Stockwinners Market Radar for February 10, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EST Aprea Therapeutics trading halted, news pending

17:16 EST CSX reaches agreement with IAM, NCFO on paid sick leave - CSX announced that it has reached an agreement with two additional railroad unions to provide paid sick leave to its employees. The agreements were reached with the International Association of Machinists and Aerospace Workers (IAM), which represents railroad machinists, and the National Conference of Firemen and Oilers (NCFO), which represents the company's utility workers. The new contracts are demonstrative of CSX's commitment to continue working with its employees and their representatives to improve the work experience of its employees. CSX recently announced contractual agreements with two other unions - the Brotherhood of Maintenance of Way and Brotherhood of Railway Carmen - with provisions of paid sick leave. Joe Hinrichs, president and chief executive officer of CSX said, "CSX is very much committed to the wellbeing of all of our employees and their families. We have a great respect for the work they do in service to our customers and the nation, and we will continue to partner with them and their representatives to ensure they have the best possible employment experience with our railroad. We appreciate the collaboration with IAM and NCFO, and are proud of the momentum we are building with our union partners to find solutions by working together."

16:53 EST Berkshire Grey confirms receipt of indication of interest from SoftBank Group - Berkshire Grey (BGRY) confirmed that it has received a non-binding indication of interest from SoftBank Group (SFTBY) to acquire all of the outstanding capital stock of the company for $1.30 per share in cash. The terms of any potential agreement between Berkshire Grey and SoftBank would be contingent on certain conditions, including completion of due diligence review and negotiation of definitive transaction documents. Berkshire Grey also noted that it is currently evaluating various alternative options, including potential financing transactions. Berkshire Grey's board of directors will carefully evaluate SoftBank's indication of interest within the context of the ongoing review of various alternatives and in consultation with its financial and legal advisors. No assurance can be given that a definitive transaction with respect to SoftBank's indication of interest or any other potential transaction will eventually be consummated. Berkshire Grey does not intend to make further announcements about any of the various alternatives that are being evaluated unless and until the board of directors has approved a specific transaction or otherwise determines that further disclosure is appropriate or necessary.

16:32 EST Aptorum Group regains compliance with Nasdaq minimum bid price - Aptorum Group Limited announced that it has received two notifications from the Nasdaq Stock Market LLC Listing Qualifications Department informing the company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1), and it does not currently meet the minimum market value of publicly held shares of $5,000,000 under Nasdaq Listing Rule 5450(b)(1)(C). The Nasdaq deficiency letter under Rule 5450(b)(1)(C) has no immediate effect on the listing of the company's Class A Ordinary Shares, and its Class A Ordinary Shares will continue to trade on The Nasdaq Global Market under the symbol "APM" at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(D), the company has been given 180 calendar days, or until August 7, 2023, to regain compliance with Rule 5450(b)(1)(C). If at any time before August 7, 2023, the company's MVPHS closes at $5,000,000 or more for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation that the company has achieved compliance and the matter will be closed.

16:31 EST Vulcan Materials raises quarterly dividend 7.5% to 43c from 40c per share - The dividend will be payable on March 20 to shareholders of record at the close of business on March 6.

16:20 EST American Homes 4 Rent raises quarterly distribution 22% to 22c per share - The distribution will be payable in cash on March 31 to shareholders of record on March 15.

16:05 EST Marriott names CEO Capuano as president and CEO - Marriott said its board has appointed current CEO, Anthony "Tony" Capuano, as President and CEO effective February 24, 2023. As previously announced, Marriott's current President, Stephanie Linnartz, will be stepping down to become CEO of Under Armour.

15:39 EST Aesther Healthcare Acquisition Corp. trading halted, volatility trading pause

13:36 EST Alliance Entertainment completes business combination with Adara Acquisition - Alliance Entertainment, a distributor and wholesaler of music, movies, video games, electronics, arcades, and collectibles, and Adara Acquisition Corp., a special purpose acquisition corporation, have completed the previously announced business combination which was approved at an extraordinary general meeting of Adara's shareholders on January 18. Beginning on February 13, Alliance Entertainment's shares and warrants will be quoted on the OTC under the ticker symbols "ADRA" and "ADRA WS", respectively. Concurrent with Alliance Entertainment's OTC quotation, Adara Acquisition Corp. has been delisted from the NYSE American. Alliance Entertainment also intends to seek to list on the Nasdaq Capital Market as soon as practicable after the close of the business combination and subject to satisfying the conditions for initial listing. Chairman Bruce Ogilvie and CEO Jeff Walker will continue to lead the combined company, along with its current management team. This transaction values Alliance Entertainment at approximately $480M. "We believe that today's milestone combined with our strong revenue growth, expanding customer base and product offering, and several successful acquisitions, will help accelerate our future expansion initiatives. Alliance Entertainment today is well positioned to continue to capitalize on shifts towards eCommerce and Omni-Channel strategies, especially with retailers and manufacturers vastly increased reliance on their DTC, or Direct to Consumer, fulfillment and distribution partners. We are at an inflection point that now positions us to execute a multi-prong growth strategy that we expect will deliver a double-digit revenue growth rate with strong cash generation to the bottom line," said Jeff Walker, CEO of Alliance Entertainment.

13:01 EST Genius Brands announces 1-for-10 reverse stock split - Genius Brands International will effect a 1-for-10 reverse stock split of its outstanding common stock, which will be effective for trading purposes as of the commencement of trading on February 13, 2023. The reverse stock split was approved by the Board of Directors of the Company in accordance with Nevada law and is intended to increase the per share trading price of the Company's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "GNUS" and under a new CUSIP number, 37229T 509. As a result of the reverse stock split, every 10 pre-split shares of common stock outstanding will become one share of common stock, with each shareholder's pro rata ownership of the Company remaining the same. The reverse stock split will proportionately reduce the number of shares of authorized common stock from 400,000,000 to 40,000,000 shares. The reverse split will also apply to common stock issuable upon the exercise of the Company's outstanding warrants and stock options.

12:17 EST Ameren boosts quarterly dividend to 63c per share from 59c - Ameren declared a quarterly cash dividend on its common stock of 63c per share, a 7% increase from the prior quarterly cash dividend of 59c per share, resulting in an annualized equivalent dividend rate of $2.52 per share. The previous annualized equivalent dividend rate was $2.36 per share. "Today's increase affirms the Ameren Board of Directors' confidence in our sustained long-term growth strategy, which includes a robust pipeline of future investments that will continue to modernize the grid, enable our transition to a cleaner energy future, drive increasing value for our customers and provide strong returns for our shareholders," the company said in a statement. Ameren anticipates dividend growth will be in line with the company's long-term earnings per share growth expectations and within a payout ratio of 55% to 70%. The common share dividend is payable March 31, 2023, to shareholders of record at the close of business on March 15, 2023.

12:10 EST Elevate Credit says ISS, Glass Lewis recommend stockholders vote 'for' deal - Elevate Credit announced that independent proxy advisory firms Institutional Shareholder Services Inc., or "ISS," and Glass, Lewis & Co. have each recommended that stockholders vote "for" the previously announced all-cash acquisition of the company by an affiliate of Park Cities Asset Management at the company's upcoming special meeting of stockholders scheduled for February 15. As previously announced, the company and an affiliate of Park Cities have entered into a definitive merger agreement pursuant to which each outstanding share of common stock of the company, other than certain shares as set forth in the merger agreement, will be converted into the right to receive $1.87 per share. The all-cash transaction values the equity of the company at approximately $67M, inclusive of the equity expected to be rolled over in the transaction by certain members of management. The transaction, which was approved by the Elevate board of directors, is expected to close in the first quarter of 2023, subject to closing conditions specified in the merger agreement. All regulatory approvals required as conditions to the proposed merger have been obtained, Elevate said.

12:00 EST Knowles falls -16.7% - Knowles is down -16.7%, or -$3.15 to $15.71.

12:00 EST Alteryx rises 10.1% - Alteryx is up 10.1%, or $6.09 to $66.18.

12:00 EST Protolabs rises 23.3% - Protolabs is up 23.3%, or $7.11 to $37.53.

11:50 EST BTCS clarifies staking operations in response to SEC complaint against Kraken - BTCS clarified in a press release how StakeSeeker, its non-custodial staking-as-a-service platform, differs from other industry staking programs after the Securities and Exchange Commission on February 9 charged Kraken with failing to register the offer and sale of their crypto asset staking-as-a-service program. BTCS's non-custodial staking-as-a-service platform, StakeSeeker, "differs from Kraken's custodial model in several key material ways," the company stated. Charles Allen, BTCS's CEO, said: "When you stake with us, you are not an investor in our platform. You are a delegator to our nodes. If we go bankrupt, you do not get in line because we don't have your crypto assets, you unstake them and move on. As the oldest public company in the crypto and blockchain sector, we've learned many lessons over the years. For example, we once held crypto at Mt. Gox but luckily withdrew it prior to its implosion. We learned from that near miss in 2014 and keep minimal crypto at exchanges." The company added: "When you stake with us, you are participating in a blockchain's consensus mechanism, and you do not transfer ownership of your crypto assets to us. In light of recent failures such as FTX, Blockfi, and Celsius we encourage investors and crypto enthusiasts alike to learn about the value proposition of our non-custodial staking model. Your keys, your crypto, stake (not steak) with us. Many investors ask why we don't offer staking for Ethereum, and the reason is simple. It's a proof-of-stake blockchain, not a delegated proof-of-stake blockchain, and in our opinion, there isn't currently a clear path to offer Ethereum staking without inadvertently creating a security. While we believe our non-custodial staking does not create securities, we can provide no assurances that either the SEC or other regulatory authorities will agree."

11:18 EST Bristol-Myers, 2seventy Bio present results from KarMMa-3 studyof Abecma - Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) announced the first publication and presentation of results from KarMMa-3, a pivotal Phase 3, open-label, global, randomized, controlled study evaluating Abecma compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who were refractory to their last regimen. Data from KarMMa-3 are being published in The New England Journal of Medicine and simultaneously presented at the EBMT and the European Hematology Association's 5th European CAR T-cell Meeting on Friday, February 10 in an oral presentation during the Best Abstract Session. At a median follow up of 18.6 months, treatment with Abecma demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival compared with standard regimens, with a median PFS of 13.3 months vs. 4.4 months, respectively. This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. Results for the key secondary endpoint of overall response rate also met statistical significance with the majority of patients treated with Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In comparison, less than half of patients who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. Responses with Abecma were durable with a median duration of 14.8 months compared with 9.7 months for standard regimens. Clinical benefit with Abecma was consistently observed across difficult-to-treat subgroups. Abecma exhibited a consistent and generally predictable safety profile, including no new safety signals, with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity. In patients treated with Abecma, 88% experienced any grade CRS, with Grade 3/4 events occurring in 4% of patients. Two patients experienced a Grade 5 CRS event. Median time to onset of CRS was 1 day and median duration of CRS was 3.5 days. Any grade neurotoxicity occurred in 15% of patients, with Grade 3/4 neurotoxicity occurring in 3% of patients, and no Grade 5 events reported. Median time to onset of neurotoxicity was 3 days and median duration of neurotoxicity was 2 days. Bristol Myers Squibb and 2seventy bio intend to include these data in a planned supplemental Biologics License Application submission to the U.S. Food and Drug Administration in 2023.

10:00 EST Magna falls -11.7% - Magna is down -11.7%, or -$7.56 to $57.03.

10:00 EST Knowles falls -14.5% - Knowles is down -14.5%, or -$2.73 to $16.13.

10:00 EST Oscar Health rises 16.3% - Oscar Health is up 16.3%, or 62c to $4.42.

09:58 EST HUMBL launches HUMBL Wallet - HUMBL announced that HUMBL has delivered a mobile wallet offering digital assets, a search engine and verified social media profiles in one application. The HUMBL Wallet is now approved and available on the Apple App Store in over 140 countries.

09:47 EST Sylvamo falls -10.4% - Sylvamo is down -10.4%, or -$4.92 to $42.60.

09:47 EST Oshkosh falls -12.1% - Oshkosh is down -12.1%, or -$12.29 to $88.97.

09:47 EST Alteryx rises 13.4% - Alteryx is up 13.4%, or $8.07 to $68.16.

09:38 EST Guardforce AI Co Ltd trading resumes

09:33 EST Guardforce AI Co Ltd trading halted, volatility trading pause

09:23 EST Ra Medical Systems announces date of special shareholder meeting - Ra Medical Systems announced the date of March 21, 2023 as the date of its special shareholder meeting. Shareholders of record as of February 3, 2023 are entitled to vote at the meeting. Among other items, shareholders are requested to vote in favor of a previously announced $8 million private financing, and to vote in favor of the conversion of RMED preferred stock into common stock, the majority of which will not be converted until mid-2024, at the earliest. The preferred stock was issued in connection with the acquisition of Catheter Precision, Inc., earlier this year.

09:18 EST Manchester United suitors unsure Glazer family wants full club sale, ESPN says - Potential bidders for Manchester United believe the club's owners, the Glazer family, are aiming to secure a partner investor rather than a full sale of their controlling stake in the team, sources tell ESPN's Mark Ogden and Rob Dawson. Raine Group, the investment bank overseeing the process to either sell the club or attract a substantial new investment, have set a February 17 "soft deadline" for potential investors to register their interest and Britain's richest man, Jim Ratcliffe, is the only confirmed bidder in the process, though there has been reported interest from Qatar and Saudi Arabia in buying or investing, the report noted. Reference Link

09:07 EST Movella announces closing of business combination with Pathfinder Acquisition - Movella Holdings announced the completion of its previously announced business combination with Pathfinder Acquisition (PFDR), a special purpose acquisition company. The Business Combination was approved by the respective Boards of Directors and shareholders of Pathfinder and Movella. The combined company will operate as "Movella Holdings Inc.", and its common stock and warrants are expected to begin trading on the Nasdaq Stock Market under the ticker symbol "MVLA" and "MVLAW", respectively, on February 13, 2023. "With the completion of this combination, Movella can further invest in its world-class technology and talent to accelerate growth and capture exciting opportunities in emerging growth markets such as the metaverse, as well as its core growth markets," said David Chung, CEO of Pathfinder, who will become a director on Movella's Board. "We are honored to partner with Ben and the Movella management team to continue bringing great solutions to market and shape the industry." Transaction Overview: The Business Combination values Movella at a pro forma enterprise value of $504M. Existing shareholders of Movella, including Kleiner Perkins, GIC and Columbia Threadneedle, rolled 100% of their ownership into the combined company. The transaction was supported by $75M of financing from affiliates of Francisco Partners, a leading technology focused private investment firm with over $45B of cumulative committed capital. Under the terms of the investment, FP acquired $75M of Pathfinder common stock prior to closing through a direct placement of Pathfinder stock. Under the terms of the financing, Movella issued to FP a 5-year PIK note. This structure gives Movella the right to direct the sale of FP's purchased stock into the public market at any time following the closing of the transaction until the repayment or prepayment of the note, the proceeds of which will provide material credits against the note balance at a repayment or refinancing event.

08:49 EST Altus Power, CBRE and Blackstone advance Community Solar Partnership Program - Altus Power (AMPS) announced, in partnership with Blackstone (BX) and CBRE (CBRE), Altus Power has advanced its Community Solar Partnership Program for large enterprises by offering each company's employees the opportunity to subscribe to the benefits of clean electricity from solar arrays owned and operated by Altus Power. Employees who subscribe to Altus Power's Community Solar Partnership Program will receive a discount on the power they use compared with their local utility, generating savings on their monthly utility bills while also supporting the transition to clean energy. The Community Solar Partnership Program has been implemented in New York City and Westchester County, New York, where employees from both CBRE and Blackstone's programs were selected and are currently benefitting from credits on their electricity bills driven by energy that is generated by Altus Power from its Zerega community solar project. Zerega generates clean electricity locally on the rooftop of a large self-storage facility in the Bronx, New York. Altus Power and CBRE plan to extend the program to employees in Hawaii, Maryland and New Jersey where Altus Power is developing additional solar assets tailored to community solar customers. There is additional potential for expansion of this partnership in Minnesota, Massachusetts and Illinois, where Altus Power also has assets serving community solar customers.

08:47 EST Blink Charging partners with Hertz for EV charging during Big Game - Blink Charging (BLNK) has teamed up with Hertz (HTZ) to provide FREE EV charging to Hertz customers renting electric vehicles while visiting for the big game over the weekend in the greater Phoenix area. The demand for rental cars during large, high-profile events increases significantly, and Hertz has brought in additional EV rentals to meet that need. To help customers charge their EV rentals, Blink is providing free, reliable, fast charging to customers who rent from all Phoenix-area Hertz locations. As drivers pick up their EV from participating Hertz locations, they will receive a Blink activation card that can be used for charging at the many publicly available Blink chargers in the greater Phoenix area for free until 12:00 a.m. MST, Tuesday, February 14.

08:44 EST Processa Pharmaceuticals announces $6.25M registered direct offering - Processa Pharmaceuticals announced that it has entered into definitive agreements with retail investors for the purchase and sale of 7,812,544 common shares at a purchase price of $0.80 per share in a registered direct offering priced at the market under the Nasdaq rules. The closing of the offering is expected to occur on or about February 14, 2023, subject to the satisfaction of customary closing conditions. Spartan Capital Securities, LLC acted as the sole placement agent for this transaction. The gross proceeds to the Company from the registered direct offering are expected to be $6.25 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for future clinical trials, research and development expenses, and for working capital and other general corporate purposes.

08:34 EST Refreshing USA to go public via merger with Integrated Wellness Acquisition - Refreshing USA and Integrated Wellness Acquisition Corp announced they have entered into a definitive agreement and plan of merger. Under the Merger Agreement, IWAC Holdings Inc., a newly formed Delaware corporation, will acquire both Refreshing USA and Integrated Wellness and upon the closing of the proposed transaction, Pubco will operate under the "Refreshing USA" name and is expected to be listed on New York Stock Exchange under the new ticker symbol "RUSA." Refreshing USA is a national US independent automated and unattended retailer in synch with retail automation trends and labor concerns throughout the world. Refreshing USA was established in 2020 with the goal of revolutionizing the convenience services industry and to deliver the perfect refreshment experience with state-of-the-art equipment, fresh and appealing products, and unparalleled service. Following the Transaction, Refreshing USA will continue to be led by its highly experienced leadership team of growth experts, including Ryan Wear, Founder and Chief Executive Officer; Jeremy Briggs, Director of Finance; Doug Potts, Director of Administration; Mike Melton, Director of Operations; Bryce Froberg, Director of Sales and Marketing; and Nickolas Streeter, Director of Research and Development. Under the terms of the Merger Agreement, the Transaction is valued at an estimated pro-forma enterprise value of approximately $197.97 million. At close, Refreshing USA expects up to $105.78 million of gross cash proceeds, assuming no redemptions by Integrated Wellness' shareholders, and intends to use net proceeds to fund continuing growth and expansion of the business, both organically and via acquisitions. Upon completion of the Transaction, Refreshing USA shareholders will retain 100% of their equity and own 52.67% of the pro forma company at closing, in each case assuming no redemptions by Integrated Wellness' public shareholders. The Transaction is expected to close in the first half of 2023 and is subject to approval by Integrated Wellness' shareholders, regulatory approval, and other customary closing conditions.

08:30 EST T. Rowe Price reports preliminary AUM $1.35T at January 31 - Preliminary net outflows for January 2023 were $5.7B.

08:19 EST Casella Waste introduces sustainability-linked credit facility - Casella Waste Systems announced an amendment to its existing $650 million credit facility that links borrowing costs to progress in achieving certain annual sustainability goals. The company also announced an amendment to its credit facility associated with the early adoption of Term SOFR as its reference rate, replacing LIBOR in advance of its anticipated cessation later this year. The company established the following two measurable key performance indicators as part of its Sustainability-Linked Credit Facility: Improving its safety performance by lowering its Total Recordable Incident Rate; and Growing its Resource Solutions business by reducing, reusing, or recycling more tons of solid waste material.

08:09 EST Newell Brands chairman to transition to new position, Robert Steele to succeed - Newell Brands announced a series of steps to refresh the company's board of directors and its leadership. Patrick Campbell has served as the chairman of the board for five years. Effective upon the conclusion of the company's 2023 Annual Meeting of Stockholders on May 16, Campbell will transition from his position as chairman, while remaining a director nominated for re-election at the annual meeting. The board of directors has designated independent director Robert Steele as the next chairman of the board, effective May 16, upon the conclusion of the annual meeting. Robert Steele has served on Newell Brands' board of directors since April 2018. He is the founder and CEO of Steele Consulting, a consulting firm. Steele is the retired vice chairman, global health and well-being, for the Procter & Gamble company. During his 35-year tenure with Procter & Gamble, Mr. Steele held a variety of other executive leadership positions, including Group President Global Household Care and Group President of North American Operations.

08:07 EST Rigetti Computing appoints Jeffrey Bertelsen as CFO, David Rivas as CTO - In connection with updating its business plan, the Company announced leadership changes at the CFO and CTO positions. Jeffrey Bertelsen will replace Rigetti's current CFO, Brian Sereda, effective February 15, 2023, and Mr. Sereda will thereafter remain with the Company as a non-executive employee until March 31, 2023, in order to support the transition. Mr. Bertelsen comes to the Company with more than 25 years of experience as a finance executive, most recently as CFO and COO of CyberOptics Corporation. In addition, effective February 9, 2023, David Rivas has been promoted to Chief Technology Officer, replacing Mike Harburn who is leaving the Company, effective February 9. Mr. Rivas previously served as Rigetti's Senior Vice President, Systems and Services since March 2019, overseeing the engineering and operations of Rigetti's Quantum Cloud Services platform.

08:06 EST Rigetti Computing updates business strategy, including technology roadmap - Rigetti Computing announced that its Board has approved an updated business strategy, including revisions to its technology roadmap. In connection with this updated strategy, the Company will transition to a newly appointed CFO and CTO and is implementing a workforce reduction in order to focus the organization and its resources on nearer-term strategic priorities. "Upon assuming my role as CEO, we have moved quickly to review and confirm key strategic priorities for the nearer term," stated Dr. Subodh Kulkarni. "The Company's revised technology roadmap will, concentrate on the goal to deliver the anticipated Ankaa-1 84-qubit system in Q1 2023, aiming to deliver denser qubit spacing and tunable couplers expected to enable better performance compared to Rigetti's current 80-qubit Aspen-M system; prioritize increasing the performance of the anticipated Ankaa-1 84-qubit system once it is launched and focus efforts to achieve narrow quantum advantage, the point at which a quantum computer is able to solve a practical, operationally relevant problem significantly better, faster, or cheaper than a current classical solution. Specifically, upon the anticipated launch of the Ankaa-1 84-qubit system, Rigetti plans to focus its efforts on improving the performance of the system with the goal of reaching at least 99% 2-qubit gate fidelity on the anticipated Ankaa-2 84-qubit system, and if this target is achieved, Rigetti plans to shift its focus to scaling to develop the anticipated Lyra 336-qubit system." An updated Investor Presentation, including the revised technology roadmap reflecting these changes, has been published on the Investor section of the Company's website, and the Company's previously announced roadmap should no longer be referred to or relied upon. Rigetti believes that this revised business plan and technology roadmap will enable it to concentrate its software application development strategy on what the Company believes to be the highest likelihood applications for demonstrating nearer term narrow quantum advantage.

08:05 EST Aemetis hosts CDFA Secretary Karen Ross at Keyes biofuels facility - Aemetis announced that it hosted California Department of Food and Agriculture, CDFA, Secretary Karen Ross for a discussion and site tours of the company's renewable biofuel and dairy-based renewable natural gas, RNG, facilities on February 9, 2023. Former CDFA and USDA Secretary Ann Veneman, Stanislaus County Supervisor Vito Chiesa, and other dignitaries joined the tour and discussion of the company's vision and leadership regarding the creation of a Circular Bioeconomy in California's Central Valley that couples the production of low or below zero carbon intensity renewable fuels with the region's abundant agricultural waste and by-products. The visit was organized in conjunction with the Stanislaus 2030 regional economic development initiative and BEAM Circular, a new hub for the circular bioeconomy in the North San Joaquin Valley. "We strongly support the outstanding work that Secretary Ross has done at CDFA to promote agriculture's central role in addressing global warming, coupled with the advancement of policies and programs that private sector companies such as Aemetis can utilize to meet California's aggressive decarbonization goals," said Eric McAfee, Chairman and CEO of Aemetis, Inc.

08:02 EST Blueprint Medicines: FDA puts partial clinical hold on the Phase 1/2 VELA trial - Blueprint Medicines announced that the U.S. FDA verbally informed the company on February 8 that it has placed a partial clinical hold on the Phase 1/2 VELA trial of BLU-222 due to visual adverse events observed in a limited number of patients. Patients currently enrolled in the trial are continuing on study drug at this time, and additional patients will not be enrolled until the partial clinical hold is resolved. BLU-222 is currently being evaluated in the Phase 1 dose escalation portion of the VELA trial. Patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs. The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. All events resolved with dose interruption or reduction. No treatment-emergent abnormal findings, including uveitis, have been observed in patients who have received detailed ophthalmologic examinations. "Patient safety is our first priority, and we are working closely with the FDA to investigate the reported visual adverse events as well as amend the VELA trial protocol to provide specific guidance to investigators on how to monitor for and manage these events should they occur," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "We have confidence in the benefit-risk profile of BLU-222 based on the activity and safety data we have seen to date in the dose escalation study. In addition, we recognize the urgency to treat patients with CDK2-vulnerable cancers, many of whom have seen their disease progress after exhausting all other options, and we aim to resume enrollment as expeditiously and responsibly as possible." Consistent with prior guidance, Blueprint Medicines plans to present initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.

08:01 EST VYNE Therapeutics announces 1-for-18 reverse stock split - VYNE Therapeutics announced that its Board of Directors has approved a reverse stock split of the Company's common stock at a ratio of 1-for-18. The reverse stock split was previously approved by stockholders at the Special Meeting of Stockholders on January 12, 2023. The reverse stock split will become effective after market close on Friday, February 10, 2023 and shares will begin trading on a split-adjusted basis when the market opens on Monday, February 13, 2023. VYNE's common stock will continue to be traded on the Nasdaq Capital Market under the symbol VYNE. The reverse stock split is intended to enable VYNE to regain compliance with the $1.00 minimum bid price required for continued listing on the Nasdaq Capital Market. The new CUSIP number for VYNE's common stock following the reverse stock split will be 92941V 308. At a special meeting of stockholders held on January 12, 2023, VYNE's stockholders approved a reverse stock split of VYNE's common stock through an amendment to its Certificate of Incorporation at a ratio of not less than 1-for-10 and not more than 1-for-25, with such ratio to be determined by the Board of Directors.

07:36 EST Sunshine Biopharma enters research agreement with Jewish General Hospital - Sunshine Biopharma announced the signing of a research agreement with Sir Mortimer B. Davis Jewish General Hospital, a McGill University Health Center hospital located in Montreal, Quebec, Canada. The research effort will be focused on advancing the development of Sunshine Biopharma's Adva-27a anticancer compound through the IND-enabling studies. At any time the research results become conclusive and Sunshine Biopharma wishes to proceed to conducting a Phase I clinical trial, the Jewish General Hospital is prepared to negotiating a new agreement to define the responsibilities and obligations of the parties for such Phase I clinical trial to be performed. Adva-27a had previously been shown to be effective at destroying multidrug resistant cancer cells originating from pancreatic cancer, breast cancer, small-cell lung cancer and uterine sarcoma. The research will be conducted under the direction of Dr. Gerald Batist, Head of the Department of Oncology at the Jewish General Hospital and Director of the McGill Center for Translational Research in Cancer based at the Lady Davis Institute for Medical Research.

07:32 EST Phio Pharmaceuticals gets positive DMC recommendation for trial of PH-762 - Phio Pharmaceuticals announced that an independent Data Monitoring Committee completed its prespecified review of interim safety data in the company's Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma. The trial is ongoing at the Gustave Roussy Institute, one of the largest cancer centers in Europe. PH-762 is an INTASYL compound that reduces the expression of cell death Protein 1, a protein that inhibits T cells' ability to kill cancer cells. Decreasing the expression of PD-1 increases the capacity of T cells to kill cancer cells. Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol. In addition to the Phase 1b study in France, Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, early in the 2nd half of 2023.

07:24 EST Hillstream announces initial results from pembrolizumab, HSB-1216 combination - Hillstream BioPharma announced initial results evaluating the synergy of HSB-1216 with immune checkpoint inhibitors in KRAS G12C-mutated non-small cell lung cancer cells, Calu-1, with Pembrolizumab, an anti-PD-1 antibody. The study demonstrated significantly greater tumor inhibition of Calu-1 cells, when grown with human PBMCs and treated with HSB-1216 and Pembrolizumab. "We are greatly encouraged by the initial results showing crosstalk and synergy between an established and validated immuno-oncology pathway, anti-PD-1, and Ferroptosis, a new emerging iron-dependent cell death pathway and mechanism of action for HSB-1216," said Randy Milby, Hillstream's CEO.

07:10 EST Orchard Therapeutics announces proposed ADS ratio change - Orchard Therapeutics announced that it plans to change the ratio of its American Depositary Shares to its ordinary shares, nominal value GBP 0.10 per share, from the current ADS Ratio of one ADS to one ordinary share to a new ADS Ratio of one ADS to ten ordinary shares. The Company anticipates that the ADS Ratio Change will be effective on or about March 10, 2023. For the company's ADS holders, the change in the ADS Ratio will have the same effect as a one-for-ten reverse ADS split and is intended to enable the company to regain compliance with the Nasdaq minimum bid price requirement. On the Effective Date, registered holders of company ADSs held in certificated form will be required on a mandatory basis to surrender their certificated ADSs to the depositary bank for cancellation and will receive one new ADS in exchange for every ten existing ADSs then-held. Holders of uncertificated ADSs in the Direct Registration System and in The Depository Trust Company will have their ADSs automatically exchanged and need not take any action. The exchange of every ten then-held ADSs for one new ADS will occur automatically, at the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by the depositary bank. Orchard's ADSs will continue to be traded on the Nasdaq Capital Market under the ticker symbol "ORTX." No fractional new ADSs will be issued in connection with the change in the ADS Ratio.

07:09 EST Conformis sees Q1 product revenue $12M-$13M - The company said, "This range reflects the disruption related to the transition to our new business model and continued manufacturing and supply chain challenges."

07:03 EST Autoscope Technologies begins trading on OTCQX Market - Autoscope Technologies Corporation announced that they have qualified to trade on the OTCQX Best Market. Autoscope Technologies Corporation previously traded on NASDAQ.

06:58 EST Global Payments reauthorizes up to $1.5B of share repurchase capacity

06:36 EST KalVista's sebetralstat shows positive Phase 2 data in The Lancet publication - KalVista announced that results from the phase 2 trial evaluating the efficacy and safety of oral sebetralstat for the on-demand treatment of hereditary angioedema - HAE - attacks has been published in the international weekly medical journal, The Lancet. The phase 2 study showed that oral sebetralstat was well tolerated and led to rapid suppression of plasma kallikrein activity, resulting in significantly increased time to use of conventional treatment, reduced attack severity, and faster time to symptom relief and resolution compared to placebo. KalVista anticipates clinical results from its ongoing phase 3 KONFIDENT trial for sebetralstat for on-demand treatment in HAE in the second half of this year. Time to use of conventional treatment within 12 h of study drug administration was significantly longer with sebetralstat versus placebo; sebetralstat significantly reduced time to onset of symptom relief, with a median time of 1.6 hours versus 9 hours for attacks treated with placebo; time to conventional attack treatment use or worsening in severity by 1 level or more, whichever came first, within 12 h of study administration was significantly longer after treatment with sebetralstat than after treatment with placebo; median time to attack resolution was significantly shorter with sebetralstat than with placebo. Sebetralstat was well-tolerated and no serious adverse events were reported. The proportion of drug-related treatment-emergent adverse events was similar in attacks treated with sebetralstat and placebo.

06:33 EST Essent Group increases quarterly dividend 2c to 25c per share - Essent Group has increased its quarterly cash dividend to 25c per common share from 23c per common share. The dividend is payable on March 20 to shareholders of record on March 10.

05:26 EST Goal Acquisitions, Digital Virgo Group submit draft registration statement - Goal Acquisitions and Digital Virgo Group announced the confidential submission on February 8 with the U.S. Securities and Exchange Commission of a draft registration statement on Form F-4 in relation to a previously announced business combination between Goal and Digital Virgo. The agreement between Goal and Digital Virgo relating to the business combination was amended and restated as of February. Upon closing of the business combination, Digital Virgo is expected to be the publicly traded entity for the combined company. Closing is conditioned upon, among other things, regulatory and shareholder approval.

05:17 EST Genentech reports both BALATON, COMINO studies meet primary endpoint - Genentech, a member of Roche, announced new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo in macular edema due to branch and central retinal vein occlusion at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on February 11 at Angiogenesis, Exudation, and Degeneration 2023, organized by Bascom Palmer Eye Institute in Florida. In the BALATON and COMINO studies, patients were randomized 1:1 to receive six monthly injections of either Vabysmo or aflibercept for 20 weeks, with the primary endpoint measured at week 24. Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept. The average vision gains from baseline were comparable between the two treatments in both studies. In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks. Additionally, the percentage of patients gaining 15 or more letters was comparable across treatment arms in both studies. Fluid in the retina in the back of the eye, which may result from blood vessel leakage, can cause swelling and blurry vision. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness, or CST. In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions were -311.4 microm in the Vabysmo arm and -304.4 microm in the aflibercept arm. In COMINO, CST reductions were -461.6 microm in the Vabysmo arm and -448.8 microm in the aflibercept arm. Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint. In BALATON, one-third of patients treated with Vabysmo had an absence of leakage compared to one-fifth of aflibercept patients. In COMINO, the rates were 44% for Vabysmo patients versus 30% for aflibercept patients. In both studies, Vabysmo's safety profile was consistent with previous trials. The most common adverse reaction was conjunctival hemorrhage. Safety results were consistent across study arms. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.

05:09 EST GSK announces FDA approval for Jemperli - GSK reported that the FDA granted full approval for Jemperli for the treatment of adult patients with mismatch repair-deficient, or dMMR, recurrent or advanced endometrial cancer, as determined by a FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.