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NEW YORK, April 20, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held from June 2 - 6, 2017, at McCormick Place in Chicago, Illinois. Details of the data presentations are outlined below. The above abstracts will be released publicly on May 17, 2017 through the ASCO meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com. TG Therapeutics will also host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:15pm CT.  The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom.  This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review.   This event will also be broadcast via conference call.  To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Cautionary Statement Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that the pending GENUINE confirmation scans may have a negative effect on the topline data presented; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk of the willingness of the FDA to review the data for approval and any likelihood of FDA approval or disapproval and the timing of filing of a BLA for TG-1101; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, April 20, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held from June 2 - 6, 2017, at McCormick Place in Chicago, Illinois. Details of the data presentations are outlined below. The above abstracts will be released publicly on May 17, 2017 through the ASCO meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com. TG Therapeutics will also host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:15pm CT.  The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom.  This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review.   This event will also be broadcast via conference call.  To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Cautionary Statement Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that the pending GENUINE confirmation scans may have a negative effect on the topline data presented; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk of the willingness of the FDA to review the data for approval and any likelihood of FDA approval or disapproval and the timing of filing of a BLA for TG-1101; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, April 20, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held from June 2 - 6, 2017, at McCormick Place in Chicago, Illinois. Details of the data presentations are outlined below. The above abstracts will be released publicly on May 17, 2017 through the ASCO meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com. TG Therapeutics will also host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:15pm CT.  The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom.  This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review.   This event will also be broadcast via conference call.  To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Cautionary Statement Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that the pending GENUINE confirmation scans may have a negative effect on the topline data presented; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk of the willingness of the FDA to review the data for approval and any likelihood of FDA approval or disapproval and the timing of filing of a BLA for TG-1101; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, April 20, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held from June 2 - 6, 2017, at McCormick Place in Chicago, Illinois. Details of the data presentations are outlined below. The above abstracts will be released publicly on May 17, 2017 through the ASCO meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com. TG Therapeutics will also host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:15pm CT.  The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom.  This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review.   This event will also be broadcast via conference call.  To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Cautionary Statement Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that the pending GENUINE confirmation scans may have a negative effect on the topline data presented; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk of the willingness of the FDA to review the data for approval and any likelihood of FDA approval or disapproval and the timing of filing of a BLA for TG-1101; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


News Article | April 28, 2017
Site: www.acnnewswire.com

NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announces its audited consolidated results for the fiscal year ended December 31, 2016: - Expansion of Nanobiotix clinical development program - six clinical trials running in seven indications-activities in relation to the market access of NBTX3, Nanobiotix' lead product, have impacted operating expenses as planned - Increase of revenues with a $1M milestone payment from PharmaEngine - Consolidation of the cash available at EUR 21.1M strengthened by the completion of a private placement executed in March 2016 Income statement 2016 2015 ---------------------------------------------------------------------- Total revenue EUR 5,421,613 4,015,229 ---------------------------------------------------------------------- Sales 1,558,101 265,543 License 1,075,372 183,893 Other sales 99,450 66,179 Services 383,279 15,471 ---------------------------------------------------------------------- Other revenue 3,863,512 3,749,686 Subsidies 98,095 199,838 Research Tax Credit 3,703,278 3,546,035 Other 62,139 3,814 Cost of sales -- -- R&D costs (16,915,243) (13,901,898) Selling, General and Administrative (SG&A) (8,370,208) (5,963,488) (Market Access, BD & other corporate costs) Costs associated with payments in shares (1,990,855) (1,291,491) ---------------------------------------------------------------------- Core operating loss (21,854,693) (17,141,647) ---------------------------------------------------------------------- Net Interest Income (*) 64,607 138,562 ---------------------------------------------------------------------- Core pre-tax loss (21,790,086) (17,003,084) ---------------------------------------------------------------------- Tax (90,425) -- ---------------------------------------------------------------------- Net Profit & Loss (21,880,511) (17,003,084) ---------------------------------------------------------------------- * Interest Income minus Interest Expenses Financial Review Total Revenue in 2016 amounts to EUR 5.4M vs. EUR 4.0M in 2015 mainly due to: - Sales revenue from PharmaEngine amount to EUR 1,558K (vs. EUR 265,5K in 2015), with (1) EUR 184K coming from the upfront payment received in 2012 and linearized on an annual basis (2) EUR 890K (US$ 1M) coming from a milestone payment triggered by the injection of the first patient in Nanobiotix' Soft Tissue Sarcoma (STS) pivotal phase, and (3) EUR 483K for re-invoicing of services and material; and - Other revenue of EUR 3,863.5K (vs. EUR 3,749.7K in 2015) mainly generated by the Research Tax Credit (CIR) and evolving in correlation with the level of R&D activities. Total Operating expenses reach EUR 27.3M in 2016 vs. EUR 21.2M in 2015: - R&D expenses at EUR 16.9M (+EUR 3M) to support the acceleration of clinical programs (EUR 7.2M), the manufacturing activities (EUR 3.5M) and the preclinical research developments (EUR 3.9M) - SG&A costs reached EUR 8.4M (+EUR 2.4M) mainly due to the ongoing support in market access and launch readiness (EUR 2.5M), Business Development activities (EUR 1,3M) and other corporate costs, in accordance with the group development plan - Cost associated with share based payment reached EUR 2.0M in 2016 (vs. EUR 1.3M in 2015) which proceeds to an accounting evaluation (non-cash expenses). Total consolidated Headcount reached 67 FTEs in 2016 vs. 60 FTEs in 2015 in line with the development of the company. Total loss after tax amounts to EUR -21,9M (vs. EUR -17,0M FYE 2015) in line with planned operations. FYE 2016 cash available amounts to EUR 21.1M as per expectations. In April 2017 the Company has completed a private placement of EUR 25.1M providing additional resources to support the group development. This operation has been the opportunity for Nanobiotix institutional shareholders to reinforce their position and to welcome new shareholders from US and EU. Post year-end events Recommendation to continue the Phase II/III study in Soft Tissue Sarcoma- In March 2017, Nanobiotix announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the ongoing phase II/III trial of NBTXR3 in Soft Tissue Sarcoma (Act.in.sarc study), based on the safety and efficacy data. The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study - 104 patients were analyzed out of a total of 156. The completion of recruitment is planned by the end of Q2 2017 and the full data is expected by the end of 2017. Presentation of NBTXR3 preclinical data- Nanobiotix announced in March 2017, the presentation of NBTXR3 preclinical studies demonstrating 1) the antitumor efficacy of NBTXR3 in five different in vivo human cancer models and 2) the antitumor efficacy of NBTXR3 in combination with chemotherapy, in both in vitro and in vivo studies. These data have been presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C (April 1-5, 2017). Presentation of NBTXR3 clinical data- Nanobiotix announced in April 2017 the presentation of the Phase I/II data of Nanobiotix's European head and neck trial with NBTXR3 at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also announced the expansion of Nanobiotix's Immuno-Oncology program into patients focused on the objective of turning cold tumors into hot tumors and will present the first clinical data from this program mid-year. Completion of a private placement of EUR 25,1M- To reinforce its development, Nanobiotix completed a EUR 25.1 million private placement in early April 2017, corresponding to 1,596,527 new shares, which have been placed with qualified institutional investors in the United States and Europe. The order book was well covered based on strong demand from new life sciences specialist and generalist investors as well as existing shareholders reinforcing their position. This private placement will be used for i) next clinical steps of the head and neck cancer program with NBTXR3, both in the U.S. and Europe, (ii) market preparations for NBTXR3's launch on the European market, (iii) expansion of Nanobiotix's Immuno-Oncology program into patients, and (iv) general corporate purposes. Governance- Beginning of 2017, Nanobiotix appointed Alain Dostie, a senior executive from the pharmaceutical industry, as its Chief Operating Officer (COO) to oversee operations and product commercialization. Next financial press release: revenue for Q1 2017 on May 15, 2017. About NANOBIOTIX: www.nanobiotix.com Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration. NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. The Company started in 2016 a new preclinical research program in Immuno-oncology with its lead product NBTXR3, which could have the potential to bring a new dimension to cancer immunotherapies. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States. Contact: Nanobiotix Sarah Gaubert Director, Communications & Public Affairs +33 1 40 26 07 55 / Noel Kurdi Director, Investor Relations +1 646 241 4400 / Media relations France - Springbok Consultants Marina Rosoff +33 6 71 58 00 34 United States - RooneyPartners Marion Janic +1 212 223 4017 Disclaimer- This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the update of the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorite des Marches Financiers) under number D.16-0732-A01 on December 27, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.


Schilsky R.L.,American Society of Clinical Oncology
Nature Reviews Clinical Oncology | Year: 2014

Implementing personalized cancer care requires a sound understanding of cancer genomics, familiarity with the analytical methods used to study cancer, knowledge of the mechanisms of action of targeted drugs, and ways to assimilate and understand complex data sets. Perhaps the greatest challenge is obtaining the drugs predicted to be beneficial based on the genomic profile of a patient's tumour. A potential solution is creation of a national facilitated access programme and registry for off-label use of targeted anti-cancer drugs. Within such a programme, patients could receive the targeted agent matched to the genomic profile of their tumour. Physicians would receive guidance in interpretation of complex genomic tests and access to drugs. Pharmaceutical companies, payers and regulators would receive data on off-label drug and test use and clinical outcomes to inform their research and development plans and coverage decisions and to track real-world safety. Although recently launched prospective clinical trials will determine the true benefit of matching drugs to genomic alterations, the approach proposed here will facilitate delivery of personalized medicine services to participating patients while at the same time making observations that allow us to learn from each patient to inform clinical care and future research initiatives. © 2014 Macmillan Publishers Limited. All rights reserved.


Schilsky R.L.,American Society of Clinical Oncology
Clinical Cancer Research | Year: 2015

Defining clinically meaningful outcomes for clinical trials provides a foundation for assessing and improving the value of cancer care by conducting multidisciplinary research in clinical trial design, comparative effectiveness, patient preferences, health outcomes, and economics captured through analysis of data generated in clinical trials and real-world clinical practice. © 2014 American Association for Cancer Research.


Trent L.,American Society of Clinical Oncology
Journal of Oncology Practice | Year: 2014

With unsustainable and rising health care costs reaching what are regularly termed crisis levels, the United States' current fragmented and inefficient health care system is in need of reforms that will allow oncology practices to adapt to changing delivery systems that put the patient at the center of care. Oncology accounts for roughly 10% of all health care costs and is a prime target for reform-minded stakeholders, particularly in the realm of reimbursement for care. ASCO believes that successful physician payment reform will be physician led and driven. This article was developed by the ASCO Clinical Practice Committee Payment Reform Workgroup and underwent subsequent review and approval by the full Clinical Practice Committee and the ASCO Board of Directors. The following represents an abridged version of the original document, edited for length. The entire document may be found at www.asco.org/paymentreform. It includes a critical survey of the current reimbursement landscape and lays out the foundation for a comprehensive, multifaceted solution that would replace the current fee for service structure. This foundation includes quality measurements and incentives, a replacement for the current "buy and bill" system for chemotherapy drugs, value-based pathways, episodic or bundled care payments, and care coordination to decrease use of expensive resources. ASCO intends to pursue further development, modeling, and testing of these concepts and invites others in the oncology community to prepare to lead efforts to a more rational and stable payment plan that will support high-quality care for our patients. Copyright © 2014 by American Society of Clinical Oncology.


Kirkwood M.K.,American Society of Clinical Oncology
Journal of Oncology Practice | Year: 2015

The US cancer care system remains in a state of transition. In 2014, the United States made significant progress in cancer care as demonstrated by improvement in the 5-year cancer survival rate for many cancer types and a record 14.5 million cancer survivors, as well as by the availability of 10 new drugs and several new tests for the diagnosis, treatment, or management of cancer.1 At the same time, a growing demand for cancer services, turbulence in the cancer care delivery system, and growing concerns about cost of care are creating uncertainties about the capacity of the system to continue to provide high-quality care for all patients with cancer. These factors have focused attention on the need for better definitions of value and meaningful ways to assess quality. In this second annual State of Cancer Care in America report, the American Society of Clinical Oncology (ASCO) chronicles the challenges currently facing the US cancer care system. The report provides background and context to help understand what is happening today in cancer care and describes trends in the cancer care workforce and diverse practice environment that may affect cancer care in the coming years. Copyright © 2015 by American Society of Clinical Oncology.


Gilmore T.R.,American Society of Clinical Oncology
Journal of oncology practice / American Society of Clinical Oncology | Year: 2013

The Quality Oncology Practice Initiative (QOPI) Certification Program (QCP) evaluates individual outpatient oncology practice performance in areas that affect patient care and safety and builds on the American Society of Clinical Oncology (ASCO) QOPI by assessing the compliance of a practice with certification standards based on the ASCO/Oncology Nursing Society standards for safe chemotherapy administration. To become certified, a practice must attain a benchmark quality score on certification measures in QOPI and attest that it complies with 17 QCP standards. Structured on-site reviews, initially performed in randomly selected practices, became mandatory beginning in September 2011. Of 111 practices that have undergone on-site review, only two were fully concordant with all of the standards (median, 11; range, seven to 17). Most practices were subsequently able to modify practice to become QOPI certified. The QCP addresses the call from the Institute of Medicine to close the quality gap by aligning evidence-based guidelines and consensus-driven standards with requirements for oncology practices to develop and maintain structural safety components, such as policies and procedures that ensure practice performance. On-site practice evaluation is a high-impact component of the program.

Loading American Society of Clinical Oncology collaborators
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