Stockwinners Market Radar for December 24, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EST Fuwei Films trading halted, news pending

17:39 EST Leidos awarded $102.21M Army contract - Leidos was awarded a $102.21M contract to provide support services for strategic planning, vision setting, programmatic review evaluation, and other programmatic support to the congressionally directed medical research programs and other subordinate organizations within the U.S. Army Medical Research and Development Command, Fort Detrick, Maryland. This support encompasses providing meeting support, programmatic support services, administrative support services, and publicity and public affairs support to collaborate the inputs and outcomes of strategic planning, vision setting, and programmatic review. It is anticipated this contract will provide support services for 120-150 program announcements and at least 10 broad agency announcements per fiscal year. Place of performance is Frederick, Maryland. The period of performance is February 1, 2023, to January 31, 2028. Funds will be obligated on the initial task order, after award of the base indefinite-delivery/indefinite-quantity contract. U.S. Army Medical Research Acquisition Activity is the contracting activity.

17:37 EST SportsTek Acquisition announces termination of LOI and liquidation - SportsTek Acquisition announced that the non-binding letter of intent with Metavisio, a French company specializing in building, marketing, and selling laptops, whose securities are listed on Euronext Growth in Paris, with respect to a proposed business combination transaction, has been mutually terminated by the parties. In addition, the Company announced today that the board of directors of the Company has elected to abandon and not implement the extension that was approved by stockholders on December 20, 2022, because despite significant efforts to identify and complete an initial business combination, the Board does not believe that the Company will be able to complete an initial business combination on favorable terms even with the extension. In making its decision, the Board has carefully considered the costs, benefits, and risks of prolonging the Company's life, including the current adverse market conditions and increased regulatory uncertainty around SPACs. As a result, the Company intends to dissolve and liquidate in accordance with the provisions of its Amended and Restated Certificate of Incorporation and will redeem all of the outstanding shares of common stock that were included in the units issued in its initial public offering. As of the close of business on December 27, 2022, the Public Shares will be deemed cancelled and will represent only the right to receive the redemption amount.

17:35 EST Glenfarne Merger announces delisting from Nasdaq - Glenfarne Merger previously announced that it intends to dissolve and liquidate in accordance with its Amended and Restated Certificate of Incorporation, as amended, including the redemption of all of its outstanding shares of Class A common stock that were included in the units issued in its initial public offering on December 16, 2022 because the company will not be able to consummate an initial business combination within the time period required by its Certificate of Incorporation. The company announced that its trust account established in connection with the company's initial public offering has been liquidated and that 26,914,546 of the company's public shares were submitted to the company's transfer agent, Continental Stock Transfer & Trust Company, and were redeemed on December 21, 2022 at a price of approximately $10.10 per share. As of December 22, 2022, an additional 339,716 public shares were delivered to the company's transfer agent and were redeemed on December 22, 2022 at the same redemption price. Trading of the company's public shares on the Nasdaq Stock Market were suspended on December 16, 2022 and Nasdaq filed with the SEC on December 16, 2022 a Form 25 to delist the company's securities from Nasdaq. The company thereafter expects to file a Form 15 with the SEC to terminate the registration of its securities under the Securities Exchange Act of 1934, as amended. The company's securities will not be listed or registered on another national exchange or on a quotation medium.

17:05 EST Pareteum announces voluntary delisting from Nasdaq - Tuesday Morning announced that it has notified The Nasdaq Stock Market of the company's decision to voluntarily delist its common stock from the Nasdaq Capital Market and its intent to file a Form 25 with the U.S. SEC on or about January 2, 2023. As a result, the company expects the delisting of its common stock to become effective on or about January 12, 2023.

16:33 EST Fanhua CEO withdraws preliminary non-binding going private proposal - Fanhua announced that its board of directors has received a notice dated December 19, 2022 from Yinan Hu, founder, chairman and CEO of Fanhua, stating that he has determined to withdraw the preliminary non-binding going private proposal dated December 16, 2021, effective immediately. Yinan Hu, Chairman and CEO of Fanhua, said: "With the going private proposal I made last year, I meant to take it as an opportunity to drive internal strategic transformation of the company. In view of the recent announcement by the Public Company Accounting Oversight Board which substantially eases the delisting risk of China-based U.S.-listed companies and the preliminary successful results of the company's strategic transformation, I believe that maintaining the company's listing status in the U.S. is more in the long-term interest of the company."

16:31 EST BigBear.ai receives continued listing notice from NYSE - BigBear.ai announced that on December 20, 2022 it received written notice from the New York Stock Exchange that it is not in compliance with the continued listing standards set forth in Rule 802.01C of the NYSE Listed Company Manual that requires listed companies to maintain an average closing share price of at least $1.00 over a consecutive 30 trading-day period. As required by the NYSE, BigBear.ai responded to the Notice and expressed its intent to cure this deficiency. BigBear.ai has six months following the receipt of the Notice to cure the deficiency and regain compliance, subject to the extension of such deadline in the event that BigBear.ai undertakes to conduct a reverse stock split following its next annual stockholders meeting. BigBear.ai can regain compliance at any time during the cure period if, on the last trading day of any calendar month during the cure period, its common stock has a closing price of at least $1.00 and an average closing price of at least $1.00 over the 30 consecutive trading-day period ending on the last trading day of that month. BigBear.ai will closely monitor the closing share price of its common stock and is considering all available options and intends to regain compliance with the NYSE listing standards by pursuing measures that are in the best interests of BigBear.ai and its stockholders, including potentially through the consummation of a reverse stock split, subject to stockholder approval.

16:17 EST Provident Bancorp announces senior leadership transitions - Provident Bancorp announced changes to the executive leadership team and named a new Board Chair, effective January 1, 2023. In a mutual decision by the Board and Dave Mansfield, CEO and Board Member, Mansfield separated from both Provident Bancorp and BankProv effective December 20, 2022. Carol Houle, CFO, and Joe Reilly, who has been serving as the Board Chair, will serve as interim Co-CEOs and Co-Presidents. Laurie Knapp, who has been serving as the Audit Committee Chair, will serve as Board Chair.

16:08 EST Orrstown Financial to sell Path Valley branch to Juniata - The Juniata Valley Bank, a wholly-owned subsidiary of Juniata Valley Financial Corp., and Orrstown Bank, a wholly-owned subsidiary of Orrstown Financial (ORRF), jointly announced that they have entered into a purchase and assumption agreement providing for the sale of Orrstown's Path Valley branch, located at 16400 Path Valley Road in Spring Run, Pennsylvania, to Juniata. Pursuant to the terms of the agreement, The Juniata Valley Bank has agreed to assume certain deposit liabilities totaling approximately $31.7M and purchase certain assets, including the Path Valley branch real estate, furniture, equipment and cash. No Orrstown loans are being purchased or sold in the transaction. The transaction is subject to customary deposit balance adjustments and closing conditions, including the receipt of all required regulatory approvals, and is expected to close in the second quarter of 2023. The Path Valley branch will remain open as an Orrstown Bank branch through closing and, after closing, will become a branch of The Juniata Valley Bank. Customers of the Path Valley branch will receive additional information regarding the transaction in the near future. Additional information on the transaction will be available in current reports on Form 8-K to be filed by both Juniata and Orrstown.

16:06 EST Vince Holding announces sale of intellectual property of Rebecca Taylor - Vince Holding announced that the company's indirectly wholly owned subsidiary, Rebecca Taylor, completed the sale of its intellectual property and certain related ancillary assets to RT IPCO, LLC, an affiliate of Ramani Group. The sale was completed as part of the wind down of the Rebecca Taylor business previously announced by the company.

16:00 EST Metacrine trading halted, news pending

14:06 EST Acer Therapeutics receives FDA approval for NDA for Olpruva - Acer Therapeutics received approval from the FDA for its new drug application, or NDA, for Olpruva for oral suspension, according to a letter posted to the agency's site. Reference Link

12:05 EST Aptiv completes acquisition of Wind River from TPG - Aptiv has completed the acquisition of Wind River. The company said, "Wind River software enables the secure development, deployment, operations and servicing of mission-critical intelligent systems." The company's technology is in over two billion edge devices across more than 1,700 customers in industries, including aerospace and defense, telecommunications, industrial, medical and automotive. Aptiv said, "By integrating the Wind River Studio cloud-native software platform into Aptiv's industry-leading Smart Vehicle Architecture, Aptiv will enable customers to unlock the full potential of the software-defined vehicle throughout its complete lifecycle." The initial release of the integrated end-to-end solution will be showcased in January at CES 2023. The transaction is valued at $3.5B, instead of the initial purchase price of $4.3B agreed to in January 2022. Aptiv and the seller agreed to the amended purchase price, in part, as a result of certain changes in Wind River's current operating structure required to bring the regulatory approval process to a satisfactory conclusion. These changes will not impact the strategic direction of Wind River nor expectations for its value creation, but will require certain one-time costs and recurring operating expenses. The transaction is expected to be accretive to adjusted earnings per share in 2023. The company will provide further details regarding the transaction on the fourth quarter earnings call on February 2, 2023.

12:00 EST TAL Education falls -10.6% - TAL Education is down -10.6%, or -$1.07 to $9.01.

12:00 EST Nine Energy Service rises 8.9% - Nine Energy Service is up 8.9%, or $1.08 to $13.15.

12:00 EST Annovis Bio rises 15.2% - Annovis Bio is up 15.2%, or $1.71 to $12.95.

10:28 EST Kalera shareholders approve 100-for-1 reverse stock split - Kalera announced that shareholders approved a reverse stock split of its outstanding ordinary shares at a ratio of 100-for-1. The reverse stock split will become effective today, December 23, 2022, and Ordinary Shares will begin trading on a split-adjusted basis when the Nasdaq opens today. The Ordinary Shares will continue to trade on the Nasdaq under the existing trading symbol "KAL". The reverse stock split was approved by Kalera's shareholders at the extraordinary general meeting held on December 22, 2022. The reverse stock split is primarily intended to increase the Company's per share trading price and bring the Company into compliance with the Nasdaq's listing requirement regarding minimum share price.

10:12 EST Arbor Realty co-funds Emerald Empire's purchase of Pangea's Chicago portfolio - Arbor Realty Trust announced that it recently co-funded one of the largest Fannie Mae Structured Adjustable-Rate Mortgage loans of 2022 in support of New York-based Emerald Empire's acquisition of Pangea Properties' Chicago portfolio. The deal was primarily financed by Arbor Realty Trust. NewPoint Real Estate Capital also participated in the transaction. The sale spans several hundred properties and thousands of units, of which 97% are considered "affordable" at 60% of Area Median Income.

10:00 EST TAL Education falls -6.5% - TAL Education is down -6.5%, or -66c to $9.42.

10:00 EST Azul rises 7.3% - Azul is up 7.3%, or 45c to $6.60.

10:00 EST ProShares UltraShort Bloomberg Natural Gas rises 9.2% - ProShares UltraShort Bloomberg Natural Gas is up 9.2%, or $2.08 to $24.66.

09:47 EST AMC Entertainment falls -4.5% - AMC Entertainment is down -4.5%, or -22c to $4.69.

09:47 EST Gol Linhas rises 6.7% - Gol Linhas is up 6.7%, or 19c to $3.03.

09:47 EST ProShares UltraShort Bloomberg Natural Gas rises 8.4% - ProShares UltraShort Bloomberg Natural Gas is up 8.4%, or $1.89 to $24.47.

09:36 EST Kalera PLC trading resumes

09:31 EST Digital Transformation Opportunites Corp trading halted, volatility trading pause

09:28 EST Neonode, EPICNPOC sign MoU on multimodal HMI development platform - Neonode and EPICNPOC have signed a memorandum of understanding to deliver a multimodal HMI development platform for automotive OEMs and tier-one suppliers that combines contactless touch input with graphical user interfaces, script recognition, voice interfaces, gesture sensing, audio and lighting for use in vehicle cockpits. Neonode's patented contactless touch technology is now integrated into EPICNPOC's catalog of plug-n-play components and offered in both product and service solutions, in particular into EPICNPOC's BOWL platform.

09:04 EST Blue Apron receives non compliance notification from Nasdaq - Blue Apron received written notice on December 21, from the New York Stock Exchange, or NYSE, that the company is not in compliance with the NYSE continued listing standards, which require it to maintain: a minimum average closing price of at least $1.00 per share over a consecutive 30-day trading period; and an average global market capitalization of at least $50M over a consecutive 30-day trading period and, at the same time, a total stockholders' equity equal to or greater than $50M. The company plans to notify the NYSE by January 6, 2023 of its receipt of the notice and that it intends to submit a plan to cure both the global market capitalization listing standard deficiency and the minimum share price listing standard deficiency.

09:02 EST Outlook enters definitive agreement for $31.8M convertible promissory note - Outlook Therapeutics announced that it has entered into a Securities Purchase Agreement, SPA, with an accredited investor, and pursuant to the SPA, issued the lender an unsecured convertible promissory note with a face amount of $31,820,000. The closing of the financing is expected to occur on December 28, 2022, subject to satisfaction of closing conditions, including the receipt of at least $25.0 million of equity financing. The proceeds from the Note and a previously announced equity financing, which remains subject to satisfaction of customary closing conditions, are expected to provide funding through the anticipated U.S. Food and Drug Administration approval of ONS-5010 expected in the third calendar quarter of 2023. The Note will bear interest at the annual rate of 9.5%, matures on January 1, 2024 and is convertible into the Company's common stock beginning on April 1, 2023 at an initial conversion price of $2.00 per share. The Company has the right to convert all or any portion of the outstanding balance under the Note into shares of common stock at a conversion price of $2.00 per share if certain conditions have been met at the time of conversion, including if at any time after the six-month anniversary of the closing date, the daily volume-weighted average price of the Company's common stock on Nasdaq equals or exceeds $2.50 per share for a period of 30 consecutive trading days. Net proceeds of the Note are expected to be approximately $30 million after original issue discount and after deducting the Lender's transaction costs covered by the Company in connection with the issuance.

08:55 EST HighPeak Energy CEO buys $1.1M in common stock - In a regulatory filing, HighPeak Energy disclosed that its CEO Jack Hightower bought 50K shares of common stock on December 21 in a total transaction size of $1.1M.

08:47 EST BM Technologies board authorizes $10M share repurchase plan - Without the immediate need for capital to close the merger and support bank balance sheet growth, the Company's Board of Directors has concurrently authorized the repurchase of up to $10 million of shares and warrants.

08:37 EST Safe & Green subsidiary to spin-off thirty percent of company to stockholders - Safe & Green announced that the company's subsidiary, SGB Development Corp. has changed its name to Safe and Green Development , and that the company further intends to spin-off thirty percent of Safe and Green Development to the company's stockholders, to form an independent, publicly traded company. The company intends to spin-off thirty percent of Safe and Green Development Corporation to focus on its core competency of commercial and residential real estate while supporting the future growth and profitability of both companies. With the spin-off, Safe and Green Development Corporation and its parent company, Safe & Green Holdings Corporation, intend to provide clarity to investors regarding the business model and characteristics of each company and unlock significant shareholder value. Safe & Green Development Corp. will have an independent board of directors, with Paul Galvin serving as executive chairman.

08:35 EST Ace Global Business Acquisition enters proposed merger pact with LE Worldwide - Ace Global Business Acquisition announced that it has entered into a definitive merger agreement with LE Worldwide Limited, a key component provider of data-enabled greenhouse farming solutions, providing for a proposed business combination that, if consummated, will result in LE becoming a publicly listed company. Subject to the terms and conditions set forth in the Merger Agreement, upon the closing of the transactions, the parties plan to remain NASDAQ-listed under a new ticker symbol. Subject to the terms and conditions set forth in the BCA, under the terms of the Merger Agreement, Ace will merge with and into ACBA Merger Sub I Limited, a British Virgin Islands business company and wholly owned subsidiary of the Ace, such that Purchaser will be the surviving entity. Immediately following the Reincorporation Merger, the Parties of the Agreement shall effect a merger of ACBA Merger Sub II Limited, a British Virgin Islands business company and wholly owned subsidiary of Purchaser, formed for the sole purpose of merging with and into LE in which LE will be the surviving entity and a wholly owned subsidiary of Purchaser. Upon the closing of the Acquisition Merger, each share of Purchaser common stock will be entitled to one vote on all matters subject to vote at general and special meetings of the post-business combination company. Upon the Acquisition Merger becoming effective, the Purchaser shall pay an aggregate consideration of $150,000,000 to the company's shareholders which shall be issued and divided into $10.00 per Ordinary Share of the Purchaser. As part of the transaction, Ace will aim to secure cash proceeds exceeding $20M from a private investment in public equity, and the company will have a pre-money enterprise value of approximately $150M at closing.

08:32 EST Regeneron: MHLW in Japan grants marketing, manufacturing approval for Libtayo - Regeneron Pharmaceuticals announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Libtayo as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.

08:30 EST Walmart to stay majority shareholder of both Flipkart, PhonePe following split - In a regulatory filing, Walmart furnished to the SEC a press release that Flipkart and PhonePe issued on December 23, which announced the full separation of PhonePe from Flipkart for strategic purposes resulting in an organizational structure for PhonePe that is independent from Flipkart. Walmart will remain the majority shareholder of both the Flipkart and PhonePe business groups following the separation, the company noted. "As a result of the separation of the businesses, the company anticipates recording reorganization expenses which include various income and other taxes, as well as employee compensation and transaction expenses. These reorganization expenses are non-core expenses and will be treated as an adjustment to earnings per share when the company reports its results for the fourth quarter of its fiscal year ending January 31, 2023," Walmart stated.

08:12 EST Wheeler REIT announces extension of exchange offer, consent solicitation - Wheeler Real Estate Investment Trust announced the extension of its previously announced offer to exchange any and all outstanding shares of the Company's Series D Cumulative Convertible Preferred Stock for 6.00% Subordinated Notes due 2027, to be newly issued by the Company, and the related solicitation of consents from the holders of Series D Preferred Stock to certain amendments to the Company's charter that will modify the terms of the Series D Preferred Stock. The expiration date of the Exchange Offer and Consent Solicitation has been extended from 11:59 p.m., New York City time, on December 22, 2022, to 11:59 p.m., New York City time, on January 6, 2023, to allow additional time for the holders of Series D Preferred Stock to tender their shares of Series D Preferred Stock in the Exchange Offer.

08:06 EST DMG Blockchain Solutions receives majority of equipment from Bitmain - DMG Blockchain Solutions announces it has received the majority of the equipment it has ordered from Bitmain: 785 PH/s of the S19j Pro model and 210 PH/s of S19 XP model enabling nearly 1 EH/s of mining capacity. DMG expects to achieve more than 1 EH/s early in 2023 when it receives its remaining batch - 42 PH/s of the S19 XP. The company also plans to order additional miners based on its accumulated credit with Bitmain as well as make opportunistic miner purchases in the open market. In addition, DMG has made significant progress upgrading its Terra Pool software and expects to run its first Petra transactions through Terra Pool on the Bitcoin main-net early in 2023. Petra will enable the movement of bitcoin using carbon neutral energy sources and work in concert with its Walletscore technology, which screens out transactions with wallet addresses that have been blacklisted by the US Department of Treasury's OFAC. The company also announces that Steven Eliscu, DMG's COO, recently purchased 100,000 of DMG shares in an open market purchase.

08:05 EST EHang announces strategic partnership with Qingdao West Coast New Area - EHang announced its strategic partnership with Qingdao West Coast New Area, one of China's national new areas in Shandong province. This partnership comes with a binding US$10,000,000 equity investment and a potential additional investment of US$10,000,000 in the future. Through this strategic partnership, EHang plans to develop its AAV business and the urban air mobility, UAM, industry and market in Qingdao with the goal to make Qingdao a world-class UAM application demonstration area. Additionally, EHang intends to establish a Northeast Asia regional headquarters as well as a national firefighting business center in Qingdao West Coast New Area. As part of this partnership, Qingdao West Coast New Area's investment arm will initially invest a total of US$10,000,000 in the Company through a private placement of newly issued Class A ordinary shares of the Company. The private placement is expected to close in the first quarter of 2023, subject to the receipt of certain investment-related regulatory approvals and clearances in China and the satisfaction of other customary closing conditions. Xin Fang, Chief Operating Officer of EHang, commented, "This strategic investment and business partnership is a significant milestone for EHang's long-term growth. With more funding and strong product demands in the Qingdao local market, which is estimated to reach the level of RMB100 million in two years, EHang expects to accelerate the development of Qingdao's AAV industry through new aviation business and low-altitude economy. We believe our cooperation will propel Qingdao to be a world-class, innovative UAM application demonstration area with comprehensive AAV industrial chains and commercial operations."

08:03 EST Locafy regains compliance with Nasdaq minimum bid price requirement - Locafy announced that it has received notice from The Nasdaq Stock Market on December 22, 2022 informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market and that the matter is now closed. On June 30, 2022, Locafy received notice from Nasdaq that the Company was not in compliance with the Rule, as its ordinary shares failed to meet a closing bid price of $1.00 or more for 30 consecutive business days. The Company conducted a 1-for-20 reverse split of its ordinary shares on December 7, 2022, to aid the compliance process. To regain compliance with the Rule, the Company's ordinary shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days. This requirement was met on December 21, 2022.

08:02 EST Immutep announces results of FDA meeting on eftilagimod alpha - Immutep announces the results of a positive follow-up Type C meeting with the US Food and Drug Administration regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha, in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer. The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application. Based on the encouraging efficacy, favourable safety, and learnings from the randomised AIPAC Phase IIb trial,patients will receive efti and paclitaxel on the same day and treatment will continue until disease progression. The patient population has also been expanded to include triple-negative breast cance, an aggressive form of breast cancer with limited treatment options. Immutep CEO, Marc Voigt, commented: "As recently announced, our late-stage clinical development efforts for efti are now focused on frontline NSCLC in combination with anti-PD-1 therapy, given the large market opportunity and need for more durable and tolerable options. With this said, progress reported to date with the FDA and EMA provides Immutep and its potential partners flexibility for late-stage clinical development of efti plus standard-of-care chemotherapy to address the high unmet need for metastatic breast cancer patients, while maintaining their quality of life as was shown in the AIPAC trial." FDA have agreed to test 90mg efti dosing in combination with paclitaxel driven predominantly by the safety profile of the AIPAC Phase IIb trial, along with the FDA's Project Optimus initiative in oncology.

07:46 EST Amcor completes sale of three factories in Russia to HS Investments - Amcor announced it completed the sale of its three factories in Russia to HS Investments, a Russian-based investor, after receiving all necessary regulatory approvals and cash proceeds, including receipt of closing cash balances. The cash and debt free consideration value is EUR 370M. The Russian business produces flexible and cartons packaging from one site in St. Petersburg and two sites in Novgorod and employs approximately 900 people. Amcor's three sites in Russia generated approximately 2% of total Amcor sales in fiscal 2022. Cash proceeds are expected to be used primarily for debt repayment and share repurchases. The transaction is not expected to have a material impact on the outlook for fiscal 2023.

07:35 EST Bed Bath & Beyond reports Rosenzweig voluntarily resigned from board - In a regulatory filing, Bed Bath & Beyond disclosed that on and effective as of December 20, Benjamin Rosenzweig voluntarily resigned from the board of directors of the company. "Mr. Rosenzweig's resignation was not the result of any disagreement with the company, its management, board of directors or any committee of the board of directors," the filing stated.

07:31 EST Valneva completes BLA submission to FDA for chikungunya vaccine candidate - Valneva "announces that it has completed rolling submission of the Biologics License Application to the U.S. Food and Drug Administration for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above. This BLA application follows final pivotal Phase 3 data reported in March 2022 and final lot-to-lot consistency results reported in May 2022. A clinical study of VLA1553 in adolescents is ongoing in Brazil, which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination."Reference Link

07:01 EST Asante Gold announces results of annual, special general meeting - Asante Gold announces the results of its annual meeting of shareholders held on December 21, 2022. At the Meeting, all matters presented for approval by management were duly authorized and approved, as follows: Fixing the number of Directors at nine; Election of the directors as proposed in the Company's management information circular dated November 25, 2022; Appointment of Auditors; and Approving the Amended and Restated Equity Incentive Plan. As the voting results show, there was a group of shareholders represented at the Meeting who voted against the election of some of the Directors as well as the approval of the Company's Amended and Restated Equity Incentive Plan. It appears that two Directors of the Company, despite having voted for board business which included endorsement of management recommendations for all business proposed, participated in a solicitation of shareholders of the Company against the business they had endorsed in the Circular. The Company is commencing an investigation into these solicitation efforts. The Company cautions that these actions appear to be part of an effort to attempt to take control of the Company without paying fair value to other shareholders. Shareholders are cautioned to take no steps in relation to matters which may be raised by dissidents whom appear to be seeking to promote their own interests over those of all shareholders of the Company.

07:00 EST Exelixis announces initiation of STELLAR-304 Phase 3 trial of zanzalintinib - Yesterday, Exelixis (EXEL) announced the initiation of STELLAR-304, a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in patients with advanced non-clear cell renal cell carcinoma, or nccRCC. Zanzalintinib, which was adopted as the generic name for XL092, is a next-generation tyrosine kinase inhibitor in development for multiple advanced tumor types. STELLAR-304 is sponsored by Exelixis and Bristol Myers Squibb (BMY) is providing nivolumab for the trial. STELLAR-304 is a global, multicenter, randomized phase 3 open-label study that will enroll approximately 291 patients with unresectable, locally advanced or metastatic nccRCC with no prior systemic anticancer therapy. One prior systemic adjuvant therapy, including immune checkpoint inhibitor therapy and excluding sunitinib, is allowed for completely resected RCC and if recurrence occurred at least six months after the last dose of adjuvant therapy. Patients will be randomized 2:1 to receive either zanzalintinib in combination with nivolumab or sunitinib monotherapy. The primary objective of the study is to evaluate the efficacy of the combination, as measured by duration of progression-free survival and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the Blinded Independent Radiology Committee. The secondary endpoint is duration of overall survival. "In September at ESMO 2022, we presented zanzalintinib phase 1 data which demonstrated promising clinical activity across a range of tumors with a manageable safety profile. We were particularly encouraged by the activity of zanzalintinib in advanced kidney cancer patients, including patients with non-clear cell subtypes. Based on this zanzalintinib data and given that nivolumab has shown activity in non-clear cell kidney cancer, we are excited to evaluate this combination regimen in this population in STELLAR-304. STELLAR-304 is the first and only randomized controlled phase 3 study to focus specifically across non-clear cell renal cell carcinoma subtypes, a patient population with limited clinical data and poorer treatment outcomes. We look forward to continuing our legacy of working towards improving care for all kidney cancer patients," said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis.

06:40 EST Steward Health Care extends current credit agreement through December 2023 - Yesterday, Steward Health Care System announced the completion of the extension of their ABL agreement with its lenders, through December 2023. Led by Citibank, N.A. as administrative agent, the new agreement amends and restates in its entirety Steward's previous credit agreement. Steward Chairman and CEO Dr. Ralph de la Torre commented, "The Covid pandemic, and its aftermath, exposed serious fault lines in the traditional approach to health care. Steward used lessons from the pandemic to refocus its nationally acclaimed value-based model. The extension of our ABL coupled with our reengineered structure position us extraordinarily well for the coming year. We look forward to leading the industry in this new era of health care and continuing to provide world class care to our patients."

06:28 EST Iris Energy: 160MW of data center capacity not affected by BC gov't decision - Iris Energy announced that its 160MW of data center capacity is not affected by the recent announcement by the Government of British Columbia. On December 21, 2022, the Government of British Columbia announced a temporary 18-month suspension on new and early stage BC Hydro connection requests from cryptocurrency mining projects due to unprecedented interest. According to the release, cryptocurrency mining projects that are operational, and a small number of projects that are well advanced in BC Hydro's connection process, will not be affected. As a result, the company's 160MW of data center capacity at Canal Flats (30MW), Prince George (50MW) and Mackenzie (80MW) is unaffected.

06:01 EST Immuron receives FDA approval for Travelan IND application - Immuron is pleased to announce that it has received approval from the U.S. FDA to proceed with the clinical evaluation of Travelan. The Investigational New Drug application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active. As a result of this approval the company will proceed with the planned clinical trial in the United States. The safety and protective efficacy of Travelan will be tested utilizing a controlled human infection-model clinical trial design. Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023.

05:24 EST Genentech announces FDA approval of Lunsumio - Genentech, a member of Roche, announced that the FDA has approved Lunsumio for the treatment of adult patients with relapsed or refractory, or R/R, follicular lymphoma, or FL, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks.

05:17 EST DBV Technologies announces FDA lifts partial clinical hold on VITESSE trial - DBV Technologies announced that the FDA has lifted the partial clinical hold on the company's VITESSE Phase 3 clinical trial that will evaluate the modified Viaskin Peanut 250 microgram patch in peanut-allergic children ages 4 to 7 years. The updated protocol will be submitted to study sites for subsequent Institutional Review Boards, or IRB, /Ethics Committees, or EC, approval. In the Partial Clinical Hold, or PCH, letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a biologics license application, or BLA. The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events, or AEs, to adverse events of special interest, or AESIs, and an increase in the number of trial participants on active treatment. Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed. Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency's review of a potential BLA for Viaskin Peanut as a peanut allergy treatment. In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter. The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol: The updated VITESSE Instructions for Use, or IFU, will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day's patch. The updated IFU now outlines that Viaskin Peanut 250 microgram is to be worn for as close to a full day as possible with a minimum daily wear time of 20 hours each day. Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform. Four AEs will be classified as AESIs. These AEs - which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site reactions - were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed. DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years. The company does not expect the additional safety study to have an impact on the company's cash runway guidance as DBV had included a provision for a possible supplemental safety trial in its cash runway assumptions. The company reiterated that cash on-hand is sufficient to fund operations through VITESSE topline data.

05:02 EST BioNTech initiates BNT165b1 study - BioNTech announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the company's BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein.