum average closing price requirement of the NYSE. The new CUSIP number for the Common Stock following the Reverse Split will be 69120X206. At the Company's annual meeting of stockholders held on June 23 the Company's stockholders approved the proposal to authorize the Board, in its sole and absolute discretion, to effect the Reverse Split at a ratio to be determined by the Board, ranging from 1-for-10 to 1-for-20 and to reduce the authorized number of shares of Common Stock and the authorized and unissued shares of the Company's preferred stock. On June 26, the Board approved the Reverse Split at a ratio of 1-for-14.

08:48 EDT OceanPal regains compliance with Nasdaq minimum bid price rule - OceanPal announced that on June 23, 2023, the Company received notification from the Nasdaq Listing Qualifications department of The Nasdaq Stock Market confirming it has cured the minimum bid price deficiency regaining compliance with Listing Rule 5550(a)(2) and this matter is now closed.

08:45 EDT Stratasys spikes 11% higher after revised 3D Systems proposal

08:45 EDT Gladstone Land completes sale of unfarmed parcel in Florida for $9.6M - Gladstone Land has completed the sale of an unfarmed parcel in Florida for $9.6 million. This provided a 343% return on investment and resulted in a capital gain of approximately $6.4 million.

08:44 EDT Bavarian Nordic reports Phase 3 results for COVID-19 booster vaccine - Bavarian Nordic reported topline results from a Phase 3 non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate. The two-part study enrolled a total of 4,205 adults who either previously completed primary vaccination or had already received one booster dose of a licensed COVID-19 vaccine. The active, controlled part enrolled 622 participants who were randomized 1:1 to receive either a single 100 microgram dose of ABNCoV2, or a single 30 microgram adult booster dose of Comirnaty. The results from this group showed that ABNCoV2 was non-inferior to Comirnaty in terms of neutralizing antibodies against the SARS-CoV-2, thus meeting the study's primary objective. The second part of the study, which is evaluating the safety and tolerability of a single 100 microgram dose of ABNCoV2, has enrolled 3,583 participants into 2 cohorts according to whether they had completed primary vaccination only or primary plus booster vaccination. Results from this group will become available in the third quarter of 2023. Given the continued mutations of SARS-CoV-2 and emergence of new and more distant variants, causing changes in the regulatory requirements and guidelines, the primary objective, while important, is likely insufficient to support a product approval on its own. ABNCoV2 has been designed to induce a broader protective response and therefore the secondary objectives that will compare ABNCoV2 to Comirnaty in terms of neutralizing antibodies against circulating variants will be important to understand the current effectiveness of ABNCoV2. These results are anticipated in the third quarter of 2023.

08:42 EDT Stratasys gets revised acquisition proposal from 3D Systems for $7.50 cash+ - Stratasys (SSYS) confirmed that it has received a revised unsolicited non-binding indicative proposal from 3D Systems (DDD) to acquire Stratasys for $7.50 in cash and 1.3223 newly issued shares of 3D Systems common stock per ordinary share of Stratasys. The Stratasys Board of Directors will carefully review the revised 3D Systems proposal in consultation with its independent financial and legal advisors and in accordance with its duties under applicable law, and its obligations under Stratasys' merger agreement with Desktop Metal. The Stratasys Board has not changed its unanimous approval, recommendation and declaration of advisability of the previously announced transaction with Desktop Metal, Inc. (DM) . The Desktop Metal transaction, which is expected to be completed in the fourth quarter of 2023, is subject to customary closing conditions, including the approval of Stratasys' shareholders and Desktop Metal's stockholders and the receipt of certain governmental and regulatory approvals. Stratasys shareholders do not need to take any action at this time with respect to the 3D Systems revised proposal. J.P. Morgan is acting as exclusive financial advisor to Stratasys, and Meitar Law Offices and Wachtell, Lipton, Rosen & Katz are serving as legal counsel.

08:40 EDT Hess Midstream LP announces repurchase of $100M of Class B units by subsidiary - Hess Midstream LP announced the execution of a definitive agreement providing for the repurchase of approximately $100M of Class B units by its subsidiary, Hess Midstream Operations LP, from affiliates of Hess Corporation and Global Infrastructure Partners, Hess Midstream's sponsors. The terms of the proposed unit repurchase transaction were unanimously approved by the board of directors of Hess Midstream's general partner, based on the unanimous approval and recommendation of its conflicts committee composed solely of independent directors. Pursuant to the terms of the repurchase agreement, the repurchased units will be cancelled upon the closing of the unit repurchase transaction, which is expected to result in increased distributable cash flow per Class A share providing capacity for incremental distribution growth above Hess Midstream's annual distribution target of at least 5% through 2025, consistent with Hess Midstream's return of capital framework.

08:38 EDT Real Good Food announces expansion of entrees into 4,000+ Walmart stores - The Real Good Food Company (RGF) announced the expansion of their Breaded Chicken and Asian Entrees platforms into Walmart (WMT) stores nationwide. By the end of June 2023, 4,000+ Walmart stores nationwide will now carry these items. "Consumers are looking for more nutritious options than what is available today, and our expansion in over 4,000 Walmart stores provides virtually every American with easy access to more nutritious versions of the foods that we all love," said Bryan Freeman, Executive Chairman of Real Good Foods. "Lack of access to better, more nutritious foods is the leading problem in the growing diabetes epidemic, where 1 in 3 people are now pre-diabetic in the US; we are excited to offer foods that not only provide the right nutrition but also taste delicious. We are proud to offer these options at Walmart stores nationwide and look forward to more opportunities to improve human health."

08:37 EDT Workhorse Group begins W750 production, enters partnership with Smyrna Truck - Workhorse Group announced it has started production of the W750 at its manufacturing facility in Union City, Indiana. The Company also announced it has entered into a partnership with Smyrna Truck to be its first certified electric vehicle dealer in Georgia. "The milestones we are announcing today reflect the important progress we are making advancing our product roadmap and executing our strategic growth plans," said Workhorse CEO Rick Dauch. "We could not be more excited to see the W750 rolling out of our Union City facility, and we are poised to ramp up production of it in the coming months. In addition, we are thrilled to announce this dealer partnership with Smyrna Truck, expanding on our network for customers. We look forward to partnering with the Smyrna Truck team, who share our goal of delivering safe, reliable electric vehicles with the highest standard of service to customers."

08:36 EDT Bridgeline Digital's Celebros chosen by Paul Byron Shoes - Bridgeline Digital announced that Paul Byron Shoes has chosen Bridgeline's AI-driven search solution Celebros to power its online business. The partnership will leverage the AB Commerce platform, supported by Bridgeline's long-term Irish partner, Magico, to enhance ecommerce capabilities in Ireland. "We're thrilled to partner with Paul Byron Shoes, such a trusted name in Ireland's retail market," said Ari Kahn, CEO of Bridgeline Digital. "We can't wait to see their online success grow."

08:35 EDT SurgePays announces partnership with ParichuteConnect - SurgePays announced that it has entered into a Distribution Agreement with ParichuteConnect, a social impact investor who looks to use their investment dollars to effect social improvements, to drive signups in the Affordable Connectivity Program, ACP, for their focus populations across the United States. President of SurgePays Fintech, Jeremy Gies said, "This agreement is a great opportunity for SurgePays to expand our ACP subscriber base by partnering with local grassroots and even national government organizations. Social awareness and corporate responsibility are foundational to our business model of providing access to the internet and wireless services to the underserved and lower-income markets in our country. With our capability to enroll new wireless customers through a social impact distributor like ParichuteConnect, we can create win-win scenarios, grow the SurgePays network, and increase the benefits offered by our partners."

08:34 EDT Inozyme announces dosing of first infant in Phase 1b trial of INZ-701 - Inozyme Pharma announced dosing of the first patient in its ENERGY-1 trial, a Phase 1b clinical trial of INZ-701 in infants with ENPP1 Deficiency. "Initiation of the ENERGY-1 trial in infants is an important milestone as we continue to advance INZ-701 with the goal of improving the lives of patients with ENPP1 Deficiency across all age groups. We are committed to a global program to identify and treat all newborns with this condition," said Kurt Gunter, M.D., senior vice president and chief medical officer of Inozyme.

08:32 EDT BioSig Technologies advances collaboration on machine learning, AI solutions - BioSig Technologies announced that it is advancing the research and development of an artificial intelligence medical device platform in collaboration with technical advisory partner Reified Labs. The platform's foundational machine learning model is anticipated to be based on integrated healthcare datasets, beginning with ECG and IECG data acquired by BioSig's first product, the PURE EP Platform. Electrophysiology-focused technological solutions developed under the terms of the collaboration may be integrated into PURE EP technology for potential commercial application. "The cutting-edge work this collaboration started in early 2019 to lay a foundation in AI was ahead of the curve, and our initial findings may have several potentially valuable clinical applications worthy of further exploration," commented Kenneth Londoner, Chairman and CEO of BioSig Technologies, Inc.

08:31 EDT ASP Isotopes secures $9M supply contract with U.S. customer - ASP Isotopes announced that the Company has entered into a supply contract for a highly enriched isotope with a US Customer valued at approximately $9M. The customer is expected to make a prepayment during Q3 of 2023 of approximately $900,000. ASP Isotopes expects to commence the supply of the enriched isotope during Q1 of 2024. "This supply contract represents the first supply contract that ASP Isotopes has entered with a US customer. As a US Company, we are driven to help other US entities source a commercially reliable supply of isotopes. We continue to receive considerable interest from both US and non-US customers regarding our ability to supply isotopes required for many end markets, including healthcare, technology, and green energy. We look forward to the further buildout of our facilities and continuing to execute on our business plan. As we continue to scale our operations, we believe we are well positioned to further capitalize on the significant and growing demand for our proprietary technology and process." said Paul Mann, Chairman and CEO of ASP Isotopes.

08:25 EDT A2Z Smart Technologies completes pilot phase at Carrefour - A2Z Smart Technologies Corp.'s (AZ) subsidiary, Cust2Mate, announced the completion of the pilot phase at Carrefour (CRRFY). Since March 2023, the smart carts have undergone testing at Carrefour's flagship Hypermarket store in Ste Genevieve Des Bois, near Paris, receiving positive feedback and achieving excellent customer satisfaction. As part of the rollout phase, Carrefour and Cust2Mate are looking to initially deploy smart carts in two Carrefour hypermarket stores in Q4 of this year.

08:22 EDT Blink Charging integrates former SemaConnect chargers into global network - Blink Charging announced the successful transition of all former SemaConnect networked chargers and services to the new Blink Network. This move showcases the Blink Network's technology and user-friendly design, providing enhanced visibility for site hosts and a reliable charging experience for drivers. The transition also marks the final step in integrating SemaConnect into the Blink Charging family following its acquisition in June 2022. "The integration of our SemaConnect chargers into the Blink Network is a significant milestone, symbolizing the culmination of our efforts to fully merge the two companies after rebranding the units and operations earlier this year. By combining their strengths and value, we can assure our customers that they have access to state-of-the-art chargers paired with the innovative products and exceptional service they deserve," said Brendan Jones, President and Chief Executive Officer of Blink Charging.

08:21 EDT OrthoPediatrics launches, first case using GIRO Growth Modulation System - OrthoPediatrics announced the limited launch and the completion of the first clinical case using the new GIRO Growth Modulation System. The GIRO tether device is indicated for pediatric patients to aid in the correction of angular deformities of long bones and limb length discrepancy. Two configurations of the system are available, the GIRO Screw configuration for deformities in the femur and tibia, humerus, radius and ulna or ankle and the GIRO Post configuration for limb length discrepancy of the femur and tibia. Joe Hauser, President of Trauma and Deformity Correction at OrthoPediatrics, added, "The first clinical case with the GIRO Growth Modulation system represents a milestone for our business as we continue to leverage the technology and expertise of our colleagues at OrthoPediatrics Canada. This system provides our pediatric orthopedic surgeon partners with a new option to treat their patients, we are excited to see this technology improve the care of kids."

08:20 EDT Aemetis RNG production exceeds plan by 20% during Q2 - Aemetis announced that its Aemetis Biogas subsidiary is operating the Central Dairy Project production facilities 24 hours per day, seven days per week, and exceeded the RNG production plan by approximately 20% during Q2 2023. "The June 21st announcement by the federal EPA of the Renewable Volume Obligation for years 2023, 2024 and 2025 significantly increased the mandate for the D3 Renewable Identification Numbers generated by RNG," said Eric McAfee, Chairman and CEO of Aemetis, Inc. "Each MMBtu of dairy RNG generates 11.7 D3 RINs and the Aemetis Five Year Plan expects 1 million MMBtu in year 2025. The price of D3 RINs has already increased about 30% to $2.85 since the RVO was announced last week."

08:19 EDT iBio appoints Brenner as CEO, Duran as CFO - iBio announced the appointments of Martin Brenner, DVM, Ph.D. as Chief Executive Officer, CEO; and Felipe Duran as Chief Financial Officer, CFO, effective immediately. Dr. Brenner will also continue to serve as iBio's Chief Scientific Officer, a role he has held since December 2020. Dr. Brenner most recently served as the CSO at Pfenex. Prior to serving as the Company's Interim Chief Financial Officer, Mr. Duran was iBio's Vice President of Financial Planning and Analysis from April 2021 to February 2023.

08:18 EDT Warner Bros. Games and NetEase announce launch of 'Harry Potter: Magic Awakened' - Warner Bros. Games (WBD) and NetEase (NTES) announced Harry Potter: Magic Awakened, the highly anticipated, free-to-play collectible card roleplay game set in the wizarding world is now available. Starting today, players in various territories in the Americas, Europe, Africa, Oceania and the Middle East can download the game for free on the App Store for iOS and Google Play for Android. Co-developed and co-published by Warner Bros. Games and NetEase Games, Harry Potter: Magic Awakened is the latest title released under Portkey Games, the label dedicated to creating new mobile and videogame experiences inspired by the wizarding world that place the player at the center of their own adventure.

08:16 EDT Superlatus appoints Eugenio Bortone as president, COO - Superlatus, which on June 23, 2023 announced the signing of a binding letter of intent to be acquired by TRxADE HEALTH, announced new appointments to the Company's management team. Dr. Eugenio Bortone - President and COO: He has held several positions in PepsiCo that included Sr. Global Technical Extrusion Leader, and Senior Scientist for the Global Nutrition Group. Tim Alford currently serves as the interim CEO and will transition into the position of Chief Commercialization Officer to focus on the aggressive M&A strategy of the Group and will work closely with Dr. Bortone and the Board. The Board of Directors of both companies have unanimously approved the LOI, and the Merger would be expected to close in late third quarter or early fourth quarter of 2023.

08:15 EDT electroCore announces its TAC-STIM nVNS was selected to be part of AFRL A2PEX - electroCore announced that its TAC-STIM non-invasive vagus nerve stimulation, nVNS, Human Performance product, has been selected to be a part of the Air Force Research Laboratories, AFRL, Real-Time Assessing and Augmenting Cognitive Performance in Extreme Environments, A2PEX, Grant Program. A2PEX is a five-year project led by the Florida Institute for Human and Machine Cognition, IHMC, that includes internationally-recognized leaders in wearable technologies from industry and academia. The goal of A2PEX is to build a wearable system to sense, assess and augment cognitive performance in operational environments. Sensors developed by A2PEX partners will develop electrophysiological and biomarker sensors to assess Airmen stress/fatigue in extreme environments. electroCore's proprietary TAC-STIM nVNS has been commissioned by IHMC for integration into the A2PEX system to mitigate fatigue and augment performance. TAC-STIM is a form of nVNS for human performance and has been developed in collaboration with the United States Department of Defense Biotech Optimized for Operational Solutions and Tactics, or "BOOST" program and AFRL.

08:13 EDT Ocuphire Pharma presents APX3330 ZETA-1 clinical data at ADA conference - Ocuphire Pharma announced that a late-breaking poster and ePoster theater presentation titled Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment-Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy was presented by retina specialist and ZETA-1 clinical trial investigator, Victor H. Gonzalez, M.D. at the 83rd Scientific Sessions of the American Diabetes Association, ADA, in San Diego, CA on Saturday, June 24, 2023. "We were pleased to present our ZETA-1 data on oral APX3330 at the world's largest diabetes meeting that features important diabetic advances," said Rick Rodgers, Interim Chief Executive Officer. "In this trial, APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy, as measured by the percentage of subjects with binocular 3-step worsening in DRSS, our anticipated Phase 3 primary endpoint. Compared to the current intravitreal injection options, a non-invasive convenient oral therapy that prevents disease progression could shift the treatment paradigm and broaden the prescriber base to include not only eye care physicians but primary care and endocrinologists. We look forward to an End of Phase 2 meeting with the FDA to confirm the Phase 3 study design and continue advancing APX3330 towards potential approval."

08:12 EDT Immutep completes A$80M capital raise - Immutep announces the completion of an A$80 million capital raise to support its late-stage and expanding clinical development pipeline. With this new capital, Immutep believes it is fully funded for its current and expanded clinical program through to Q1 CY2026 with a pro-forma cash balance of A$135.2M.

08:11 EDT Sysco announces Sysco Shop availability in Spanish - Sysco announced that Sysco Shop, the company's ecommerce platform, is now available in Spanish. Sysco is focused on making the shopping experience easier and more personalized for customers. Other enhancements to Sysco Shop include easier navigation, personalized offers, intelligent product recommendations, delivery tracking, enhanced photos and product descriptions and improved search quality results.

08:09 EDT Jeld-Wen appoints Wendy Livingston as Chief Human Resources Officer - Jeld-Wen announced the appointment of Wendy Livingston as Executive Vice President and Chief Human Resources Officer effective June 27. Livingston replaces Tim Craven, who previously announced his plan to leave the company in July. Livingston joins the company from Spreetail, a multinational e-commerce company, where she served as the Chief People Officer. Prior to Spreetail, Livingston was senior vice president and CHRO for Harsco, a global environmental services company with more than 13,000 employees. She also spent more than 20 years at The Boeing Company in positions including vice president, corporate human resources, and vice president, talent & leadership development.

08:09 EDT CME Group announces expansion of WTI options - CME Group announced plans to expand WTI Crude Oil options to include Monday and Wednesday expiries. Pending regulatory review, the new contracts will begin trading on July 31.

08:07 EDT Regulus: First subject dosed in second cohort of Phase 1b MAD study of RGSL8429 - Regulus Therapeutics announced the dosing of the first patient in the second cohort of the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "Following the positive safety review of patients in the first cohort, we were excited to initiate screening for the second cohort last month," said Jay Hagan, CEO of Regulus Therapeutics. "Now with dosing of the first patient in the second cohort, our Phase 1b MAD trial is progressing well. We are on track to deliver topline data from the first cohort around the end of the third quarter of this year. This is another important milestone in our effort to develop a novel treatment for patients with ADPKD."

08:06 EDT BriaCell announces FDA approval of registrational study for Bria-IMT - BriaCell Therapeutics received approval from FDA on its pivotal registrational study design for Bria-IMT in combination with a checkpoint inhibitor in advanced metastatic breast cancer. FDA has approved the study design, the primary and secondary endpoints, and patient population in BriaCell's upcoming pivotal registration clinical study. The study will include advanced metastatic breast cancer patients who have exhausted all other treatment options. The trial will be a randomized, open-label study comparing the Bria-IMT combination regimen with an immune check point inhibitor in one arm with treatment of physicians' choice in another arm in advanced metastatic breast cancer. A third smaller arm with the Bria-IMT regimen alone will be included in the study to address FDA's combination drug assessment requirements. Upon achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT combination regimen following the Biologics Licensing Application filing process. Patient recruitment and dosing will commence in summer 2023.

08:06 EDT Genpact, Walmart extend partnership in North America - Genpact (G) announced it has extended its partnership with Walmart (WMT) to continue to support its North American finance and accounting operations. The current extension builds on the relationship that the two companies began in 2018 in North America which has since expanded to other markets in Latin America and South Africa.

08:05 EDT Medicenna Therapeutics expects cash to fund operations through 3Q24 - As of March 31, 2023, cash and cash equivalents were $33.6 million, compared to $20.5 million on March 31, 2022. These funds are expected to provide the Company with sufficient capital to execute its current planned expenditures through the key milestones of the ABILITY study and through calendar Q3 2024 based on its current plans and projections.

08:04 EDT Booz Allen awarded position on $2.6B IRS EDOS contract - Booz Allen Hamilton announced that it was awarded a position on the Internal Revenue Service Enterprise Development, Operations Services contract, a Blanket Purchase Agreement with a ceiling value of $2.6B. The multiple-award BPA has a seven-year period of performance. The IRS's information technology teams work to deliver IT services and solutions that drive effective tax administration. The transformational EDOS contract supports IRS' applications development portfolio to modernize mission critical applications efficiently and cost-effectively, while implementing annual tax season legislative requirements. EDOS is designed for task orders that will support the filing season and the agency's legislatively mandated modernization goals.

08:04 EDT Medicenna Therapeutics announces expected upcoming milestones - Initial anti-tumor activity data from ABILITY's fifth and sixth dose escalation cohort expected in calendar Q3 2023. Commencement of the ABILITY study's Phase 2 single agent dose expansion portion expected in calendar Q3 2023. Clinical update from the ABILITY study's Phase 2 single agent portion expected in calendar Q4 2023. Commencement of the ABILITY study's Phase 2 combination portion expected in calendar Q4 2023.

08:03 EDT GM Defense to prototype energy storage unit - GM Defense, a subsidiary of General Motors, was selected by the Department of Defense's Defense Innovation Unit to prototype an energy storage unit. GM Defense's solution will meet the requirements of DIU's Stable Tactical Expeditionary Electric Power program. STEEP seeks to support tactical microgrid and energy management capabilities in austere locations, reducing logistical requirements and the reliance on fossil fuels as the primary energy source across the DoD. GM Defense will leverage GM's advanced electric vehicle propulsion architecture, the Ultium Platform, to deliver a scalable and adaptable energy storage unit that supports the tactical energy requirements of the warfighter. The prototype solution will provide uninterruptable and sustainable power for mission critical equipment, such as command and control, communications, radar and weapons systems in remote areas or where a stable power grid is absent. GM Defense's STEEP energy storage system will provide intelligent tactical microgrid capabilities that work with hydrogen-powered generators, stationary and mobile battery electric power or existing fuel-powered generators to support efficient power management and distribution.

07:57 EDT Emergent BioSolutions CEO Robert Kramer to retire, Haywood Miller named interim - Emergent BioSolutions announced that Robert Kramer Sr. has informed the Board of Directors of his intention to retire from Emergent. Mr. Kramer will step down from his role as President and CEO of Emergent and as a member of the Company's Board, effective immediately. The Board has appointed Haywood Miller as interim CEO while it conducts a search to identify a new permanent CEO, considering both internal and external candidates and with the assistance of a leading executive search firm. Mr. Miller, Managing Director at Berkeley Research Group, has served as an advisor to the Company and its executive management team for the last several months. In order to ensure a smooth transition, Mr. Kramer will serve as an advisor to the Company until August 1, 2023.

07:54 EDT CMS proposes 1.6% payment increase for dialysis operators in 2024 - On June 26, the Centers for Medicare & Medicaid Services, or CMS, issued a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease, or ESRD, Prospective Payment System, or PPS, for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury, or AKI, dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program, or QIP. For calendar year 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6%. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies, the CMS stated. DaVita (DVA) and Fresenius Medical (FMS), which provide dialysis and related services, are down 5% and 4%, respectively, in Tuesday pre-market trading following the CMS notice. Reference Link

07:45 EDT Arrowhead files for regulatory clearance to initiate a Phase 1 study of ARO-SOD1 - Arrowhead Pharmaceuticals announced that it has filed an application for approval to initiate a Phase 1 clinical trial of ARO-SOD1, an RNAi-based investigational medicine designed to reduce expression of superoxide dismutase 1 in the central nervous system as a potential treatment for patients with amyotrophic lateral sclerosis caused by SOD1 mutations. ARO-SOD1 is the first therapeutic candidate designed for delivery to the CNS to enter clinical studies that leverages Arrowhead's Targeted RNAi Molecule platform. "The ARO-SOD1 program entering clinical studies represents the further expansion of our proprietary TRiMTM platform, which now includes product candidates addressing a multitude of diverse disease areas that target the liver, lung, muscle, and CNS," said Chris Anzalone, Ph.D., president and CEO of Arrowhead. Pending regulatory clearance, Arrowhead intends to proceed with AROSOD1-1001, a Phase 1 randomized, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-SOD1 in adult patients with ALS harboring a SOD1 mutation considered to be causative of ALS. The study is designed to enroll up to 24 subjects. An application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.

07:42 EDT ARway.ai reports sales pipeline of over $2.5M in potential enterprise contracts - ARway.ai announced that its sales pipeline has jumped over 70% in just six weeks to over $2.5 million in potential enterprise contracts. These enterprise deals represent a significant revenue opportunity for ARway.ai as it expands its reach across the globe in the indoor navigation industry. The Company is in late stage negotiations with a number of enterprise accounts and expects to continue building its pipeline of sales opportunities throughout the year.

07:41 EDT Auddia combines AI algorithm with natural language processing technology - Auddia has combined its AI algorithm with natural language processing in a new audio classification model that can be applied to podcasts to deliver ad-free listening. Auddia launched its faidr audio Superapp in February of 2022 and recently released faidr 3.0, which adds podcasts and an exclusive content offering branded as faidrRadio. The app utilizes Auddia's proprietary AI-based audio-classification algorithm to deliver ad-free AM/FM listening. The new AI model, when it is fully rolled out, is expected to be added to faidr to deliver ad-free podcasts.

07:38 EDT MeiraGTx announces clinical data from AQUAx Phase 1 study of AAV2-hAQP1 - MeiraGTx Holdings announcedclinical data from the completed Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia. Full data from the AQUAx Phase 1 study is expected to be reported at a scientific meeting in the second half of 2023. AQUAx is an open label, multi-center, dose escalation study of a single administration of AAV2-hAQP1 to one or both parotid glands in participants with radiation-induced salivary hypofunction and grade 2/3 xerostomia. There were 4 escalating dose cohorts with 3 participants per cohort for both unilaterallly and bilaterally treated participants. All participants were followed for 1-year post-treatment in the Phase 1 AQUAx study and were then enrolled in a long-term follow-up study for a total of 5 years. The primary endpoint was safety and the secondary endpoints included change from baseline to 12 months in patient-reported measures of xerostomia symptoms using the Global Rate of Change Questionnaire, or GRCQ, and the Xerostomia Questionnaire, or XQ. In addition, whole saliva flow rate was assessed. The study was conducted at 4 centers, with 3 in the US and 1 in Canada. Treatment appears safe and well tolerated at each dose tested with no dose-limiting toxicity or treatment-related serious adverse events. Efficacy Data presented from the 24 participants treated in the AQUAx study: Improvements observed in both of the patient reported assessments of xerostomia symptoms, Global Rate of Change Questionnaire and Xerostomia Questionnaire, in both unilateral and bilateral treated cohorts at 12 months post-treatment; Improvements in salivary flow were seen in unilateral as well as bilateral cohorts; Early long-term follow-up data suggest durability of improvement out to at least 3 years post-treatment. McMaster Global Rate of Change Questionnaire: Bilateral Cohorts to 12 Months: 10/12 participants at 12 months reported symptoms of dry mouth as "better" following treatment ; Each of these 10 participants rated changes in xerostomia scores that were "important" or "very important" with a score of 2 or more at 12 months; 5 participants rated the change in xerostomia symptoms with the highest improvement scores of 6 or 7 denoting a "very important improvement"; No participant reported worsening of xerostomia symptoms. Unilateral Cohorts to 12 Months: 8/12 participants at 12 months reported symptoms of dry mouth as "better" following treatment; Each of these 8 participants rated changes in xerostomia scores that were "important" or "very important" with a score of 2 or more at 12 months; 4 of these participants rated the change in xerostomia symptoms with the highest improvement scores of 6 or 7 denoting "a very important improvement"; Improvement in xerostomia symptoms persisted through 2 years in 4 participants and 3 years in 3 participants who reached these timepoints; No participant reported worsening of xerostomia symptoms. Combined Unilateral and Bilateral Cohorts: Overall, the average improvement in GRCQ score was greater in bilaterally treated participants compared to those treated unilaterally; Improvements were maintained and increased over time in both unilateral and bilateral cohorts ;A 2-point change in GRCQ is considered important by patients; Changes of 3 points or greater are considered a substantial improvement over standard of care and "transformative" by KOLs; Unilaterally treated cohorts achieved overall improvement of greater than3 points at 12 months; Bilaterally treated cohorts achieved overall improvement of greater than3 points at 2 months and an overall improvement of 4 points by 6 months, with this 4-point improvement maintained at 12 months Xerostomia Questionnaire: Xerostomia Questionnaire PRO measure scoring scale; An improvement of 8 points or more is considered clinically meaningful; A decrease in score of 10 or greater is considered a substantial improvement over standard of care and "transformative" by KOLs. Change from Baseline Unilateral and Bilateral Cohorts; Unilateral: 7/12 had score improvements greater than or equal to8 at 12 months; Bilateral: 9/12 had score improvements greater than or equal to8 at 12 months; Overall: 16/24 had an improvement following treatment of greater than or equal to8 points; 50% of unilaterally treated participants and 75% of bilaterally treated participants at 12 months achieved at least a 10-point improvement; There was good concordance between the responses on the GRCQ and XQ. Average Change from Baseline Unilateral and Bilateral Cohorts: In unilaterally treated participants, an average 13-point improvement from baseline in XQ was seen at 12 months; In bilaterally treated participants, an average 21-point improvement from baseline in XQ was seen at 12 months; In both groups, XQ scores improved greater than8 points soon after treatment, and greater than10 points within 2 months after treatment; This level of benefit is considered transformative by KOLs; The degree of improvement in scores was greater in bilaterally treated participants compared to those treated unilaterally. Whole Saliva Flow:; Bilaterally Treated Participants: Unstimulated Whole Saliva Flow; Meaningful increase in whole saliva flow was seen in bilaterally treated participants ; The overall unstimulated whole saliva flow rate improved to an average of 0.33 mL/min which is within the normal range for unstimulated whole saliva production; Normal unstimulated whole salivary flow rate averages 0.3-0.4 mL/min; The average percentage change from baseline was 83% at 12 months; Based on both absolute whole resting saliva as well as the overall percentage change from baseline - the improvement in unstimulated salivary flow in the bilaterally treated participants appears to be of a clinically meaningful size that could result in improvement in xerostomia symptoms. Unilaterally Treated Participants: Absolute Whole Saliva Measures: Increase in whole salivary flow was also observed in unilaterally treated participants despite the data being confounded by significant manipulation of the salivary glands just prior to stimulated saliva collection, and only a single treated gland contributing to the whole saliva volume; Stimulated whole saliva in the unilaterally treated cohorts increased to greater than 0.7ml/min which is above the range of stimulated saliva flow that is considered hyposalivation; Hyposalivation is less than0.5 to 0.7ml/min for stimulated whole saliva flow. AAV2-hAQP1 Persists in Parotid Gland for at Least 24 Months After Treatment: Biopsies were obtained in 7/15 participants enrolled in the National Institutes of Health, single site, Phase 1 study MGT001, using the same batch of drug product used in the AQUAx study; 6/7 biopsies showed the presence of AAV2-hAQP1 genomes greater than or equal to12 months post-treatment; There is an increase in copy number of transduced vector genomes normalized to DNA with increasing dose; Immunohistochemistry of tissue from a core needle biopsy showed AQP1 protein expression in acinar cells transduced with AAV2-hAQP1.

07:37 EDT AppTech Payments grants patent license to PayToMe.co - AppTech Payments has granted a patent license to PayToMe.co, a Silicon Valley-based company focused on digital financial services. "As a leader in specialty payments, this transaction is another example of AppTech licensing its patent portfolio and receiving an equity stake in PayToMe, while bridging the gap between traditional banking systems and evolving customer needs," said Luke D'Angelo, Chairman & CEO of AppTech Payments Corp. "We believe in the power of collaboration and are confident that this relationship will unlock new growth opportunities for both companies and more promising startups in the Fintech space." The following AppTech patents are licensed under this agreement: Computer to Mobile Two-Way Chat System & Method; Mobile-to-Mobile Payment System and Method; System and Method for Delivering Web Content to a Mobile Device; Mobile Commerce Framework

07:35 EDT Centogene, Lifera enter strategic collaboration with formation of a JV - CENTOGENE and Lifera announced a strategic collaboration with the formation of a Joint Venture, JV, to increase local and regional access and rapid delivery of world-class multiomic testing to patients in Saudi Arabia and countries of the Gulf Cooperation Council, GCC. Under the terms of the collaboration, CENTOGENE will receive a $30M mandatory convertible loan from Lifera. CENTOGENE will provide its diagnostics and multiomics expertise to the JV, which together with Lifera's strong local presence and resources, will establish widespread access to local state-of-the-art genetic sequencing tailored to regional needs. The JV will build an advanced laboratory and bioinformatics infrastructure - leveraging the CENTOGENE Biodatabank. The JV will develop capabilities for genetic testing and interpretation, working collaboratively with CENTOGENE globally - serving as a vehicle for large national screening and genomics programs. "Teaming up with Lifera marks a significant step forward in our mission to deliver data-driven, life-changing answers to patients around the world and forms a pathway to achieving sustainable growth and profitability for CENTOGENE," said Kim Stratton, Chief Executive Officer at CENTOGENE. "As part of Vision 2030, Saudi Arabia has designed impressive programs to improve health outcomes throughout the region. This JV will now build on CENTOGENE's extensive know-how and current leading position in the Saudi market, as well as Lifera's deep understanding of the local healthcare landscape to actively contribute to these healthcare initiatives. This, along with Lifera's investment, secures CENTOGENE a committed strategic partner for the future." Under the terms of the agreement, Lifera and CENTOGENE will make an investment into the JV. CENTOGENE will also be eligible for significant JV performance-related milestone payments and revenue-based royalties until the year 2033. Both parties will be represented on the board of the JV. The agreement also foresees that two Lifera representatives will join CENTOGENE's Supervisory Board.

07:32 EDT Harpoon announces completion of enrollment in Phase 1 study of HPN217 - Harpoon Therapeutics announced the completion of planned patient enrollment in the Phase 1 dose escalation study evaluating the safety, tolerability, and pharmacokinetics of HPN217 in patients with relapsed/refractory multiple myeloma. Additional patients currently in screening will also be allowed to enroll. "We are pleased to have achieved this important milestone for Harpoon, with the enrollment of the first of our two TriTAC clinical compounds having completed dose escalation as planned," said Julie Eastland, President and CEO of Harpoon Therapeutics. "The identification of the recommended dose(s) for Phase 2 and the presentation of Phase 1 data is anticipated by the end of 2023."

07:32 EDT Drilling Tools International appoints Roe Patterson to board of directors - Drilling Tools International announced the appointment of Mr. Roe Patterson to the DTI Board of Directors, effective June 21, 2023. Mr. Patterson will serve as a member of the Audit Committee of the Board. Following the appointment of Mr. Patterson, the Board is comprised of seven Directors, four of whom are independent. Mr. Patterson currently manages and invests in multiple companies inside and outside of the energy sector, including ClearWell Dynamics and Ventana Midstream.

07:31 EDT CoreCard joins Russell 3000 Index - CoreCard Corporation joined the broad-market Russell 3000 Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective June 26.

07:27 EDT Critical Elements Lithium appoints senior director of sustainable development - Critical Elements Lithium announced the appointment of Nancy Duquet-Harvey as Senior Director of Sustainable Development and Environment. She has contributed to the successful implementation of numerous environmental programs at several mining companies, including Agnico Eagle - Nunavut, Alamos Gold - Young-Davidson, Kirkland Lake Gold - Macassa Mine, New Britannia Mine - Manitoba and Kinross Gold - Macassa Mine, Bell Creek Mill.

07:21 EDT Xtract One's SmartGateway receives TSA, APL validation - Xtract One Technologies announced its SmartGateway patron screening solution was tested by the TSA for effectiveness and suitability, and as a result, will be included in the TSA's 2023 approved product list. The extensive testing was completed by Johns Hopkins University's Applied Physics Laboratory, on behalf of the TSA.

07:19 EDT Arch Biopartners receives FDA approval to proceed with Phase II AKI trial - Arch Biopartners received a "Study May Proceed" letter from the U.S. Food and Drug Administration for a Phase II human trial for LSALT peptide targeting cardiac surgery-associated acute kidney injury. LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the lungs, liver and kidneys. This decision follows the FDA's review of the Company's investigational new drug application submitted to the FDA's Division of Cardiology and Nephrology on May 26, 2023. The IND application included preclinical data, Phase I and Phase II clinical data to date, manufacturing processes, and the protocol design for the CS-AKI Phase II trial. The CS-AKI trial has plans to recruit up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the U.S., Turkey, and Canada. Patient recruitment is expected to begin in the fall of 2023, pending approvals from local health authorities, ethics committees and internal review boards. There will be an independent Data Safety Monitoring Board which will monitor the safety of the patients enrolled in the trial. This study is designed to produce a signal of efficacy that would justify a larger Phase III trial.

07:17 EDT Osisko reports underground sampling results at Trixie, Tintic project - Osisko Development announces underground sampling results from its ongoing exploration program at its 100%-owned Trixie test mine, within the Company's wider Tintic Project, located in the historic East Tintic Mining District in central Utah, U.S.A. Chris Lodder, President of Osisko Development, commented, "The underground face chip sampling at Trixie continues to define mineralized zones, namely below the main 625 level and into the 750 level at Trixie, and further to the south of the deposit closer to the Sioux Ajax fault within our current drill areas. These results will assist in furthering our knowledge of the extents of the deposit and improve our targeting in our underground exploration program at Trixie."

07:16 EDT Origin Materials begins startup of Origin 1 CFM plant - Origin Materials announced it has begun startup of Origin 1, the world's first commercial CMF plant, located in Sarnia, Ontario, in-line with prior guidance. The new plant will supply industry with intermediate chemicals and materials that can be used across a wide range of end markets, including clothing, textiles, plastics, packaging, car parts, tires, carpeting, toys, fuels, and more with a $1 trillion addressable market. The plant represents a scale-up of Origin's technology platform for converting sustainable wood residues into versatile intermediate chemicals. CMF is a versatile chemical building-block that can be used to make numerous downstream products, including para-xylene, which is the precursor to PET plastic, and FDCA, which can be used in numerous sustainable products and materials such as the next-gen polymer PEF. The plant will also produce HTC, whose applications include sustainable carbon black for automotive tires.

07:16 EDT Yellow Corp files lawsuit against International Brotherhood of Teamsters - Yellow Corporation has filed a complaint in the U.S. District Court for the District of Kansas against the International Brotherhood of Teamsters and certain of its affiliates. The company said, "The complaint alleges that the defendants breached their binding union contract with Yellow causing more than $137 million in damages by unjustifiably blocking, for over eight months, Yellow's restructuring plan to modernize its business, which is necessary to compete against non-union carriers that dominate the LTL business today. These modernization efforts, known as One Yellow, are essential to the Company's survival. Without these crucial reforms, which are standard practice in the industry today, Yellow likely will not survive, 30,000 jobs will be lost, including 22,000 union jobs, and its shareholders, including the federal government, which owns 30.1% of Yellow stock, will be severely damaged. Yellow remains a critical part of the domestic supply chain with hundreds of thousands of customers -- large and small -- relying on the Company to deliver freight coast-to-coast. Driving Yellow out of business will badly damage the supply chain, lessen competition and raise the price of shipped goods in the LTL market and feed inflation....The complaint also alleges that Sean O'Brien, IBT General President, orchestrated these breaches and has prevented Yellow from meeting with IBT leadership. For several years, the IBT had endorsed the company's modernization effort and, in fact, approved the first of the effort's three phases before the IBT reversed itself taking, in Mr. O'Brien's words, a "militant approach" to blocking Yellow's modernization.Completion of One Yellow in 2023 is critical to Yellow's ability to survive, particularly given that Yellow faces, among other things, the imminent need to refinance $1.3 billion in debt-a $567.4 million term loan maturing on June 30, 2024, and a $729.4 million U.S. Treasury loan maturing on September 30, 2024. Nonetheless, as alleged, the Union has blocked Yellow's completion of One Yellow, triggering grave uncertainty for employees, investors and customers, and has knowingly intended to cause Yellow's economic ruin. Moreover, Sean O'Brien has taken up the role of public agitator for the company's demise, recently tweeting an image of a headstone in a cemetery with "Yellow" on it. He has continued to hide behind numerous false, unconstructive, and irresponsible social media posts maligning the company, while refusing to discuss a path forward with the Company itself. The situation might have been avoided if the Union had participated in meetings months ago or otherwise agreed to sit down and negotiate in good faith. Yellow must now take immediate steps to try to save itself. Yellow is entitled to $137.3 million for the injury the Union has caused Yellow, and continues to cause Yellow, and in the event of its demise, at least $1.5 billion for the loss in enterprise value Yellow is sustaining as a result of the Union's breaches."

07:14 EDT GXO Logistics expands partnership with Abercrombie & Fitch - GXO Logistics (GXO) announced that it has expanded its partnership with leading global specialty apparel and accessories retailer Abercrombie & Fitch (ANF), managing its ecommerce fulfillment and returns in the U.K. from its dedicated, newly refurbished 170,000-square-foot facility outside London. Gavin Williams, GXO's Managing Director, UK and Ireland, commented, "After successfully launching a major warehouse operation in the U.S. last year, we're excited to bring Abercrombie & Fitch to the U.K. with a dedicated warehouse, underpinned by our WMS, to seamlessly manage their fulfilment and returns. Our facility puts stock closer to Abercrombie & Fitch's U.K. consumers, improving delivery and returns processing speeds and reducing environmental impact. This is a long-term, global partnership, and we're looking forward to supporting their growth plans in the U.K."

07:13 EDT Alpha Healthcare Acquisition III to acquire Carmell Therapeutics - Alpha Healthcare Acquisition III announced the execution of a non-binding letter of intent, or LOI, to acquire a commercial stage regenerative medicine company conditioned upon the closing of ALPA's initial business combination with Carmell Therapeutics Corporation, a Phase 2 stage regenerative medicine platform company developing allogeneic plasma-based biomaterials for active soft tissue repair, aesthetics and orthopedic indications. ALPA has set a stockholders meeting to consider the previously announced business combination with Carmell for July 11. Stockholders of record as of June 20 are eligible to vote at the meeting with a redemption deadline of July 7. If the proposals at the meeting are approved, the parties anticipate that the business combination will close shortly thereafter, subject to the satisfaction of all other closing conditions. Upon closing, the combined company will be renamed Carmell Therapeutics Corporation and the common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol. Shukla will serve as executive chairman and Randy Hubbell will serve as CEO of the combined company. The target manufactures and develops human allograft products for active soft tissue repair, aesthetics and orthopedic indications. The Target's marketed products meet all criteria for regulation under section 361 of the PHS Act and 21 CFR part 1271 as affirmed by the FDA Tissue Reference Group, or TRG. As of March 31, 2023, the Target had achieved approximately $50M in unaudited trailing twelve month net revenue and approximately $5M in unaudited TTM EBITDA from the sales of its products. During the second quarter, two of the Target's products were added to CMS Part B Drug and Biological Average Sales Price pricing files and the Target became a preferred vendor via a national pricing contract with one of the top three largest group purchasing organizations serving over 1,500 hospitals in the United States. Per the terms of the LOI, the Target's shareholders will receive $65M in initial equity value, plus up to $75M in Milestone Equity Payments linked with the achievement of revenue and business milestones. The target's shareholders will be locked up for 12 months following closing. The transaction is subject to completion of due diligence, customary documentation, shareholder approval and other customary conditions. The transaction is expected to close in the second half of 2023. Upon closing of the transaction, the Target would operate as wholly owned subsidiary of the combined company.

07:11 EDT Plug Power to design, deliver 10MW PEM electrolyzer to HOPE project - Plug Power is part of a consortium of companies that received a $21.8M dollar grant from the European Commission to build an offshore hydrogen production plant. As a member of the nine-company consortium HOPE, Plug will design and deliver a 10-megawatt proton exchange membrane, PEM, electrolyzer system to the site in the North Sea, off the port of Ostend, Belgium. This 10MW offshore hydrogen project aims to prove the commercial sustainability of renewable offshore hydrogen production, with the end goal to enable the deployment of commercial large-scale solutions. "We are grateful for the European Commission's support to demonstrate the viability of offshore green hydrogen production at scale," said Andy Marsh, Plug's CEO. "Once successfully demonstrated, we anticipate private sector investments in offshore hydrogen production will accelerate." The grant, covering a period of five years, will be used to finance the design phases, the supply of equipment and the construction work, as well as research, development and innovation work focusing on optimizing technological solutions and the operation of this type of infrastructure.

07:10 EDT Algernon engages Maxim Group to explore spin-off of ifenprodil program - Algernon Pharmaceuticals engaged Maxim Group to provide financial advisory and investment banking services, and to assist in identifying and evaluating potential M&A and strategic opportunities, including the potential spin-off of the Company's NP-120 chronic cough research program. Ifenprodil is an N-methyl-D-aspartate receptor antagonist specifically targeting the NMDA-type subunit 2B, which prevents glutamate signaling. Ifenprodil represents a novel first-in-class potential treatment for chronic cough and is thought to interfere with central signaling in the brain, suppressing the urge to cough.

07:09 EDT Nkarta announces updated data from Phase 1 study of NKX101 - Nkarta announced updated data from its Phase 1 study of NKX101 to treat patients with relapsed or refractory acute myeloid leukemia. NKX101 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target NKG2D ligands on cancer cells. Four of six patients in one dose expansion cohort achieved a best composite complete response after receiving at least one cycle of NKX101. In this cohort, a cycle consisted of three weekly doses of NKX101 at 1.5 billion cells per dose after treatment with fludarabine and Ara-C for lymphodepletion. Ara-C is an established and important drug in the treatment of AML across treatment lines, including first line therapy. Exposure to Ara-C is also known to upregulate NKG2D ligands, potentially increasing sensitivity of cancerous cells to NK-cell mediated killing. Data from the NKX101 study suggest Ara-C has the potential to be an effective agent for lymphodepletion. Nkarta expects to enroll 12 to 20 additional patients in the expansion cohort using Flu/Ara-C lymphodepletion of the Phase 1 clinical trial and provide a clinical update in the first half of 2024. Nkarta also plans to introduce protocol changes intended to standardize criteria for retreatment and consolidation and simplify study logistics for enrolled patients. NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses donor-derived NK cells engineered to target NKG2D ligands on cancer cells. NKX101 is being evaluated in a dose-escalation Phase 1 study as a multi-dose, multi-cycle cellular therapy in patients with r/r AML. As of June 10, 2023, a total of 36 patients with r/r AML were enrolled, compared to 17 at the previous update of April 21, 2022. Thirty patients with r/r AML were treated with NKX101 after lymphodepletion with fludarabine and cyclophosphamide, through dose finding and a separate dose expansion cohort. The majority of patients had poor risk disease. The patients in these cohorts were heavily pre-treated, with 2 median lines of therapy and 27/30 having been treated with venetoclax. A separate, expansion cohort enrolled 6 patients who received lymphodepletion with Flu/Ara-C followed by 3 weekly doses of NKX101 at 1.5 billion cells per dose. This cohort included 5/6 patients with poor risk disease and other additional high-risk clinical features such as early relapse after allogeneic hematopoietic cell transplant and chemo-refractory disease. The patients in this cohort were also heavily pre-treated, with 2 median lines of therapy and all having been previously treated with venetoclax-containing regimens. NKX101 was well tolerated. No dose-limiting toxicities were observed across all cohorts. The safety profile of NKX101 was consistent across both lymphodepletion regimens. The emerging safety profile of NKX101 is positively differentiated from those of many cell therapies. In patients with r/r AML that received lymphodepletion with Flu/Cy, limited CAR T-like toxicities were observed, including 5 less than or equal tograde 2 infusion reactions, 5 cases of less than or equal tograde 2 cytokine release syndrome, 1 case of grade 2 immune effector cell-associated neurotoxicity syndrome, and no graft-versus-host disease. The most common higher-grade adverse events were myelosuppression - a condition resulting in fewer red blood cells, white blood cells and platelets, as well as infection, which are common in this patient population post lymphodepletion. In patients with r/r AML in the expansion cohort using Flu/Ara-C lymphodepletion, there were no observations of CRS, ICANS or GvHD of any grade. Myelosuppression and infection remained the most common higher-grade adverse events. However, there were no greater thangrade 3 infections, and no treatment-associated fatalities. In patients with r/r AML that received Flu/Ara-C lymphodepletion, 4 of 6 achieved CR/CRi and 3 of 6 achieved a complete response with hematologic recovery. Two of the 4 reported complete responses were MRD negative. MRD negativity is broadly viewed as an important quantitative measure of disease burden in AML and is associated with increased disease-free survival and decreased risk of recurrence. One patient with MRD positive CR underwent allogeneic HCT and remains in CR at 4 months. Another patient with CR has no detectable disease by flow cytometry and additional MRD testing is pending. Flu and Ara-C are often combined with other chemotherapies, such as idarubicin and mitoxantrone in r/r AML, and such combinations have been used as a part of comparator arms in multiple registrational studies, with CR rates between 10-12%. In patients with r/r AML that received Flu/Cy lymphodepletion, and the highest doses of NKX101, 4 of 18 achieved CR/CRiand 3 of 18 achieved a complete response with hematologic recovery CR. There were no CRs at the lower doses of NKX101.

07:07 EDT Black Diamond Therapeutics announces initial dose escalation data on BDTX-1535 - Black Diamond Therapeutic announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535. The new data from the dose escalation portion of the Phase 1 study demonstrated clinical proof of activity of BDTX-1535 in NSCLC patients harboring both acquired resistance and intrinsic driver EGFR mutations. Initial phase 1 dose escalation data: The BDTX-1535 PK profile obtained during dose escalation in NSCLC and GBM patients showed a linear increase in exposure with an average half-life of approximately 15 hours that supports a daily dosing schedule with sufficient and sustained steady state target mutation coverage achieved at 100 mg QD dose level and above. BDTX-1535 was generally well tolerated by NSCLC and GBM patients and the overall safety profile was consistent with the EGFR tyrosine kinase inhibitor class of drugs. Based on additional data updates as of June 16, 2023, 5 of 12 NSCLC patients in a subgroup, who had measurable disease at study start, and underwent post baseline tumor assessment by RECIST1.1, demonstrated radiographic confirmed partial response. Confirmed PRs were observed in NSCLC patients with a wide range of EGFR mutations including classical and intrinsic driver mutations and acquired C797S resistance mutation, as well as complex mutations that include a combination of classical, intrinsic, and acquired resistance mutations. Based on emerging PK, safety, tolerability and radiographic response data, enrollment will commence at the BDTX-1535 200 mg QD dose in two expansion cohorts of NSCLC patients with acquired resistance or intrinsic driver mutations who received up to two prior lines of therapy including a third-generation EGFR TKI.

07:05 EDT Autolus Therapeutics announces publication in Cancer Immunology Research - Autolus Therapeutics announced a publication in Cancer Immunology Research entitled: 'Enhancing CAR T cell therapy using Fab-Based Constitutively Heterodimeric Cytokine Receptors.' For CAR T cells to be effective, they must engraft in the patient, expand to sufficient numbers and persist at the site of disease. To address this, Righi et al describe dFabCCR, a constitutive cytokine receptor architecture. dFabCCR is a highly versatile T cell engineering component which can transmit arbitrary cytokine signals to a CAR T cell: cytokine signals normally associated with T cells such as IL2 and IL7 can be transmitted, these maintain T cells as IL2/7 exposure would do. "Achieving sufficient CAR T cell expansion and persistence can be difficult when targeting solid cancer antigens," said Dr Martin Pule, Chief Scientific Officer and Founder of Autolus. "Development of the dFabCCR architecture allows us to supply CAR T cells with versatile constitutive cytokine signals overcoming a barrier to effective CAR T cell therapies for solid cancer and is another powerful entry in our toolkit of T cell engineering components."

07:03 EDT Ceva's sensor fusion software selected by Maxeye for digital pen - Ceva announced that Shenzhen Qianfenyi Intelligent Technology, or Maxeye, a developer of complete stylus and touch solutions, has licensed and deployed Ceva's MotionEngine Air sensor fusion software in an advanced digital pen for a global mobile OEM. This pen was recently launched alongside a flagship tablet, with the MotionEngine Air software enabling the pen with sensor fusion algorithms for high-precision motion and cursor control functionality.

07:03 EDT AC Immune receives FDA Fast Track designation for ACI-24.060 - AC Immune announced that it has received Fast Track designation, FTD, from the U.S. Food and Drug Administration, FDA, for its wholly-owned anti-amyloid beta active immunotherapy-candidate, ACI-24.060, for treatment of Alzheimer's disease. This follows FDA clearance of the Investigational New Drug, IND, application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with DS. Furthermore, the first individual with DS has been dosed in ABATE. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are delighted to see the quality and importance of our ACI-24.060 program reflected in the granting of Fast Track designation, which offers opportunities for expedited development and regulatory review. This regulatory progress underscores the attraction of an active immunotherapy targeting toxic species of Abeta. By inducing a polyclonal response including antibodies against both oligomeric Abeta and pyroglutamate-Abeta, ACI-24.060 targets the same toxic species as disease modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase 3 clinical trials. As ACI-24.060, created using our SupraAntigen platform, specifically targets the most toxic forms of Abeta, we believe it may offer best-in-class efficacy with all the potential advantages in safety, administration and distribution that can be expected from a vaccine. We look forward to showing in H1 2024 the effect of ACI-24.060 on amyloid plaque reduction, a surrogate marker for disease modification."

06:48 EDT Pfizer's application for hemophilia B gene therapy accepted by FDA - Pfizer announced that the FDA has accepted the company's Biologics License Application - BLA - for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application for fidanacogene elaparvovec has also been accepted and is under review by the EMA. Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus capsid and a high-activity variant of human coagulation Factor IX - FIX - gene. For people living with hemophilia B, the goal of this gene therapy is to enable them to produce FIX themselves via this one-time treatment rather than needing regular intravenous infusions of FIX, as is the current standard of care. The Phase 3 BENEGENE-2 study, which met its primary endpoint of non-inferiority and superiority in the annualized bleeding rate of total bleeds post-fidanacogene elaparvovec infusion versus prophylaxis regimen with FIX, administered as part of usual care. Fidanacogene elaparvovec was generally well-tolerated, with a safety profile consistent with Phase 1/2 results. The FDA has set a Prescription Drug User Fee Act goal date in 2Q24. Fidanacogene elaparvovec has been granted Breakthrough, Regenerative Medicines Advanced Therapy and orphan drug designations from the FDA.

06:43 EDT Sanofi announces primary endpoint was met in its Phase 2b study of amlitelimab - The primary endpoint was met in a Phase 2b study, STREAM-AD, of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes. Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified. Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, "While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options. We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases."

06:40 EDT AstraZeneca says Xigduo XR approved in China for adults with type-2 diabetes - AstraZeneca's Xigduo XR, a once-daily fixed-dose combination, has been approved by China's National Medical Products Administration, or NMPA, for the treatment of adults with type-2 diabetes as an adjunct to diet and exercise to improve glycaemic control, the company announced.

06:34 EDT Brookfield Reinsurance offers to acquire American Equity for $55.00 per share - Brookfield (BN) announced that following close of markets on June 26, 2023, Brookfield Reinsurance (BNRE) delivered a letter to the board of directors of American Equity Investment Life Holding Company (AEL) setting forth a proposal to acquire all of the outstanding shares of common stock of AEL not already owned by Brookfield Reinsurance for aggregate consideration of $55.00 per AEL share. As consideration for each AEL share, shareholders will receive $38.85 in cash and a number of Brookfield Asset Management Ltd. (BAM) class A limited voting shares having a value equal to $16.15 based on the unaffected 90-day VWAP as of June 23, 2023, resulting in total consideration of $55.00 per AEL share, subject to adjustment in certain circumstances as set forth in the proposal, a copy of which is attached hereto. Brookfield Reinsurance intends to acquire from Brookfield Corporation (BN) shares of Brookfield Asset Management required to satisfy the non-cash consideration offered to AEL shareholders. Subject to this occurring, BAM's public float will increase by approximately 10%, which is strategically important as BAM continues to broaden its shareholder base. Brookfield Corporation's interest in Brookfield Asset Management will decrease from 75% to approximately 73%. Accordingly there will be no net new issuance of shares of BAM1, BN or BNRE and no dilution to BAM, BN or BNRE shareholders as a result of this transaction. Brookfield Reinsurance will have the option to pay cash for the share portion of the transaction if the shares of BAM are trading below where they are trading at the current time such that the aggregate consideration per AEL share would be less than $54.00 per share. In this circumstance, Brookfield Reinsurance may elect, in its sole discretion, to pay the non-cash consideration in cash instead of utilizing BAM shares in the transaction. The proposal represents a premium of 35% to the closing price as of June 23, 2023, the last trading day prior to delivery of the letter, and a 42% premium to the 90-day volume weighted average price as of the same date, in each case, for the AEL common shares.

06:19 EDT Saudi Public Investment Fund buys more shares of Lucid for $1.8B - In a regulatory filing, Lucid said that the Saudi Public Investment Fund bought 265,693,703 shares of the company's stock in a private placement of common stock for an average price of $6.83 a share, representing an aggregate purchase price of approximately $1.8B. The purchase was made on June 22. Saudi's PIF now owns about 65% of the common stock outstanding, up from about 60% before the purchase.

06:10 EDT ChargePoint's NACS solutions available for EV charging deployments - ChargePoint announced the availability of NACS connector options for new orders and for currently installed CP6000, CPE 250, and Express Plus customers. The addition of NACS enabled solutions, in addition to J1772 or Combined Charging System solutions, enables customers to serve the charging needs of any EV in any parking space. ChargePoint's DC line of products along with ChargePoint's home-based AC line of products, will be sold or can be reconfigured with NACS connector options later this year. Similarly, ChargePoint's newest commercial and light fleet product, the CP6000 will be sold or can be reconfigured with NACS connector options in early 2024.

06:05 EDT Metals Acquisition ships copper concentrate from the CSA Copper Mine - Metals Acquisition announces that the first shipment of copper concentrate from the CSA Copper Mine has been shipped from the port of Newcastle, New South Wales. The concentrate shipment contained approximately 2,300 tonnes of copper and 28,000 ounces of silver.

06:04 EDT Amazon Business says Business Prime Duo now free with Prime membership - Amazon Business, the Amazon B2B procurement store, announced that Business Prime Duo, previously $69 per year, is now free for Amazon Prime members who also purchase for businesses. Business Prime Duo is an Amazon Business membership that helps small-business owners by bringing together business buying tools and access to business-only pricing on select items, alongside fast, free business delivery. Now small-business owners can access Business Prime Duo as part of their Prime membership-at no additional cost-alongside the savings, convenience, and entertainment benefits they already know and love from Prime.

05:54 EDT Meta launches features to give teens, parents ways to manage time on apps - Meta said in a blog post: "Today we're announcing new features to support teens and families and make it even easier to manage the time they spend on our apps. We're bringing parental supervision to Messenger, so parents can see how teens spend their time and who they interact with on Messenger. We're also introducing new tools to limit unwanted interactions in Instagram DM and Messenger, launching Quiet Mode on Instagram globally, nudging teens to set time limits on Facebook and giving parents even more ways to supervise their teens on Instagram... Today's updates were designed to help teens feel in control of their online experiences and help parents feel equipped to support their teens. We'll continue to collaborate with parents and experts to develop additional features that support teens and their families." Reference Link

05:15 EDT Lordstown Motors files complaint against Foxconn, Chapter 11 bankruptcy - Lordstown Motors announced a strategic restructuring process. As part of the process, Lordstown filed litigation against global technology company Hon Hai Technology Group and certain of its affiliates, or Foxconn, in the United States Bankruptcy Court for the District of Delaware. The company believes the litigation details Foxconn's fraud and willful and consistent failure to live up to its commercial and financial commitments to the company. Foxconn's actions led to material damage to the company as well as its future prospects, according to the company. In addition, Lordstown is commencing a marketing and sale process for the Endurance vehicle and related assets. To accomplish this, Lordstown is restructuring under Chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court. Lordstown further anticipates that the restructuring will enable an expedited timeline for hearing Lordstown's litigation against Foxconn. The complaint filed against Foxconn centers on a partnership Lordstown's management team entered into with Foxconn to combine Lordstown's technology, vehicle engineering team and manufacturing facility in Lordstown, Ohio with Foxconn's resources, supply chain capabilities and positionto form a new, scalable joint vehicle development platform. Under the partnership, Lordstown agreed to divest its most valuable assets to Foxconn, namely its Lordstown, Ohio manufacturing facility, which is one of the largest in North America, along with its manufacturing and operational employees. The up-front purchase price for the Lordstown manufacturing facility reflected the expected benefits of the contractual assurances from Foxconn that Foxconn would support the Endurance pickup truck in a variety of ways and follow through on a joint vehicle development program, leveraging what was purported to be Foxconn's established and extensive EV ecosystem and meeting its commitments to the Lordstown community. The lawsuit details the fact that Foxconn had no intention of living up to its commitments, particularly with respect to the new vehicle development platform. In addition to the action Lordstown is taking to redress Foxconn's conduct, it seeks to maximize the value of the company's assets and efficiently resolve its contingent liabilities through a Chapter 11 restructuring process. Lordstown has filed motions with the Court seeking authority to commence a marketing and sale process under section 363 of the U.S. Bankruptcy Code to realize the full value of its Endurance vehicle and related assets. To ensure a transition into Chapter 11, the company filed with the Court a series of customary "first day" motions to continue operating the business and uphold its commitments to stakeholders during the process. The company expects to receive approval of these routine "first day" requests in short order. The company enters Chapter 11 with cash on hand and is debt-free.