Stockwinners Market Radar for June 05, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:53 EDT AMC Entertainment chief content officer Frank sells over 21,000 class A shares - In a regulatory filing, AMC Entertainment chief content officer Elizabeth Frank disclosed the sale of 21,462 class A common shares of the company on June 3 at a price of $43.54 per share.

17:39 EDT AMC Entertainment chief HR officer Chavarria sells over 40,000 class A shares - In a regulatory filing, AMC Entertainment chief HR officer Carla Chavarria disclosed the sale of 40,346 class A common shares of the company on June 3 at a price of $62.6716 per share.

17:18 EDT Evercore co-CEO sells 7,245 class A common shares - In a regulatory filing, Evercore co-CEO Ralph Schlosstein disclosed the sale of 7,245 class A common shares of the company on June 2 at a price of $147.04 per share.

17:06 EDT Volaris names Alejandro de Iturbide Gutierrez chief legal officer - Volaris announced the appointment of Jose Alejandro de Iturbide Gutierrez as Chief Legal Officer of Volaris, effective as of June 16, 2021, reporting directly to Enrique Javier Beltranena Mejicano, President and Chief Executive Officer of Volaris. Alejandro de Iturbide has extensive experience in the legal field, having previously served as General Counsel, Managing Director and Secretary of the Board of Directors of Grupo Financiero Citibanamex, having also held the positions in Mexico of General Counsel at General Electric and Barclays Capital, among others.

16:39 EDT Six Royal Caribbean ships will sail from Florida, Texas in July, August - Royal Caribbean International has announced that six of its ships will begin sailing from major U.S. cruise ports in Florida and Texas in July and August. The cruise line's comeback will kick off on July 2 in Miami, the cruise capital of the world, with Freedom of the Seas embarking on a special Fourth of July weekend sailing to Perfect Day at CocoCay. By the end of August, 12 Royal Caribbean ships will be cruising once again across The Bahamas, Caribbean, Alaska and Europe. "This is it. Vacationers can finally plan to take their precious time off this summer and truly get away after what has been a challenging time for everyone. I would like to sincerely thank our guests and travel partners for their incredible patience and understanding during this very difficult period. Thanks in large part to the successful rollout of vaccines, the world of adventure is beginning to open up, and we are all excited to start delivering great vacations to our guests, who have increasingly told us they are getting vaccinated. As of today, 90% of all vacationers booking with Royal Caribbean are either vaccinated or planning to get vaccinated in time for their cruise," said Michael Bayley, president and CEO, Royal Caribbean International. "We also thank Governor DeSantis of Florida, Miami-Dade County Mayor Daniella Levine Cava, Broward County Mayor Steve Geller and Chairman of the Canaveral Port Authority board Wayne Justice and board commissioners for their steadfast support of our industry and for providing access to vaccines to the thousands of crew on our ships off the eastern seaboard. This act of understanding and humanity has been deeply appreciated, and we are grateful for their support, which is enabling the health and safety of our guests, crew members and the communities we visit."

16:31 EDT Stamps.com to settle securities class action, sees cash outflow of $66M-$77M - On May 28 and June 3, Stamps.com reached an agreement in principle and signed a term sheet to settle a pending securities class action and stockholder derivative cases, respectively. Based on currently available information related to expected insurance recoveries and legal costs, and assuming the settlements are finalized and obtain final approval from the respective Courts, the company estimates a net cash outflow of approximately $66M-$77M. The company and the other defendants have denied and continue to deny each and all of the claims alleged in the Securities Class Action and the Derivative Actions, and the proposed settlements contain no admission of liability, wrongdoing, or responsibility by any of the defendants.

16:17 EDT ODP Corporation confirms receipt of Staples Proposal to buy consumer business - The ODP Corporation confirmed that its Board of Directors has received a proposal from USR Parent, the parent company of Staples and a portfolio company of Sycamore Partners, to acquire the company's consumer business for $1B in cash. ODP's Board of Directors is carefully reviewing Staples' proposal with the assistance of its financial and legal advisors to determine the course of action that it believes is in the best interests of the company and its shareholders. No action is required by the company's shareholders at this time. Last month, the company announced a plan to separate into two independent, publicly-traded companies, each with a unique and highly focused strategy and investment profile.

16:13 EDT Conmed CEO sells over 42,000 common shares - In a regulatory filing, Conmed president and CEO Curt Hartman disclosed the sale of 42,347 common shares of the company on June 3 at a price of $132.087 per share.

16:06 EDT Lordstown Motors receives Nasdaq notice of non-compliance - Lordstown Motors announced that it received an expected notice from the Listing Qualifications Department of The Nasdaq Stock Market on May 28 stating that the company is not in compliance with Nasdaq Listing Rule 5250(c)(1) because it has not yet filed its Quarterly Report on Form 10-Q for the quarter ended March 31 with the SEC. The Notice has no immediate effect on the listing or trading of the company's common stock on the Nasdaq Capital Market.

16:02 EDT Skylight Health to begin trading on Nasdaq on June 7 - Skylight Health Group is pleased to announce that the company's common shares will commence trading on June 7 on the Nasdaq Capital Market under the ticker symbol "SLHG". The company's Nasdaq listing is expected to increase access to investment in Skylight Health from retail and institutional investors globally. Furthermore, as a company with growing U.S healthcare operations the company believes that it is appropriate for it to list on a U.S. exchange and have access to a much larger capital market and expects to improve liquidity for its common shares and, in turn, optimize its cost of capital. In conjunction with the new Nasdaq symbol, the company announces that effective Monday, June 7, its common shares on the TSX Venture Exchange will now trade under the new symbol "SLHG." Upon commencement of listing of the company's common shares on Nasdaq, the common shares will no longer be quoted on the OTC Markets.

15:32 EDT Liminal BioSciences: FDA approves BLA for Ryplazim - Liminal BioSciences announced that the U.S. FDA has approved Ryplazim for the treatment of patients with plasminogen deficiency type 1 through its subsidiary, Prometic Biotherapeutics, holder of the biological license application for Ryplazim. With this approval, Ryplazim becomes the first FDA approved therapy for this rare genetic disorder.

15:17 EDT Sorrento reports 'positive results' from partner Kelun in Phase 1 study of A166 - Sorrento Therapeutics announced that Sichuan Kelun-Biotech Biopharmaceutical, or "Kelun," a license and development partner, will present posters at this year's American Society of Clinical Oncology, or ASCO, meeting to be held June 5-6, releasing Phase 1 data for its HER2-ADC, A166. To generate this site-specific third generation antibody drug conjugate. or ADC, Kelun partnered with Levena Biopharma, a wholly owned subsidiary of Sorrento, which provided the patent-protected technologies for the generation and production of A166, including a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, K-Lock, a site-specific conjugation technology and an enzymatically cleavable linker. Compared to its commercial competitors, A166 demonstrated a better safety profile in the initial study and potentially better efficacy, as shown in the overall response rate, or ORR, of 71.4% at 6.0 mg/kg vs DS-8201, which has an ORR of 60.9% at 5.4 mg/kg, Sorrento stated.

14:35 EDT Tio Tech A receives Nasdaq notice related to delayed Form 10-Q filing - Tio Tech A announced that it received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC indicating that, as a result of not having timely filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, the company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required periodic financial reports with the Securities and Exchange Commission. The Notice has no immediate impact on the listing of the company's securities, which will continue to trade on Nasdaq, subject to the company's compliance with the other continued listing requirements of Nasdaq. Under the Nasdaq listing rules, the company has 60 calendar days from the date of the Notice to file the Form 10-Q. If the company is unable to file the Form 10-Q with the SEC by August 2, 2021, the company intends to submit a plan to regain compliance with the Nasdaq listing rules on or prior to that date. If Nasdaq accepts the plan, Nasdaq can grant the company an exception of up to 180 calendar days from the due date of the Form 10-Q, or until November 22, 2021, to regain compliance. However, there can be no assurance that Nasdaq will accept the company's plan to regain compliance or that the company will be able to regain compliance within any extension period granted by Nasdaq. If the company fails to timely regain compliance with Nasdaq's listing rules, the common stock of the company will be subject to delisting on Nasdaq. The company plans to file the Form 10-Q as soon as practicably possible.

14:32 EDT Kite says Tecartus shows high response rate in adults in Phase 1/2 study - Kite, a Gilead company, announced results from the primary analysis of ZUMA-3, a global, multicenter, single-arm, open-label Phase 1/2 study evaluating its chimeric antigen receptor T-cell therapy Tecartus in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The data were simultaneously published in The Lancet and presented during an oral session at the 2021 American Society of Clinical Oncology Annual Meeting from June 4-8. "Outcomes in adults with acute lymphoblastic leukemia are poor relative to what is observed in children, with less than half of people over 20 years of age expected to survive the illness. It is on this background that CAR T-cell therapy with brexucabtagene autoleucel was tested in adults with relapsed B-ALL in ZUMA-3," said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. "In this international, multicenter study, we observed a response rate of 71%. Importantly, the majority of these responses were associated with undetectable minimal residual disease." In the pivotal Phase 2 portion of the trial, 71 patients with relapsed or refractory disease were enrolled. Among treated patients, 47% had received three or more prior therapies. At a median follow-up of 16.4 months, 71% of treated patients achieved a complete response or CR with incomplete hematological recovery, with 31% in ongoing response at data cut-off. 97% of those responders had deep molecular remission, with undetectable minimal residual disease, and median overall survival among all responders was not reached. Among 25 patients with prior blinatumomab treatment, the CR/CRi rate was 60%. Among all treated patients, median duration of response, relapse-free survival, and OS were 12.8 months, 11.6 months and 18.2 months, respectively. Grade greater than or equal to3 adverse events occurred in 95% of patients, with anemia and pyrexia most frequently reported. Grade greater than or equal to3 cytokine release syndrome and neurologic events occurred in 24% and 25% of patients, respectively, and were generally reversed with treatment. Two Grade 5 treatment-related events occurred. Based on these data, the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL, with a target action date under the Prescription Drug User Fee Act of October 1, 2021. If approved, Tecartus would become the first and only CAR T-cell therapy approved for adults with relapsed or refractory ALL.

14:11 EDT Chimerix receives FDA approval for Tembexa for treatment of smallpox - Chimerix announced that the U.S. Food and Drug Administration has granted TEMBEXA tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients, including neonates. "We are delighted to report our first FDA approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year. With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and Development Authority (BARDA) toward a procurement contract to support national preparedness," said Mike Sherman, Chief Executive Officer of Chimerix.

14:07 EDT Esports organization TSM signs $210M naming rights partnership with FTX - Global esports organization TSM announced a $210M, multi-year partnership deal split between FTX Trading Limited and West Realm Shires Services Inc, owners and operators of FTX.com and FTX.US respectively. FTX.US has partnered with TSM in relation to the US, and FTX.com internationally. As part of this new relationship, FTX.com and FTX.US have, together, secured exclusive naming rights for TSM, which will now be known as 'TSM FTX'. As part of the deal, TSM FTX will distribute cryptocurrency to each of its players and employees as well as purchasing $1M in FTT, FTX's native token. "When I met Sam Bankman-Fried, I immediately knew we had to work together," said Andy Dinh, Founder and CEO of TSM. "Not only did TSM FTX fit perfectly as a brand, Sam is an innovative CEO that is in every way ahead of his time. Against all odds as a young ambitious entrepreneur, he has been able to disrupt markets by making smart decisions and by surrounding himself with smart people. He has proven that you can build a multi-billion-dollar business that can grow incredibly fast at scale - all while charging a fraction of what other platforms charge, and creating a culture of community and focus on social impact. This deal is extremely important to the future of our organization, but it was equally as important for me personally to partner with such a visionary leader. Just as a shared passion of gaming connects people around the world across ages, continents, and language barriers, Sam built a company that connects the world around a shared value of currency. I am extremely proud he chose to work with TSM."

13:55 EDT ADC Therapeutics announces updated clinical data from Phase 2 LOTIS-2 trial - ADC Therapeutics announced updated clinical data from the Zylonta Phase 2 LOTIS-2 trial in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, were presented at the 2021 American Society of Clinical Oncology, or ASCO, Annual Meeting, which is being held virtually June 4-8. Key data at the March 1, 2021 data cut include: Overall response rate, or ORR, was 48.3% and complete response rate, or CRR, was 24.8%; Median duration of response, or mDoR, of 13.4 months for the 70 responders; Median duration of response not reached for patients with a complete response. "The maturing duration of response from the ZYNLONTA Phase 2 trial reported at ASCO reflects the strong data set that served as the basis of the accelerated FDA approval in April. We are especially encouraged to see this positive trend continue to strengthen in a heavily pre-treated patient population, including patients with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients older than 65," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics.

13:41 EDT FDA approves Chimerix drug to treat smallpox - The U.S. Food and Drug Administration announced it has approved Tembexa to treat smallpox. "Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon... Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S. medical countermeasures response. Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. Effectiveness was determined by measuring animals' survival at the end of the studies. More animals treated with Tembexa survived compared to the animals treated with placebo. FDA approved Tembexa under the agency's Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans," the FDA stated. FDA granted approval of Tembexa to Chimerix. Reference Link

13:21 EDT Extended Stay America says ISS recommends vote for amended Blackstone deal - Extended Stay America and its paired-share REIT, ESH Hospitality (STAY) announced that Institutional Shareholder Services, or ISS, an independent proxy advisory firm, has reversed its prior voting recommendation. ISS recommends that Extended Stay shareholders vote for the now amended and higher $20.50 per paired share acquisition agreement with a 50/50 joint venture between funds managed by Blackstone Real Estate Partners (BX) and Starwood Capital Group at the company's special meetings of shareholders, which is scheduled to be adjourned to June 11, according to Extended Stay. Doug Geoga, Chairman of the boards of the company, said, "The ISS recommendation is consistent with our firm belief that this transaction is the right outcome for shareholders and provides superior value to our continued operation as a public company. In addition to the unanimous support of our Boards, we are also pleased to note that the transaction is now supported by a number of our large shareholders who had previously expressed concerns."

13:09 EDT Roblox announces 'launch party' for Warner Bros' 'In the Heights' - Roblox (RBLX) and AT&T's (T) Warner Bros. Pictures announced plans for a "virtual launch party" celebrating the film "In the Heights." The companies said the "first-of-its-kind Launch Party on Roblox brings the music, dance, and Latin American culture of the film's iconic Washington Heights neighborhood to the Roblox metaverse and on June 11, 2021 at 6 p.m. PDT, visitors will have the opportunity to participate in what is expected to be the largest virtual flash mob ever."

13:03 EDT Baker Hughes reports U.S. rig count down 1 to 456 rigs - Baker Hughes reports that the U.S. rig count is down 1 from last week to 456 with oil rigs unchanged at 359, gas rigs down 1 to 97, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 172 rigs from last year's count of 284, with oil rigs up 153 gas rigs up 21 and miscellaneous rigs down 2. The U.S. Offshore Rig Count is down 1 to 13, unchanged year-over-year. The Canada Rig Count is up 15 from last week to 77, with oil rigs up 15 to 43, gas rigs unchanged at 34. The Canada Rig Count is up 56 rigs from last year's count of 21, with oil rigs up 36, gas rigs up 20.

13:00 EDT Baker Hughes reports U.S. rig count down 1 to 456 rigs

12:42 EDT Facebook says content by politicians won't be treated differently - Facebook said in a statement: "We grant our newsworthiness allowance to a small number of posts on our platform. Moving forward, we will begin publishing the rare instances when we apply it. Finally, when we assess content for newsworthiness, we will not treat content posted by politicians any differently from content posted by anyone else. Instead, we will simply apply our newsworthiness balancing test in the same way to all content, measuring whether the public interest value of the content outweighs the potential risk of harm by leaving it up."

12:35 EDT Facebook says Trump can be reinstated in two years if conditions permit

12:22 EDT Celsius, iHeartMedia enter multiyear podcast agreement - Celsius and iHeartMedia announced a multiyear agreement to co-produce a new iHeartRadio Original podcast hosted by Celsius CEO Alex Mashinksy and distributed through the iHeartPodcast Network. Scheduled to launch later this year, podcast will feature Alex discussing a wide-ranging set of topics both inside and outside crypto, including fintech trends, personal finance, trade and regulation. The podcast will be available on the iHeartRadio App and everywhere podcasts are heard. The two companies are also pursuing a broader partnership across iHeartMedia's multiple audio platforms to bring further awareness of blockchain and cryptocurrencies to mainstream audiences at scale.

12:00 EDT PagerDuty falls -9.5% - PagerDuty is down -9.5%, or -$3.88 to $36.75.

12:00 EDT TAL Education falls -10.6% - TAL Education is down -10.6%, or -$3.52 to $29.75.

12:00 EDT IDT Corp rises 14.6% - IDT Corp is up 14.6%, or $4.26 to $33.53.

11:58 EDT DTE Energy declares spin-off dividend of DT Midstream shares - DTE Energy (DTE) announced that its board of directors has declared a pro rata dividend of the outstanding shares of DT Midstream common stock, to be distributed at 12:01 a.m. ET on July 1, 2021, to DTE's shareholders of record as of 5:00 p.m. ET on June 18, 2021, the record date for the distribution. The distribution is subject to the satisfaction or waiver of certain conditions. As previously announced, DTE shareholders will retain their current shares of DTE Energy common stock and, on the distribution date, each DTE shareholder will also receive, for every two shares of DTE common stock owned as of the record date, a distribution of one share of DT Midstream common stock. Fractional shares of DT Midstream common stock will not be distributed to DTE shareholders. Instead, the fractional shares of DT Midstream common stock will be aggregated and sold in the open market, with the net proceeds distributed pro rata in cash payments to DTE shareholders who would otherwise receive a fractional share of DT Midstream common stock. Beginning on or about June 17, 2021 and continuing until, but not including, the distribution date, it is expected that DT Midstream common stock will trade on a "when-issued" basis on the NYSE under the ticker symbol "DTM WI." On Wednesday, June 30, 2021, when-issued trading of DT Midstream common stock will end and on Thursday, July 1, 2021, DT Midstream common stock will begin trading "regular way" on the NYSE under the ticker symbol "DTM." DTE will continue to trade on the NYSE under the ticker symbol "DTE." Jerry Norcia, DTE Energy president and CEO, said: "Today's announcement marks another important milestone toward completing the planned spin-off of DTE's non-utility Midstream business. Following the separation, DTE will be a best-in-class predominantly pure-play utility that is well positioned to continue delivering clean, safe, reliable and affordable energy and significant value creation. DT Midstream will also be poised for success and value creation with numerous growth opportunities as a premier, independent midstream company with assets in premium basins connected to major demand markets."

11:24 EDT Smart Sand announces 'favorable verdict' in dispute with U.S. Well Services - Smart Sand (SND) announced that the Superior Court of the State of Delaware issued a verdict in favor of Smart Sand in its lawsuit against a subsidiary of U.S. Well Services (USWS) following the trial that took place in December 2020. In the case, Smart Sand alleged, along with certain other related claims, that U.S. Well breached a multi-year contract under which Smart Sand supplied frac sand to U.S. Well, and claimed total damages of approximately $54M. U.S. Well denied that it breached the contract and asserted counterclaims for the misuse of U.S. Well's confidential information. U.S. Well abandoned its counterclaims after the trial. The court ruled that U.S. Well breached the long-term take-or-pay Master Product Purchase Agreement between the company and U.S. Well by failing to purchase minimum required tonnages of frac sand. The court directed the parties to submit a form of final judgment in favor of Smart Sand and against U.S. Well, which the company said it expects will become publicly available by the end of June 2021. Charles Young, CEO of Smart Sand, said, "We are extremely pleased with the Court's ruling that U.S. Well breached the PPA we negotiated together." Young added that, "while we did not seek this fight, we battled to successfully vindicate our contractual rights once U.S. Well stopped performing its end of the bargain and then refused to pay us for amounts due under our agreement. We will continue to pursue our rights to maximize our recovery under this verdict."

11:15 EDT GigCapital4 Inc trading resumes

11:11 EDT Mosaic down 4% to $35.79 after announcing closure of mine shafts

11:08 EDT Mosaic immediately closing K1 and K2 potash mine shafts at Esterhazy - Mosaic announced earlier that it is immediately closing the K1 and K2 potash mine shafts at Esterhazy. "Closing K1 and K2 are key pieces of the transition to K3 but the timeline for the closure has been accelerated by nine months due to a recent acceleration of brine inflows," the company said in a statement. Mosaic is planning to resume production at the Colonsay potash mine and recalling workers "as soon as practical." This restart "will offset a portion of the production lost by the early closure of the K1 and K2 shafts at Esterhazy, and position the company to take advantage of the expected strong potash markets in 2022 and beyond," according to Mosaic. By March of 2022, the company's annualized potash production could increase by 2M tonnes from 2020 levels, as Esterhazy K3 ramps up to full capacity and Colonsay returns to service, it added. As a result of these operational changes, Mosaic expects to eliminate brine management expenses after July 2021 and "materially increase 2022 available potash capacity to take advantage of the expected potash market strength." During the expected transition period of July 2021 to March 2022, the company anticipates its potash production to be reduced by approximately one million tonnes. By mid-2022, available annualized operational MOP capacity is expected to be 10.5M tonnes.

11:01 EDT Sprouts Farmers Market opens Orlando produce distribution center - Sprouts Farmers Market opened a new produce distribution center in Orlando, marking its first distribution center in Florida and its seventh across the country. Since opening its first store in the state in 2017, Sprouts has been rapidly expanding across Florida. The center will serve all the grocer's current 23 stores in the state and the additional 10 locations planned to open in Florida this year. The 135,000 square-foot facility was built for Sprouts and includes 34 degrees F and 55 degrees F storage and fruit ripening rooms that are ideal for the wide variety of fresh produce Sprouts offers. Sprouts recently announced it will drive efficiencies across its network of fresh distribution centers by locating them within 250 miles of the stores they serve, allowing for fresher, local assortment. Sprouts is partnering with Penske Logistics as its third-party logistics provider for the distribution center and dedicated transportation fleet which created 57 new full-time jobs in the market.

10:40 EDT GigCapital4 Inc trading halted, news pending

10:10 EDT Purple Innovation appoints Patrice Varni as chief marketing, digital officer - Purple Innovation announced Patrice Varni as chief marketing and digital officer at its Lehi, UT headquarters. With responsibility for the Company's marketing, customer experience, eCommerce, and product development, Varni will be instrumental in building upon Purple's strong marketing roots and taking the brand to new levels. Most recently, Patrice was the Chief Marketing Officer and President of Dermstore/

10:00 EDT PagerDuty falls -6.4% - PagerDuty is down -6.4%, or -$2.62 to $38.01.

10:00 EDT Pershing Square Tontine Holdings falls -11.2% - Pershing Square Tontine Holdings is down -11.2%, or -$2.80 to $22.25.

10:00 EDT Asana rises 9.0% - Asana is up 9.0%, or $3.31 to $40.10.

09:47 EDT PagerDuty falls -6.7% - PagerDuty is down -6.7%, or -$2.72 to $37.91.

09:47 EDT Pershing Square Tontine Holdings falls -11.2% - Pershing Square Tontine Holdings is down -11.2%, or -$2.80 to $22.25.

09:47 EDT Asana rises 8.6% - Asana is up 8.6%, or $3.17 to $39.97.

09:39 EDT Taronis Fuels appoints Kevin Foti as CEO - Taronis Fuels announced several important developments, including naming Kevin Foti as CEO, the addition of Wilbur Ross to the Company's Board of Directors, and the closing of a private placement of approximately $16.5M of common stock to institutional and accredited investors to permit the Company to reduce debt obligations and pursue several important growth initiatives. The private placement was completed at a fixed price of $3.00 per share of common stock, with no warrants issued to investors. Foti has over 30 years of experience in the industrial gas business with Praxair, Inc. / Linde PLC where he most recently served for four years as President of the multi-billion US industrial gas merchant and on-site business. Foti joined the Company's Board of Directors on June 4, 2021 and will commence serving as the Company's CEO on June 14, 2021. Taronis Fuels is equally excited to welcome Wilbur Ross to the Company's Board of Directors. Mr. Ross' career has included most recently serving his country as Secretary of Commerce. As part of Kevin Foti and Wilbur Ross joining the Board, Tom Wetherald and Peter Molloy will step down at the end of 2021 enabling a smooth transition. At approximately 55 days following the replacement of the prior management team, the Company is providing an update on the new Board's 100-day plan. The new Board pledged to analyze the needs of the business and to make impactful and deliberate decisions. The Company recently completed that analysis which led to the following actions: Management has finished its initial assessment around reducing the high fixed expenses of the Company. This led to ceasing the Company's international operations, re-focusing R&D around commercial production efforts, and integrating the Company's accounting teams into corporate. This included some difficult decisions to reduce staff which is now complete. The Board thanks all of those impacted for their contributions to the Company. The next phase of cost actions will focus on operating expense reductions, including sub-leasing certain office space as well justifying all G&A spend. The Company's accounting team, led by CFO Mary Pat Thompson, has been working diligently to restate the Company's financial statements. This effort has included working openly with the SEC, engaging external forensic audit and IT consultants, and investing in the Company's internal accounting team. This process is progressing well and should be completed in Q4 2021. This effort is a critical step in restoring confidence in the Company and completing an uplisting by the end of this year. The Company completed today a private placement of approximately $16.5 million of its shares of common stock at a fixed price of $3.00 per share to institutional and accredited investors led by the Company's newest board member Wilbur Ross. This is in addition to the $4.25m bridge financing previously announced which was also priced at $3.00 per share. This capital will allow the Company to complete several growth initiatives, retire debt obligations to sellers, invest in high return capital investments and pursue several complementary acquisitions. The Company anticipates this capital will fund the business through the anticipated uplisting in Q4 2021. Notably, this capital raise included significant insider participation, with no less than 10 senior employees and Board members making new investments into this round. Kingswood Capital Markets, division of Benchmark Investments, Inc., acted as the exclusive placement agent for the transaction. The Company has completed its initial review of MagneGas which has resulted in new and expanded distribution in the US market. The characteristics of this fuel which include that is it renewable or "green", safer, and more cost effective than Acetylene in many applications remain an enormous market opportunity for the company. We anticipate sharing more news about its go-to-market strategy in Q4 2021. The Company also previously announced it will cease its international operations which were focused on selling MagneGas systems. These efforts would have required large incremental amounts of capital which offered a lower risk adjusted return than US opportunities.

09:37 EDT Assertio Holdings regains compliance with Nasdaq minimum bid price rule - Assertio Holdings announced that that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market indicating that the Company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules Accordingly, the Company has regained compliance with the Minimum Bid Price Requirement and this matter is now closed.

09:36 EDT Aadi Bioscience presents emerging data for FYARRO - Aadi Bioscience presented preliminary data from its lead investigational product candidate, FYARRO, during the 2021 ASCO Annual Meeting being held virtually from June 4-8, 2021. The poster is entitled "Institutional experience with nab-sirolimus in patients with malignancies harboring TSC1 or TSC2 mutations". Eight patients with malignancies and neoplasms bearing TSC1 or TSC2 inactivating alterations and representing histologies other than malignant PEComa were treated in a multi-institution expanded access program with FYARRO at 100 mg/m2 on day one and day eight of a 21-day cycle. RECIST v1.1 criteria were used for response analysis. Data cutoff occurred in March 2021. Patients had a median of 3.5 lines of prior therapy and 6 of 8 patients were mTOR inhibitor-naive. Treatment duration for all patients ranged from 0.7 to 12.0+ months. Five of 8 patients continued on treatment as of the data cutoff and 3 of 8 patients discontinued. Reasons for discontinuation were progressive disease and an adverse event. Of the 8 patients treated, 7 patients were evaluable for response analysis and 1 patient progressed before the first scan. Five of 8 patients achieved a confirmed partial response. Amongst the patients who were mTOR inhibitor-naive, 5 of 6 achieved a confirmed PR. Duration of response at data cutoff ranged from 3.1 to 9.7+ months and 3 of 5 responders continue on treatment. Treatment-emergent adverse events that were greater than or equal to30% included edema, infections, mucositis, and pain, nail changes and vomiting, and hypertension and nausea. The majority of events were grade one or grade two. Treatment-related serious adverse events were reported in 2 patients and included hyperglycemia and infection; and acute kidney injury possibly secondary to administration of contrast. Three of 8 patients had a dose reduction from 100 mg/m2 to 75 mg/m2.

09:33 EDT Surgalign reports inducement grants under Nasdaq listing rule - Surgalign Holdings announced that it has granted equity awards to six employees, none of whom are executive officers, as an inducement for them to accept employment with Surgalign, and representing the right to purchase or receive, in the aggregate, up to 179,667 shares of Surgalign common stock. The awards were granted on June 1, 2021 under the Surgalign Holdings, Inc. 2021 Inducement Plan, and include 116,751 options with an exercise price of $1.80 and 62,916 restricted stock units. One-fourth of the stock option award vests on the first anniversary of the date of grant, and 1/48th of the award vests on each subsequent monthly anniversary of the date of grant, such that the award will be fully vested on the fourth anniversary of the date of grant, subject to continued employment through the applicable vesting date. One-third of the restricted stock units vest on the first anniversary of the date of grant, and one-eighth of the remaining restricted stock units vest on each subsequent quarterly anniversary of the date of grant, such that the award will be fully vested on the third anniversary of the date of grant, subject to continued employment through the applicable vesting date.

09:33 EDT Agenus to present on balstilimab, provide clinical update on AGEN2373 - Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented data demonstrating the differentiation of balstilimab as an anti-PD-1 antibody as well as data from a Phase 1 clinical trial of AGEN2373, a CD137 agonist antibody, at the American Society of Clinical Oncology Annual Meeting 2021 from June 4 - 8, 2021. Agenus submitted a Biologics License Application to the U.S. Food and Drug Administration on April 19, 2021 for the use of balstilimab in patients with recurrent or metastatic cervical cancer. This submission was based on data from a Phase 2 trial in patients with recurrent or metastatic cervical cancer. These data show a response rate of 20% in PD-L1 positive tumors and an overall response rate of 15%, with a median duration of response of 15.4 months. Balstilimab shows responses across histology subgroups and in populations of patients typically unresponsive to commercially available therapies, such as patients with PD-L1 negative tumors. Preclinical studies using Agenus' proprietary R&D VISION platform underscored these observed clinical data. VISION demonstrates that balstilimab may be superior to currently approved anti-PD-1 antibodies such as pembrolizumab and nivolumab. Balstilimab showed superior tumor killing in both PD-L1 positive and PD-L1 negative tumors compared to commercially available anti-PD-1 antibodies in these studies. AGEN2373 is a CD137 agonist antibody designed to overcome limitations seen with first-generation CD137 agonist antibodies, particularly the development of liver toxicity. In this first-in-human study of AGEN2373 in patients with advanced solid tumors, no dose limiting toxicities were seen at doses up to 3 mg/kg; notably, no liver toxicity has been observed well above the threshold at which liver toxicity is usually seen with other CD-137 agonist antibodies. Five patients demonstrated stable disease out of 22 patients treated with AGEN2373 monotherapy, with prolonged stable disease observed in three of these patients. AGEN2373 is expected to provide benefit especially in combination therapy, and combination trials are in planning.

09:31 EDT G1 Therapeutics presents data on phase 2 trial on COSELA - G1 Therapeutics presented results from analyses evaluating the immune effects of trilaciclib in patients with extensive-stage small cell lung cancer following two Phase 2 clinical trials. Results of the analyses, presented at the American Society of Clinical Oncology annual virtual meeting, demonstrated that patients receiving COSELA prior to chemotherapy had greater peripheral T-cell clonal expansion than patients receiving placebo. The goal of clonal expansion is to amplify the number of specific lymphocytes to enable the body to have sufficient numbers of antigen-specific lymphocytes to mount an effective immune response. The genomic analysis of DNA followed two Phase 2 trials in patients with ES-SCLC. Researchers subsequently evaluated patient tumor cells and peripheral blood to quantify the abundance of specific T-cell receptors at baseline and after treatment with either COSELA or placebo prior to chemotherapy. In both studies, peripheral T-cell clonal expansion was greater among patients receiving COSELA versus patients receiving placebo. Among patients receiving E/C: Patients receiving COSELA who demonstrated an antitumor response had significantly more peripheral clonal expansion than placebo responders and a greater number of tumor-associated expanded clones. COSELA responders had more newly detected expanded peripheral clones compared with placebo responders and COSELA non-responders. Increased clonal expansion in trilaciclib responders was more evident after two cycles of E/C versus four, suggesting that trilaciclib results in a rapid T-cell response. Among patients receiving E/C/A: Patients receiving COSELA who demonstrated an antitumor response had significantly more peripheral clonal expansion than placebo responders and COSELA non-responders, and a greater number of tumor-associated expanded clones. COSELA responders also had more newly expanded peripheral clones compared with placebo responders and COSELA non-responders. There was no increase in tumor-associated expanded clones among trilaciclib responders compared to placebo responders, possibly due to the time point at which clonal expansion was assessed.

09:28 EDT Y-mAbs Therapeutics announces data for DANYELZA - Y-mAbs Therapeutics announced that Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's Hospital will present frontline data for DANYELZA and GM-CSF for consolidation of high-risk neuroblastoma patients in complete remission at the American Society of Clinical Oncology Virtual Annual Meeting on June 4, 2021 Patients received five cycles of DANYELZA and GM-CSF in a compassionate use setting for consolidation of HR-NB in first or subsequent complete remission. DANYELZA was administered in an outpatient setting on days 1, 3 and 5 at 9.0 mg/kg/cycle in combination with GM-CSF, and treatment cycles were repeated every four weeks. From June 2017 to November 2020, a total of 73 patients were treated: 55 patients in first CR and 18 patients in second or more CR. The three-year event free survival for patients in first CR was 74% and 19% for second or later CR. The three-year overall survival for the patients in first CR was 92% and 66% for second or later CR patients. Dr. Mora reported two-year EFS and OR at the Company's R&D Day in December 2020 and those data have been maintained for the three-year follow up.

09:25 EDT Celldex presents preliminary data from CDX-527 phase 1 dose escalation trial - Celldex Therapeutics announced preliminary data from the company's Phase 1 dose escalation study of PD-L1xCD27 bispecific antibody CDX-527 in patients with advanced malignancies. These data were presented in a poster session as part of the American Society of Clinical Oncology 2021 Annual Meeting taking place June 4-8, 2021. These are the first candidate developed from Celldex's bispecific platform which utilizes the Company's proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. Summary of preliminary data from ongoing Phase 1 Trial of CDX-527: As of the data cut-off on April 16, 2021, 11 patients were enrolled in the first 5 dose escalation cohorts, 0.03 mg/kg through 3 mg/kg. CDX-527 was well tolerated, with no dose-limiting toxicities or treatment related serious adverse events observed. Pharmacokinetics and receptor occupancy demonstrate good exposure starting at the 1 mg/kg dose and no evidence of significant anti-drug antibodies impact. Pharmacodynamic parameters demonstrate biological activity consistent with immune activation including: transient increase in pro inflammatory cytokines/chemokines, upregulation of activation marker on T cells and particularly NK cells and a decrease in regulatory T cells. Patients continue to be enrolled in the dose escalation phase of the trial. The Phase 1 study is an open label dose-escalation and expansion study in 40 patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy. The study is designed to determine an MTD during the dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion is designed to further evaluate the tolerability, and biologic and anti-tumor effects of selected dose levels in specific tumor types. Celldex expects to report additional safety, PK, PD and clinical activity data from this study during 2022.

09:24 EDT Provectus announces data from Phase 1 trial of PV-10 - Provectus announced that preliminary full study data from the Company's Phase 1 clinical trial of investigational cancer immunotherapy PV-1 for the treatment of neuroendocrine tumors metastatic to the liver refractory to somatostatin analogs and peptide receptor radionuclide therapy is be presented at the American Society of Clinical Oncology 2021 Annual Meeting, held June 4-8 online. Highlights from the mNET Presentation at ASCO 2021: Baseline and disease characteristics 12 patients; 50% male; median age of 66 years; Primary tumor sites: 7 small bowel, 2 pancreas, 1 caecal, and 2 unknown; NET grades: 5 Grade 1 and 7 Grade 2; Refractory to SSA and PRRT; symptomatic progressive disease PV-10 treatment summaryl Median of 1 hepatic NET lesion injected; median of 1 injection cycle; 8 patients received 1 PV-10 treatment. Safety: Mild-to-moderate post-procedure pain reported by most patients; Grade 3 photosensitivity reaction in 1 patient, Grade 3 elevation of hepatic enzymes in 1 patient, and carcinoid flare in 2 patients; Injected lesion efficacy; 42% partial response and 42% objective response rate; Patient-level efficacy; 83%a disease control rate; Progression-free survival: median 9.2 months ; Overall survival: median 22.5 months; 6 patients undergoing response follow-up at the data cut-off of April 30, 2021. Immune response: Upregulation of NK cells and activated CD4+ T cells was observed in peripheral blood collected 7 and 28 days post-PV-10 injection; Biomarkers and quality of life; Chromogranin A levels remained stable in 10 patients; QOL assessments showed stable or improved carcinoid symptoms and global health status in most patients. This clinical trial, a single-center study at The Queen Elizabeth Hospital in Adelaide, Australia that completed enrollment in 2020, is led by Tim Price, MBBS, DHlthSc, FRACP, Head of Clinical Oncology Research and Chair of the combined Hematology and Medical Oncology Unit at TQEH and Clinical Professor in the Faculty of Medicine at the University of Adelaide. The primary endpoint of the trial is safety. Secondary endpoints include ORR of injected target and measurable bystander lesions, target lesion somatostatin receptor expression, and biochemical response. Disease response assessments are conducted by independent review using Response Evaluation Criteria in Solid Tumors criteria. Six patients in the first cohort each received one percutaneously-administered injection of PV-10 to one target lesion per treatment cycle. Patients in the six-person second cohort can receive PV-10 injections of multiple lesions per cycle.

09:21 EDT Achilles Therapeutics presents phase I/IIa clinical trial design of CHIRON - Achilles Therapeutics presented a poster at the American Society of Clinical Oncology Annual Meeting 2021, which is being held in a virtual format from June 4-8, 2021. The poster presentation highlights the design of the ongoing phase I/IIa CHIRON clinical trial evaluating clonal neoantigen T cells in patients with advanced non-small cell lung cancer. The primary objective of the trial is to assess the safety and tolerability of cNeT as monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor, and will also evaluate the clinical efficacy as a secondary measure. Additional data evaluating cNeT persistence, phenotype, and functionality will be reviewed while also exploring potential biomarkers of clinical activity and factors affecting response. This will include analysis of patient samples using a bespoke plasma ctDNA assay. All patients enrolled in CHIRON will have been treated with at least one prior systemic therapy, inclusive of a checkpoint inhibitor unless contraindicated, have Eastern Cooperative Oncology Group Status 0-1, have locally advanced or metastatic disease, and have accessible sites for collection of adequate tissue. Patients requiring regular immunosuppression or that have previously received any investigational cell or gene therapies are not eligible.

09:20 EDT Allogene Therapeutics presents Phase 1 data on ALLO-501, ALLO-501A - Allogene Therapeutics presented data from multiple studies across lead anti-CD19 AlloCAR T therapy programs in two poster presentations at the 2021 American Society of Clinical Oncology Annual Meeting being held virtually June 4 - 8, 2021. The ASCO presentations include data from Phase 1 ALPHA and ALPHA2 trials in relapsed/refractory non-Hodgkin lymphoma, developed in collaboration with Servier, and presented in the Developmental Therapeutics - Immunotherapy session by Frederick L. Locke, M.D., Co-Leader, Moffitt Immuno-Oncology Program, Vice Chair and Associate Member Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center. Safety, pharmacokinetic and pharmacodynamic data from ALLO-647, a component of the Company's differentiated lymphodepletion regimen, will be presented in the same session by Michael Tees, M.D., M.P.H., Associate Member Physician, Colorado Blood Cancer Institute, Sarah Cannon Research Institute. Due to the virtual nature of the meeting, the ASCO presentations were finalized in advance of Allogene's CD19 Forum on May 19, 2021. As such, data presented at the CD19 Forum, accessible via this link and included below, is more comprehensive and reflects information collected as of May 12, 2021 from the ALPHA and ALPHA2 studies. The Company intends to initiate a Phase 2 trial with ALLO-501A, pending regulatory feedback, by the end of 2021. The next clinical update on the CD19 program is planned for Q4 2021. Data presented from the ALPHA trial supports the ability of a single administration of ALLO-501 to generate deep and durable responses at a rate that is similar to approved autologous CAR T therapies. As of the April 19, 2021 data cutoff, 42 patients were enrolled and 41 received ALLO-501, including nine who had previously received autologous CAR T treatment. The one patient not treated was enrolled but removed from the study prior to lymphodepletion due to lymphoma related obstructive kidney disease. In the trial, 98% of patients received ALLO-501 and the median and mean time from enrollment to the start of therapy was five days. Responses were observed across all cell doses and tumor histologies and follicular lymphoma. The percent of these patients remaining in complete response at six months following a single infusion was 29%, with 36% in LBCL and 24% in FL. An additional four FL patients in response have yet to reach the six month timepoint. As of May 12, 2021, three LBCL patients remain in CR and eight FL patients remain in CR, with the longest ongoing CRs at 15 months. Redosing led to clinical responses, with an overall Treatment Failure Free Survival for autologous naive patients of 64% and 61% at six months for FL and LBCL, respectively. ALLO-647 was used in lymphodepletion with fludarabine/cyclophosphamide at doses ranging from 39mg to 90mg. No dose limiting toxicities or graft-vs-host disease were observed and one case of Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome was reported. Cytokine release syndrome occurred in 27% of patients, was limited to Grade 1 or 2, and was manageable with standard protocols. Infection rates were similar to those observed in autologous CAR T trials. During this study, there were five treatment-emergent deaths in the absence of disease progression, one each from pneumonia, arrythmia, and stroke, and two instances of COVID-19 acquired in the community setting. Three of these patients were in ongoing CR at the time of death. ALLO-501A is a next generation anti-CD19 AlloCAR T candidate intended for a pivotal trial and is engineered without the rituximab recognition domains included in ALLO-501. This trial is only enrolling patients with relapsed/refractory LBCL. Following promising efficacy data from patients treated at dose level 2 patient enrollment in ALPHA2 focused on exploration of a consolidated dosing strategy that enabled patients who did not progress following an initial dose of ALLO-501A to receive a second, scheduled dose of cells. In consolidation dosing, 60mg ALLO-647 was provided with Flu/Cy for lymphodepletion before the first cell administration at DL2, and 30mg ALLO-647 with no Flu/Cy was provided for lymphodepletion before the second cell infusion at DL2 to patients with selective hematologic criteria. As of the April 19, 2021 data cutoff, 13 patients were enrolled and 12 patients were treated with ALLO-501A. One patient was treated with ALLO-647 but not ALLO-501A and deemed unable to proceed due to disease progression. Nine patients treated at the targeted 120M cell dose were evaluable for efficacy were CAR T naive, except for one who received prior autologous CAR T and previously had a 16-week CR followed by relapse. Data from these nine patients demonstrate efficacy and safety for ALLO-501A consistent with that observed for ALLO-501 in the ALPHA trial. As of May 12, 2021, all of the CRs remain ongoing, with a median follow-up of 2.3 months. Of the eight patients treated in the consolidation cohorts across both ALPHA studies, the ORR was 75% and CR rate was 63%, with four patients converting from a partial response at day 28 to a CR at day 56. No dose limiting toxicities, GvHD or ICANS were observed in ALPHA2.

09:18 EDT Creatd raises total ownership of Plant Camp to 89% - Creatd announced that it has completed the purchase of an additional 56% of the membership interests in Plant Camp through its wholly-owned subsidiary, Creatd Partners, bringing the company's total ownership of Plant Camp to 89%. As the majority owner, Creatd Partners will control Plant Camp's operations going forward. Additionally, Creatd will recognize all Plant Camp revenue in the Company's consolidated financial statements. Management currently estimates approximately $1M in annual revenues from this newly acquired business. Looking ahead to the third quarter, the company expects to continue accelerating sales. In the fourth quarter, the company expects to begin expanding Plant Camp's offerings by introducing one or more additional SKUs to its product line, including a nutrient-rich, kid-friendly pancake mix.

09:16 EDT TG Therapeutics announces data from Phase 1 study of TG-1701 - TG Therapeutics announced data from TG-1701, the Company's investigational once-daily, oral BTK inhibitor, as a monotherapy and as a triple therapy in combination with ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ, the Company's once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Data from this trial were made available on demand this morning during the American Society of Clinical Oncology Annual Meeting. Presentation highlights are included below. Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib in Chronic Lymphocytic Leukemia and Lymphoma : A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort, 200 mg in a dose-expansion cohort, 300 mg in a CLL dose-expansion cohort, or TG-1701 in combination with U2 in the dose escalation cohort. TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD. Adverse Events of special interest in patients treated with 200 mg and 300 mg QD of TG-1701, included Grade 3 hypertension, atrial fibrillation, and no instances of major bleeding observed. Grade 3 AEs occurring in greater than or equal to10% of patients treated with U2+1701 included diarrhea, neutropenia, ALT increase, and AST increase, and Grade 4 AEs occurring in greater than or equal to10% of patients treated with U2+1701 included neutropenia. At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates were: 95% in CLL, 65% in mantle cell lymphoma, and 95% in Waldenstrom macroglobulinemia. 100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort. At a median follow up of 15.6 months, the 1701+U2 dose escalation resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma, diffuse large B-cell lymphoma and follicular lymphoma.

09:13 EDT Biodesix partners with Datavant for lung cancer databank - Biodesix announced a strategic partnership with Datavant. Datavant provides solutions to help protect, match, and share health data. Through this partnership, Biodesix will anonymize the lung cancer portion of their expansive sample and data biobank using Datavant's proprietary tokenization process and connect it to multiple real-world data sets while compliantly and securely protecting patient privacy. Given the significant need for robustly curated real-world evidence linked to outcomes, claims data, comprehensive standard of care data and biomarkers, Biodesix intends to make its databank and linked data accessible to their research and biopharma partners. Real-world patient level data not only helps physicians improve treatment decisions, it also informs researchers and biopharma companies on key decisions throughout the product development cycle, from early discovery to late stage clinical development, including such uses as meaningful RWE synthetic control arms. The lung cancer-specific portion of Biodesix's 150,000 sample and data and biobank includes both baseline and longitudinal samples with proteomic and genomic laboratory results. A portion of the database includes treatment decisions and outcomes data for patients enrolled in the Company's ongoing INSIGHT study. This unique observational study enrolls non-small cell lung cancer patients across all stages and histologies collecting blood draws at baseline and serially at progression. The dataset records the treatment plan, clinical characteristics and will track three-year outcomes for all NSCLC patients from 33 academic and community clinical practices. By linking this data to other datasets, the partnership will provide a more complete longitudinal view of patient health, while protecting patient privacy.

09:13 EDT Golden Nugget Online launches IGT games in Michigan - Golden Nugget Online Gaming (GNOG) increases their assortment of games offered in Michigan with the launch of International Game Technology's (IGT) slot and table games on GoldenNuggetCasino.com. The four time "Operator of the Year" winner and 2021 "Mobile Operator of the Year" is extending its current game portfolio by offering over 50 additional games, including player favorite slots like "Cleopatra" and "the innovative "Wheel of Fortune Megaways" slot game, where players have over a hundred thousand ways to win.

09:11 EDT Eli Lilly announces new data from investigational use of Verzenio - Eli Lilly announced new data for the investigational use of Verzenio in high risk early breast cancer, and for its oral selective estrogen receptor degrader LY3484356 at the 57th Annual Meeting of the American Society of Clinical Oncology. Lilly is presenting an exploratory analysis from the positive Phase 3 monarchE trial evaluating Verzenio, a CDK4/6 inhibitor, in a subgroup of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative high risk early breast cancer who had received neoadjuvant chemotherapy. In an exploratory analysis of a pre-specified subgroup of patients who received neoadjuvant chemotherapy, the addition of Verzenio to endocrine therapy resulted in a numerically greater effect size when compared to the intent-to-treat population. This subgroup of patients made up more than 36% of the total trial population, had larger tumors at initial diagnosis and were more commonly premenopausal, representing one of the highest risk subgroups of patients in monarchE. Treatment with Verzenio in combination with standard adjuvant ET decreased the risk of breast cancer recurrence in these patients by 38.6% compared to ET alone. This corresponds to a 6.6% difference in the two-year rate of invasive disease-free survival between arms. The addition of Verzenio to ET also reduced the risk of developing metastatic disease by 39%. This corresponds to a 6.7% difference in two-year distant relapse-free survival rates - or time to developing breast cancer that has spread to other parts of the body - between the arms. This subgroup analysis was exploratory and not alpha-controlled for testing statistical significance. Safety data from the monarchE trial were consistent with the known safety profile of Verzenio and no new safety signals were observed.

09:10 EDT iTeos Therapeutics announces new phase 1/2a data on inupadenant - iTeos Therapeutics announced new clinical data from its ongoing Phase 1/2a clinical trial of inupadenant, a next-generation adenosine receptor antagonist, at the American Society of Clinical Oncology Annual Meeting 2021. Updated results from the single-agent dose-escalation and expansion portions of the trial provided evidence of durable antitumor activity in patients with advanced solid tumors and indicated safety consistent with previously reported results. Three serious adverse events considered possibly related to treatment with inupadenant had plausible alternate causes and do not represent a new safety concern for the program. Additionally, preliminary analyses of pre-treatment tumor biopsies indicated that the expression of A2AR is associated with clinical outcomes in patients with solid tumors treated with single agent inupadenant. The ongoing Phase 1/2a trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of inupadenant monotherapy to define the maximum tolerated dose and recommended Phase 2 dose of inupadenant as a single agent and in combination with pembrolizumab and/or chemotherapy in patients with advanced solid tumors. As of the data cut-off, 43 patients had enrolled in the single-agent dose-escalation and expansion parts of the study. Results presented at ASCO 2021 provided an update on 21 patients enrolled in the single-agent dose-escalation and new data on 22 patients enrolled in the dose expansion. Durable responses and stable disease greater than six months were observed in five patients with advanced solid tumors, including: previously reported partial responses: ongoing for more than 12 months in one patient with castrate-resistant prostate cancer, and lasting for more than 8 months in one patient with melanoma resistant to both pembrolizumab and ipilimumab; and stable disease in a patient with non-small cell lung cancer enrolled in the expansion, with ongoing treatment for more than 10 months. The safety of inupadenant monotherapy was consistent with previously presented data. The most frequent adverse events were fatigue, anemia, decreased appetite and constipation. Drug-related serious adverse events were reported in three of the 43 enrolled patients. Evaluation of pre-treatment biopsies indicated that higher expression of A2AR was associated with longer survival and either tumor regression or stable tumor size in patients with solid tumors treated with single agent inupadenant. Based on the promising Phase 1/2a data to date, iTeos plans to further evaluate inupadenant in combination with pembrolizumab and in combination with chemotherapy in Phase 1b/2 studies, with an initial focus on patients with castrate-resistant prostate cancer, anti-PD-1-resistant melanoma and triple negative breast cancer.

09:09 EDT Roblox board member sells 75K shares of common stock - In a regulatory filing last night, Roblox disclosed that its board member Chris Carvalho sold 75K shares of common stock on June 1st in a total transaction size of $7.1M, reducing his stake by about 5%.

09:07 EDT Cellectar Biosciences presents data in Waldenstrom's Macroglobulinemia - Cellectar Biosciences presented a poster at the American Society of Clinical Oncology Annual meeting. In conjunction with the poster presentation, management will host a KOL call with the lead investigator for the company's Phase 2 CLOVER-1 study of CLR 131 in patients with relapsed/refractory B-cell hematologic cancers, Dr. Sikander Ailawadhi, M.D. of the Mayo Clinic. The poster presentation entitled: Treatment Free Remission and Overall Response Rate Results in Patients with Relapsed/Refractory Waldenstrom's Macroglobulinemia Treated with CLR 131 is an in-depth update of six patients from the company's Phase 2a study of CLR 131 in Waldenstrom's macroglobulinemia. To date, data have shown: 100% overall response rate, 83.3% major response rate and a 16.7% complete response rate. Median time to initial response was 22 days after first infusion. Median time to major response, as defined as at least a 50% reduction in IgM, was 44 days after first infusion. Mean treatment free remission, as defined as the time from the last CLR 131 infusion to progression of disease, is 1.1 years and remains ongoing. Duration of response has not been reached, with 100% of the MYD88 wild type and high risk patients exceeding 8.5 months. Progression free survival for both MYD88 wild type patients as well as the high-risk subgroup has not been reached after 18 months; PFS for multidrug refractory patients was 11 months. The most frequently reported treatment emergent adverse events were cytopenias.

09:07 EDT Comtech awarded 5G location services contract in Australia - Comtech announced that it was awarded its first international 5G location services contract with a tier-one mobile network operator in Australia. "We are pleased to continue working with this long-standing customer who has leveraged Comtech's location technology platforms over the years to support the increasing demands of public safety services across the 3G, 4G and now also 5G networks," said Fred Kornberg, chairman of the board and CEO of Comtech Telecommunications Corp. "We have a proven track record of long-term customer relationships where our location technology supports enterprises worldwide."

09:05 EDT Y-mAbs Therapeutics announces presentation of Phase 1 data for omburtamab - Y-mAbs Therapeutics announced that Dr. Mark Souweidane, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine will present interim phase 1 dose-escalation data for omburtamab for diffuse intrinsic pontine glioma at the American Society of Clinical Oncology Virtual Annual Meeting on June 4, 2021 The phase 1 dose-escalation study with administration via convection enhanced delivery, showed that dosing of omburtamab radiolabeled with 8 mCi of 124-Iodine appeared to be well-tolerated and provided distribution volume to potentially cover tumor volumes of up to 20 cm3. The median overall survival of all 46 patients in the study increased by three to four months as compared to the historical control group. The study will continue dose escalation for both infused volume and dose. Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

09:04 EDT Gilead announces new ASCENT study data - Gilead announced new data from the Phase 3 ASCENT study evaluating Trodelvy in relapsed or refractory metastatic triple-negative breast cancer, or TNBC. In this subgroup analysis of brain metastases-negative patients who received only one line of prior systemic therapy in the metastatic setting in addition to having disease recurrence or progression within 12 months of adjuvant chemotherapy, Trodelvy improved progression-free survival, or PFS, with a 59% reduction in the risk of disease worsening or death and a median PFS of 5.7 months versus 1.5 months with chemotherapy. Trodelvy also extended median overall survival to 10.9 months versus 4.9 months with chemotherapy. The results were presented at the 2021 American Society of Clinical Oncology, or ASCO, annual meeting. Additional results showed Trodelvy demonstrated a higher overall response rate compared with chemotherapy. Efficacy results from this subgroup were consistent with those observed in the overall ASCENT study population. The safety profile of Trodelvy in this subgroup was consistent with prior reports. The most frequent Grade three treatment-related adverse reactions for Trodelvy compared to chemotherapy were neutropenia, leukopenia, diarrhea, anemia and fatigue. One patient in this subgroup who received Trodelvy experienced febrile neutropenia. Adverse reactions leading to treatment discontinuation were low across both groups. There were no treatment-related deaths with Trodelvy in this subgroup. Two additional ASCENT subgroup analyses that support the efficacy benefit of Trodelvy were also presented at the meeting - one evaluating Trodelvy efficacy by patients' age and the other comparing Trodelvy with specific single-agent chemotherapy chosen by the patients' treating physicians.

09:03 EDT Novartis says tislelizumab met OS primary endpoint in esophageal cancer trial - Novartis announced results from the pivotal Phase III RATIONALE 302 trial showing the investigational anti-PD-1 immune checkpoint inhibitor tislelizumab improved overall survival, or OS, versus chemotherapy. The study evaluated tislelizumab in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma, or ESCC, who had received prior systemic therapy. Results from RATIONALE 302 in ESCC showed tislelizumab extended median OS by 2.3 months compared to chemotherapy with a 30% reduction in the risk of death. In PD-L1 positive patients, tislelizumab extended median OS by 3.5 months with a 46% reduction in the risk of death, the company noted. Results were presented at the 2021 American Society of Clinical Oncology, or ASCO, Annual Meeting. "These data show that tislelizumab has the potential to help patients with esophageal squamous cell carcinoma - one of the deadliest types of cancers - live longer. We are excited about these results from the newest asset in our portfolio of transformational medicines and look forward to sharing these data with regulatory authorities, as we continue to explore the full potential of this uniquely designed anti-PD-1 antibody," added Jeff Legos, Ph.D., MBA, Senior Vice President and Head of Oncology Drug Development.

09:02 EDT Beyond Meat appoints Phil Hardin as CFO, Deanna Jurgens as CGO - Beyond Meat (BYND) announced the appointments of Phil Hardin as FO, Deanna Jurgens as Chief Growth Officer and Margaret "Jackie" Trask as Chief People Officer. Phil Hardin most recently served as Vice President, Finance for Amazon (AMZN) Advertising and held several other leadership roles during his tenure at Amazon, including Director, Finance for EU Customer Fulfillment, Director, Investor Relations for Amazon.com, and Director, Finance for Kindle Content & Digital Subsidiaries. Mr. Hardin will join Beyond Meat in July 2021. Jurgens joins Beyond Meat as Chief Growth Officer after serving as Chief Global Sales Officer at skincare company Rodan & Fields, where she was responsible for sales across the United States, Canada, Australia and Japan. Trask joins Beyond Meat as Chief People Officer after 14 years of leading human resources and employee processes at cosmetics company JAFRA Cosmetics International, where she most recently served as Senior Vice President of Worldwide Human Resources.

08:55 EDT BorgWarner completes tender offer, acquires 89.08% of AKASOL AG - BorgWarner announced that it has completed the tender offer for shares of AKASOL AG, resulting in BorgWarner owning 89.08% of AKASOL's outstanding shares following completion of the tender offer. The acquisition further strengthens BorgWarner's commercial vehicle and industrial electrification capabilities, which positions the company to capitalize on what it believes to be a fast-growing battery pack market. AKASOL is now a majority-owned subsidiary of BorgWarner. AKASOL's headquarters are in Darmstadt, Germany, and as previously announced, AKASOL will be run independently. Subject to approval of the shareholders at the AKASOL annual general meeting on June 30, BorgWarner expects to be represented with three of the five members of AKASOL's Supervisory Board. BorgWarner will assess what additional actions, if any, it will take to achieve full control and ownership of AKASOL including, without limitation, the delisting of AKASOL's shares.

08:46 EDT CSX board approves three-for-one stock split - CSX Corporation announced that its Board of Directors has approved a 3-for-1 stock split to be distributed to shareholders as a stock dividend. Each shareholder of record at the close of business on June 18, 2021, will receive two additional shares of CSX common stock for each share held as of this record date. The new shares will be distributed on June 28, 2021. The regular, quarterly cash dividend of 28c per share payable on June 15, 2021, will not be impacted by the stock split. Based on the current dividend rate, the post-split quarterly dividend on the company's common stock would be 9.3c per share.

08:43 EDT Live Ventures to resume quarterly earnings calls - Live Ventures announced that it plans to reinstate quarterly earnings calls. The company anticipates that stockholders, potential investors, analysts, and other interested parties will have an opportunity to ask questions of members of Live Ventures' senior management team. The company plans to discuss the following fiscal period at the below noted estimated dates as follows: Fiscal Full Year / Fiscal First Quarter Mid-February; Fiscal Second Quarter Mid-May; Fiscal Third Quarter Mid-August. Exact dates and times, together with information on how to participate on each call will be announced prior to each earnings call.

08:42 EDT Greenlight Capital Re announces investment in Paxafe, terms not disclosed - Greenlight Re Innovations has announced an investment in Paxafe, a supply-chain visibility and analytics platform focused on high value and perishable cargo. Shippers and insurers have historically lacked certain basic insights into shipments' location, condition, and custody. Paxafe introduces innovative solutions to these challenges. Using IoT sensors that advise of the cargo's location, Paxafe's 'CONTXT' platform provides an interactive timeline that displays a full chain of custody. The platform also tracks environmental data such as temperature, humidity, pressure, tilt, shock, and light to identify conditions in which there is an elevated risk of cargo damage. When such conditions arise, the platform communicates actionable information to the affected parties to prevent or mitigate adverse events that might otherwise occur.

08:42 EDT U.S. Bancorp expects credit environment to remain strong - Comments taken from the Bernstein Strategic Decisions Conference.

08:31 EDT Ardmore Shipping announces agreement for investment in Element 1 Corp. - Ardmore Shipping announced that it has entered into definitive agreements for the previously announced strategic investment into Element 1 Corp.'s unique methanol-to-hydrogen technology, including the establishment of the e1 Marine joint venture and Ardmore's purchase of an approximately 10% equity stake in Element 1 Corp. In a related transaction, Ardmore also entered into a definitive agreement for Maritime Partners to invest at least $25M and up to $40M in the company's newly created Series A 8.5% Cumulative Redeemable Perpetual Preferred Shares.

08:20 EDT Immutep reports data from TACTI-002 Phase II study of LAG-3 therapy - Immutep (IMMP) announces new interim data from its Phase II TACTI-002 study with a data cut-off date of 16 April 2021. The data will be presented in two poster presentations by Dr Tim Clay, Investigator, St John of God Subiaco Hospital, Perth, Australia and Dr Irene Brana, Investigator, Vall d'Hebron Institute of Oncology, Barcelona, Spain at the American Society of Clinical Oncology's 2021 Annual Meeting in on-demand sessions available from 9 am on 4 June 2021, US Eastern Time at this year's virtual conference. TACTI-002 is being conducted in collaboration with Merck. The study is evaluating the combination of Immutep's lead product candidate eftilagimod alpha with MSD's KEYTRUDA in up to 183 patients with non-small cell lung cancer in 1st and 2nd line or 2nd line head and neck squamous cell carcinoma. 1st line NSCLC - Part A: Sustained and durable responses: 15 patients with responses giving an ORR of 41.7% on an intention-to-treat basis and 48.4% in evaluable patients, as assessed by blinded independent committee read; None of the patients with a confirmed response progressed within 6 months and the median duration of response is currently estimated to be more than 13 months in patients unselected for PD-L1 expression; 2/36 patients had a Complete Response and 23/36 of patients had a target lesion decrease; Durable responses observed in all PD-L1 subgroups as assessed by local investigator read for example: ORR in the greater than or equal to 1% PD-L1 subgroup was 44.0%; ORR in the less than 50% PD-L1 subgroup was 31.6%; ORR in the greater than or equal to 50% PD-L1 subgroup was 53.8%; Median overall PFS is 8.2 months in patients unselected for PD-L1 expression, as assessed by local investigator read. This is very promising for a chemo-free 1st line regimen. Median PFS increases to 11.8 months in the greater than or equal to 50% PD-L1 subgroup and median PFS in the less than 1% PD-L1 subgroup is 4.1 months. Conclusion: The data presented for 1st line NSCLC is very encouraging and will be broadened by the ongoing recruitment in this patient population to form a solid basis for late-stage clinical development. 2nd line HNSCC - Part C: 11 patients with responses giving an ORR of 29.7% on an intention-to-treat basis and 35.5% in evaluable patients; Durable responses with now 5 patients having a Complete Response. So far median duration of response is not yet reached. None of the patients with a response progressed within 6 months; In patients unselected for PD-L1 expression, median PFS is 2.1 months and median OS is 12.6 months; In patients in PD-L1 CPS greater than or equal to 1 subgroup, ORR is 45.8%, median PFS is 4.1 months, and median OS is 12.6 months; Conclusion: The 2nd line HNSCC data is mature and continues to be very encouraging and forms an excellent basis to move into the 1st line HNSCC indication via Immutep's randomised Phase IIb TACTI-003 study which is expected to start in mid-2021. 2nd line NSCLC - Part B: Stage 1 results were reported in November 2020 at SITC and Overall Survival is trending favourably. Stage 2 recently opened for patient enrolment and combined results from Stages 1 & 2 are expected to be reported later this year. The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far. Trial recruitment continues to progress well, with 127 patients out of up to 183 already participating at 12 clinical sites across Australia, Europe, the UK and US. At present, recruitment is ongoing for the expansion stage of Part A and Stage 2 of Part B. Recruitment details for each Part of the trial are shown below and are current as at 1 June 2021. Immutep currently expects to report further interim data from Part A, final data from Part C, and new results from Stages 1 & 2 of Part B in 2H calendar year 2021 or early calendar year 2022.

08:15 EDT Cyclerion Therapeutics announces licensing agreement with Akebia Therapeutics - Cyclerion Therapeutics (CYCN) announced that it has entered into an exclusive, global license agreement with Akebia Therapeutics (AKBA) for the development and commercialization of praliciguat, an oral sGC stimulator. Under the terms of the agreement, Akebia has obtained an exclusive license to research, develop and commercialize praliciguat globally and will be solely responsible for these activities going forward. Cyclerion is eligible to receive up to $225M in pre-commercial milestones, including up to $15M in the first 18 months. Total potential future development, regulatory, and commercialization milestone payments could result in up to $585M. Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages. "We are very pleased to license praliciguat to Akebia, whose demonstrated leadership in kidney disease and extensive R&D and commercialization capabilities make it an ideal partner for the future development of praliciguat. This transaction provides Cyclerion with meaningful participation in any potential near and longer-term value creation and enables us to focus on our mission to develop treatments for cognitive impairment, including our foundational assets CY6463 and CY3018, where we see enormous clinical promise," said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion.

08:15 EDT Gaming and Leisure Properties completes acquisition of two gaming properties - Gaming and Leisure Properties (GLPI) announced the completion of its previously announced transaction to acquire the land and real estate assets of Tropicana Evansville from Caesars Entertainment (CZR) and The Dover Downs Hotel and Casino from Bally's (BALY) for an aggregate purchase price of approximately $484M in cash. The company funded the transaction with cash on hand which was in part generated by its equity raise completed on October 29, 2020. Simultaneous with the closing of the transaction, the company entered into a triple-net master lease agreement with Bally's. The master lease has an initial total annual cash rent of $40M and an initial term of 15 years with four 5-year tenant renewal options, as well as annual lease escalation terms based on the Consumer Price Index, with a 1% floor and 2% ceiling, subject to CPI meeting a .5% threshold. Peter Carlino, Chairman and CEO of GLPI commented, "We are pleased to add these high-quality regional assets to our portfolio, expand our roster of operators, and gain geographic exposure to a new state. Bally's is one of the nation's most dynamic regional gaming operators and we look forward to further supporting the execution of their growth plans. In particular, we look forward to adding their Mardi Gras and Golden casinos in Blackhawk, Colorado and their Jumer's Casino and Hotel in Rock Island, Illinois to our existing master lease as we further expand our partnership."

08:12 EDT Reservoir Media acquires Tommy Boy Music, terms not disclosed - Reservoir (RSVR) has acquired independent Hip-Hop and Electronic record label Tommy Boy Music. The deal comprises 6,000+ masters including Coolio's "Gangsta's Paradise," House of Pain's "Jump Around," and Afrika Bambaataa & The Soulsonic Force's "Planet Rock". Tommy Boy Music helped to launch the careers of Hip-Hop icons such as Queen Latifah, Coolio, De La Soul, Naughty By Nature, Afrika Bambaataa, Digital Underground, House of Pain, and Force MDs, among many others. It introduced EDM to mainstream audiences through releases by LFO, Coldcut, and 808 State, while helping to establish the Latin Freestyle and Latin Hip-Hop genres with releases by TKA, K7, and Information Society. Tommy Boy Music also includes the catalogs of Amherst Records, Harlem Music, and Halwill Music, which hold masters and publishing rights for a diverse collection of '70s Soul, Disco, and Jazz artists including The Stylistics, Van McCoy, and Glenn Medeiros. Tommy Boy Music joins Chrysalis Records, augmenting Reservoir's recorded music division and building on the company's commitment to upholding legacies and supporting great independent music. Reservoir will continue to market the catalog under the Tommy Boy label out of Reservoir's New York City headquarters with A&R and Creative led by Reservoir EVP Faith Newman and international marketing and distribution driven by Reservoir's Chrysalis Records team in London. This news comes following the announcement that Reservoir has entered into an agreement with Roth CH Acquisition II Co. (ROCC), a special purpose acquisition company, taking the first step toward becoming a publicly traded company listed on the Nasdaq.

08:10 EDT Akoya, AstraZeneca to collaborate on mIF workflows, spatial biomarker signatures - Akoya Biosciences (AKYA) announced a collaboration with AstraZeneca (AZN) to advance new multiplex immunofluorescence workflows and spatial biomarker signatures, based on Akoya's Phenoptics platform. The agreementhas the aim of elucidating the immune biology of cancer, in greater detail, to streamline drug development, clinical trials, and biomarker discovery. Immunotherapies, a rapidly growing treatment modality, utilize the immune system to combat cancer and are revolutionizing the field of oncology. While they have shown tremendous promise, only a subset of patients achieves durable response, impacting drug efficacy rates and approvals. There is a pressing need for predictive biomarkers that can accurately stratify responders from non-responders. However, identifying suitable biomarkers requires an in-depth understanding of tumor pathophysiology. A recent multi-institutional study of immuno-oncology biomarker modalities found that mIF-based spatial biomarkers have the potential to address this gap by analyzing the spatial architecture of tumor tissue sections, and mapping how tumor and immune cells organize and interact within the tumor microenvironment. With this collaboration, AstraZeneca's immuno-oncology division will partner with Advanced Biopharma Solutions, a premium service offering from Akoya, to leverage the comprehensive spatial phenotyping capabilities of the Phenoptics platform to study drug mechanism of action, confirm target biology prevalence, and discover predictive signatures for subsequent trial designs. The aim of this collaboration will be the development and implementation of predictive assays and analysis frameworks to enable AstraZeneca, and the pharmaceutical industry in general, to advance a spatial biomarker-informed drug development strategy for immunotherapy. The results could lead to increased trial success rates and advancement of precision medicine.

08:07 EDT Phio Pharmaceuticals reports 'positive' in vivo data on use of INTASYL - Phio Pharmaceuticals announced positive in vivo data that provide further evidence on the utility of its INTASYL self-delivering RNAi therapy platform in the field of immuno-oncology. The new study data show how INTASYL can be easily deployed to target multiple proteins and provide evidence of the synergy of the company's pipeline products. In the study, INTASYL specifically dual-targeting BRD4 and PD-1 elicited complete tumor responses in an in vivo hepatoma model, and significantly outperformed the efficacy of small molecule and antibody treatments towards the same targets. In this study, the company assessed the efficacy of mouse/human BRD4-targeting INTASYL PH-894 as monotherapy or co-formulated with mouse PD-1 targeting INTASYL mPH-762, in treating a subcutaneous Hepa1-6 model of murine hepatoma in C57BL/6N mice. Positive controls included JQ-1, a small molecule inhibitor of BRD4 and anti-mouse PD-1 monoclonal antibody or both treatments.

08:07 EDT Vincerx Pharma presents clinical data on VIP512 - Vincerx Pharma announced the presentation of safety and efficacy data from the Phase 1 study of VIP152, the Company's PTEFb/CDK9 inhibitor, in patients with double-hit lymphoma at the 2021 American Society of Clinical Oncology Annual Meeting being held virtually from June 4-8. Key presentation highlights include the following. Poster presentation, titled, "Safety and efficacy of VIP152, a PTEFb / CDK9 inhibitor, in patients with double-hit lymphoma." CDK9 mediates the transcription of oncogenes such as MYC and MCL-1, which play a critical role in a variety of cancers. VIP152, a potent and selective inhibitor of CDK9, has completed dose escalation in patients with advanced malignancies. Significant monotherapy clinical activity was observed with a favorable safety profile; seven patients with solid tumors had disease control during the dose escalation portion of the study, including a patient with pancreatic cancer and a patient with salivary gland cancer; one patient with double-hit DLBCL, who was treated with VIP152 30 mg once weekly, achieved metabolic complete remission; and no patients discontinued due to adverse events. An expansion cohort of 6 additional patients with DHL were dosed with VIP152 30 mg once weekly: all patients with DHL had received front-line R-CHOP or R-EPOCH, with two patients having had prior stem cell transplant, and additional therapies include R-DHAP, R-GemOx, R-ICE and durvalumab. Four patients had 2 prior lines of therapy and 3 patients had greater than or equal to 3 prior lines of therapy. Three patients had been refractory to their last treatment. Six patients had advanced disease at study entry; VIP152 had a favorable safety profile, with most common adverse events being Grade 1 and Grade 2 severity. Two patients had a serious AE. No patients withdrew from treatment due to any AEs; Pharmacodynamic biomarker analysis showed significant reduction, lasting at least 4 hours, of MYC, PCNA and MCL-1 mRNA in all patients; Anti-tumor activity consisted of 2 metabolic complete responses in 7 patients, based on investigator-assessed FDG-PET scans; Both metabolic CRs were durable, with patients remaining on treatment for 3.7 and 2.3 years until study withdrawal due to the COVID pandemic. Both patients had metabolic CRs at the time of study exit; The results from this expansion cohort of 7 patients with DHL, a cancer known to have MYC translocations, suggests that reduction of MYC expression for at least 4 hours can provide durable complete remissions lasting several years. The favorable safety profile of VIP152 allowed for long-term dosing in elderly patients with advanced disease.

08:05 EDT Elanco names Marcela Kirberger as general counsel - Elanco (ELAN) named Marcela Kirberger as general counsel and corporate secretary. She joins the Elanco executive committee at the company's Greenfield, Indiana-based headquarters on June 22. Kirberger will have responsibility for all of Elanco's legal functions. She joins the company with more than 20 years of corporate legal experience advising and leading companies through transformation to address evolving internal, national, and international challenges. Most recently, Kirberger was general counsel and corporate secretary at the North American headquarters of Roche Diagnostics (RHHBY), where she had executive responsibility for the legal function, overseeing the areas of commercial, compliance, litigation, legal regulatory risk, privacy, operations and labor and employment.

08:03 EDT SQZ Biotechnologies presents initial results from SQZ-PBMC-HPV trial - SQZ Biotechnologies presented initial results from its ongoing Phase 1 clinical trial of SQZ-PBMC-HPV demonstrating that the investigational cell therapy is safe and well-tolerated and can stimulate immune responses in certain patients with advanced or metastatic Human Papillomavirus positive, or HPV16+, tumors. The trial also showed that the company's clinical stage manufacturing process of its autologous cell therapy is fast and reliable. The monotherapy stage trial data of the company's first Antigen Presenting Cell, or APC, platform candidate was presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting; poster presentation 2536. A primary outcome measure in the monotherapy dose escalation phase of the trial is safety and tolerability. Findings from the trial show that SQZ-PBMC-HPV was safe and well-tolerated at all tested dose levels with patients receiving 2 to 10 doses. No dose-limiting toxicities were observed. There were no grade 3 or higher treatment related serious adverse events, or SAEs. In one patient, a grade 2 cytokine release syndrome and immune-related reaction was observed. A related grade 3 adverse event (AE, anemia) was observed in another patient. Manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. All patient batches were produced under current good manufacturing practice regulations, met specifications, and yielded multiple cryopreserved doses in less than 24 hours. The findings show that doses of SQZ-PBMC-HPV were released and available for administration approximately one week from the time a patient's cells were drawn. Antigen presentation was confirmed in all patient batches independent of individual patient medical history or prognostic score.

08:02 EDT Ovid Therapeutics appoints Jeff Rona as Chief Business, Financial Officer - Ovid Therapeutics announced that current Chief Business Officer Jeffrey Rona has expanded his role to include Chief Financial Officer responsibilities. Jeffrey Rona has more than 25 years of experience as an investment banker, Chief Business Officer, and Chief Financial Officer in the life sciences.

07:34 EDT Intellia Therapeutics to presents interim data from Phase 1 study of NTLA-2001 - Intellia Therapeutics, announced that a late-breaking abstract featuring interim Phase 1 clinical data from NTLA-2001, the Company's lead CRISPR/Cas9 in vivo therapy in development as a single-dose, systemically administered treatment for transthyretin amyloidosis, has been selected for an oral presentation at the 2021 Peripheral Nerve Society Annual Meeting, taking place this month. The presentation will include interim data from the ongoing dose-escalation portion of Intellia's Phase 1 trial evaluating NTLA-2001 in people living with hereditary ATTR amyloidosis with polyneuropathy. Following safety assessment and dose optimization, Intellia intends to further evaluate NTLA-2001 in a broader population of people with ATTR amyloidosis, including those with cardiomyopathy. "These findings represent Intellia's first clinical data readout and an important step forward in our commitment to develop breakthrough genome editing treatments for people living with severe diseases, such as transthyretin amyloidosis," said Intellia President and CEO John Leonard, M.D. "By knocking out the disease-causing gene, NTLA-2001 is designed to halt progression and potentially reverse the disease with a single dose, offering the potential of meaningful improvement over the standard of care, which requires chronic, lifelong administration. These interim data will provide a view of NTLA-2001's safety and activity profile as the dose-escalation portion of our study progresses, as well as insight into the promise of our modular platform to develop other systemically delivered in vivo CRISPR/Cas9 therapies across a range of diseases with unmet need."

07:32 EDT Cronos Group, Ginkgo Bioworks amend collabooration, license agreement - Cronos Group and Ginkgo Bioworks announced an amended collaboration and license agreement that will enable the companies to accelerate the commercialization of cultured cannabinoids at scale. The Amended Agreement with Ginkgo will enable Cronos Group to commercialize products using cultured cannabinoids ahead of reaching the originally stated productivity targets, while maintaining the incentives to continue to develop towards and achieve the previously agreed upon efficiency and cost goals. This approach is expected to facilitate Cronos Group's cultured cannabinoid products being first to market in Canada, which will drive significant market knowledge and consumer insights that are expected to help deliver future novel and innovative consumer-driven products. Cronos Group expects that the final productivity target for CBG will be achieved prior to September 2021, as previously announced. The Amended Agreement follows the receipt of Cronos Fermentation's processing license in April 2021, and most recently the receipt of its CRA license. With the Amended Agreement and both licenses in hand, Cronos Fermentation commenced commercial production of CBG today. Cronos Group is prioritizing rare cannabinoids, such as CBG, and plans to sequence commercial production and subsequent product launches based on this approach. Under the terms of the companies' original agreement, Cronos Group agreed to issue to Ginkgo up to 14.7 million common shares in the aggregate upon Ginkgo's demonstration that certain microorganisms are capable of producing the agreed upon eight target cannabinoids above specified minimum productivity levels, with tranches of common shares issued as each of the eight milestone events are reached. Under the Amended Agreement, milestone events have been established for the early commercialization by Cronos Group of products incorporating the target cannabinoids, such that, within each tranche of common shares to be issued, one-third of the common shares in the tranche will be issued on the date that Cronos Group sells a product that incorporates the relevant target cannabinoid to a third party. The remaining two-thirds of the common shares within such tranche will be issued upon Ginkgo's demonstration that the relevant microorganisms can produce the relevant target cannabinoid above the corresponding productivity level in the original agreement. The aggregate number of common shares potentially issuable to Ginkgo has not changed as a result of the Amended Agreement. Cronos Group has the exclusive right to use and commercialize certain key patented intellectual property for the use of microorganisms developed for the production of the target cannabinoids globally. All R&D work undertaken by Ginkgo is being conducted in compliance with U.S. federal law regarding controlled substances. Cronos Group intends to produce and distribute the target cannabinoids globally, where permitted by applicable law and subject to applicable regulatory approvals and has received confirmation that this method of production is permitted under the Cannabis Act.

07:23 EDT Jushi's Franklin Bioscience to open 19th BEYOND/HELLO location - Jushi Holdings announced its subsidiary, Franklin Bioscience, will open the Company's 12th BEYOND / HELLO medical marijuana dispensary in Pennsylvania, and the 19th BEYOND / HELLO retail location nationally. BEYOND / HELLO Hazleton will begin serving patients and caregivers on Monday, June 7, 2021 at 10:00 a.m. Jushi subsidiaries plan to open an additional six new dispensaries before year end, which is expected to continue to deliver added value to Pennsylvania patients.

07:18 EDT Brookfield: IPL board 'erred' in concluding Pembina offer as 'superior proposal' - Brookfield Infrastructure Partners (BIP), together with its institutional partnershas filed a notice of variation, chang e and extension to acquire all of the outstanding common shares of IPL (IPPLF). The company said, "We note IPL's press release issued yesterday in which the IPL Board of Directors reiterated their support for the arrangement agreement entered into with Pembina (PBA) on June 1st in an all-share transaction. We do not believe that any of the justifications provided by the Company outweigh the overwhelming factors laid out in our press release of June 2nd supporting the superiority of our 74%/26% cash/share offer when compared to the all-share, Alternative Transaction. We also would note the following omissions from the IPL Board's analysis: As IPL's largest shareholder, with 9.75% ownership of IPL shares and a total economic interest in the Company of 19.65%, we are not supportive of the all-share, Alternative Transaction and intend to vote against it. In the event the Alternative Transaction is successful, Brookfield Infrastructure will become a significant shareholder in Pembina with up to an approximately C$1.6 billion economic interest. Brookfield Infrastructure does not intend to be a long-term investor in Pembina. The Brookfield Block, in addition to the shares then held by event-driven funds and any other institutional shareholders who lack desire to own shares in Pembina, will therefore create a substantial and protracted overhang on Pembina's shares. The IPL Board and its advisors ought to have considered these obvious factors in making its determination of the value of the all-share consideration offered in the Alternative Transaction. The Alternative Transaction will require a lengthy timeline to closing, accompanied by uncertainty due to numerous conditions to which the Offer from Brookfield Infrastructure is not subject. The Alternative Transaction exposes IPL shareholders' all-share consideration to a host of risks, which do not appear to have been appropriately evaluated against our Offer by the IPL Board. For example, as of June 1st, the required regulatory and antitrust reviews under the Alternative Transaction were yet to commence and given the overlap between the two companies, we see uncertainty in the outcome and timeline of these reviews. Furthermore, failure to receive certain regulatory approvals would enable Pembina to terminate the transaction without an obligation to pay IPL the reverse termination fee. These considerations, along with typical business environment risks such as commodity price volatility, changes in interest rates and potential tax code changes, expose the all-share consideration to valuation risk due to the protracted closing timeline. We find it highly surprising that the IPL Board would be advocating for an all-share proposal when feedback from the IPL Special Committee and its advisors, during our interactions with them, indicated they favoured an all-cash offer. Were the IPL Board genuinely interested in advocating for share consideration on behalf of shareholders of IPL, they would be required to take into account Brookfield Infrastructure's long history of generating attractive value for shareholders. The IPL Board made no inquiries regarding the growth opportunities and outlook for Brookfield Infrastructure. We have US$2.3 billion of contracted backlog and are targeting investments of US$2 billion annually in growth initiatives. With the current favourable economic backdrop, we are optimistic we can build upon our strong track record where over the past decade we have been able to grow our dividend by an average of 10% per annum and have generated average annual total shareholder returns of 18%. As we stated in our previous press release on June 2, 2021, we believe IPL's Board erred in concluding that the Alternative Transaction is a superior proposal for IPL shareholders. This error, combined with the highly favourable terms granted by the IPL Board to Pembina, including an egregious break fee, suggests a prioritization of defeating the Offer over achieving the best outcome for all stakeholders. Regardless, by bringing our Offer forward, IPL shareholders will have the opportunity to decide for themselves with the benefit of full transparency. "

07:14 EDT Boston Properties acquires two Massachusetts lab buildings for $100M in cash - Boston Properties announced that it has acquired 153 & 211 Second Avenue, two lab properties comprising 153,000 square-feet in Waltham, Massachusetts. The company acquired the two lab buildings from an affiliate of Montana Avenue Capital Partners for a gross purchase price of $100M in cash. The two buildings are 100% leased to a pharmaceutical company and are adjacent to BXP's 200 West Street building, a 272,000 square feet property, a portion of which was recently converted to lab space.

07:13 EDT Versus Systems completes acquisition of Xcite Interactive - Versus Systems announced the completion of its previously announced acquisition of Xcite Interactive. The acquisition was completed through a merger of a wholly-owned subsidiary of Versus with and into Xcite. "Versus will add its proprietary prizing engine to Xcite's newly developed XEO platform that is already in use with multiple professional sports teams and live major events. This rewards-based engagement will expand into TV and streaming while capitalizing on Xcite's connections with more than 150 sports teams and brands. The new Versus-XEO platform will allow fans to interact with their favorite shows, games, and events to win real-world prizes inside apps, streams, and broadcasts," the company said. The transaction comes on the heels of a successful Versus-Xcite beta test during the Canelo Alvarez - Billy Joe Saunders middleweight title fight held at the AT&T Stadium in Dallas, Texas on May 8, 2021. In partnership with Frias Agency, Versus worked with Keurig Dr. Pepper brand Crush, rewarding over one thousand winning audience members with Crush soda alongside signed boxing gloves and DAZN codes to watch the fight. Matthew Pierce and Versus President and CFO Craig Finster will retain their roles at the subsidiary, with the Versus Board of Directors also becoming the Xcite Board. Pursuant to the definitive acquisition agreement, Versus paid approximately $15.2M dollars to acquire the capital stock of Xcite, for a combination of Versus common shares and cash. Continuing employees of Xcite will also receive options to purchase Versus shares from an approximately $2.25M retention equity plan. The overall consideration is subject to customary post-closing adjustments.

07:12 EDT Precision BioSciences provides update on PBCAR0191 study, PBCAR19B data - Precision BioSciences announced progress on two strategies designed to optimize the durability of allogeneic CAR T therapy in patients with relapsed/refractory, or R/R, non-Hodgkin lymphoma, or NHL. The company reported updated interim results from its Phase 1/2a study of PBCAR0191, the company's investigational, off-the-shelf, allogeneic CAR T cell therapy targeting CD19. As of May 21, 12 patients with R/R NHL were enrolled and evaluated for response to PBCAR0191 with enhanced lymphodepletion, or eLD. The company also reported preclinical data demonstrating the potential mechanism by which its investigational immune evading stealth cell, PBCAR19B, may avoid rejection by T cells and natural killer, or NK, cells. Use of eLD mitigated PBCAR0191 rejection and markedly increased peak cell expansion and area under the curve, each as compared to sLD. A single dose of PBCAR0191 cells following eLD yielded clinical responses in the majority of patients, with overall response rates, or ORR, and complete response, or CR, rates of 75% and 50%, respectively at Day 28. Five of nine responding patients who received PBCAR0191 cells following eLD remained progression-free, including 4/9 evaluable subjects with responses lasting greater than four months. Assessment of duration of response is on-going. Median interval from confirmation of eligibility to start of LD was 1 day, reinforcing the potential feasibility for rapid delivery of off-the-shelf, allogeneic, cellular therapy for high-risk patients. As of May 21, PBCAR0191 with eLD continued to show acceptable tolerability without evidence of graft versus host disease, or GvHD, and with a similar frequency of immune effector cell-associated neurotoxicity syndrome, or ICANS, and cytokine release syndrome, or CRS, compared to patients who received sLD. Infections occurred more frequently when PBCAR0191 was dosed following eLD. Three treatment emergent deaths without disease progression occurred, including two cases of infection and one case of cardiac arrest after a choking incident. Two of these patients were in ongoing complete responses at time of death. Only one death, as previously reported on December 4, 2020 was assessed by the investigator as possibly related to study treatment. Over 80% of subjects had advanced and aggressive lymphomas and 75% had stage III/IV disease. Subjects had received a median of seven lines of therapy prior to study enrollment and 33% of subjects had prior CD19-directed CAR therapy.

07:11 EDT Novartis reports clinically relevant improvement in median OS in NETTER-1 study - Novartis reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival, or PFS. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months compared to the control arm. "While this analysis did not reach statistical significance, the analyses of overall survival may have been impacted by multiple factors, including the crossover of patients from the control arm receiving subsequent radioligand therapy as well as heterogenous subsequent anti-cancer treatments in both study arms," the company said. No new safety signals emerged in the final analysis. At this final analysis, no new safety signals emerged in the long-term safety follow-up with a median of 6.3 years. In terms of secondary hematological malignancies, no new cases of MDS or acute leukemia were reported in the long term follow up. These results will be presented during the 2021 American Society of Clinical Oncology, or ASCO, Annual Meeting on June 4.

07:07 EDT 4D pharma completes enrollment in one study, discontinues enrollment in another - 4D pharma announced the completion of its target enrollment of 30 patients for Part A of its Phase I/II clinical trial of MRx-4DP0004 in patients with partly-controlled asthma. Following the completion of enrollment of Part A, 4D pharma expects to announce topline results from these patients in the second half of 2021. 4D pharma also announces the voluntary discontinuation of enrollment in the Phase II study of MRx-4DP0004 for the treatment of hospitalized patients with COVID-19 in the UK, in order to focus on its core LBP pipeline candidates due to the increase in vaccination rates, declining hospitalization rates, and progress in the MRx-4DP0004 asthma clinical trial.

07:04 EDT BeyondSpring first patient dosed in triple combination study - BeyondSpring announced that the first patient had been dosed in the Phase 1b/2 investigator-initiated trial, studying the safety and tolerability of plinabulin, in triple combination therapy with both PD-1/PD-L1 antibody and radiation therapy. This triple combination is actively recruiting at The University of Texas MD Anderson Cancer Center, with Dr. Vivek Subbiah as principal investigator, in seven metastatic or locally advanced cancers, which include bladder cancer, melanoma, Merkel cell cancer, MSI-H cancers, non-small cell lung cancer, renal cell cancer, and small cell lung cancer. The study is titled "An Open-label, Single-center, Phase 1b/2 Study to Evaluate the Safety of Plinabulin in Combination with Radiation/Immunotherapy in Patients with Select Advanced Malignancies after progression on PD-1 or PD-L1 Targeted Antibodies." Patients will receive a triple combo treatment of RT + plinabulin + anti-PD-1/PD-L1 mAb in Cycle 1, followed by anti-PD-1/PD-L1 mAb and plinabulin combo regimen in Cycle 2 and beyond until disease progression or development of unacceptable toxicity, withdrawal from study treatment, or discontinuation of this study. Plinabulin will be tested in combination with five different PD-1/PD-L1 immunotherapies and the exact dosing and treatment schedule will be determined by treatment cycle for each immunotherapy agent. The first patient progressed on Keytruda and chemotherapy in first-line NSCLC, and has been dosed with RT, plinabulin and Keytruda. Plinabulin, a selective immunomodulating microtubule-binding agent, induces maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to selectively target cancer cells. It has been demonstrated to revert resistance to PD-1/PD-L1 mAb with an objective response rate of 43% when combined with checkpoint inhibitors in a Phase 1 SCLC study, will be presented on June 4, 2021 at the ASCO Lung Cancer Poster Session. This triple combination regimen is supported by data including greater than 80% tumor reduction in PD-1 mAb non-responsive tumor models as presented at AACR in June 2020. Additionally, recent data, published in Frontiers in Oncology1, has shown that plinabulin elicits a strong anti-cancer immune response, which polarizes macrophages and increases the ratio of M1-like/M2-like tumor-associated macrophages, further strengthening the support for the anti-tumor immune effects of plinabulin.

07:04 EDT Senseonics says PROMISE study shows 'strong accuracy' of 180 day CGM sensor - Senseonics announced the results of the PROMISE Study evaluating the accuracy and safety of the next generation Eversense CGM System for up to 180 days with reduced calibrations. At an oral presentation at the 14th Annual ATTD Meeting results were presented for both the primary sensor and for a secondary sensor with modified chemistry, referred to as the SBA sensor, in a subset of study participants. Overall mean absolute relative difference, or MARD, against reference value was 9.1% for the primary sensor over 49,000 paired points and 8.5% for the SBA sensor over 12,000 paired points. The percent sensor readings within 20 mg/dL or 20% of reference values were as follows: Across the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor; In the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the agreement rates were 89.4% and 92.2% for the primary sensor and 96.5% and 96.8% for the SBA sensor, respectively. Confirmed hypoglycemic alert detection rate was 93% for primary sensor and 94% for the SBA sensor. There were no related serious adverse events, all sensors were removed during the initial removal procedure and 1.1% of patients had a mild infection at the procedure site. "We are very pleased with the results of the PROMISE Study which demonstrate an excellent safety and accuracy profile for the 180-day sensor. This study was initiated December 2018 and we're very grateful to the tireless Clinical Investigators and the devoted study subjects for participating in this important clinical trial. As we await hearing from the US and European regulatory agencies concerning our pre-market submissions of data from both the primary and the SBA sensors, we are pleased to continue to offer the Eversense CGM systems in both the US and Europe with our commercialization partner, Ascensia Diabetes Care," said Tim Goodnow, PhD, President and CEO of Senseonics.

07:03 EDT Penske Automotive enters Charlotte, North Carolina market though acquisition - Penske Automotive announced that it has entered the Charlotte, North Carolina market area with the acquisition of Mercedes-Benz of South Charlotte. The acquisition is expected to add $150M in annualized revenues. Mercedes-Benz of South Charlotte represents Penske Automotive Group's 26th world-wide dealership for the Mercedes-Benz brand. The South Charlotte location was originally founded in 2006 and expands the company's operations to a new market area which is ranked as one of the largest population growth areas in the United States. The dealership includes over 70,000 square feet of facilities, including 50 service bays, to meet the growing demands of this new market for the company.

07:02 EDT GSX Techedu changes name to Gaotu Techedu - Gaotu Techedu announced that it has changed its name from GSX Techedu to Gaotu Techedu, effective immediately. The American depositary shares of the company, every three representing two Class A ordinary shares, par value $0.0001 per share, will begin trading under the new corporate name on June 7.

07:01 EDT Verano Holdings opens Zen Leaf Lawrence in New Jersey - Verano Holdings announced the opening of Zen Leaf Lawrence. Located near Trenton and the Pennsylvania border, this is the third Zen Leaf dispensary in New Jersey, joining existing storefronts in Elizabeth and Neptune, and is one of less than 20 dispensaries currently operating in the state.

06:33 EDT Hamilton Beach, Clorox enter trademark licensing deal to launch air purifiers - Hamilton Beach (HBB) announced that it has entered into an exclusive multiyear trademark licensing agreement with Clorox (CLX). Under the agreement, Hamilton Beach Brands plans to launch a line of premium air purifiers under the Clorox brand name that will remove 99.97% of allergens and particulates from pollen, dust, smoke and mold as well as household appliances designed to kill viruses and bacteria. Hamilton Beach Brands and Clorox are collaborating in the development of this new line of air purifiers, with some scheduled to be launched this year and other products to be added in 2022. Over time, the companies plan to develop additional appliances for the home health and wellness market. Hamilton Beach Brands will source and market the new line and distribute the products through both online and brick-and-mortar channels. Distribution is planned for the U.S., Canada and Mexico markets. The initial Clorox air purifiers will have true HEPA filters that are designed to capture 99.97% of allergens and particulates from pollen, dust, smoke and mold as well as reduce viruses and bacteria in the air. Product pricing at retail is expected to range from $89.99 to $229.99.

06:20 EDT Cathie Wood's ARK Investment bought 4.5K shares of Alphabet on Thursday

06:17 EDT AstraZeneca's Imfinzi demonstrates improved survival in Stage III lung cancer - The company states: "Updated results from the positive PACIFIC Phase III trial showed AstraZeneca's Imfinzi, or durvalumab, demonstrated a sustained, clinically meaningful overall survival and progression-free survival benefit at five years in patients with unresectable, Stage III non-small cell lung cancer who had not progressed following concurrent chemoradiation therapy. Results from the updated post-hoc analyses showed an estimated five-year OS rate of 42.9% for patients treated with Imfinzi versus 33.4% for those on placebo after CRT. Median OS was 47.5 months for Imfinzi versus 29.1 for placebo. Following a maximum treatment course of one year, an estimated 33.1% of patients treated with Imfinzi had not progressed five years after enrolment versus 19% for placebo. These results build on the primary PFS and OS analyses published in The New England Journal of Medicine in 2017 and 2018, which demonstrated a sustained, significant benefit with Imfinzi for these primary endpoints."

06:10 EDT Bitcoin falls after Tesla's Musk tweets breakup meme - Tesla CEO Elon Musk posted a tweet Thursday night with a meme about a couple breaking up over over the male quoting Linkin Park lyrics along with the hashtag #Bitcoin and a broken heart emoji. Following the tweet, the CEO added another post to the thread showing a couple videochatting with the female saying, "I miss you". Bitcoin has fallen roughly 6% to $36,907.50 in pre-market trading, according to Tradeblock. Reference Link

06:03 EDT Hooker Furniture CEO 'cautiously optimistic' - "Our consolidated orders and backlogs are more than double historical norms as we head into the summer months," said CEO Jeremy Hoff. "Given this strong position, we're cautiously optimistic, considering the industry-wide supply chain, logistics and raw materials shortages and inflation. We believe we have mitigated these dynamics as much as possible through surcharges and price increases, yet these supply-side factors are unpredictable and often involve unexpected changes occurring almost daily." "Several macroeconomic factors provide a nice runway for growth such as the ongoing strong housing market and favorable demographics with the massive Millennial generation becoming highly engaged in household formation and home furnishing purchases. On the negative side, we expect increased competition for the consumers' discretionary income from industries such as travel, apparel and in-person events as the COVID-19 vaccinations continue to roll out," said Hoff. "While we expect the extraordinary levels of demand for home furnishings to diminish somewhat, we also expect that demand for home furnishings will settle into a higher level of demand than pre-pandemic. Consumers aren't going to fall out of love with their homes, and we are positioned to help them enhance their homes with comfortable, stylish and quality home furnishings. We believe our company is strongly positioned to win in this environment," Hoff concluded.

05:58 EDT EU opens investigation into potential anticompetitive conduct of Facebook - The European Commission has opened a formal antitrust investigation to assess whether Facebook violated EU competition rules by using advertising data gathered in particular from advertisers in order to compete with them in markets where Facebook is active such as classified ads. The formal investigation will also assess whether Facebook ties its online classified ads service "Facebook Marketplace" to its social network, in breach of EU competition rules. Executive Vice-President Margrethe Vestager, in charge of competition policy, said: "Facebook is used by almost 3 billion people on a monthly basis and almost 7 million firms advertise on Facebook in total. Facebook collects vast troves of data on the activities of users of its social network and beyond, enabling it to target specific customer groups. We will look in detail at whether this data gives Facebook an undue competitive advantage in particular on the online classified ads sector, where people buy and sell goods every day, and where Facebook also competes with companies from which it collects data. In today's digital economy, data should not be used in ways that distort competition." As part of its in-depth investigation, the Commission will examine in detail whether Facebook's position in social networks and online advertising allows it to harm competition in neighboring markets, where Facebook is also active thanks to its social network, and in particular in online classified ads. Reference Link

05:40 EDT Sanofi partners with BIG, EORTC and AFT to initiate SERD trial - Sanofi is partnering with the Breast International Group, or BIG, the European Organization for Research and Treatment of Cancer, or EORTC, and the Alliance Foundation Trials, or AFT, to initiate a pivotal trial of an oral selective estrogen receptor degrader, or SERD, in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi's amcenestrant vs tamoxifen for women with estrogen receptor-positive, or ER+, breast cancer who were unable to continue their adjuvant aromatase inhibitor, or AI, therapy. As per the terms of the pre-study agreement, Sanofi will be the sponsor and will provide funding and investigational drug product for the global study. BIG will conduct the study within the BIG network, EORTC will oversee study management and data analysis, as well as the medical management, and AFT will conduct the United States portion of the study. Sanofi will conduct this global study in selected countries outside the geographical scope of the academic networks, as further described in a follow-on agreement under negotiation among the four parties. The protocol is being developed in collaboration with all four parties, including AFT, BIG, EORTC and Sanofi.

05:33 EDT The9 to acquire Montcrypto to build 20MW supply of electricity in Calgary - The9 announced that it signed a definitive agreement to acquire Montcrypto, a Canadian company, to build a 20MW supply of electricity in Calgary, Canada. The carbon-neutral infrastructure of Montcrypto provides a greener and more environmentally friendly power supply to the cryptocurrency mining business of The9. Montcrypto had signed natural gas procurement contracts with local oil extraction companies and plans to build carbon-neutral cryptocurrency mining facilities by using natural gas as the source of electricity power generation. According to the agreement, The9 plans to invest a total of C$7.6M in Montcrypto in two phases to obtain the controlling stake in Montcrypto. Upon the completion of the two phases, the power capacity of the mining facilities will be 20MW, which can supply electricity to operate more than 6,000 S19j Antminers. The9 also promotes the implementation of carbon neutrality strategies among its supply and demand chain partners. Montcrypto has a complete solution for the use of clean energy, which can efficiently convert the byproduct natural gas from oil drilling into low-cost electricity, thereby supporting the construction of carbon-neutral cryptocurrency mining facilities. Montcrypto will cooperate with oil companies in the Calgary area to deploy mobile and modular cryptocurrency mining facilities at the oil well sites, and convert natural gas through a series of processing procedures such as recovery, pretreatment, and energy conversion of the natural gas. This provides a stable supply of electricity for mass cryptocurrency mining machines. According to the agreement, The9 will pay hosting fee to Montcrypto at a rate of CAD0.037/kWh for a period of five years. When all the 20MW carbon-neutral mining facilities are put into use, the byproduct natural gas in the area will be reduced by approximately 53M cubic meters every year, and the greenhouse gas emissions of 128,000 tons of carbon dioxide equivalent will be reduced. The9 also announced the closing of the investment in Skychain Technologies, a cryptocurrency mining facilities company listed in TSX Venture Exchange in Canada. The9's investment in Skychain is for its expansion in the capacity from 20MW to 32MW. The expansion of the mining site is located in Birtle, Manitoba, Canada. Upon the completion of the expansion, The9 will deploy its cryptocurrency mining machines there. Other than the investments in the construction of the two cryptocurrency mining facilities companies in Canada, The9 is also actively seeking for more efficient and environmentally friendly mining sites around the world for the deployment of its cryptocurrency mining machines.

05:23 EDT Acuity Brands acquires DS business from ams OSRAM, terms undisclosed - ams OSRAM announced the sale of the North America-Based Digital System, or DS, business, which primarily manufactures lighting control systems, electronics and drivers, to Acuity Brands. Acuity Brands is acquiring the Digital Systems business in the US, Canada and Mexico, which currently have about 1100 employees. ams OSRAM North America Digital Systems business develops and manufactures lighting components including drivers, LED light engines, electronic ballast and connected components and is one of the largest LED lighting driver companies in North America. The acquisition of ams OSRAM's LED drivers and team expands Acuity Brands capabilities and its advanced LED driver portfolio. The company will take over the DS business in the U.S., Canada and Mexico, including the production facility in Monterrey, Mexico. The transaction is expected to close during the summer of 2021. The parties have agreed not to disclose financial details.

05:11 EDT Pharvaris to present PK, PD data for PHA121 - Pharvaris announced that the company will present bradykinin challenge data supporting the pharmacokinetic, or PK, and pharmacodynamic, or PD, profile of PHA121 for the treatment of hereditary angioedema, or HAE, at the 12th C1 Inhibitor Deficiency and Angioedema Workshop, to be held virtually June 3-6. Pharvaris established a proof-of-concept model for HAE in non-human primates using bradykinin, an endogenous peptide known to mediate signs and symptoms of HAE. The model was validated utilizing icatibant, a marketed injectable B2 receptor antagonist, providing back-translation from human clinical experience with icatibant. The objective of the study was to investigate the ability of PHA121 to attenuate blood-pressure changes induced by bradykinin injection. In this model, PHA121 inhibited bradykinin-induced changes in blood pressure at all doses tested with a faster onset of action than icatibant and the duration of the effect was dose dependent. PHA121 was also orally administered in two double-blind, placebo-controlled single-ascending-dose studies up to 50 mg, with PK and safety observed for 72 hours, in healthy volunteers. PD effects were evaluated with a nonlinear mixed-effect PK/PD model using 12 mg and 22 mg doses and compared to historical icatibant data. PK/PD analysis showed significant inhibition of bradykinin-induced hemodynamic changes with an average composite EC50 of 2.4 ng/mL and EC85 of 13.8 ng/mL. Single-dose treatment of PHA121 demonstrated effective bradykinin inhibition. Quantitative modeling indicates that single oral doses of PHA121 will maintain pharmacologically active drug levels for a substantially longer time than 30 mg of subcutaneous icatibant.