ET - PALM BEACH, Fla., May 19, 2021 (GLOBE NEWSWIRE) -- BurgerFi International Inc. (Nasdaq: BFI, BFIIW), one of the nation’s fastest-growing premium fast-casual concepts, Fast Casuals’ #1 Brand of the year for 2021 in the Top 100 Movers and Shakers list and USA Today’s 10Best Readers’ Choice for 2021, is reporting financial results for the first quarter ended March 31, 2021. LiquidityAt March 31, 2021, the Company had $34.7 million in unrestricted cash, compared to $37.2 million at December 31, 2020. In addition, trial-in-progress (TiPs) summaries of phase 3 trials evaluating epcoritamab and the investigational antibody-drug conjugate (ADC) tisotumab vedotin in patients with cervical cancer will be presented. If there’s one thing I’m absolutely certain about, it’s that vaccinations will be a prerequisite for travel. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. Preliminary drug activity observed in both relapsed/refractory Ewing sarcoma and Advanced Solid Tumor (AST) trials Presentations include full data from dose-escalation stage of Phase 1/2 clinical trial evaluating seclidemstat in Ewing sarcoma and preliminary data from ongoing AST trial HOUSTON, May 19, 2021 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, announced today the publication by the American Society of Clinical Oncology (ASCO) of three abstracts accepted for poster presentations during the ASCO 2021 Annual Meeting. About Salarius PharmaceuticalsSalarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. The report, produced by the Global Travel Taskforce, shows how international travel could resume from 17 May 2021 at the earliest, in an accessible and affordable way. Qantas had to cut back unintentionally 30% of their workforce with many being put on job keeper government scheme, which is finishing today after which the future for the staff on job keeper is uncertain. Examples of such statements include, but are not limited to, statements relating to the following: the company’s growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma, Ewing-related sarcomas and other cancers; the status and anticipated progress and milestones of the company’s clinical trials in Advanced Solid Tumors and Ewing sarcoma; the expansion of the company’s clinical trials to include Ewing-related sarcomas; the company’s belief as to being well-capitalized through the completion of its clinical trials for seclidemstat and beyond; Salarius’ goal to maximize the potential of seclidemstat; and Salarius developing seclidemstat for several cancers with high unmet medical need. But since vaccination has begun in lots of countries around the world and coronavirus cases are growing in Europe, the US, India and South America whilst in Australia, we are doing well with a zero-rate local transmission in all states, which is due to the strict closure of our international borders and the good tracing system implemented by the state governments. As alluded to in the previous section, travel bubbles will also almost certainly call for all travellers to be vaccinated. BurgerFi is providing the following limited modeling assumptions related to its plans for 2021: The Company plans to open approximately 30 new restaurants in 2021, as well as approximately 15-20 new Ghost Kitchens.Capital expenditures are planned to be approximately $15 million for 2021, primarily to support new restaurant construction. After almost a year of severely limited or no travel, we're all itching to plan vacations for 2021. Qantas plans to restart its international flight calendar from July 2021 onwards but it is unclear if international borders will be open by then. With this purchase order, The Valens Company becomes an official supplier of cannabis products in the Province of New Brunswick. The combination of cirmtuzumab plus ibrutinib has been well tolerated, with treatment emergent adverse events and hematologic abnormalities consistent with, or slightly lower than those reported for ibrutinib alone. Employee complimentary meals are excluded from the computation. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Media Release no. 2 2 Additional paid-in capital 261,820 261,298 Accumulated deficit (10,435) (2,225)TOTAL STOCKHOLDERS' EQUITY 251,387 259,075 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 284,521 $ 289,116 BurgerFi International Inc., and SubsidiariesConsolidated Statements of Operations As Opes Acquisition Corp.’s historical financial information is excluded from the Predecessor financial information, the business, and thus financial results, of the Successor and Predecessor entities, are expected to be largely consistent, excluding the impact on certain financial statement line items that were impacted by the Business Combination. About DARZALEX®(daratumumab)DARZALEX® (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. I saw a handful of hotels offering special ‘air travel bubble’ packages, with lower prices than their public rates. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates, statements about the Company’s balance sheet position, and statements related to the goals, plans and expectations for the Company’s ongoing clinical studies. DARZALEX® and DARZALEX FASPRO® are trademarks of Janssen Pharmaceutica NV. Got $500? With his extensive leadership experience in field and corporate marketing, he is uniquely qualified to collaborate with all stakeholders to help us unlock our brand’s potential and drive growth. We look forward to the continuing development of cirmtuzumab,” said Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial and the first author on the 2021 ASCO poster presentation. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. International Travel May Resume In 2nd Half Of 2021. Corporate-owned restaurant sales growth refers to the percentage change is sales at all corporate-owned restaurants in one period from the same period in the prior year. Key findings include data showing that seclidemstat has a manageable safety profile with no significant hematological toxicities, which can be a limitation for other LSD1 inhibitors. Even if you’re able to travel, you may find yourself restricted in terms of movement upon arrival. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. Enrollment is ongoing and the study is intended to support global registrations. These policies cover overseas medical expenses and emergency medical evacuations arising from COVID-19, and it’s surely only a matter of time before other providers follow suit. appeared first on SingSaver Blog - We Compare, You Save. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. Patients had high-risk factors and were heavily pre-treated at study entry, 70% with a high Ki-67 proliferative index (≥30%), 15% with intermediate/high sMIPI prognostic score, and a median of two systemic prior therapies (range 1-5). The airline industry for one is starting to make small preparations for summer. Heathrow immigration queues ‘are like a petri dish’ as international travel resumes Jen Mills Monday 17 May 2021 10:41 pm Share this … All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. More information is available at https://oncternal.com. Tweet; Facebook; Mail; International travel could resume in October once the Australian adult population has been vaccinated against COVID-19. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. A replay will be available after the completion of the call on the Investors and Media section of our website. DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.6 Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in our Annual Report on Form 10-K for the year ended December 31, 2020 and those discussed in other documents we file with the Securities and Exchange Commission. A restaurant which is closed permanently, such as upon termination of the lease, or other permanent closure, is immediately removed from the same store sales computation. https://www.cnn.com/travel/article/international-trips-2021-pandemic Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced updated data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC) who received prior platinum-based chemotherapy. However, the controversial fact looks more positive than that for international travel to commence sooner, beginning with the New Zealand two-way bubble which starts on 18 April and I am pretty optimistic that toward the end of 2021 there will be more travel bubble in place and others that will impose the conditions that travellers are fully vaccinated against Covid-19. However, services will not be operational on May 18, 23, and 30. We will remove this and make the necessary changes. FOTIVDA, AVEO’s oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), is approved by the U.S. Food and Drug Administration for the treatment of adults with relapsed or refractory advanced RCC following two or more prior systemic therapies. Even after 75% of the population is fully vaccinated the re-start will be slow and trust in international travel will take years to rehabilitate. MAbs. This was mentioned by the Australian authorities when discussing a travel bubble between Singapore and Australia, and was recently announced as a requirement for Hong Kong residents intending to travel to Singapore under the existing travel bubble (which all but guarantees it’ll be a requirement for Singaporeans too). If you've got more than $1,000 in your checking account, you need to make these moves as fast as possible. So, the big open question remains “will international travel commence in 2021?” I think the answer is probably no, except for a few tightly managed travel bubbles… The presentations will include clinical data evaluating the investigational bispecific antibody epcoritamab (DuoBody®-CD3xCD20) in patients with Non-Hodgkin Lymphoma (NHL), several studies evaluating Janssen Biotech, Inc. (Janssen)’s daratumumab and the subcutaneous formulation of daratumumab, and multiple abstracts evaluating Janssen’s bispecific program, which leverages Genmab’s DuoBody technology platform. However, there is the bright perspective of advancement with the vaccination and potential travel bubbles with countries like New Zealand, Singapore, Pacific Islands, and some other Asian countries that may start before the end of this year, there is a good possibility that most of their staff will recommence their fulltime position soon. 05CVR no. That made sense, as the initial travel bubble called for just one flight per day in each direction. About CirmtuzumabCirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is in clinical development and has not been approved by the FDA for any indication. If it’s any consolation, these shouldn’t hamper your vacation plans unless you’re the type of traveller who really goes off the beaten path. What Should You Expect? Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a collaboration to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. We will also discuss in more detail the preliminary drug activity data observed in FET-rearranged sarcoma patients from our Advanced Solid Tumor (AST) trial that supports our continued development of seclidemstat as single-agent therapy in select sarcomas.” The full abstracts are available on ASCO’s 2021 Meeting Library. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the clinical development of zenocutuzumab, future clinical trial results, clinical activity and safety profile of Zeno in the on-going eNRGy trial and EAP, including in previously treated pancreatic cancer, and each cohort of the eNRGy trial. Singapore alleged nickel hoaxer gets new charges as victims grow, Bitcoin tumbles to $30,000 after China warning, Musk remarks, 5 REITs That Remain Unaffected by the Return to Phase 2, Singapore broker up 544% in a year eyes China for more gains, Capitol Police Officers: 'Inconceivable' To 'Downplay' Capitol Riot, SQZ Biotechnologies to Present First Clinical Data at the American Society of Clinical Oncology Annual Meeting from Ongoing Phase 1 Study in Patients with Advanced or Metastatic HPV+ Tumors, AVEO Oncology Announces Presentation of Long-Term Efficacy Follow Up, Additional Tolerability Data from the Phase 3 TIVO-3 Study of FOTIVDA® (tivozanib) in Relapsed or Refractory Renal Cell Carcinoma, Style, stat! A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,8,9,10,11 Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Vaccines will be key to this, so it goes without saying that anyone who wishes to travel should get vaccinated as soon as possible. ASCO 2021 will take place June 4-8, 2021 via a virtual platform. “Corporate-Owned Restaurant Sales” represent the sales generated by corporate-owned restaurants. Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial innovaTV 301, versus investigator’s choice of chemotherapy in recurrent or metastatic cervical cancer. Here’s what’s coming. Click here for details. The Company plans to present updated data from the randomized cohort (Part 3) in the second half of 2021. “We are excited to have the opportunity to present clinical data regarding safety, dosing, and initial efficacy signals for seclidemstat during ASCO 2021,” said David Arthur, President and Chief Executive of Salarius Pharmaceuticals. An oral presentation containing an updated interim analysis with a data cutoff date of April 13, 2021 will be presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2021 ASCO Annual Meeting on Friday, June 4, 2021 from 11:00 AM -2:00 PM ET. What Should You Expect? While the past 12 months have wreaked unprecedented havoc on the travel industry worldwide, I’m cautiously optimistic about some form of leisure travel resuming in the second half of this year. For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn. The increase in travellers may cause an increase in hotel rates, but again it really depends on whether the influx of visitors is sufficient to put pressure on existing room supply. BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. When travel does resume, some have voiced concerns that airlines and hotels might hike their prices to take advantage of early adopters. To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube. 2020 Feb;52: 102625. doi: 10.1016/j.ebiom.2019.102625. Toll-free replay number: 1-855-859-2056International replay number: 1-404-537-3406Replay ID: 2977159 Key Metrics DefinitionsThe following definitions apply to the terms listed below: “Systemwide Restaurant Sales” is presented as informational data in order to understand the aggregation of, franchised stores sales, ghost kitchen and corporate-owned stores sales performance. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, today announced the presentation of additional data from the Phase 3 TIVO-3 study comparing FOTIVDA® (tivozanib) to sorafenib in relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” and similar terms or expressions or the negative thereof. “DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing.” EBioMedicine. The Valens Company Inc. (TSX: VLNS) (OTCQX: VLNCF) (the "Company," "The Valens Company" or "Valens"), a leading manufacturer of cannabis products, today announced that it has received its first purchase order for Valens-manufactured products from Cannabis NB, a subsidiary of New Brunswick Liquor Corporation (ANBL) and the only legal recreational cannabis retailer in New Brunswick. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. About Advaxis, Inc.Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. We remain in active dialogue with the US FDA concerning potential pivotal study designs and the potential pathway to seeking regulatory approval.” The results that will be presented in poster form at ASCO 2021 include an increased population of 26 patients with relapsed/refractory MCL enrolled in the dose-finding and dose-expansion cohorts of the CIRLL clinical trial (Part 1 + Part 2), of whom 18 were evaluable for efficacy as of the April 16, 2021 data cut-off date. “Same Store Sales” is used to evaluate the performance of our store base, which excludes the impact of new stores and closed stores, in both periods under comparison. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. PMID: 31981978; PMCID: PMC6992935.2Rafiq, Sarwish, et al. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. - Total Revenue Increased 32% Year-Over-Year in the First Quarter, Same Store Sales Up 11% in Corporate Owned Restaurants and Systemwide Sales Up 19% - - Digital Channel Sales Increase 98% Year-Over-Year in the First Quarter - - Company to Hold Conference Call Tomorrow, May 20th, at 8:30 a.m. At the onset of the pandemic, many travel insurance providers moved quickly to exclude COVID-19 coverage from their policies. A restaurant which is temporarily closed (including as a result of the Covid-19 pandemic), is included in the same store sales computation. Read these next:Best Travel Insurance In Singapore (2021)5 Ways To Score Discounts On Your Next Cruise To NowhereUltimate Guide To Digital Multi-Currency Accounts (2021)Is It Worth Paying For Airport Lounge Access?Credit Card Benefits You Didn’t Know You Had. announced that it will resume international travel operations in July 2021. Forward-looking statements include statements regarding Oncternal’s belief that the interim results support further development of cirmtuzumab and Oncternal’s expectation regarding the timing and results of any discussions with the FDA, including with respect to potential pivotal study designs. “The translational results from the study provide interesting insights on the potential mechanism of action by which the addition of ADXS-503 may may be effective in this patient population.” Ken Berlin, Chief Executive Officer of Advaxis, said, “We are encouraged by these updated results which continue to support the potential of ADXS-503 to enhance and/or restore sensitivity to checkpoint inhibitors. About BurgerFi International (Nasdaq: BFI, BFIIW)Established in 2011, BurgerFi is among the nation's fastest-growing better burger concepts with approximately 120 BurgerFi restaurants domestically and internationally. G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. The enrolled patients also had negative prognostic features, making the results even more compelling. Overseas Adventure Travel (O.A.T.) All statements, other than statements of historical facts, included in this press release are forward-looking statements. BurgerFi repaid and then terminated its revolving credit line in January 2021. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Dr. Andrew Joe, Chief Medical Officer at Merus stated, “We continue to be encouraged by the observed clinical activity and safety profile of Zeno in the ongoing eNRGy trial, especially in previously treated patients with pancreatic cancer. About Non-GAAP Financial MeasuresTo supplement our consolidated financial statements, which are prepared and presented in accordance with GAAP, we use the measure Adjusted EBITDA. Will international travel in 2021 recommence? “Our success demonstrates the continued momentum from the COVID-19 pandemic recovery, supported by growth in our number of locations, strong results from our digital channel, the execution of our marketing strategy and successful limited time offerings. Insurance underwriters have realised that people are unwilling to travel if they don’t receive explicit assurances about COVID-19, and if no one travels, no one buys travel insurance. We believe that this non-GAAP financial measure provides meaningful supplemental information regarding our performance and liquidity by excluding certain items that may not be indicative of our recurring core business operating results.
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