Stockwinners Market Radar for November 12, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:34 EST Group 1 Automotive announces sale of Brazil operations - Group 1 Automotive announced that its wholly-owned subsidiary GPI SA, LLC has entered into a Share Purchase Agreement with Original Holdings S.A., a sociedade por acoes incorporated in Brazil and an affiliate of Simpar S.A, a publicly listed company in Brazil, with UAB Motors Participacoes Ltda., a wholly-owned subsidiary of Group 1, as an intervening party. Pursuant to the terms and conditions set forth in the Agreement, Original will acquire 100% of the issued and outstanding equity interests of UAB from the company for BRL 510M in cash. The company has made customary representations, warranties, covenants, and indemnities relating to UAB and its business in the Agreement and the Transaction is subject to manufacturers approval. The parties anticipate closing the Transaction before the end of the second quarter of 2022. As of year-end 2020, UAB operated 17 dealerships which generated BRL 1.264B in annual revenue and retailed over 8,131 new and used vehicles, accounting for approximately 2.3% of total revenues of Group 1.

18:09 EST Chefs' Warehouse CEO Pappas sells 300,000 common shares - In a regulatory filing, Chefs' Warehouse president and CEO Christopher Pappas disclosed the sale of 300,000 common shares of the company on November 9 at a price of $35.32 per share.

17:48 EST Green Plains director Knudsen sells 64,226 common shares - In a regulatory filing, Green Plains director Ejnar Knudsen III disclosed the sale of 64,226 common shares of the company on November 10 at a price of $39.9786 per share.

17:43 EST Ecolab CTO Berger sells 5,948 common shares - In a regulatory filing, Ecolab executive VP and CTO Larry Berger disclosed the sale of 5,948 common shares of the company on November 9 at a price of $230.874 per share.

17:25 EST Moderna reports interim data from Phase 1 clinical study of mRNA-2752 - Moderna announced interim data from an ongoing Phase 1 clinical study of mRNA-2752 (Triplet) in patients with accessible solid tumors and lymphomas. The data showed that the company's mRNA Triplet program given in combination with AstraZeneca's (AZN) durvalumab was tolerated at all dose levels tested and elicited evidence of anti-tumor activity. The recommended dose for expansion is up to of 8mg mRNA-2752 + durvalumab. "We are encouraged by the interim data from our Triplet program, which combines three mRNAs into one therapy injected directly into the tumor. Our intratumoral mRNA technology allows for the delivery of mRNAs encoding for multiple proteins that act locally to modulate the tumor microenvironment, without systemic toxicity," said Praveen Aanur, M.D., Vice President, Therapeutic Area Head for Oncology Development at Moderna. "These interim results demonstrate the potential role of immune modulation on clinical outcomes and we look forward to full results from the dose expansion arm of the study."

17:14 EST Mantle Ridge reports 5.7% stake in Dollar Tree, may seek talks - In a regulatory filing, Mantle Ridge disclosed a 5.7% stake in Dollar Tree, representing 12,729,873 shares. The hedge fund said in the filing, which allows for activism, that it believes the shares are undervalued and intends to have conversations, meetings and other communications with certain members of the company's board of directors and management team, stockholders and other persons, in each case to discuss the company's business, operations, strategies, governance, the composition of the executive suite and board and possibilities for changes thereto, as well as other matters related to Dollar Tree.

17:04 EST Peltz's Trian Fund buys GE, cuts Sysco in Q3 - Nelson Peltz's Trian Fund Management disclosed in an SEC filing its holdings as of September 30, 2021. The fund increased its stake in two holdings in the third quarter, including by size of previous position Janus Henderson (JHG) and General Electric (GE). Trian decreased its stake in six holdings, including by size of previous position Sysco (SYY), Wendy's (WEN), Mondelez (MDLZ), Comcast Class A (CMCSA), and Ferguson (FERG). The fund's top holdings as of September 30, in order of size, were Ferguson, Comcast Class A, Sysco, Janus Henderson, and Invesco (IVZ).

16:34 EST Regenxbio reports additional positive interim data from trials of RGX-314 - Regenxbio announced additional positive interim data from the ongoing Phase II AAVIATE trial and the ongoing Phase II ALTITUDE trial of RGX-314 using in-office suprachoroidal delivery for the treatment of wet age-related macular degeneration and diabetic retinopathy without center-involved diabetic macular edema, respectively. The results were presented at the American Academy of Ophthalmology 2021 Annual Meeting by Robert L. Avery, M.D., Founder of California Retina Consultants and Research Foundation. "We are pleased to share this initial data from Cohort 2 of the AAVIATE trial which provides encouraging evidence of the emerging clinical profile of RGX-314 for the treatment of wet AMD using suprachoroidal delivery. In the data reported today, RGX-314 was observed to be well tolerated in Cohort 2, with stable visual acuity and retinal thickness as well as a meaningful reduction in anti-VEGF treatment burden at six months," said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. "We look forward to providing additional updates from the program." "These initial results from patients in Cohort 2 of the AAVIATE trial at six months after suprachoroidal administration of RGX-314 reinforce the potential impact that RGX-314 could have on the overall clinical management of patients with wet AMD," said Dr. Avery. "I am encouraged by the six-month data in Cohort 2 and look forward to reviewing further data from Cohorts 1-3 and from the higher dose level in Cohorts 4 and 5."

16:32 EST S&P Global, IHS Markit merger receives conditional DOJ approval - S&P Global (SPGI) and IHS Markit (INFO) announced that they have reached a proposed agreement with the Antitrust Division of the U.S. Department of Justice that permits the companies to proceed with their $44B combination. Consistent with the commitments both companies have made to obtain regulatory approval in other jurisdictions, the proposed agreement with the DOJ requires the companies to divest IHS Markit's Oil Price Information Services, Coal, Metals and Mining, and PetroChem Wire businesses. The companies previously announced an agreement to sell these businesses to News Corp. The proposed agreement with the DOJ, which remains subject to court approval, does not require the companies to make any additional divestitures. Subject to the receipt of remaining regulatory approvals and satisfaction or waiver of specified closing conditions, S&P Global and IHS Markit continue to expect the merger to close in the first quarter of 2022.

16:17 EST Stewart to acquire PropStream for $175M - Stewart Information Services announced its entry into an agreement to acquire PropStream, a company in residential real estate data and analytics for investors, realtors, real estate agents, brokers and lenders. Since its founding more than fifteen years ago, PropStream has been an innovator in aggregating and standardizing property data and delivering value-added solutions to its customers through a single digital point of access. The purchase price is $175M and will be funded with available company resources. The company expects to close the transaction on Monday, November 15. The transaction is immediately accretive. PropStream will continue operating as a standalone company.

16:12 EST Regeneron announces $3B share repurchase program - Regeneron announced that its Board of Directors authorized a share repurchase program of up to $3B of the company's outstanding common stock. The program has no time limit and can be discontinued at any time. No shares have been repurchased under the program to date. As of November 12, $1.8M remained available for share repurchases under the prior $1.5B share repurchase program authorized in January 2021.

15:48 EST Celsius Holdings says received subpoena from SEC in August - In a regulatory filing, Celsius Holdings stated: "On January 8, 2021, we received a letter from the SEC Division of Enforcement seeking the production of documents in connection with a non-public fact-finding inquiry by the SEC to determine whether violations of the federal securities laws have occurred. On August 20, 2021, the SEC issued a subpoena for production of documents in connection with the matter. Neither the January 8, 2021 SEC letter nor the August 20, 2021 subpoena means that the SEC has concluded that the company or anyone else has violated the federal securities laws. We have cooperated and will continue to cooperate with the SEC staff in its investigation. At this time, however, we cannot predict the length, scope, or results of the investigation or the impact, if any, of the investigation on our results of operations."

15:11 EST FTC approves modifications to Bristol-Myers divestiture agreement - The Federal Trade Commission has approved certain modifications to Bristol Meyers Squibb's (BMY), or BMS's, divestiture agreements that the FTC approved and incorporated into its order as part of a consent that was required when BMS acquired Celgene in 2019. The modifications relate to certain confidential provisions of the divestiture agreements and are necessary to ensure that Amgen (AMGN) continues as a viable competitor with the Otezla product. As a condition of BMS's acquisition of Celgene, the FTC required BMS to divest to Amgen the psoriasis treatment drug, Otezla. The $13.4B divestiture settled FTC charges that BMS's proposed $74B acquisition of Celgene would violate federal antitrust law. The Commission initially voted 3-2 to approve the final order in November 2019. The Commission's initial vote to issue the complaint and accept the proposed consent order was 3-2, it noted. Reference Link

13:21 EST CyrusOne up 2% to $84.24 after WSJ says near takeover deal

13:02 EST Baker Hughes reports U.S. rig count up 6 to 556 rigs - Baker Hughes reports that the U.S. rig count is up 6 from last week to 556 with oil rigs up 4 to 454, gas rigs up 2 to 102, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 244 rigs from last year's count of 312, with oil rigs up 218 gas rigs up 29 and miscellaneous rigs down 3. The U.S. Offshore Rig Count is up 2 to 15, up 2 year-over-year. The Canada Rig Count is up 8 from last week to 168, with oil rigs up 6 to 101, gas rigs up 2 to 67. The Canada Rig Count is up 79 rigs from last year's count of 89, with oil rigs up 62, gas rigs up 17.

13:01 EST United Airlines adds 44 flights to Las Vegas ahead of CES 2022 - United Airlines is expanding its schedule to make it easier for CES 2022 attendees to join the in-person show in Las Vegas. The airline is adding 14 new direct flights in early January between Las Vegas and San Jose, Calif., Boston, Fort Lauderdale, and Orlando, and is also adding 30 flights from its hub airports in San Francisco, Los Angeles, New York/Newark, and Washington D.C./Dulles. This represents a capacity increase of 37% compared to its usual January schedule to Las Vegas. "The return of in-person conferences and events is a very positive sign in the pandemic recovery, and United is uniquely positioned to capitalize on this increase in demand," said Ankit Gupta, senior vice president of Domestic Planning and United Express. "We're adding about 80% of the capacity we did for CES in 2020, demonstrating that business travel is on the rebound and our customers are eager to reunite with clients and colleagues." Between Oct. 27 and Nov. 9, searches on United.com for flights to Las Vegas during CES 2022 were up 70% compared to the prior two-week period. And according to a recent survey of United's business customers, nearly 20% say they expect travel to meetings and conferences will exceed pre-pandemic levels in 2022. United will fly 81 flights into Las Vegas during the peak arrival days of January 3-4, and 109 flights on the peak departure days of January 8-10.

12:10 EST Adtran reports start of acceptance period of takeover offer for ADVA Optical - Acorn HoldCo, a wholly-owned subsidiary of ADTRAN, published the offer document for the voluntary public takeover offer to all shareholders of ADVA Optical Networking SE for the exchange of all ADVA shares for Acorn HoldCo shares. ADTRAN and ADVA intend to combine the two companies and create a global, scaled provider of end-to-end fiber networking solutions for communications service provider, enterprise, and government customers. Upon completion of the business combination, Acorn HoldCo is expected to become the holding company for both ADTRAN and ADVA. As of today, ADVA shareholders can accept the Offer by tendering their ADVA shares at the exchange ratio of 0.8244 Acorn HoldCo common shares in exchange for each ADVA share. ADTRAN Chairman and CEO Tom Stanton stated, "We are excited that we have received approval from BaFin and can now move forward with the launch of our offer. We are hopeful that ADVA shareholders will quickly embrace this offer, not only for the premium it provides but for the long-term potential resulting from this combination of two innovative, industry-leading companies."

12:00 EST Natura &Co falls -19.6% - Natura &Co is down -19.6%, or -$2.90 to $11.85.

12:00 EST Farfetch rises 18.3% - Farfetch is up 18.3%, or $7.20 to $46.61.

12:00 EST Regis rises 19.7% - Regis is up 19.7%, or 59c to $3.58.

11:04 EST Lincoln National board boosts buyback authorization to $1.5B - Lincoln Financial Group announced that the board of directors of Lincoln National Corporation has authorized an increase to the company's securities repurchase authorization, bringing the total aggregate authorization to $1.5B. This authorization provides additional capacity to execute our previously communicated plans for incremental and ongoing share repurchases as well as debt paydown, which management discussed on the call related to the reinsurance transaction with Resolution Life held on September 17, 2021 and on the company's third quarter earnings call held on Thursday, November 4, 2021.

10:48 EST Tesla CEO Musk sells additional 639,737 shares - Tesla CEO Elon Musk this morning disclosed the sale of an additional 639,737 shares of the automaker for about $687M. This brings the total Tesla stock sales by Musk this week to about $5.7B. Tesla in morning trading is down $18.24 to $1,045.27.

10:39 EST Tesla CEO Musk sells additional 639,737 of shares - Tesla CEO Elon Musk this morning disclosed the sale of an additional 639,737 shares of the automaker for about $687M. This brings the total Tesla stock sales by Musk this week to about $5.7B. Tesla in morning trading is down $18.24 to $1,045.27.

10:26 EST Ubisoft's 'Far Cry 6' debuts as October's best-selling game in U.S., says NPD - NPD analyst Mat Piscatella said that Ubisoft's (UBSFY) "Far Cry 6" debuted as October's best-selling game in the U.S., instantly becoming the 8th best-selling game of 2021 to date. "Far Cry 6" ranked 1st on both PlayStation (SONY) and Xbox (MSFT) platforms in October. Warner Bros. Interactive's (T) "Back 4 Blood" was October's #2 best-selling game, also ranking 2nd on both PlayStation and Xbox platforms. Nintendo's (NTDOY) "Metroid Dread" debuted as October's #3 best-selling game, while also ranking 1st on Switch. "Metroid Dread" achieved the highest launch month sales of any "Metroid" franchise release in tracked history. Other games in the top ten for October U.S. sales include EA's (EA) "Madden NFL 22," "NHL 22," and "FIFA 22," Sega's (SGAMY) "Demon Slayer," Square Enix's (SQNXF) "Marvel's Guardians of the Galaxy," Nintendo's "Mario Party Superstars," and Take-Two's (TTWO) "NBA 2K22." Other companies in the video game software space include Activision Blizzard (ATVI), Capcom (CCOEY), and Tencent (TCEHY). Reference Link

10:22 EST U.S. video game spending grew 16% y/y in October, says NPD - NPD analyst Mat Piscatella said that October 2021 consumer spending across video game hardware, content and accessories in the U.S. grew 16% vs YA, reaching an October record $4.4B. Year-to-date consumer spending reached $46.7B, gaining 12% when compared to the same period in 2020. Hardware dollar sales gained 82% compared to a year ago, helping lead the market to 16% total YoY growth. Content was also strong - double-digit percentage gains were achieved across all content segments in October vs YA. October video game hardware dollar sales increased 82% when compared to October 2020, to $472M. Year-to-date hardware spending has increased 53% when compared to the same period a year ago, reaching $3.9B. The Nintendo Switch (NTDOY) was the best-selling hardware platform of October in both units and dollars, aided by the launch of the Nintendo Switch - OLED Model. Sony's (SONY) PlayStation 5 remains the best-selling hardware platform of 2021 year-to-date in dollars, while Nintendo Switch leads in units. Microsoft (MSFT) is also a publicly traded company in the gaming hardware space. Reference Link

10:00 EST F45 Training falls -11.2% - F45 Training is down -11.2%, or -$1.79 to $14.22.

10:00 EST Natura &Co falls -16.3% - Natura &Co is down -16.3%, or -$2.40 to $12.34.

10:00 EST Xponential Fitness rises 12.9% - Xponential Fitness is up 12.9%, or $2.51 to $22.04.

10:00 EST Farfetch rises 16.6% - Farfetch is up 16.6%, or $6.54 to $45.95.

09:52 EST Intrusion names Tony Scott as president and CEO, effective November 15 - Intrusion on Thursday appointed Tony Scott as its new President and CEO, who will assume the role on Monday, November 15, 2021. Prior to his appointment, Scott had been serving as the founder and CEO of the TonyScottGroup, LLC., a Washington DC and Silicon Valley-based consulting and venture capital firm focused on early-stage cybersecurity and privacy technologies. "We are pleased to welcome Tony to INTRUSION and believe his unparalleled expertise, decades of executive leadership and highly regarded reputation will provide significant benefit to the Company at this critical stage of our evolution," said INTRUSION's Chairman, Tony LeVecchio.

09:47 EST Eneti falls -12.3% - Eneti is down -12.3%, or -$1.25 to $8.95.

09:47 EST Xponential Fitness rises 17.7% - Xponential Fitness is up 17.7%, or $3.45 to $22.98.

09:47 EST RLX Technology rises 22.0% - RLX Technology is up 22.0%, or 99c to $5.48.

09:27 EST StealthGas announces record date for distribution of Imperial Petroleum shares - StealthGas announced that the record date for the spin-off distribution of common shares and 8.75% Series A Cumulative Redeemable Perpetual Preferred Shares of Imperial Petroleum Inc., the newly formed subsidiary that will act as the holding company for its four tanker vessels, is November 23, 2021. StealthGas stockholders will receive one Imperial Petroleum common share and one Imperial Petroleum Series A Preferred Share for every eight shares and forty-eight shares, respectively, of StealthGas common stock owned at the close of business on November 23, 2021. The distribution is expected to be made on or about December 3, 2021. Fractional common shares and fractional Series A Preferred Shares will not be distributed. Instead, the distribution agent will aggregate fractional common shares and fractional Series A Preferred Shares, respectively, into whole shares, sell such whole shares in the open market at prevailing rates promptly after our common shares and Series A Preferred Shares, respectively, commence trading on the Nasdaq Capital Market, and distribute the net cash proceeds from the sales pro rata to each holder who would otherwise have been entitled to receive fractional common shares or fractional Series A Preferred Shares, as applicable, in the distribution. Shares of StealthGas Inc. common stock will trade with due bills from the Record Date through and including the Distribution Date. Accordingly, shareholders of StealthGas Inc. as of the Record Date must continuously hold such shares of StealthGas Inc. common stock through and including the Distribution Date in order to receive shares of Imperial Petroleum Inc. in the spin-off. The spin-off transaction is expected to be completed on or around December 3, 2021, and remains subject to Imperial Petroleum Inc.'s registration statement on Form F-1 being declared effective by the Securities and Exchange Commission and the approval of the listing of Imperial Petroleum Inc.'s common shares and Series A Preferred Shares on the Nasdaq Capital Market.

09:18 EST J&J understands 'historical significance' of separation, CEO Gorsky says

09:17 EST Johnson & Johnson has appetite for tuck-in M&A deals - Comments taken from J&J's conference call discussing its split into two companies.

09:14 EST Tinley Beverage Company to produce beverages for Soma Beverage - The Tinley Beverage Company (TNYBF) announces that Soma Beverage Company's non-alcoholic craft-style "Hoppin' High Ride", developed in collaboration with the brew masters at BJ's Restaurants (BJRI), will be produced without preservatives through a new closed-loop cannabis infusion and pasteurization process at Tinley's Long Beach facility. "We are delighted to be on the road to producing Soma's 'High Ride' at Lakewood," said Richard Gillis, President and COO, Tinley USA, Office of the CEO. "This innovative partnership between Soma and BJ's taps several new capabilities in our facility, including closed-loop intake and infusion, tunnel pasteurization to avoid added preservatives, and exacting control of product specifications--all to help ensure consistent craft quality, THC potency and performance, and overall taste experience."

09:09 EST Kyndryl Holdings, Microsoft announce global strategic partnership - Kyndryl (KD) and Microsoft (MSFT) announced a landmark global strategic partnership that will combine their market-leading capabilities in service of enterprise customers. The deal with Microsoft is Kyndryl's first since recently becoming an independent public company and provides incremental multi-billion dollar revenue opportunities for the two companies. Together the companies will bring to market state-of-the-art solutions built on the Microsoft Cloud that will accelerate hybrid cloud adoption, modernize applications and processes, support mission-critical workloads, and further enable modern work experiences for customers. The long-term partnership will open additional markets and new customers to Kyndryl across all industries and illustrates the speed and commitment the company is placing on forging strong relationships with leading enterprise technology innovators. Microsoft becomes Kyndryl's only Premier Global Alliance Partner, increasing Microsoft's access to the $500B managed services market where Kyndryl leads.

09:08 EST KP Tissue sees Q4 adjusted EBITDA lower than Q3 2021 - "We are seeing activities and behaviour start to return to more pre-COVID levels in both the Consumer and Away-From-Home segments. However, cost inflation and lagged pricing in the fourth quarter are expected to impact results. Q4 2021 Adjusted EBITDA is therefore expected to be lower than Q3 2021 and higher than Q4 2020."

09:07 EST Sorrento Therapeutics announces publication of trial results of abivertinib - Sorrento Therapeutics announced the peer-reviewed publication of significant results from a study of abivertinib on 227 heavily pretreated NSCLC patients in the journal Clinical Cancer Research, authored by Dr. Yi-Long Wu. Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR/BTK inhibitor, which is structurally distinct from osimertinib. The 300 mg BID abivertinib dose was based upon the pharmacokinetics, efficacy and safety profiles characterized in prior studies. In the study, 227 patients received this dose for a median treatment duration of 24.6 weeks. Among 209 response evaluable patients, confirmed ORR was 52.2% and the DCR was 88.0%. The median DoR and PFS were 8.5 months and 7.5 months, respectively. The median OS was 24.9 months. All patients reported at least 1 AE, with 96.9% reporting treatment-related AEs. Treatment-related serious AEs were reported in 13.7% of patients. Death was reported in 4.4% of patients, and none was deemed related to abivertinib. With the ORR of 52.2%, and OS of 24.9 months, comparable to approved 3rd generation EGFR inhibitors, abivertinib demonstrated significantly efficacious effects in overcoming resistant mutation in NSCLC. Based on these results, Sorrento is conducting an independent review process with long-term follow up data and intends to request a pre-NDA meeting with FDA. "We are very encouraged by the publication of these significant positive results of abivertinib on the treatment of advanced and heavily pretreated NSCLC lung cancer in Clinical Cancer Research and look forward to bringing abivertinib into the armamentarium of this multi-billion dollar indication," said Dr. Henry Ji, Chairman and CEO of Sorrento.

09:06 EST Senmiao Technology reports October completed orders up 1.6% - Senmiao Technology announced the operating metrics for its proprietary online ride-hailing platform for the month of October. In October, Senmiao reported over 1.0M total completed orders, a 1.6% increase from September 2021. Numbers reported in August, September, and October include the number of completed orders from Meituan's ride-hailing platform utilizing Senmiao's network of cars and drivers for a set monthly fee. Since the launch of Senmiao's online ride-hailing platform in October 2020, approximately 13.8 million rides have been completed using its platform. Over 1.4 million rides have been completed on the Major Platform under Senmiao's new partnership with Meituan, which commenced in August 2021. The number of drivers completing rides via the platform in October 2021 was over 7,000, a decrease of approximately 7% from September 2021.

09:05 EST G1 Therapeutics announces results from analysis of Phase 2 study of trilaciclib - G1 Therapeutics announced results from an immunologic analysis of Phase 2 study data showing that trilaciclib enhances both CD4 and CD8 T cell function in certain patients with metastatic triple negative breast cancer, mTNBC, when administered prior to chemotherapy. Patients receiving placebo prior to chemotherapy did not demonstrate enhanced T cell function. Results of the immunologic analysis are being presented in a poster session at the 36th Annual Meeting of The Society for Immunotherapy of Cancer, SITC, Nov. 10-14, 2021. In the exploratory analysis, researchers sought to investigate the immune mechanisms underlying the improved rate of overall survival shown in the 2020 Phase 2 trial of TNBC patients receiving trilaciclib in combination with gemcitabine/carboplatin, GCb, compared with GCb alone. The researchers evaluated tumor samples and peripheral blood samples from patients at baseline and after trilaciclib/GCb administration or after placebo/GCb administration to identify differential gene expression and changes in immune function between the two groups. Among the findings in the poster titled, "Immune Profiling to Investigate Improved Survival in Patients with Metastatic Triple-Negative Breast Cancer Receiving Trilaciclib Prior to Chemotherapy": Patients who received trilaciclib prior to GCb showed increased T cell function as measured by greater production of inflammatory cytokines; Patients who received trilaciclib had fewer immune suppressing cells known as myeloid-derived suppressor cells than patients who received GCb alone, whether they were responders or non-responders to treatment; Non-responders to trilaciclib/GCb had a reduction in circulating CD4 and CD8 T cells and a decreased production of inflammatory cytokines

09:04 EST Orbital Energy appoints Nick Grindstaff as CFO - Orbital Energy Group announced that Nick Grindstaff has been appointed CFO, effective November 16. Grindstaff will replace Daniel Ford, who will remain with the company for a period of time to ensure a smooth transition. Grindstaff has more than 20 years of experience in the infrastructure services industry. Most recently, he served as Vice President - Finance and Treasurer at Quanta Services, a leading international provider of specialty contracting services. Grindstaff holds a Master of Science degree in Accounting and a Bachelor of Science in Finance from the University of Houston - Clear Lake.

09:03 EST InnovAge appoints Patrick Blair as president - InnovAge Holding announced that its board of directors has appointed Patrick Blair as President effective Dec.1, 2021. Blair's initial responsibilities will be to run InnovAge's operations and execute on its near-term growth plans, including expansion into three new sites in fiscal year 2023. Blair brings a wealth of experience to this role, having held senior positions at leading health plans and the nation's largest non-profit home health care provider. Blair joins InnovAge from BAYADA Home Health Care where he was group president responsible for overall quality and financial performance of the Home Health, Hospice and Personal Care businesses.

09:02 EST Abbott says Aveir leadless pacemaker met primary endpoints in pivotal trial - Abbott announced new, late-breaking data from the global Leadless II IDE study evaluating Abbott's investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The data shows the Aveir device met its pre-specified primary endpoints and suggest that the Aveir system, once approved, could offer new benefits for patients who require the use of a pacemaker to treat slow heart rhythms. The findings were presented in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society and simultaneously published in the Journal of the American College of Cardiology: Clinical Electrophysiology. The data from the study has also been submitted to the U.S. FDA as the Aveir leadless pacemaker is evaluated for U.S. approval.

09:00 EST Aligos Therapeutics presents posters on NASH at Liver Meeting 2021 - Aligos Therapeutics will present several poster presentations on NASH at The Liver Meeting 2021, hosted by the American Association for the Study of Liver Diseases, AASLD. Title: Preclinical Pharmacokinetic Profiling of ALG-055009, a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of Nonalcoholic Steatohepatitis, and Prediction of its Human Pharmacokinetics. Summary: The nonclinical pharmacokinetic properties of ALG-055009 in several animal model species indicate efficacious doses in the clinic are likely to be once daily doses in the sub- to low milligram range and there is likely a with low risk of drug-drug interactions. Title: Development of a Novel Seven-Day Dosing Mouse Efficacy Model to Evaluate Thyroid Hormone Receptor Agonists for the Treatment of NASH. Summary: Authors developed a high-cholesterol diet mouse model for efficient in vivo screening of THR-beta agonists as potential therapeutic agents in nonalcoholic steatohepatitis. The model appears to be predictive of patient response at clinically relevant exposures and provides a rapid alternative to the time-consuming standard efficacy models developed through high-fat diet administration.

08:59 EST Cellectis presents preclinical data on UCARTMESO - Cellectis announced the first preclinical data on UCARTMESO, its allogeneic CAR-T cell product candidate targeting mesothelin, being developed for patients with mesothelin-expressing solid tumors. The data were presented in a poster session at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting titled "Mesothelin targeting allogeneic CAR-T cells engineered to overcome tumor immunosuppressive microenvironment". The poster presentation highlighted the following preclinical data: Mesothelin is an interesting target for CAR-T cell therapy for solid tumors because it is highly and consistently expressed in mesothelioma and pancreatic cancers. It is also over-expressed in subsets of other solid tumors while modestly expressed in healthy cells, indicating that targeting mesothelin may result in a safe and effective therapy. UCARTMESO product candidate is composed of allogeneic non-alloreactive T cells edited with TALEN-encoding mRNAs to disrupt TRAC, CD52 and TGFBR2 genes, and transduced ex vivo with a recombinant lentiviral vector to express a second-generation CAR targeting MSLN. It is the first TALEN-induced triple knock out product candidate in the allogeneic CAR-T space. The preclinical data demonstrated potent activity of UCARTMESO in vitro and in vivo against MSLN expressing cell lines, and in vivo activity in pancreatic and pleural mesothelioma mouse models. Due to TGFBR2 KO, UCARTMESO was shown to restore IL2RA upregulation upon in vitro activation, even in media rich in TGFB1, which contributes to the immune suppressive microenvironment in tumors.

08:57 EST Akero Therapeutics presents analysis from Phase 2a BALANCED study - Akero Therapeutics announced a new, blinded, post-hoc analysis of its Phase 2a BALANCED study of efruxifermin in biopsy-confirmed patients with non-alcoholic steatohepatitis, which will be presented in a poster at The Liver Meeting of the American Association for the Study of Liver Diseases, Nov. 12-15, 2021. The analysis, entitled "Characterization of Histologic Patterns of Improvement Following Treatment With Efruxifermin in NASH Patients With Fibrosis," evaluated pre- and post-treatment biopsies in 40 EFX-treated patients from the BALANCED study. These post-treatment biopsies showed improvements in histological features of steatohepatitis in 87% and fibrosis in 80% of EFX-treated patients after 16 weeks of treatment. Patterns of disease regression were evident in many patients who did not meet the categorical thresholds for either NASH resolution without worsening of fibrosis or at least a one-stage improvement in fibrosis without worsening of NASH. For example, some patients achieved resolution of hepatocyte ballooning without complete resolution of NASH, and some patients with bridging fibrosis showed evidence of features of fibrosis regression without complete reversion to a lower, non-bridging stage. These and other qualitative improvements, which are consistent with previously reported reductions in categorical scores, provide further evidence of the potential rapidity of EFX's disease modifying activity. The BALANCED study was a randomized, placebo-controlled Phase 2a trial that enrolled 80 biopsy-confirmed, pre-cirrhotic NASH patients who received either placebo or EFX for 16 weeks as a weekly subcutaneous injection in one of three doses: 28 mg, 50 mg, or 70 mg. Of the 40 EFX-treated patients who received end-of-treatment biopsies, 48% achieved a one-stage improvement in fibrosis without worsening of NASH, and 48% achieved NASH resolution without worsening of fibrosis. These two endpoints remain the FDA-recommended endpoints for Phase 3 clinical trials in pre-cirrhotic NASH patients. The analysis presented at AASLD was proposed by Cynthia A. Behling, M.D., Ph.D., a liver pathologist at Pacific Rim Pathology Medical Group in San Diego who was the central reader for the BALANCED study, based on her assessments of biopsies concurrent with categorical scoring and blinded to both treatment arm and biopsy sequence. The analysis provides a more detailed view of histological change than is reflected in the categorical, FDA-recommended scoring for NASH resolution and fibrosis stage. Moreover, two target populations at elevated risk of NASH progression-carriers of the PNPLA3 risk allele and/or those with Type 2 diabetes-showed comparable qualitative and/or quantitative histological improvements to the rest of the patients in the BALANCED study.

08:56 EST Albireo Pharma announces Phase 3 data on Bylvay in PFIC - Albireo Pharma announced new data from the Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension study of Albireo's product, Bylvay, and first data from preclinical studies of cholestatic and viral disease product candidate, A2342. The data demonstrate evidence of long-term treatment benefits of Bylvay based on improved liver health and function across progressive familial intrahepatic cholestasis types that reduce the disease burden in the treatment of pruritus in PFIC. In addition, the company will showcase the first data from A2342 showing potential of sodium-taurocholate co-transporting peptide inhibition in viral and cholestatic liver diseases. The data will be presented at the American Association for the Study of Liver Diseases The Liver Meeting 2021, which is being held virtually November 12 - 15. The Company will present data on Bylvay in one oral presentation and four posters. Bylvay is a potent, non-systemic ileal bile acid transport inhibitor that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Key findings include: Long-Term Clinical Benefit Across PFIC Types with Large and Sustained Improvements in Serum Bile Acids and Pruritus: Results of pooled analysis in patients with PFIC from two Phase 3 studies show that Bylvay was associated with sustained improvements in mean serum bile acids and pruritus scores over time. Overall, 84 patients received Bylvay during the pooled analysis period, and the overall median exposure from the first dose of Bylvay was 53 weeks. sBA responders had larger improvements in pruritus than sBA non-responders or partial responders as defined by those who did not meet sBA response criteria reflecting either perceived treatment effects or patients with a partial sBA response. Approximately 40% of patients met criteria for sBA response during Bylvay treatment. When treatment response was defined by sBA and/or pruritus criteria, approximately 60% of patients treated with Bylvay achieved a treatment response. In addition, there are a number of patients that are partial responders. Bylvay Reduced Autotaxin, Pruritus and sBAs: Autotaxin can be a marker of liver injury in cholestatic patients and elevated levels have been also associated with increased pruritus. Bylvay treatment reduced autotaxin, pruritus and sBAs with change or percent change from baseline to weeks 25 - 48 in patients with PFIC.: Results of this pooled analysis in children with PFIC from PEDFIC 1 and PEDFIC 2 studies show that Bylvay reduced autotaxis, pruritus and sBAs. Significant correlations were observed between reductions in each pair of these parameters. Improvement in Hepatic Health, Sleep and Growth: Bylvay treatment for up to 72 weeks in patients with PFIC was associated with effects on hepatic parameters, growth and sleep. Overall, 84 patients received Bylvay during the pooled analysis period, and the overall median exposure from the first dose of Bylvay was 53 weeks. From baseline to week 72, responders had mean improvement in hepatic health parameters in transaminases and total bilirubin levels, quality of sleep and growth, with greater improvement observed in responders compared with non-responders. sBA responders had large decreases in caregiver-reported percentage of days patients had scratching associated with bleeding, needed soothing and needed help falling asleep; increases or smaller changes were observed in sBA non-responders. Patients who were non-responders had more pronounced growth deficits at baseline; however, with treatment, mean height and weight Z scores increased in both responders and non-responders. Natural Variation in Clinical Signs and Symptoms: Prior to the start of PEDFIC 1, patients with PFIC1 and PFIC2 had considerable variations in sBAs and had variations in pruritus scores. These data highlight that patients with PFIC experience natural fluctuations in clinical signs and symptoms because of their underlying disease. Before study start in the overall population, the median of per-patient standard deviations across all pre-treatment measurements was 42 mumol/L for sBAs and 0.6 for pruritus scores. Clinical Benefits of Bylvay in PFIC3 and PFIC6: During up to 54 weeks of Bylvay treatment, patients with PFIC3 and PFIC6 experienced clinical benefits, including reductions in sBAs and improvement in pruritus symptoms, growth and sleep parameters. Patients with PFIC3 and PFIC6 experienced mean reductions vs. baseline in sBAs improvement in pruritus symptoms, height, weight and sleep parameters, through week 36. The observed safety and tolerability profile of Bylvay was consistent across studies, treatment groups and doses, regardless of PFIC classification or BSEP subtype. No drug-related serious adverse events were reported in either PEDFIC 1 or PEDFIC 2. Treatment-related diarrhea/frequent bowel movements reported in 9.5% of Bylvay treated patients in PEDFIC 1 and 5% of placebo-treated patients. Individual abstracts present data for specific safety and tolerability.

08:54 EST Madrigal Pharmaceuticals announces data on study of resmetirom at AASLD meeting - Madrigal Pharmaceuticals announced the presentation of "positive" clinical data from the open-label portion of its ongoing MAESTRO-NAFLD-1 study of resmetirom at the AASLD The Liver Meeting. Poster: "Biomarkers, imaging and safety in resmetirom 52-week non-cirrhotic NASH Phase 3 clinical trial, completed open-label arm of MAESTRO-NAFLD-1." MAESTRO-NAFLD-1 is a Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom being conducted in 1,200 patients with NAFLD and presumed NASH. A 171-patient 100 mg open-label arm of the study was completed in July 2021. Patients in the open-label arm demonstrated rapid and sustained reduction in hepatic fat on MRI-PDFF greater than 50% and liver volume greater than 20%, and fibrosis as assessed by biomarkers, magnetic resonance elastography, and vibration-controlled transient elastography and controlled attenuation parameter, LDLc and atherogenic lipids, liver enzymes and inflammatory biomarkers. Poster Presentation: "Liver volume reduction in resmetirom treated non-cirrhotic and cirrhotic NASH patients." In a 36-week Phase 2 serial MRI-PDFF and liver biopsy study in adults with biopsy-confirmed NASH and hepatic fat fraction greater than or equal to 10%, resmetirom-treated patients showed statistically significant liver fat reduction associated with NASH resolution as assessed by liver biopsy compared to placebo. In a secondary analysis, statistically significant reduction in liver volume of ~21% in resmetirom-treated non-cirrhotic NASH patients as compared with placebo was observed. Liver volume reduction was also observed in an open-label resmetirom-treated cohort of well-compensated NASH cirrhotic patients who also had greatly elevated liver volume at baseline. Liver volume reduction was much greater than expected in these patients based on the small reduction in MRI-PDFF. "Utilization of the MAST (MRI-PDFF-MRE-AST) score to predict NASH on liver biopsy in MAESTRO-NASH and assess response to resmetirom in MAESTRO-NAFLD-1." The purpose of this analysis was to investigate the utility of the MAST scores for non-invasive identification of patients with NASH with significant fibrosis in the MAESTRO-NASH and MAESTRO-NAFLD-1 Phase 3 studies of resmetirom. The results show that MAST is predictive of fibrosis stage in NASH and of the level of NASH activity in the NASH liver. The investigators concluded that in the absence of a liver biopsy, elevated MAST score in the setting of metabolic syndrome may predict NASH with significant liver fibrosis. "NASH with Fibrosis: Updates from the Resmetirom Clinical Program." Will include a discussion of NASH disease state, provide an update on the resmetirom development program, review the mechanism of action and summarize new data presented at The Liver Meeting 2021 from the Phase 2 and Phase 3 trials.

08:52 EST DatChat announces sponsorship of The Breakfast Club - DatChat announced their sponsorship of the Breakfast Club and exclusive "Building Black Biz" interview of DatChat Chief Operating Officer, Dan Zeno. The Breakfast Club is a national syndication by Premiere Networks and airs on nearly 100 stations nationwide, in addition to streaming on iHeartRadio.com, streaming on the iHeartRadio app and broadcasting on Revolt TV. The sponsorship campaign is set to begin on November 15th, 2021.

08:49 EST Omniq receives additional $3M purchase agreement from logistics client - OMNIQ has received an approximately $4M purchase agreement from a top, Midwest-based, 3PL, third-party logistics client. omniQ will supply Android-based rugged data collection, computing and communication equipment to the 3PL customer's distribution centers across the United States. The 3PL customer has annual revenue of over $400M and more than 3,000 employees. The multi-year deployment including the previous agreement announced on October 27, 2021 is valued at approximately $7M. Shai Lustgarten, President & CEO at Quest, commented, "The momentum continuous, concurrent with many opportunities generated by our Dangot Computers new subsidiary, this $3.0 million additional order is yet another example of repeat business, demonstrating the value of omniQ's existing customer base and the success of our business strategy. Moreover, our Company has built a solid reputation as experts in sophisticated solutions providing our customers cutting edge technology and software."

08:45 EST Assembly Biosciences presents new data on ABI-4334, ABI-H3733 at AASLD meeting - Assembly Biosciences reported preclinical data from the company's newly selected core inhibitor candidate, ABI-4334, and clinical results from the Phase 1a study of ABI-H3733 in healthy volunteers at the American Association for the Study of Liver Diseases, AASLD, The Liver Meeting. New data from the Phase 2 study of its investigational candidate vebicorvir will be highlighted in an oral presentation on Sunday, November 14. In the late-breaking poster entitled "Preclinical characterization of ABI-4334, a novel, highly potent core inhibitor for the treatment of chronic hepatitis B virus infection," preclinical data demonstrate that 4334 inhibits pgRNA encapsidation and cccDNA formation with single-digit nanomolar potency against both these mechanisms of action and is also active across all HBV genotypes. Evaluation in preclinical models predicts that a 300 mg dose of 4334 once a day will achieve trough concentration values that are approximately 200-fold greater than the EC50 needed to block pgRNA encapsidation and approximately 40-fold greater than the EC50 needed to block cccDNA formation. Phase 1 studies with 4334 are planned for 2022. The poster entitled "Safety and pharmacokinetics of ABI-H3733, a novel 2nd generation HBV core inhibitor: Results from a Phase 1a study in healthy volunteers," includes data from a dose escalation study in 40 healthy volunteers. ABI-H3733, a novel next-generation core inhibitor also designed for increased potency against the formation of cccDNA, was generally well tolerated with no serious adverse events, and all subjects completed the study. Oral liquid formulation doses were administered as single doses of 100 mg, 250 mg, or 500 mg or daily over 5 days at 250 mg. A Phase 1b study evaluating 3733 in patients with chronic HBV infection is planned to start in 2022. Vebicorvir, the company's lead core inhibitor product candidate, is the focus of an oral presentation entitled "HBV pgRNA and DNA both rebound immediately following discontinuation of the core inhibitor vebicorvir despite continued NrtI treatment in patients with HBeAg positive chronic hepatitis B virus infection: Findings from a Phase 2 open label study." The data demonstrate that treatment with VBR in combination with NrtI, of both initially treatment-naive and virologically suppressed patients, led to a deeper level of viral suppression as measured by pgRNA and HBV DNA levels.

08:42 EST Cue Biopharma presents updated data from CUE-101 program - Cue Biopharma announced the presentation of interim data further demonstrating the tolerability and antitumor activity potential of CUE-101 as a monotherapy as part of the Company's ongoing clinical trial for the treatment of recurrent/metastatic HPV+ head and neck cancer in a poster at the Society for Immunotherapy of Cancer's 36th Annual Meeting. Early data from the CUE-101 combination study with pembrolizumab will also be discussed, supporting the potential for mechanistic activity in frontline HPV+ HNSCC patients. SITC 2021 will be held in Washington, D.C. and virtually November 10-14. Additionally, the Company will present two posters highlighting the broad potential of the interleukin 2 -based CUE-100 series for treating multiple cancers. This includes representative preclinical data from CUE-102, Cue Biopharma's next clinical candidate developed to selectively target Wilms' Tumor 1 cancers, and preclinical progress on the Company's Neo-STAT and RDI-STATplatforms, which provide modularity, flexibility and scalability and address tumor heterogeneity and tumor resistance or escape mechanisms. SITC 2021 Presentation Highlights: Title: A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. Data as of November 2, 2021, include: A durable partial response with an ongoing duration of 30 weeks and five durable stable disease responses, as determined by RECIST 1.1. criteria, out of the 13 evaluable patients dosed at the recommended Phase 2 dose of 4mg/kg as part of the monotherapy trial. Pharmacodynamic signals of expansion of HPV16+ cytotoxic T cells were observed in the monotherapy trial, which confirm CUE-101 mechanism of action by activation of tumor-specific T cells. Demonstrated favorable tolerability to date, with more than 190 cumulative doses administered. Reported mild adverse events resolved while patients continued therapy. Early signs of clinical activity of CUE-101 in combination with pembrolizumab with 3 out of 3 patients from cohort 2 at 2mg/kg, demonstrating tumor reductions in target lesions on their first scan after having received two cycles of therapy. Cohort 3 is currently enrolling. Title: CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies: Multiple in vitro assessments demonstrated that CUE-102 selectively activated and expanded WT1-specific CD8+ T cells from peripheral blood mononuclear cells of healthy donors. These CUE-102-expanded CD8+ T cells exhibited polyfunctional and cytotoxic responses upon challenge with WT1-presenting target cells. Data showed that the attenuation of the interleukin 2 domains of CUE-102 led to a reduction of indiscriminate IL-2 activity, similar to results obtained with CUE-101. In vivo studies in human leukocyte antigen-A2 transgenic mice confirmed that CUE-102 elicited and expanded WT1-specific CD8+ T cells from naive mice without significantly altering the frequencies of other immune lineages. The WT1-specific CD8+ T cells expanded in vivo exhibited polyfunctionality and selectively killed WT1-presenting target cells in vivo. Title: Targeting engineered interleukin-2 to antigen specific T cells via novel biologic platforms: Data demonstrated that the Company's Neo-STAT biologics can be engineered with a diversity of T cell epitopes by efficient conjugation into an empty HLA-binding pocket, and that these molecules activated and expanded antigen specific T cells in vitro. Data additionally demonstrated that the Company's RDI-STAT biologics, were able to expand anti-viral T cell repertoires and drive anti-viral T cell redirected killing of tumor-associated antigen-expressing cells. In contrast to pan anti-CD3 bispecific molecules, RDI-STATs demonstrated significantly lower induction of pro-inflammatory cytokines, thus avoiding systemic activation of all T cells and offering a superior safety profile.

08:40 EST Canadian National joins United Nation's Race to Zero campaign - CN announces "its commitment to setting a target in line with a 1.5 degrees C scenario and to achieving net-zero carbon emissions by 2050. By doing so, CN is the first North American railroad to formally commit to having a net-zero target by joining the Business Ambition for 1.5 degrees C and the United Nations' Race To Zero campaign," the company said. "As a world-class transportation leader and trade-enabler, CN handles over C$250B worth of goods and carries more than 300 million tons of cargo annually, and is proud to be moving all these products in a sustainable way. CN's pledge to net-zero carbon emissions by 2050 further builds upon our commitment to short-, medium- and long-term targets, robust and transparent climate change disclosures, and our goal to continue to lead our sector in the transition to a low-carbon economy. CN has a strong track record of fuel and carbon efficiency and, in 2020, achieved its best locomotive fuel efficiency ever - over 4% better than the previous record set in 2019 - which avoided approximately 275,000 tonnes of emissions. We will continue to decarbonize our operations and, in turn, will enable our customers to reduce their transportation supply chain emissions and support their and our growth in sustainable products and markets," said Jean-Jacques Ruest, President and Chief Executive Officer.

08:38 EST ARIA Cybersecurity secures $1.8M contract for network monitoring - ARIA Cybersecurity Solutions announces the receipt of a multi-million, multi-site sale of ARIA SDS solution from a national intelligence agency. The ARIA SDS products will be a critical component of the government's solution to improve network visibility on networks vital to national security to detect communication performance and cybersecurity-related issues.

08:37 EST ChemoCentryx receives positive recommendation for use of TAVNEOS by EMA - ChemoCentryx (CCXI) announced that the European Medicines Agency's, EMA, Committee for Medicinal Products for Human Use, CHMP, adopted a positive opinion recommending marketing authorization for the Company's TAVNEOS, an orally administered selective complement 5a receptor inhibitor, in combination with a rituximab or cyclophosphamide regimen, indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis, GPA, or microscopic polyangiitis, MPA. "The CHMP recommendation to authorize TAVNEOS represents a positive step toward our goal of making TAVNEOS available in key markets throughout the world," said Thomas Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Following the recent regulatory approvals in the U.S. and Japan, we hope that patients in Europe suffering from this debilitating and deadly disease may soon have access to TAVNEOS." Following the CHMP's positive opinion, the European Commission will render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022. Under the terms of the Company's Kidney Health Alliance with Vifor Pharma (GNHAF), Vifor Pharma has exclusive rights to commercialize TAVNEOS in countries outside of the United States.

08:35 EST Embraer says Brazilian Government reduces certain contract values by 25% - The company said, "Embraer S.A. informs its shareholders and the market that it became aware on this date of the Brazilian Federal Government's decision to unilaterally reduce by 25% the total value of Contracts 002/DCTA-COPAC/2014 and 10/DCTA-COPAC/2014, signed in 2014 between the Federal Government, Embraer, and one of its subsidiaries. The Contracts contemplate the supply of 28 KC-390 aircraft by Embraer to the Federal Government. As soon as it is formally notified by the Federal Government, the company will seek legal measures relating to the economic and financial rebalancing of the Contracts, as well as evaluating the effects of the reduction of the Contracts on its business and results. Embraer reinforces its commitment to the KC-390/C-390 Millennium project, the new generation multi-mission aircraft, as well as its belief in the export potential of this product, which brings unique innovations in its category and which has already been acquired by two European nations. Finally, Embraer reiterates its role as a strategic partner of the Brazilian Air Force in the development and implementation of high added value technological solutions and products, a partnership established for over 50 years."

08:31 EST Patrick Industries raises quarterly dividend to 33c from 28c per share - The dividend is payable on December 13 to shareholders of record at the close of business on November 29.

08:29 EST Oncorus report initial data from ongoing Phase 1 trial of ONCR-177 at SITC 2021 - Oncorus presented initial safety, tolerability and immune activation and clinical response data from its ongoing Phase 1 open-label, multi-center, dose escalation and expansion clinical trial of ONCR-177 at the Society for Immunotherapy of Cancer's, SITC, 36th Annual Meeting, taking place November 12-14th in Washington, D.C. and virtually. In the fully enrolled and completed surface lesion dose escalation part of the Phase 1 study, ONCR-177 was well tolerated with no dose-limiting toxicities. In addition, three of eight evaluable patients at RP2D with cutaneous melanoma, squamous cell carcinoma of the head and neck, and mucosal melanoma, experienced clinical benefit after two doses of ONCR-177. ONCR-177, Oncorus' lead oncolytic HSV product candidate, is an intratumorally administered viral immunotherapy being developed for multiple solid tumor indications. Oncorus has engineered its proprietary HSV platform to develop improved iTu-administered viral immunotherapies that have the potential to enhance potency without sacrificing safety, a challenge that has been encountered by earlier-generation programs in this class. ONCR-177 incorporates two orthogonal safety strategies to allow for replication only in tumors. Theodore Ashburn, M.D., Ph.D., President and CEO of Oncorus, commented, "We are excited by these data as they provide strong proof of concept for our HSV platform. To see clinical benefit in heavily pretreated patients across multiple histologies is a testament to the promise of our platform, of ONCR-177, and of our ability to deliver a potent, multidimensional attack on cancer without sacrificing safety, thanks to our novel engineering. Furthermore, these data also support the development of ONCR-GBM, our HSV preclinical candidate being developed to specifically treat brain tumors, including glioblastoma multiforme, as well as potential future HSV programs. With several important milestones slated for 2022, we look forward to continuing to provide updates on ONCR-177 and the rest of our pipeline."

08:27 EST MiNK Therapeutics announces preliminary data from phase 1 study of agenT-797 - MiNK Therapeutics announced preliminary survival data from its phase 1 study of, agenT-797, iNKT cell therapy, in intubated COVID-19 acute respiratory distress syndrome patients, and also presented new insights on its iNKT programs in cancer at the Society for Immunotherapy of Cancer's, SITC, 36th Annual Meeting. MiNK data demonstrated: AgenT-797 in COVID-19 respiratory failure showed a 77% survival rate in older, ventilated patients compared to the national average approximating 20-30%; AgenT-797 demonstrated early signals of tumor biomarker suppression and disease stabilization beyond 6 months in relapsed/refractory multiple myeloma without lymphodepletion; MiNK has developed proprietary methods for the study of iNKTs, including a digital PCR-based methodology to track unmodified allogeneic iNKT cells in patients and a xenograft model for the study of agenT-797 to recapitulate human iNKT cell distribution and evaluate efficacy in tumor models; iNKTs infiltrate tumors where they are activated and proliferate over time. Flow cytometric analysis revealed infiltration of iNKT cells to the blood, spleen, bone marrow, and liver; iNKTs demonstrated potent preclinical tumor killing and cytotoxicity in solid and liquid cancers with a reduction in tumor size in the iNKT treated models; MiNK's novel CAR discovery platform, CARDIS, enables rapid and efficient identification of CAR candidates; MiNK's allogeneic iNKT cells can be engineered for selective targeting and Agent-F6 -BCMA-CAR-INKT is a highly potent cell therapy product showing cytotoxicity against BCMA expressing tumors cells. Novel-CAR-iNKT INDs are planned for 2022.

08:25 EST Emerita Resources reports intersections of drill holes at Iberia Belt West, Spai - Emerita Resources announces that it has tendered for three additional diamond drills to be mobilized to the Iberia Belt West project bringing the total to five drills. The contracts are being finalized and it is expected rigs will arrive on the site within the next two weeks. Results have been received for drill holes IN017, IN021 and IN023. These drill holes were step outs to the nort. Mhineralization was encountered at shallower depths than expected due to the presence of a reverse fault that has displaced the mineralization up dip and closer to surface. Holes were extended until they also intercepted the mineralization at depth on the other side of the fault. Highlights: Drilling has demonstrated the mineralization continues to depth and has been displaced nearer surface along a reverse fault to the north. Mineralization in the "North Block" has been intersected by three holes, IN017, IN21 and IN23, which represents a continuous strike length of 300 m. Those intercepts are between 70 and 100 m deep. These three holes show 2 intercepts: a first intercept corresponding to the North Block and a second deeper intercept, which corresponds to the extension of the lens in the South Block. At depth, the three holes have also intercepted the South Block. The deepest extent of the South Block mineralization is approximately 150 m in this area of the deposit in hole IN021 which intersected 5.5m from 151.70 m deep, grading 0.8% Cu, 2.8% Pb, 5.7% Zn, 0.28 g/t Au, 62.5 g/t Ag. Hole IN023 is the westernmost hole. Grades are somewhat lower close to the fault as there is less massive sulphide mineralization and more stringer and semi massive mineralization due to structural effects in the high strain zone close to the structure. The mineralization continues to the west in both the south and north blocks, where a strong geophysical conductor has been identified by the TEM survey. This area also contains historical mine workings with two underground levels indicating the presence of mineralization. The mineralization also continues to the east in the North and South Blocks for approximately 400 m where a small historical mining excavation is located. These mining excavations are thought to be at least a century old. The depth extent and lateral continuity of the North Block mineralization block is currently being evaluated by holes IN024, IN025 and IN027. Due to restrictions related to hunting season holes to the west will commence after November 15. True widths are expected to be 90-95% of intersection width. Assays were conducted at ALS Laboratories, a certified independent assay lab.

08:23 EST Corvus Pharmaceuticals presents updated data from mupadolimab Phase 1/1b trial - Corvus Pharmaceuticals announced updated results from its Phase 1/1b clinical trial of mupadolimab, a humanized monoclonal antibody directed against CD73 with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses, and inhibiting the production of immunosuppressive adenosine in the tumor microenvironment. The clinical data, along with pre-clinical data, further strengthen mupadolimab's mechanism of action and demonstrate its potential anti-tumor activity in cancer patients. The data were made available today in an on-demand, electronic poster format for registered participants of the Society for Immunotherapy of Cancer Annual Meeting, which is taking place from November 10 to 14, 2021. The poster is also being presented in-person at SITC by Jason J. Luke, M.D., principal investigator of the trial and Director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and Associate Professor of Medicine at the University of Pittsburgh School of Medicine. Mupadolimab is being studied in a Phase 1/1b clinical trial in patients with a variety of advanced, refractory cancers, including NSCLC and HNSCC that have failed previous treatment with anti-PD-1 therapy and chemotherapy. The study design included mupadolimab dose escalation from 1 mg/kg to 24 mg/kg intravenous infusion every 3 weeks until disease progression or dose limiting toxicities were reached. Cohorts of patients were treated with mupadolimab monotherapy; combination with ciforadenant, Corvus' small molecule inhibitor of the A2A receptor; combination with pembrolizumab; or triplet combination with ciforadenant and pembrolizumab. The data presented at SITC showed that mupadolimab doses of 12mg/kg are optimal, resulting in complete occupancy of the CD73 target and maximal effects on B cell activation. In the assessment of anti- tumor activity in patients receiving optimal doses of mupadolimab, tumor regression was seen in five patients who had progressive disease as best response to most recent therapy, which included anti-PD(L)1 therapy. This indicates that tumor regression could occur in patients with tumors refractory to anti-PD(L)1 that are treated with mupadolimab. Additional mupadolimab oncology program highlights from the SITC poster presentation include: Pharmacokinetic and pharmacodynamic results showed complete CD73 target occupancy with mupadolimab at doses of 12 mg/kg and higher. Doses up to 18 mg/kg were tolerated without dose limiting toxicities. Within 30 minutes of mupadolimab intravenous infusion, a reduction in B cells in blood was seen, consistent with redistribution of B cells to lymphoid tissues. Corvus presented updated preclinical data characterizing mupadolimab's dual mechanism of action: Mupadolimab is an IgG1 humanized antibody that has been engineered to be Fc gamma receptor binding deficient. Lab data demonstrated that it completely blocks adenosine production from AMP without a hook effect, which is a reduction in binding with higher concentrations of antibody that may limit efficacy to a narrow range of concentrations. In vitro studies showed that binding of mupadolimab to B cells stimulates activation and differentiation into plasmablasts in a mechanism that is independent of adenosine. In vitro studies showed that T cell functions are inhibited by adenosine monophosphate and restored by the addition of mupadolimab. Corvus analyzed CD73 expression in tumor biopsies, obtained from outside sources, using immunohistochemistry from 75 patients with NSCLC and 31 patients with HNSCC. High CD73 expression was seen in tumor cells and/or stroma in all patients. In HNSCC, CD73 expression is predominantly stromal. Corvus is also developing mupadolimab as a therapeutic for infectious disease, starting with COVID-19. Preclinical data with humanized mice inoculated with SARS-CoV-2 and influenza viral antigens showed that treatment with mupadolimab enhanced antibody responses that were viral specific, demonstrating its potential to be a universal therapy or adjuvant for viral diseases. In September, Corvus announced results from its Phase 3 clinical trial of mupadolimab for COVID-19, which have been published online at medRxiv.org. The results, which cover 40 patients that were enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. Due to the small sample size, the results did not reach statistical significance. No drug related adverse events were reported in the trial.

08:20 EST Adicet Bio presents preclincial data for ADI-002 - Adicet Bio announced the presentation of new preclinical data supporting its Glypican-3 targeted allogeneic, off-the-shelf gamma delta chimeric antigen receptor T cell development candidate for solid tumors at the 36th Society for Immunotherapy of Cancer Annual Meeting. ADI-002 is an investigational allogeneic gamma delta CAR-T cell therapy developed and engineered by Adicet to express a GPC3-targeted CAR and a cell intrinsic soluble form of IL-15 designed to promote additional expansion and activity at the site of tumor engagement. It is the first of Adicet's product candidates designed specifically to target solid tumors. Results presented at the SITC Annual Meeting detail findings from in vitro and in vivo preclinical evaluations of ADI-002. ADI-002 demonstrated expansion of gamma delta 1 T cells during manufacture with a predominant naive-like phenotype. ADI-002 cells also demonstrated high expression of innate activating receptors, including NKG2D and DNAM-1, while maintaining a lower abundance of cells expressing exhaustion markers PD-1, LAG-3, TIGIT, and TIM-3. In vitro, ADI-002 demonstrated potent and specific cytotoxicity against GPC3-positive cancer cell lines associated with high and low levels of target expression. The demonstrated in vitro killing activity of ADI-002 on cancer cells was associated with release of multiple effector cytokines. ADI-002 further demonstrated enhanced depth, duration and persistence of in vitro killing activity and was associated with increased proliferative potential. In vivo, ADI-002 was evaluated in mice engrafted with human hepatocellular carcinoma tumors that naturally express GPC3. ADI-002 exhibited potent antitumor activity following a single dose without evident toxicities or graft versus host effects. Tissue-specific homing and proliferation of ADI-002 were compared to that of GPC3-targeted alphabeta CAR-T cells. ADI-002 cells specifically homed to, and proliferated within the tumors, whereas alphabeta CAR-T cells demonstrated high levels of off-target proliferation in mouse organ systems. These results demonstrate that, unlike alphabeta CAR-T cells, ADI-002 and the Company's gamma delta T cell platform achieved reduced alloreactive potential in these models without the need for manipulation of T cell receptors or incurring additional risks associated with genome editing. Together, Adicet believes these data support initial evaluation of safety and efficacy for ADI-002 in GPC3-positive malignancies.

08:18 EST Actinium Pharmaceuticals reports HER2-ARC + anti-CD47 SITC poster highlights - Actinium Pharmaceuticals announced that data highlighting an anti-HER2 antibody radiation conjugate in combination with a CD47 blocking antibody immunotherapy in solid tumor models are being presented at the 36th Annual Meeting of the Society for Immunotherapy for Cancer November 12th - 14th. Actinium evaluated the anti-HER2 antibody trastuzumab conjugated with either Actinium-225 or Lutetium-177 radioisotope payloads to explore potential synergies in combination with CD47 blocking antibodies. CD47 is a macrophage checkpoint which is upregulated in certain cancers, that acts as a "don't eat me" signal on cancer cells to suppress phagocytosis and evade detection and destruction by the immune system. Actinium is exploring ARC combinations with CD47 blocking antibodies in solid tumors and blood cancers to evaluate mechanistic synergies including the ability to upregulate the cell surface "eat me" signal calreticulin via targeted radiotherapy. HER2-ARC + anti-CD47 SITC Poster Highlights: HER2 targeting properties remained intact after radiolabeling trastuzumab with Ac-225 or Lu-177 as determined by binding to HER2 expressing cells. Calreticulin cell surface levels were increased in multiple cell lines after exposure to HER2-ARC. Phagocytosis was increased as much as 2-fold with the combination of a HER2-ARC and an anti-CD47 antibody compared to either as a single agent . Enhanced therapeutic efficacy with both improved tumor control and survival with the HER2-ARC and anti-CD47 blocking antibody combination compared to either as a single agent shown solid tumors in vivo models.

08:13 EST Journey Medical prices $35.2M IPO - Journey Medical Corporation, a subsidiary of Fortress Biotech, announced the pricing of its initial public offering of common stock. Journey Medical's pricing of its underwritten public offering consisted of 3,520,000 shares of its common stock at a price to the public of $10 per share for gross proceeds to Journey Medical of $35.2 million. Journey Medical expects to receive approximately $31.4 million in net proceeds from the offering, after deducting underwriting commissions and estimated offering expenses. Journey Medical also has granted the underwriters a 30-day option to purchase up to 528,000 additional shares of common stock, at the public offering price, less the underwriting discount, to cover over-allotments, if any. All of the shares of common stock are being offered by Journey Medical. Journey Medical's common stock is expected to begin trading on the Nasdaq Capital Market on November 12, 2021 under the ticker symbol "DERM." The offering is expected to close on November 16, 2021, subject to customary closing conditions.

08:11 EST Monopar Therapeutics plans to raise additional funds and/or engage partner - Cash and cash equivalents as of September 30, 2021, were $22.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through December 2022. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development beyond the Phase 1b clinical trial.

08:09 EST Dice Therapeutics expects cash to fund operations through 2023 - Cash and cash equivalents and marketable securities totaled $335.7 million at September 30, 2021. The company expects its current cash position to fund operations through the end of 2023 and through key clinical milestones.

08:07 EST Actinium reports data from Actimab-A in combination with a CD47 studies - Actinium Pharmaceuticals announced that data highlighting Actimab-A in combination with a CD47 blocking antibody immunotherapy are being presented at the 36th Annual Meeting of the Society for Immunotherapy for Cancer November 12th - 14th. The poster presentation highlights that in multiple AML cell lines, Actimab-A induced an increase in cell surface calreticulin as much as 3-times higher than control. When combined with a CD47 blocking antibody, enhanced pro-phagocytic immune response was seen in vitro across 3 AML cell lines. In vivo studies in disseminated AML tumor models showed a significant increase in survival with the Actimab-A plus CD47 immunotherapy combination compared to single agent therapy. Actimab-A is an antibody radiation conjugate comprised of a CD33 targeting antibody armed with the alpha-emitting radioisotope Actinium-225, which has shown single agent anti-leukemic activity in a Phase 2 trial as well as synergy in combination with chemotherapy and targeted agents in Phase 1 trials.

08:06 EST Prometheus announces upcoming milestones - Final results from the Phase 1a trial of PRA023 expected in 4Q 2021; New indication announcement for PRA023 in 4Q 2021; Investigational Device Exemption submission of the companion diagnostic for PRA023 planned for 3Q 2022; IND submission for PR600 planned for 3Q 2022; Topline results from the ARTEMIS-UC Phase 2 study expected in 4Q 2022; Topline results from APOLLO-CD Phase 2a study expected in 4Q 2022.

08:05 EST Candel Therapeutics expects cash to fund operations into Q2 of 2023 - Cash and cash equivalents as of September 30, 2021 were $88.4M, as compared to $35.1Mas of December 31, 2020. The increase was due to successful completion of the Company's initial public offering in August 2021, which provided net proceeds of $71.3 million, after deducting underwriting discounts and commissions and offering expenses and the use of $18.3 million to fund operating activities and capital expenditures for the nine months ended September 30, 2021.

08:05 EST Walgreens Boots Alliance, VillageMD to expand primary care practices in Florida - Walgreens Boots Alliance and VillageMD announced plans to open 20 new Village Medical at Walgreens primary care practices in the Tampa area over the next year. The first Village Medical at Walgreens location in Tampa opened on October 26 at 6996 U.S. Highway 19 North in Pinellas Park, with several more openings to follow in early 2022. These openings represent expansion into the second major market in Florida, following Orlando, which will have 10 locations by the end of 2021.

08:03 EST The9 expands U.S. crypto mining operations - NBTC Limited, a wholly-owned subsidiary of The9 Limited, and Compute North announced an agreement for Compute North to provide more than 32MW of capacity for 10,000 Bitmain S19j miners that NBTC will deploy in the United States, beginning in the second quarter of 2022. NBTC has an additional 14,000 Bitmain S19j miners that are expected to be deployed with hosting partners in other countries such as Canada, starting from December this year.

08:02 EST Prelude Therapeutics expects cash to fund operations into second half of 2023 - Cash, cash equivalents, and marketable securities as of September 30, 2021 were $320.9 million.

07:59 EST Aileron Therapeutics expects cash to fund operations into 2H23 - Cash, cash equivalents and investments on September 30, 2021 were $52.2 million. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

07:58 EST Apellis reiterates plan to submit NDA for pegcetacoplan in 1H22 - Apellis Pharmaceuticals announced that it received formal, written feedback from the U.S. Food and Drug Administration that further reinforces the company's plans to submit a New Drug Application for intravitreal pegcetacoplan for geographic atrophy secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase 3 DERBY and OAKS studies and the Phase 2 FILLY study. In the written feedback, the FDA stated that they do not make a distinction between Phases, provided a clinical trial is adequate and well controlled, and that all three studies appear to be adequate and well controlled. Based on this feedback, Apellis remains on track to submit an NDA in the first half of 2022 and believes that no additional studies will be needed for the NDA submission.

07:56 EST Agenus presents clincial data for AGEN1181 - Agenus announced the presentation of new clinical data for AGEN1181 as monotherapy and in combination with balstilimab at the Society for Immunotherapy of Cancer 36th Annual Meeting. As of the data cut-off date of September 17, 2021, one hundred and sixteen patients received AGEN1181 in a dose escalation study to determine the optimal monotherapy dose and combination dose with balstilimab. Of note, this population was heavily pre-treated, with over half of these patients receiving at least 3 prior lines of therapy and nearly a third of patients receiving prior anti-PD-1 therapy. There were four cases of confirmed objective responses to AGEN1181 monotherapy. These include a complete response in MSS endometrial cancer, and partial responses in pancreatic cancer, as well as PD-1 refractory cervical cancer. These are the first reported responses to CTLA-4 monotherapy in these disease settings. The fourth response was in a patient with PD-1 refractory melanoma. Of note, three of the monotherapy responders expressed the low affinity FcgammaRIIIA receptor, which is associated with lack of response to first-generation CTLA-4 inhibitors. Significant benefit was also observed with the combination of AGEN1181 and balstilimab across multiple "cold" cancers studied, with greater than60% of evaluable patients receiving at least 1 mg/kg AGEN1181 experiencing disease control. Among 20 evaluable patients with microsatellite stable colorectal cancer, where PD-1 inhibitors have historically shown limited to no activity2-5, there were three confirmed PRs and one unconfirmed PR. In addition, ten cases of stable disease were observed, with one patient's tumor burden reduced by 27%. The disease control rate among these MSS CRC patients was 70%. Among 9 evaluable ovarian cancer patients receiving at least 1 mg/kg of AGEN1181 in combination with balstilimab, there were three confirmed PRs and two cases of SD. Compelling clinical activity was also seen in MSS-endometrial cancer as both patients treated with combination therapy demonstrated PRs; all three patients with MSS endometrial cancer treated with AGEN1181 had objective responses. Additional responders to combination therapy include 1 confirmed PR in a NSCLC patient who failed prior PD-1 therapy, 2 confirmed PRs in visceral angiosarcoma, and 1 unconfirmed PR in leiomyosarcoma. Responses in this Phase 1 trial have been durable, with half lasting at least 24 weeks and the majority ongoing. AGEN1181 was well tolerated with no hypophysitis, pneumonitis, or high-grade hepatitis. Rates of gastrointestinal and skin toxicities were comparable to those observed with first-generation CTLA-4 inhibitors. Based on these data, multi-arm, randomized phase 2/3 trials investigating AGEN1181 as monotherapy and in combination with balstilimab in MSS-CRC and gynecological cancers are being initiated. The design of these trials may support a potential filing for full and/or accelerated approval based on the magnitude of benefit demonstrated in the studies. Combination studies of AGEN1181 with AGEN2373, a conditionally active CD137 agonist, are expected to begin later this year in PD-1 refractory melanoma.

07:54 EST Aravive announces preliminary data from Phase 1b of ABV-500 with cabozantinib - Aravive announced positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept, AVB-500, in combination with cabozantinib in patients with clear cell renal cell carcinoma, ccRCC. A subset of these data was included in a poster presentation at the Society for Immunotherapy of Cancer's 36th Annual Meeting. "We are encouraged by batiraxcept's early profile in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "The current response rate of batiraxcept in combination with cabozantinib is encouraging. Cabozantinib alone produces response rates between 17-28% in a similar population. In heavily pretreated patients, batiraxcept demonstrates clinical activity across the 15 mg/kg and 20 mg/kg doses with a tolerable safety profile. These results reinforce our confidence in the potential of batiraxcept to improve outcomes across multiple types of cancer by targeting the GAS6/AXL signaling pathway. We look forward to initiating the Phase 2 trial in the fourth quarter of 2021 and building on these promising data." Safety Data: Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities. There have been no batiraxcept-related serious adverse events reported to date. There were no batiraxcept-related Grade 4 or 5 adverse events. 3 patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib. All events are known adverse events associated with cabozantinib use. PK/PD Data: PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients. Clinical Activity Data: Best overall response of partial response was observed in 7 of 16 evaluable patients across both dose levels. 9 of 16 patients had a best overall response of stable disease. No patients had progressive disease at their first radiological exam. 7 of 16 patients have had at least 16 weeks of follow up. 5 of the 7 patients have confirmed partial responses and 2 of the 7 patients achieved confirmed stable disease. 88% of patients had tumor decrease from baseline. 4 patients had 1 or more target lesions completely disappear. 2 patients had target lesions decrease from baseline by more than 76%. This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg.

07:52 EST Tempest Therapeutics presents data supporting dual mechanism of TPST-1495 - Tempest Therapeutics reported in vitro and in vivo preclinical data demonstrating the potent dual mechanistic activity of TPST-1495, an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin pathway. The data show that TPST-1495 effectively promotes anti-tumor activity through both T cell-dependent and -independent mechanisms. TPST-1495 is currently being evaluated in an ongoing Phase 1a/1b dose and schedule optimization trial in patients with solid tumors. Presentation Highlights: TPST-1495 therapy promotes anti-tumor activity through both T cell-independent and T-cell dependent mechanisms, as evidenced by TME infiltration of effector immune cell populations and tumor antigen-specific CD8+ T cells; TPST-1495 therapy confers a significant survival advantage compared to therapy with single EP2 or EP4 antagonists, or the NSAID Celecoxib, in the APCmin/+ spontaneous tumor mouse model of CRC; TPST-1495 confers near complete restoration of immune function including activation of human antigen-specific CD8+ T cells in vitro, even in the presence of elevated PGE2 concentrations at which single EP4 or EP2 inhibitors are not effective. A summary of the near-term clinical development strategy that focuses on patients with histologies known to be prostaglandin-driven, as well as patients with the PIK3CA mutation, a potential biomarker.

07:50 EST Beam Therapeutics reports preclinical data for multiplex edited CAR T cells - Beam Therapeutics announced new preclinical research demonstrating the ability of the company's multiplex edited CAR T cells to target CD5-positive tumors, leading to tumor clearance in vivo. The data are highlighted in a poster titled, "CD5 knockout enhances the potency of multiplex base-edited allogeneic anti-CD5 CAR T-cell therapy for the treatment of T-cell malignancies," at the Society for Immunotherapy of Cancer's 36th Annual Meeting, being held Nov. 10-14, 2021. CAR T therapies have the potential to address a number of T-cell malignancies, but their therapeutic potential is often hindered by technological limitations in their development and application. Beam has developed a process using base editing to simultaneously silence five target genes, including CD5 and PD1, to create allogeneic anti-CD5 CAR T-cells with enhanced effector function for potential use as off-the-shelf treatments for T-cell malignancies. Key findings reported in the poster include: Multiplexed base editing resulted in anti-CD5 CAR T cells with 94-98% editing efficiency at all 5 target loci and transduction efficiency of over 85%, which Beam believes is an efficiency at which the likelihood of graft versus host disease, CAR T rejection, and immunosuppression would be greatly reduced; CD5 knockout improved production of a combination of proinflammatory cytokines, including a greater than 300% increase in IL-2 production; CD5 knockout greatly improved in vivo efficacy of anti-CD5 CAR T cells in a xenograft mouse model of T-ALL compared to unedited cells. CD5 edited anti-CD5 CAR T cells were able to clear established tumor in a dose dependent manner; however, unedited anti-CD5 CAR T cells failed to clear initial tumor at all doses despite demonstrating in vitro efficacy. Mice previously cleared of tumor underwent additional tumor challenges to assess the persistence and functionality of anti-CD5 CAR T cells and were cleared of tumor both a second and third time, indicating extended persistence of functional anti-CD5 CAR T cells in vivo.

07:48 EST Achilles Therapeutics presents data on cNeT from VELOS Process 2 manufacturing - Achilles Therapeutics presented two posters at the Society for Immunotherapy of Cancer Annual Meeting demonstrating the ability to detect, quantify, and track patient-specific clonal neoantigen-reactive T cells and generate increased cNeT doses from VELOS Process 2 manufacturing. cNeT target clonal neoantigens, which are unique targets expressed on every cancer cell within a patient but not on healthy tissue. Samra Turajlic, MD, PhD, Chief Investigator for Achilles' Phase I/IIa THETIS trial for metastatic malignant melanoma at the Royal Marsden NHS Foundation Trust in London, UK, presented Poster 543, entitled 'Sensitive quantification and tracking of the active components of a clonal neoantigen T cell therapy: From manufacture to peripheral circulation' which shows Achilles' ability to detect, quantify and track patient-specific cNeT pre- and post-infusion in the ongoing PI/IIa CHIRON and THETIS clinical trials for non-small cell lung cancer and metastatic malignant melanoma, respectively. Joseph Robinson, PhD, Senior Scientist, Process Development at Achilles Therapeutics, presented Poster 193, 'The Achilles VELOS Process 2 boosts the dose of highly functional clonal neoantigen-reactive T cells for precision personalized cell therapies' highlighting data from a proof-of-concept study showing an 18-fold increase in median cNeT generated from VELOS Process 2 compared to Process 1. Data presented from the first eight patients dosed across the first-in-human PI/IIa CHIRON and THETIS trials confirm the ability of Achilles' VELOS manufacturing process to generate fit, polyclonal cNeT that can target multiple cancer neoantigens present on all tumor cells. Achilles' platform can detect, quantify and track the patient-specific cNeT during manufacturing and post patient administration, allowing for extensive product characterization and immune-monitoring. At the data cut-off for this presentation, five patients with melanoma and three patients with NSCLC had received their cNeT infusion. The median age of the cohort was 57 years and patients had received a median of 2.5 lines of prior therapy. 88% of the cNeT products dosed targeted multiple clonal neoantigens present on all tumor cells. In these seven products, the number of individual reactivities ranged from two to twenty-eight and cNeT were detected in the blood of 71% (5 of 7) of the patients following infusion at time points up to six weeks post dosing. Best response in the eight dosed patients was stable disease in 63% in this initial, low-dose cohort generated using VELOS Process 1. The tolerability profile was generally similar to that of standard TIL products that have not been enriched for cNeT reactivity, with none of the higher-grade adverse events more commonly associated with the use of higher doses of interleukin-2. There were no suspected unexpected serious adverse reactions reported since the previous update on the first six patients earlier in 2021. Overall, in the cohort there were three events of cytokine release syndrome and one ICANS event deemed to be possibly related to cNeT treatment. A previously disclosed case of encephalopathy was subsequently deemed unlikely related to cNeT treatment following an Independent Data Safety Monitoring Committee review. The median cNeT dose in patients in this low-dose, Process 1 cohort was 14.2 million cNeT, which is in line with previous updates. VELOS Process 1 manufacturing generated doses between 0.1 million and 287 million cNeT. cNeT reactivity, defined as the percentage of clonal neoantigen-reactive cells in the final dosed products, ranged from 5% to 77%. As the dataset expands and matures, these metrics of detection and expansion will be correlated with product, clinical and genomic characteristics to determine variables associated with peripheral cNeT dynamics and clinical response.

07:46 EST Arrowhead presents interim data from AROAAT2002 study - Arrowhead (ARWR) announced additional interim clinical data from the ongoing AROAAT2002 study, an open-label Phase 2 clinical study of ARO-AAT, also known as TAK-999, the company's second-generation investigational RNA interference, or RNAi, therapeutic being co-developed with Takeda (TAK) as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency, or AATD. The data were presented in a late-breaking poster at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease, or AASLD. ARO-AAT treatment allowed clearance of liver Z-AAT protein. Total liver Z-AAT was reduced by 72-100%. ARO-AAT treatment improved liver fibrosis. Overall, six of 14 patients had a one point or greater improvement in METAVIR fibrosis stage from baseline to week 24 or 48, six of 14 patients had no change from baseline to week 24 or 48, two of 14 patients had an increase from F2 at baseline to F3 at week 48, although both patients had profound reduction in PAS+D globule burden and reduced ALT and GGT after treatment. ARO-AAT treatment reduced histological globule burden. All patients had a one point or greater reduction in PAS+D globule burden. ARO-AAT treatment improved biomarkers of liver health. Mean reduction from baseline ranged from 42% to 56% for ALT and from 33% to 54% for GGT at week 28 and week 72. All groups showed normalized ALT and GGT following treatment. No treatment emergent adverse events leading to drug discontinuation, dose interruptions, or study withdrawal. No treatment emergent adverse events related to change in pulmonary status or pulmonary function were reported. No clinically meaningful changes in ppFEV1 from baseline were observed at Week 40 or at Week 72. Four SAEs were reported: EBV-related myocarditis, diverticulitis, dyspnea, and vestibular neuronitis, all of which involve confounding factors or alternative etiology.

07:44 EST Iovance Biotherapeutics announces clinical data for LN-145 at SITC 2021 meeting - Iovance Biotherapeutics announced additional clinical data for its tumor infiltrating lymphocyte, TIL, therapy LN-145 in patients with metastatic non-small cell lung cancer, NSCLC, who enrolled in Cohort 3B of the ongoing basket study IOV-COM-202. The results are available in a poster at the Society for Immunotherapy of Cancer, SITC, Annual Meeting, November 12-14, 2021, Washington, D.C. and virtual. The results demonstrate the feasibility of TIL cell therapy in heavily pre-treated patients with NSCLC, and warrant continued investigation of LN-145 as a single-agent and in combination in patients with mNSCLC in ongoing Iovance clinical studies IOV-LUN-202 and IOV-COM-202. Following one-time treatment with LN-145 monotherapy, the overall response rate is 21.4% in the full analysis set and 25% in the efficacy-evaluable set, including one complete response and five partial responses. Two responders, including the CR, had PD-L1 negative tumors and two responders had tumors with KRAS mutations. One complete response and one partial response are ongoing at 20.7 months and 3.0 months, respectively, at a median study follow up of 9.8 months. The treatment-emergent adverse event profile is consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. The heavily pre-treated patients in Cohort 3B had received a median of 2 prior therapies. All patients had progressed on prior immune checkpoint inhibitor therapy and all six responders received prior chemotherapy. TIL were most commonly grown and manufactured from tumor samples resected from the lung. Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "We are pleased to present our clinical data for LN-145 in metastatic non-small cell lung cancer to the physician community at SITC. There remains a very significant unmet need to increase response rates and prolong survival in the second-line non-small cell lung cancer treatment setting. The data for LN-145 in this signal-finding cohort demonstrated the potential for TIL in metastatic non-small cell lung cancer across a diverse set of patients and informed our ongoing IOV-LUN-202 clinical study in second-line lung cancer. Iovance is committed to advancing both TIL alone and TIL combinations to address multiple non-small cell lung cancer patient populations." Iovance is currently enrolling patients in the IOV-LUN-202 clinical study to investigate LN-145 in second-line mNSCLC where patients have progressed on prior ICI and chemotherapy.

07:42 EST Celldex presents preclinical data from CDX-585 - Celldex Therapeutics announced preclinical data from CDX-585, the Company's bispecific antibody with dual targeting of ILT4 and PD-1 checkpoint pathways, developed from its bispecific antibody platform. These data were presented in a poster session as part of the Society for Immunotherapy of Cancer's 36th Annual Meeting. The data show CDX-585 effectively combines the blockade of ILT4 and PD-1 into one molecule, with favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies. CDX-585 is the first compound from Celldex's research and collaboration agreement with Biosion, Inc. and combines Celldex's ILT4 mAb with Biosion's PD-1 mAb. In the preclinical data presented at SITC, the simultaneous inhibition of ILT4 and PD-1 checkpoints with CDX-585 led to myeloid and T cell activation which may potentially demonstrate clinical utility, particularly in the T cell checkpoint inhibitor refractory setting. CDX-585 promoted T cell activation as measured by mixed lymphocyte reactions superior to that achieved by the combination of ILT4 and PD-1 monoclonal antibodies. CDX-585 also demonstrated anti-tumor activity in a humanized mouse model of melanoma and had a favorable pharmacokinetic profile in pilot studies, without adverse effects of treatment noted in clinical observations or clinical chemistry.

07:41 EST iKena Oncology presents data from IK-175 AHR antagonist program - Ikena Oncology announced data from multiple presentations at the Society for Immunotherapy of Cancer 36th Annual Meeting from their IK-175 AHR antagonist program. The ongoing IK-175 clinical trial is currently recruiting patients in both monotherapy and combination cohorts with nivolumab. The three poster presentations explore the process of advancing IK-175, an oral selective Aryl Hydrocarbon Receptor antagonist, in multiple tumor types, including urothelial carcinoma, a type of bladder cancer with a high prevalence of active AHR signaling. AHR is a transcription factor that facilitates tumor progression by allowing cancer cells to evade the immune system. Cancer cells release multiple different AHR ligands, including kynurenine, activating the pathway and fostering an immunosuppressive effect within the tumor microenvironment. Inhibiting the AHR pathway could promote immune recognition of cancer cells, making it a compelling drug target. Presentation details: Title: Computational biology and tissue-based approaches to inform indication selection for a novel AHR inhibitor: Presentation describes methods used to identify indications dependent on AHR signaling and how patient selection strategies were designed, including: A proprietary RNA-based gene signature of AHR activation, RNA analysis and protein activation. Genomic profiling of solid and hematological cancers to identify those harboring AHR gene amplifications. Analysis of tissue microarrays of 15 different tumor types to identify those with highest prevalence of nuclear AHR protein expression, reflective of AHR activation. These analyses revealed that there is a high prevalence of nuclear AHR expression, AHR gene amplification and AHR-target gene expression in urothelial carcinoma, suggesting aberrant AHR activation may play an important role in the progression of this tumor type. Title: Analytical validation of a novel immunohistochemistry assay to determine nuclear AHR expression in human bladder cancer: Poster reviews the process of developing a novel immunohistochemistry assay to measure AHR signaling through nuclear protein expression in tumors: 199 human bladder cancer formalin-fixed, paraffin embedded samples were used to establish and confirm a cutoff of greater than or equal to 65% cells that are nuclear 2+ and 3+ positive in the tumor region. The nuclear AHR IHC assay for urothelial carcinoma was developed and analytically validated in a CLIA certified lab and showed greater than or equal to 95% accuracy, specificity, sensitivity, and precision. The novel assay has been implemented in the ongoing IK-175 Phase 1b clinical study for prospective patient enrichment. Title: TRIAL IN PROGRESS: A Phase 1a/b Study of IK-175, an Oral AHR Inhibitor, Alone and in Combination with Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma. Poster describes the Phase 1 trial of IK-175, a first-in-human, open-label, multicenter dose escalation and expansion study to evaluate the safety and tolerability of IK-175 administered as a single agent and in combination with nivolumab, a PD-1 checkpoint inhibitor in solid tumors and in urothelial carcinoma. Primary endpoints include identification of maximum tolerated dose and characterizing any dose-limiting toxicities. In addition to safety and tolerability of IK-175 as a monotherapy and in combination with nivolumab, the secondary objectives of the study include evaluating disease responses. Pharmacokinetics, pharmacodynamics and preliminary antitumor activity are being evaluated at multiple timepoints within the treatment cycle. The study is being conducted in adult patients with locally advanced or metastatic solid tumors and urothelial carcinoma, an indication identified to have high frequency of AHR signaling. AHR nuclear localization is being measured as a predictive biomarker in patients with urothelial carcinoma. Study enriched to include a minimum of 10 patients having a positive AHR nuclear localization test enrolled in the combination arm of the trial. The trial is currently recruiting for both treatment arms.

07:38 EST Verrica Pharmaceuticals sees cash funding operations into Q3 of 2022 - As of September 30, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $79.5M.

07:36 EST Neximmune announces upcoming clinical updates - NEXI-001: Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022. NEXI-002: Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology Annual Meeting in December 2021. NEXI-003: Investigational New Drug submission planned for mid-year 2022.

07:36 EST Arena Minerals commences resource drilling at Sal de la Puna Project - Arena Minerals is pleased to announce the commencement of drilling on the Sal de la Puna Project located in the Pastos Grandes basin within Salta province, Argentina. Arena is operating the drill program on behalf of Sal de la Puna Holdings Ltd., which is jointly owned by Arena and Ganfeng New Energy Technology Development. The drill program is focused on the Almafuerte and Graciela blocks which border Millennial Lithium's Pastos Grandes project to the south and south-east and consists of 3,000 metres with the objective of both increasing the category of the current resource and increasing the SDLP Project's resource base. For more information on the drill program please refer to press release dated October 28, 2021.

07:34 EST Vertex Pharmaceuticals receives CHMP recommendation for Kaftrio combination - Vertex Pharmaceuticals announced that the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion for the label extension of Kaftrio in a combination regimen with ivacaftor, for the treatment of cystic fibrosis, or CF, in patients ages six through elven years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene.

07:31 EST Amgen says LUMYKRAS receives positive opinion from EMA CHMP - Amgen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS, known as LUMAKRAS in the U.S., for the treatment of adults with advanced non-small-cell lung cancer with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.

07:30 EST Terns Pharmaceuticals highlights clinical data from multiple NASH programs - Terns Pharmaceuticals announced that multiple presentations of results from clinical trials of TERN-101 and TERN-501 will be delivered at The Liver Meeting Digital Experience 2021, the annual meeting of the American Association for the Study of Liver Diseases, which will be held virtually from November 12-15, 2021. An oral presentation titled "Liver-distributed FXR Agonist TERN-101 Demonstrates Favorable Safety and Efficacy Profile in NASH Phase 2a LIFT Study" will be delivered by Rohit Loomba, M.D., MHSc, director of the UC San Diego NAFLD Research Center and director of Hepatology at UC San Diego School of Medicine. This presentation will highlight the safety and efficacy of TERN-101 after 12 weeks of treatment in patients with NASH. TERN-101 was overall safe and well-tolerated at all doses studied with no discontinuations due to adverse events, including pruritus. In the TERN-101 5 and 10 mg groups, no differences from placebo in percentage change in low density lipoproteincholesterol or high density lipoprotein cholesterol from baseline to Week 12 were observed. TERN-101 demonstrated numerical reductions in alanine transaminase and MRI proton density fat fractio in the 10 and 15 mg groups, and significant reductions in gamma-glutamyl transferase in all dose groups. Corrected T1, a marker of liver inflammation and fibrosis, declined significantly as early as Week 6 with persistent decreases through Week 12 in all TERN-101 groups compared to placebo. These data support further clinical studies of TERN-101 for the treatment of NASH, either alone or in combination with other agents. A second clinical presentation titled "Liver-distributed FXR Agonist TERN-101 Leads to Corrected T1 Response and a Population Shift to Lower cT1 Risk Categories in NASH Phase 2a LIFT Study" will be delivered by Eric Lawitz, M.D., director of the Texas Liver Institute and Clinical Professor of Medicine at University of Texas Health Science Center. This presentation will detail the cT1 responses observed during the Phase 2a LIFT Study. cT1 relaxation time, measured in milliseconds, is a magnetic resonance imaging-based test that is a composite biomarker of inflammation and fibrosis. Mean cT1 values declined in a significant and dose-dependent manner from baseline to Week 12 for all TERN-101 doses. cT1 changes at Week 6 strongly correlated with changes at Week 12. A higher proportion of patients treated with TERN-101 for 12 weeks had a cT1 response compared to placebo. TERN-101 treatment for 12 weeks also led to an increased proportion of cT1 low risk patients, and a decreased proportion of high-risk patients. cT1 may serve as a biomarker of TERN-101 treatment response as early as Week 6. Overall, cT1 declines in the LIFT Study indicate significant improvements in fibro-inflammation following TERN-101 treatment in NASH patients. In addition, a third clinical presentation titled "Single Doses of the THR-beta Agonist TERN-501 are Well Tolerated and Result in Dose-dependent Changes in LDL Cholesterol and Sex Hormone Binding Globulin in a First-in-Human Clinical Trial" will be delivered by Barry Crittenden, M.D., Executive Director, Clinical Research and Medical Affairs at Terns. This presentation will highlight data from the single ascending dose cohort of TERN-501 up to 60 mg. All SAD doses of TERN-501 were overall safe, well-tolerated and exhibited dose-proportional plasma exposures with low variability. Significant decreases in LDL cholesterol, total cholesterol, and apolipoprotein B were observed by Day 3 following single dose administration of TERN-501 in one or more dose groups with dose-dependent reductions on Day 4. TERN-501 also demonstrated significant effects on sex hormone binding globulin. SHBG is a protein produced in the liver following activation of the thyroid hormone receptor in hepatocytes and is a marker of THR-beta target engagement linked to NASH histologic efficacy. Significant increases in SHBG were observed following a single dose of greater than or equal to10 mg TERN-501 with dose dependent increases through 30 mg, indicating potent target engagement at all evaluated dose levels. Importantly, increases in SHBG have been associated with robust reductions in MRI-PDFF and NAFLD Activity Score in a precedent late-stage clinical NASH trial.

07:29 EST Nurix Therapeutics presents data from preclinical studies on NX-0255 - Nurix Therapeutics announced the presentation of preclinical studies demonstrating that its CBL-B inhibitor, NX-0255, enhances the number and quality of T cells expanded from tumors for use in tumor infiltrating lymphocyte therapy. These results will be presented by Nurix in a poster session at the Society for Immunotherapy of Cancer conference held at the Washington Convention Center on Saturday, November 13. Nurix also congratulates Michael T. Lotze, M.D., Nurix's chief cellular therapy officer, who will be honored at the conference with the 2021 SITC Lifetime Achievement Award. As a key step toward advancing DeTIL-0255 into the clinic, Nurix performed a series of experiments on human tumors to characterize the effects of CBL-B inhibition using NX-0255 on the production and quality of TIL. Tumor samples were obtained from 16 patients with ovary, colon, lung, head and neck, breast, or vulva carcinomas. Tumors from patients were cultured either in the presence of recombinant human IL-2 alone to generate TIL or in combination with NX-0255 + rhIL-2 to generate DeTIL-0255, Nurix's cell therapy clinical candidate. Compared to TIL, DeTIL-0255 demonstrated: Increased T cell expansion; Reduced expression of markers associated with T cell exhaustion such as PD-1, LAG-3 and TIM-3; Increased cytotoxicity as measured by increased perforin, granzyme B, and the degranulation marker CD107a; Increased 4-1BB, a surrogate marker of tumor reactivity; and Increased T cell receptor diversity. Taken together, these findings support advancing DeTIL-0255 into human clinical trials as a potentially superior, drug-enhanced TIL product candidate. Nurix's cell therapy programs are headed by Dr. Lotze, whose dedication and contributions to the field of immunotherapy for cancer are to be recognized at the SITC annual meeting with the 2021 SITC Lifetime Achievement Award.

07:27 EST Scholar Rock presents initial clinical data from Part A of DRAGON trial - Scholar Rock presented initial clinical data from Part A of its DRAGON Phase 1 proof-of-concept trial at the ongoing 36th Society for Immunotherapy of Cancer, or SITC, annual meeting, which supported dose selection and advancement into Part B. The DRAGON trial is investigating SRK-181, a selective inhibitor of TGFbeta1 activation, in patients with locally advanced or metastatic solid tumors that have shown primary resistance to checkpoint inhibitor therapies. The main objectives of DRAGON Part A are to evaluate the safety and tolerability of SRK-181 alone or in combination with anti-PD-(L)1 checkpoint inhibitor therapy and to determine the recommended dose for the Part B dose expansion phase. Part A1 enrolled patients who have experienced treatment failure from available standard of care therapy, and Part A2 enrolled patients who did not respond to prior anti-PD-(L)1 therapy. Based on the safety and pharmacokinetic data from Part A, Scholar Rock has initiated Part B, which is evaluating SRK-181 dosed 1500 mg every three weeks in patients receiving an approved anti-PD-(L)1 therapy dosed Q3W and 1000 mg every two weeks in patients receiving an approved anti-PD-(L)1 therapy dosed Q2W. As of September 7, 29 patients have been dosed in Part A of the trial. The median number of prior lines of therapy was 4 for Part A1 and 4 for Part A2. As of October 12, no dose-limiting toxicities were observed with SRK-181 in Part A. Doses up to 3000 mg Q3W and 2000 mg Q2W as a monotherapy in Part A1 and 1600 mg Q3W in combination with anti-PD-(L)1 therapy in Part A2 have been evaluated. The most common treatment-emergent adverse events of any grade related to treatment were fatigue, decreased appetite, and nausea and rash maculo-papular. Preliminary data showed a pharmacokinetic profile of SRK-181 consistent with that which is generally observed for monoclonal antibodies. Preliminary anti-tumor effects were assessed using RECIST1.1 and reported based upon local investigator reads: Among 19 patients in Part A1, eight patients had a best response of stable disease. There were three patients with ovarian cancer in Part A1; each of these patients had stable disease, with tumor regression observed in two patients. Among 10 patients in Part A2, one patient with renal cell carcinoma who had a lack of response to prior anti-PD-1 therapy had a partial response after treatment with SRK-181 dosed 800 mg Q3W in combination with the same anti-PD-1 therapy. In addition, four patients had a best response of SD.

07:26 EST Nurix Therapeutics announces IND clearance for DeTIL-0255 - Nurix Therapeutics announced that the Food and Drug Administration has cleared Nurix's Investigational New Drug Application for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte therapy. DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patient's tumor expanded ex vivo with NX-0255, a small molecule Casitas B lineage lymphoma-b inhibitor developed by Nurix. DeTIL-0255 is a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Based on extensive preclinical characterization, Nurix believes DeTIL-0255 could allow a broader application of TIL therapy in a range of solid tumors. DeTIL-0255 will be the subject of a poster presentation by Nurix at the Society for Immunotherapy of Cancer conference held at the Washington Convention Center on Saturday, November 13. DeTIL-0255 complements Nurix's oral CBL-B inhibitor drug candidate, NX-1607, which is currently in a Phase 1a clinical trial. The Phase 1 trial of DeTIL-0255 is an open-label, non-randomized clinical trial anticipated to enroll up to 50 patients with gynecological malignancies following a safety run-in. The three expansion cohorts will enroll either patients with recurrent or persistent platinum-resistant epithelial ovarian cancer, patients with recurrent, metastatic, or persistent cervical cancer, or patients with advanced or recurrent endometrial cancer. Nurix is currently working to initiate this trial at multiple sites in the United States that have experience in conducting TIL and other adoptive cell therapy trials.

07:23 EST Angion Biomedica expects cash to fund planned operations through 2022 - As of September 30, 2021, Angion had cash and cash equivalents totaling $102.7 million. Angion expects current cash resources, combined with the potential milestones payable under its license agreement with Vifor for the development and commercialization of ANG-3777 in renal indications, to be sufficient to fund planned operations through the end of 2022.

07:19 EST Vaccitech announces upcoming milestones - At the virtual AASLD's The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12. At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200. In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment. In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection. In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer. In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.

07:17 EST Compugen reports data from Phase 1 dose escalation monotherapy study of COM902 - Compugen announced the presentation of preliminary results from its ongoing Phase 1 dose escalation study evaluating COM902, Compugen's anti-TIGIT antibody, in patients with advanced solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held on November 10-14. "The primary objective of this Phase 1 dose escalation study of COM902 monotherapy was to evaluate safety and tolerability and we were pleased to see that COM902 was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached." said principal investigator and presenting author, Ecaterina Elena Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center. "It is encouraging to achieve a disease control rate of 50% in these heavily pretreated patients who typically do not respond to PD- (L)1 inhibitors. I look forward to enrolling patients in the combination study with COM701 to continue exploring new therapeutic options for patients in need." Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "COM902 high- affinity anti-TIGIT antibody was well tolerated, showed early signs of anti-tumor activity in heavily pretreated patients with advanced solid tumors and as we expected avoided depletion of major TIGIT positive expressing lymphocytes, supporting our rationale for choosing a reduced Fc effector function anti-TIGIT antibody. These data are encouraging, in line with our science suggesting that TIGIT is a combination agent and serves as the basis for exploring our differentiated TIGIT combination strategy. In addition to our triplet study blocking PVRIG, TIGIT and PD-1 pathways, we are already enrolling patients in our Phase 1 study of COM902 in combination with COM701 for the first clinical evaluation of dual blockade of TIGIT and PVRIG in a PD-(L)1-free regimen."

07:16 EST Sio Gene Therapies continues to expect cash to sustain operations into 4Q22 - Pavan Cheruvu, M.D., Chief Executive Officer of Sio Gene Therapies. said, "I'm also excited by the progress this year on the development of a reliable, suspension-based manufacturing process that has generated clinical trial material for the future development of AXO-Lenti-PD. This represents an inflection point for the program that clarifies our path forward in Parkinson's disease. We are pleased to end our second fiscal quarter of 2021 with cash runway into calendar Q4 2022 and a capable team that looks forward to continued execution."

07:16 EST Compugen reports preliminary data comparing PVRIG to TIGIT and PD-1 - Compugen announced the presentation of new translational preliminary data detailing the differentiated profile of PVRIG compared to TIGIT and PD-1 as a novel checkpoint in the DNAM axis, supporting its potential role as a dominant checkpoint involved in stem-like memory T cells and dendritic cell interaction at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held on November 10-14. "We believe evidence is growing to consistently demonstrate that PVRIG is a novel and differentiated checkpoint with a potential unique role in cancer immunotherapy" said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "For cancer immunotherapy to work, T cells are needed at the tumor site and recent studies suggest that early-memory (stem-like) T cells and DCs play an important role in this process. Here we show for the first-time preliminary data demonstrating greater induction of activated DC markers in the serum of two patients responding to our potentially first in class anti-PVRIG antibody, COM701, in combination with nivolumab compared to non-responders, potentially because of DC- T cell interaction. This preliminary data is in line with our recent scientific finding showing that PVRL2, the ligand of PVRIG, is abundantly expressed across DCs types, while PVRIG, measured by both gene and protein expression, is uniquely and dominantly expressed on early memory cells in contrast to TIGIT and PD-1." Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "These new preliminary data further support our earlier findings that PVRIG plays a distinct role within the DNAM axis which we believe is important for triggering robust immune responses in the tumor microenvironment. PVRIG blockade may lead to key mechanistic differences as compared to other DNAM axis members, namely TIGIT and PD-1, with the potential to enhance T cell proliferation and tumor infiltration to address both inflamed and less inflamed tumor types where current checkpoint inhibitors have not shown success. With our potentially first-in-class anti- PVRIG antibody, COM701, we are uniquely positioned to target the DNAM axis in combination with TIGIT and PD-1/L1 inhibitors and look forward to continued translation of these scientific learnings across our ongoing clinical programs."

07:11 EST HCW Biologics expects cash to fund operations into 2023 - Cash and cash equivalents: On September 30, 2021, the Company's cash balance was $15.1 million, short-term investments were $25.0 million and long-term investments were $10.0 million. The net proceeds from the IPO were $49.0 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from existing or new out-licensing agreements.

07:08 EST Catalyst Biosciences announces expected milestones - Submit an IND for CB 4332. Announce a development candidate from Catalyst's ProTUNE(TM) platform that leverages the Company's knowledge of CFI. Complete transfer of CBIO supported activities to Biogen for CB 2782-PEG, the C3 degrader for the potential treatment of dry AMD.

07:06 EST GSK, Vir say primary endpoint met in COMET-TAIL Phase 3 trial in early COVID-19 - GlaxoSmithKline (GSK) and Vir Biotechnology (VIR) announced headline data from the randomized, multi-center, open-label COMET-TAIL Phase 3 trial, which achieved its primary endpoint, demonstrating intramuscular administration of sotrovimab was non-inferior to intravenous administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents 12 years of age and older. The COMET-TAIL Phase 3 trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration arm of the trial, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm. The adjusted difference between the IM and IV arms of the trial was 1.07% with a 95% confidence interval of -1.25% to 3.39%. The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial's primary endpoint in consultation with the US Food and Drug Administration. The companies plan to progress regulatory submissions globally, including ongoing discussions with the FDA regarding the existing Emergency Use Authorization for sotrovimab.

07:04 EST Compugen presents preliminary results from COM902 trial - Compugen announced the presentation of preliminary results from its ongoing Phase 1 dose escalation study evaluating COM902, Compugen's anti-TIGIT antibody, in patients with advanced solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held on November 10-14. The study enrolled 18 patients with advanced solid tumors who exhausted all available standard therapies. The study population was heavily pretreated with the median number of prior therapies was seven, with a minimum of two and maximum of 16. COM902 administered IV Q3W was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached. One patient in the 0.01 mg/kg dose cohort reported a dose limiting toxicity of Grade 2 vomiting, and one patient in the 1 mg/kg dose cohort had a DLT of Grade 3 atrial fibrillation; these were assessed by the investigator as possibly related to study treatment with COM902. No DLTs were reported at any other COM902 doses including higher doses. COM902 3 mg/kg IV Q3W has been selected as the recommended dose for expansion. Best response of stable disease, or SD, was reported in nine patients, with six patients having confirmed SD and three patients with SD of at least six months. No depletion of major lymphocyte populations expressing TIGIT in the peripheral blood analysis COM902 monotherapy expansion cohort is enrolling up to 10 patients. A PD-1-free regimen of COM902 cohort expansion in combination with COM701 has been initiated.

07:03 EST Akero Therapeutics continues to see cash funding operations into Q3 of 2023 - Akero's cash, cash equivalents and short-term marketable securities for the period ended September 30, 2021 were $215.1 million.

06:58 EST Aecom awarded contract for new runway at Denver International Airport - AECOM announced it has been awarded a contract to provide program management services for the development of the seventh runway at Denver International Airport, or DEN. In this role, AECOM will coordinate environmental assessment activities and manage the preliminary design effort. In addition to environmental coordination and leading the design management, AECOM will facilitate sustainability initiatives, including early integration with Envision and Leadership in Energy and Environmental Design framework; provide program controls to balance scope, schedule, risk, and budget; support construction procurement through coordination, alternative delivery analysis, and document preparation; conduct public outreach activities to connect with and inform local businesses and community stakeholders; and oversee and report on program-level disadvantaged business enterprise participation and engagement.

06:53 EST Novo Nordisk says Ozempic 2.0 mg recommended for approval by EMA's CHMP - Novo Nordisk announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending a label extension for the existing marketing authorization for Ozempic, a once-weekly glucagon-like peptide-1 analogue, to introduce a new dose of 2.0 mg. Ozempic is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults. Novo Nordisk expects a final approval by the European Commission within approximately two months, and Ozempic 2.0 mg will be launched in the EU in the first half of 2022. The label expansion for semaglutide 2.0 mg is under regulatory review in the U.S. "The recommendation for the EU label extension of Ozempic with the 2.0 mg dose is an important step towards offering additional options to people with type 2 diabetes who need treatment intensification to achieve their individualized glycemic targets," said Martin Lange, executive vice president, Development at Novo Nordisk.

06:47 EST Brown & Brown acquires Heacock Insurance Group, terms not disclosed - J. Scott Penny, chief acquisitions officer of Brown & Brown, and Stacey Heacock Weeks, Jason Heacock and Ford Heacock, III the principals of Heacock Insurance Group, announced that Brown & Brown has acquired the assets of Heacock Insurance. Heacock Insurance is a fifth-generation, family-owned agency providing risk management solutions for its central Florida customers since 1922.

06:41 EST Spectrum Brands sees $230M-$250M of additional inflation during FY22 - From a capital structure perspective, the company is targeting a long-term net leverage ratio of 2.0-2.5 times after full deployment of HHI proceeds.

06:12 EST Toshiba announces plan to split into three standalone companies - Toshiba Corporation announced a plan to separate into three standalone companies to create enhanced value for shareholders. This Plan is the culmination of nearly five months of work by the Strategic Review Committee of Toshiba's board of directors to: Undertake a rigorously objective review process; Consider a full range of options to unlock shareholder value; Take into consideration the direct input of shareholders and potential investors, both strategic and financial; and Develop the best approach for the Company to optimize value for shareholders and other important stakeholders. Under the Plan, Toshiba said it would be rejuvenated following its transformation into three separate entities that are each better organized and focused to unlock shareholder value in a much more credible and effective way than the Company can achieve in its current form. The company said: "To be clear, the Separation Plan is only the beginning of a process that contemplates a significant transformation of each independent company, positioning them better for sustained profitable growth while securing near-term returns for shareholders. In addition, the SRC has recommended to the Board that it undertake immediately seven clearly defined commitments to enhance corporate value - including share buybacks and asset dispositions - during the preparation phase of the Separation Plan." Reference Link

06:06 EST Athersys' Healios reports update from studies involving MultiStem HLCM051 - Athersys reports that HEALIOS, its development and commercial partner in Japan, provided an update earlier this morning regarding its clinical programs for acute respiratory distress syndrome, or ARDS, and ischemic stroke involving MultiStem, HLCM051, invimestrocel, in its FY2021 Q3 financial results presentation. Healios noted that following its Q3 announcement of topline data from its ONE-BRIDGE clinical trial evaluating the safety and efficacy of MultiStem cell therapy in patients with ARDS, it has continued to consult with the Pharmaceuticals and Medical Devices Agency, or PMDA, regarding preparations for filing for regulatory approval for MultiStem for the treatment of ARDS. Currently, Healios is targeting the filing of the application for this orphan regenerative medicine product for Q4 2021/Q1 2022. Healios also provided an update regarding the timing of disclosure of topline data from its double-blind, placebo-controlled TREASURE study to evaluate MultiStem treatment in ischemic stroke patients. As a result of advice from the PMDA, Healios now plans to disclose topline results from the study after data has been collected from the one-year follow-up visit of the last patient enrolled. Healios expects this last follow-up visit to take place in March 2022. Unblinding for data analyses will occur after the collection of information from the last patient follow-up visit.

05:54 EST Lordstown delays Endurance deliveries to Q3 of 2022 - The company said in last night's earnings release, "Since the beginning of the fourth quarter, we have begun building the first of what we expect to be approximately 100 pre-production vehicles that we will use to pursue a variety of validation activities aimed at achieving full homologation. This is a modest delay from earlier expectations as component and material shortages, along with other supply chain challenges, remain an issue for Lordstown Motors just as they are for the industry at large. We now expect that commercial production and deliveries of the Endurance will begin in the third quarter of 2022." Shares of Lordstown are down 11% to $6.16 in premarket trading.

05:18 EST Hepsiburada announces joint performance advertising platform with Facebook - Hepsiburada (HEPS) announced a joint performance advertising platform in partnership with Facebook (FB). Managed Partner Ads, or MPA, is a next-generation social media advertising platform designed to be used exclusively by Hepsiburada's small and mid-size enterprises, or SMEs. The platform allows SMEs to place targeted ads on Facebook and Instagram. Once live, the ads will be seen by millions of potential customers on Facebook and Instagram, helping to boost sales. The platform also enables businesses selling on Hepsiburada to manage their advertising campaigns. The platform's goal is to enable SMEs who sell their products on Hepsiburada to increase their web traffic by a factor of 10 and potentially triple their sales through advertising on Facebook and Instagram. The sign-up process for SMEs before they can gain access to the Hepsiburada-specific Facebook ad panel is user-friendly and includes five steps; asset identification, budget setting, ad creation, product review and preview.