Stockwinners Market Radar for July 26, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:54 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Moderna (MRNA) announced a modification to its contract with the Biomedical Advanced Research and Development Authority, or BARDA, for an additional commitment of up to $472M to support late stage clinical development including the expanded Phase 3 study of the company's mRNA vaccine candidate against COVID-19. An earlier award from BARDA for up to $483M was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration and consultations with Operation Warp Speed over the past several months, the company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the company's late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955M. The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and is expected to begin tomorrow, July 27. 2. HSBC (HSBC) has issued a statement defending its cooperation with U.S. prosecutors in a case against China's Huawei Technologies after Chinese state media said the bank had set Huawei up, The Wall Street Journal's Margot Patrick reports. HSBC said the U.S. Justice Department made formal requests for information about Huawei, a former HSBC client, and that it didn't "set a trap" for Huawei to break U.S. sanctions, as Chinese newspaper People's Daily wrote in an article Friday. The statement comes amid intensifying U.S.-China tensions over trade, Hong Kong and Huawei that have put HSBC in the crosshairs as an Asia-focused trade bank with a large U.S. operation, the author notes. 3. With earnings arriving next week, it's time for McDonald's (MCD) stock to regain its shine, Ben Levisohn wrote in this week's edition of Barron's. McDonald's was hit hard during the first stages of the pandemic, with a quarter of its stores forced to close, sales tumbling, and the company having to aid franchisees who saw business collapse because of COVID-19. Even worse, competitors like Chipotle Mexican Grill (CMG) and Domino's Pizza (DPZ)-with app-driven delivery businesses-have seen their stocks surge, and now it's McDonald's turn, the author noted. Signs point to big improvements for fast-food generally and McDonald's in particular, and with Americans back in their cars-but still preferring not to dine in restaurants-the drive-through is the place to go, he added. 4. SAP (SAP) announced its intent to take Qualtrics public through an initial public offering in the U.S. "Qualtrics is the creator of the Experience Management category, a large, fast growing and rapidly evolving market. SAP intends to remain the majority owner of Qualtrics. SAP's primary objective for the IPO is to fortify Qualtrics' ability to capture its full market potential within Experience Management. This will help to increase Qualtrics' autonomy and enable it to expand its footprint both within SAP's customer base and beyond," the company said. SAP currently owns 100% of Qualtrics shares. SAP will retain majority ownership of Qualtrics and has no intention of spinning off or otherwise divesting its majority ownership interest. Since SAP, as majority shareholder, will continue to fully consolidate Qualtrics, the transaction is not expected to have an impact on SAP's 2020 or longer-term financial targets. 5. Plug Power (PLUG), Ballard Power Systems (BLDP), and Bloom Energy (BE) were mentioned cautiously in this week's edition of Barron's.

17:28 EDT TCR2 Therapeutics announces interim data for Phase 1 of TC-210 trial - TCR2 Therapeutics announced interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors. All five patients showed tumor regression including two RECIST unconfirmed partial responses - one of which remains subject to independent central review - and two patients with stable disease through six months. Translational data further demonstrated TRuC-T cell expansion and activation. A manageable toxicity profile was observed with only one patient exhibiting TC-210-related non-hematologic grade greater than 2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity. The primary objectives of the Phase 1 portion of the study are to define the safety profile of TC-210 in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose. Secondary objectives include overall response rate and disease control rate. Exploratory objectives include the assessment of expansion, tumor infiltration, and persistence of TC-210 T cells. TC-210 was generally well tolerated, with no patients experiencing neurotoxicity or on-target, off-tumor toxicities. Three patients experienced Cytokine Release Syndrome, which was Grade 1 in two patients and Grade 3 in one patient. The patient experiencing Grade 3 CRS also developed Grade 3 pneumonitis during the first week post infusion that responded to tocilizumab and steroid therapy. This patient died 34 days post treatment due to fungal sepsis, which was deemed unrelated to TC-210. Because of the earlier pneumonitis event, however, the Safety Review Team recommended the expansion of the cohort from three to six patients. None of the subsequent three patients treated at DL1 developed pneumonitis or CRS above Grade 1. All five patients treated with TC-210 T cells have had at least one disease response assessment. The DCR was 100%, with all patients experiencing tumor regression. The median change in the sum of diameters of target lesions was -42%. The ORR was 40% according to RECIST v1.1. TC-210 therapy induced a significant reduction in FDG uptake by PET imaging in two evaluable patients, including one patient who achieved a complete metabolic response. The Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-210, TCR2's T-cell receptor fusion construct directed against mesothelin. The trial is enrolling patients with mesothelin expressing NSCLC, ovarian cancer, cholangiocarcinoma, and malignant pleural/peritoneal mesothelioma. The Phase 1 dose escalation portion of the clinical trial utilizes a modified 3+3 design with four increasing TC-210 T cell doses. At each dose, TC-210 will be tested in two separate dose levels: first without lymphodepletion and then following lymphodepleting chemotherapy. The Phase 1 portion of the clinical trial is ongoing. In the Phase 2 portion of the clinical trial, approximately 50 patients are planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort will include ten patients, except the NSCLC cohort which will include 20 patients with eight patients to receive TC-210 as single agent and 12 patients to receive TC-210 in combination with a programmed cell death 1 blocking antibody.

15:32 EDT Moderna's BARDA agreement expanded to support Phase 3 trial of COVID vaccine - Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority, or BARDA, for an additional commitment of up to $472M to support late stage clinical development including the expanded Phase 3 study of the company's mRNA vaccine candidate against COVID-19. An earlier award from BARDA for up to $483M was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration and consultations with Operation Warp Speed over the past several months, the company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the company's late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955M. The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and is expected to begin tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 microgram dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427. The company said it remains on track to be able to deliver approximately 500M doses per year, and possibly up to 1B doses per year, beginning in 2021 from the company's internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent's biologics facility in Indiana. Initial funding of $1.3B for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the company's most recent public equity offering in May 2020.

15:04 EDT PG&E provides update on equity exit financing over-allotment outcome - PG&E announced that the underwriters of its previously announced underwritten public offering of equity units, which closed on July 1, 2020, have exercised in full their over-allotment option to purchase an additional 1,454,545 prepaid forward stock purchase contracts to create 1,454,545 equity units, for total net proceeds to PG&E of approximately $119M. The underwriters' option to purchase up to an additional 42,337,263 shares of common stock expired without exercise. PG&E expects to settle the additional equity units issuance on August 3, 2020. In connection with the additional equity units issuance, PG&E expects to redeem approximately $121M of previously announced prepaid forward stock purchase contracts entered into with certain investors in order to backstop the over-allotment option granted to the underwriters in connection with the public offering of equity units. PG&E also expects to issue approximately $402M of shares of common stock to such investors in respect of all unredeemed prepaid forward stock purchase contracts at a settlement price per share of $9.50, which is approximately 42.3M shares. Pursuant to a true-up mechanism entered into in connection with PG&E's Plan of Reorganization, PG&E expects to issue an additional 748,415 shares of common stock to the PG&E Fire Victim Trust. Such shares, together with all other shares of common stock previously issued to the PG&E Fire Victim Trust, represent 22.19% of the outstanding common stock of PG&E as of the effective date of the Plan. Closing of the additional equity units issuance is subject to the satisfaction or waiver of customary closing conditions.